Nordimet
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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

  



 

2 

 
1 NAME OF THE MEDICINAL PRODUCT 
 
Nordimet 7.5 mg solution for injection in pre-filled pen  
Nordimet 10 mg solution for injection in pre-filled pen  
Nordimet 12.5 mg solution for injection in pre-filled pen  
Nordimet 15 mg solution for injection in pre-filled pen  
Nordimet 17.5 mg solution for injection in pre-filled pen  
Nordimet 20 mg solution for injection in pre-filled pen  
Nordimet 22.5 mg solution for injection in pre-filled pen  
Nordimet 25 mg solution for injection in pre-filled pen 
 
Nordimet 7.5 mg solution for injection in pre-filled syringe  
Nordimet 10 mg solution for injection in pre-filled syringe 
Nordimet 12.5 mg solution for injection in pre-filled syringe 
Nordimet 15 mg solution for injection in pre-filled syringe 
Nordimet 17.5 mg solution for injection in pre-filled syringe 
Nordimet 20 mg solution for injection in pre-filled syringe 
Nordimet 22.5 mg solution for injection in pre-filled syringe 
Nordimet 25 mg solution for injection in pre-filled syringe 
 
 
2 QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of solution contains 25 mg of methotrexate. 

 

Nordimet 7.5 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 7.5 mg methotrexate in 0.3 mL 
 
Nordimet 10 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 10 mg methotrexate in 0.4 mL 
 
Nordimet 12.5 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 12.5 mg methotrexate in 0.5 mL 
 
Nordimet 15 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 15 mg methotrexate in 0.6 mL 
 
Nordimet 17.5 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 17.5 mg methotrexate in 0.7 mL 
 
Nordimet 20 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 20 mg methotrexate in 0.8 mL 
 
Nordimet 22.5 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 22.5 mg methotrexate in 0.9 mL 
 
Nordimet 25 mg solution for injection in pre-filled pen  
Each pre-filled pen contains 25 mg methotrexate in 1.0 mL 
 
Nordimet 7.5 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 7.5 mg methotrexate in 0.3 mL 
 
Nordimet 10 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 10 mg methotrexate in 0.4 mL 
 



 

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Nordimet 12.5 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 12.5 mg methotrexate in 0.5 mL 
 
Nordimet 15 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 15 mg methotrexate in 0.6 mL 
 
Nordimet 17.5 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 17.5 mg methotrexate in 0.7 mL 
 
Nordimet 20 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 20 mg methotrexate in 0.8 mL 
 
Nordimet 22.5 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 22.5 mg methotrexate in 0.9 mL 
 
Nordimet 25 mg solution for injection in pre-filled syringe 
Each pre-filled syringe contains 25 mg methotrexate in 1.0 mL 
 
 
For the full list of excipients, see section 6.1. 
 
 
3 PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg. 
 
 
4 CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Nordimet is indicated for the treatment of 
-  active rheumatoid arthritis in adult patients, 
- polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to  
 nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,  
-  severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of 

therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe 
psoriatic arthritis in adult patients. 

 
4.2 Posology and method of administration 
 
Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and 

a full understanding of the risks of methotrexate therapy. 

 
Patients must be educated and trained in the proper injection technique when self-administering 

methotrexate. The first injection of Nordimet should be performed under direct medical supervision. 

  



 

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Important warning about the dosage of Nordimet 

In the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis,psoriasis and psoriatic 

arthritis requiring dosing once a week. Nordimet must only be used once a week. Dosage errors in 

the use of Nordimet can result in serious adverse reactions, including death. Please read this section 

of the summary of product characteristics very carefully. 

 

When switching from oral use to subcutaneous use, a reduction in the dose may be required, due to 

the variable bioavailability of methotrexate after oral administration. 
 
Folic acid or folinic acid supplementation may be considered in accordance with current therapeutic 
guidelines. 

 

The overall duration of treatment is decided by the doctor. 
 
Posology 
 
Dosage in adult patients with rheumatoid arthritis 
The recommended initial dose is 7.5 mg of methotrexate once weekly, administered 
subcutaneously. Depending on the individual activity of the disease and patient tolerability, the 

initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. However, 

doses exceeding 20 mg per week can be associated with significant increase in toxicity, especially 
bone marrow suppression. Response to treatment can be expected after approximately 4-8 weeks. 

Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the 

lowest possible effective maintenance dose. Symptoms may return after treatment discontinuation. 
 
Methotrexate treatment of rheumatoid arthritis represents long-term treatment. 
 
Dosage in patients with psoriasis vulgaris and psoriatic arthritis 
It is recommended that a test dose of 5-10 mg be administered subcutaneously one week prior to 

initiation of therapy, in order to detect idiosyncratic adverse effects. The recommended initial dose 
is 7.5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in 

general, exceed a weekly dose of 25 mg of methotrexate. Doses exceeding 20 mg per week can be 

associated with significant increase in toxicity, especially bone marrow suppression. Response to 
treatment can generally be expected after approximately 2-6 weeks. Depending on the clinical 

picture and the changes of laboratory parameters, the therapy is then continued or discontinued. 
 
Once the desired therapeutic result has been achieved, dose should be reduced gradually to the 
lowest possible effective maintenance dose. In a few exceptional cases a higher dose than 25 mg 

might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of 

methotrexate as toxicity will markedly increase. 
 
Methotrexate treatment of severe psoriasis vulgaris and psoriatic arthritis represents long-term 
treatment. 
 
Special populations 
 
Elderly 
Dose reduction should be considered in elderly patients due to reduced liver and kidney function as 

well as lower folate reserves which occur with increased age (see sections 4.4, 4.5, 4.8 or 5.2) 
 

  



 

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Renal impairment 
Methotrexate should be used with caution in patients with impaired renal function (see sections 4.3 
and 4.4). The dose should be adjusted as follows: 
 

Creatinine clearance (ml/min) Dose 

≥ 60 100 % 

30-59 50 % 

< 30 Nordimet must not be used 

 
Patients with hepatic impairment 
Methotrexate should be administered with great caution, if at all, to patients with significant current 

or previous liver disease, especially when caused by alcohol. Methotrexate is contraindicated if 

bilirubin values are > 5 mg/dl (85.5 µmol/L) (see section 4.3). 
 
Use in patient with a third distribution space (pleural effusions, ascitis) 
As the half-life of methotrexate can be prolonged to 4 times the normal length in patients who 

possess a third distribution space, dose reduction or, in some cases, discontinuation of methotrexate 

administration may be required (see sections 5.2 and 4.4). 
 
Paediatric population 

 

Dosage in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic 
arthritis 
The recommended dose is 10-15 mg/m² body surface area (BSA) per week.  

In therapy-refractory cases the weekly dose may be increased up to 20 mg/m² BSA per week. 
However, an increased monitoring frequency is indicated if the dose is increased. Parenteral 

administration is limited to subcutaneous injection. Patients with JIA should always be referred to a 

rheumatology unit specializing in the treatment of children/adolescents. 
 
The safety and efficacy of Nordimet in children < 3 years of age have not been established (see 
section 4.4). No data available. 
 
Method of administration 
It must be explicitly pointed out to the patient that Nordimet is applied only once a week. It is 
recommended to specify a certain day of the week as “day for injection”.  
 
Nordimet is for subcutaneous use (see section 6.6.).  
 
The medicinal product is for single use only. The solution is to be visually inspected prior to use. 
Only clear solutions practically free from particles should be used. 
Any contact of methotrexate with skin and mucosa is to be avoided. In case of contamination, the 

affected parts are to be rinsed immediately with plenty of water (see section 6.6). 
 
Please refer to the patient information leaflet for instructions on how to use the pre-filled pen or pre-

filled syringe. 
 
  



 

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4.3 Contraindications 
 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Severe hepatic impairment, if serum if bilirubin is > 5 mg/dl (85.5 µmol/l) (see section 4.2). 
- Alcohol abuse. 
- Severe renal impairment (creatinine clearance less than 30 ml/min) (see sections 4.2 and 4.4). 
- Pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, 

thrombocytopenia or significant anaemia. 
- Immunodeficiency. 
- Serious, acute or chronic infections such as tuberculosis and HIV. 
- Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease. 
- Pregnancy and breast-feeding (see section 4.6). 
- Concurrent vaccination with live vaccines. 

 
4.4 Special warnings and precautions for use 
 
Patients must be clearly advised that the therapy is to be administered once a week, and not every 

day. Incorrect administration of methotrexate can lead to severe, including potentially lethal adverse 
reactions. Healthcare professionals and patients should be clearly instructed. 
 
Patients receiving therapy should be appropriately monitored, so that signs of possible toxic effects 

or adverse reactions can be recognised and assessed without delay. Hence, methotrexate should be 
only administered by, or under the supervision of, doctors whose knowledge and experience include 

the use of antimetabolite therapy. 
Due to the risk of severe or even fatal toxic reactions, patients should be thoroughly informed by the 

doctor about the risks (including early signs and symptoms of toxicity) and recommended safety 
measures. They are to be informed about the necessity to immediately consult the physician if 

symptoms of intoxication occur, as well as about the subsequent necessary monitoring of symptoms 

of intoxication (including regular laboratory tests). 
Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone 

marrow suppression. 
 
Skin and mucosal contact with methotrexate is to be avoided. In the case of contamination, the parts 

concerned should be rinsed with plenty of water. 

 
Fertility and reproduction 

 
Fertility 

Methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea in 

humans, during and for a short period after cessation of therapy, and to cause impaired fertility, 
affecting spermatogenesis and oogenesis during the period of its administration - effects that appear 

to be reversible on discontinuing therapy.  

 
Teratogenicity – Reproductive risk 

Methotrexate causes embryotoxicity, abortion and foetal defects in humans. Therefore, the possible 

risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed 

with female patients of childbearing potential (see section 4.6). The absence of pregnancy must be 
confirmed before Nordimet is used. If women of a sexually mature age are treated, effective 

contraception must be performed during treatment and for at least six months after.  

 
For contraception advice for men, see section 4.6. 

 
  



 

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Recommended examinations and safety measures 
 
Before initiating therapy or upon resuming therapy after a rest period 
Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum 

albumin, chest X-ray and renal function tests must be conducted. If clinically indicated, exclude 

tuberculosis and hepatitis. 
 
During therapy 

The tests below must be conducted every week during  the first two weeks, then every two weeks 

for the next month; afterwards, depending on leukocyte count and stability of the patient, at least 
once monthly during the next six months and at least every three months thereafter. 
Increased monitoring frequency should also be considered when increasing the dose. Particularly 

elderly patients should be examined for early signs of toxicity in short intervals. 
 
- Examination of the oral cavity and throat for mucosal changes. 

 
- Complete blood count with differential blood count and platelets. 

Haematopoietic suppression induced by methotrexate may occur abruptly and at apparently 

safe doses. In the event of any significant drop in leukocytes or platelets, treatment must be 

discontinued immediately and appropriate supportive therapy instituted. Patients must be 
instructed to report all signs and symptoms suggestive of infection. In patients concomitantly 

taking haematotoxic medicinal products (e.g. leflunomide), the blood count and platelets 

should be closely monitored.  

 
- Liver function tests. 

Particular attention should be paid to the onset of liver toxicity. Treatment should not be 

initiated or should be discontinued if there are any abnormalities in liver function tests or 

liver biopsies, or if these develop during therapy. Such abnormalities should return to normal 
within two weeks; after which, treatment may be resumed at the discretion of the doctor. 

 
Temporary increases in transaminases to two or three times the upper limit of normal have 

been reported in patients at a frequency of 13-20 %. Persistent anomalies of liver-related 

enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity. 
 

Enzyme diagnostics does not allow any reliable prediction of the development of a 

morphologically detectable hepatotoxicity, i.e. even in case of normal transaminases, hepatic 

fibrosis only histologically identifiable or, more rarely, also hepatocirrhosis may be present. 
 

In rheumatological indications, there is no evidence to support use of liver biopsies in 

monitoring hepatotoxicity. For psoriasis patients the need of a liver biopsy prior to and during 

therapy is controversial. Further research is needed to establish whether serial liver chemistry 
tests or propeptide of type III collagen can detect hepatotoxicity sufficiently. This assessment 

should differentiate between patients without any risk factors and patients with risk factors, 

e.g. excessive prior alcohol consumption, persistent elevation of liver enzymes, history of 
liver disease, family history of hereditary liver disorders, diabetes mellitus, obesity and 

previous contact with hepatotoxic medicinal products or chemicals and prolonged 

methotrexate treatment or cumulative doses of 1.5 g or more. 
 

In the event of a constant increase in liver-related enzymes, consideration should be given to 
reducing the dose or discontinuing therapy. 

 
Due to the potentially toxic effect on the liver, additional hepatotoxic medicinal products 

should not be given during treatment with methotrexate unless clearly necessary and alcohol 
consumption should be avoided or greatly reduced (see section 4.5). Closer monitoring of 

liver enzymes should be undertaken in patients concomitantly taking other hepatotoxic 

medicinal products (e.g. leflunomide). 
 



 

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Increased caution should generally be exercised in patients with insulin-dependent diabetes 

mellitus, as during methotrexate therapy hepatocirrhosis developed in isolated cases without 
intermittent increase in transaminases. 

 
- Renal function should be monitored via renal function tests and urinanalysis (see sections 4.2 

and 4.3). If serum creatinine is increased, the dose should be reduced. As methotrexate is 
predominantly excreted via the renal route, increased concentrations can be expected in cases 

of renal impairment, which may result in severe adverse reactions. In cases of possible renal 

impairment (e.g. in elderly patients), closer monitoring is required. This particularly applies 

to the co-administration of medicinal products which affect methotrexate excretion, cause 
kidney damage (e.g. NSAIDs) or can potentially lead to haematopoietic disorders. In patients 

with impaired renal function, concomitant administration of NSAIDs is not recommended. 

Dehydration may also potentiate the toxicity of methotrexate. 
 
- Assessment of respiratory system. 

Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung 

function test. Acute or chronic interstitial pneumonitis, often associated with blood 

eosinophilia, may occur and deaths have been reported. Symptoms typically include 
dyspnoea, cough (especially a dry non-productive cough), thoracic pain and fever for which 

patients should be monitored at each follow-up visit. Patients should be informed of the risk 

of pneumonitis and advised to contact their doctor immediately should they develop 
persistent cough or dyspnoea.  

 

In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in 

rheumatologic and related indications. This event may also be associated with vasculitis and 
other comorbidities. Prompt investigations should be considered when pulmonary alveolar 

haemorrhage is suspected to confirm the diagnosis. 
 
 Methotrexate should be discontinued in patients with pulmonary symptoms and a thorough 

investigation (including chest x-ray) should be made to exclude infection and tumours. If 

methotrexate induced lung disease is suspected, treatment with corticosteroids should be 

initiated and treatment with methotrexate should not be restarted. 
 

Pulmonary diseases induced by methotrexate were not always completely reversible. 
 

Pulmonary symptoms require a quick diagnosis and discontinuation of methotrexate therapy. 

Pulmonary diseases induced by methotrexate, like pneumonitis, can occur acutely at any time 
of therapy, they were not always completely reversible and have been reported already at all 

doses (inclusive low doses of 7.5 mg/week). 

 

During methotrexate therapy, opportunistic infection can occur including pneumocystis 
jiroveci pneumonia, which may take a lethal course. If a patient presents with pulmonary 

symptoms, the possibility of pneumocystis jiroveci pneumonia should be taken into account. 
 

Special caution is required in patients with impaired pulmonary function. 
 
- Methotrexate may, due to its effect on the immune system, impair the response to 

vaccinations and interfere with the result of immunological tests. Concurrent vaccination 

using live vaccines must not be carried out. 

 
Particular caution should be exercised in the presence of inactive, chronic infections (e.g. 

herpes zoster, tuberculosis, hepatitis B or C) due to possible activation. 
 
  



 

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Malignant lymphomas may occur in patients receiving low-dose methotrexate; in which case, 

methotrexate must be discontinued. If lymphomas should fail to regress spontaneously, initiation of 
cytotoxic therapy is required. 
In patients with pathological accumulation of liquid in body cavities (“third space”), such as ascites 

or pleural effusions, the plasma elimination half-life of methotrexate is prolonged. Pleural effusions 
and ascites should be drained prior to initiation of methotrexate treatment. 
 
Conditions leading to dehydration such as emesis, diarrhoea or stomatitis, can increase the toxicity 

of methotrexate due to elevated levels of the active substance. In these cases use of methotrexate 

should be interrupted until the symptoms cease. 
 
Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may 

decrease the effectiveness of methotrexate. 
  
Radiation induced dermatitis and sun-burn can reappear under methotrexate therapy 
(recall-reaction). Psoriatic lesions can exacerbate during UV-irradiation and simultaneous 

administration of methotrexate. 
 
Concomitant administration of folate antagonists such as trimethoprim /sulphamethoxazole has 
been reported to cause an acute megaloblastic pancytopenia in rare instances. 
 
Encephalopathy / Leukoencephalopathy have been reported in oncologic patients receiving 

methotrexate therapy and cannot be excluded for methotrexate therapy in non-oncologic 
indications. 

 

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 
“sodium-free“. 

 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In animal experiments non-steroidal anti-inflammatory drugs (NSAIDs) including salicylic acid 
caused reduction of tubular methotrexate secretion and consequently increased its toxic effects. 

However, in clinical studies, where NSAIDs and salicylic acid were given as concomitant medicinal 

products to patients with rheumatoid arthritis, no increase of adverse reactions was observed. 

Treatment of rheumatoid arthritis with such drugs can be continued during low-dose methotrexate 
therapy but only under close medical supervision. 
Regular alcohol consumption and administration of additional hepatotoxic medicinal products 

increase the probability of hepatotoxic effects of methotrexate. 
Patients taking potentially hepatotoxic and haematoxic medicinal products during methotrexate 

therapy (e.g. leflunomide, azathioprine, sulphasalazine, and retinoids) should be closely monitored 

for possibly increased hepatotoxicity. Alcohol consumption must be avoided during treatment with 

methotrexate. 
 
Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the 

probability of severe haematoxic effects of methotrexate. 
 
One should be aware of pharmacokinetic interactions between methotrexate, anticonvulsant 
medicinal products (reduced methotrexate blood levels), and 5-fluorouracil (increased t½ of 

5--fluorouracil).  

Salicylates, phenylbutazone, phenytoin, barbiturates, tranquillisers, oral contraceptives, 
tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid displace 

methotrexate from serum albumin binding and thus increase bioavailability (indirect dose increase).  

Probenecid and mild organic acids may also reduce tubular methotrexate secretion, and thus cause 
indirect dose elevations, too. 
 

 

  



 

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Antibiotics, like penicillin, glycopeptides, sulfonamides, ciprofloxacin and cefalotin can, in 

individual cases, reduce the renal clearance of methotrexate, so that increased serum concentrations 
of methotrexate with simultaneous haematological and gastro-intestinal toxicity may occur. 
 
Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum 

antibiotics may reduce intestinal methotrexate absorption or interfere with the enterohepatic 
circulation, due to inhibition of the intestinal flora or suppression of bacterial metabolism. 
 
Under (pre-)treatment with substances that may have adverse effects on the bone marrow (e.g. 

sulphonamides, trimethoprim-sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility 
of marked haematopoietic disorders should be considered. 
 
Co-administration of medicinal products which cause folate deficiency (e.g. sulphonamides, 

trimethoprim-sulphamethoxazole) can lead to increased methotrexate toxicity. Particular caution 

should therefore also be exercised in the presence of existing folic acid deficiency. 
On the other hand, concomitant administration of folinic acid containing drugs or of vitamin 

preparations, which contain folic acid or derivatives, may impair methotrexate efficacy. 
 
A rise in the toxicity of methotrexate is generally not anticipated when methotrexate is used 
concomitantly with other antirheumatic agents (e.g. gold compounds, penicillamine, 

hydroxychloroquine, sulfasalazine, azathioprine, cyclosporin). 
 
Though the combination of methotrexate and sulfasalazine may enhance methotrexate efficacy by 
sulfasalazine related inhibition of folic acid synthesis, and thus may lead to an increased risk of 

adverse reactions, these were only observed in single patients within several trials. 
 
Co-administration of proton-pump inhibitors such as omeprazole or pantoprazole can lead to 
interactions: concomitant administration of methotrexate and omeprazole has led to a delay in the 

renal elimination of methotrexate. In combination with pantoprazole, inhibited renal elimination of 

the 7-hydroxymethotrexate metabolite, with myalgia and shivering, was reported in one case. 
 
Methotrexate may reduce theophylline clearance. Therefore, theophylline blood levels should be 

monitored under concomitant methotrexate administration. 
 
Excessive consumption of beverages containing caffeine or theophylline (coffee, soft drinks 

containing caffeine, black tea) should be avoided during methotrexate therapy since the efficacy of 
methotrexate may be reduced due to possible interaction between methotrexate and 

methylxanthines at adenosine receptors. 
The combined use of methotrexate and leflunomide may increase the risk for pancytopenia. 
Methotrexate leads to increased plasma levels of mercaptopurines. Therefore, the combination of 

these may require dose adjustment. 
 
Particularly in the case of orthopaedic surgery where susceptibility to infection is high, a 
combination of methotrexate with immune-modulating medicinal products must be used with 

caution. 

 

The use of nitrous oxide potentiates the effect of methotrexate on folate metabolism, yielding 
increased toxicity such as severe unpredictable myelosuppression and stomatitis. Whilst this effect 

can be reduced by administering calcium folinate, the concomitant use of nitrous oxide and 

methotrexate should be avoided. 
 
Colestyramine can increase the non-renal elimination of methotrexate by interrupting the 

enterohepatic circulation. Delayed methotrexate clearance should be considered in combination 

with other cytostatic medicinal products. Radiotherapy during use of methotrexate can increase the 
risk of soft tissue or bone necrosis.  
 
  



 

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On account of its possible effect on the immune system, methotrexate can falsify vaccinal and test 

results (immunological procedures to record the immune reaction). During methotrexate therapy 
concurrent vaccination with live vaccines must not be carried out (see sections 4.3 and 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential / contraception in females 
Women must not get pregnant during methotrexate therapy, and effective contraception must be 

used during treatment with methotrexate and at least 6 months thereafter (see section 4.4). Prior to 

initiating therapy, women of childbearing potential must be informed of the risk of malformations 
associated with methotrexate and any existing pregnancy must be excluded with certainty by taking 

appropriate measures, e.g. a pregnancy test. During treatment pregnancy tests should be repeated as 

clinically required (e.g. after any gap of contraception). Female patients of reproductive potential 

must be counselled regarding pregnancy prevention and planning. 
 
Contraception in males 

It is not known if methotrexate is present in semen. Methotrexate has been shown to be genotoxic in 

animal studies, such that the risk of genotoxic effects on sperm cells cannot completely be 
excluded. Limited clinical evidence does not indicate an increased risk of malformations or 

miscarriage following paternal exposure to low-dose methotrexate (less than 30 mg/week). For 

higher doses, there is insufficient data to estimate the risks of malformations or miscarriage 
following paternal exposure. 

As precautionary measures, sexually active male patients or their female partners are recommended 

to use reliable contraception during treatment of the male patient and for at least 6 months after 

cessation of methotrexate. Men should not donate semen during therapy or for 6 months following 
discontinuation of methotrexate. 

 

Pregnancy 
Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3). 

If pregnancy occurs during treatment with methotrexate and up to six months thereafter, medical 

advice should be given regarding the risk of harmful effects on the child associated with treatment 

and ultrasonography examinations should be performed to confirm normal foetal development. 
In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester 

(see section 5.3). Methotrexate has been shown to have a teratogenic effect in humans; it has been 

reported to cause foetal death and/or congenital abnormalities (e.g. craniofacial, cardiovascular, 
central nervous system and extremity-related).  

 

Methotrexate is a powerful human teratogen, with an increased risk of spontaneous abortions, 
intrauterine growth restriction and congenital malformations in case of exposure during pregnancy.  

 

• Spontaneous abortions have been reported in 42.5% of pregnant women exposed to low-
dose methotrexate treatment (less than 30 mg/week), compared to a reported rate of 22.5% 
in disease-matched patients treated with drugs other than methotrexate. 

 

• Major birth defects occurred in 6.6% of live births in women exposed to low-dose 
methotrexate treatment (less than 30 mg/week) during pregnancy, compared to 

approximately 4% of live births in in disease-matched patients treated with drugs other than 

methotrexate. 
Insufficient data is available for methotrexate exposure during pregnancy higher than 30 mg/week, 

but higher rates of spontaneous abortions and congenital malformations are expected. 

 

When methotrexate was discontinued prior to conception, normal pregnancies have been reported.  

 
  



 

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Breast-feeding 
As methotrexate is transferred into human milk and may cause toxicity in breast-feeding children, 
treatment is contraindicated during breast-feeding (see section 4.3). If use of methotrexate during 

the breast-feeding period should become necessary, breast-feeding is to be stopped prior to 

treatment. 
 
Fertility 
Methotrexate affects spermatogenesis and oogenesis and may decrease fertility. In humans, 

methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea. 

These effects appear to be reversible after discontinuation of therapy in most cases. 
 
4.7 Effects on ability to drive and use machines 
 
Nordimet has minor influence on the ability to drive and use machines. Central nervous system 

(CNS) symptoms, such as fatigue and confusion, can occur during treatment.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary 
toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock 

and Stevens-Johnson syndrome. 
 
Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal 

disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver 

function tests (e.g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase 
(ASAT), bilirubin, alkaline phosphatase). Other frequently (common) occurring adverse reactions 

are leukopenia, anaemia, thrombopenia, headache, tiredness, drowsiness, pneumonia, interstitial 

alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhoea, exanthema, 

erythema and pruritus. 
 
The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal 

disorders. 
 
List of adverse reactions 
Frequencies are defined using the following convention: 
very common (≥ 1/10) common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare 

(≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in order of 

decreasing seriousness. 

 

Infections and infestations 
Uncommon: Pharyngitis. 

Rare: Infection (incl. reactivation of inactive chronic infection), sepsis, conjunctivitis. 
 
Neoplasms benign, malignant and unspecified (including cysts and polyps) 

Very rare: lymphoma (see “description” below) 
 
Blood and lymphatic system disorders 

Common: Leukopenia, anaemia, thrombopenia. 

Uncommon: Pancytopenia. 

Very rare: Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative 
disorders (see “description below”). 

Not known: Eosinophilia 
 
  



 

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Immune system disorders 

Rare: Allergic reactions, anaphylactic shock, hypogammaglobulinaemia. 
 

Metabolism and nutrition disorders  

Uncommon: Precipitation of diabetes mellitus.  
 

Psychiatric disorders 

Uncommon: Depression, confusion. 

Rare: Mood alterations. 
 

Nervous system disorders 

Common: Headache, tiredness, drowsiness. 
Uncommon: Dizziness. 

Very rare: Pain, muscular asthenia, paraesthesia/hypoaesthesia, changes in sense of taste (metallic 

taste), convulsions, meningism, acute aseptic meningitis, paralysis. 

Not known: Encephalopathy/ Leukoencephalopathy. 
 

Eye disorders  

Rare: Visual disturbances.  
Very rare: Impaired vision, Retinopathy.  
 

Cardiac disorders  
Rare: Pericarditis, pericardial effusion, pericardial tamponade. 
 

Vascular disorders 

Rare: Hypotension, thromboembolic events  
 

Respiratory, thoracic and mediastinal disorders 

Common: Pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia. 
Symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not 

productive cough, shortness of breath and fever. 

Rare: Pulmonary fibrosis, Pneumocystis jiroveci pneumonia, shortness of breath and bronchial 
asthma, pleural effusion. 

Not known: Epistaxis, pulmonary alveolar haemorrhage. 
 

Gastrointestinal disorders 
Very common: Stomatitis, dyspepsia, nausea, loss of appetite, abdominal pain. 

Common: Oral ulcers, diarrhoea. 

Uncommon: Gastrointestinal ulcers and bleeding, enteritis, vomiting, pancreatitis. 
Rare: Gingivitis. 

Very rare: Haematemesis, haematorrhea, toxic megacolon. 
 

Hepatobiliary disorders (see section 4.4) 
Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and 

bilirubin). 

Uncommon: Cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin. 
Rare: Acute hepatitis. 

Very rare: Hepatic failure. 
 
Skin and subcutaneous tissue disorders 

Common: Exanthema, erythema, pruritus. 

Uncommon: Photosensitisation, loss of hair, increase in rheumatic nodules, skin ulcer, herpes 

zoster, vasculitis, herpetiform eruptions of the skin, urticaria. 
Rare: Increased pigmentation, acne, petechiae, ecchymosis, allergic vasculitis. 

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), increased 

pigmentary changes of the nails, acute paronychia, furunculosis, telangiectasia.  
Not known: Skin exfoliation / dermatitis exfoliative  



 

14 

Musculoskeletal and connective tissue disorders 

Uncommon: Arthralgia, myalgia, osteoporosis. 
Rare: Stress fracture. 

Not known: Osteonecrosis of jaw (secondary to lymphoproliferative disorders) 

 
Renal and urinary disorders 

Uncommon: Inflammation and ulceration of the urinary bladder, renal impairment, disturbed 

micturition. 

Rare: Renal failure, oliguria, anuria, electrolyte disturbances. 
Not known: Proteinuria. 

 

Reproductive system and breast disorders 
Uncommon: Inflammation and ulceration of the vagina. 

Very rare: Loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation, vaginal 

discharge. 

 
General disorders and administration site conditions 

Rare: Fever, wound-healing impairment. 

Not known: Asthenia, injection site necrosis, oedema. 
 

Description of selected adverse reactions 

Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of 
lymphoma and other lymphoproliferative disorders which subsided in a number of cases once 

treatment with methotrexate had been discontinued.  

 

The appearance and degree of severity of undesirable effects depends on the dosage level and the 
frequency of administration. However, as severe undesirable effects can occur even at lower doses, 

it is indispensable that patients are monitored regularly by the doctor at short intervals. 

Only mild local skin reactions (such as burning sensations, erythema, swelling, discolouration, 
pruritus, severe itching, pain) were observed with subcutaneous use, decreasing during therapy. 

 

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 
 

4.9 Overdose 

 
Symptoms of overdose 

The adverse toxic effects of methotrexate mainly affect the haematopoietic and gastrointestinal 

system. Symptoms include leukocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, 

bone marrow depression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal 
ulceration and gastrointestinal bleeding. Some patients showed no signs of overdose. There are 

reports of death due to sepsis, septic shock, renal failure and aplastic anaemia. 

 
Treatment of overdose 

Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate. In 

the event of accidental overdose, a dose of calcium folinate equal to or higher than the offending 
dose of methotrexate should be administered intravenously or intramuscularly within 1 hour, and 

dosing continued until serum level of methotrexate are below 10-7 mol/L. 

 

In the event of a massive overdose, hydration and urinary alkalisation may be required to prevent 
precipitation of methotrexate and/or its metabolites within the renal tubules. Neither haemodialysis 

nor peritoneal dialysis has been shown to improve methotrexate elimination. Effective methotrexate 

clearance has been reported with acute, intermittent haemodialysis using a high-flux dialyser. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

15 

In patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis or 

psoriasis vulgaris, administration of folic or folinic acid may reduce methotrexate toxicity 
(gastrointestinal symptoms, inflammation of oral mucosa, hair loss and increase of liver enzymes) 

(see section 4.5). Prior to using folic acid products, monitoring of vitamin B12 levels is 

recommended, since folic acid may mask an existing vitamin B12 deficiency, particularly in adults 
over 50 years of age. 

 

 

5 PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 

 
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other 

immunosuppressants. ATC code: L04AX03 

 

Methotrexate is a folic acid antagonist which belongs to the class of cytotoxic agents known as 
antimetabolites. It acts by the competitive inhibition of the enzyme dihydrofolate reductase and thus 

inhibits DNA synthesis. It has not yet been clarified, as to whether the efficacy of methotrexate, in 

the management of psoriasis, psoriatic arthritis and chronic polyarthritis, is due to an 
anti-inflammatory or immunosuppressive effect and to which extent a methotrexate-induced 

increase in extracellular adenosine concentration at inflamed sites contributes to these effects.  

 
5.2 Pharmacokinetic properties 

 

Absorption 

After oral application, methotrexate is absorbed from the gastrointestinal tract. When administered 
in low doses (7.5 mg/m2 to 80 mg/m2 BSA), methotrexate has a mean bioavailability of 

approximately 70%, although considerable inter- and intra-subject variations are possible 

(25-100%). Plasma peak concentrations are attained within 1-2 hours. Subcutaneous, intravenous 
and intramuscular administration demonstrated similar bioavailability. 

 

Distribution 
Approximately 50% of methotrexate is bound to serum proteins. Upon being distributed into body 

tissues, high concentrations particularly in liver, kidneys and spleen in form of polyglutamates can 

be found, which can be retained for weeks or months. When administered in small doses, 

methotrexate passes into the body fluids in minimal amounts; under high doses (300 mg/kg body 
weight), concentrations between 4 and 7 µg/ml have been measured in the body fluids. Average 

terminal half-life is 6-7 hours and demonstrates considerable variation (3-17 hours). Half-life may 

be prolonged to 4 times the normal length in patients with third spaces (pleural effusion, ascites). 
 
Biotransformation 
Approximately 10% of the administered methotrexate is metabolised intrahepatically. The major 

metabolite is 7-hydroxymethotrexate. 
 
Elimination 
Excretion takes place, mainly in unchanged form, primarily renal via glomerular filtration and 

active secretion in the proximal tubulus. Approx. 5-20% of methotrexate and 1-5% of 7-

hydroxymethotrexate are eliminated via the bile. Pronounced enterohepatic blood flow exists. 
 
In case of renal insufficiency, elimination is delayed significantly. Impaired elimination in presence 

of hepatic insufficiency is not known. 
 
Methotrexate passes the placental barrier in rats and monkeys. 
 
  



 

16 

5.3 Preclinical safety data 
 
Chronic toxicity 
Chronic toxicity studies in mice, rats and dogs showed toxic effects in the form of gastrointestinal 

lesions, myelosuppression and hepatotoxicity. 
 
Mutagenic and carcinogenic potential 
Long-term studies in rats, mice and hamsters did not show any evidence of a tumorigenic potential 

of methotrexate. Methotrexate induces gene and chromosome mutations both in vitro and in vivo. A 

mutagenic effect is suspected in humans. 
 
Reproductive toxicology 
Teratogenic effects have been identified in four species (rats, mice, rabbits, cats). In rhesus 

monkeys, no malformations comparable to humans occurred. 
 

 

6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Sodium hydroxide (for pH adjustment) 

Water for injections 

 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other 

medicinal products. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Store below 25°C. 
Keep the pre-filled pen and pre-filled syringe in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Pre-filled pen 

Pre-filled pen with a 1 mL type I glass syringe with attached stainless steel needle and a chlorobutyl 

rubber plunger stopper. The pre-filled pens contain 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 
0.9 ml or 1 ml of solution for injection. Each pack contains 1 pre-filled pen and one alcohol swab 

and multipacks containing 4 (4 packs of 1 or 1 pack of 4), 6 (6 packs of 1) and 12 (3 packs of 4) 

pre-filled pens and alcohol swabs. 

 
Pre-filled syringe 

1 mL type I glass syringe with attached stainless steel needle, a chlorobutyl rubber plunger stopper 

and a needle guard to prevent needlestick injury and re-use. The pre-filled syringes contain 0.3 ml, 
0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml or 1 ml solution for injection. Each pack contains 1 

pre-filled syringe and two alcohol swabs and multipacks containing 4 (4 packs of 1), 6 (6 packs of 

1) and 12 (12 packs of 1) pre-filled syringes and alcohol swabs. 
 

Not all pack sizes may be marketed.  
 



 

17 

6.6 Special precautions for disposal and other handling 
 
Handling and disposal must be consistent with that of other cytotoxic preparations in accordance 
with local requirements. Pregnant health care personnel should not handle and/or administer 

methotrexate. 
 
Methotrexate should not come into contact with the skin or mucosa. In the event of contamination, 
the affected area must be rinsed immediately with ample amount of water.  
 
Nordimet is for single use only and any unused solution must be discarded. 
 
Any unused product or waste material should be disposed of in accordance with local requirements 
for cytotoxic agents. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Nordic Group B.V. 
Siriusdreef 41 
2132 WT Hoofddorp 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 

 

Nordimet 7.5 mg solution for injection in pre-filled pen 
EU/1/16/1124/001 - 1 pack 

EU/1/16/1124/009 - 4 pack (4 packs of 1) 

EU/1/16/1124/010 - 6 pack 

EU/1/16/1124/057 - 4 pack (1 pack of 4) 
EU/1/16/1124/058 - 12 pack 

 

Nordimet 10 mg solution for injection in pre-filled pen 
EU/1/16/1124/002 - 1 pack 

EU/1/16/1124/011 - 4 pack (4 packs of 1) 

EU/1/16/1124/012 - 6 pack 
EU/1/16/1124/059 - 4 pack (1 pack of 4) 

EU/1/16/1124/060 - 12 pack 

 

Nordimet 12.5 mg solution for injection in pre-filled pen 
EU/1/16/1124/003 - 1 pack 
EU/1/16/1124/013 - 4 pack (4 packs of 1) 

EU/1/16/1124/014 - 6 pack 
EU/1/16/1124/061 - 4 pack (1 pack of 4) 

EU/1/16/1124/062 - 12 pack 

 

Nordimet 15 mg solution for injection in pre-filled pen 
EU/1/16/1124/004 - 1 pack 
EU/1/16/1124/015 - 4 pack (4 packs of 1) 

EU/1/16/1124/016 - 6 pack 
EU/1/16/1124/063 - 4 pack (1 pack of 4) 

EU/1/16/1124/064 - 12 pack 

 
  



 

18 

Nordimet 17.5 mg solution for injection in pre-filled pen 
EU/1/16/1124/005 - 1 pack 
EU/1/16/1124/017 - 4 pack (4 packs of 1) 

EU/1/16/1124/018 - 6 pack 

EU/1/16/1124/065 - 4 pack (1 pack of 4) 
EU/1/16/1124/066 - 12 pack 

 

Nordimet 20 mg solution for injection in pre-filled pen 
EU/1/16/1124/006 - 1 pack 
EU/1/16/1124/019 - 4 pack (4 packs of 1) 

EU/1/16/1124/020 - 6 pack 

EU/1/16/1124/067 - 4 pack (1 pack of 4) 
EU/1/16/1124/068 - 12 pack 

 

Nordimet 22.5 mg solution for injection in pre-filled pen 
EU/1/16/1124/007 - 1 pack 
EU/1/16/1124/021 - 4 pack (4 packs of 1) 

EU/1/16/1124/022 - 6 pack 

EU/1/16/1124/069 - 4 pack (1 pack of 4) 
EU/1/16/1124/070 - 12 pack 

 

Nordimet 25 mg solution for injection in pre-filled pen 
EU/1/16/1124/008 - 1 pack 

EU/1/16/1124/023 - 4 pack (4 packs of 1) 

EU/1/16/1124/024 - 6 pack 

EU/1/16/1124/071 - 4 pack (1 pack of 4) 
EU/1/16/1124/072 - 12 pack 

 

Nordimet 7.5 mg solution for injection in pre-filled syringe 
EU/1/16/1124/025 - 1 pack 

EU/1/16/1124/026 - 4 pack 

EU/1/16/1124/027 - 6 pack 
EU/1/16/1124/049 - 12 pack 

 

Nordimet 10 mg solution for injection in pre-filled syringe 

EU/1/16/1124/028 - 1 pack 
EU/1/16/1124/029 - 4 pack 

EU/1/16/1124/030 - 6 pack 

EU/1/16/1124/050 - 12 pack 

 
Nordimet 12.5 mg solution for injection in pre-filled syringe 
EU/1/16/1124/031 - 1 pack 
EU/1/16/1124/032 - 4 pack 
EU/1/16/1124/033 - 6 pack 

EU/1/16/1124/051 - 12 pack 

 

Nordimet 15 mg solution for injection in pre-filled syringe 
EU/1/16/1124/034 - 1 pack 
EU/1/16/1124/035 - 4 pack 

EU/1/16/1124/036 - 6 pack 
EU/1/16/1124/052 - 12 pack 

 

Nordimet 17.5 mg solution for injection in pre-filled syringe 
EU/1/16/1124/037 - 1 pack 
EU/1/16/1124/038 - 4 pack 

EU/1/16/1124/039 - 6 pack 

EU/1/16/1124/053 - 12 pack  



 

19 

Nordimet 20 mg solution for injection in pre-filled syringe 
EU/1/16/1124/040 - 1 pack 
EU/1/16/1124/041 - 4 pack 

EU/1/16/1124/042 - 6 pack 

EU/1/16/1124/054 - 12 pack 
 

Nordimet 22.5 mg solution for injection in pre-filled syringe 
EU/1/16/1124/043 - 1 pack 
EU/1/16/1124/044 - 4 pack 
EU/1/16/1124/045 - 6 pack 

EU/1/16/1124/055 - 12 pack 

 
Nordimet 25 mg solution for injection in pre-filled syringe 
EU/1/16/1124/046 - 1 pack 

EU/1/16/1124/047 - 4 pack 

EU/1/16/1124/048 - 6 pack 
EU/1/16/1124/056 - 12 pack 

 

 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 18 August 2016 
 

 

10. DATE OF REVISION OF THE TEXT 

 
Detailed information on this medicinal product is available on the website of the European 

Medicines Agency (http://www.ema.europa.eu) 

 

 
  

http://www.ema.europa.eu/


 

20 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 
A.        MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

B.        CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C.        OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D.        CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 

AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

  

  



 

21 

A.      MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers responsible for batch release 

Cenexi - Laboratoires Thissen S.A. 

Rue de la Papyrée 2-6 
B-1420 Braine-L'Alleud 

Belgium 

 

QPharma AB 
Agneslundsvagen 27 

P.O. Box 590 

SE-201 25 Malmo 
Sweden 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 
 

 

B.      CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 
 

 

C.       OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 

• Periodic safety update reports  
  

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D.       CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

  

• Risk Management Plan (RMP) 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the  agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed 

subsequent updates of the RMP. 

 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached.  
  

• Obligation to conduct post-authorisation measures  
 

The MAH shall complete, within the stated timeframe, the below measures: 

Description Due date 

The MAH should implement the agreed targeted follow-up 

questionnaires for all medication errors resulting in overdose. 

From the date of notification 

of the Commission 
Decision* 

*Referral EMEA/H/A-31/1463  



 

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 

23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



 

24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 7.5 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.3 ml contains 7.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection 

7.5 mg/0.3 ml 

1 pre-filled pen (0.3 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 

can’t be sold separately 
4 pre-filled pens (0.3 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

  

  

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic: handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   



 

25 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/009 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/010 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/058 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 7.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 



 

26 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN:  



 

27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 7.5 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.3 ml contains 7.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection 

7.5 mg/0.3 ml 

1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

  

  

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic: handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

28 

 

 

8. EXPIRY DATE 

 
EXP: 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/026 4 pre-filled syringes (4 packs of 1) 
EU/1/16/1124/027 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/049 12 pre-filled syringes (12 packs of 1) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 7.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 



 

29 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 10 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.4 ml contains 10 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

10 mg/0.4 ml 

1 pre-filled pen (0.4 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 

can’t be sold separately 
4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   



 

31 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) 
EU/1/16/1124/060 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 10 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 



 

32 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 10 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.4 ml contains 10 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

10 mg/0.4 ml 

1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

34 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/029 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/030 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/050 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 10 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

35 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 12.5 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.5 ml contains 12.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

12.5 mg/0.5 ml 

1 pre-filled pen (0.5 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 

can’t be sold separately 
4 pre-filled pens (0.5 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   



 

37 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/062 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 12.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 



 

38 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN:  



 

39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 12.5 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.5 ml contains 12.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

12.5 mg/0.5 ml 

1 pre-filled syringe (0.5 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

40 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/032 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/033 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/051 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 12.5 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

41 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 15 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.6 ml contains 15 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.  

15 mg/0.6 ml 

1 pre-filled pen (0.6 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 

can’t be sold separately 
4 pre-filled pens (0.6 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   



 

43 

 

8. EXPIRY DATE 

 
EXP: 

 

 

9. SPECIAL STORAGE CONDITIONS 

 
Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 
The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/064 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 
 

16. INFORMATION IN BRAILLE 

 

Nordimet 15 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 

 



 

44 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN:  



 

45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 15 mg solution for injection in pre-filled syringe 
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.6 ml contains 15 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.  

15 mg/0.6 ml 

1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

46 

 

8. EXPIRY DATE 

 
EXP: 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/035 4 pre-filled syringes (4 packs of 1) 
EU/1/16/1124/036 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/052 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 15 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 



 

47 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 17.5 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.7 ml contains 17.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

17.5 mg/0.7 ml 

1 pre-filled pen (0.7 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 

can’t be sold separately 
4 pre-filled pens (0.7 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   



 

49 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/017 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/018 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/066 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 17.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 



 

50 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 17.5 mg solution for injection in pre-filled syringe 
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.7 ml contains 17.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

17.5 mg/0.7 ml 

1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

52 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/038 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/039 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/053 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 17.5 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

53 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

54 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 20 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.8 ml contains 20 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.   

20 mg/0.8 ml 

1 pre-filled pen (0.8 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 
can’t be sold separately 

4 pre-filled pens (0.8 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 
  



 

55 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/019 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/020 6 pre-filled pens (6 packs of 1) 
EU/1/16/1124/068 12 pre-filled pens (3 packs of 4) 

 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 



 

56 

16. INFORMATION IN BRAILLE 

 

Nordimet 20 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 

 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 20 mg solution for injection in pre-filled syringe 
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.8 ml contains 20 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

20 mg/0.8 ml 

1 pre-filled syringe (0.8 ml) with pre-assembled needle and needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

58 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/042 6 pre-filled syinges (6 packs of 1) 
EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 20 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

59 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

60 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 22.5 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.9 ml contains 22.5 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.   

22.5 mg/0.9 ml 

1 pre-filled pen (0.9 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 
can’t be sold separately 

4 pre-filled pens (0.9 ml) with pre-assembled needle and 4 alcohol swabs. Component of a 

multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 
  



 

61 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/021 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/022 6 pre-filled pens (6 packs of 1) 
EU/1/16/1124/070 12 pre-filled pens (3 packs of 4) 

 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 



 

62 

16. INFORMATION IN BRAILLE 

 

Nordimet 22.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 

 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

63 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 22.5 mg solution for injection in pre-filled syringe 
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.9 ml contains 22.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

22.5 mg/0.9 ml 

1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

64 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/044 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/045 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/055 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 22.5 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

65 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN:  



 

66 

 

 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 25 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 1.0 ml contains 25 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.   

25 mg/1.0 ml 

1 pre-filled pen (1 ml) with pre-assembled needle and 1 alcohol swab. Component of a multipack, 
can’t be sold separately 

4 pre-filled pens (1 ml) with pre-assembled needle and 4 alcohol swabs. Component of a multipack, 

can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 
  



 

67 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/023 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/024 6 pre-filled pens (6 packs of 1) 
EU/1/16/1124/072 12 pre-filled pens (3 packs of 4) 

 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 



 

68 

16. INFORMATION IN BRAILLE 

 

Nordimet 25 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 

 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN: 

  



 

69 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

NO BLUE BOX IS INCLUDED 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 25 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 1.0 ml contains 25 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

25 mg/1.0 ml 

1 pre-filled syringe (1 ml) with pre-assembled needle with needle guard and 2 alcohol swabs. 

Component of a multipack, can’t be sold separately 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 



 

70 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/047 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/048 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/056 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 25 mg  
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 
 

 



 

71 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 

SN: 
NN: 



 

72 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 7.5 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.3 ml contains 7.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection 

7.5 mg/0.3 ml 

1 pre-filled pen (0.3 ml) with pre-assembled needle and 1 alcohol swab 

Multipack: 4 (4 packs of 1) pre-filled pens (0.3 ml) with pre-assembled needle and alcohol swabs 
Multipack: 4 (1 pack of 4) pre-filled pens (0.3 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.3 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.3 ml) with pre-assembled needle and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

  

  

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

  



 

73 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic: handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/001 1 pre-filled pen 

EU/1/16/1124/009 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/010 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/057 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/058 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 



 

74 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 7.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

75 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 7.5 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.3 ml contains 7.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection 

7.5 mg/0.3 ml 

1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

Multipack: 12 (12 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Subcutaneous use. 

Methotrexate is injected once weekly. 

Read the package leaflet before use. 
  

  

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

76 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic: handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/025 1 pre-filled syringe 

EU/1/16/1124/026 4 pre-filled syringes (4 packs of 1) 
EU/1/16/1124/027 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/049 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
  



 

77 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nordimet 7.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 
PC: 

SN: 

NN: 



 

78 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 10 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.4 ml contains 10 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

10 mg/0.4 ml 

1 pre-filled pen (0.4 ml) with pre-assembled needle and 1 alcohol swab 

Multipack: 4 (4 packs of 1) pre-filled pens (0.4 ml) with pre-assembled needle and alcohol swabs 
Multipack: 4 (1 pack of 4) pre-filled pens (0.4 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.4 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.4 ml) with pre-assembled needle and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

  



 

79 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/002 1 pre-filled pen 

EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/059 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/060 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

80 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 10 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

81 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 10 mg solution for injection in pre-filled syringe 
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.4 ml contains 10 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

10 mg/0.4 ml 

1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

Multipack: 12 (12 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Subcutaneous use. 

Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

82 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution.  
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/028 1 pre-filled syringe 
EU/1/16/1124/029 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/030 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/050 12 pre-filled syringes (12 packs of 1) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 



 

83 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 10 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

84 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 12.5 mg solution for injection in pre-filled pen  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.5 ml contains 12.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

12.5 mg/0.5 ml 

1 pre-filled pen (0.5 ml) with pre-assembled needle and 1 alcohol swab 

Multipack: 4 (4 packs of 1) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs 
Multipack: 4 (1 pack of 4) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.5 ml) with pre-assembled needle and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

  



 

85 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/003 1 pre-filled pen 

EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/061 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/062 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

86 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 12.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

87 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 12.5 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.5 ml contains 12.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

12.5 mg/0.5 ml 

1 pre-filled syringe (0.5 ml) with pre-assembled needle with needle guard and 2 alcohol swab 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

Multipack: 12 (12 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Subcutaneous use. 

Methotrexate is injected once weekly 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

88 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/031 1 pre-filled syringe 
EU/1/16/1124/032 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/033 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/051 12 pre-filled syringes (12 packs of 1) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 



 

89 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 12.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

90 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 15 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.6 ml contains 15 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.  

15 mg/0.6 ml 

1 pre-filled pen (0.6 ml) with pre-assembled needle and 1 alcohol swab 
Multipack: 4 (4 packs of 1) pre-filled pens (0.6 ml) with pre-assembled needle and alcohol swabs 

Multipack: 4 (1 pack of 4) pre-filled pens (0.6 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.6 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.6 ml) with pre-assembled needle and alcohol swabs 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

  



 

91 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/004 1 pre-filled pen 
EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/063 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/064 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

92 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 15 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

93 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 15 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.6 ml contains 15 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.  

15 mg/0.6 ml 

1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle 

guard and alcohol swabs 
Multipack: 12 (12 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

94 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 
Keep the syringe in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 
requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V.  

Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/034 1 pre-filled syringe 
EU/1/16/1124/035 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/036 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/052 12 pre-filled syringes (12 packs of 1) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 

 



 

95 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 15 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

96 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 17.5 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.7 ml contains 17.5 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.   

17.5 mg/0.7 ml 

1 pre-filled pen (0.7 ml) with pre-assembled needle and 1 alcohol swab 
Multipack: 4 (4 packs of 1) pre-filled pens (0.7 ml) with pre-assembled needle and alcohol swabs 

Multipack: 4 (1 pack of 4) pre-filled pens (0.7 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.7 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.7 ml) with pre-assembled needle and alcohol swabs 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

  



 

97 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/005 1 pre-filled pen 

EU/1/16/1124/017 4 pre-filled pens (4 packs of 1) 

EU/1/16/1124/018 6 pre-filled pens (6 packs of 1) 
EU/1/16/1124/065 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/066 12 pre-filled pens (3 packs of 4) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 
 



 

98 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 17.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

99 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 17.5 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.7 ml contains 17.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

17.5 mg/0.7 ml 

1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle 

guard and alcohol swabs 
Multipack: 12 (12 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

100 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/037 1 pre-filled syringe 

EU/1/16/1124/038 4 pre-filled syringes (4 packs of 1) 
EU/1/16/1124/039 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/053 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 

 



 

101 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 17.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

102 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 20 mg solution for injection in pre-filled pen  

 

methotrexate 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.8 ml contains 20 mg methotrexate (25mg/ml) 
 

 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 
Sodium hydroxide  

Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection.   

20 mg/0.8 ml 

1 pre-filled pen (0.8 ml) with pre-assembled needle and 1 alcohol swab 
Multipack: 4 (4 packs of 1) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs 

Multipack: 4 (1 pack of 4) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.8 ml) with pre-assembled needle and alcohol swabs 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

  



 

103 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/006 1 pre-filled pen 

EU/1/16/1124/019 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/020 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/067 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/068 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

104 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 20 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

105 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 20 mg solution for injection in pre-filled syringe  
 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.8 ml contains 20 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

20 mg/0.8 ml 

1 pre-filled syringe (0.8 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 

Multipack: 4 (4 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle 
guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle 

guard and alcohol swabs 
Multipack: 12 (12 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use. 

Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 

 

  



 

106 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 
 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/040 1 pre-filled syringe 
EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/042 6 pre-filled syringes (6 packs of 1) 

EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1) 

 
 

13. BATCH NUMBER 

 

Batch: 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 



 

107 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 20 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

108 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 22.5 mg solution for injection in pre-filled pen  

 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 0.9 ml contains 22.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

22.5 mg/0.9 ml 

1 pre-filled pen (0.9 ml) with pre-assembled needle and 1 alcohol swab 
Multipack: 4 (4 packs of 1) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs 

Multipack: 4 (1 pack of 4) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (0.9 ml) with pre-assembled needle and alcohol swabs 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 
  



 

109 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/007 1 pre-filled pen 

EU/1/16/1124/021 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/022 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/069 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/070 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

110 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 22.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

111 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 22.5 mg solution for injection in pre-filled syringe  

 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 0.9 ml contains 22.5 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

22.5 mg/0.9 ml 

1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 
Multipack: 4 (4 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle 

guard and alcohol swabs 
Multipack: 12 (12 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

  



 

112 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/043 1 pre-filled syringe 

EU/1/16/1124/044 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/045 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/055 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 



 

113 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 22.5 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 



 

114 

 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED PEN CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 25 mg solution for injection in pre-filled pen  

 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen of 1.0 ml contains 25 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

25 mg/1.0 ml 

1 pre-filled pen (1 ml) with pre-assembled needle and 1 alcohol swab 
Multipack: 4 (4 packs of 1) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs 

Multipack: 4 (1 pack of 4) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs 

Multipack: 12 (3 packs of 4) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 
Methotrexate is injected once weekly. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 
  



 

115 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 
 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

8. EXPIRY DATE 

 

EXP: 

 
 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 
 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  
Siriusdreef 41 

2132 WT Hoofddorp 

The Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/008 1 pre-filled pen 

EU/1/16/1124/023 4 pre-filled pens (4 packs of 1) 
EU/1/16/1124/024 6 pre-filled pens (6 packs of 1) 

EU/1/16/1124/071 4 pre-filled pens (1 pack of 4) 

EU/1/16/1124/072 12 pre-filled pens (3 packs of 4) 
 

 

13. BATCH NUMBER 

 

Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 



 

116 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 25 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

  



 

117 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PRE-FILLED SYRINGE CARTON 

OUTER LABEL CONTAINS BLUE BOX 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Nordimet 25 mg solution for injection in pre-filled syringe  

 

methotrexate 

 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe of 1.0 ml contains 25 mg methotrexate (25mg/ml) 

 
 

3. LIST OF EXCIPIENTS  

 

Sodium chloride 

Sodium hydroxide  
Water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Solution for injection.   

25 mg/1.0 ml 

1 pre-filled syringe (1 ml) with pre-assembled needle with needle guard and 2 alcohol swabs 
Multipack: 4 (4 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

Multipack: 6 (6 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle 

guard and alcohol swabs 
Multipack: 12 (12 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle 

guard and alcohol swabs 

 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Subcutaneous use 

Methotrexate is injected once weekly. 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

  



 

118 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Cytotoxic : handle with caution. 

 

Use only once a week  

on …………………………………………………………….. (include weekday of use in full)   

 

 

8. EXPIRY DATE 

 

EXP: 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

Keep the syringe in the outer carton in order to protect from light. 

 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 
Any unused medicinal product or waste material should be disposed in accordance with local 

requirements. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Nordic Group B.V.  

Siriusdreef 41 
2132 WT Hoofddorp 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1124/046 1 pre-filled syringe 

EU/1/16/1124/047 4 pre-filled syringes (4 packs of 1) 

EU/1/16/1124/048 6 pre-filled syringes (6 packs of 1) 
EU/1/16/1124/056 12 pre-filled syringes (12 packs of 1) 

 

 

13. BATCH NUMBER 

 
Batch: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 



 

119 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 
Nordimet 25 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE  

 
2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  

 

PC: 
SN: 

NN: 

 
  



 

120 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 7.5 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

7.5 mg / 0.3 ml 

 

Use only once a week 

 

 
  



 

121 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 10 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

10 mg / 0.4 ml 

 

Use only once a week 

  



 

122 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 12.5 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

12.5 mg / 0.5 ml 

 

Use only once a week 

 

  



 

123 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 15 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

15 mg / 0.6 ml 

 

Use only once a week 

 

 
  



 

124 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 17.5 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

17.5 mg / 0.7 ml 

 

Use only once a week 

 

 



 

125 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 20 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

20 mg / 0.8 ml 

 

Use only once a week 

 

 



 

126 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 22.5 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

22.5 mg / 0.9 ml 

 

Use only once a week 

 

 
 



 

127 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for  

 

Blister - PRE-FILLED SYRINGE 

 
 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Nordimet 25 mg solution for injection  
methotrexate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Nordic Group B.V. 

 

 

3. EXPIRY DATE 

 
EXP: 

 

 

4. BATCH NUMBER 

 
Batch: 

 

 

5. OTHER 

 
SC 

25 mg / 1.0 ml 

 

Use only once a week 

 



 

128 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS  

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 7.5 mg solution for injection  
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

7.5 mg / 0.3 ml 
 

 

6. OTHER 

 

 
 

 

 
 

 

 

 
 

 

 
 

 

 

 
 

 

 
 

 

 
 



 

129 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 10 mg solution for injection 
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

10 mg / 0.4 ml 
 

 

6. OTHER 

 

  



 

130 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 12.5 mg solution for injection  
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

12.5 mg / 0.5 ml 
 

 

6. OTHER 

 

  



 

131 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 15 mg solution for injection   
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

15 mg / 0.6 ml 
 

 

6. OTHER 

 

  



 

132 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 17.5 mg solution for injection   
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

17.5 mg / 0.7 ml 
 

 

6. OTHER 

 

  



 

133 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 20 mg solution for injection   
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

20 mg / 0.8 ml 
 

 

6. OTHER 

 

  



 

134 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 22.5 mg solution for injection   
methotrexate 

SC 

 
 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Batch: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

22.5 mg / 0.9 ml 
 

 

6. OTHER 

 

  



 

135 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

PRE-FILLED PEN / PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Nordimet 25 mg solution for injection methotrexate 
SC 

 

 

2. METHOD OF ADMINISTRATION 

 
 

3. EXPIRY DATE 

 

EXP: 

 
 

4. BATCH NUMBER 

 

Batch: 

 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

25 mg / 1.0 ml 

 
 

6. OTHER 

 

  



 

136 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

137 

Package leaflet: Information for the user 
 

Nordimet 7.5 mg solution for injection in pre-filled pen 
Nordimet 10 mg solution for injection in pre-filled pen 

Nordimet 12.5 mg solution for injection in pre-filled pen 
Nordimet 15 mg solution for injection in pre-filled pen 

Nordimet 17.5 mg solution for injection in pre-filled pen 
Nordimet 20 mg solution for injection in pre-filled pen 

Nordimet 22.5 mg solution for injection in pre-filled pen 
Nordimet 25 mg solution for injection in pre-filled pen 

 
methotrexate 

 
Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 
- If  you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Nordimet is and what it is used for 
2. What you need to know before you use Nordimet 
3. How to use Nordimet 
4. Possible side effects 
5. How to store Nordimet 
6. Contents of the pack and other information 

 
 

1. What Nordimet is and what it is used for 
 
Nordimet contains the active substance methotrexate which works by:  
- reducing  inflammation or swelling, and  
-         reducing the activity of the immune system (the body’s own defense mechanism). An 

overactive immune system has been linked to inflammatory diseases. 
 

Nordimet is a medicine used to treat a range of inflammatory diseases: 
- active rheumatoid arthritis in adults. Active rheumatoid arthritis is an inflammatory condition 

that affects the joints; 
-  severe, active juvenile idiopathic arthritis in five or more joints (the condition is therefore 

called polyarthritic), in patients who have had an inadequate response to nonsteroidal 
anti-inflammatory drugs (NSAIDs); 

- a severe form of treatment resistant psoriasis (also called severe recalcitrant disabling 

psoriasis), in adult patients who have had an inadequate response to other treatments 
including phototherapy (light therapy), PUVA (ultraviolet light therapy), and retinoids (group 

of medicines derived from vitamin A).  
 
 



 

138 

2. What you need to know before you use Nordimet 
 
Do not use Nordimet if: 

- you are allergic to methotrexate or any of the other ingredients of this medicine (listed in 

section 6) 
- you have severe kidney disease (your doctor will be able to tell you if you have severe kidney 

disease) 
- you have severe liver disease (your doctor will be able to tell you if you have severe liver 

disease) 
- you have disorders of the blood-forming system 
- your alcohol consumption is high 
- you have an impaired immune system 
- you have a severe or existing infection, e.g. tuberculosis or HIV 
- you have gastrointestinal ulcers 
- you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”) 
- you receive vaccinations with live vaccines at the same time. 
 
Warnings and precautions 
Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported 

with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact 

your doctor immediately. 
 

Important warning about the dosing of Nordimet 
Methotrexate for the therapy of rheumatic diseases or diseases of the skin must only be used once 
weekly. Incorrect dosing of methotrexate may lead to serious adverse effects which may be fatal. 

Please read section 3 of this package leaflet very carefully. 
 
Talk to your doctor before using Nordimet if: 
- you have diabetes mellitus and are being treated with insulin 
-  you have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles [herpes 

zoster]) 
- you have/had any liver or kidney disease 
- you have problems with lung function 
- you are severely overweight 
- you have abnormal accumulation of liquid in the abdomen or in the cavity between the lungs 

and chest wall (ascites, pleural effusions) 
- you are dehydrated or suffer from conditions leading to dehydration (e.g. dehydration as a 

result of vomiting, diarrhoea or inflammation of the mouth and lips) 
 
If you have experienced problems with your skin after radiation therapy (radiation induced 
dermatitis) or sun-burn, these conditions can reappear when taking Nordimet. 
 
Children, adolescents and elderly 
Dose instructions depend on the patient’s body weight. 
 

Use in children under 3 years of age is not recommended due to insufficient experience of using this 

medicine in this age group. 
 
Children, adolescents and the elderly being treated with Nordimet should be kept under close 

medical surveillance to identify possible side effects as early as possible. 
 
The dose for elderly patients should be lowered due to age-related reduced liver and kidney 
function. 
 
Special precautionary measures for treatment with Nordimet 
Methotrexate temporarily affects sperm and egg production, which is reversible in most cases. 

Methotrexate can cause miscarriage and severe birth defects. You must avoid becoming pregnant 



 

139 

when using methotrexate and for at least six months after treatment has stopped. See also section 

“Pregnancy, breast-feeding and fertility”.  
Skin changes caused by psoriasis can worsen during treatment with Nordimet if exposed to 

ultraviolet irradiation. 
 
Before the start of treatment and recommended follow-up examinations and precautions 
Before treatment is started your doctor may carry out blood tests, and also check how well your 

kidneys and liver are working. You may also have a chest X-ray. Further tests may also be done 

during and after treatment. Do not miss appointments for blood tests. 
 
If the results of any of these tests are abnormal, treatment will only be resumed when all readings 

are back to normal. 
 
Even when Nordimet is used at low doses, serious side effects can occur. Your doctor will carry out 

blood and urine tests to make sure that any side effects are identified quickly. 
 
Other medicines and Nordimet 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines, including medicines obtained without a prescription and herbal or natural medicinal 
products. 
 
It is especially important to tell your doctor if you are taking: 
- other treatments for rheumatoid arthritis or psoriasis such as leflunomide, sulphasalazine 

(a medicine that besides arthritis and psoriasis is also used to treat ulcerative colitis), aspirin, 

phenylbutazone, or amidopyrine 
-      alcohol (drinking alcohol should be avoided while you are taking Nordimet) 
-      azathioprine (used to prevent rejection after an organ transplant) 
-      retinoids (used to treat psoriasis and other skin disorders) 
-      anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or 

carbamazepine 
-      cancer treatments 
-      barbiturates (sleeping injection) 
-      tranquillisers 
-      oral contraceptives 
-      probenecid (used to treat gout) 
-      antibiotics 
-      pyrimethamine (which is used to prevent and treat malaria) 
-      vitamin preparations containing folic acid 
-      proton-pump inhibitors (medicines that reduce the production of gastric acid and that are used 

to treat severe heartburn or ulcers), such as omeprazole 
-      theophylline (used to treat asthma) 
- any vaccination with a live vaccine (must be avoided), such as measles, mumps, influenza or 

yellow fever vaccines. 
 
Nordimet with food, drink and alcohol 
During treatment with Nordimet, you must not drink any alcohol and should avoid excessive 

consumption of coffee, soft drinks containing caffeine and black tea as this may enhance side 

effects or interfere with the efficacy of Nordimet. Also, make sure you drink plenty of liquids 
during treatment with Nordimet because dehydration (reduction in body water) can increase the 

toxicity of Nordimet. 
 



 

140 

Pregnancy, breast-feeding and fertility 
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
Pregnancy 
Do not use Nordimet during pregnancy or if you are trying to become pregnant. Methotrexate can 
cause birth defects, harm unborn babies or cause miscarriages. It is associated with malformations 

of the skull, face, heart and blood vessels, brain and limbs. Therefore, it is very important that 

methotrexate is not given to pregnant patients or patients planning to become pregnant. In women 

of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. 
a pregnancy test before starting treatment. You must avoid becoming pregnant whilst taking 

methotrexate and for at least 6 months after treatment is stopped by using reliable contraception 

throughout this time (see also section “Warnings and precautions”). 
 
If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor 

as soon as possible. You should be offered advice regarding the risk of harmful effects on the child 

through treatment. 
If you wish to become pregnant you should consult your doctor, who may refer you for specialist 

advice before the planned start of treatment. 
 
Breast-feeding 
Do not breast-feed during treatment because methotrexate passes into breast milk. If your doctor 

considers treatment with methotrexate absolutely necessary during the lactation period, you must 

stop breast-feeding. 
 
Male fertility 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 

father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded. 

Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation. 
Methotrexate can affect sperm production with the potential to cause birth defects. Therefore, you 

should avoid fathering a child or to donate semen whilst taking methotrexate and for at least 6 

months after treatment is stopped.  
 
Driving and using machines 
Side effects affecting the central nervous system, such as tiredness and dizziness, may occur during 

treatment with Nordimet. In some cases, the ability to drive vehicles and/or use machines may be 

impaired. If you feel tired or dizzy, you should not drive or use machines. 
 
Nordimet contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, and so is essentially 

“sodium-free”. 
 
 
3. How to use Nordimet 

 

Important warning about the dose of Nordimet 

Use Nordimet only once a week for the treatment of rheumatoid arthritis, active juvenile idiopathic 

arthritis, psoriasis and psoriatic arthritis requiring dosing once a week. Using too much of Nordimet 

may be fatal. Please read section 3 of this leaflet very carefully. If you have any questions, please 

talk to your doctor or pharmacist before you take this medicine. 

 
Always use this medicine exactly as your doctor has told you. Check with your doctor or 

pharmacist if you are not sure. 

 
 



 

141 

Nordimet is administered once a week only. You and your doctor can decide on a suitable day each 

week to receive your injection. 
 
Incorrect administration of Nordimet can lead to severe side effects that may be fatal.  
 
The recommended dose is: 

 
Dose in patients with rheumatoid arthritis 
The recommended starting dose is 7.5 mg methotrexate once a week.  
 
The doctor may increase the dose if the used dose is not effective but tolerated well. The average 

weekly dose is 15-20 mg. Generally, a weekly dose of 25 mg should not be exceeded. Once 
Nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective 

maintenance dose. 

 
Generally, improvement of symptoms can be expected after 4-8 weeks of treatment. Symptoms may 

return if treatment with Nordimet is stopped. 
 
Dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic 

arthritis 
The doctor will calculate the dose required from the child’s body surface area (m2), and the dose is 

expressed as mg/m2.  
 
Use in children under < 3 years is not recommended due to insufficient experience in this age 
group. 
 
Use in adults with severe forms of psoriasis vulgaris or psoriatic arthritis 
Your doctor will give you a single test dose of 5-10 mg, in order to assess possible side effects.  
If the test dose is well tolerated, treatment will be continued after a week with a dose of 

approximately 7.5 mg.  

 
Response to treatment can generally be expected after 2-6 weeks. Depending on the effects of 

treatment and results of blood and urine tests, the therapy is then continued or stopped. 

 

Method and duration of administration 
Nordimet is given as injection under the skin (subcutaneously). It must be injected once weekly and 

it is recommended to always inject Nordimet on the same day of the week.  
 
At the start of your treatment, Nordimet may be injected by medical staff. However, your doctor 
may decide that you can learn how to inject Nordimet yourself. You will receive appropriate 

training for you to do this. Under no circumstances should you attempt to inject yourself, unless you 

have been trained to do so. 

 
The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, 

juvenile idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with Nordimet is a long-term 

treatment. 
 

How to give yourself an injection of Nordimet 
If you have difficulty handling the pen, ask your doctor or pharmacist. Do not try to inject yourself 

if you have not been trained on how to do so. If you are not sure what to do, talk to your doctor or 
nurse immediately. 
 



 

142 

Before injecting yourself with Nordimet 
-  Check the expiry date on the medicine. Do not use if the date has passed. 
-  Check the pen is not damaged and the medicine in it is a clear, yellow solution. If not, use 

another pen. 
-  Check your last injection site to see if the last injection caused any redness, change in skin 

colour, swelling, oozing or is still painful, if so talk to your doctor or nurse. 
-  Decide where you are going to inject the medicine. Change the place where you inject each 

time. 
 
Instructions on injecting yourself with Nordimet 
1) Wash your hands thoroughly with soap and water. 
 
2) Sit or lie in a relaxed, comfortable position. Make sure you can see the skin area you are going to 

inject.  
 
3) The pen is pre-filled and ready to use. Visually inspect the pen. You should see a yellow fluid 

through the viewing window. You may see a small air bubble, this does not affect the injection and 

will not harm you. 
 
A droplet may appear at the tip of the needle. This is normal. 
 
4) Choose an injection site and clean it with the enclosed alcohol swab. It requires 30-60 seconds to 

be effective. The skin on the front side abdominal wall and the skin at the front of the thigh are 
suitable as injection sites. 
 
5) While holding the body of the pen, pull the cap off. Once you have taken the cap off, keep the 

pen in your hand. Do not allow the pen to touch anything else. This is to make sure that the pen is 
not accidentally activated and that the needle stays clean. 
 

 
 
 
6) Make a fold in the skin by gently pinching the skin of the injection place with your forefinger 
and thumb. Make sure you hold the skin fold throughout the injection. 
 
7) Move the pen towards the skin fold (site of injection) with the needle shield pointing directly at 

the site of injection. Place the yellow needle shield against the area of injection so that the entire rim 
of the needle shield is touching the skin. 
 
  



 

143 

 
 
8) Apply downward pressure on the pen on to your skin until you hear and feel a “click”. 
This activates the pen and the solution will inject automatically into the skin. 
 
 

 
 
9) The injection lasts for a maximum of 10 seconds. You will feel and hear a second “click” once 
the injection is completed. 
 

 
 
 
 
 
 
 
 
 

 

 
10) Wait another 2-3 seconds before removing the pen from your skin. The safety shield on the pen 

is now locked to prevent any needlestick injuries. You can now let go of the skin fold. 
 

 
 
11) Visually inspect the pen through the viewing window. You should see green plastic. This means 

that all the fluid has been injected. Discard the used pen into the sharps bin provided. Close the 
container lid tightly and place the container out of reach of children. If you accidently get 

methotrexate on the surface of the skin or soft tissues you must rinse with plenty of water. 



 

144 

 
If you use more Nordimet than you should 
Follow the dose recommendations of your treating doctor. Do not change the dose without your 
doctor’s recommendation. 
 
If you suspect that you have used too much Nordimet, tell your doctor or contact the nearest 

hospital immediately. Take your medicine package and this leaflet with you if you go to a doctor or 
hospital. 
 
An overdose of methotrexate can lead to severe toxic reactions. Overdose symptoms may include 

easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, 
coughing up blood or vomit that looks like coffee grounds, and decreased urinating. See also 

section 4. 
 
If you forget to use Nordimet 
Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose 

as normal. Ask your doctor for advice. 
 
If you stop taking Nordimet 
You should not interrupt or discontinue Nordimet treatment before discussing with your doctor. If 
you suspect that you are experiencing side effects, contact your doctor immediately for advice. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of 
the eyelids, face or lips, rash or itching (especially affecting your whole body). 
 

Serious side effects 
If you develop any of the following side effects, contact your doctor immediately: 
- inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness 

of breath, breathlessness at rest, chest pain, or fever)  
- spitting or coughing blood 
- severe peeling or blistering of the skin 
- unusual bleeding (including vomiting blood) or bruising 
- severe diarrhoea 
- ulcers in mouth 
- black or tarry stools 
- blood in the urine or stools 
- tiny red spots on the skin 
- fever 
- yellowing of the skin (jaundice) 
- pain or difficulty in passing urine 
- thirst and/or frequent urination 
- fits (convulsions) 
- loss of consciousness 
- blurred or decreased vision 

 



 

145 

The following side effects have also been reported: 
 
Very common (may affect more than 1 in 10 people): 
loss of appetite, nausea (feeling sick), vomiting, tummy pain, inflammation and ulcers in the mouth 

and throat, and increase in liver enzymes. 
 
Common (may affect up to 1 in 10 people): 
Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets 

(leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the 

lungs (pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, 
reddening of the skin, itching. 
 
Uncommon (may affect up to 1 in 100 people): 
Decrease in the number of blood cells and platelets , dizziness, confusion, depression, fits, 

inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver 
disorders, diabetes, decreased blood protein, nettle rash, light sensitivity, brown skin, hair loss, 

increase of rheumatic nodules, shingles, painful psoriasis, joint or muscle pain, osteoporosis 

(reduction of bone mass), inflammation and ulcers of the bladder (possibly with blood in the urine), 
painful urination, severe allergic reactions, inflammation and ulcers of the vagina, slow wound 

healing. 
 
Rare (may affect up to 1 in 1,000 people): 
Inflammation of the sac around the heart, fluid in the sac around the heart, severe visual 

disturbance, mood fluctuations, low blood pressure, blood clots, sore throat, interruption of 

breathing, asthma, inflammation of the digestive tract, bloody stools, inflamed gums, abnormal 

digestion, acute hepatitis (inflammation of the liver), changed colour of nails, acne, red or purple 
spots due to vessel bleeding, bone fracture, kidney failure, decrease or absence of urine, electrolyte 

disturbances, defective sperm formation, menstruation disorders. 
 
Very rare (may affect up to 1 in 10,000 people): 
Infections, severe failure of the bone marrow, liver failure, swollen glands, sleeplessness, pain, 

muscle weakness, sensation of numbness or tingling / having less sensitivity to stimulation than 

normal, changes in sense of taste (metallic taste), inflammation of the lining of the brain causing 
paralysis or vomiting, red eyes, damage to the retina of the eye, fluid in the lungs, vomiting blood, 

cold sores, protein in the urine, fever, loss of sex drive, problems having an erection, infection 

around a fingernail, severe complications of the gastrointestinal tract, boils, small blood vessels in 

the skin, fungal infections, damage to the blood vessels of the skin, vaginal discharge, infertility, 
male breast enlargement (gynaecomastia), inflammation of the brain, lymphoproliferative disorders 

(excessive growth of white blood cells). 
 
Frequency not known (cannot be estimated from the available data): 
Bleeding from the lungs, bone damage in the jaw (secondary to excessive growth of white blood 

cells), tissue destruction at injection site, redness and shedding of skin, swelling. 

 
Only mild local skin reactions were observed with Nordimet and these decreased during therapy. 
 
Nordimet may cause a reduction in the number of white blood cells and your resistance to infection 

may be decreased. If you experience an infection with symptoms such as fever and serious 

deterioration of your general condition, or fever with local infection symptoms such as sore 
throat/sore pharynx/sore mouth or urinary problems you should see your doctor immediately. A 

blood test will be taken to check for possible reduction of white blood cells (agranulocytosis). It is 

important to tell your doctor that you are taking Nordimet. 
 
Methotrexate is known to cause bone disorders such as joint and muscle pain and osteoporosis. The 

frequency of these risks in children is not known.  
 
  



 

146 

Nordimet may cause serious (sometimes life-threatening) side effects. Your doctor will do tests to 

check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, 
lymphoma) and changes in the kidney and the liver. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety 

of this medicine. 
 
 
5.       How to store Nordimet 
 
Keep this medicine out of the sight and reach of children.  

 
Do not use this medicine after the expiry date which is stated on the label of the pre-filled pen and 
the carton after EXP. The expiry date refers to the last day of that month. 
 
Store below 25°C. 
Keep the pen in the outer carton in order to protect from light. 
 
Do not use this medicine if you notice that the solution is not clear and contains particles. 
 
Nordimet is for single use only. Any used pen should be discarded. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6.          Contents of the pack and other information 
 
What Nordimet contains 
The active substance is methotrexate. 1 ml of solution contains 25 mg methotrexate. 
The other ingredients are sodium chloride, sodium hydroxide and water for injections. 
 
The following pens are available: 
Pre-filled pens of 0.3 ml containing 7.5 mg methotrexate.  
Pre-filled pens of 0.4 ml containing 10 mg methotrexate 
Pre-filled pens of 0.5 ml containing 12.5 mg methotrexate 
Pre-filled pens of 0.6 ml containing 15 mg methotrexate  
Pre-filled pens of 0.7 ml containing 17.5 mg methotrexate  
Pre-filled pens of 0.8 ml containing 20 mg methotrexate  
Pre-filled pens of 0.9 ml containing 22.5 mg methotrexate  
Pre-filled pens of 1.0 ml containing 25 mg methotrexate 
 
What Nordimet looks like and contents of the pack 
Nordimet pre-filled pens contain a clear, yellow solution for injection. The pre-filled pens are 

designed to prevent needlestick injury and reuse. 
 
Nordimet is available in packs containing 1 or 4 pre-filled pens of 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 

0.7 ml, 0.8 ml, 0.9 ml or 1.0 ml solution for injection with attached needle and 1 or 4 alcohol swabs 

and in multipacks of 4 and 6 cartons, each containing 1 pre-filled pen solution for injection with 
attached needle and one alcohol swab. Nordimet is also available in multipacks containing 12 pre-

filled pens in 3 cartons (4 pens and alcohol swabs per carton). 

 
Not all pack sizes may be marketed.  

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

147 

Marketing Authorisation Holder  
 
Nordic Group B.V. 
Siriusdreef 41 
2132 WT Hoofddorp 
The Netherlands 
 
Manufacturer 
 
CENEXI - Laboratoires Thissen 
Rue de la Papyrée 2-6 
B-1420 Braine-l’Alleud 
Belgium 

 
QPharma AB 
Agneslundsvagen 27 

P.O. Box 590 

SE-201 25 Malmo 

Sweden 

 
This leaflet was last revised in  

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http//www.ema.europa.eu.  
  



 

148 

Package leaflet: Information for the user 
 

Nordimet 7.5 mg solution for injection in pre-filled syringe 
Nordimet 10 mg solution for injection in pre-filled syringe 

Nordimet 12.5 mg solution for injection in pre-filled syringe 
Nordimet 15 mg solution for injection in pre-filled syringe 

Nordimet 17.5 mg solution for injection in pre-filled syringe 
Nordimet 20 mg solution for injection in pre-filled syringe 

Nordimet 22.5 mg solution for injection in pre-filled syringe 
Nordimet 25 mg solution for injection in pre-filled syringe 

 
methotrexate 

 
Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 
- If  you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Nordimet is and what it is used for 
2. What you need to know before you use Nordimet 
3. How to use Nordimet 
4. Possible side effects 
5. How to store Nordimet 
6. Contents of the pack and other information 

 
 

1. What Nordimet is and what it is used for 
 
Nordimet contains the active substance methotrexate which works by:  
- reducing  inflammation or swelling, and  
-         reducing the activity of the immune system (the body’s own defense mechanism). An 

overactive immune system has been linked to inflammatory diseases. 
 

Nordimet is a medicine used to treat a range of inflammatory diseases: 
- active rheumatoid arthritis in adults. Active rheumatoid arthritis is an inflammatory condition 

that affects the joints; 
-  severe, active juvenile idiopathic arthritis in five or more joints (the condition is therefore 

called polyarthritic), in patients who have had an inadequate response to nonsteroidal 
anti-inflammatory drugs (NSAIDs); 

- a severe form of treatment resistant psoriasis (also called severe recalcitrant disabling 

psoriasis), in adult patients who have had an inadequate response to other treatments 
including phototherapy (light therapy), PUVA (ultraviolet light therapy), and retinoids (group 

of medicines derived from vitamin A).  
 
 



 

149 

2. What you need to know before you use Nordimet 
 
Do not use Nordimet if: 

- you are allergic to methotrexate or any of the other ingredients of this medicine (listed in 

section 6) 
- you have severe kidney disease (your doctor will be able to tell you if you have severe kidney 

disease) 
- you have severe liver disease (your doctor will be able to tell you if you have severe liver 

disease) 
- you have disorders of the blood-forming system 
- your alcohol consumption is high 
- you have an impaired immune system 
- you have a severe or existing infection, e.g. tuberculosis or HIV 
- you have gastrointestinal ulcers 
- you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”) 
- you receive vaccinations with live vaccines at the same time. 
 
Warnings and precautions 
Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported 

with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact 

your doctor immediately. 
 

Important warning about the dosing of Nordimet 
Methotrexate for the therapy of rheumatic diseases or diseases of the skin must only be used once 
weekly. Incorrect dosing of methotrexate may lead to serious adverse effects which may be fatal. 

Please read section 3 of this package leaflet very carefully. 
 
Talk to your doctor before using Nordimet if: 
- you have diabetes mellitus and are being treated with insulin 
-  you have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles [herpes 

zoster]) 
- you have/had any liver or kidney disease 
- you have problems with lung function 
- you are severely overweight 
- you have abnormal accumulation of liquid in the abdomen or in the cavity between the lungs 

and chest wall (ascites, pleural effusions) 
- you are dehydrated or suffer from conditions leading to dehydration (e.g. dehydration as a 

result of vomiting, diarrhoea or inflammation of the mouth and lips) 
 
If you have experienced problems with your skin after radiation therapy (radiation induced 
dermatitis) or sun-burn, these conditions can reappear when taking Nordimet. 
 
Children, adolescents and elderly 
Dose instructions depend on the patient’s body weight. 
 

Use in children under 3 years of age is not recommended due to insufficient experience of using this 

medicine in this age group. 
 
Children, adolescents and the elderly being treated with Nordimet should be kept under close 

medical surveillance to identify possible side effects as early as possible. 
 
The dose for elderly patients should be lowered due to age-related reduced liver and kidney 
function. 
 
Special precautionary measures for treatment with Nordimet 
Methotrexate temporarily affects sperm and egg production, which is reversible in most cases. 

Methotrexate can cause miscarriage and severe birth defects. You must avoid becoming pregnant 



 

150 

when using methotrexate and for at least six months after treatment has stopped. See also section 

“Pregnancy, breast-feeding and fertility”.  
Skin changes caused by psoriasis can worsen during treatment with Nordimet if exposed to 

ultraviolet irradiation. 
 
Before the start of treatment and recommended follow-up examinations and precautions 
Before treatment is started your doctor may carry out blood tests, and also check how well your 

kidneys and liver are working. You may also have a chest X-ray. Further tests may also be done 

during and after treatment. Do not miss appointments for blood tests. 
 
If the results of any of these tests are abnormal, treatment will only be resumed when all readings 

are back to normal. 
 
Even when Nordimet is used at low doses, serious side effects can occur. Your doctor will carry out 

blood and urine tests to make sure that any side effects are identified quickly. 
 
Other medicines and Nordimet 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines, including medicines obtained without a prescription and herbal or natural medicinal 
products. 
 
It is especially important to tell your doctor if you are taking: 
- other treatments for rheumatoid arthritis or psoriasis such as leflunomide, sulphasalazine 

(a medicine that besides arthritis and psoriasis is also used to treat ulcerative colitis), aspirin, 

phenylbutazone, or amidopyrine 
-      alcohol (drinking alcohol should be avoided while you are taking Nordimet) 
-      azathioprine (used to prevent rejection after an organ transplant) 
-      retinoids (used to treat psoriasis and other skin disorders) 
-      anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or 

carbamazepine 
-      cancer treatments 
-      barbiturates (sleeping injection) 
-      tranquillisers 
-      oral contraceptives 
-      probenecid (used to treat gout) 
-      antibiotics 
-      pyrimethamine (which is used to prevent and treat malaria) 
-      vitamin preparations containing folic acid 
-      proton-pump inhibitors (medicines that reduce the production of gastric acid and that are used 

to treat severe heartburn or ulcers), such as omeprazole 
-      theophylline (used to treat asthma) 
- any vaccination with a live vaccine (must be avoided), such as measles, mumps, influenza or 

yellow fever vaccines. 
 
Nordimet with food, drink and alcohol 
During treatment with Nordimet, you must not drink any alcohol and should avoid excessive 

consumption of coffee, soft drinks containing caffeine and black tea as this may enhance side 

effects or interfere with the efficacy of Nordimet. Also, make sure you drink plenty of liquids 
during treatment with Nordimet because dehydration (reduction in body water) can increase the 

toxicity of Nordimet. 
 



 

151 

Pregnancy, breast-feeding and fertility 
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
Pregnancy 
Do not use Nordimet during pregnancy or if you are trying to become pregnant. Methotrexate can 
cause birth defects, harm unborn babies or cause miscarriage. It is associated with malformations of 

the skull, face, heart and blood vessels, brain and limbs. Therefore, it is very important that 

methotrexate is not given to pregnant patients or patients planning to become pregnant. In women 

of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. 
a pregnancy test before starting treatment. You must avoid becoming pregnant whilst taking 

methotrexate and for at least 6 months after treatment is stopped by using reliable contraception 

throughout this time (see also section “Warnings and precautions”). 
 
If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor 

as soon as possible. You should be offered advice regarding the risk of harmful effects on the child 

through treatment. 
If you wish to become pregnant you should consult your doctor, who may refer you for specialist 

advice before the planned start of treatment. 
 
Breast-feeding 
Do not breast-feed during treatment because methotrexate passes into breast milk. If your doctor 

considers treatment with methotrexate absolutely necessary during the lactation period, you must 

stop breast-feeding. 
 
Male fertility 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 

father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded. 

Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation. 
Methotrexate can affect sperm production with the potential to cause birth defects. Therefore, you 

should avoid fathering a child or to donate semen whilst taking methotrexate and for at least 6 

months after treatment is stopped.  
 
Driving and using machines 
Side effects affecting the central nervous system, such as tiredness and dizziness, may occur during 

treatment with Nordimet. In some cases, the ability to drive vehicles and/or use machines may be 

impaired. If you feel tired or dizzy, you should not drive or use machines. 
 
Nordimet contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, and so is essentially 

“sodium-free”. 
 
 
3. How to use Nordimet 
 

Important warning about the dose of Nordimet 

Use Nordimet only once a week for the treatment of rheumatoid arthritis, active juvenile idiopathic 

arthritis,psoriasis and psoriatitic arthritis requiring dosing once a week. Using too much of 

Nordimet may be fatal. Please read section 3 of this leaflet very carefully. If you have any 

questions, please talk to your doctor or pharmacist before you take this medicine. 

 
Always use this medicine exactly as your doctor has told you. Check with your doctor or 

pharmacist if you are not sure. 
 
 



 

152 

Nordimet is administered once a week only. You and your doctor can decide on a suitable day each 

week to receive your injection. 
 
Incorrect administration of Nordimet can lead to severe side effects that may be fatal.  
 
The recommended dose is: 

 
Dose in patients with rheumatoid arthritis 
The recommended starting dose is 7.5 mg methotrexate once a week.  
 
The doctor may increase the dose if the used dose is not effective but tolerated well. The average 

weekly dose is 15-20 mg. Generally, a weekly dose of 25 mg should not be exceeded. Once 
Nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective 

maintenance dose. 

 
Generally, improvement of symptoms can be expected after 4-8 weeks of treatment. Symptoms may 

return if treatment with Nordimet is stopped. 
 
Dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic 

arthritis 
The doctor will calculate the dose required from the child’s body surface area (m2), and the dose is 

expressed as mg/m2.  
 
Use in children under < 3 years is not recommended due to insufficient experience in this age 
group. 
 
Use in adults with severe forms of psoriasis vulgaris or psoriatic arthritis 
Your doctor will give you a single test dose of 5-10 mg, in order to assess possible side effects.  
If the test dose is well tolerated, treatment will be continued after a week with a dose of 

approximately 7.5 mg.  

 
Response to treatment can generally be expected after 2-6 weeks. Depending on the effects of 

treatment and results of blood and urine tests, the therapy is then continued or stopped. 

 

Method and duration of administration 
Nordimet is given as injection under the skin (subcutaneously). It must be injected once weekly and 

it is recommended to always inject Nordimet on the same day of the week.  
 
At the start of your treatment, Nordimet may be injected by medical staff. However, your doctor 
may decide that you can learn how to inject Nordimet yourself. You will receive appropriate 

training for you to do this. Under no circumstances should you attempt to inject yourself, unless you 

have been trained to do so. 

 
The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, 

juvenile idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with Nordimet is a long-term 

treatment. 
 

How to give yourself an injection of Nordimet 
If you have difficulty handling the syringe, ask your doctor or pharmacist. Do not try to inject 

yourself if you have not been trained on how to do so. If you are not sure what to do, talk to your 
doctor or nurse immediately. 
 



 

153 

Before injecting yourself with Nordimet 
-  Check the expiry date on the medicine. Do not use if the date has passed. 
-  Check the syringe is not damaged and the medicine in it is a clear, yellow solution. If not, use 

another syringe. 
-  Check your last injection site to see if the last injection caused any redness, change in skin 

colour, swelling, oozing or is still painful, if so talk to your doctor or nurse. 
-  Decide where you are going to inject the medicine. Change the place where you inject each 

time. 
 
Instructions on injecting yourself with Nordimet 
1) Wash your hands thoroughly with soap and water. 
 
2) Sit or lie in a relaxed, comfortable position. Make sure you can see the skin area you are going to 

inject.  
 
3) The syringe is pre-filled and ready to use. Open the blister pack by peeling back the top layer all 

the way off the blister pack as shown. 

 

 
 

4) Precaution: DO NOT lift the product by the plunger or needle cover. Remove the syringe from 

the box by the body as shown in the picture below.  
 

 
 
5) Visually inspect the syringe. You should see a yellow fluid through the viewing window. You 

may see a small air bubble, this does not affect the injection and will not harm you. 
 
6) Choose an injection site and clean it with the enclosed alcohol swab. It requires 30-60 seconds to 
be effective. The skin on the front side abdominal wall and the skin at the front of the thigh are 

suitable as injection sites. 
 
7) While holding the body of the syringe, pull the cap off.  
 



 

154 

 
 
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead to a 

loss of the medicine. Once you have taken the cap off, keep the syringe in your hand. Do not allow 

the syringe to touch anything else. This is to make sure that the needle stays clean. 
 
8) Hold the syringe in the hand you write with (like a pencil) and with your other hand, make a fold 

in the skin by gently pinching the skin of the injection place with your forefinger and thumb. Make 

sure you hold the skin fold throughout the injection. 
 
9) Move the syringe towards the skin fold (site of injection) with the needle shield pointing directly 

at the site of injection. Insert the full length of the needle into the skin fold. 

 

10) Press down on the plunger with your finger until the syringe is empty. This will send the 
medication under the skin.  
 

 
 
11) Remove the needle by pulling it out straight. The safety shield on the syringe will automatically 

cover the needle to prevent any needlestick injuries. You can now let go of the skin fold. 
 

 
 
Note: the safety system allowing release of the safety shield, can only be activated when the syringe 

has been emptied by pressing the plunger all the way down.  

 
  



 

155 

12) Discard the used syringe into the sharps bin provided. Close the container lid tightly and place 

the container out of reach of children. If you accidently get methotrexate on the surface of the skin 
or soft tissues you must rinse with plenty of water. 
 
If you use more Nordimet than you should 
Follow the dose recommendations of your treating doctor. Do not change the dose without your 
doctor’s recommendation. 
 
If you suspect that you have used too much Nordimet, tell your doctor or contact the nearest 

hospital immediately. Take your medicine package and this leaflet with you if you go to a doctor or 
hospital. 
 
An overdose of methotrexate can lead to severe toxic reactions. Overdose symptoms may include 

easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, 

coughing up blood or vomit that looks like coffee grounds, and decreased urinating. See also 
section 4. 
 
If you forget to use Nordimet 
Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose 
as normal. Ask your doctor for advice. 
 
If you stop taking Nordimet 
You should not interrupt or discontinue Nordimet treatment before discussing with your doctor. If 
you suspect that you are experiencing side effects, contact your doctor immediately for advice. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of 

the eyelids, face or lips, rash or itching (especially affecting your whole body). 
 

Serious side effects 
If you develop any of the following side effects, contact your doctor immediately: 
- inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness 

of breath, breathlessness at rest, chest pain, or fever)  
- spitting or coughing blood 
- severe peeling or blistering of the skin 
- unusual bleeding (including vomiting blood) or bruising 
- severe diarrhoea 
- ulcers in mouth 
- black or tarry stools 
- blood in the urine or stools 
- tiny red spots on the skin 
- fever 
- yellowing of the skin (jaundice) 
- pain or difficulty in passing urine 
- thirst and/or frequent urination 
- fits (convulsions) 
- loss of consciousness 
- blurred or decreased vision 

 
  



 

156 

The following side effects have also been reported: 
 
Very common (may affect more than 1 in 10 people): 
loss of appetite, nausea (feeling sick), vomiting, tummy pain, inflammation and ulcers in the mouth 

and throat, and increase in liver enzymes. 
 
Common (may affect up to 1 in 10 people): 
Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets 

(leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the 

lungs (pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, 
reddening of the skin, itching. 
 
Uncommon (may affect up to 1 in 100 people): 
Decrease in the number of blood cells and platelets , dizziness, confusion, depression, fits, 

inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver 
disorders, diabetes, decreased blood protein, nettle rash, light sensitivity, brown skin, hair loss, 

increase of rheumatic nodules, shingles, painful psoriasis, joint or muscle pain, osteoporosis 

(reduction of bone mass), inflammation and ulcers of the bladder (possibly with blood in the urine), 
painful urination, severe allergic reactions, inflammation and ulcers of the vagina, slow wound 

healing. 
 
Rare (may affect up to 1 in 1,000 people): 
Inflammation of the sac around the heart, fluid in the sac around the heart, severe visual 

disturbance, mood fluctuations, low blood pressure, blood clots, sore throat, interruption of 

breathing, asthma, inflammation of the digestive tract, bloody stools, inflamed gums, abnormal 

digestion, acute hepatitis (inflammation of the liver), changed colour of nails, acne, red or purple 
spots due to vessel bleeding, bone fracture, kidney failure, decrease or absence of urine, electrolyte 

disturbances, defective sperm formation, menstruation disorders. 
 
Very rare (may affect up to 1 in 10,000 people): 
Infections, severe failure of the bone marrow, liver failure, swollen glands, sleeplessness, pain, 

muscle weakness, sensation of numbness or tingling / having less sensitivity to stimulation than 
normal, changes in sense of taste (metallic taste), inflammation of the lining of the brain causing 

paralysis or vomiting, red eyes, damage to the retina of the eye, fluid in the lungs, vomiting blood, 

cold sores, protein in the urine, fever, loss of sex drive, problems having an erection, infection 

around a fingernail, severe complications of the gastrointestinal tract, boils, small blood vessels in 
the skin, fungal infections, damage to the blood vessels of the skin, vaginal discharge, infertility, 

male breast enlargement (gynaecomastia), inflammation of the brain, lymphoproliferative disorders 

(excessive growth of white blood cells). 
 
Frequency not known (cannot be estimated from the available data): 

Bleeding from the lungs, bone damage in the jaw (secondary to excessive growth of white blood 

cells), tissue destruction at injection site, redness and shedding of skin, swelling. 
 
Only mild local skin reactions were observed with Nordimet and these decreased during therapy. 
 
Nordimet may cause a reduction in the number of white blood cells and your resistance to infection 

may be decreased. If you experience an infection with symptoms such as fever and serious 
deterioration of your general condition, or fever with local infection symptoms such as sore 

throat/sore pharynx/sore mouth or urinary problems you should see your doctor immediately. A 

blood test will be taken to check for possible reduction of white blood cells (agranulocytosis). It is 

important to tell your doctor that you are taking Nordimet. 
 
Methotrexate is known to cause bone disorders such as joint and muscle pain and osteoporosis. The 

frequency of these risks in children is not known.  
 
  



 

157 

Nordimet may cause serious (sometimes life-threatening) side effects. Your doctor will do tests to 

check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, 
lymphoma) and changes in the kidney and the liver. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety 

of this medicine. 
 
 
5.       How to store Nordimet 
 
Keep this medicine out of the sight and reach of children.  

 
Do not use this medicine after the expiry date which is stated on the label of the pre-filled syringe 
and the carton after EXP. The expiry date refers to the last day of that month. 
 
Store below 25°C. 
Keep the syringe in the outer carton in order to protect from light. 
 
Do not use this medicine if you notice that the solution is not clear and contains particles. 
 
Nordimet is for single use only. Any used syringe should be discarded. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6.          Contents of the pack and other information 
 
What Nordimet contains 
The active substance is methotrexate. 1 ml of solution contains 25 mg methotrexate. 
The other ingredients are sodium chloride, sodium hydroxide and water for injections. 
 
The following syringes are available: 
Pre-filled syringes of 0.3 ml containing 7.5 mg methotrexate.  
Pre-filled syringes of 0.4 ml containing 10 mg methotrexate 
Pre-filled syringes of 0.5 ml containing 12.5 mg methotrexate 
Pre-filled syringes of 0.6 ml containing 15 mg methotrexate  
Pre-filled syringes of 0.7 ml containing 17.5 mg methotrexate  
Pre-filled syringes of 0.8 ml containing 20 mg methotrexate  
Pre-filled syringes of 0.9 ml containing 22.5 mg methotrexate  
Pre-filled syringes of 1.0 ml containing 25 mg methotrexate 
 
What Nordimet looks like and contents of the pack 
Nordimet pre-filled syringes contain a clear, yellow solution for injection. The pre-filled syringes 

contain a safety system designed to prevent needlestick injury and reuse. 
 
Nordimet is available in packs containing 1 pre-filled syringe of 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 

0.7 ml, 0.8 ml, 0.9 ml or 1.0 ml solution for injection with attached needle with needle guard and 

two alcohol swabs and in multipacks of 4, 6 and 12 cartons, each containing 1 pre-filled syringe 
solution for injection with attached needle with needle guard and two alcohol swabs. 

 

Not all pack sizes may be marketed. 
  

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

158 

Marketing Authorisation Holder  
 
Nordic Group B.V. 
Siriusdreef 41 
2132 WT Hoofddorp 
The Netherlands 
 
Manufacturer 
 
CENEXI - Laboratoires Thissen 
Rue de la Papyrée 2-6 
B-1420 Braine-l’Alleud 
Belgium 

 
 
This leaflet was last revised in 
 
Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http//www.ema.europa.eu. 
  



 

159 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annex IV 

Scientific conclusions and grounds for the variation to the terms of the marketing 

authorisation(s) 



 

160 

Scientific conclusions 

Taking into account the PRAC Assessment Report on the PSUR(s) for methotrexate, the scientific 

conclusions of CHMP are as follows:  

In view of the available data on medication errors due to handling issues resulting from lack of 

training with parenteral products suitable for self-administration the PRAC concluded that the 

product information (Section 4.2 of the SmPC and Section 3 of the PL) of products containing 

methotrexate suitable for parenteral self-administration by patients (i.e. prefilled syringes and 

prefilled pens) should be amended accordingly. 

For products without any indication in oncology or extra-uterine pregnancy, the PRAC concluded 

that the existing wording in the product information (Section 4.5 of the SmPC) concerning the 

interaction between methotrexate and nitrous oxide should be amended to provide more clarity.  

In view of available data on skin exfoliation from the literature, spontaneous reports, including in 

some cases a close temporal relationship, and a positive de-challenge and/or re-challenge, the 

PRAC considers that a causal relationship between methotrexate and skin exfoliation / exfoliative 

dermatitis is established. The PRAC concluded that an update of section 4.8 of the SmPC to add the 

adverse reaction “skin exfoliation / dermatitis exfoliative” with a frequency “not known” was 

warranted for all methotrexate containing products. The PL should be amended accordingly. 

In view of available data on paraesthesia / hypoaesthesia (not restricted to extremities) from 

spontaneous reports, including in some cases a close temporal relationship, and a positive re-

challenge, and existing product information the PRAC considers a causal relationship between 

methotrexate and paraesthesia / hypoaesthesia (not restricted to extremities) is at least a reasonable 

possibility. The PRAC concluded that an update of section 4.8 of the SmPC to add or amend the 

adverse reaction “paraesthesia / hypoaesthesia” not restricted to the extremities with a frequency of 

“very rare” was warranted for low dose methotrexate-containing products. The PL should be 

amended accordingly. 

In view of available data on oedema from spontaneous reports, including in some cases a close 

temporal relationship, and a positive de-challenge the PRAC considers a causal relationship 

between methotrexate and oedema is at least a reasonable possibility. The PRAC concluded that an 

update of section 4.8 of the SmPC to add the adverse reaction “oedema” with a frequency “not 

known” was warranted for low dose methotrexate-containing products. The PL should be amended 

accordingly. 

The CHMP agrees with the scientific conclusions made by the PRAC. 

Grounds for the variation to the terms of the marketing authorisation(s) 

On the basis of the scientific conclusions for methotrexate the CHMP is of the opinion that the 

benefit-risk balance of the medicinal products containing methotrexate is unchanged subject to the 

proposed changes to the product information. 

The CHMP recommends that the terms of the marketing authorisations should be varied. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A.        MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B.        CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.        OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D.        CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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'Text': 'light therapy', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'puva (ultraviolet light therapy', 'Type': 'TREATMENT', 'BeginOffset': 891, 'EndOffset': 922}, {'Text': 'retinoids (group of medicines', 'Type': 'TREATMENT', 'BeginOffset': 929, 'EndOffset': 958}, {'Id': 8, 'BeginOffset': 972, 'EndOffset': 981, 'Score': 0.7038760185241699, 'Text': 'vitamin a', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}]}
{'Title': '2. what you need to know before you use nordimet', 'Section_Content': 'do not use nordimet if: - you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6) - you have severe kidney disease (your doctor will be able to tell you if you have severe kidney disease) - you have severe liver disease (your doctor will be able to tell you if you have severe liver disease) - you have disorders of the blood-forming system - your alcohol consumption is high - you have an impaired immune system - you have a severe or existing infection, e.g. tuberculosis or hiv - you have gastrointestinal ulcers - you are pregnant or breast-feeding (see section "pregnancy, breast-feeding and fertility") - you receive vaccinations with live vaccines at the same time. warnings and precautions acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate. if you experience symptoms of spitting or coughing up blood you should contact your doctor immediately. important warning about the dosing of nordimet methotrexate for the therapy of rheumatic diseases or diseases of the skin must only be used once weekly. incorrect dosing of methotrexate may lead to serious adverse effects which may be fatal. please read section 3 of this package leaflet very carefully. talk to your doctor before using nordimet if: - you have diabetes mellitus and are being treated with insulin - you have inactive, prolonged infections (e.g. tuberculosis, hepatitis b or c, shingles [herpes zoster]) - you have/had any liver or kidney disease - you have problems with lung function - you are severely overweight - you have abnormal accumulation of liquid in the abdomen or in the cavity between the lungs and chest wall (ascites, pleural effusions) - you are dehydrated or suffer from conditions leading to dehydration (e.g. dehydration as a result of vomiting, diarrhoea or inflammation of the mouth and lips) if you have experienced problems with your skin after radiation therapy (radiation induced dermatitis) or sun-burn, these conditions can reappear when taking nordimet. children, adolescents and elderly dose instructions depend on the patient\'s body weight. use in children under 3 years of age is not recommended due to insufficient experience of using this medicine in this age group. children, adolescents and the elderly being treated with nordimet should be kept under close medical surveillance to identify possible side effects as early as possible. the dose for elderly patients should be lowered due to age-related reduced liver and kidney function. special precautionary measures for treatment with nordimet methotrexate temporarily affects sperm and egg production, which is reversible in most cases. methotrexate can cause miscarriage and severe birth defects. you must avoid becoming pregnant 139 when using methotrexate and for at least six months after treatment has stopped. see also section "pregnancy, breast-feeding and fertility". skin changes caused by psoriasis can worsen during treatment with nordimet if exposed to ultraviolet irradiation. before the start of treatment and recommended follow-up examinations and precautions before treatment is started your doctor may carry out blood tests, and also check how well your kidneys and liver are working. you may also have a chest x-ray. further tests may also be done during and after treatment. do not miss appointments for blood tests. if the results of any of these tests are abnormal, treatment will only be resumed when all readings are back to normal. even when nordimet is used at low doses, serious side effects can occur. your doctor will carry out blood and urine tests to make sure that any side effects are identified quickly. other medicines and nordimet tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal or natural medicinal products. it is especially important to tell your doctor if you are taking: - other treatments for rheumatoid arthritis or psoriasis such as leflunomide, sulphasalazine (a medicine that besides arthritis and psoriasis is also used to treat ulcerative colitis), aspirin, phenylbutazone, or amidopyrine - alcohol (drinking alcohol should be avoided while you are taking nordimet) - azathioprine (used to prevent rejection after an organ transplant) - retinoids (used to treat psoriasis and other skin disorders) - anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or carbamazepine - cancer treatments - barbiturates (sleeping injection) - tranquillisers - oral contraceptives - probenecid (used to treat gout) - antibiotics - pyrimethamine (which is used to prevent and treat malaria) - vitamin preparations containing folic acid - proton-pump inhibitors (medicines that reduce the production of gastric acid and that are used to treat severe heartburn or ulcers), such as omeprazole - theophylline (used to treat asthma) - any vaccination with a live vaccine (must be avoided), such as measles, mumps, influenza or yellow fever vaccines. nordimet with food, drink and alcohol during treatment with nordimet, you must not drink any alcohol and should avoid excessive consumption of coffee, soft drinks containing caffeine and black tea as this may enhance side effects or interfere with the efficacy of nordimet. also, make sure you drink plenty of liquids during treatment with nordimet because dehydration (reduction in body water) can increase the toxicity of nordimet. pregnancy, breast-feeding and fertility if you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. pregnancy do not use nordimet during pregnancy or if you are trying to become pregnant. methotrexate can cause birth defects, harm unborn babies or cause miscarriages. it is associated with malformations of the skull, face, heart and blood vessels, brain and limbs. therefore, it is very important that methotrexate is not given to pregnant patients or patients planning to become pregnant. in women of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. a pregnancy test before starting treatment. you must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after treatment is stopped by using reliable contraception throughout this time (see also section "warnings and precautions"). if you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible. you should be offered advice regarding the risk of harmful effects on the child through treatment. if you wish to become pregnant you should consult your doctor, who may refer you for specialist advice before the planned start of treatment. breast-feeding do not breast-feed during treatment because methotrexate passes into breast milk. if your doctor considers treatment with methotrexate absolutely necessary during the lactation period, you must stop breast-feeding. male fertility the available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week. however, a risk cannot be completely excluded. methotrexate may be genotoxic. this means that the medicine may cause genetic mutation. methotrexate can affect sperm production with the potential to cause birth defects. therefore, you should avoid fathering a child or to donate semen whilst taking methotrexate and for at least 6 months after treatment is stopped. driving and using machines side effects affecting the central nervous system, such as tiredness and dizziness, may occur during treatment with nordimet. in some cases, the ability to drive vehicles and/or use machines may be impaired. if you feel tired or dizzy, you should not drive or use machines. 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{'Title': '3. how to use nordimet', 'Section_Content': 'important warning about the dose of nordimet use nordimet only once a week for the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, psoriasis and psoriatic arthritis requiring dosing once a week. using too much of nordimet may be fatal. please read section 3 of this leaflet very carefully. if you have any questions, please talk to your doctor or pharmacist before you take this medicine. always use this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. nordimet is administered once a week only. you and your doctor can decide on a suitable day each week to receive your injection. incorrect administration of nordimet can lead to severe side effects that may be fatal. the recommended dose is: dose in patients with rheumatoid arthritis the recommended starting dose is 7.5 mg methotrexate once a week. the doctor may increase the dose if the used dose is not effective but tolerated well. the average weekly dose is 15-20 mg. generally, a weekly dose of 25 mg should not be exceeded. once nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective maintenance dose. generally, improvement of symptoms can be expected after 4-8 weeks of treatment. symptoms may return if treatment with nordimet is stopped. dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis the doctor will calculate the dose required from the child\'s body surface area (m2), and the dose is expressed as mg/m2. use in children under < 3 years is not recommended due to insufficient experience in this age group. use in adults with severe forms of psoriasis vulgaris or psoriatic arthritis your doctor will give you a single test dose of 5-10 mg, in order to assess possible side effects. if the test dose is well tolerated, treatment will be continued after a week with a dose of approximately 7.5 mg. response to treatment can generally be expected after 2-6 weeks. depending on the effects of treatment and results of blood and urine tests, the therapy is then continued or stopped. method and duration of administration nordimet is given as injection under the skin (subcutaneously). it must be injected once weekly and it is recommended to always inject nordimet on the same day of the week. at the start of your treatment, nordimet may be injected by medical staff. however, your doctor may decide that you can learn how to inject nordimet yourself. you will receive appropriate training for you to do this. under no circumstances should you attempt to inject yourself, unless you have been trained to do so. the duration of treatment is determined by the treating physician. treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with nordimet is a long-term treatment. how to give yourself an injection of nordimet if you have difficulty handling the pen, ask your doctor or pharmacist. do not try to inject yourself if you have not been trained on how to do so. if you are not sure what to do, talk to your doctor or nurse immediately. before injecting yourself with nordimet - check the expiry date on the medicine. do not use if the date has passed. - check the pen is not damaged and the medicine in it is a clear, yellow solution. if not, use another pen. - check your last injection site to see if the last injection caused any redness, change in skin colour, swelling, oozing or is still painful, if so talk to your doctor or nurse. - decide where you are going to inject the medicine. change the place where you inject each time. instructions on injecting yourself with nordimet 1) wash your hands thoroughly with soap and water. 2) sit or lie in a relaxed, comfortable position. make sure you can see the skin area you are going to inject. 3) the pen is pre-filled and ready to use. visually inspect the pen. you should see a yellow fluid through the viewing window. you may see a small air bubble, this does not affect the injection and will not harm you. a droplet may appear at the tip of the needle. this is normal. 4) choose an injection site and clean it with the enclosed alcohol swab. it requires 30-60 seconds to be effective. the skin on the front side abdominal wall and the skin at the front of the thigh are suitable as injection sites. 5) while holding the body of the pen, pull the cap off. once you have taken the cap off, keep the pen in your hand. do not allow the pen to touch anything else. this is to make sure that the pen is not accidentally activated and that the needle stays clean. 6) make a fold in the skin by gently pinching the skin of the injection place with your forefinger and thumb. make sure you hold the skin fold throughout the injection. 7) move the pen towards the skin fold (site of injection) with the needle shield pointing directly at the site of injection. place the yellow needle shield against the area of injection so that the entire rim of the needle shield is touching the skin. 8) apply downward pressure on the pen on to your skin until you hear and feel a "click". this activates the pen and the solution will inject automatically into the skin. 9) the injection lasts for a maximum of 10 seconds. you will feel and hear a second "click" once the injection is completed. 10) wait another 2-3 seconds before removing the pen from your skin. the safety shield on the pen is now locked to prevent any needlestick injuries. you can now let go of the skin fold. 11) visually inspect the pen through the viewing window. you should see green plastic. this means that all the fluid has been injected. discard the used pen into the sharps bin provided. close the container lid tightly and place the container out of reach of children. if you accidently get methotrexate on the surface of the skin or soft tissues you must rinse with plenty of water. if you use more nordimet than you should follow the dose recommendations of your treating doctor. do not change the dose without your doctor\'s recommendation. if you suspect that you have used too much nordimet, tell your doctor or contact the nearest hospital immediately. take your medicine package and this leaflet with you if you go to a doctor or hospital. an overdose of methotrexate can lead to severe toxic reactions. overdose symptoms may include easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and decreased urinating. see also section 4. if you forget to use nordimet do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose as normal. ask your doctor for advice. if you stop taking nordimet you should not interrupt or discontinue nordimet treatment before discussing with your doctor. if you suspect that you are experiencing side effects, contact 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). serious side effects if you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood - severe peeling or blistering of the skin - unusual bleeding (including vomiting blood) or bruising - severe diarrhoea - ulcers in mouth - black or tarry stools - blood in the urine or stools - tiny red spots on the skin - fever - yellowing of the skin (jaundice) - pain or difficulty in passing urine - thirst and/or frequent urination - fits (convulsions) - loss of consciousness - blurred or decreased vision 145 the following side effects have also been reported: very common (may affect more than 1 in 10 people): loss of appetite, nausea (feeling sick), vomiting, tummy pain, inflammation and ulcers in the mouth and throat, and increase in liver enzymes. common (may affect up to 1 in 10 people): reduced blood cell formation with decrease in white and/or red blood cells and/or platelets (leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the lungs (pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, reddening of the skin, itching. uncommon (may affect up to 1 in 100 people): decrease in the number of blood cells and platelets , dizziness, confusion, depression, fits, inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver disorders, diabetes, decreased blood protein, nettle rash, light sensitivity, brown skin, hair loss, increase of rheumatic nodules, shingles, painful psoriasis, joint or muscle pain, osteoporosis (reduction of bone mass), inflammation and ulcers of the bladder (possibly with blood in the urine), painful urination, severe allergic reactions, inflammation and ulcers of the vagina, slow wound healing. rare (may affect up to 1 in 1,000 people): inflammation of the sac around the heart, fluid in the sac around the heart, severe visual disturbance, mood fluctuations, low blood pressure, blood clots, sore throat, interruption of breathing, asthma, inflammation of the digestive tract, bloody stools, inflamed gums, abnormal digestion, acute hepatitis (inflammation of the liver), changed colour of nails, acne, red or purple spots due to vessel bleeding, bone fracture, kidney failure, decrease or absence of urine, electrolyte disturbances, defective sperm formation, menstruation disorders. very rare (may affect up to 1 in 10,000 people): infections, severe failure of the bone marrow, liver failure, swollen glands, sleeplessness, pain, muscle weakness, sensation of numbness or tingling / having less sensitivity to stimulation than normal, changes in sense of taste (metallic taste), inflammation of the lining of the brain causing paralysis or vomiting, red eyes, damage to the retina of the eye, fluid in the lungs, vomiting blood, cold sores, protein in the urine, fever, loss of sex drive, problems having an erection, infection around a fingernail, severe complications of the gastrointestinal tract, boils, small blood vessels in the skin, fungal infections, damage to the blood vessels of the skin, vaginal discharge, infertility, male breast enlargement (gynaecomastia), inflammation of the brain, lymphoproliferative disorders (excessive growth of white blood cells). frequency not known (cannot be estimated from the available data): bleeding from the lungs, bone damage in the jaw (secondary to excessive growth of white blood cells), tissue destruction at injection site, redness and shedding of skin, swelling. only mild local skin reactions were observed with nordimet and these decreased during therapy. nordimet may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. if you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/sore pharynx/sore mouth or urinary problems you should see your doctor immediately. a blood test will be taken to check for possible reduction of white blood cells (agranulocytosis). it is important to tell your doctor that you are taking nordimet. methotrexate is known to cause bone disorders such as joint and muscle pain and osteoporosis. the frequency of these risks in children is not known. nordimet may cause serious (sometimes life-threatening) side effects. your doctor will do tests to check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, lymphoma) and changes in the kidney and the liver. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'nordimet', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 21, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9653276205062866, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7972280383110046}]}, {'Text': 'any sudden wheeziness', 'Type': 'PROBLEM', 'BeginOffset': 134, 'EndOffset': 155}, {'Id': 24, 'BeginOffset': 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0.9038504362106323}]}, {'Id': 244, 'BeginOffset': 4579, 'EndOffset': 4591, 'Score': 0.9591796398162842, 'Text': 'methotrexate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 259, 'BeginOffset': 4610, 'EndOffset': 4624, 'Score': 0.9676987528800964, 'Text': 'bone disorders', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.8931840658187866}]}, {'Id': 260, 'BeginOffset': 4633, 'EndOffset': 4654, 'Score': 0.36440667510032654, 'Text': 'joint and muscle pain', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7091770172119141}]}, {'Id': 240, 'BeginOffset': 4643, 'EndOffset': 4649, 'Score': 0.9891451001167297, 'Text': 'muscle', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 261, 'BeginOffset': 4659, 'EndOffset': 4671, 'Score': 0.9992011189460754, 'Text': 'osteoporosis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 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0.9583445191383362, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6454603672027588}]}, {'Id': 272, 'BeginOffset': 5148, 'EndOffset': 5160, 'Score': 0.8725186586380005, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7092121839523315}]}, {'Id': 273, 'BeginOffset': 5214, 'EndOffset': 5225, 'Score': 0.40836578607559204, 'Text': 'appendix v.', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6187501549720764}]}, {'Id': 274, 'BeginOffset': 5239, 'EndOffset': 5251, 'Score': 0.8666620850563049, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7439308166503906}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 5307, 'EndOffset': 5320}]}
{'Title': '5. how to store nordimet', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the label of the pre-filled pen and the carton after exp. the expiry date refers to the last day of that month. store below 25. keep the pen in the outer carton in order to protect from light. do not use this medicine if you notice that the solution is not clear and contains particles. nordimet is for single use only. any used pen should be discarded. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'nordimet', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '25.', 'Type': 'NUMBER', 'BeginOffset': 249, 'EndOffset': 252}, {'Text': 'the pen in the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 258, 'EndOffset': 285}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 329, 'EndOffset': 342}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what nordimet contains the active substance is methotrexate. 1 ml of solution contains 25 mg methotrexate. the other ingredients are sodium chloride, sodium hydroxide and water for injections. the following pens are available: pre-filled pens of 0.3 ml containing 7.5 mg methotrexate. pre-filled pens of 0.4 ml containing 10 mg methotrexate pre-filled pens of 0.5 ml containing 12.5 mg methotrexate pre-filled pens of 0.6 ml containing 15 mg methotrexate pre-filled pens of 0.7 ml containing 17.5 mg methotrexate pre-filled pens of 0.8 ml containing 20 mg methotrexate pre-filled pens of 0.9 ml containing 22.5 mg methotrexate pre-filled pens of 1.0 ml containing 25 mg methotrexate what nordimet looks like and contents of the pack nordimet pre-filled pens contain a clear, yellow solution for injection. the pre-filled pens are designed to prevent needlestick injury and reuse. nordimet is available in packs containing 1 or 4 pre-filled pens of 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml or 1.0 ml solution for injection with attached needle and 1 or 4 alcohol swabs and in multipacks of 4 and 6 cartons, each containing 1 pre-filled pen solution for injection with attached needle and one alcohol swab. nordimet is also available in multipacks containing 12 pre- filled pens in 3 cartons (4 pens and alcohol swabs per carton). not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'nordimet', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 47, 'EndOffset': 59, 'Score': 0.996619462966919, 'Text': 'methotrexate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9570043087005615, 'RelationshipScore': 0.9904138445854187, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 61, 'EndOffset': 65, 'Text': '1 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 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