Cegfila
1 

ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

     This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

1. NAME OF THE MEDICINAL PRODUCT 

Cegfila 6 mg solution for injection in pre-filled syringe 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The 

concentration is 10 mg/mL based on protein only**. 

*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with

polyethylene glycol (PEG).

** The concentration is 20 mg/mL if the PEG moiety is included. 

The potency of this product should not be compared to the potency of another pegylated or 

nonpegylated protein of the same therapeutic class. For more information, see section 5.1 

Excipient with known effect 

Each pre-filled syringe contains 30 mg sorbitol (E420). For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Solution for injection 

Clear, colourless solution for injection. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications 

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients 
treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia 

and myelodysplastic syndromes). 

4.2 Posology and method of administration 

Cegfila therapy should be initiated and supervised by physicians experienced in oncology and/or 

haematology. 

Posology 

One 6 mg dose (a single pre-filled syringe) of Cegfila is recommended for each chemotherapy cycle, 
given at least 24 hours after cytotoxic chemotherapy. 



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Special populations 

Paediatric population 

The safety and efficacy of pegfilgrastim in children has not yet been established. Currently available 

data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.  

Patients with renal impairment 

No dose change is recommended in patients with renal impairment, including those with end stage 

renal disease. 

Method of administration 

Cegfila is injected subcutaneously. The injections should be given into the thigh, abdomen or upper 

arm. For instructions on handling of the medicinal product before administration, see section 6.6. 

4.3 Contraindications 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

4.4 Special warnings and precautions for use 

Traceability

In order to improve the traceability of biologic medicinal products, the name and the batch number of 

the administered product should be clearly recorded. 

Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for 
pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). 

However, the long-term effects of Cegfila have not been established in AML; therefore, it should be 

used with caution in this patient population. 

Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects 
may be seen on some non-myeloid cells in vitro. 

The safety and efficacy of Cegfila have not been investigated in patients with myelodysplastic 

syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should 

not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast 

transformation of chronic myeloid leukaemia from AML. 

The safety and efficacy of Cegfila administration in de novo AML patients aged < 55 years with 

cytogenetics t (15;17) have not been established. 

The safety and efficacy of Cegfila have not been investigated in patients receiving high dose 

chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic 

chemotherapy beyond established dosage regimens. 

Pulmonary adverse events

Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF 

administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher 

risk (see section 4.8). The onset of pulmonary signs such as cough, fever, and dyspnoea in association 
with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with 

increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome 

(ARDS). In such circumstances Cegfila should be discontinued at the discretion of the physician and 

the appropriate treatment given (see section 4.8). 

Glomerulonephritis 

Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally,  

events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and 



4 

pegfilgrastim. Urinalysis monitoring is recommended. 

Capillary leak síndrome 
Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration 

and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients 

who develop symptoms of capillary leak syndrome should be closely monitored and receive standard 

symptomatic treatment, which may include a need for intensive care (see section 4.8). 

Splenomegaly and splenic ruptura 

Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal 

cases, have been reported following administration of pegfilgrastim (see section 4.8). Therefore, 

spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of 

splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip 

pain. 

Thrombocytopenia and anaemia 

Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full 

dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of 

platelet count and haematocrit is recommended. Special care should be taken when administering 
single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.  

Sickle cell anaemia 

Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or 

sickle cell disease (see section 4.8). Therefore, physicians should use caution when prescribing Cegfila 
in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters 

and laboratory status and be attentive to the possible association of this medicinal product with splenic 

enlargement and vaso-occlusive crisis. 

Leukocytosis

White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1 % of 

patients receiving pegfilgrastim therapy. No adverse events directly attributable to this degree of 

leukocytosis have been reported. Such elevation in white blood cells is transient, typically seen 24 to 
48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal 

product. Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be 

performed at regular intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected 

nadir, this medicinal product should be discontinued immediately. 

Hypersensitivity 

Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have 
been reported in patients treated with pegfilgrastim. Permanently discontinue Cegfila in patients with 

clinically significant hypersensitivity. Do not administer Cegfila to patients with a history of 

hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy 

should be administered, with close patient follow-up over several days. 

Stevens-Johnson syndrome 
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in 

association with pegfilgrastim treatment. If the patient has developed SJS with the use of 

pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.  

Immunogenicity 
As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of 

antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all 

biologics; however, they have not been associated with neutralising activity at present.  

Aortitis 

Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The 



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symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory 

markers (e.g. C-reactive protein and white blood cell count). In most cases aortitis was diagnosed by 
CT scan and generally resolved after withdrawal of G-CSF (see section 4.8). 

 

Other warnings 

The safety and efficacy of Cegfila for the mobilisation of blood progenitor cells in patients or healthy 

donors has not been adequately evaluated. 

Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been 
associated with transient positive bone imaging findings. This should be considered when interpreting 

bone-imaging results. 

 

This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 

mg/mL. The additive effect of concomitantly administered products containing sorbitol (or fructose) 
and dietary intake of sorbitol (or fructose) should be taken into account.  

 

This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say 

essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Cegfila 

should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical 

trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of 

Cegfila with any chemotherapy agent has not been evaluated in patients. In animal models 
concomitant administration of pegfilgrastim and 

5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.  

 

Possible interactions with other haematopoietic growth factors and cytokines have not been 

specifically investigated in clinical trials. 
 

The potential for interaction with lithium, which also promotes the release of neutrophils, has not been 

specifically investigated. There is no evidence that such an interaction would be harmful.  

 

The safety and efficacy of Cegfila have not been evaluated in patients receiving chemotherapy 

associated with delayed myelosuppression e.g., nitrosoureas. 
 

Specific interaction or metabolism studies have not been performed, however, clinical trials have not 

indicated an interaction of pegfilgrastim with any other medicinal products. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in 

animals have shown reproductive toxicity (see section 5.3). Cegfila is not recommended during 

pregnancy and in women of childbearing potential not using contraception.  

 
Breast-feeding 

There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk a risk 

to the newborns/infants cannot be excluded. A decision must be made whether to discontinue 

breast-feeding or to discontinue/abstain from Cegfila therapy taking into account the benefit of breast-

feeding for the child and the benefit of therapy for the woman. 
 

Fertility 

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative 

weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body 

surface area) (see section 5.3). 
 



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4.7 Effects on ability to drive and use machines 

Cegfila has no or negligible influence on the ability to drive and use machines. 

4.8 Undesirable effects 

Summary of the safety profile 

The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and 
musculoskeletal pain (common). Bone pain was generally of mild to moderate severity, transient and 

could be controlled in most patients with standard analgesics. 

Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, 

flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon 

[≥ 1/1,000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients 
receiving pegfilgrastim (uncommon) (see section 4.4). 

Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as 

uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following 

administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of 
selected adverse reactions” below. 

Splenomegaly, generally asymptomatic, is uncommon. 

Splenic rupture including some fatal cases is uncommonly reported following administration of 
pegfilgrastim (see section 4.4). Uncommon pulmonary adverse reactions including interstitial 

pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. 

Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome 

(ARDS), which may be fatal (see section 4.4). 

Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell 
disease (uncommon in sickle cell patients) (see section 4.4). 

Tabulated list of adverse reactions 

The data in the table below describe adverse reactions reported from clinical trials and spontaneous 

reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing 

seriousness.



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MedDRA 

system organ 

class 

Adverse reactions 

Very 

common 

Common Uncommon Rare Very rare 

(≥ 1/10) (≥ 1/100 
to < 1/10) 

(≥ 1/1,000 
to < 1/100) 

(≥ 1/10,000 
to < 1/1,000) 

(< 1/10,000) 

Blood and 
lymphatic 

system 
disorders 

Thrombocytope 
nia1

Leukocytosis1

Sickle cell 
crisis2; 

Splenomegaly2; 
Splenic rupture2

Immune 

system 

disorders 

Hypersensitivity 

reactions; 

Anaphylaxis 

Metabolism 
and nutrition 

disorders 

Elevations in 
uric acid 

Nervous 
system 
disorders 

Headache1

Vascular 

disorders 

Capillary leak 

syndrome1
Aortitis 

Respiratory, 

thoracic and 

mediastinal 
disorders 

Acute 

Respiratory 

Distress 

Syndrome2; 

Pulmonary 
adverse 

reactions 

(interstitial 

pneumonia, 

pulmonary 
oedema, 

pulmonary 

infiltrates and 

pulmonary 

fibrosis) 
Haemoptysis 

Pulmonary 

hemorrhage 

Gastrointestina 
l disorders

Nausea1

Skin and 

subcutaneous 
tissue disorders 

Sweet’s 
syndrome (acute 

febrile 

dermatosis)1,2; 

Cutaneous 

vasculitis1,2

Stevens-

Johnson 
syndrome 



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MedDRA 

system organ 

class 

Adverse reactions 

Very 

common 

Common Uncommon Rare Very rare 

(≥ 1/10) (≥ 1/100 
to < 1/10) 

(≥ 1/1,000 
to < 1/100) 

(≥ 1/10,000 

to < 1/1,000) 

(< 1/10,000) 

Musculoskeleta 

l and

connective

tissue disorders

Bone pain Musculoskeletal 

pain (myalgia, 

arthralgia, pain 

in extremity, 

back pain, 
musculoskeletal 
pain, neck pain) 

Renal and 
urinary 
disorders 

Glomerulo- 

nephritis2

General 
disorders and 

administration 

site conditions 

Injection site 
pain, 

Non-cardiac 

chest pain 1

Injection site 

reactions2

Investigations Elevations in 
lactate 

dehydrogenase 

and alkaline 

phosphatase1; 

Transient 

elevations in 

LFT's for ALT 
or AST1

1 See section “Description of selected adverse reactions” below. 
2 This adverse reaction was identified through post-marketing surveillance but not observed in 

randomised, controlled clinical trials in adults that supported the marketing authorisation. The 

frequency category was estimated from a statistical calculation based upon 1,576 patients receiving 

pegfilgrastim in nine randomised clinical trials. 

Description of selected adverse reactions 

Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying 

haematological malignancies may play a role. 

Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. 
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown. 

Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain 

(common) have occurred on initial or subsequent treatment with pegfilgrastim. 

Common cases of leukocytosis (White Blood Count [WBC] > 100 × 109/L) have been reported (see 

section 4.4). 

Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated 

clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, 
with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following 

cytotoxic chemotherapy. 

Nausea and headaches were very commonly observed in patients receiving chemotherapy.  



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Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST 
(aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following 
cytotoxic chemotherapy. These elevations are transient and return to baseline. 

Common cases of thrombocytopenia have been reported. 

Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte 
colony-stimulating factor use. These have generally occurred in patients with advanced malignant 
diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see 
section 4.4). 

Paediatric population 
The experience in children is limited. A higher frequency of serious adverse reactions in younger 
children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 
12-21 years respectively (80 % and 67 %) and adults. The most common adverse reaction reported 
was bone pain (see section 5.1 and 5.2).

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 

Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy 

volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse 

events were similar to those in subjects receiving lower doses of pegfilgrastim. 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties 

Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13 

Cegfila is a biosimilar medicinal product. Detailed information is available on the website of the 

European Medicines Agency http://www.ema.europa.eu. 

Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the 
production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of 
recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule. 
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim 
and filgrastim have been shown to have identical modes of action, causing a marked increase in 
peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or 
lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal 
or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with other 
haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial 
cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar 
effects may be seen on some non-myeloid cells in vitro. 



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In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer 

undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of 
pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of 

febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 

daily administrations). In the absence of growth factor support, this regimen has been reported to 

result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile 

neutropenia.  

In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 

neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group 

(difference 0.23 days, 95 % CI −0.15, 0.63). Over the entire study, the rate of febrile neutropenia was 

13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 

%, 95 % CI of −19 %, 5 %). In a second study (n = 310), which used a weight-adjusted dose (100 μg 
/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared 

with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI 

−0.36, 0.30). The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and

18 % of patients treated with filgrastim (difference 9 %, 95 % CI of −16.8 %,−1.1 %).

In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on 

the incidence of febrile neutropenia was evaluated following administration of a chemotherapy 

regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 

4 cycles). Nine hundred and twenty eight patients were randomised to receive either a single dose of 

pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle. The 

incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared 

with placebo (1 % versus 17 %, p < 0.001). The incidence of hospitalisations and IV anti-infective use 
associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group 

compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001). 

A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de 

novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, 
administered during induction chemotherapy. Median time to recovery from severe neutropenia was 

estimated as 22 days in both treatment groups. Long term outcome was not studied (see section 4.4). 

In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients 
receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide 

(VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 × 109) was 

observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years 

and 12-21 years (6 days and 3.7 days, respectively) and adults. 

Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 

years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, 
respectively) and adults (see sections 4.8 and 5.2). 

5.2 Pharmacokinetic properties 

After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim 

occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained 

during the period of neutropenia after myelosuppressive chemotherapy. The elimination of 

pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with 

increasing dose. Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, 
which becomes saturated at higher doses. Consistent with a self-regulating clearance mechanism, the 

serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see 

figure 1). 



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Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count 
(ANC) in chemotherapy treated patients after a single 6 mg injection 

 

 
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Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not 

expected to be affected by renal or hepatic impairment. In an open label, single dose study (n = 31) 
various stages of renal impairment, including end-stage renal disease, had no impact on the 

pharmacokinetics of pegfilgrastim. 

 

Elderly 

Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is 
similar to that in adults. 

 

Paediatric population 

The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who 

received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. The youngest 
age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) 

(47.9 ± 22.5 μg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/mL 

and 29.3 ± 23.2 μg·hr/mL, respectively) (see section 5.1). With the exception of the youngest age 

group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with 

high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of 

doxorubicin/docetaxel (see sections 4.8 and 5.1). 
 

5.3 Preclinical safety data 
 

Preclinical data from conventional studies of repeated dose toxicity revealed the expected 
pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, 

extramedullary haematopoiesis and splenic enlargement. 

 

There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim 

subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity 

(embryo loss) at cumulative doses approximately 4 times the recommended human dose, 
which were not seen when pregnant rabbits were exposed to the recommended human dose. 

In rat studies, it was shown that pegfilgrastim may cross the placenta. Studies in rats indicated 

that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, 

and intrauterine survival were unaffected by pegfilgrastim given subcutaneously. The 

relevance of these findings for humans is not known. 

 



12 
 

 

6. PHARMACEUTICAL PARTICULARS 
 

6.1 List of excipients 
 

Sodium acetate* Sorbitol (E 420) 
Polysorbate 20 Water for injections 

Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) 

 
*Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.  

 

6.2 Incompatibilities 
 

This medicinal product must not be mixed with other medicinal products, particularly with 

sodium chloride solutions. 

 

6.3 Shelf life 
 

2 years 

 

6.4 Special precautions for storage 
 

Store in a refrigerator (2 °C – 8 °C). 

 
Cegfila may be exposed to room temperature (not above 30º C) for a maximum single period of up to 

96 hours. Cegfila left at room temperature for more than 96 hours should be discarded. 

 

Do not freeze. Accidental exposure to freezing temperatures for two periods of less than 72 hours each 

does not adversely affect the stability of Cegfila. 
 

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

 

6.5 Nature and contents of container 
 
Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an 

automatic needle guard. 

 

Each pre-filled syringe contains 0.6 mL of solution for injection. Pack size of one pre-filled syringe in 

a blistered packaging. 

 

6.6 Special precautions for disposal and other handling 
 

Before administration, Cegfila solution should be inspected visually for particulate matter. Only a 

solution that is clear and colourless should be injected. 

 

Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive. Allow the pre-filled 

syringe to reach room temperature before injecting. 

 

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

 
 

7. MARKETING AUTHORISATION HOLDER 
 

Mundipharma Corporation (Ireland) Limited,  

Millbank House, Arkle Road,  

Sandyford Industrial Estate, Dublin 18,  

Ireland 



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8. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1409/001 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 December 2019 

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. 



14 
 

 
 

 
 
 

 
 

 
 
 

 
 
 

 

 

ANNEX II 

 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) 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 

 



15 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance  

3P BIOPHARMACEUTICALS SL 

C/ Mocholi 2, Poligono Industrial 

Mocholi 31110 Noain 
Spain 

 

Name and address of the manufacturer responsible for batch release  

PharmaKorell GmbH 

Marie-Curie-Str. 8 

79539 
Loerrach 

Germany 

 
 

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 (PSURs) 
 

The requirements for submission of PSURs 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 marketing authorisation holder (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.  



16 
 

 
 

 
 
 

 
 

 
 
 

 
 
 

 
 

 
 
 

 
 
 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



17 
 

 
 

 
 
 

 
 

 
 
 

 
 
 

 
 

 
 
 

 
 
 

 
 

 

A. LABELLING 



18 
 

 
 
 

 

Cegfila 6 mg solution for injection in pre-filled syringe 

pegfilgrastim 
 

 

 

Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.  
 

 

 

Excipients: sodium acetate, sorbitol (E 420), polysorbate 20, and water for injections. See package 

leaflet for further information. 
 
 

 
Solution for injection 

1 pre-filled syringe with automatic needle guard (0.6 mL). 
 

 

 

For single use only. For subcutaneous use. 

Important: read the package leaflet before handling pre-filled syringe 
 

 

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. 
 

 

 

Avoid vigorous shaking. 
 
 

 
EXP 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON FOR BLISTERED SYRINGE 

1. NAME OF THE MEDICINAL PRODUCT 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

3. LIST OF EXCIPIENTS 

4. PHARMACEUTICAL FORM AND CONTENTS 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

8. EXPIRY DATE 



19 
 

 
 

Store in a refrigerator. Do not freeze. 

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

 
 

 

Mundipharma Corporation (Ireland) Limited,  

Millbank House, Arkle Road,  
Sandyford Industrial Estate, Dublin 18,  

Ireland 
 

 

 

EU/1/19/1409/001 
 
 

 

Lot 
 

 

 
 

 
 

 

Cegfila 
 
 

 

2D barcode carrying the unique identifier included. 
 
 

 

PC: 

SN: 

NN: 

9. SPECIAL STORAGE CONDITIONS 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

12. MARKETING AUTHORISATION NUMBER(S) 

15. INSTRUCTIONS ON USE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

13. BATCH NUMBER 

14. GENERAL CLASSIFICATION FOR SUPPLY 

16. INFORMATION IN BRAILLE 

17. UNIQUE IDENTIFIER – 2D BARCODE 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



20 
 

 
 
 

 

Cegfila 6 mg solution for injection pegfilgrastim 
 

 

 

Mundipharma 
 

 

EXP 
 

 

 

Lot 
 

 

 

Logo 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER PACK WITH SYRINGE 

1. NAME OF THE MEDICINAL PRODUCT 

4. BATCH NUMBER 

5. OTHER 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

3. EXPIRY DATE 



21 
 

 
 
 

 

Cegfila  

6 mg pegfilgrastim 

SC 
 

 

 
 

 

EXP 
 

 

 

Lot 
 

 

 

0.6 mL 
 

 

 

Mundipharma 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SYRINGE LABEL 

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

3. EXPIRY DATE 

2. METHOD OF ADMINISTRATION 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

4. BATCH NUMBER 

6. OTHER 



22 
 

 
 

 
 
 

 
 

 
 
 

 
 
 

 
 

 
 
 

 
 
 

 
 

 

B. PACKAGE LEAFLET 



23 
 

Package leaflet: Information for the user 
 

Cegfila 6 mg solution for injection in pre-filled syringe 

pegfilgrastim 

 

        This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

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, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may 

harm them, even if their symptoms of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 
possible side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 
1. What Cegfila is and what it is used for 
2. What you need to know before you use Cegfila 
3. How to use Cegfila 
4. Possible side effects 
5. How to store Cegfila 
6. Contents of the pack and other information 
 
 

1. What Cegfila is and what it is used for 
 

Cegfila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 

similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body. 

 

Cegfila is used in adult patients to reduce the duration of neutropenia (low white blood cell count) and 

the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by 
the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells 

are important as they help your body fight infection. These cells are very sensitive to the effects of 

chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells 

fall to a low level there may not be enough left in the body to fight bacteria and you may have an 

increased risk of infection. 
 

Your doctor has given you Cegfila to encourage your bone marrow (part of the bone which makes 

blood cells) to produce more white blood cells that help your body fight infection.  

 
 

2. What you need to know before you use Cegfila Do not use 

Cegfila if 

- you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of 
the other ingredients of this medicine. 

 

Warnings and precautions 

 

Talk to your doctor, pharmacist or nurse before using Cegfila: 

 



24 
 

- if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 
breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the 

skin that itch 

- if you experience a cough, fever and difficulty breathing. This can be a sign of Acute 
Respiratory Distress Syndrome (ARDS) 

- if you have any of the following or combination of the following side effects: 
- swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness . These 

could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak 
from the small blood vessels into your body. See section 4. 

- if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 
problem with your spleen (splenomegaly) 

- if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 
oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 

infiltration) 

- if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) 
or decreased blood platelet counts, which reduces the ability of your blood to clot 

(thrombocytopenia). Your doctor may want to monitor you more closely. 

- if you have sickle cell anaemia. Your doctor may monitor your condition more closely. 
- if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the 

face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing 
these could be signs of a severe allergic reaction. 

- Inflammation of the aorta (the large blood vessel which transports blood from the heart to the 
body) has been reported rarely in cancer patients and healthy donors. The symptoms can include 

fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor 

if you experience these symptoms. 
 

Your doctor will check your blood and urine regularly as Cegfila can harm the tiny filters inside your 
kidneys (glomerulonephritis). 

 

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Cegfila. Stop 

using Cegfila and seek medical attention immediately if you notice any of the symptoms described in 

section 4. 
 

You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Cegfila, unless instructed by your 

doctor. 

 

Loss of response to pegfilgrastim 

 

If you experience a loss of response or failure to maintain a response with pegfilgrastim 
treatment, your doctor will investigate the reasons why including whether you have 

developed antibodies which neutralise pegfilgrastim’s activity.  

 

Other medicines and Cegfila 

 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

Pregnancy and breast-feeding 

 
Ask your doctor or pharmacist for advice before taking any medicine. Cegfila has not been tested in 

pregnant women. It is important to tell your doctor if you: 

- are pregnant; 

- think you may be pregnant; or 
- are planning to have a baby. 
 



25 
 

If you become pregnant during Cegfila treatment, please inform your doctor. 
 

Unless your doctor directs you otherwise, you must stop breast-feeding if you use Cegfila. 

 

Driving and using machines 

 

Cegfila has no or negligible effect on the ability to drive or use machines. 
 

Cegfila contains sorbitol (E 420) and sodium acetate 

 
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL. 

 

This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say 

essentially ‘sodium-free’. 

 
 

3. How to use Cegfila 
 

Cegfila is for use in adults aged 18 and over. 

 
Always use Cegfila exactly as your doctor has told you. You should check with your doctor or 

pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your 

skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of 

chemotherapy at the end of each chemotherapy cycle. 

 
Do not shake Cegfila vigorously as this may affect its activity. 

 

Injecting Cegfila yourself 

 

Your doctor may decide that it would be more convenient for you to inject Cegfila yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been 

trained. 

 

For further instructions on how to inject yourself with Cegfila, please read the section at the end of this 

leaflet. 

 
If you use more Cegfila than you should 

 

If you use more Cegfila than you should contact your doctor, pharmacist or nurse. 

 

If you forget to inject Cegfila 
 

If you have forgotten a dose of Cegfila, you should contact your doctor to discuss when you should 

inject the next dose. 
 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.  

 

 
4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

 

Please tell your doctor immediately if you have any of the following or combination of the following 
side effects: 

- swelling or puffiness, which may be associated with passing water less frequently, difficulty 
breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 

symptoms generally develop in a rapid fashion. These could be symptoms of an uncommon 



26 
 

(may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes 
blood to leak from the small blood vessels into your body and needs urgent medical attention. 

 

Very common side effects (may affect more than 1 in 10 people): 

- bone pain. Your doctor will tell you what you can take to ease the bone pain. 
- nausea and headaches. 
 

Common side effects (may affect up to 1 in 10 people): 

- pain at the site of injection. 
- general aches and pains in the joints and muscles. 
- some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 

become low which might result in bruising. 

 

Uncommon side effects (may affect up to 1 in 100 people): 

- allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin 
that itch. 

- serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 
breathing, swelling of the face). 

- increased spleen size. 
- spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen. 

- breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor. 
- Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role. 

- cutaneous vasculitis (inflammation of the blood vessels in the skin). 
- damage to the tiny filters inside your kidneys (glomerulonephritis). 
- redness at the site of injection. 
- coughing up blood (haemoptysis). 
 

Rare side effects (may affect up to 1 in 1,000 people) 
- Inflammation of the aorta (the large blood vessel which transports blood from the heart to the 

body), see section 2. 

- Bleeding from the lung (pulmonary haemorrhage). 
- Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often 

with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes 
and can be preceded by fever and flu-like symptoms. Stop using Cegfila if you develop these 

symptoms and contact your doctor or seek medical attention immediately. See also section 2. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. 



27 
 

5. How to store Cegfila 
 

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 carton and on the syringe label 

after EXP. The expiry date refers to the last day of that month. 
 

Store in a refrigerator (2 °C - 8 °C). 

 

You may take Cegfila out of the refrigerator and keep it at room temperature (not above 30° 
C) for no longer than 4 days. Once a syringe has been removed from the refrigerator and has 

reached room temperature (not above 30° C) it must either be used within 4 days or disposed 
of. 

 

Do not freeze. Cegfila may be used if it is accidentally frozen for two periods of less than 72 hours 

each. 
 

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

 

Do not use this medicine if you notice it is cloudy or there are particles in it.  

 

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 to protect the environment. 
 

 

6. Contents of the pack and other infor mation  
 

What Cegfila contains 

- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 
- 0.6 mL of solution. 
- The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for 

injections. See section 2. 

 

What Cegfila looks like and contents of the pack 

Cegfila is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL). 
 

Each pack contains 1 pre-filled glass syringe with an attached stainless steel needle and needle cap. 

The syringe is provided with an automatic needle guard. 

 

Marketing Authorisation Holder 

Mundipharma Corporation (Ireland) Limited,  
Millbank House, Arkle Road,  

Sandyford Industrial Estate, Dublin 18,  

Ireland 

 

Manufacturer  
PharmaKorell GmbH  

Marie-Curie-Strasse 8  

D-79539 Lörrach  

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 



28 
 

België/Belgique/Belgien 
Mundipharma Comm. VA 

Tél/Tel: +32 15 45 11 80 

info@mundipharma.be 

Lietuva 
EGIS Pharmaceuticals PLC atstovybė 

Tel.:+ 370 5 231 4658 

info@egis.lt 

България 

ТП„Мундифарма Гезелшафт м.б.Х.“ 

Teл.: + 359 2 962 13 56 
mundipharma@mundipharma.bg 

Luxembourg/Luxemburg 

Mundipharma Comm. VA 

Tél/Tel: +32 15 45 11 80 
info@mundipharma.be 

Česká republika 

Mundipharma GesmbH. Austria - organizační 

složka ČR 
Tel: + 420 222 318 221 

office@mundipharma.cz 

Magyarország 

Egis Gyógyszergyár Zrt. 

Tel.: +36 1 803 5555 
mailbox@egis.hu 

Danmark 

Mundipharma A/S Tlf: 

+ 45 45 17 48 00 

mundipharma@mundipharma.dk 

Malta 

Mundipharma Corporation (Ireland) Limited 

Tel: +353 1 206 3800 

Deutschland 

STADAPHARM GmbH 

Tel: +49 6101 6030 

 

Nederland 

Mundipharma Pharmaceuticals B.V. 

Tel: + 31 (0)33 450 82 70 

info@mundipharma.nl 

Eesti 
KBM Pharma OÜ 

Tel: +372 733 8080 

Norge 
Mundipharma AS Tlf: 

+ 47 67 51 89 00 

post@mundipharma.no 

Ελλάδα 

Mundipharma Corporation (Ireland) Limited 

Τηλ: + 353 1 206 3800 

Österreich 

Mundipharma Gesellschaft m.b.H. Tel: 

+43 (0)1 523 25 05-0 
info@mundipharma.at 

España 
Mundipharma Pharmaceuticals, S.L. 

Tel: +34 91 3821870 

infomed@mundipharma.es 

Polska 
Mundipharma Polska Sp. z o.o. 

Tel.: + (48 22) 866 87 12 

biuro@mundipharma.pl 

France  

Laboratoires Biogaran 
Tél: +33 (0) 800 970 109 

 

Portugal 

Mundipharma Farmacêutica Lda 
Tel: +351 21 901 31 62 

medinfo@mundipharma.pt 



29 

Hrvatska 
Medis Adria d.o.o 

Tel: + 385 (0) 1 230 34 46 

info@medisadria.hr 

România 
Egis Pharmaceuticals PLC România Tel: 

+40 21 412 00 17

office@egis.ro

Ireland 
Mundipharma Pharmaceuticals Limited 

Tel: +353 1 206 3800 

Slovenija 
Medis, d.o.o. 

Tel: +386 158969 00 

info@medis.si 

Ísland Slovenská republika 

Icepharma hf. Mundipharma Ges.m.b.H.-o.z. 

Sími: + 354 540 8000 Tel: + 4212 6381 1611 

icepharma@icepharma.is mundipharma@mundipharma.sk 

Italia Suomi/Finland 

Mundipharma Pharmaceuticals Srl Mundipharma Oy 

Tel: +39 02 3182881 Puh/Tel: + 358 (0)9 8520 2065 

infomedica@mundipharma.it info@mundipharma.fi 

Κύπρος Sverige 

Mundipharma Pharmaceuticals Ltd Mundipharma AB 
Τηλ: +357 22 815656 Tel: + 46 (0)31 773 75 30 

info@mundipharma.com.cy info@mundipharma.se 

Latvija 

EGIS Pharmaceuticals PLC parstavniecibas 

Tel: + 371 676 13 859 

info@egis.lv 

This leaflet was last revised in {month YYYY}. 

Other sources of information 

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

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



30 
 

Instructions for use 
 

Guide to parts 
Before use After use 

Before use 
 

 

 

After use 

 
Used plunger 

Plunger  

 
Syringe label 

 
Used syring barrel 

Finger grips 
 

Syringe label 
 

Syringe barrel Used needle 

Syringe safety guard 
Used needle safety 
spring 

Needle safety spring  

 

Needle cap on 
 

Needle cap off 

 

Important 

Before you use a Cegfila pre-filled syringe with automatic needle guard, read this important 
information: 

 It is important that you do not try to give yourself the injection unless you have received training 
from your doctor or healthcare provider. 

 Cegfila is given as an injection into the tissue just under the skin (subcutaneous injection).  

 

 Do not remove the needle cap from the pre-filled syringe until you are ready to inject. 
 

 Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new 

pre-filled syringe and call your doctor or healthcare provider. 
 

 Do not attempt to activate the pre-filled syringe prior to injection. 
 

 Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe 
 

 Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering 

your injection. 

Call your doctor or healthcare provider if you have any questions. 



31 
 

 

 

C Inspect the medicine and pre-filled syringe. 

 
 
 
 
 
 
 
 
 

 Do not use the pre-filled syringe if: 

   The medicine is cloudy or there are particles in it. It must be a clear and colourless 
liquid. 

   Any part appears cracked or broken. 

   The needle cap is missing or not securely attached. 

   The expiry date printed on the label has passed the last day of the month shown.  

In all cases, call your doctor or healthcare provider. 

Step 1: Prepare 

A Remove the pre-filled syringe tray from the package and gather the supplies needed for your 
injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container 

(not included). 

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes 

before injecting. Wash your hands thoroughly with soap and water. 

 

On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. 

 Do not try to warm the syringe by using a heat source such as hot water or microwave. 

 Do not leave the pre-filled syringe exposed to direct sunlight. 

 Do not shake the pre-filled syringe. 

 Keep pre-filled syringes out of the sight and reach of children. 

B Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove 

the pre-filled syringe from the tray.   

 

 
 

 

 
 

 
 

 
 

 

For safety reasons: 

 Do not grasp the plunger. 

 Do not grasp the needle cap. 

Grab here 

Medicine 



32 
 

Step 2: Get ready 

A Wash your hands thoroughly. Prepare and clean your injection site. 

 

Upper arm 

Belly 

Upper thigh 

You can use: 

  Upper part of your thigh. 

  Belly, except for a 5 cm (2-inch) area right around your belly button. 

  Outer area of upper arm (only if someone else is giving you the injection).  

Clean the injection site with an alcohol wipe. Let your skin dry. 

 Do not touch the injection site before injecting. 

 Do not inject into areas where the skin is tender, bruised, red, or hard. 

Avoid injecting into areas with scars or stretch marks.  



33 
 

 
 

C Pinch your injection site to create a firm surface. 

  

 

 

 
Its important to keep the skin pinched when injecting. 

 

Step 3: Inject 

A Hold the pinch. INSERT the needle into skin. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 

 Do not touch the cleaned area of the skin. 

Carefully pull the needle cap straight out and away from your body. B 



34 
 

 

 

C RELEASE your thumb. Then LIFT the syringe off skin.   

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. 

 Do not put the needle cap back on used pre-filled syringes 

B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the 
way down through the snap. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 It is important to push down through the “snap” to deliver your full dose.  

 

“SNAP” 



35 
 

 
 

Healthcare professionals only 

The trade name and the batch number of the administered product should be clearly recorded 
in the patient file. 

Remove and save the pre-filled syringe label 

 
 

 

 

Turn the plunger to move the label into a position where you can remove the syringe label 



36 
 

 

Step 4: Finish 

A Discard the used pre-filled syringe and other supplies in a sharps disposal container. 

  
 

 

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to 

dispose of medicines no longer required. These measures will help to protect the environment. 

Keep the syringe and sharps disposal container out of sight and reach of children. 
 

 Do not reuse the pre-filled syringe. 
 

 Do not recycle pre-filled syringes or throw them into household waste. 

 

B Examine the injection site. 

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. 

Apply a plaster if needed. 

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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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{'Title': '2. what you need to know before you use cegfila', 'Section_Content': 'do not use cegfila if - you are allergic to pegfilgrastim, filgrastim, e. coli derived proteins, or any of the other ingredients of this medicine. warnings and precautions talk to your doctor, pharmacist or nurse before using cegfila: 24 - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch - if you experience a cough, fever and difficulty breathing. this can be a sign of acute respiratory distress syndrome (ards) - if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness . these could be symptoms of condition called "capillary leak syndrome" which causes blood to leak from the small blood vessels into your body. see section 4. - if you get left upper abdominal pain or pain at the tip of your shoulder. this may be a sign of a problem with your spleen (splenomegaly) - if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration) - if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). your doctor may want to monitor you more closely. - if you have sickle cell anaemia. your doctor may monitor your condition more closely. - if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction. - inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors. the symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. tell your doctor if you experience these symptoms. your doctor will check your blood and urine regularly as cegfila can harm the tiny filters inside your kidneys (glomerulonephritis). severe skin reactions (stevens-johnson syndrome) have been reported with the use of cegfila. stop using cegfila and seek medical attention immediately if you notice any of the symptoms described in section 4. you should talk to your doctor about your risks of developing cancers of the blood. if you develop or are likely to develop cancers of the blood, you should not use cegfila, unless instructed by your doctor. loss of response to pegfilgrastim if you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim\'s activity. other medicines and cegfila tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. pregnancy and breast-feeding ask your doctor or pharmacist for advice before taking any medicine. cegfila has not been tested in pregnant women. it is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - are planning to have a baby. if you become pregnant during cegfila treatment, please inform your doctor. unless your doctor directs you otherwise, you must stop breast-feeding if you use cegfila. driving and using machines cegfila has no or negligible effect on the ability to drive or use machines. cegfila contains sorbitol (e 420) and sodium acetate this medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / ml. this medicine 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{'Title': '3. how to use cegfila', 'Section_Content': 'cegfila is for use in adults aged 18 and over. always use cegfila exactly as your doctor has told you. you should check with your doctor or pharmacist if you are unsure. the usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. do not shake cegfila vigorously as this may affect its activity. injecting cegfila yourself your doctor may decide that it would be more convenient for you to inject cegfila yourself. your doctor or nurse will show you how to inject yourself. do not try to inject yourself if you have not been trained. for further instructions on how to inject yourself with cegfila, please read the section at the end of this leaflet. if you use more cegfila than you should if you use more cegfila than you should contact your doctor, pharmacist or nurse. if you forget to inject cegfila if you have forgotten a dose of cegfila, you should contact your doctor to discuss when you should inject the next dose. if you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.', 'Entity_Recognition': [{'Text': 'cegfila', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '18', 'Type': 'NUMBER', 'BeginOffset': 34, 'EndOffset': 36}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 192, 'EndOffset': 193}, {'Id': 0, 'BeginOffset': 242, 'EndOffset': 246, 'Score': 0.9432533979415894, 'Text': 'skin', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'a pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 254, 'EndOffset': 274}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 307, 'EndOffset': 309}, {'Id': 3, 'BeginOffset': 340, 'EndOffset': 352, 'Score': 0.8527652025222778, 'Text': 'chemotherapy', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'each chemotherapy cycle', 'Type': 'TREATMENT', 'BeginOffset': 367, 'EndOffset': 390}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1135, 'EndOffset': 1148}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. please tell your doctor immediately if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. these symptoms generally develop in a rapid fashion. these could be symptoms of an uncommon 26 (may affect up to 1 in 100 people) condition called "capillary leak syndrome" which causes blood to leak from the small blood vessels into your body and needs urgent medical attention. very common side effects (may affect more than 1 in 10 people): - bone pain. your doctor will tell you what you can take to ease the bone pain. - nausea and headaches. common side effects (may affect up to 1 in 10 people): - pain at the site of injection. - general aches and pains in the joints and muscles. - some changes may occur in your blood, but these will be detected by routine blood tests. your white blood cell count may become high for a short period of time. your platelet count may become low which might result in bruising. uncommon side effects (may affect up to 1 in 100 people): - allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch. - serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face). - increased spleen size. - spleen rupture. some cases of splenic rupture were fatal. it is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen. - breathing problems. if you have a cough, fever and difficulty breathing please tell your doctor. - sweet\'s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role. - cutaneous vasculitis (inflammation of the blood vessels in the skin). - damage to the tiny filters inside your kidneys (glomerulonephritis). - redness at the site of injection. - coughing up blood (haemoptysis). rare side effects (may affect up to 1 in 1,000 people) - inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. - bleeding from the lung (pulmonary haemorrhage). - stevens-johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. stop using cegfila if you develop these symptoms and contact your doctor or seek medical attention immediately. see also section 2. reporting of side effects if you get any side effects, talk to 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{'Title': '5. how to store cegfila', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': None, 'Entity_Recognition': None}