Ryzodeg
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
Ryzodeg 100 units/mL solution for injection in cartridge 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 
2.56 mg insulin degludec and 1.05 mg insulin aspart). 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.  
 
*Produced in Saccharomyces cerevisiae by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
Solution for injection (FlexTouch). 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
Solution for injection (Penfill).  
 
Clear, colourless, neutral solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years. 
 
4.2 Posology and method of administration 
 
Posology 
This medicinal product is a soluble insulin product consisting of the basal insulin degludec and the 
rapid-acting prandial insulin aspart. 
 
The potency of insulin analogues, including Ryzodeg, is expressed in units. One (1) unit of this insulin 
corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin 
detemir or 1 unit of biphasic insulin aspart. 
 
Ryzodeg is to be dosed in accordance with the individual patient’s needs. Dose-adjustments are 
recommended to be based on fasting plasma glucose measurements. 
 
Adjustment of dose may be necessary if patients undertake increased physical activity, change their 
usual diet or during concomitant illness. 
 
Patients with type 2 diabetes mellitus 
Ryzodeg can be administered once or twice daily with the main meal(s) alone, in combination with 



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oral antidiabetic medicinal products, and in combination with bolus insulin (see section 5.1). When 
using Ryzodeg once-daily, changing to twice daily should be considered when higher doses are 
needed, e.g. to avoid hypoglycaemia. Split the dose based on individual patient’s needs and administer 
with main meals. 
 
Patients with type 1 diabetes mellitus 
Ryzodeg can be administered once daily at mealtime in combination with short-/rapid-acting insulin at 
the remaining meals. 
 
Flexibility in dosing time 
Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the 
main meal(s). 
 
If a dose of this medicinal product is missed, the patient can take the missed dose with the next main 
meal of that day and thereafter resume the usual dosing schedule. Patients should not take an extra 
dose to make up for a missed dose. 
 
Initiation 
Patients with type 2 diabetes mellitus 
The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage 
adjustments. 
 
Patients with type 1 diabetes mellitus 
The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements. 
This medicinal product is to be used once daily at mealtime in combination with short-/rapid-acting 
insulin at the remaining meals followed by individual dosage adjustments.  
 
Transfer from other insulin medicinal products 
Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and 
timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic 
treatment may need to be adjusted.  
 
Patients with type 2 diabetes mellitus 
Patients switching from once-daily basal or premix insulin therapy can be converted unit-to-unit to 
once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous total daily insulin 
dose. 
 
Patients switching from more than once-daily basal or premix insulin therapy can be converted 
unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous 
total daily insulin dose. 
 
Patients switching from basal/bolus insulin therapy to Ryzodeg will need to convert their dose based 
on individual needs. In general, patients are initiated on the same number of basal units. 
 
Patients with type 1 diabetes mellitus 
The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements in 
combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage 
adjustments. 
 
Special populations 
Elderly (≥ 65 years old) 
Ryzodeg can be used in the elderly. Glucose monitoring is to be intensified and the insulin dose 
adjusted on an individual basis (see section 5.2). 
 
Renal and hepatic impairment 
Ryzodeg can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified 
and the insulin dose adjusted on an individual basis (see section 5.2). 



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Paediatric population 
There is no clinical experience with the use of this medicinal product in children below the age of 
2 years. 
This medicinal product can be used in adolescents and children from the age of 2 years (see section 
5.1). When changing from another insulin regimen to Ryzodeg, dose reduction of total insulin needs to 
be considered on an individual basis in order to minimise the risk of hypoglycaemia (see section 4.4).  
 
Ryzodeg should be used with special caution in children 2 to 5 years old because data from the clinical 
trial indicate that there may be a higher risk for severe hypoglycaemia in children in this age group 
(see sections 4.4, 4.8 and 5.1). 
 
Method of administration 
Subcutaneous use only. 
 
This medicinal product must not be administered intravenously as it may result in severe 
hypoglycaemia.  
This medicinal product must not be administered intramuscularly as it may change the absorption. 
This medicinal product must not be used in insulin infusion pumps. 
This medicinal product must not be drawn from the cartridge of the pre-filled pen into a syringe (see 
section 4.4). 
 
Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the 
thigh. Injection sites are always to be rotated within the same region in order to reduce the risk of 
lipodystrophy. 
 
Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases 
the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, 
patients must follow the instructions described in the instructions for use accompanying the package 
leaflet (see section 6.6). 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist 
injection needles. The pre-filled pen delivers 1–80 units in steps of 1 unit. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
Ryzodeg comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery 
systems and NovoFine or NovoTwist injection needles. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Hypoglycaemia 
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. 
 
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see 
sections 4.5, 4.8 and 4.9). 
In children, extra care should be taken to match insulin doses with food intake and physical activities 
in order to minimise the risk of hypoglycaemia. Ryzodeg may be associated with higher occurrence of 
severe hypoglycaemia compared to a basal-bolus regimen in the paediatric population, particularly in 
children 2 to 5 years old (see section 5.1). For this age group, Ryzodeg should be considered on an 
individual basis. 
 
Patients whose blood glucose control is greatly improved (e.g. by intensified insulin therapy) may 



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experience a change in their usual warning symptoms of hypoglycaemia and must be advised 
accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes. 
 
Concomitant illness, especially infections and fever, usually increases the patient's insulin 
requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or 
thyroid gland may require changes in the insulin dose. 
 
As with other basal insulin products or insulin products with a basal component, the prolonged effect 
of Ryzodeg may delay recovery from hypoglycaemia. 
 
Hyperglycaemia 
Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. 
 
Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to 
hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially 
infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement. 
 
Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They 
include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry 
mouth, and loss of appetite as well as acetone odour of breath. In type 1 diabetes mellitus, untreated 
hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. 
 
Transfer from other insulin medicinal products 
Transferring a patient to another type, brand or manufacturer of insulin must be done under medical 
supervision and may result in the need for a change in dosage. 
 
Combination of pioglitazone and insulin medicinal products 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac failure. This should be kept in mind 
if treatment with the combination of pioglitazone and Ryzodeg is considered. If the combination is 
used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. 
Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. 
 
Eye disorder 
Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated 
with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control 
decreases the risk of progression of diabetic retinopathy. 
 
Avoidance of accidental mix-ups 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between Ryzodeg and other insulin products.  
 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
To avoid dosing errors and potential overdose, patients and healthcare professionals should never use 
a syringe to draw the medicinal product from the cartridge in the pre-filled pen. 
 
In the event of blocked needles, patients must follow the instructions described in the instructions for 
use accompanying the package leaflet (see section 6.6). 
 
Insulin antibodies 
Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin 
antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or 
hypoglycaemia. 



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Sodium 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
A number of medicinal products are known to interact with glucose metabolism. 
 
The following substances may reduce the insulin requirement 
Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors 
(MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids 
and sulfonamides. 
 
The following substances may increase the insulin requirement 
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth 
hormone and danazol. 
 
Beta-blockers may mask the symptoms of hypoglycaemia. 
 
Octreotide/lanreotide may either increase or decrease the insulin requirement. 
 
Alcohol may intensify or reduce the hypoglycaemic effect of insulin. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There is no clinical experience with the use of this medicinal product in pregnant women. 
 
Animal reproduction studies have not revealed any difference between insulin degludec and human 
insulin regarding embryotoxicity and teratogenicity.  
 
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are 
recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually 
decrease in the first trimester and increase subsequently during the second and third trimesters. After 
delivery, insulin requirements usually return rapidly to pre-pregnancy values. 
 
Breast-feeding 
There is no clinical experience with Ryzodeg during breast-feeding. In rats, insulin degludec was 
secreted in milk; the concentration in milk was lower than in plasma. 
 
It is unknown whether insulin degludec/insulin aspart is excreted in human milk. No metabolic effects 
are anticipated in the breast-fed newborn/infant. 
 
Fertility 
Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
This medicinal product has no or negligible influence on the ability to drive and use machines. 
However, the patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. 
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a 
car or using machines).  
 
Patients must be advised to take precautions to avoid hypoglycaemia while driving. This is particularly 
important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or 
have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these 



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circumstances. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently reported adverse reaction during treatment is hypoglycaemia (see section 
‘Description of selected adverse reactions’ below). 
 
Tabulated list of adverse reactions  
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA 
System Organ Class. Frequency categories are defined according to 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) and not known (cannot be estimated from the available data). 
 
System organ class Frequency Adverse reaction 
Immune system disorders Rare  Hypersensitivity 

Urticaria 
Metabolism and nutrition disorders Very common  Hypoglycaemia 
Skin and subcutaneous tissue disorders Not known  Lipodystrophy 
General disorders and administration site conditions Common  Injection site reactions 

Uncommon  Peripheral oedema 
 
Description of selected adverse reactions 
Immune system disorders 
With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either 
insulin itself or the excipients may potentially be life-threatening. 
 
With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, 
tiredness and itching) and urticaria were reported rarely. 
 
Hypoglycaemia 
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe 
hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or 
permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur 
suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, 
unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, 
vision changes, headache, nausea and palpitation. 
 
Lipodystrophy 
Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous 
rotation of the injection site within the particular injection area may help to reduce the risk of 
developing these reactions. 
 
Injection site reactions 
Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, 
swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with 
Ryzodeg. These reactions are usually mild and transitory and they normally disappear during 
continued treatment. 
 
Paediatric population 
Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation 
of pharmacokinetic properties (see section 5.2). Safety and efficacy have been demonstrated in a trial 
in children aged 2 to less than 18 years. The frequency, type and severity of adverse reactions in the 
paediatric population do not indicate differences to the experience in the general diabetes population 
with the exception of a signal of higher occurrence of severe hypoglycaemia compared to a basal-
bolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 4.2, 4.4 
and 5.1).  



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Other special populations 
Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in 
the elderly and in patients with renal or hepatic impairment do not indicate any differences to the 
broader experience in the general population. 
 
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 
 
A specific overdose for insulin cannot be defined. However, hypoglycaemia may develop over 
sequential stages if a patient is dosed with more insulin than required: 
 
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products 

containing sugar. It is therefore recommended that the patient always carries glucose-containing 
products. 

 
• Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated 

with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or 
with glucose given intravenously by a healthcare professional. Glucose must be given 
intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon 
regaining consciousness, administration of oral carbohydrates is recommended for the patient in 
order to prevent a relapse. 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, intermediate- 
or long-acting combined with fast-acting, ATC code: A10AD06. 
 
Mechanism of action 
Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the 
same pharmacological effects as human insulin. 
 
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the 
binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose 
output from the liver.  
 
Pharmacodynamic effects 
The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (Figure 1), 
and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and 
the basal component insulin degludec.  
 
The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous 
injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into 
the circulation leading to a flat and stable glucose-lowering effect. This effect is maintained in the 
co-formulation with insulin aspart and does not interfere with the rapid-acting insulin aspart 
monomers. 
 
Ryzodeg has a rapid onset of action occurring soon after injection providing mealtime coverage while 
the basal component has a flat and stable action profile providing continuous coverage of the basal 

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


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insulin requirements. The duration of action of a single-dose of Ryzodeg is beyond 24 hours. 
 

 

 

Time since injection (hours) 
Treatment IDegAsp 0.8 U/kg 

G
lu

co
se

 In
fu

si
on

 R
at

e 
(m

g/
(k

g*
m

in
)) 

 
Figure 1: Pharmacodynamics, single dose – Mean glucose infusion rate profile – Patients with 
type 1 diabetes – 0.8 U/kg Ryzodeg – Trial 3539 
 
The total and maximum glucose-lowering effects of Ryzodeg increase linearly with increasing doses. 
Steady state will occur after 2–3 days of dose administration. 
 
There is no difference in the pharmacodynamic effect of this medicinal product between elderly and 
younger patients. 
 
Clinical efficacy and safety 
Seven multinational, randomised, controlled, open-label, treat-to-target clinical studies of between 26 
and 52 weeks’ duration were conducted exposing a total of 1,761 patients with diabetes mellitus (1 
study involving 362 patients in type 1 diabetes mellitus and 6 studies involving 1,399 patients in type 
2 diabetes mellitus) to Ryzodeg. Ryzodeg administered once daily o.d. was compared to insulin 
glargine (100 units/mL) (IGlar) o.d. in two trials in type 2 diabetes mellitus (Table 1). Ryzodeg b.i.d. 
was compared to biphasic insulin aspart 30 (BIAsp 30) b.i.d. in two trials in type 2 diabetes mellitus 
(Table 2) and to insulin degludec (IDeg) o.d. plus insulin aspart (IAsp) 2–4 times daily in one trial in 
type 2 diabetes mellitus. In one trial in type 2 diabetes mellitus Ryzodeg o.d. was compared to insulin 
glargine (IGlar) o.d. plus IAsp o.d. After 26 weeks of treatment the Ryzodeg dose could be split into 
b.i.d. In all trials in type 2 diabetes mellitus, oral antidiabetic drugs (OADs) were allowed. Ryzodeg 
o.d. plus insulin aspart (IAsp) was also compared to o.d. or b.i.d. insulin detemir (IDet) plus IAsp in 
type 1 diabetes mellitus (Table 3). 
 
Non-inferiority in HbA1c change from baseline to end-of-trial was confirmed in 6 of the 7 studies 
against all comparators when treating patients to target, whereas non-inferiority was not confirmed in 
one study (comparing IDegAsp b.i.d. with IDeg o.d. plus IAsp 2–4 times daily) in type 2 diabetes 
mellitus. 
 
There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg. 
 
Patients with type 2 diabetes mellitus 
In two trials combining insulin and OAD treatment in both insulin-naïve (insulin initiation) and 
insulin-using (insulin intensification) patients with type 2 diabetes mellitus, Ryzodeg o.d. 
demonstrated similar glycaemic control (HbA1c) compared to IGlar (administered according to label) 
(Table 1). As Ryzodeg contains a rapid-acting mealtime insulin (insulin aspart), prandial glycaemic 
control at the dosing meal is improved relative to administering basal insulin only; see trial results in 
Table 1. A lower rate of nocturnal hypoglycaemia (defined as episodes between midnight and 6 a.m. 
confirmed by plasma glucose < 3.1 mmol/L or by patient needing third party assistance) was observed 
with Ryzodeg relative to IGlar (Table 1). 



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Ryzodeg b.i.d. demonstrated similar glycaemic control (HbA1c) compared with BIAsp 30 b.i.d. in 
patients with type 2 diabetes mellitus. It demonstrates superior improvements in fasting plasma 
glucose levels compared to patients treated with BIAsp 30. Ryzodeg causes a lower rate of overall and 
nocturnal hypoglycaemia (Table 2). 
 
Ryzodeg b.i.d. was compared with IDeg o.d. plus IAsp (2–4 daily injections) in patients with type 2 
diabetes mellitus treated with basal insulin in need of treatment intensification with mealtime insulin. 
The study design included a standardised treatment schedule but allowed for certain adjustments to 
meet individual needs. Both treatments improved glycaemic control with an estimated mean reduction 
with Ryzodeg (-1.23%) against IDeg plus IAsp (-1.42%) for the primary endpoint of change from 
baseline in HbA1c at 26 weeks. This did not meet the pre-specified non-inferiority margin of 0.4% 
[0.18 (-0.04; 0.41)]. There were no statistically significant differences between the two treatment 
groups.  
 
In one trial of patients with type 2 diabetes mellitus treated with basal insulin, in need of treatment 
intensification with mealtime insulin, Ryzodeg o.d. was compared to IGlar o.d. plus IAsp o.d. over 
26 weeks. After 26 weeks, the Ryzodeg dose could be split into b.i.d. dosing in the Ryzodeg arm and 
additional IAsp doses could be administered at other meals (up to 3 times daily) in the IGlar arm. The 
study design included a standardised treatment schedule but allowed for certain adjustments to meet 
individual needs. Ryzodeg o.d. demonstrated similar glycaemic control (HbA1c) compared to IGlar 
o.d. plus IAsp o.d. after 26 weeks (the estimated mean reductions are -1.01% vs -1.09%). Ryzodeg 
o.d.or b.i.d demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp 1–
3 times daily after 38 weeks (the estimated mean reductions are -1.17% vs -1.26%). Ryzodeg showed 
a lower rate of nocturnal hypoglycaemia compared to IGlar o.d. plus IAsp during 26 weeks (0.42 vs 
0.76 estimated rates per patient year of exposure) and 38 weeks (0.51 vs 0.83 estimated rates per 
patient year of exposure). 
 
Patients with type 1 diabetes mellitus 
In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining 
meals demonstrated similar glycaemic control (HbA1c and fasting plasma glucose) with a lower rate of 
nocturnal hypoglycaemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table 
3). 
 
There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg. 
 
Table 1 Result from two 26-weeks’ trials in type 2 diabetes mellitus with Ryzodeg given once 
daily 

 Ryzodeg (o.d.)1  
Insulin naïve 

IGlar (o.d.)1  
Insulin naïve 

Ryzodeg (o.d.)2              
Insulin users 

IGlar (o.d.)2  
Insulin users 

N 266 263 230 233 
Mean HbA1c (%) 
End of trial 
Mean change 

7.2 
-1.65 

7.2 
-1.72 

7.3 
-0.98 

7.4 
-1.00 

 Difference: 0.03 [-0.14;0.20] Difference: -0.03 [-0.20;0.14] 
Fasting Plasma Glucose (FPG) (mmol/L) 
End of trial 
Mean change 

6.8 
-3.32 

6.3 
-4.02 

6.3 
-1.68 

6.0 
-1.88 

 Difference: 0.51 [0.09;0.93] Difference: 0.33 [-0.11;0.77] 
Prandial Blood glucose Increment 90 minutes after dosing meal (Plasma) (mmol/L) 
End of trial 
Mean change  

1.9 
-1.5 

3.4 
-0.3 

1.2 
-1.5 

2.6 
-0.6 

Hypoglycaemia Rate (per patient year of exposure) 
Severe  0.01 0.01 0.00 0.04 



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Confirmed3 4.23 1.85 4.31 3.20 
 Ratio: 2.17 [1.59;2.94] Ratio: 1.43 [1.07;1.92] 
Nocturnal 
confirmed3 

0.19 0.46 0.82 1.01 

 Ratio: 0.29 [0.13;0.65] Ratio: 0.80 [0.49;1.30] 
1 Once-daily regimen + Metformin 
2 Once-daily regimen + Metformin ± pioglitazone ± DPP-4 inhibitor 
3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing 
third party assistance. Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. 
 
Table 2 Result from two 26-weeks’ trials in type 2 diabetes mellitus with Ryzodeg given twice 
daily 

 Ryzodeg (b.i.d.)1 
Insulin users 

BIAsp 30 
(b.i.d.)1        

Insulin users 

Ryzodeg (b.i.d.)2 
Insulin users 

BIAsp 30 
(b.i.d.)2  

Insulin users 
N 224 222 280 142 
Mean HbA1c (%) 
End of trial 
Mean change 

7.1 
-1.28 

7.1 
-1.30 

7.1 
-1.38 

7.0 
-1.42 

 Difference: -0.03 [-0.18;0.13] Difference: 0.05 [-0.10;0.20] 
FPG (mmol/L) 
End of trial 
Mean change 

5.8 
-3.09 

6.8 
-1.76 

5.4 
-2.55 

6.5 
-1.47 

 Difference: -1.14 [-1.53;-0.76] Difference: -1.06 [-1.43;-0.70] 
Hypoglycaemia Rate (per patient year of exposure) 
Severe  0.09 0.25 0.05 0.03 
Confirmed 3 9.72 13.96 9.56 9.52 
 Ratio: 0.68 [0.52;0.89] Ratio: 1.00 [0.76;1.32] 
Nocturnal confirmed3 0.74 2.53 1.11 1.55 
 Ratio: 0.27 [0.18;0.41] Ratio: 0.67 [0.43;1.06] 

1 Twice-daily regimen ± metformin ± pioglitazone ± DPP-4 inhibitor 
2 Twice-daily regimen ± metformin 
3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing 
third party assistance. Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. 
 
Table 3 Result of a 26-weeks’ trial in type 1 diabetes mellitus with Ryzodeg given once daily 

 Ryzodeg (o.d.)1  IDet (o.d./b.i.d.)2  

N 366 182 
Mean HbA1c (%) 
End of trial 
Mean change 

7.6 
-0.73 

7.6 
-0.68 

 Difference: -0.05 [-0.18;0.08] 
FPG (mmol/L) 
End of trial 
Mean change  

8.7 
-1.61 

8.6 
-2.41 

 Difference: 0.23 [-0.46;0.91] 
Hypoglycaemia Rate (per patient year of exposure) 
Severe  0.33 0.42 
Confirmed3 39.2 44.3 
 Ratio: 0.91 [0.76;1.09] 
Nocturnal confirmed3 3.71 5.72 



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 Ratio: 0.63 [0.49;0.81] 
1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements 
2 Once- or twice-daily regimen + insulin aspart to cover mealtime insulin requirements 
3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing 
third party assistance. Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. 
 
Cardiovascular safety 
DEVOTE was a randomised, double-blind, and event-driven clinical trial focusing on insulin 
degludec, the long-acting component of Ryzodeg. The trial had a median duration of 2 years and 
compared the cardiovascular safety of insulin degludec vs insulin glargine (100 units/mL) in 7,637 
patients with type 2 diabetes mellitus at high risk of cardiovascular events.  
The primary analysis was time from randomisation to first occurrence of a 3-component major adverse 
cardiovascular event (MACE) defined as cardiovascular death, non-fatal myocardial infarction, or 
non-fatal stroke. The trial was designed as a non-inferiority trial to exclude a pre-specified risk margin 
of 1.3 for the hazard ratio (HR) of MACE comparing insulin degludec to insulin glargine. The 
cardiovascular safety of insulin degludec as compared to insulin glargine was confirmed (HR 0.91 
[0.78; 1.06]) (Figure 2).  
Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin 
regimen) were aligned with the primary analysis. At baseline, HbA1c was 8.4% in both treatment 
groups and after 2 years HbA1c was 7.5% both with insulin degludec and insulin glargine.  
 
 

Primary analysis (3-point MACE) 

CV Death 

Non-fatal Stroke 

Non-fatal MI 

All cause death 

0.90 (0.65-1.23) 

0.85 (0.68-1.06) 

0.91 (0.76-1.11) 

0.96 (0.76-1.21) 

0.91 (0.78-1.06) 

Hazard Ratio 
(95% CI) 

71 (1.86) 

144 (3.77) 

202 (5.29) 

136 (3.56) 

325 (8.51) 

Insulin degludec 
N (%) 

79 (2.07) 

169 (4.43) 

221 (5.79) 

142 (3.72) 

356 (9.32) 

Insulin glargine 
N (%) 

0.7 0.9 1 1.1 1.3 
Favours 

insulin degludec 
Favours 

insulin glargine 
 

N: Number of subjects with a first EAC confirmed event during trial. %: Percentage of subjects with a first EAC confirmed event relative to 
the number of randomised subjects. EAC: Event adjudication committee. CV: Cardiovascular. MI: Myocardial infarction. CI: 95% 
confidence interval. 
Figure 2 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular 
endpoints in DEVOTE 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of trials with 
Ryzodeg in: 
• Neonates and infants from birth to less than 12 months of age with type 1 diabetes mellitus. 
• In all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for 

information on paediatric use). 
 
The efficacy and safety of Ryzodeg have been studied in a randomised controlled clinical trial in 
children and adolescents with diabetes mellitus type 1 for a period of 16 weeks (n=362). Patients in the 
Ryzodeg arm included 40 exposed children aged 2–5 years, 61 children aged 6–11 years and 80 
adolescents aged 12–17 years. Ryzodeg dosed once daily with the main meal plus insulin aspart for the 
remaining meals showed similar reduction in HbA1c at week 16 and no differences in FPG and SMPG 
compared to comparator insulin detemir dosed once or twice daily plus mealtime insulin aspart. At 
week 16, the mean total daily insulin dose was 0.88 vs 1.01 units/kg in the Ryzodeg and insulin 
detemir arms, respectively. The rates (events per patient-year of exposure) of confirmed 
hypoglycaemia (ISPAD 2009 definition: 46.23 vs 49.55) and nocturnal confirmed hypoglycaemia 
(5.77 vs 5.40) were comparable with Ryzodeg vs insulin detemir whereas the rate of severe 
hypoglycaemia (0.26 vs 0.07) was higher in the Ryzodeg arm although the difference was not 
statistically significant. Few severe hypoglycaemic episodes were reported in each group; the observed 
rate of severe hypoglycaemia within the Ryzodeg arm was higher for subjects aged 2–5 years 



13 

compared to subjects aged 6–11 years or 12–17 years (0.42 vs 0.21 and 0.21 respectively). An efficacy 
and safety evaluation for adolescent patients with type 2 diabetes mellitus has been made using data 
from adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes 
mellitus. This assessment supports the use of Ryzodeg in adolescent patients with type 2 diabetes 
mellitus. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
After subcutaneous injection, soluble and stable multi-hexamers of insulin degludec are formed 
creating a depot of insulin in the subcutaneous tissue, while not interfering with the rapid release of 
insulin aspart monomers into the circulation. Insulin degludec monomers gradually separate from the 
multi-hexamers thus resulting in a slow and continuous delivery of insulin degludec into the 
circulation. Steady-state serum concentration of the basal component (insulin degludec) is reached 
after 2–3 days of daily Ryzodeg administration. 
 
The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg. 
The pharmacokinetic profile for insulin aspart appears 14 minutes after injection with a peak 
concentration after 72 minutes. 
 
Distribution 
The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in 
human plasma. Insulin aspart has a low binding to plasma proteins (<10%), similar to that seen with 
regular human insulin. 
 
Biotransformation 
Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites 
formed are inactive. 
 
Elimination 
The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption 
from the subcutaneous tissue. The half-life of the basal component (insulin degludec) at steady state is 
25 hours independent of dose. 
 
Linearity 
Total exposure with Ryzodeg increases proportionally with increasing dose of the basal component 
(insulin degludec) and the mealtime component (insulin aspart) in type 1 and type 2 diabetes mellitus. 
 
Gender 
There is no gender difference in the pharmacokinetic properties of Ryzodeg. 
 
Elderly, race, renal and hepatic impairment 
There are no clinically relevant differences in the pharmacokinetics of Ryzodeg between elderly and 
younger adult patients, between races or between healthy subjects and patients with renal or hepatic 
impairment. 
 
Paediatric population 
The pharmacokinetic properties of Ryzodeg in type 1 diabetes mellitus were investigated in children 
(6–11 years) and adolescents (12–18 years) and compared to adults after single dose administration. 
The steady-state pharmacokinetic properties of the insulin degludec component of Ryzodeg were 
investigated using a population pharmacokinetic analysis in children down to 1 year of age. 
Total exposure and peak concentration of insulin aspart were higher in children than in adults and 
were similar for adolescents and adults. 
The pharmacokinetic properties of insulin degludec in children (1–11 years) and adolescents (12–
18 years) were at steady state comparable to those observed in adults with type 1 diabetes mellitus. 
Total exposure of insulin degludec after single dose administration was, however, higher in children 
and adolescents than in adults with type 1 diabetes mellitus. 



14 

 
5.3 Preclinical safety data 
 
Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, 
repeated dose toxicity, carcinogenic potential, and toxicity to reproduction. 
 
The ratio of mitogenic relative to metabolic potency for insulin degludec is comparable to that of 
human insulin. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glycerol 
Metacresol 
Phenol 
Sodium chloride 
Zinc acetate 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products. 
 
Substances added to Ryzodeg may cause degradation of insulin degludec and/or insulin aspart. 
 
Ryzodeg must not be added to infusion fluids. 
 
6.3 Shelf life 
 
30 months. 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 
4 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C – 8°C). Keep the cap on the 
pen in order to protect from light. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 
4 weeks. Do not store above 30°C. Do not refrigerate. Keep the cartridges in the outer carton in order 
to protect from light. 
 
6.4 Special precautions for storage 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
Before first use: 
Store in a refrigerator (2°C – 8°C). Do not freeze.  
Keep away from the freezing element.  
Keep the cap on the pen in order to protect from light. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
Before first use:  
Store in a refrigerator (2°C – 8°C). Do not freeze. 
Keep away from the freezing element.  



15 

 
Keep the cartridges in the outer carton in order to protect from light. 
 
For storage conditions after first opening of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet 
(halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene. 
 
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 
5) (without needles) pre-filled pens. 
Not all pack sizes may be marketed. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet 
(halobutyl/polyisoprene) in a carton. 
 
Pack sizes of 5 and 10 cartridges. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
This medicinal product is for use by one person only. It must not be refilled. 
 
Ryzodeg must not be used if the solution does not appear clear and colourless. 
 
Ryzodeg which has been frozen must not be used. 
 
A new needle must always be attached before each use. Needles must not be re-used. The patient 
should discard the needle after each injection. 
 
In the event of blocked needles, patients must follow the instructions described in the instructions for 
use accompanying the package leaflet. 
 
Any waste material should be disposed of in accordance with local requirements. 
 
For detailed instructions for use, see the package leaflet. 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up 
to a length of 8 mm. It delivers 1–80 units in steps of 1 unit. Detailed instructions accompanying the 
pre-filled pen must be followed. 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for 
repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 
8 mm. Detailed instructions accompanying the delivery system must be followed. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 



16 

 
 
8. MARKETING AUTHORISATION NUMBERS 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
EU/1/12/806/001 
EU/1/12/806/002 
EU/1/12/806/003 
EU/1/12/806/004 
EU/1/12/806/005 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
EU/1/12/806/007 
EU/1/12/806/008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 January 2013 
Date of latest renewal: 21 September 2017 
 
 
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/


17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS 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 

 
 



18 

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

 
Name and address of the manufacturers of the biological active substances  
 
Novo Nordisk A/S 
Hallas Allé 
DK-4400 Kalundborg 
Denmark 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
Name and address of the manufacturer responsible for batch release 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports (PSUR) 
 
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 modfied, 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. 

 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (100 units/mL pre-filled pen (FlexTouch)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
70% insulin degludec / 30% insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCES 
 
One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 
1 mL solution contains 100 units of insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 
2.56 mg insulin degludec and 1.05 mg insulin aspart) 
 
 
3. LIST OF EXCIPIENTS 
 
Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide 
(for pH adjustment) and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection (FlexTouch)  
 
1 x 3 mL 
1 x 3 mL + 7 NovoFine needles 
1 x 3 mL + 7 NovoTwist needles 
5 x 3 mL 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 

 
Needles are not included 
Read the package leaflet before use. 
Subcutaneous 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 WARNINGS, IF NECESSARY 
 
Use only clear, colourless solution 
Single patient use only 
Do not withdraw solution from the pen 
 
 



22 

8. EXPIRY DATE 
 
EXP 
After first opening: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C – 8°C) 
Do not freeze 
 
After first opening: Can be stored in a refrigerator (2°C – 8°C). Do not store above 30°C. Keep the cap 
on the pen 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 

 
Discard the needle safely after each injection 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/12/806/001 1 pen of 3 mL 
EU/1/12/806/002 1 pen of 3 mL and 7 NovoFine needles 
EU/1/12/806/003 1 pen of 3 mL and 7 NovoTwist needles 
EU/1/12/806/004 5 pens of 3 mL 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ryzodeg pre-filled pen 100 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



23 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



24 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PEN LABEL (100 units/mL pre-filled pen (FlexTouch)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Ryzodeg 100 units/mL solution for injection  
70% insulin degludec / 30% insulin aspart  
FlexTouch 
 
 
2. METHOD OF ADMINISTRATION 
 
SC use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 



25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACK LABEL (100 units/mL pre-filled pen (FlexTouch)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
70% insulin degludec / 30% insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCES 
 
One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 
1 mL solution contains 100 units of insulin degludec/insulin aspart in the ration of 70/30 (equivalent to 
2.56 mg insulin degludec and 1.05 mg insulin aspart) 
 
 
3. LIST OF EXCIPIENTS 
 
Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide 
(for pH adjustment) and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection (FlexTouch)  
 
Multipack: 10 (2 packs of 5) 3 mL pre-filled pens 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous 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 WARNINGS, IF NECESSARY 
 
Use only clear, colourless solution 
Single patient use only 
Do not withdraw solution from the pen 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening: Use within 4 weeks 
 



26 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C – 8°C) 
Do not freeze 
 
After first opening: Can be stored in a refrigerator (2°C – 8°C). Do not store above 30°C. Keep the cap 
on the pen 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 

 
Discard the needle safely after each injection 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/12/806/005 10 pens of 3 mL 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ryzodeg pre-filled pen 100 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
  



27 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



28 

PARTICULARS TO APPEAR ON THE INNER PACKAGING 
 
INNER CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ryzodeg 100 units/mL solution for injection in pre-filled pen 
70% insulin degludec / 30% insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCES 
 
One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution 
1 mL solution contains 100 units of insulin degludec/insulin aspart in the ration of 70/30 (equivalent to 
2.56 mg insulin degludec and 1.05 mg insulin aspart) 
 
 
3. LIST OF EXCIPIENTS 
 
Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide 
(for pH adjustment) and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection (FlexTouch)  
 
5 x 3 mL. Component of a multipack, cannot be sold separately 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 

 
Read the package leaflet before use 
Subcutaneous 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 WARNINGS, IF NECESSARY 
 
Use only clear, colourless solution 
Single patient use only 
Do not withdraw solution from the pen 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening: Use within 4 weeks 



29 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C – 8°C) 
Do not freeze 
 
After first opening: Can be stored in a refrigerator (2°C – 8°C). Do not store above 30°C. Keep the cap 
on the pen 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 

 
Discard the needle safely after each injection 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/12/806/005 10 pens of 3 mL 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ryzodeg pre-filled pen 100 
 
 
 



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (100 units/mL cartridge (Penfill)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ryzodeg 100 units/mL solution for injection in cartridge 
70% insulin degludec / 30% insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCES 
 
One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution 
1 mL solution contains 100 units of insulin degludec/insulin aspart in the ratio of 70/30 (equivalent to 
2.56 mg insulin degludec and1.05 mg insulin aspart) 
 
 
3. LIST OF EXCIPIENTS 
 
Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide 
(for pH adjustment) and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection (Penfill) 
 
5 x 3 mL 
10 x 3 mL 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous 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 WARNINGS, IF NECESSARY 
 
Use only clear, colourless solution 
Single patient use only 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening: Use within 4 weeks 
 



31 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C – 8°C) 
Do not freeze 
 
After first opening: Do not refrigerate. Do not store above 30°C. Keep the cartridge 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 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/12/806/007 5 cartridges of 3 mL 
EU/1/12/806/008 10 cartridges of 3 mL 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ryzodeg cartridge 100 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:



32 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (100 units/mL cartridge (Penfill)) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Ryzodeg 100 units/mL solution for injection  
70% insulin degludec / 30% insulin aspart  
Penfill 
 
 
2. METHOD OF ADMINISTRATION 
 
SC use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 
 

  



33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



34 

Package leaflet: Information for the patient 
 

Ryzodeg 100 units/mL solution for injection in pre-filled pen 
70% insulin degludec / 30% insulin aspart 

 
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 signs 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 Ryzodeg is and what it is used for 
2. What you need to know before you use Ryzodeg 
3. How to use Ryzodeg 
4. Possible side effects 
5. How to store Ryzodeg 
6. Contents of the pack and other information 
 
 
1. What Ryzodeg is and what it is used for 
 
Ryzodeg is used to treat diabetes mellitus in adults, adolescents and children from the age of 2 years. It 
helps your body reduce your blood sugar level. 
 
This medicine contains two types of insulin: 
• Basal insulin called insulin degludec, this has a long blood sugar-lowering effect. 
• Rapid-acting insulin called insulin aspart, this lowers your blood sugar soon after you inject it. 
 
 
2. What you need to know before you use Ryzodeg 
 
Do not use Ryzodeg: 
• if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this 

medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Ryzodeg. Be especially aware of the following: 
 
• Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low 

blood sugar in section 4. 
• High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for 

high blood sugar in section 4. 
• Switching from other insulin medicines – the insulin dose may need to be changed if you switch 

from another type, brand or manufacturer of insulin. Talk to your doctor. 
• Pioglitazone used together with insulin, see ‘Pioglitazone’ below. 
• Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of 

diabetic eye disorder. If you experience eye problems, talk to your doctor. 
• Ensuring you use the right type of insulin – always check the insulin label before each injection 

to avoid accidentally confusing Ryzodeg with other insulin products.  
 
If you have poor eyesight, please see section 3. 
 
Children and adolescents 



35 

Ryzodeg can be used in adolescents and children from the age of 2 years with diabetes mellitus. 
Ryzodeg should be used with special caution in children 2 to 5 years old. The risk for very low blood 
sugar may be higher in this age group. There is no experience with the use of this medicine in children 
below the age of 2 years. 
 
Other medicines and Ryzodeg 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level, this may mean your insulin dose has to be 
changed. 
 
Listed below are the most common medicines which may affect your insulin treatment. 
 
Your blood sugar level may fall (hypoglycaemia) if you take: 
• other medicines for diabetes (oral and injectable) 
• sulfonamides, for infections 
• anabolic steroids, such as testosterone 
• beta-blockers, for high blood pressure. They may make it harder to recognise the warning signs 

of too low blood sugar (see section 4 ‘Warning signs of too low blood sugar’) 
• acetylsalicylic acid (and other salicylates), for pain and mild fever 
• monoamine oxidase (MAO) inhibitors, for depression 
• angiotensin converting enzyme (ACE) inhibitors, for some heart problems or high blood 

pressure. 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• danazol, for endometriosis 
• oral contraceptives (birth control pills) 
• thyroid hormones, for thyroid problems 
• growth hormone, for growth hormone deficiency 
• glucocorticoids such as ‘cortisone’, for inflammation 
• sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma 
• thiazides, for high blood pressure or if your body keeps too much water (water retention). 
 
Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone 
(acromegaly). They may increase or decrease your blood sugar level. 
 
Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with 
long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with 
pioglitazone and insulin experienced the development of heart failure. Inform your doctor immediately 
if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or 
localised swelling (oedema). 
 
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse. 
 
Ryzodeg with alcohol 
If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. 
You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
It is not known if Ryzodeg affects the baby in pregnancy or during breast-feeding. If you are pregnant 
or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or 
pharmacist for advice before taking this medicine. Your insulin dose may need to be changed during 
pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding too 
low blood sugar (hypoglycaemia) is particularly important for the health of your baby. 
 
Driving and using machines 
Having too low or too high blood sugar can affect your ability to drive or use any tools or machines. If 
your blood sugar is too low or too high, your ability to concentrate or react might be affected. This 



36 

could be dangerous to yourself or others. Ask your doctor whether you can drive if: 
• you often get too low blood sugar 
• you find it hard to recognise too low blood sugar. 
 
Important information about some of the ingredients in Ryzodeg 
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is 
essentially ‘sodium-free’. 
 
 
3. How to use Ryzodeg 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use the pen 
without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled 
pen. 
 
The pre-filled pen can provide a dose of 1–80 units in one injection in steps of 1 unit. 
 
Your doctor will decide with you: 
• how much Ryzodeg you will need each day and at which meal(s) 
• when to check your blood sugar level and if you need a higher or lower dose. 
 
Flexibility in dosing time 
• Always follow your doctor’s recommendation for dose. 
• Ryzodeg can either be used once or twice each day. 
• Use with the main meal(s); you can change the time of dosing as long as Ryzodeg is dosed with 

the largest meal(s). 
• If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a 

change in diet may alter your need for insulin. 
 
Based on your blood sugar level, your doctor may change your dose. 
 
When using other medicines, ask your doctor if your treatment needs to be adjusted. 
 
Use in elderly (≥ 65 years old) 
Ryzodeg can be used in elderly, but you may need to check your blood sugar level more often. Talk to 
your doctor about changes in your dose. 
 
If you have kidney or liver problems 
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk 
to your doctor about changes in your dose. 
 
Injecting your medicine 
Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use the pre-filled 
pen. 
• Check the name and strength on the label of the pen to make sure it is Ryzodeg 100 units/mL. 
 
Do not use Ryzodeg  
• in insulin infusion pumps. 
• if the pen is damaged or has not been stored correctly (see section 5 ‘How to store Ryzodeg’).  
• if the insulin does not appear clear and colourless. 
 
How to inject 
• Ryzodeg is given as an injection under the skin (subcutaneous injection). Do not inject it into a 

vein or muscle. 



37 

• The best places to inject are the front of your waist (abdomen), upper arms or the front of your 
thighs. 

• Change the place within the area where you inject each day to reduce the risk of developing 
lumps and skin pitting (see section 4). 

• Always use a new needle for each injection. Re-use of needles may increase the risk of blocked 
needles leading to inaccurate dosing. Dispose of the needle safely after each use. 

• Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential 
overdose. 

 
Detailed instructions for use are provided on the other side of this leaflet. 
 
If you use more Ryzodeg than you should 
If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 
4 ‘Too low blood sugar’. 
 
If you forget to use Ryzodeg 
If you forget a dose, inject the missed dose with your next large meal on that day and thereafter 
resume your usual dosing schedule. Do not inject a double dose to make up for a forgotten dose.  
 
If you stop using Ryzodeg 
Do not stop using your insulin without talking to your doctor. If you stop using your insulin, this could 
lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood), 
see advice in section 4 ‘Too high blood sugar’. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect 
more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much, you may 
become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If 
you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. 
See advice in ‘Too low blood sugar’ below. 
 
If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Ryzodeg, 
stop using this medicine and see a doctor straight away. The signs of a serious allergic reaction are:  
• the local reactions spread to other parts of your body 
• you suddenly feel unwell with sweating 
• you start being sick (vomiting) 
• you experience difficulty in breathing 
• you experience rapid heartbeat or feeling dizzy. 
 
Other side effects include: 
 
Common (may affect up to 1 in 10 people) 
Local reactions: Local reactions at the place you inject yourself may occur. The signs may include: 
pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your 
doctor if they do not disappear after a few weeks. Stop using Ryzodeg and see a doctor straight away 
if the reactions become serious. For more information, see ‘serious allergic reaction’ above. 
 
Uncommon (may affect up to 1 in 100 people) 
Swelling around your joints: When you first start using your medicine, your body may keep more 
water than it should. This causes swelling around your ankles and other joints. This is usually only 
short-lasting. 
 
Rare (may affect up to 1 in 1,000 people) 



38 

This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, 
nausea, tiredness and itching. 
 
Frequency not known (cannot be estimated from the available data) 
Skin changes where you use the injection (lipodystrophy): It is not known if Ryzodeg may cause 
lipodystrophy but such skin changes have been seen with other types of insulin. Fatty tissue under the 
skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). Changing where you inject each time 
may reduce the risk of developing these skin changes. If you notice these skin changes, tell your 
doctor or nurse. If you keep injecting in the same place, these reactions can become more severe and 
affect the amount of medicine your body gets from the pen. 
 
General effects from diabetes treatment 
• Too low blood sugar (hypoglycaemia) 
 
Too low blood sugar may happen if you: 
drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal. 
 
Warning signs of too low blood sugar – these may come on suddenly:  
Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; 
tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, 
difficulty in concentrating; short-lasting changes in your sight. 
 
What to do if you get too low blood sugar 
• Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry 

glucose tablets or a high sugar snack, just in case). 
• Measure your blood sugar if possible and rest. You may need to measure your blood sugar more 

than once, as with all basal insulin products improvement from the period of low blood sugar 
may be delayed.  

• Wait until the signs of too low blood sugar have gone or when your blood sugar level has 
settled. Then carry on with your insulin as usual. 

 
What others need to do if you pass out  
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out.  
 
Let them know that if you pass out, they must: 
• turn you on your side  
• get medical help straight away 
• not give you any food or drink because you may choke. 
 
You may recover more quickly from passing out with an injection of glucagon. This can only be given 
by someone who knows how to use it.  
• If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.  
• If you do not respond to a glucagon injection, you will have to be treated in a hospital.  
• If severe low blood sugar is not treated over time, it can cause brain damage. This can be short 

or long-lasting. It may even cause death. 
 
Talk to your doctor if: 
• your blood sugar got so low that you passed out 
• you have used an injection of glucagon 
• you have had too low blood sugar a few times recently. 
This is because the dosing or timing of your insulin injections, food or exercise may need to be 
changed. 
 
• Too high blood sugar (hyperglycaemia) 
 
Too high blood sugar may happen if you: 



39 

eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough 
insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without 
talking to your doctor. 
 
Warning signs of too high blood sugar – these normally appear gradually:  
Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, 
feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).  
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the 
blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic 
coma and eventually death. 
 
What to do if you get too high blood sugar 
• Test your blood sugar level. 
• Test your urine for ketones. 
• Get medical help straight away. 
 
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. 
 
 
5. How to store Ryzodeg 
 
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 pen label and carton, after ‘EXP’. 
The expiry date refers to the last day of that month. 
 
Before first use 
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezing element. Keep the cap 
on the pen in order to protect from light. 
 
After first opening or if carried as a spare 
You can carry your Ryzodeg pre-filled pen (FlexTouch) with you and keep it at room temperature (not 
above 30°C) or in a refrigerator (2°C to 8°C) for up to 4 weeks. 
 
Always keep the cap on the pen when you are not using it in order to protect from light.  
 
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 Ryzodeg contains 
• The active substances are insulin degludec and insulin aspart. Each mL of solution contains 

100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin 
degludec and 1.05 mg insulin aspart). Each pre-filled pen contains 300 units of insulin 
degludec/insulin aspart in 3 mL solution. 

• The other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, 
hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see 
section 2).  

 
What Ryzodeg looks like and contents of the pack 
Ryzodeg is presented as a clear and colourless solution for injection in pre-filled pen (300 units per 
3 mL). 

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


40 

 
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without 
needles) pre-filled pens of 3 mL. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 

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


41 

Instructions on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen 
(FlexTouch)  
 
Please read these instructions carefully before using your FlexTouch pre-filled pen. 
If you do not follow the instructions carefully, you may get too little or too much insulin, which can 
lead to too high or too low blood sugar level. 
 
Do not use the pen without proper training from your doctor or nurse. 
Start by checking your pen to make sure that it contains Ryzodeg 100 units/mL, then look at the 
illustrations below to get to know the different parts of your pen and needle. 
 
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use 
this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch 
pre-filled pen. 
 
Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. You can select a 
maximum of 80 units per dose, in steps of 1 unit. Your pen is designed to be used with NovoTwist 
or NovoFine single-use disposable needles up to a length of 8 mm.  
 

 Important information 
Pay special attention to these notes as they are important for correct use of the pen. 

 
 



42 

 

 
Ryzodeg pre-filled pen and 
needle (example) 
(FlexTouch) 

Pen cap 

Insulin scale 

Insulin window 

Pen label 

Dose counter 

Dose pointer 

Dose  
selector 
Dose  
button 

R
yzodeg

 
                      FlexTouch 

Outer  
needle cap 

Inner 
needle cap 

Needle 

Paper tab 

Dose 
button 
with 3 
lines  

 
1 Prepare your pen 
 
• Check the name and strength on the label of your pen, to make sure that it contains Ryzodeg 

100 units/mL. This is especially important if you take more than one type of insulin. If you take 
a wrong type of insulin, your blood sugar level may get too high or too low. 

 
• Pull off the pen cap. 
 



43 

 A 

 
 
• Check that the insulin in your pen is clear and colourless. 

Look through the insulin window. If the insulin looks cloudy, do not use the pen. 
 
 

  

B 

 
 
• Take a new needle and tear off the paper tab. 
 
 

  

C 

 
 
• Push the needle straight onto the pen. Turn until it is on tight. 
 
 

  

D 

 
 
• Pull off the outer needle cap and keep it for later. You will need it after the injection, to 

correctly remove the needle from the pen. 
 
 E 

 
 
• Pull off the inner needle cap and throw it away. If you try to put it back on, you may 

accidentally stick yourself with the needle. 
 
A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin 



44 

flow. 
 
 F 

 
 

 Always use a new needle for each injection. 
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and 
inaccurate dosing. 

 
 Never use a bent or damaged needle. 

 
2 Check the insulin flow 
 
• Always check the insulin flow before you start. This helps you to ensure that you get your 

full insulin dose. 
• Turn the dose selector to select 2 units. Make sure the dose counter shows 2. 
 
 A 

2 units 
selected 

 
 
• Hold the pen with the needle pointing up. 

Tap the top of the pen gently a few times to let any air bubbles rise to the top. 
 
 B 

 
 
• Press and hold in the dose button until the dose counter returns to 0. 

The 0 must line up with the dose pointer. 
A drop of insulin should appear at the needle tip. 

 



45 

 C 

 
 
A small air bubble may remain at the needle tip, but it will not be injected. 
 
If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle 
and repeat steps 2A to 2C once more. 
 
If a drop of insulin still does not appear, dispose of the pen and use a new one. 

 
 Always make sure that a drop appears at the needle tip before you inject. This makes sure 

that the insulin flows. 
If no drop appears, you will not inject any insulin, even though the dose counter may move. 
This may indicate a blocked or damaged needle. 
 

 Always check the flow before you inject. If you do not check the flow, you may get too little 
insulin or no insulin at all. This may lead to too high blood sugar level. 

 
3 Select your dose 
 
• Make sure the dose counter shows 0 before you start. 

The 0 must line up with the dose pointer. 
• Turn the dose selector to select the dose you need, as directed by your doctor or nurse.  
 
If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose. 
 
The pen can dial up to a maximum of 80 units. 
 
 

  

A 

5 units 
selected 

24 units 
selected 

Examples 

 
 
The dose selector changes the number of units. Only the dose counter and dose pointer will show how 
many units you select per dose. 
 
You can select up to 80 units per dose. When your pen contains less than 80 units, the dose counter 



46 

stops at the number of units left. 
 
The dose selector clicks differently when turned forwards, backwards or past the number of units left. 
Do not count the pen clicks. 
 

 Always use the dose counter and the dose pointer to see how many units you have selected 
before injecting the insulin. 
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may 
get too high or too low. Do not use the insulin scale, it only shows approximately how much 
insulin is left in your pen. 

 
4 Inject your dose 
 
• Insert the needle into your skin as your doctor or nurse has shown you. 
 
• Make sure you can see the dose counter. 

Do not touch the dose counter with your fingers. This could interrupt the injection. 
 
• Press and hold down the dose button until the dose counter returns to 0. 

The 0 must line up with the dose pointer. 
You may then hear or feel a click. 

 
• Leave the needle under the skin for at least 6 seconds to make sure you get your full dose. 
 
 A 

6 seconds 

 
 
• Pull the needle and pen straight up from your skin. 

If blood appears at the injection site, press lightly with a cotton swab. Do not rub the area. 
 
 

  

B 

 
 
You may see a drop of insulin at the needle tip after injecting. This is normal and does not affect your 



47 

dose. 
 

 Always watch the dose counter to know how many units you inject. 
The dose counter will show the exact number of units. Do not count the pen clicks. Hold the 
dose button down until the dose counter returns to 0 after the injection. If the dose counter stops 
before it returns to 0, the full dose has not been delivered, which may result in too high blood 
sugar level.  

 
5 After your injection 
 
• Lead the needle tip into the outer needle cap on a flat surface without 

touching the needle or the outer needle cap. 
 
 

  

A 

 
 
• Once the needle is covered, carefully push the outer needle cap completely on. 
 
• Unscrew the needle and dispose of it carefully. 
 
 

  

B 

 
 
• Put the pen cap on your pen after each use to protect the insulin from light. 
 
 

  

C 

 
 
Always dispose of the needle after each injection in an appropriate sharps container. This reduces 
the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the 
needle is blocked, you will not inject any insulin.  
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, 
pharmacist or local authorities. Do not place the used needle in household waste. 
 

 Never try to put the inner needle cap back on the needle. You may stick yourself with the 
needle. 

 
 Always remove the needle after each injection and store your pen without the needle 

attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles 
and inaccurate dosing. 

 
6 How much insulin is left? 
 



48 

• The insulin scale shows you approximately how much insulin is left in your pen. 
 

 

 A 

Approx. 
how much 

insulin is 
left  

 
• To see precisely how much insulin is left, use the dose counter: 

Turn the dose selector until the dose counter stops. 
If it shows 80, at least 80 units are left in your pen. 
If it shows less than 80, the number shown is the number of units left in your pen. 
 

 B 

Dose 
counter 

stopped: 
52 units 

left 

Example 

 
 
• Turn the dose selector back until the dose counter shows 0. 
 
• If you need more insulin than the units left in your pen, you can split your dose between two 

pens. 
 
  Be very careful to calculate correctly if splitting your dose.  

If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too 
little or too much insulin, which can lead to too high or too low blood sugar level. 

 
  Further important information 

 
• Always keep your pen with you.  
 
• Always carry an extra pen and new needles with you, in case of loss or damage. 
 
• Always keep your pen and needles out of sight and reach of others, especially children. 
 
• Never share your pen or your needles with other people. It might lead to cross-infection. 
 
• Never share your pen with other people. Your medicine might be harmful to their health. 
 
• Caregivers must be very careful when handling used needles to reduce the risk of needle 

injury and cross-infection.  
 
Caring for your pen 
 
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to 
too high or too low blood sugar level. 
 
• Do not leave the pen in a car or other place where it can get too hot or too cold. 
 



49 

• Do not expose your pen to dust, dirt or liquid. 
 
• Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a 

moistened cloth. 
 
• Do not drop your pen or knock it against hard surfaces. 

If you drop it or suspect a problem, attach a new needle and check the insulin flow before you 
inject. 

 
• Do not try to refill your pen. Once empty, it must be disposed of. 
 
• Do not try to repair your pen or pull it apart. 



50 

Package leaflet: Information for the patient 
 

Ryzodeg 100 units/mL solution for injection in cartridge 
70% insulin degludec / 30% insulin aspart 

 
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 signs 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 Ryzodeg is and what it is used for 
2. What you need to know before you use Ryzodeg 
3. How to use Ryzodeg 
4. Possible side effects 
5. How to store Ryzodeg 
6. Contents of the pack and other information 
 
 
1. What Ryzodeg is and what it is used for 
 
Ryzodeg is used to treat diabetes mellitus in adults, adolescents and children from the age of 2 years. It 
helps your body reduce your blood sugar level. 
 
This medicine contains two types of insulin: 
• Basal insulin called insulin degludec, this has a long blood sugar-lowering effect. 
• Rapid-acting insulin called insulin aspart, this lowers your blood sugar soon after you inject it. 
 
 
2. What you need to know before you use Ryzodeg 
 
Do not use Ryzodeg: 
• if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this 

medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Ryzodeg. Be especially aware of the following: 
 
• Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low 

blood sugar in section 4. 
• High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for 

high blood sugar in section 4. 
• Switching from other insulin medicines – the insulin dose may need to be changed if you switch 

from another type, brand or manufacturer of insulin. Talk to your doctor. 
• Pioglitazone used together with insulin, see ‘Pioglitazone’ below. 
• Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of 

diabetic eye disorder. If you experience eye problems, talk to your doctor. 
• Ensuring you use the right type of insulin – always check the insulin label before each injection 

to avoid accidentally confusing Ryzodeg with other insulin products.  
 
If you have poor eyesight, please see section 3. 
 
Children and adolescents 



51 

Ryzodeg can be used in adolescents and children from the age of 2 years with diabetes mellitus. 
Ryzodeg should be used with special caution in children 2 to 5 years old. The risk for very low blood 
sugar may be higher in this age group. There is no experience with the use of Ryzodeg in children 
below the age of 2 years. 
 
Other medicines and Ryzodeg 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level, this may mean your insulin dose has to be 
changed. 
 
Listed below are the most common medicines which may affect your insulin treatment.  
 
Your blood sugar level may fall (hypoglycaemia) if you take: 
• other medicines for diabetes (oral and injectable) 
• sufonamides, for infections 
• anabolic steroids, such as testosterone 
• beta-blockers, for high blood pressure. They may make it harder to recognise the warning signs 

of too low blood sugar (see section 4 ‘Warning signs of too low blood sugar’) 
• acetylsalicylic acid (and other salicylates), for pain and mild fever 
• monoamine oxidase (MAO) inhibitors, for depression 
• angiotensin converting enzyme (ACE) inhibitors, for some heart problems or high blood 

pressure. 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• danazol, for endometriosis 
• oral contraceptives (birth control pills) 
• thyroid hormones, for thyroid problems 
• growth hormone, for growth hormone deficiency 
• glucocorticoids such as ‘cortisone’, for inflammation 
• sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma 
• thiazides, for high blood pressure or if your body keeps too much water (water retention). 
 
Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone 
(acromegaly). They may increase or decrease your blood sugar level. 
 
Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. Some patients with 
long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with 
pioglitazone and insulin experienced the development of heart failure. Inform your doctor immediately 
if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or 
localised swelling (oedema). 
 
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse. 
 
Ryzodeg with alcohol 
If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. 
You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
It is not known if Ryzodeg affects the baby in pregnancy or during the breast-feeding. If you are 
pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 
or pharmacist for advice before taking this medicine. Your insulin dose may need to be changed 
during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. 
Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby. 
 
Driving and using machines 
Having too low or too high blood sugar can affect your ability to drive or use any tools or machines. If 
your blood sugar is too low or too high, your ability to concentrate or react might be affected. This 



52 

could be dangerous to yourself or others. Ask your doctor whether you can drive if: 
• you often get too low blood sugar 
• you find it hard to recognise too low blood sugar. 
 
Important information about some of the ingredients in Ryzodeg 
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is 
essentially ‘sodium-free’. 
 
 
3. How to use Ryzodeg 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this 
insulin product without help. Get help from a person with good eyesight who is trained to use the pen. 
 
Your doctor will decide with you: 
• how much Ryzodeg you will need each day and at which meal(s) 
• when to check your blood sugar level and if you need a higher or lower dose. 
 
Flexibility in dosing time 
• Always follow your doctor’s recommendation for dose. 
• Ryzodeg can either be used once or twice each day. 
• Use with the main meal(s); you can change the time of dosing as long as Ryzodeg is dosed with 

the largest meal(s). 
• If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a 

change in diet may alter your need for insulin. 
 
Based on your blood sugar level, your doctor may change your dose. 
 
When using other medicines, ask your doctor if your treatment needs to be adjusted. 
 
Use in elderly (≥ 65 years old) 
Ryzodeg can be used in elderly, but you may need to check your blood sugar level more often. Talk to 
your doctor about changes in your dose. 
 
If you have kidney or liver problems 
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk 
to your doctor about changes in your dose. 
 
Injecting your medicine  
Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use it. 
• Please also read the manual that comes with your insulin delivery system. 
• Check the name and strength on the label to make sure it is Ryzodeg 100 units/mL. 
 
Do not use Ryzodeg  
• in insulin infusion pumps. 
• if the cartridge or the delivery system you are using is damaged. Take it back to your supplier. 

See your delivery system manual for further instructions. 
• if the cartridge is damaged or has not been stored correctly (see section 5 ‘How to store 

Ryzodeg’). 
• if the insulin does not appear clear and colourless. 
 
How to inject 
• Ryzodeg is given as an injection under the skin (subcutaneous injection). Do not inject it into a 

vein or muscle. 



53 

• The best places to inject are the front of your waist (abdomen), upper arms or the front of your 
thighs. 

• Change the place within the area where you inject each day to reduce the risk of developing 
lumps and skin pitting (see section 4). 

• Always use a new needle for each injection. Re-use of needles may increase the risk of blocked 
needles leading to inaccurate dosing. Dispose of the needle safely after each use. 

 
If you use more Ryzodeg than you should 
If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 
4 ‘Too low blood sugar’. 
 
If you forget to use Ryzodeg 
If you forget a dose, inject the missed dose with your next large meal on that day and thereafter 
resume your usual dosing schedule. Do not inject a double dose to make up for a forgotten dose.  
 
If you stop using Ryzodeg 
Do not stop using your insulin without talking to your doctor. If you stop using your insulin, this could 
lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood), 
see advice in section 4 ‘Too high blood sugar’. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect 
more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much, you may 
become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If 
you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. 
See advice in ‘Too low blood sugar’ below. 
 
If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Ryzodeg, 
stop using this medicine and see a doctor straight away. The signs of a serious allergic reaction are:  
• the local reactions spread to other parts of your body 
• you suddenly feel unwell with sweating 
• you start being sick (vomiting) 
• you experience difficulty in breathing 
• you experience rapid heartbeat or feeling dizzy. 
 
Other side effects include: 
 
Common (may affect up to 1 in 10 people) 
Local reactions: Local reactions at the place you inject yourself may occur. The signs may include: 
pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your 
doctor if they do not disappear after a few weeks. Stop using Ryzodeg and see a doctor straight away 
if the reactions become serious. For more information, see ‘serious allergic reaction’ above. 
 
Uncommon (may affect up to 1 in 100 people) 
Swelling around your joints: When you first start using your medicine, your body may keep more 
water than it should. This causes swelling around your ankles and other joints. This is usually only 
short-lasting. 
 
Rare (may affect up to 1 in 1,000 people) 
This medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, 
nausea, tiredness and itching. 
 
Frequency not known (cannot be estimated from the available data) 



54 

Skin changes where you use the injection (lipodystrophy): It is not known if Ryzodeg may cause 
lipodystrophy but such skin changes have been seen with other types of insulin. Fatty tissue under the 
skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). Changing where you inject each time 
may reduce the risk of developing these skin changes. If you notice these skin changes, tell your 
doctor or nurse. If you keep injecting in the same place, these reactions can become more severe and 
affect the amount of medicine your body gets. 
 
General effects from diabetes treatment 
• Too low blood sugar (hypoglycaemia) 
 
Too low blood sugar may happen if you: 
drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal. 
 
Warning signs of too low blood sugar – these may come on suddenly:  
Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; 
tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, 
difficulty in concentrating; short-lasting changes in your sight. 
 
What to do if you get too low blood sugar 
• Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry 

glucose tablets or a high sugar snack, just in case). 
• Measure your blood sugar if possible and rest. You may need to measure your blood sugar more 

than once, as with all basal insulin products improvement from the period of low blood sugar 
may be delayed.  

• Wait until the signs of too low blood sugar have gone or when your blood sugar level has 
settled. Then carry on with your insulin as usual. 

 
What others need to do if you pass out  
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out.  
 
Let them know that if you pass out, they must: 
• turn you on your side  
• get medical help straight away 
• not give you any food or drink because you may choke. 
 
You may recover more quickly from passing out with an injection of glucagon. This can only be given 
by someone who knows how to use it. 
• If you are given glucagon, you will need sugar or a sugary snack as soon as you come round. 
• If you do not respond to a glucagon injection, you will have to be treated in a hospital. 
• If severe low blood sugar is not treated over time, it can cause brain damage. This can be short 

or long-lasting. It may even cause death. 
 
Talk to your doctor if: 
• your blood sugar got so low that you passed out 
• you have used an injection of glucagon 
• you have had too low blood sugar a few times recently. 
This is because the dosing or timing of your insulin injections, food or exercise may need to be 
changed. 
 
• Too high blood sugar (hyperglycaemia) 
 
Too high blood sugar may happen if you: 
eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough 
insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without 
talking to your doctor. 
 



55 

Warning signs of too high blood sugar – these normally appear gradually: 
Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, 
feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting). 
These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the 
blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic 
coma and eventually death. 
 
What to do if you get too high blood sugar 
• Test your blood sugar level. 
• Test your urine for ketones. 
• Get medical help straight away. 
 
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. 
 
 
5. How to store Ryzodeg 
 
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 Penfill label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 
 
Before first use 
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezing element.  
 
After first opening or if carried as a spare 
Do not refrigerate. You can carry your Ryzodeg cartridge (Penfill) with you and keep it at room 
temperature (not above 30°C) for up to 4 weeks. 
 
Always keep Ryzodeg Penfill in the outer carton when you are not using it in order to protect from 
light.  
 
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 Ryzodeg contains 
• The active substances are insulin degludec and insulin aspart. Each mL of solution contains 

100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin 
degludec and 1.05 mg insulin aspart). Each cartridge contains 300 units of insulin 
degludec/insulin aspart in 3 mL solution. 

• The other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, 
hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see 
section 2). 

 
What Ryzodeg looks like and contents of the pack 
Ryzodeg is presented as a clear and colourless solution for injection in a cartridge (300 units per 
3 mL). 
 
Pack sizes of 5 and 10 cartridges of 3 mL.  
Not all pack sizes may be marketed. 
 

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


56 

Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé  
DK-2880 Bagsværd, Denmark 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 

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

	ANNEX ISUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES 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
{'Title': '1. what ryzodeg is and what it is used for', 'Section_Content': 'ryzodeg is used to treat diabetes mellitus in adults, adolescents and children from the age of 2 years. it helps your body reduce your blood sugar level. this medicine contains two types of insulin: basal insulin called insulin degludec, this has a long blood sugar-lowering effect. rapid-acting insulin called insulin aspart, this lowers your blood sugar soon after you inject it.', 'Entity_Recognition': [{'Text': 'ryzodeg', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'ryzodeg', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 7}, {'Id': 6, 'BeginOffset': 25, 'EndOffset': 42, 'Score': 0.9457853436470032, 'Text': 'diabetes mellitus', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9673027396202087}]}, {'Id': 7, 'BeginOffset': 95, 'EndOffset': 96, 'Score': 0.15250933170318604, 'Text': '2', 'Category': 'PROTECTED_HEALTH_INFORMATION', 'Type': 'AGE', 'Traits': []}, {'Text': 'your blood sugar level', 'Type': 'TEST', 'BeginOffset': 130, 'EndOffset': 152}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 154, 'EndOffset': 167}, {'Id': 1, 'BeginOffset': 190, 'EndOffset': 197, 'Score': 0.9347787499427795, 'Text': 'insulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.5112894177436829, 'RelationshipScore': 0.9999991655349731, 'RelationshipType': 'DOSAGE', 'Id': 0, 'BeginOffset': 177, 'EndOffset': 186, 'Text': 'two types', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 2, 'BeginOffset': 199, 'EndOffset': 212, 'Score': 0.988825261592865, 'Text': 'basal insulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.5112894177436829, 'RelationshipScore': 0.9997773766517639, 'RelationshipType': 'DOSAGE', 'Id': 0, 'BeginOffset': 177, 'EndOffset': 186, 'Text': 'two types', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 3, 'BeginOffset': 220, 'EndOffset': 236, 'Score': 0.9202861785888672, 'Text': 'insulin degludec', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'blood sugar', 'Type': 'TEST', 'BeginOffset': 254, 'EndOffset': 265}, {'Id': 4, 'BeginOffset': 283, 'EndOffset': 303, 'Score': 0.9852576851844788, 'Text': 'rapid-acting insulin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 311, 'EndOffset': 325, 'Score': 0.9402785897254944, 'Text': 'insulin aspart', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'your blood sugar', 'Type': 'TEST', 'BeginOffset': 339, 'EndOffset': 355}]}
{'Title': '2. what you need to know before you use ryzodeg', 'Section_Content': "do not use ryzodeg: if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor, pharmacist or nurse before using ryzodeg. be especially aware of the following: low blood sugar (hypoglycaemia) if your blood sugar is too low, follow the guidance for low blood sugar in section 4. high blood sugar (hyperglycaemia) if your blood sugar is too high, follow the guidance for high blood sugar in section 4. switching from other insulin medicines the insulin dose may need to be changed if you switch from another type, brand or manufacturer of insulin. talk to your doctor. pioglitazone used together with insulin, see 'pioglitazone' below. eye disorder fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. if you experience eye problems, talk to your doctor. ensuring you use the right type of insulin always check the insulin label before each injection to avoid accidentally confusing ryzodeg with other insulin products. if you have poor eyesight, please see section 3. children and adolescents 35 ryzodeg can be used in adolescents and children from the age of 2 years with diabetes mellitus. ryzodeg should be used with special caution in children 2 to 5 years old. the risk for very low blood sugar may be higher in this age group. there is no experience with the use of this medicine in children below the age of 2 years. other medicines and ryzodeg tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. some medicines affect your blood sugar level, this may mean your insulin dose has to be changed. listed below are the most common medicines which may affect your insulin treatment. your blood sugar level may fall (hypoglycaemia) if you take: other medicines for diabetes (oral and injectable) sulfonamides, for infections anabolic steroids, such as testosterone beta-blockers, for high blood pressure. they may make it harder to recognise the warning signs of too low blood sugar (see section 4 'warning signs of too low blood sugar') acetylsalicylic acid (and other salicylates), for pain and mild fever monoamine oxidase (mao) inhibitors, for depression angiotensin converting enzyme (ace) inhibitors, for some heart problems or high blood pressure. your blood sugar level may rise (hyperglycaemia) if you take: danazol, for endometriosis oral contraceptives (birth control pills) thyroid hormones, for thyroid problems growth hormone, for growth hormone deficiency glucocorticoids such as 'cortisone', for inflammation sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma thiazides, for high blood pressure or if your body keeps too much water (water retention). octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly). they may increase or decrease your blood sugar level. pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema). if any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse. ryzodeg with alcohol if you drink alcohol, your need for insulin may change. your blood sugar level may either rise or fall. you should therefore monitor your blood sugar level more often than usual. pregnancy and breast-feeding it is not known if ryzodeg affects the baby in pregnancy or during breast-feeding. if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. your insulin dose may need to be changed during pregnancy and after delivery. careful control of your diabetes is needed in pregnancy. avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby. driving and using machines having too low or too high blood sugar can affect your ability to drive or use any tools or machines. if your blood sugar is too low or too high, your ability to concentrate or react might be affected. this 36 could be dangerous to yourself or others. ask your doctor whether you can drive if: you often get too low blood sugar you find it hard to recognise too low blood sugar. important information about some of the ingredients in ryzodeg this medicine contains less than 1 mmol sodium (23 mg) per dose. this means that the medicine is essentially 'sodium-free'.", 'Entity_Recognition': [{'Text': 'ryzodeg', 'Type': 'PRODUCT_NAME', 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{'Title': '3. how to use ryzodeg', 'Section_Content': "always use this medicine exactly as your doctor has told you. check with your doctor, pharmacist or nurse if you are not sure. if you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use the pen without help. get help from a person with good eyesight who is trained to use the flextouch pre-filled pen. the pre-filled pen can provide a dose of 180 units in one injection in steps of 1 unit. your doctor will decide with you: how much ryzodeg you will need each day and at which meal(s) when to check your blood sugar level and if you need a higher or lower dose. flexibility in dosing time always follow your doctor's recommendation for dose. ryzodeg can either be used once or twice each day. use with the main meal(s); you can change the time of dosing as long as ryzodeg is dosed with the largest meal(s). if you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin. based on your blood sugar level, your doctor may change your dose. when using other medicines, ask your doctor if your treatment needs to be adjusted. use in elderly (≥ 65 years old) ryzodeg can be used in elderly, but you may need to check your blood sugar level more often. talk to your doctor about changes in your dose. if you have kidney or liver problems if you have kidney or liver problems, you may need to check your blood sugar level more often. talk to your doctor about changes in your dose. injecting your medicine before you use ryzodeg for the first time, your doctor or nurse will show you how to use the pre-filled pen. check the name and strength on the label of the pen to make sure it is ryzodeg 100 units/ml. do not use ryzodeg in insulin infusion pumps. if the pen is damaged or has not been stored correctly (see section 5 'how to store ryzodeg'). if the insulin does not appear clear and colourless. how to inject ryzodeg is given as an injection under the skin (subcutaneous injection). do not inject it into a vein or muscle. the best places to inject are the front of your waist (abdomen), upper arms or the front of your thighs. change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting (see section 4). always use a new needle for each injection. re-use of needles may increase the risk of blocked needles leading to inaccurate dosing. dispose of the needle safely after each use. do not use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose. detailed instructions for use are provided on the other side of this leaflet. if you use more ryzodeg than you should if you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 'too low blood sugar'. if you forget to use ryzodeg if you forget a dose, inject the missed dose with your next large meal on that day and thereafter resume your 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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. hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect more than 1 in 10 people). it can be very serious. if your blood sugar level falls too much, you may become unconscious. serious hypoglycaemia may cause brain damage and may be life-threatening. if you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. see advice in 'too low blood sugar' below. if you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in ryzodeg, stop using this medicine and see a doctor straight away. the signs of a serious allergic reaction are: the local reactions spread to other parts of your body you suddenly feel unwell with sweating you start being sick (vomiting) you experience difficulty in breathing you experience rapid heartbeat or feeling dizzy. other side effects include: common (may affect up to 1 in 10 people) local reactions: local reactions at the place you inject yourself may occur. the signs may include: pain, redness, hives, swelling and itching. the reactions usually disappear after a few days. see your doctor if they do not disappear after a few weeks. stop using ryzodeg and see a doctor straight away if the reactions become serious. for more information, see 'serious allergic reaction' above. uncommon (may affect up to 1 in 100 people) swelling around your joints: when you first start using your medicine, your body may keep more water than it should. this causes swelling around your ankles and other joints. this is usually only short-lasting. rare (may affect up to 1 in 1,000 people) 38 this medicine can cause allergic reactions such as hives, swelling of the tongue and lips, diarrhoea, nausea, tiredness and itching. frequency not known (cannot be estimated from the available data) skin changes where you use the injection (lipodystrophy): it is not known if ryzodeg may cause lipodystrophy but such skin changes have been seen with other types of insulin. fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). changing where you inject each time may reduce the risk of developing these skin changes. if you notice these skin changes, tell your doctor or nurse. if you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets from the pen. general effects from diabetes treatment too low blood sugar (hypoglycaemia) too low blood sugar may happen if you: drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal. warning signs of too low blood sugar these may come on suddenly: headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight. what to do if you get too low blood sugar eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case). measure your blood sugar if possible and rest. you may need to measure your blood sugar more than once, as with all basal insulin products improvement from the period of low blood sugar may be delayed. wait until the signs of too low blood sugar have gone or when your blood sugar level has settled. then carry on with your insulin as usual. what others need to do if you pass out tell everyone you spend time with that you have diabetes. tell them what could happen if your blood sugar gets too low, including the risk of passing out. let them know that if you pass out, they must: turn you on your side get medical help straight away not give you any food or drink because you may choke. you may recover more quickly from passing out with an injection of glucagon. this can only be given by someone who knows how to use it. if you are given glucagon, you will need sugar or a sugary snack as soon as you come round. if you do not respond to a glucagon injection, you will have to be treated in a hospital. if severe low blood sugar is not treated over time, it can cause brain damage. this can be short or long-lasting. it may even cause death. talk to your doctor if: your blood sugar got so low that you passed out you have used an injection of glucagon you have had too low blood sugar a few times recently. this is because the dosing or timing of your insulin injections, food or exercise may need to be changed. too high blood sugar (hyperglycaemia) too high blood sugar may happen if you: 39 eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without talking to your doctor. warning signs of too high blood sugar these normally appear gradually: flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting). these may be signs of a very serious condition called ketoacidosis. this is a build-up of acid in the blood because the body is breaking down fat instead of sugar. if not treated, this could lead to diabetic coma and eventually death. what to do if you get too high blood sugar test your blood sugar level. test your urine for ketones. get medical help straight away. 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.", 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{'Title': '5. how to store ryzodeg', '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 pen label and carton, after 'exp'. the expiry date refers to the last day of that month. before first use store in a refrigerator (2 to 8). do not freeze. keep away from the freezing element. keep the cap on the pen in order to protect from light. after first opening or if carried as a spare you can carry your ryzodeg pre-filled pen (flextouch) with you and keep it at room temperature (not above 30) or in a refrigerator (2 to 8) for up to 4 weeks. always keep the cap on the pen when you are not using it in order to protect from light. 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': 'ryzodeg', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 265, 'EndOffset': 266}, {'Text': 'the cap', 'Type': 'TREATMENT', 'BeginOffset': 326, 'EndOffset': 333}, {'Text': 'the pen', 'Type': 'TREATMENT', 'BeginOffset': 337, 'EndOffset': 344}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 528, 'EndOffset': 530}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 559, 'EndOffset': 560}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 572, 'EndOffset': 573}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what ryzodeg contains the active substances are insulin degludec and insulin aspart. each ml of solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart). each pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 ml solution. the other ingredients are glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for ph adjustment) and water for injections (see section 2). what ryzodeg looks like and contents of the pack ryzodeg is presented as a clear and colourless solution for injection in pre-filled pen (300 units per 3 ml). pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens of 3 ml. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'ryzodeg', 'Type': 'PRODUCT_NAME', 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