NovoRapid

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid 100 units/ml solution for injection in vial 
NovoRapid Penfill 100 units/ml solution for injection in cartridge 
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen 
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen 
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen 
NovoRapid PumpCart 100 units/ml solution for injection in cartridge 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
NovoRapid vial 
1 vial contains 10 ml equivalent to 1,000 units.1 ml solution contains 100 units insulin aspart* 
(equivalent to 3.5 mg). 
 
NovoRapid Penfill 
1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* 
(equivalent to 3.5 mg). 
 
NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch 
1 pre-filled pen contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* 
(equivalent to 3.5 mg). 
 
NovoRapid PumpCart 
1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution contains 100 units insulin aspart* 
(equivalent to 3.5 mg). 
 
*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
 
The solution is clear, colourless and aqueous.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 
year and above.  
 
4.2 Posology and method of administration 
 
Posology 
 
The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency 
of human insulin is expressed in international units. 
 
NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should 
normally be used in combination with intermediate-acting or long-acting insulin.  
 



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Moreover NovoRapid vial and NovoRapid PumpCart can be used for continuous subcutaneous insulin 
infusion (CSII) in pump systems. 
 
NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other 
healthcare staff, is applicable.  
 
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal 
glycaemic control. 
 
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day. 
In a basal-bolus treatment regimen 50–70% of this requirement may be provided by NovoRapid and 
the remainder by intermediate-acting or long-acting insulin. 
 
Adjustment of dose may be necessary if patients undertake increased physical activity, change their 
usual diet or during concomitant illness. 
 
Special populations 
 
Elderly (≥ 65 years old) 
NovoRapid can be used in elderly patients. 
In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an 
individual basis. 
 
Renal and hepatic impairment 
Renal or hepatic impairment may reduce the patient’s insulin requirements. 
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin 
aspart dose adjusted on an individual basis. 
 
Paediatric population 
NovoRapid can be used in children and adolescents aged 1 year and above in preference to soluble 
human insulin when a rapid onset of action might be beneficial, for example, in the timing of the 
injections in relation to meals (see sections 5.1 and 5.2).  
 
The safety and efficacy of NovoRapid in children below 1 year of age have not been established. 
No data are available.  
 
Transfer from other insulin medicinal products 
 
When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the 
dose of the basal insulin may be necessary. NovoRapid has a faster onset and a shorter duration of 
action than soluble human insulin. When injected subcutaneously into the abdominal wall, the onset of 
action will occur within 10–20 minutes of injection. The maximum effect is exerted between 1 and 
3 hours after the injection. The duration of action is 3 to 5 hours. 
 
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see 
section 4.4). 
 
Method of administration  
 
NovoRapid is a rapid-acting insulin analogue.  
NovoRapid is administered subcutaneously by injection in the abdominal wall, the thigh, the upper 
arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same 
region in order to reduce the risk of lipodystrophy. Subcutaneous injection in the abdominal wall 
ensures a faster absorption than other injection sites. Compared to soluble human insulin the faster 
onset of action of NovoRapid is maintained regardless of the injection site. The duration of action will 
vary according to the dose, injection site, blood flow, temperature and level of physical activity.  
 



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Due to the faster onset of action, NovoRapid should generally be given immediately before a meal. 
When necessary NovoRapid can be given soon after a meal.  
 
NovoRapid vial/NovoRapid PumpCart 
Continuous Subcutaneous Insulin Infusion (CSII) 
NovoRapid may be used for CSII in pump systems suitable for insulin infusion. CSII should be 
administered in the abdominal wall. Infusion sites should be rotated. 

 
When used with an insulin infusion pump, NovoRapid should not be mixed with any other insulin 
medicinal products. 
 
Patients using CSII should be comprehensively instructed in the use of the pump system and use the 
correct reservoir and tubing for the pump (see section 6.6). The infusion set (tubing and cannula) 
should be changed in accordance with the instructions in the product information supplied with the 
infusion set. 
 
Patients administering NovoRapid by CSII must have an alternative insulin delivery method available 
in case of pump system failure. 
 
NovoRapid vial 
Intravenous use 
If necessary, NovoRapid can be administered intravenously which should be carried out by physicians 
or other healthcare staff. 
 
For intravenous use, infusion systems with NovoRapid 100 units/ml at concentrations from 
0.05 unit/ml to 1.0 unit/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 
10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at 
room temperature for 24 hours.  
 
Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the 
infusion bag. Monitoring of blood glucose is necessary during insulin infusion. 
 
Mixing two types of insulins 
NovoRapid can only be mixed with NPH (Neutral Protamine Hagedorn) insulin in a syringe for 
subcutaneous use. When NovoRapid is mixed with NPH insulin, NovoRapid should be drawn into the 
syringe first, and the mixture should be injected immediately after mixing. Insulin mixtures should not 
be administered intravenously or used with a subcutaneous insulin infusion pump. 
 
Administration with a syringe 
NovoRapid vials are for use with insulin syringes with the corresponding unit scale. See also section 
6.2.  
 
NovoRapid Penfill 
Administration with an insulin delivery system 
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine 
or NovoTwist needles. NovoRapid Penfill is only suitable for subcutaneous injections from a reusable 
pen. If administration by syringe or intravenous injection is necessary, a vial should be used. If 
administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used. 
 
NovoRapid FlexPen 
Administration with FlexPen 
NovoRapid FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or 
NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1–60 units in increments of 
1 unit. NovoRapid FlexPen is only suitable for subcutaneous injections. If administration by syringe or 
intravenous injection is necessary, a vial should be used. If administration by infusion pump is 
necessary, a vial or NovoRapid PumpCart should be used. 
 



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NovoRapid InnoLet 
Administration with InnoLet 
NovoRapid InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable 
needles up to a length of 8 mm. InnoLet delivers 1–50 units in increments of 1 unit. NovoRapid 
InnoLet is only suitable for subcutaneous injections. If administration by syringe or intravenous 
injection is necessary, a vial should be used. If administration by infusion pump is necessary, a vial or 
NovoRapid PumpCart should be used. 
 
NovoRapid FlexTouch 
Administration with FlexTouch 
NovoRapid FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or 
NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1–80 units in increments of 
1 unit. NovoRapid FlexTouch is only suitable for subcutaneous injections. If administration by syringe 
or intravenous injection is necessary, a vial should be used. If administration by infusion pump is 
necessary, a vial or NovoRapid PumpCart should be used. 
 
NovoRapid PumpCart 
Administration via Continuous Subcutaneous Insulin Infusion (CSII) 
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with 
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.  
CSII should be administered in the abdominal wall. Infusion sites should be rotated. NovoRapid 
PumpCart is only suitable for CSII in pump systems suitable for insulin infusion. If administration by 
syringe or intravenous injection is necessary, a vial should be used. 
 
 
For detailed user instructions, please refer to the package leaflet. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients (see section 6.1). 
 
4.4 Special warnings and precautions for use 
 
Before travelling between different time zones, the patient should seek the doctor’s advice since this 
may mean that the patient has to take the insulin and meals at different times. 
 
NovoRapid PumpCart  
Misuse of NovoRapid PumpCart 
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with 
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with 
other devices not designed for NovoRapid PumpCart, as this may result in incorrect insulin dosing and 
subsequent hyper- or hypoglycaemia. 
 
Hyperglycaemia 
 
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to 
hyperglycaemia and diabetic ketoacidosis. 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, loss of appetite as well as acetone odour of breath. 
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is 
potentially lethal. 
 
Hypoglycaemia 
 
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.  



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Especially in children, care should be taken to match insulin doses (especially in basal-bolus regimens) 
with food intake, physical activities and current blood glucose level in order to minimise the risk of 
hypoglycaemia. 
 
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case 
of hypoglycaemia or if hypoglycaemia is suspected NovoRapid must not be injected. After 
stabilisation of patient’s blood glucose adjustment of the dose should be considered (see sections 4.8 
and 4.9). 
 
Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may 
experience a change in their usual warning symptoms of hypoglycaemia, and should be advised 
accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. 
 
A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia 
occurs, it may occur earlier after an injection when compared with soluble human insulin. 
 
Since NovoRapid should be administered in immediate relation to a meal, the rapid onset of action 
should be considered in patients with concomitant diseases or treatment where a delayed absorption of 
food might be expected. 
 
Concomitant illness, especially infections and feverish conditions, usually increases the patient’s 
insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or 
thyroid gland can require changes in the insulin dose. 
 
When patients are transferred between different types of insulin medicinal products, the early warning 
symptoms of hypoglycaemia may change or become less pronounced than those experienced with 
their previous insulin. 
 
Transfer from other insulin medicinal products 
 
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision. Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human 
insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may 
result in the need for a change in dose. Patients transferred to NovoRapid from another type of insulin 
may require an increased number of daily injections or a change in dose from that used with their 
usual insulin medicinal products. If an adjustment is needed, it may occur with the first dose or during 
the first few weeks or months.  
 
Injection site reactions 
 
As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, 
inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given 
area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few 
weeks. On rare occasions, injection site reactions may require discontinuation of NovoRapid. 
 
Combination of NovoRapid with pioglitazone 
 
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 heart failure. This should be kept in 
mind if treatment with the combination of pioglitazone and NovoRapid 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. 
 
Avoidance of accidental mix-ups/medication errors 
 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between NovoRapid and other insulin products. 



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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. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
A number of medicinal products are known to interact with the glucose metabolism. 
 
The following substances may reduce the patient's insulin requirements: 
Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin 
converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides. 
 
The following substances may increase the patient’s insulin requirements: 
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 
 
NovoRapid (insulin aspart) can be used in pregnancy. Data from two randomised controlled clinical 
trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on 
pregnancy or on the health of the foetus/newborn when compared to human insulin (see section 5.1). 
 
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, 
type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when 
contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase 
subsequently during the second and third trimester. After delivery, insulin requirements normally 
return rapidly to pre-pregnancy values. 
 
Breast-feeding 
 
There are no restrictions on treatment with NovoRapid during breast-feeding. Insulin treatment of the 
nursing mother presents no risk to the baby. However, the NovoRapid dose may need to be adjusted.  
 
Fertility 
 
Animal reproduction studies have not revealed any differences between insulin aspart and human insu-
lin regarding fertility. 
 
4.7 Effects on ability to drive and use machines 
 
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 
operating machinery). 
 
Patients should 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 



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hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of 
insulin. 
 
The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of 
hypoglycaemia vary with patient population, dose regimens and level of glycaemic control (see 
section 4.8, Description of selected adverse reactions). 
 
At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions 
(pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. 
These reactions are usually of transitory nature. Fast improvement in blood glucose control may be 
associated with acute painful neuropathy, which is usually reversible. 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. 
 
Tabulated list of adverse reactions 
 
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA 
frequency and 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); not known (cannot be estimated from the 
available data). 
 
Immune system disorders  Uncommon – Urticaria, rash, eruptions 

 
Very rare – Anaphylactic reactions* 
 

Metabolism and nutrition 
disorders 
 

Very common – Hypoglycaemia* 
 

Nervous system disorders Rare – Peripheral neuropathy (painful neuropathy) 
 

Eye disorders 
 

Uncommon – Refraction disorders 
 
Uncommon – Diabetic retinopathy 
 

Skin and subcutaneous tissue 
disorders 

Uncommon – Lipodystrophy* 

General disorders and 
administration site 
conditions 

Uncommon – Injection site reactions 

Uncommon – Oedema 
 

* see section 4.8, Description of selected adverse reactions. 
 
Description of selected adverse reactions 
 
Anaphylactic reactions: 
The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, 
sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and 
reduction in blood pressure) is very rare but can potentially be life threatening. 



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Hypoglycaemia: 
The most frequently reported adverse reaction is hypoglycaemia. It 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. 
 
In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and 
level of glycaemic control. During clinical trials the overall rates of hypoglycaemia did not differ 
between patients treated with insulin aspart compared to human insulin. 
 
Lipodystrophy: 
Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous 
rotation of the injection site within the particular injection area reduces the risk of developing these 
reactions. 
 
Paediatric population 
 
Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse 
reactions observed in the paediatric population do not indicate any differences to the broader 
experience in the general population. 
 
Other special populations 
 
Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse 
reactions observed in the elderly patients 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 too high doses relative to the patient’s requirement are administered: 
 
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary 

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

• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with 
glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with 
glucose given intravenously by physicians or other healthcare staff. 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 
 

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


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Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting. 
ATC code: A10AB05. 
 
Mechanism of action and pharmacodynamic effects 
 
The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following 
binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose 
output from the liver. 
 
NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a 
lower glucose concentration, as assessed within the first four hours after a meal. NovoRapid has a 
shorter duration of action compared to soluble human insulin after subcutaneous injection. 
 

 
 
Fig. I. Blood glucose concentrations following a single pre-meal dose of NovoRapid injected 
immediately before a meal (solid curve) or soluble human insulin administered 30 minutes before a 
meal (hatched curve) in patients with type 1 diabetes mellitus. 
 
When NovoRapid is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of 
injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action 
is 3 to 5 hours. 
 
Clinical efficacy 
 
Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose 
with NovoRapid compared to soluble human insulin (Fig. I). In two long-term open label trials in 
patients with type 1 diabetes comprising 1070 and 884 patients, respectively, NovoRapid reduced 
glycated haemoglobin by 0.12 [95% C.I. 0.03; 0.22] percentage points and by 0.15 [95% C.I. 0.05; 
0.26] percentage points compared to human insulin; a difference of limited clinical significance. 
 
Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal 
hypoglycaemia with insulin aspart compared with soluble human insulin. The risk of daytime 
hypoglycaemia was not significantly increased. 
 
Insulin aspart is equipotent to soluble human insulin on a molar basis. 
 
Special populations 
 



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Elderly (≥ 65 years old) 
A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human 
insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65–83 years, mean age 
70 years). The relative differences in the pharmacodynamic properties (GIRmax,AUCGIR, 0–120 min) 
between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy 
subjects and in younger patients with diabetes. 
 
Paediatric population 
A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was 
performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those 
four were younger than 4 years old) and a single dose PK/PD trial was performed in children (6–
12 years) and adolescents (13–17 years). The pharmacodynamic profile of insulin aspart in children 
was similar to that seen in adults. 
 
The efficacy and safety of NovoRapid given as bolus insulin in combination with either insulin 
detemir or insulin degludec as basal insulin has been studied for up to 12 months, in two randomised 
controlled clinical trials in adolescents and children aged 1 to less than 18 years (n=712). The trials 
included 167 children aged 1–5 years, 260 aged 6–11 and 285 aged 12–17. The observed 
improvements in HbA1c and the safety profiles were comparable between all age groups. 
 
Pregnancy 
A clinical trial comparing safety and efficacy of insulin aspart vs. human insulin in the treatment of 
pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart: 157; human insulin: 
165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the 
foetus/newborn. 
In addition the data from a clinical trial including 27 women with gestational diabetes randomised to 
treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar 
safety profiles between treatments. 
 
5.2 Pharmacokinetic properties 
 
Absorption, distribution and elimination 
 
In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the 
tendency to form hexamers as observed with soluble human insulin. NovoRapid is therefore more 
rapidly absorbed from the subcutaneous layer compared to soluble human insulin. 
 
The time to maximum concentration is, on average, half of that for soluble human insulin. A mean 
maximum plasma concentration of 492±256 pmol/l was reached 40 (interquartile range: 30–40) 
minutes after a subcutaneous dose of 0.15 unit/kg bodyweight in type 1 diabetic patients. The insulin 
concentrations returned to baseline about 4 to 6 hours after dose. The absorption rate was somewhat 
slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/l) and later tmax (60 
(interquartile range: 50–90) minutes). The intra-individual variability in time to maximum 
concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intra-
individual variability in Cmax for NovoRapid is larger.  
 
Special populations 
 
Elderly (≥ 65 years old) 
The relative differences in pharmacokinetic properties between insulin aspart and soluble human 
insulin in elderly patients (65–83 years, mean age 70 years) with type 2 diabetes were similar to those 
observed in healthy subjects and in younger patients with diabetes. A decreased absorption rate was 
observed in elderly patients, resulting in a later tmax (82 (interquartile range: 60–120) minutes), 
whereas Cmax was similar to that observed in younger patients with type 2 diabetes and slightly lower 
than in patients with type 1 diabetes. 
 
Hepatic impairment 



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A single dose pharmacokinetic study of insulin aspart was performed in 24 subjects with hepatic 
function ranging from normal to severely impaired. In patients with hepatic impairment, absorption 
rate was decreased and more variable, resulting in delayed tmax from about 50 min in subjects with 
normal hepatic function to about 85 min in patients with moderate and severe hepatic impairment. 
AUC, Cmax and CL/F were similar in patients with reduced hepatic function compared with subjects 
with normal hepatic function. 
 
Renal impairment 
A single dose pharmacokinetic study of insulin aspart in 18 subjects with renal function ranging from 
normal to severely impaired was performed. No apparent effect of creatinine clearance values on 
AUC, Cmax, CL/F and tmax of insulin aspart was found. Data were limited in patients with moderate and 
severe renal impairment. Patients with renal failure necessitating dialysis treatment were not 
investigated.  
 
Paediatric population 
The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children 
(6–12 years) and adolescents (13–17 years) with type 1 diabetes. Insulin aspart was rapidly absorbed 
in both age groups, with similar tmax as in adults. However, Cmax differed between the age groups, 
stressing the importance of the individual titration of NovoRapid. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. 
 
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, 
insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate that 
the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glycerol 
Phenol 
Metacresol 
Zinc chloride 
Disodium phosphate dihydrate 
Sodium chloride 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
Water for injections  
 
6.2 Incompatibilities 
 
Substances added to NovoRapid may cause degradation of insulin aspart.  
This medicinal product must not be diluted or mixed with other medicinal products except for mixing 
with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use, or with infusion 
fluids as described in section 4.2. 
 
6.3 Shelf life 
 
Before opening: 30 months. 
 
NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch 



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During use or when carried as a spare: The product must be stored for a maximum of 4 weeks. Store 
below 30°C. 
 
NovoRapid PumpCart 
During use or when carried as a spare: NovoRapid PumpCart carried as a spare can be kept for up to 
2 weeks below 30°C. Thereafter it can be used for up to 7 days below 37°C in an insulin infusion 
pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump 
insulin pumps.  
 
6.4 Special precautions for storage 
 
For storage conditions of the medicinal product, see section 6.3. 
 
Before opening: Store in a refrigerator (2°C – 8°C). Do not freeze. 
 
NovoRapid vial/NovoRapid Penfill 
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze.  
Keep the vial/cartridge in the outer carton in order to protect from light.  
 
NovoRapid FlexPen/NovoRapid FlexTouch 
During use or when carried as a spare: Store below 30˚C. Can be stored in a refrigerator (2˚C – 8˚C). 
Do not freeze.  
Keep the pen cap on the pen in order to protect from light. 
 
NovoRapid InnoLet 
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. 
Keep the pen cap on the pen in order to protect from light.  
 
NovoRapid PumpCart 
During use or when carried as a spare: Store below 37°C (in use) or store below 30°C (carried as a 
spare). Do not refrigerate. Do not freeze. 
Keep the cartridge in the outer carton in order to protect from light.  
 
6.5 Nature and contents of container 
 
NovoRapid vial 
10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a 
protective tamper-proof plastic cap. 
 
Pack sizes of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 x 10 ml vial. Not all pack 
sizes may be marketed. 
 
NovoRapid Penfill 
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
(bromobutyl/polyisoprene).  
 
Pack sizes of 5 and 10 cartridges. Not all pack sizes may be marketed. 
 
NovoRapid FlexPen 
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
(bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene. 
 
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens. 
Not all pack sizes may be marketed. 
 
NovoRapid InnoLet 



14 

3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
(bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene. 
 
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed. 
 
NovoRapid FlexTouch 
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
(bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.  
 
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without 
needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed. 
 
NovoRapid PumpCart 
1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure 
(bromobutyl/polyisoprene).  
 
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges. Not all pack sizes 
may be marketed. 
 
6.6 Special precautions for disposal and other handling  
 
Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous. 
 
NovoRapid which has been frozen must not be used. 
 
The patient should be advised to discard the needle after each injection. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Needles, syringes, cartridges, pre-filled pens and infusion sets must not be shared. 
 
The cartridge must not be refilled. 
 
NovoRapid vial 
NovoRapid may be used in an infusion pump system (CSII) as described in section 4.2. Tubings in 
which the inner surface materials are made of polyethylene or polyolefin have been evaluated and 
found compatible with pump use. 
 
NovoRapid PumpCart 
NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Please refer to the 
package leaflet where detailed instructions for use are provided. 
 
To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen. 
 
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with 
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section 
4.2. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been 
evaluated and found compatible with pump use.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
 
8. MARKETING AUTHORISATION NUMBERS  



15 

 
NovoRapid vial 
EU/1/99/119/001 
EU/1/99/119/008 
EU/1/99/119/015 
 
NovoRapid Penfill 
EU/1/99/119/003 
EU/1/99/119/006 
 
NovoRapid FlexPen 
EU/1/99/119/009 
EU/1/99/119/010 
EU/1/99/119/011 
EU/1/99/119/017 
EU/1/99/119/018 
 
NovoRapid InnoLet 
EU/1/99/119/012 
EU/1/99/119/013 
EU/1/99/119/014 
 
NovoRapid FlexTouch 
EU/1/99/119/019 
EU/1/99/119/020 
EU/1/99/119/021 
EU/1/99/119/022 
EU/1/99/119/023 
 
NovoRapid PumpCart 
EU/1/99/119/024 
EU/1/99/119/025 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 7 September 1999 
Date of last renewal: 30 April 2009 
 
 
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/


16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

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

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 



17 

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

 
Name and address of the manufacturers of the biological active substance 
 
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 manufacturers responsible for batch release 
 
NovoRapid Vial, InnoLet, FlexTouch and PumpCart: 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
NovoRapid Penfill and FlexPen: 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
Novo Nordisk Production SAS 
45, Avenue d’Orléans 
F-28000 Chartres 
France 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines webportal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



18 

 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (VIAL) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid 100 units/ml solution for injection 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 vial of 10 ml  
5 vials of 10 ml  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use solution only if clear and colourless 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 



22 

 
Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Do not refrigerate. Store below 30°C  
Do not freeze 
Keep the vial 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 

 
Discard the needle 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/1/99/119/001 1 vial of 10 ml 
EU/1/99/119/008  5 vials of 10 ml 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (VIAL) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid 100 units/ml solution for injection  
Insulin aspart 
SC, IV use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 ml 
1 vial of 10 ml contains 1,000 units 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 
 
  



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER WRAPPER LABEL ON MULTIPACK (VIAL – with blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid 100 units/ml solution for injection  
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
Multipack: 5 packs of 1 x 10 ml vial 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use solution only if clear and colourless 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



25 

Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Do not refrigerate. Store below 30°C 
Do not freeze 
Keep the vial 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 

 
Discard the needle 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/1/99/119/015 5 packs of 1 x 10 ml vial 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON FOR MULTIPACK (VIAL – without blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid 100 units/ml solution for injection 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 vial of 10 ml. Component of a multipack, cannot be sold separately.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use solution only if clear and colourless 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



27 

Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Do not refrigerate. Store below 30°C  
Do not freeze 
Keep the vial 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 

 
Discard the needle 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/1/99/119/015 5 packs of 1 x 10 ml vial 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid 
 
 



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (CARTRIDGE. Penfill) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid Penfill 100 units/ml solution for injection in cartridge 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 cartridge contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 x 3 ml cartridges 
10 x 3 ml cartridges 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 
 
 



29 

9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Do not refrigerate. Store below 30°C 
Do not freeze 
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 

 
Discard the needle 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/1/99/119/003  5 cartridges of 3 ml 
EU/1/99/119/006  10 cartridges of 3 ml 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid Penfill 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



30 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (CARTRIDGE. Penfill) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid Penfill 100 units/ml solution for injection  
Insulin aspart 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Penfill 
 
 
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 
 
 



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (PRE-FILLED PEN. FlexPen) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 x 3 ml pre-filled pen 
5 x 3 ml pre-filled pens 
10 x 3 ml pre-filled pens 
1 x 3 ml pre-filled pen + 7 NovoFine needles 
1 x 3 ml pre-filled pen + 7 NovoTwist needles 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
 
 
8. EXPIRY DATE 



32 

 
EXP/ 
During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Store below 30°C. Can be stored in a refrigerator (2˚C to 8˚C) 
Do not freeze 
Keep the pen cap on 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 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/1/99/119/011 1 pen of 3 ml 
EU/1/99/119/009 5 pens of 3 ml 
EU/1/99/119/010 10 pens of 3 ml 
EU/1/99/119/017 1 pen of 3 ml and 7 NovoFine needles 
EU/1/99/119/018 1 pen of 3 ml and 7 NovoTwist needles 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid FlexPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 



33 

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



34 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PEN LABEL (PRE-FILLED PEN. FlexPen) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid FlexPen 100 units/ml solution for injection 
Insulin aspart 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
FlexPen 
 
 
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 
 
 



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (PRE-FILLED PEN. InnoLet) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 x 3 ml pre-filled pen 
5 x 3 ml pre-filled pens 
10 x 3 ml pre-filled pens 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
 
 
8. EXPIRY DATE 
 
EXP/ 



36 

During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
During use: Do not refrigerate. Store below 30°C 
Do not freeze 
Keep the pen cap on 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 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/1/99/119/012  1 pen of 3 ml 
EU/1/99/119/013  5 pens of 3 ml 
EU/1/99/119/014  10 pens of 3 ml 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid InnoLet 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



37 

 
PC: 
SN: 
NN: 
 



38 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PEN LABEL (PRE-FILLED PEN. InnoLet) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid InnoLet 100 units/ml solution for injection 
Insulin aspart 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
InnoLet 
 
 
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 
 
 



39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (PRE-FILLED PEN. FlexTouch) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 x 3 ml pre-filled pen 
5 x 3 ml pre-filled pens 
1 x 3 ml pre-filled pen + 7 NovoFine needles 
1 x 3 ml pre-filled pen + 7 NovoTwist needles 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
 
 
8. EXPIRY DATE 
 



40 

EXP/ 
During use: Use within 4 weeks 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C) 
During use: Store below 30°C. Can be stored in a refrigerator (2˚C to 8˚C) 
Do not freeze 
Keep the pen cap on 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 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/1/99/119/019  1 pen of 3 ml 
EU/1/99/119/020  5 pens of 3 ml 
EU/1/99/119/022  1 pen of 3 ml and 7 NovoFine needles 
EU/1/99/119/023  1 pen of 3 ml and 7 NovoTwist needles 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid FlexTouch 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 



41 

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



42 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PEN LABEL (PRE-FILLED PEN. FlexTouch) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid FlexTouch 100 units/ml solution for injection 
Insulin aspart 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
FlexTouch 
 
 
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 
 
 
  



43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER WRAPPER LABEL ON MULTIPACK (PRE-FILLED PEN. FlexTouch – with blue 
box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
Multipack: 2 x (5 x 3 ml) 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 



44 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C) 
During use: Store below 30°C. Can be stored in a refrigerator (2˚C to 8˚C) 
Do not freeze 
Keep the pen cap on 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 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/1/99/119/021 2 x (5 x 3 ml) 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid FlexTouch 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 



45 

NN: 



46 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON FOR MULTIPACK (PRE-FILLED PEN. FlexTouch – without blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 x 3 ml pre-filled pens. Component of a multipack, cannot be sold separately. 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use: Use within 4 weeks 
 



47 

 
9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C) 
During use: Store below 30°C. Can be stored in a refrigerator (2˚C to 8˚C) 
Do not freeze 
Keep the pen cap on 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 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/1/99/119/021  2 x 5 pens of 3 ml 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid FlexTouch 
 



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (CARTRIDGE. PumpCart) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid PumpCart 100 units/ml solution for injection in cartridge 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 cartridge contains 1.6 ml equivalent to 160 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 x 1.6 ml cartridges 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Only for use in pumps designed for NovoRapid PumpCart 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use in pump: Use within 7 days 
 
 



49 

9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
Carried as a spare: Can be kept for up to two weeks below 30°C 
During use: Do not refrigerate. Store below 37°C 
Do not freeze 
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 NUMBER 
 
EU/1/99/119/024  5 cartridges of 1.6 ml 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid PumpCart 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



50 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE 
PACKAGING UNITS 
 
LABEL (CARTRIDGE. PumpCart) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
NovoRapid PumpCart 100 units/ml solution for injection 
Insulin aspart 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use  
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.6 ml 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 



51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER WRAPPER LABEL ON MULTIPACK (CARTRIDGE. PumpCart – with blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid PumpCart 100 units/ml solution for injection in cartridge 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 cartridge contains 1.6 ml equivalent to 160 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
Multipack: 25 (5 packs of 5) cartridges 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Only for use in pumps designed for NovoRapid PumpCart 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use in pump: Use within 7 days 
 
 



52 

9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
Carried as a spare: Can be kept for up to two weeks below 30°C 
During use: Do not refrigerate. Store below 37°C 
Do not freeze 
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 NUMBER 
 
EU/1/99/119/025   25 (5 packs of 5) cartridges 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid PumpCart 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



53 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON FOR MULTIPACK (CARTRIDGE. PumpCart – without blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NovoRapid PumpCart 100 units/ml solution for injection in cartridge 
Insulin aspart 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
1 cartridge contains 1.6 ml equivalent to 160 units. 1 ml solution contains 100 units insulin aspart 
(equivalent to 3.5 mg), 
 
 
3. LIST OF EXCIPIENTS 
 
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, 
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 x 1.6 ml cartridges. Component of a multipack, cannot be sold separately. 
 
 
5. METHOD AND ROUTES 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 solution only if clear and colourless 
For use by one person only 
Only for use in pumps designed for NovoRapid PumpCart 
 
 
8. EXPIRY DATE 
 
EXP/ 
During use in pump: Use within 7 days 
 
 



54 

9. SPECIAL STORAGE CONDITIONS 
 
Before opening: Store in a refrigerator (2°C to 8°C)  
Carried as a spare: Can be kept for up to two weeks below 30°C 
During use: Do not refrigerate. Store below 37°C 
Do not freeze 
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 NUMBER 
 
EU/1/99/119/025  25 (5 packs of 5) cartridges 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
NovoRapid PumpCart 
 
 
  



55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



56 

Package leaflet: Information for the user 
 

NovoRapid 100 units/ml solution for injection in vial 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What NovoRapid is and what it is used for 
2. What you need to know before you use NovoRapid  
3. How to use NovoRapid 
4. Possible side effects 
5. How to store NovoRapid 
6. Contents of the pack and other information 
 
 
1. What NovoRapid is and what it is used for 
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect 
occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short 
action NovoRapid should normally be taken in combination with intermediate-acting or long-acting 
insulin preparations. Moreover NovoRapid can be used for continuous infusion in a pump system. 
 
 
2. What you need to know before you use NovoRapid 
 
Do not use NovoRapid  
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 
► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 

common side effects in section 4). 
► If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If 

it is not in perfect condition when you get the vial, return the vial to your supplier. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid). 
► If the insulin does not appear clear and colourless. 
 
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice. 
 
Before using NovoRapid 



57 

 
► Check the label to make sure it is the right type of insulin. 
► Remove the protective cap. 
► Always use a new needle for each injection to prevent contamination. 
► Needles and syringes must not be shared. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor. 
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections. 
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 
• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 



58 

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia.  
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier 
after an injection when compared to soluble human insulin. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially 
‘sodium-free’. 
 
 
3. How to use NovoRapid 
 
Dose and when to take your insulin 
 
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
 
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the 
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See 
How and where to inject below for information. 
 
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor.  
 
Use in children and adolescents 



59 

 
NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human 
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in 
relation to meals.  
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject 
 
NovoRapid is for injection under the skin (subcutaneously) or for continuous infusion in a pump 
system. Administration in a pump system will require a comprehensive instruction by your healthcare 
professional. You must never inject yourself directly into a vein (intravenously) or muscle 
(intramuscularly). If necessary NovoRapid can be given directly into a vein but this must only be done 
by physicians or other healthcare staff. 
 
With each injection, change the injection site within the particular area of skin that you use. This may 
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best 
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front 
of your thighs. The insulin will work more quickly if injected into the front of your waist. You should 
always measure your blood sugar regularly. 
 
NPH (Neutral Protamine Hagedorn) insulin is the only type of insulin that can be mixed with 
NovoRapid and the mixture must be injected immediately under your skin (subcutaneously). 
NovoRapid should be drawn into the syringe before you draw your NPH insulin. 
 
How to take NovoRapid 
 
If you use only one type of insulin 
1. Draw into the syringe the same amount of air as the dose of insulin you are going to inject. 

Inject the air into the vial. 
2. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull 

the needle out of the vial. Then expel the air from the syringe and check that the dose is correct. 
 
If you have to mix two types of insulin 
1. Just before use, roll the NPH insulin between your hands until the liquid is uniformly white and 

cloudy. 
2. Draw into the syringe the same amount of air as the dose of the NPH insulin. Inject the air into 

the vial containing the NPH insulin and pull out the needle. 
3. Draw into the syringe the same amount of air as the dose of NovoRapid. Inject the air into the 

vial containing NovoRapid. Turn the vial and syringe upside down and draw up the prescribed 
dose of NovoRapid. Expel any air from the syringe and check that the dose is correct. 

4. Push the needle into the vial of the NPH insulin, turn the vial and syringe upside down and draw 
out the dose you have been prescribed. Expel any air from the syringe and check the dose. Inject 
the mixture immediately. 

5. Always mix NovoRapid and the NPH insulin in the same sequence. 
 
How to inject NovoRapid 
 
► Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse. 
► Keep the needle under your skin for at least 6 seconds to make sure you have injected all the 

insulin. 
► Discard the needle after each injection. 
 
For use in an infusion pump system 



60 

 
NovoRapid should never be mixed with any other insulin when used in a pump.  
Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a 
pump. Before use of NovoRapid in the pump system, you must have received a comprehensive 
instruction in the use and information about any actions to be taken in case of illness, too high or too 
low blood sugar or failure of the pump system.  
• Before inserting the needle, use soap and water to clean your hands and the skin where the 

needle is inserted to avoid any infection at the infusion site. 
• When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or 

the tubing. 
• Changing of the infusion set (tubing and needle) must be done according to the instructions in 

the product information supplied with the infusion set. 
 
To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is 
recommended that you measure your blood sugar level regularly. 
 
What to do in case of pump system failure 
 
You should always have an alternative delivery method for your insulin available for injection under 
the skin in case of pump system failure. 
 
If you take more insulin than you should 
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin 
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be 
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 
Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
a) Summary of serious and very common side effects  
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 
people. 
 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 



61 

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets 
or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 
must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 
Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 



62 

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects  
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes  
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 
• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid 
 
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 vial label and carton, after ‘EXP’. 
The expiry date refers to the last day of that month. 
Keep the vial in the outer carton in order to protect it from light.  
 
Before opening: Store in a refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: The product may be stored for a maximum of 4 weeks. Store 
below 30°C. Do not refrigerate or freeze. 
 
Discard the needle after each injection. 
 

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63 

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 NovoRapid contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial 

contains 1,000 units of insulin aspart in 10 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid looks like and contents of the pack 
 
NovoRapid is presented as a solution for injection. 
 
Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may 
be marketed. 
 
The solution is clear and colourless.  
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
This leaflet was last revised in  
 
Other sources of information  
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 

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


64 

Package leaflet: Information for the user 
 

NovoRapid Penfill 100 units/ml solution for injection in cartridge 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What NovoRapid is and what it is used for 
2. What you need to know before you use NovoRapid  
3. How to use NovoRapid 
4. Possible side effects 
5. How to store NovoRapid 
6. Contents of the pack and other information 
 
 
1. What NovoRapid is and what it is used for 
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect 
occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short 
action NovoRapid should normally be taken in combination with intermediate-acting or long-acting 
insulin preparations. 
 
 
2. What you need to know before you use NovoRapid 
 
Do not use NovoRapid  
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 
► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 

common side effects in section 4). 
► If the cartridge or the device containing the cartridge is dropped, damaged or crushed. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid). 
► If the insulin does not appear clear and colourless. 
 
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice. 
 
Before using NovoRapid 
 



65 

► Check the label to make sure it is the right type of insulin. 
► Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not 

use it if any damage is seen or if the rubber plunger has been drawn above the white label band 
at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the 
cartridge is damaged, take it back to your supplier. See your pen manual for further instructions. 

► Always use a new needle for each injection to prevent contamination. 
► Needles and NovoRapid Penfill must not be shared. 
► NovoRapid Penfill is only suitable for injecting under the skin using a reusable pen. Speak to 

your doctor if you need to inject your insulin by another method. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor. 
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections. 
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 
• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 



66 

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 
Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia. 
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier 
after an injection when compared to soluble human insulin. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially 
‘sodium-free’. 
 
 
3. How to use NovoRapid 
 
Dose and when to take your insulin 
 
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
 
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the 
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See 
How and where to inject below for information. 
 



67 

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor. 
 
Use in children and adolescents 
 
NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human 
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in 
relation to meals.  
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject  
NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly 
into a vein (intravenously) or muscle (intramuscularly). NovoRapid Penfill is only suitable for 
injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by 
another method. 
 
With each injection, change the injection site within the particular area of skin that you use. This may 
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best 
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front 
of your thighs. The insulin will work more quickly if injected into the front of your waist. You should 
always measure your blood sugar regularly. 
 
► Do not refill the cartridge. Once empty, it must be disposed of. 
► NovoRapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery 

systems and NovoFine or NovoTwist needles.  
► If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use 

two insulin delivery systems, one for each type of insulin. 
► Always carry a spare Penfill cartridge in case it is lost or damaged. 
 
How to inject NovoRapid 
 
► Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse 

and as described in your pen manual. 
► Keep the needle under your skin for at least 6 seconds. Keep the push-button fully depressed 

until the needle has been withdrawn from the skin. This will ensure correct delivery and limit 
possible flow of blood into the needle or insulin reservoir.  

► Remove and discard the needle after each injection. Always store NovoRapid without the needle 
attached. Otherwise the liquid may leak out which can cause inaccurate dosing. 

 
If you take more insulin than you should  
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin  
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be  
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 



68 

Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
a) Summary of serious and very common side effects  
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 
people. 
 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets 
or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 
must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 



69 

Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects 
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes 
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 
• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 

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70 

► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 
the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid 
 
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 cartridge label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light. 
NovoRapid must be protected from excessive heat and light. 
 
Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2°C to 
8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: NovoRapid Penfill that is being used or carried as a spare is 
not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 
30°C) for up to 4 weeks. 
 
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 NovoRapid contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each 

cartridge contains 300 units of insulin aspart in 3 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid looks like and contents of the pack 
 
NovoRapid is presented as a solution for injection. 
 
Pack sizes of 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed. 
 
The solution is clear and colourless.  
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
Manufacturer 
 
The manufacturer can be identified by the batch number printed on the slip of the carton and on the 
label: 
 
• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo 

Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark. 
 
• If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production 

SAS, 45 Avenue d’Orléans F-28000 Chartres, France. 



71 

 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 

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


72 

Package leaflet: Information for the user 
 

NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4.  
 
What is in this leaflet 
 
1. What NovoRapid is and what it is used for 
2. What you need to know before you use NovoRapid  
3. How to use NovoRapid 
4. Possible side effects 
5. How to store NovoRapid 
6. Contents of the pack and other information 
 
 
1. What NovoRapid is and what it is used for 
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect 
occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short 
action NovoRapid should normally be taken in combination with intermediate-acting or long-acting 
insulin preparations. 
 
 
2. What you need to know before you use NovoRapid 
 
Do not use NovoRapid  
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 
► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 

common side effects in section 4). 
► If FlexPen is dropped, damaged or crushed. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid). 
► If the insulin does not appear clear and colourless.  
 
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice. 
 
Before using NovoRapid 
 
► Check the label to make sure it is the right type of insulin. 



73 

► Always use a new needle for each injection to prevent contamination. 
► Needles and NovoRapid FlexPen must not be shared. 
► NovoRapid FlexPen is only suitable for injecting under the skin. Speak to your doctor if you 

need to inject your insulin by another method. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor.  
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections. 
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 
• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 



74 

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia.  
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier 
after an injection when compared to soluble human insulin. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially 
‘sodium-free’. 
 
 
3. How to use NovoRapid 
 
Dose and when to take your insulin 
 
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the 
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See 
How and where to inject below for information. 
 
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor.  
 
Use in children and adolescents 
 



75 

NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human 
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in 
relation to meals.  
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject 
 
NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly 
into a vein (intravenously) or muscle (intramuscularly). NovoRapid FlexPen is only suitable for 
injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. 
 
With each injection, change the injection site within the particular area of skin that you use. This may 
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best 
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front 
of your thighs. The insulin will work more quickly if injected into the front of your waist. You should 
always measure your blood sugar regularly. 
 
How to handle NovoRapid FlexPen 
 
NovoRapid FlexPen is a pre-filled, colour-coded, disposable pen containing insulin aspart. 
 
Read carefully the instructions on how to use NovoRapid FlexPen included in this package leaflet. 
You must use the pen as described in the instructions on how to use NovoRapid FlexPen. 
 
Always ensure you use the correct pen before you inject your insulin. 
 
If you take more insulin than you should  
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin  
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be 
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 
Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
a) Summary of serious and very common side effects  
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 
people. 



76 

 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets 
or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 
must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 
Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 



77 

risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects 
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes 
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 
• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid 
 
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 FlexPen label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light. 
NovoRapid must be protected from excessive heat and light. 
 

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


78 

Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2°C to 
8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: You can carry your NovoRapid FlexPen with you and keep 
it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks. If refrigerated, keep 
away from the cooling element. Do not freeze.  
 
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 NovoRapid contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-

filled pen contains 300 units of insulin aspart in 3 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid looks like and contents of the pack 
 
NovoRapid is presented as a solution for injection. 
 
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens 
of 3 ml. Not all pack sizes may be marketed. 
 
The solution is clear and colourless. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark  
 
Manufacturer 
 
The manufacturer can be identified by the batch number printed on the slip of the carton and on the 
label: 
 
• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo 

Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark. 
 
• If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production 

SAS, 45 Avenue d’Orléans F-28000 Chartres, France. 
 
Now turn over for information on how to use your FlexPen. 
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 

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


79 

Instructions on how to use NovoRapid solution for injection in FlexPen.  
 
Read the following instructions carefully before using your FlexPen. 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. 
 
Your FlexPen is a pre-filled dial-a-dose insulin pen. You can select doses from 1 to 60 units in 
increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles 
up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in 
case your FlexPen is lost or damaged. 
 
 NovoRapid FlexPen 

Pen cap Cartridge 
Residual scale 

Pointer 

Dose 
selector Push- 

button 
Big outer  
needle cap 

Inner needle cap Paper tab 

Needle 

Needle (example) 

 
 
Caring for your pen 
Your FlexPen must be handled with care.  
If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate 
dosing, which can lead to too high or too low blood sugar level.  
 
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash 
or lubricate it as it may damage the pen.  
 
Do not refill your FlexPen. Once empty, it must be disposed of. 
 
Preparing your NovoRapid FlexPen 
 
Check the name and coloured label of your pen to make sure that it contains the correct type of 
insulin. This is especially important if you take more than one type of insulin. If you take the wrong 
type of insulin, your blood sugar level may get too high or too low. 
 
A 
Pull off the pen cap.  
 

 
 
B 
Remove the paper tab from a new disposable needle. 
 
Screw the needle straight and tightly onto your FlexPen. 
 

 
 
C 
Pull off the big outer needle cap and keep it for later. 



80 

 

 
 
D 
Pull off the inner needle cap and dispose of it. 
 
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. 
 

 
 

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

 
 Be careful not to bend or damage the needle before use. 

 
Checking the insulin flow 
 
Prior to each injection small amounts of air may collect in the cartridge during normal use. To 
avoid injection of air and ensure proper dosing: 
 
E 
Turn the dose selector to select 2 units. 
 
 E 

2 units 
selected 

 
 
F 
Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a 
few times to make any air bubbles collect at the top of the cartridge. 
 
 F 

 
 
G 
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0. 
 
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no 
more than 6 times. 
 
If a drop of insulin still does not appear, the pen is defective, and you must use a new one. 
 



81 

 G 

 
 

 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 
selector 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. 
 
Selecting your dose 
 
Check that the dose selector is set at 0. 
 
H 
Turn the dose selector to select the number of units you need to inject. 
 
The dose can be corrected either up or down by turning the dose selector in either direction until the 
correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-
button as insulin will come out. 
 
You cannot select a dose larger than the number of units left in the cartridge. 
 

 
 

 Always use the dose selector and the 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 residual scale, it only shows approximately how much 
insulin is left in your pen.  

 
Making the injection 
 
Insert the needle into your skin. Use the injection technique shown by your doctor or nurse. 
 
I 
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful 
only to push the push-button when injecting. 
 
Turning the dose selector will not inject insulin. 



82 

 

 
 
J 
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. 
This will make sure you get the full dose. 
 
Withdraw the needle from the skin, then release the pressure on the push-button. 
 
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops 
before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar 
level. 
 
 J 

 
 
K 
Lead the needle into the big outer needle cap without touching it. When the needle is covered, 
carefully push the big outer needle cap completely on and then unscrew the needle.  
 
Dispose of it carefully and put the pen cap back on.  
 

 
 

 Always remove the needle after each injection and store your FlexPen without the needle 
attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles 
and inaccurate dosing. 

 
Further important information 
 

 Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks 
and cross-infection. 

 
 Dispose of your used FlexPen carefully without the needle attached. 

 
 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. 

 
 Always keep your pen and needles out of sight and reach of others, especially children. 

 



83 

Package leaflet: Information for the user 
 

NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What NovoRapid is and what it is used for 
2. What you need to know before you use NovoRapid 
3. How to use NovoRapid 
4. Possible side effects 
5. How to store NovoRapid 
6. Contents of the pack and other information 
 
 
1. What NovoRapid is and what it is used for  
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect 
occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short 
action NovoRapid should normally be taken in combination with intermediate-acting or long-acting 
insulin preparations. 
 
 
2. What you need to know before you use NovoRapid 
 
Do not use NovoRapid  
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 
► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 

common side effects in section 4). 
► If InnoLet is dropped, damaged or crushed. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid). 
► If the insulin does not appear clear and colourless.  
 
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice. 
 
Before using NovoRapid 
 
► Check the label to make sure it is the right type of insulin. 



84 

► Always use a new needle for each injection to prevent contamination. 
► Needles and NovoRapid InnoLet must not be shared. 
► NovoRapid InnoLet is only suitable for injecting under the skin. Speak to your doctor if you 

need to inject your insulin by another method. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor. 
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections. 
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 
• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 



85 

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia. 
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier 
after an injection when compared to soluble human insulin. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium-
free’. 
 
 
3. How to use NovoRapid 
 
Dose and when to take your insulin 
 
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
 
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the 
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See 
How and where to inject below for information. 
 
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor.  
 
Use in children and adolescents 



86 

 
NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human 
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in 
relation to meals.  
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject  
 
NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly 
into a vein (intravenously) or muscle (intramuscularly). NovoRapid InnoLet is only suitable for 
injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. 
 
With each injection, change the injection site within the particular area of skin that you use. This may 
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best 
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front 
of your thighs. The insulin will work more quickly if injected into the front of your waist. You should 
always measure your blood sugar regularly.  
 
How to handle NovoRapid InnoLet 
 
NovoRapid InnoLet is a pre-filled disposable pen containing insulin aspart. 
 
Read carefully the instructions on how to use NovoRapid InnoLet included in this package leaflet. 
You must use the pen as described in the instructions on how to use NovoRapid Innolet. 
 
Always ensure you use the correct pen before you inject your insulin. 
 
If you take more insulin than you should  
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin  
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be 
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 
Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4.  Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
a) Summary of serious and very common side effects  
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 



87 

people. 
 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets 
or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 
must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 
Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 



88 

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects  
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes  
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 
• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid  
 
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 InnoLet label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 

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89 

Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light. 
NovoRapid must be protected from excessive heat and light. 
 
Before opening: NovoRapid InnoLet that is not being used is to be stored in the refrigerator at 2°C to 
8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: NovoRapid InnoLet that is being used or carried as a spare 
is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 
30°C) for up to 4 weeks. 
 
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 NovoRapid contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-

filled pen contains 300 units of insulin aspart in 3 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid looks like and contents of the pack 
 
NovoRapid is presented as a solution for injection. 
 
Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed. 
 
The solution is clear and colourless.  
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
Now turn over for information on how to use your InnoLet. 
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
 
 

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


90 

Instructions on how to use NovoRapid solution for injection in InnoLet  
 
Read the instructions carefully before using your InnoLet. 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. 
 
Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. 
InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 
8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet 
is lost or damaged. 
 
 

Push-button 

Dose 
selector 

Dose scale 

Compartment 
for needles 

Residual 
scale 

Insulin 
cartridge 

Disposable needle (example) 

Pen cap 
Paper tab 

Needle 

Inner needle 
cap 

Big outer 
needle cap 

 
 
Getting started 
 
Check the name and coloured label of your InnoLet to make sure that it contains the correct type of 
insulin. This is especially important if you take more than one type of insulin. If you take the wrong 
type of insulin, your blood sugar level may get too high or too low. 
Take off the pen cap. 
 
Attaching the needle 
 
• Always use a new needle for each injection. This reduces the risk of contamination, infection, 

leakage of insulin, blocked needles and inaccurate dosing. 
• Be careful not to bend or damage the needle before use. 
• Remove the paper tab from a new disposable needle. 
• Screw the needle straight and tightly onto your InnoLet (picture 1A). 
• Pull off the big outer needle cap and the inner needle cap. You may want to store the big 

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

needle. 
 



91 

 
 
Priming to expel air prior to each injection 
 
Small amounts of air may collect in the needle and cartridge during normal use. 
 
To avoid injection of air and ensure proper dosing: 
• Dial 2 units by turning the dose selector clockwise. 
• Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a 

few times (picture 1B) to make any air bubbles collect at the top of the cartridge. 
• Keeping the needle upwards, press the push-button and the dose selector returns to 0. 
• Always make sure that a drop appears at the needle tip before injection (picture 1B). This 

makes sure the insulin flows. If not, change the needle and repeat the procedure no more than 
6 times. 

 
If a drop of insulin still does not appear, the device is defective and must not be used. 
 
• If no drop appears, you will not inject any insulin, even though the dose selector may move. 

This may indicate a blocked or damaged needle. 
 
• Always prime InnoLet before you inject. If you do not prime InnoLet, you may get too little 

insulin or no insulin at all. This may lead to too high blood sugar level. 
 
 1B 

 
 
Setting the dose 
 
• Always check that the push-button is fully depressed and the dose selector is set to 0. 
• Dial the number of units required by turning the dose selector clockwise (picture 2).  



92 

• You will hear a click for every single unit dialled. The dose can be corrected by turning the 
dial either way. Make sure not to turn the dial or correct the dose when the needle is inserted in 
the skin. This may lead to inaccurate dosing that can make your blood sugar level too high or 
too low. 

 
 Always use the dose scale and the dose selector 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 residual scale, it only shows 
approximately how much insulin is left in your pen. 

 
You cannot set a dose larger than the number of units remaining in the cartridge. 
 
 2 

 
 
Injecting the insulin  
 
• Insert the needle into your skin. Use the injection technique advised by your doctor. 
• Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as 

the dose selector returns to 0. 
• After the injection, the needle should remain under the skin for at least 6 seconds to ensure 

that the full dose has been delivered. 
• Make sure not to block the dose selector while injecting, as the dose selector must be allowed 

to return to 0 when you press the push-button. Always make sure that the dose selector returns 
to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been 
delivered, which may result in too high blood sugar level. 

• Discard the needle after each injection. 
 



93 

 3 

 
 
Removing the needle 
 
• Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully. 
• Put the pen cap back on your InnoLet to protect the insulin from light. 
 
 4 

 
 
Always use a new needle for each injection. Always remove and discard the needle after each injection 
and store your InnoLet without the needle attached. This reduces the risk of contamination, infection, 
leakage of insulin, blocked needles and inaccurate dosing. 
 
Further important information 
 
Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and 
cross-infection.  
 
Dispose of your used InnoLet carefully without the needle attached.  
 
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. 
 
Always keep your InnoLet and needles out of sight and reach of others, especially children. 
 
Caring for your pen 



94 

 
Your InnoLet is designed to work accurately and safely. It must be handled with care. If it is dropped, 
damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can 
lead to too high or too low blood sugar level. 
You can clean your InnoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it. 
This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too 
low blood sugar level. 
Do not refill your InnoLet. Once empty, it must be disposed of. 
 



95 

Package leaflet: Information for the user 
 

NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What NovoRapid is and what it is used for 
2. What you need to know before you use NovoRapid  
3. How to use NovoRapid 
4. Possible side effects 
5. How to store NovoRapid 
6. Contents of the pack and other information 
 
 
1. What NovoRapid is and what it is used for 
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect 
occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short 
action NovoRapid should normally be taken in combination with intermediate-acting or long-acting 
insulin preparations. 
 
 
2. What you need to know before you use NovoRapid 
 
Do not use NovoRapid  
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 
► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 

common side effects in section 4). 
► If FlexTouch is dropped, damaged or crushed. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid). 
► If the insulin does not appear clear and colourless.  
 
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse 
or pharmacist for advice. 
 
Before using NovoRapid 
 



96 

► Check the label to make sure it is the right type of insulin. 
► Always use a new needle for each injection to prevent contamination. 
► Needles and NovoRapid FlexTouch must not be shared. 
► NovoRapid FlexTouch is only suitable for injecting under the skin. Speak to your doctor if you 

need to inject your insulin by another method. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor.  
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections.  
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 
• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 



97 

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia.  
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier 
after an injection when compared to soluble human insulin. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodium-
free’. 
 
 
3. How to use NovoRapid 
 
Dose and when to take your insulin 
 
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
 
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the 
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See 
How and where to inject below for information. 
 
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor.  
 
Use in children and adolescents 



98 

 
NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human 
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in 
relation to meals.  
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject 
 
NovoRapid is for injection under the skin (subcutaneously). You must never inject yourself directly 
into a vein (intravenously) or muscle (intramuscularly). NovoRapid FlexTouch is only suitable for 
injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. 
 
With each injection, change the injection site within the particular area of skin that you use. This may 
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best 
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front 
of your thighs. The insulin will work more quickly if injected into the front of your waist. You should 
always measure your blood sugar regularly. 
 
How to handle NovoRapid FlexTouch 
 
NovoRapid FlexTouch is a pre-filled, colour-coded, disposable pen containing insulin aspart. 
 
Read carefully the instructions on how to use NovoRapid FlexTouch included in this package leaflet. 
You must use the pen as described in the instructions on how to use NovoRapid FlexTouch. 
 
Always ensure you use the correct pen before you inject your insulin. 
 
If you take more insulin than you should  
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin  
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be 
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 
Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
a) Summary of serious and very common side effects  
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 



99 

people. 
 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets 
or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 
must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 
Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 



100 

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects 
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes 
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 
• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid 
 
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 FlexTouch label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 

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101 

Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light. 
NovoRapid must be protected from excessive heat and light. 
 
Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2°C 
to 8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: You can carry your NovoRapid FlexTouch with you and 
keep it at a temperature below 30°C or in a refrigerator (2˚C to 8˚C) for up to 4 weeks. If refrigerated, 
keep away from the cooling element. Do not freeze.  
 
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 NovoRapid contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-

filled pen contains 300 units of insulin aspart in 3 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid looks like and contents of the pack 
 
NovoRapid is presented as a solution for injection. 
 
Pack sizes of 1 (with or without needles) or 5 (without needles) or a multipack with 2 x 5 (without 
needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed. 
 
The solution is clear and colourless.  
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
Now turn over for information on how to use your FlexTouch. 
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 

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


102 

Instructions on how to use NovoRapid 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 NovoRapid 100 units/ml, then look at the 
illustrations to the right 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 NovoRapid FlexTouch pen is a pre-filled insulin pen. NovoRapid FlexTouch contains 300 units 
of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.  
NovoRapid FlexTouch is designed to be used with NovoFine or NovoTwist single-use disposable 
needles up to a length of 8 mm.  
 
 

NovoRapid FlexTouch 

Pen cap Insulin 
scale 

Insulin 
window 

Pen label Dose  
counter 

Dose 
pointer 

Dose 
selector 

Dose 
button 

NovoRapid® 
FlexTouch® 

 
 
 

Needle (example) 

Outer 
needle cap 

Inner 
needle cap 

Needle Paper 
tab 

 

 
Preparing your NovoRapid FlexTouch pen 
 
Check the name and coloured label on your NovoRapid FlexTouch pen to make sure that it 
contains the type of insulin you need. This is especially important if you take more than one type of 



103 

insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low. 
 
A Pull off the pen cap. 
 

 
 
B 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 

 
 
C Take a new disposable needle, and tear off the paper tab. 
 
 C 

 
 
D Screw the needle straight onto the pen. Make sure the needle is on tight. 
 
 D 

 
 
E Pull off the outer needle cap and save it. You will need it after the injection to correctly remove 

the needle from the pen. 
 

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. 
 



104 

 E 

 
 

 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. 

 
 
Checking the insulin flow 
 
Make sure that you receive your full dose by always checking the insulin flow before you select 
and inject your dose. 
 
F Turn the dose selector to select 2 units. 
 
 F 

2 units 
selected 

 
 
G Hold the pen with the needle pointing up. 
 
 Tap the top of the pen a few times to let any air bubbles rise to the top. 
 
 G 

 
 
H Press the dose button with your thumb until the dose counter returns to 0. The 0 must line up 

with the dose pointer. A drop of insulin will appear at the needle tip. 
 
 If no drop appears, repeat steps F to H up to 6 times. If no drop appears after these new 

attempts, change the needle and repeat steps F to H once more. 
 
 Do not use the pen if a drop of insulin still does not appear. 
 
 H 

 



105 

 
 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. 
 
 
Selecting your dose 
 
Use the dose selector on your NovoRapid FlexTouch pen to select your dose. You can select up to 
80 units per dose. 
 
I Select the dose you need. You can turn the dose selector forwards or backwards. Stop when the 

right number of units lines up with the dose pointer. 
 
 The dose selector clicks differently when turned forwards, backwards or past the number of 

units left. 
 
 When the pen contains less than 80 units, the dose counter stops at the number of units left. 
  
 I 

5 units 
selected 

24 units 
selected 

 
 

 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. 
 

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

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. 
 
Turn the dose selector back until the dose counter shows 0. 



106 

 
If you need more insulin than the units left in your pen, you can split your dose between two pens. 
 
 

Dose 
counter 

stopped: 
52 units 

left 
 

Example 

 
 

 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. 
 
 
Injecting your dose 
 
Make sure that you receive your full dose by using the right injection technique.  
 
J 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 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. 
 

 After the dose counter has returned to 0, leave the needle under the skin for at least 6 seconds 
to make sure that you get your full dose. 

 
 

6 seconds 

J 

 
 
K Remove the needle from the skin. 
 
 After that, you may see a drop of insulin at the needle tip. This is normal and has no effect on 

the dose you just received. 
 

 Always dispose of the needle after each injection. 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. 



107 

 
 K 

 
 
L Lead the needle tip into the outer needle cap on a flat surface. Do not touch the needle or the 

cap. 
 
 Once the needle is covered, carefully push the outer needle cap completely on and then unscrew 

the needle. Dispose of it carefully, and put the pen cap back on after every use. 
 
 When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse or 

local authorities. 
 
 L 

 
 

 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. 

 
 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. 

 
 
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. 
 
• 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. 



108 

 
• Do not try to repair your pen or pull it apart. 
 
 

 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. 



109 

Package leaflet: Information for the user 
 

NovoRapid PumpCart 100 units/ml solution for injection in cartridge 
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, nurse or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What NovoRapid PumpCart is and what it is used for 
2. What you need to know before you use NovoRapid PumpCart  
3. How to use NovoRapid PumpCart 
4. Possible side effects 
5. How to store NovoRapid PumpCart 
6. Contents of the pack and other information 
 
 
1. What NovoRapid PumpCart is and what it is used for 
 
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products 
are improved versions of human insulin. 
 
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year 
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce 
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent 
complications from your diabetes. 
 
NovoRapid PumpCart is for use in a pump and covers your total daily insulin needs: both your all day 
(basal) and meal-time (bolus) insulin needs. Before you use NovoRapid PumpCart in the pump you 
must have received a comprehensive instruction by your doctor or nurse.  
 
Basal (all-day) insulin requirements: When you use NovoRapid PumpCart in a pump, your insulin 
will be constantly delivered to cover your basal need for insulin. If you change the basal insulin setting 
the change will start to affect you within 10–20 minutes. If you stop the pump, the insulin effect will 
last for 3 to 5 hours. Before you set or change the basal rate, carefully read the pump manual (user 
guide). 
 
Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within 10–
20 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for more 
information about how to adjust your bolus dose). The maximum effect occurs between 1 and 3 hours 
after the bolus delivery and the effect lasts for 3 to 5 hours.  
 
 
2. What you need to know before you use NovoRapid PumpCart 
 
Do not use NovoRapid PumpCart 
 
► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 

6, Contents of the pack and other information). 



110 

► If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very 
common side effects in section 4). 

► If the cartridge or the device containing the cartridge is dropped, damaged or crushed. 
► If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid 

PumpCart). 
► If the insulin does not appear clear and colourless.  
 
If any of these applies, do not use NovoRapid PumpCart. Talk with your doctor, nurse or pharmacist 

for advice. 
 
Before using NovoRapid PumpCart 
 
► Check the label to make sure it is the right type of insulin. 
► Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not 

use it if any damage or leakage is seen or if the rubber plunger has been drawn above the white 
label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you 
suspect the cartridge is damaged, take it back to your supplier. 

► Infusion sets (tubing and needle) and NovoRapid PumpCart must not be shared. 
► NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneously) using a 

pump. Speak to your doctor if you need to inject your insulin by another method. 
 
Warnings and precautions 
 
Some conditions and activities can affect your need for insulin. Consult your doctor: 
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.  
► If you exercise more than usual or if you want to change your usual diet, as this may affect your 

blood sugar level. 
► If you are ill, carry on taking your insulin and consult your doctor. 
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing 

of your injections. 
 
Children and adolescents 
 
Do not give this medicine to children below 1 year of age since no clinical studies have been carried 
out in children below the age of 1 year. 
 
Other medicines and NovoRapid PumpCart 
 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. 
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 the treatment of diabetes 
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• Beta-blockers (used to treat high blood pressure) 
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure) 
• Salicylates (used to relieve pain and lower fever) 
• Anabolic steroids (such as testosterone) 
• Sulphonamides (used to treat infections). 
 
Your blood sugar level may rise (hyperglycaemia) if you take: 
• Oral contraceptives (birth control pills) 
• Thiazides (used to treat high blood pressure or excessive fluid retention) 
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation) 



111 

• Thyroid hormones (used to treat thyroid gland disorders) 
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat 

asthma) 
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced 

influence on the body’s metabolic processes) 
• Danazol (medicine acting on ovulation). 
 
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually 
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may 
either increase or decrease your blood sugar level. 
 
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning 
symptoms which help you to recognise low blood sugar. 
 
Pioglitazone (tablets used for the treatment of type 2 diabetes) 
Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were 
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor 
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid 
increase in weight or localised swelling (oedema). 
 
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist. 
 
Drinking alcohol and taking NovoRapid 
 
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise 

or fall. Careful monitoring is recommended. 
 
Pregnancy and breast-feeding 
 
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor 

for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin 
dose may need to be changed during pregnancy and after delivery. Careful control of your 
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. 

► There are no restrictions on treatment with NovoRapid during breast-feeding. 
 
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-
feeding. 
 
Driving and using machines 
 
► Please ask your doctor whether you can drive a car or operate a machine: 
• If you have frequent hypoglycaemia. 
• If you find it hard to recognise hypoglycaemia. 
 
If your blood sugar is low or high, your concentration and ability to react might be affected and 
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger 
yourself or others. 
 
Important information about some of the ingredients of NovoRapid 
 
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially 
‘sodium-free’. 
 
 
3. How to use NovoRapid PumpCart 
 
Dose and when to take your insulin 



112 

 
Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your 
doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. Your bolus 
(meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake. Eat 
a meal or snack within 10 minutes of the bolus dose to avoid low blood sugar. When necessary, you 
can take the bolus dose just after you have finished eating.  
 
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one 
type or brand of insulin to another, your dose may have to be adjusted by your doctor. 
 
Use in children and adolescents 
 
NovoRapid can be used in adolescents and children aged 1 year and above. 
 
Use in special patient groups 
 
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check 
your blood sugar more regularly and discuss changes in your insulin dose with your doctor. 
 
How and where to inject  
 
NovoRapid PumpCart is only suitable for injecting under the skin (subcutaneously) using a pump. 
Never inject directly into a vein (intravenously) or muscle (intramuscularly). Speak to your doctor if 
you need to inject your insulin by another method. 
 
Before using NovoRapid PumpCart in a pump, you must have thorough training in the use of the 
pump and information about any actions to be taken in case of illness, too high or too low blood sugar 
or failure of the pump. Follow your doctor’s instructions and advice about the use of NovoRapid 
PumpCart in the pump.  
 
Normally you will inject your insulin in the front of your waist (abdomen). Alternatively, if your 
doctor recommends it, you may use your thigh or upper arm. When you change the infusion set 
(tubing and needle), be sure to change the site for inserting the needle (injection site). This may reduce 
the risk of developing lumps or skin pitting (see section 4, Possible side effects). Changing the 
infusion set must be done according to the instructions in the manual supplied with the infusion set.  
 
When you are using an insulin pump 
 
It is best to measure your blood sugar level regularly to get the maximum benefit of insulin delivery, 
and to make sure the pump is working properly. If you experience any problems contact your doctor.  
 
► NovoRapid PumpCart is only for use with a pump designed to be used with this cartridge, such 

as the Accu-Chek Insight and YpsoPump insulin pumps. 
► NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Follow the 

pump manual (user guide). 
► To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen. 
► NovoRapid should never be mixed with any other medicinal product including other insulin 

products when used in a pump.  
► Do not refill the cartridge. Once empty, it must be disposed of. 
► Always carry a spare NovoRapid PumpCart. 
 
Read carefully the instructions on how to use NovoRapid PumpCart included in this package leaflet. 
 
What to do in case of pump failure 
 
Make sure you have an alternative delivery method for your insulin available for injection under the 
skin (for example, a pen injector) in case the pump stops working. 



113 

 
If you take more insulin than you should  
 
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of 
serious and very common side effects in section 4. 
 
If you forget to take your insulin  
 
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects 
from diabetes in section 4. 
 
If you stop taking your insulin 
 
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be 
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) 
Effects from diabetes in section 4. 
 
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
a) Summary of serious and very common side effects 
 
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 
people. 
 
Low blood sugar may occur if you: 
• Inject too much insulin. 
• Eat too little or miss a meal. 
• Exercise more than usual. 
• Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2). 
 
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling 
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness 
or tremor; feeling anxious; feeling confused; difficulty in concentrating. 
 
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not 
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more 
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how 
to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are 
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. 
 
What to do if you experience low blood sugar: 
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, 

biscuits, fruit juice) and adjust insulin delivery or stop your pump. Measure your blood sugar if 
possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case. 

► When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, 
continue insulin treatment as usual. 

► If you have such a low blood sugar that it makes you pass out, if you have had need for injection 
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. 
The amount or timing of insulin, food or exercise may need to be adjusted. 

 
Tell relevant people that you have diabetes and what the consequences may be, including the risk of 
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they 



114 

must turn you on your side and get medical help straight away. They must not give you any food or 
drink due to risk of suffocation. 
 
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction) 
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 
people. 
 
Seek medical advice immediately: 
• If signs of allergy spread to other parts of your body. 
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty 

in breathing; have a rapid heartbeat; feel dizzy. 
► If you notice any of these signs, seek medical advice immediately. 
 
b) List of other side effects 
 
Uncommon side effects 
May affect less than 1 in 100 people. 
 
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and 
itching) at the injection site may occur. These usually disappear after a few weeks of taking your 
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor 
immediately. See also Serious allergic reactions above. 
 
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the 
disturbance is usually temporary. 
 
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may 
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the 
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, 
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption 
of your insulin, if you inject in such a site. 
 
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles 
and other joints. Normally this soon disappears. If not, talk to your doctor. 
 
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have 
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. 
Ask your doctor about this. 
 
Rare side effects 
May affect less than 1 in 1,000 people. 
 
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may 
get nerve related pain. This is called acute painful neuropathy and is usually transient. 
 
Reporting of side effects 
 
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
c) Effects from diabetes  
 
High blood sugar (hyperglycaemia) 
 
High blood sugar may occur if you: 

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


115 

• Have not injected enough insulin. 
• Forget to inject your insulin or stop taking insulin. 
• Repeatedly inject less insulin than you need. 
• Get an infection and/or a fever. 
• Eat more than usual. 
• Exercise less than usual. 
 
Warning signs of high blood sugar: 
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your 
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a 
fruity (acetone) smell of the breath. 
 
What to do if you experience high blood sugar: 
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you 

can, then seek medical advice immediately. 
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in 

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this 
could lead to diabetic coma and eventually death. 

 
 
5. How to store NovoRapid PumpCart 
 
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 cartridge label and carton, after 
‘EXP’. The expiry date refers to the last day of that month. 
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light. 
NovoRapid PumpCart must be protected from excessive heat and light during storage and use. 
 
Before opening: NovoRapid PumpCart that is not being used is to be stored in the refrigerator at 2°C 
to 8°C, away from the cooling element. Do not freeze. 
 
During use or when carried as a spare: NovoRapid PumpCart in use is not to be kept in the 
refrigerator. NovoRapid PumpCart carried as a spare can be kept for up to 2 weeks below 30°C. 
Thereafter it can be used for up to 7 days below 37°C in a pump designed to be used with this 
cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Keep NovoRapid PumpCart 
in the blister until use to protect it from damage. Always protect the cartridge from light during use. 
 
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 NovoRapid PumpCart contains 
 
• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each 

cartridge contains 160 units of insulin aspart in 1.6 ml solution for injection. 
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate 

dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections. 
 
What NovoRapid PumpCart looks like and contents of the pack 
 
NovoRapid PumpCart is presented as a solution for injection. 
 
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges of 1.6 ml. Not all 
pack sizes may be marketed. 
 



116 

The solution is clear and colourless.  
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark 
 
Please proceed to the information in ‘Instructions on how to use NovoRapid PumpCart pre-
filled cartridge’. 
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 

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


117 

Instructions on how to use NovoRapid PumpCart pre-filled cartridge. 
 
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used 
with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be 
used with other devices not designed for NovoRapid PumpCart, as this may result in incorrect 
insulin dosing and subsequent hyper- or hypoglycaemia. 
 
Please read these instructions carefully before using your NovoRapid PumpCart.  
 
Please also read the pump manual (user guide) that comes with your insulin pump. 
 
• NovoRapid PumpCart is ready for use directly in the pump. 
 
• NovoRapid PumpCart contains 1.6 ml insulin aspart solution, equivalent to 160 units. 
 
• This medicinal product should never be mixed with any other medicinal products. 
 
• Do not refill NovoRapid PumpCart. Once empty, it must be disposed of. 
 
• Always make sure you have a spare NovoRapid PumpCart available. 
 
• To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.  
 
• NovoRapid PumpCart must be protected from excessive heat and light during storage and use. 
 
• NovoRapid PumpCart should be kept out of reach of others, especially children. 
 
 

Plunger 
White label band 

A 

 
 
1. Before inserting a NovoRapid PumpCart cartridge into your pump 
 
• Bring NovoRapid PumpCart to room temperature. 
 
• Take NovoRapid PumpCart out of its blister package. 
 
• Check the label to make sure that it is NovoRapid PumpCart. 
 
• Check the expiry date, which is stated on the label and the carton. 
 
• Always check that NovoRapid PumpCart looks the way it should (picture A). Do not use it if 

any damage or leakage is seen or if the plunger has moved, making the bottom of the plunger 
visible above the white label band. This could be a result of leakage of insulin. In picture A the 
bottom of the plunger is hidden behind the white label band as it should be. If you suspect 
NovoRapid PumpCart is damaged, take it back to your supplier. 

 
• Check that the insulin in NovoRapid PumpCart is clear and colourless. If the insulin looks 

cloudy, do not use NovoRapid PumpCart. The cartridge may contain a minor amount of air in 
the form of small bubbles. 



118 

 
 
2. Inserting a new NovoRapid PumpCart cartridge in your pump 
 
• Follow the instructions in the pump user manual that comes with your pump to insert a new 

NovoRapid PumpCart cartridge in your pump. 
 
• Insert a NovoRapid PumpCart in the cartridge compartment of the pump. The plunger goes in 

first. 
 
• Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump. 
 
• Follow the instructions in the pump user manual to continue using your pump. 
 
3. Removing an empty NovoRapid PumpCart cartridge from your pump 
 
• Follow the instructions in the pump user manual to remove an empty NovoRapid PumpCart 

cartridge from your pump. 
 
• Remove the infusion set adapter from the empty NovoRapid PumpCart cartridge. 
 
• Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by 

your doctor or nurse. 
 
• Follow the steps described in section 1 and 2 to prepare and insert a new NovoRapid PumpCart 

into your pump. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET