Insulin aspart Sanofi

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ANNEX I  

 

SUMMARY OF PRODUCT CHARACTERISTICS  

 

  



 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

One ml solution contains 100 units (equivalent to 3.5 mg) insulin aspart*. 

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge  

 

Each cartridge contains 3 ml equivalent to 300 units insulin aspart. 

  

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

 

Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. 

Each pre-filled pen delivers 1-80 units in steps of 1 unit. 

 

*produced in Escherichia coli by recombinant DNA technology. 

 

For the full list of excipients, see section 6.1.  

 

 

3. PHARMACEUTICAL FORM 

 

Solution for injection (injection). 

Clear, colourless, aqueous solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications  

 

Insulin aspart Sanofi is indicated for the 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. 

 

Insulin aspart Sanofi 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. 

 

Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal 

glycaemic control. 

 



 

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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 Insulin aspart 

Sanofi 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. 

 

Transfer from other insulin medicinal products 

When transferring from other insulin medicinal products, adjustment of the Insulin aspart Sanofi dose 

and the dose of the basal insulin may be necessary. Insulin aspart Sanofi 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). 

 

Special populations 

Elderly  

 

Insulin aspart Sanofi 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 impairment  

 

Renal impairment may reduce the patient’s insulin requirements. 

In patients with renal impairment, glucose monitoring should be intensified and the insulin aspart dose 

adjusted on an individual basis. 

 

Hepatic impairment 

 

Hepatic impairment may reduce the patient’s insulin requirements. 

In patients with hepatic impairment, glucose monitoring should be intensified and the insulin aspart 

dose adjusted on an individual basis. 

 

Paediatric population 

 

Insulin aspart Sanofi can be used in adolescents and children 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 Insulin aspart Sanofi in children below 1 year of age have not been 

established.  

No data are available. 

 

Method of administration 

 

Insulin aspart Sanofi is for subcutaneous use. 

 

Insulin aspart is a rapid-acting insulin analogue. 

Insulin aspart Sanofi is administered subcutaneously by injection in the upper arms, thighs, buttocks or 

abdomen. 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 insulin aspart 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, insulin aspart should generally be given immediately before a meal. 

When necessary insulin aspart can be given soon after a meal. 

 

Injecting a dose 

1. Wash your hands. 

2. Choose a site for injection. 

3. Clean the skin as instructed. 

4. Remove outer needle cap. 

5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed. 

6. Press the knob. 

7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub 

the area. 

8. Using the outer needle cap, unscrew the needle and dispose of it safely. 

9. Use of injection sites should be rotated so that the same site is not used more than approximately 

once a month. 

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

 

Insulin aspart Sanofi in cartridges is only suitable for subcutaneous injections from a reusable pen. If 

administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. 

Other insulin aspart medicinal products offering such an option should be used. Insulin aspart Sanofi 

in cartridges is designated to be used in the following pens (see section 6.6):  

 

- JuniorSTAR which delivers 1-30 units of insulin aspart in 0.5 unit dose increments  

- Tactipen which delivers 1-60 units of insulin aspart in 1 unit dose increments 

- AllStar and AllStar PRO which all deliver 1-80 units of insulin aspart in 1 unit dose increments. 

 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

 

Insulin aspart Sanofi 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If 

administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. 

Other insulin aspart medicinal products offering such an option should be used. Insulin aspart Sanofi 

in pre-filled pen delivers 1-80 units in increments of 1 unit. 

 

Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 

requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 

are blind or have poor vision must be instructed to always get help/assistance from another person who 

has good vision and is trained in using the insulin device. 

 

For detailed user instructions, please refer to the package leaflet. 

 

4.3 Contraindications 

 

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

 

4.4 Special warnings and precautions for use 

 

Traceability 

 

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

of the administered product should be clearly recorded. 

 

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 



 

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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. 

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 Insulin aspart Sanofi 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 Insulin aspart Sanofi 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 Insulin aspart Sanofi 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 insulin aspart. 

 

Combination of Insulin aspart Sanofi 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 



 

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mind if treatment with the combination of pioglitazone and Insulin aspart Sanofi 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 Insulin aspart Sanofi and other insulin products. 

 

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. 

 

Travel 

 

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. 

 

Sodium 

 

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

“sodium-free”. 

 

4.5 Interaction with other medicinal products and other forms of interaction  

 

A number of medicinal products are known to interact with 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 

 

Insulin aspart Sanofi (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. 

 



 

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Breast-feeding  

 

There are no restrictions on treatment with Insulin aspart Sanofi during breast-feeding. Insulin 

treatment of the nursing mother presents no risk to the baby. However, the Insulin aspart Sanofi dose 

may need to be adjusted. 

 

Fertility 

 

Animal reproduction studies have not revealed any differences between insulin aspart and human 

insulin regarding fertility (see section 5.3). 

 

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 using 

machines).  

 

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 

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 Insulin aspart Sanofi 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 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). 

 

MedDRA system organ 

classes 

Very common Uncommon Rare Very rare 

Immune system disorders  Urticaria, rash, 

eruptions 

 Anaphylactic 

reactions* 

Metabolism and nutrition 

disorders 

Hypoglycaemia*    

Nervous system disorders   Peripheral 

neuropathy 

 



 

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(painful 

neuropathy) 

Eye disorders  Refraction 

disorders, 

diabetic 

retinopathy 

  

Skin and subcutaneous tissue 

disorders 

 Lipodystrophy*   

General disorders and 

administration site conditions 

 Injection site 

reactions, 

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. 

 

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 with insulin aspart, 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 with insulin aspart, 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. 

 

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


 

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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  

 

Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting.  

ATC code: A10AB05 

 

Insulin aspart Sanofi is a biosimilar medicinal product. Detailed information is available on the 

website of the European Medicines Agency http://www.ema.europa.eu. 
 

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.  

 

Insulin aspart 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. Insulin aspart 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 insulin aspart 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.  

 

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


 

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When insulin aspart 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 insulin aspart 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, insulin aspart 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 

 

Elderly  

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 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 insulin aspart 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 insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the 

tendency to form hexamers as observed with soluble human insulin. Insulin aspart is therefore more 

rapidly absorbed from the subcutaneous layer compared to soluble human insulin. 



 

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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 insulin aspart than for soluble human insulin, whereas the 

intra-individual variability in Cmax for insulin aspart is larger. 

 

Special populations 

 

Elderly  

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 

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 insulin aspart 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 insulin aspart. 

 

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  

 

Phenol 

Metacresol 



 

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Zinc chloride 

Polysorbate 20 

Sodium chloride 

Hydrochloric acid (for pH adjustment) 

Sodium hydroxide (for pH adjustment) 

Water for injections  

 

6.2 Incompatibilities  

 

This medicinal product must not be diluted or mixed with other medicinal products. 

 

6.3 Shelf life  

 

Before first use 

 

2 years. 

 

After first use 

 

4 weeks.  

 

6.4 Special precautions for storage  

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

 

Before first use 

Store in a refrigerator (2°C - 8°C). Do not freeze.  

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

 

After first use 

Store below 30°C. Do not refrigerate. Do not freeze. 

Keep the pen cap on the pen in order to protect from light. 

 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

 

Before first use 

Store in a refrigerator (2°C - 8°C). Do not freeze.  

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

 

After first use 

Store below 30°C. Do not refrigerate. Do not freeze. 

Keep the pen cap on the pen in order to protect from light. 

 

6.5 Nature and contents of container  

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

 

Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap 

(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber). Each cartridge contains 

3 ml of solution.  

Pack sizes: 5 or 10 cartridges  

Not all pack sizes may be marketed.  

 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen  

 



 

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Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap 

(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable 

pen injector (SoloStar).  

Each pre-filled pen contains 3 ml of solution. 

Pack sizes: 1, 5 or 10 pre-filled pens. 

Not all pack sizes may be marketed. 

 

 

6.6 Special precautions for disposal and other handling 
 

The Insulin aspart Sanofi solution should be inspected before use. This medicinal product should not 

be used if you notice that the solution is not clear, colourless and aqueous. 

 

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

requirements.  

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

 

To prevent the possible transmission of disease, each cartridge must be used by one patient only, even 

if the needle on the delivery device is changed. 

 

Insulin aspart Sanofi in cartridges are to be used with JuniorSTAR, Tactipen, AllStar or AllStar PRO 

pens as recommended (see section 4.2 and 4.4). 

 

The pen with the inserted cartridge should not be stored with the needle attached. 

 

A new needle should always be used for each injection. 

 

The manufacturer’s instructions with each individual pen must be followed for loading the cartridge, 

attaching the needle and administering the insulin injection 

  

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

 

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 

needle is changed. 

 

The pre-filled pen should not be stored with the needle attached. 

 

A new needle should always be used for each injection. 

 

Needles are not included in the pack. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

 EU/1/20/1447/001 

EU/1/20/1447/002 

EU/1/20/1447/003 

EU/1/20/1447/004 



 

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EU/1/20/1447/005 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation:  

 

 

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. 

 

  



 

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ANNEX II 

 

A. MANUFACTURER 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 

 

 



 

16 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance  

 

Sanofi-Aventis Deutschland GmbH 

Brüningstrasse 50 

Industriepark Höchst 

65926 Frankfurt am Main 

Germany 

 

Name and address of the manufacturers responsible for batch release 

 

Sanofi-Aventis Deutschland GmbH 

Brüningstrasse 50 

Industriepark Höchst 

65926 Frankfurt am Main 

Germany 

 

Sanofi-Aventis Private Co. Ltd.,   

Budapest Logistics and Distribution Platform 

Bdg. DC5, Campona utca 1.,  

Budapest, 1225, Hungary 

 

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 (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

• Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 

authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

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

an important (pharmacovigilance or risk minimisation) milestone being reached.  



 

17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



 

18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
 

  



 

19 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON (CARTRIDGE) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge 

insulin aspart 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One ml solution contains 100 units (equivalent to 3.5 mg) insulin aspart.  

Each cartridge contains 3 ml equivalent to 300 units insulin aspart. 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, hydrochloric acid and 

sodium hydroxide (for pH adjustment), water for injections. See leaflet for further information. 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

5 x 3 ml 

10 x 3 ml 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Use the cartridges only with the pens: AllStar, AllStar PRO, JuniorSTAR, Tactipen. 

Not all of these pens may be marketed in your country. 

 

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 WARNING(S), IF NECESSARY 

 

For single patient use only. 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

20 

9. SPECIAL STORAGE CONDITIONS 

 

Before first use: 

Store in a refrigerator  

Do not freeze. 

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

 

After first use: 

Store below 30°C for a maximum of 4 weeks. 

Do not refrigerate. 

Keep the pen cap on the pen in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1447/004 5 cartridges 

EU/1/20/1447/005 10 cartridges 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Insulin aspart Sanofi 100 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



 

21 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

 

  



 

22 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL (CARTRIDGE) 

 

 

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

 

Insulin aspart Sanofi 100 units/ml solution for injection  

insulin aspart 

subcutaneous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

3 ml 

 

 

6. OTHER  

 

  



 

23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON (PRE-FILLED PEN)  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 

insulin aspart 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One ml solution contains 100 units (equivalent to 3.5 mg) insulin aspart. 

Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, hydrochloric acid and 

sodium hydroxide (for pH adjustment), water for injections. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection in pre-filled pen SoloStar 

1 pen of 3 ml 

5 pens of 3 ml 

10 pens of 3 ml 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Open here 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Always use a new needle for each injection. 

For single patient use only 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

24 

9. SPECIAL STORAGE CONDITIONS 

 

Before first use: 

Store in a refrigerator. 

Do not freeze. 

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

 

After first use: 

Store below 30°C for a maximum of 4 weeks. 

Do not refrigerate.  

Keep the pen cap on the pen in order to protect from light.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1447/001 1 pen  

EU/1/20/1447/002 5 pens 

EU/1/20/1447/003 10 pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Insulin aspart 100 SoloStar 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



 

25 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN  

 

 

  



 

26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL (PRE-FILLED PEN)  
 

 

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

 

Insulin aspart Sanofi 100 units/ml solution for injection 

insulin aspart 

subcutaneous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

3 ml 

 

 

6. OTHER  

 

SoloStar 

 

  



 

27 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 



 

28 

  

Package leaflet: information for the user  

 

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge  

insulin aspart  

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

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

important information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor or pharmacist. 

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

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4.  

 

What is in this leaflet  

 

1. What Insulin aspart Sanofi is and what it is used for 

2. What you need to know before you use Insulin aspart Sanofi 

3. How to use Insulin aspart Sanofi 

4. Possible side effects 

5. How to store Insulin aspart Sanofi 

6. Contents of the pack and other information 

 

 

1. What Insulin aspart Sanofi is and what it is used for 

 

Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin 

products are improved versions of human insulin. 

 

Insulin aspart Sanofi 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 Insulin aspart 

Sanofi helps to prevent complications from your diabetes. 

 

Insulin aspart Sanofi 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 Insulin aspart Sanofi should normally be taken in combination with intermediate-acting or 

long-acting insulin preparations.  

 

 

2. What you need to know before you use Insulin aspart Sanofi 

 

Do not use Insulin aspart Sanofi  

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in 
section 6). 

• If you suspect hypoglycaemia (low blood sugar) is starting (see “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 “How to store Insulin aspart Sanofi” in 
section 5). 

• If the insulin does not appear clear and colourless. 
 



 

29 

If any of these applies, do not use Insulin aspart Sanofi. Talk with your doctor, nurse or pharmacist for 

advice. 

 

Before using Insulin aspart Sanofi  

• 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 syringes must not be shared. 

• Insulin aspart Sanofi 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 

 

Record the brand name (“Insulin aspart Sanofi”) and Lot number (included on the outer cartons and 

labels of each cartridge and pre-filled pen) of the medicine you are using and provide this information 

when reporting any side effects. 

 

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 Insulin aspart Sanofi 

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) 



 

30 

• 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. 

 

Insulin aspart Sanofi and alcohol 

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. Insulin aspart Sanofi 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 Insulin aspart Sanofi 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 use 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 use a machine. Bear in mind that you could endanger yourself or 

others. 

 

Insulin aspart Sanofi has a rapid onset of effect therefore if hypoglycaemia occurs, you may 

experience it earlier after an injection when compared to soluble human insulin. 

 

Insulin aspart Sanofi contains sodium 

This medicine contains less than 1 mmol (23 mg) sodium per dose, that to say essentially “sodium-

free”. 

 

 

3. How to use Insulin aspart Sanofi 

 

Dose and when to use 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. 

 



 

31 

Insulin aspart Sanofi is generally used immediately before a meal. Eat a meal or snack within 
10 minutes of the injection to avoid low blood sugar. When necessary, Insulin aspart Sanofi 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 

Insulin aspart Sanofi 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 

Insulin aspart Sanofi is for injection under the skin (subcutaneously). You must never inject yourself 

directly into a vein (intravenously) or muscle (intramuscularly). Insulin aspart Sanofi 100 units/ml in 

cartridges 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 you inject into the front of your waist (abdomen). 

You should always measure your blood sugar regularly. 

 

• To ensure you get the accurate dose, the Insulin aspart Sanofi cartridges are to be used only with 
the following pens:  

- JuniorSTAR which delivers doses in steps of 0.5 units 

- Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit. 

Not all of these pens may be marketed in your country. 

• Always carry a spare cartridge in case it is lost or damaged. 
 

How to inject Insulin aspart Sanofi  

• 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 10 seconds. Keep the dose button held in until the 
needle has been released from the skin. This will ensure you get your full dose. 

• Remove and discard the needle after each injection. Do not store Insulin aspart Sanofi with the 
needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing. 

• Always use a new needle for each injection. This helps stop blocked needles, contamination and 
infection. 

 

If you use more insulin than you should 

If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious 

and very common side effects” in section 4). 

 

If you forget to use your insulin 

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects 

from diabetes” in section 4). 

 

If you stop using your insulin  

Do not stop using 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 “Effects 

from diabetes” in section 4). 



 

32 

 

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. 

 

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 "Insulin aspart Sanofi with alcohol” 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 Insulin aspart Sanofi 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 up to 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. 

 



 

33 

Other side effects 

 

Uncommon (may affect up to 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 using 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 using 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 (may affect up to 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 to 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. 

 

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 using 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.  

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


 

34 

• 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 Insulin aspart Sanofi 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date 

refers to the last day of that month. 

 

Before the first use store your Insulin aspart Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep 

the cartridge in the outer carton in order to protect from light. 

 

Keep your cartridge in use at room temperature (below 30°C) for a maximum of 4 weeks. Do not put it 

near heat or in the sun. Do not keep your pen with the inserted cartridge you are using in the fridge. 

The pen with the inserted cartridge should not be stored with the needle attached. Keep the pen cap on 

the pen to protect it from light. 

 

Do not use Insulin aspart Sanofi, if it is coloured or it has solid pieces in it. You must use it only if it 

looks like water. Check this each time you inject yourself.  

 

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

throw away medicines you no longer use. These measures will help to protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Insulin aspart Sanofi contains  

• The active substance is insulin aspart. One ml of the solution contains 100 units (equivalent to 
3.5 mg) of insulin aspart. Each cartridge contains 3 ml of solution for injection, equivalent to 

300 units of insulin aspart. 

• The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, 
hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric 

acid may have been used to adjust the acidity. 

 
What Insulin aspart Sanofi looks like and contents of the pack  

Insulin aspart Sanofi, solution for injection is a clear, colourless, aqueous solution. Each cartridge 

contains 3 ml.  

 

Do not refill the cartridge. Once empty, it must be disposed of. 

 

If you are treated with Insulin aspart Sanofi in cartridge and another insulin in cartridge, you should 

use the insulin delivery systems recommended by each manufacturer, one for each type of insulin. 

 

The Insulin aspart Sanofi cartridges come in a pack of 5 or 10 cartridges.  

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer  

 

Marketing Authorisation Holder: 

sanofi-aventis groupe, 54, rue La Boétie, F - 75008 Paris, France 

 

Manufacturer:  

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 

 



 

35 

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

Authorisation Holder. 

 

België/Belgique/Belgien 

Sanofi Belgium 

Tél/Tel: +32 (0)2 710 54 00 

 

Lietuva 

UAB « SANOFI-AVENTIS LIETUVA » 

Tel: +370 5 2755224 

 

България 

SANOFI BULGARIA EOOD 

Тел.: +359 (0)2 970 53 00 

 

Luxembourg/Luxemburg 

Sanofi Belgium  

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Magyarország 

SANOFI-AVENTIS Zrt.,  

Tel.: +36 1 505 0050 

 

Danmark 

Sanofi A/S 

Tlf: +45 45 16 70 00 

 

Malta 

Sanofi S.p.A. 

Tel: +39 02 39394275 

 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

Tel : 0800 52 52 010 

Tel. aus dem Ausland: +49 69 305 21 131 

 

Nederland 

sanofi-aventis Netherlands B.V. 

Tel: +31 20 245 4000  

Eesti 

sanofi-aventis Estonia OÜ 

Tel: +372 627 34 88 

 

Norge 

sanofi-aventis Norge AS 

Tlf: +47 67 10 71 00 

 

Ελλάδα 

sanofi-aventis AEBE 

Τηλ: +30 210 900 16 00 

 

Österreich 

sanofi-aventis GmbH 

Tel: +43 1 80 185 – 0 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

France 

sanofi-aventis France 

Tél: 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 

 

Portugal 

Sanofi - Produtos Farmacêuticos, Lda 

Tel: +351 21 35 89 400 

 

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36 

 

Ireland 

sanofi-aventis Ireland Ltd. T/A SANOFI 

Tel: +353 (0) 1 403 56 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 48 00 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel: +421 2 33 100 100 

 



 

36 

Italia 

Sanofi S.p.A. 

Tel: 800 13 12 12 (domande di tipo tecnico)  

800.536389 (altre domande) 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: +358 (0) 201 200 300 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

 

This leaflet was last revised in  

 

 

Other source of information 

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

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

 



 

37 

Package leaflet: information for the user  

 

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen  

insulin aspart  

 

 This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

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

important information for you. 

 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor, 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 to 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 Insulin aspart Sanofi is and what it is used for 

2. What you need to know before you use Insulin aspart Sanofi 

3. How to use Insulin aspart Sanofi 

4. Possible side effects 

5. How to store Insulin aspart Sanofi 

6. Contents of the pack and other information 

 

 

1. What Insulin aspart Sanofi is and what it is used for 

 

Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin 

products are improved versions of human insulin. 

 

Insulin aspart Sanofi 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 Insulin aspart 

Sanofi helps to prevent complications from your diabetes. 

 

Insulin aspart Sanofi 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 Insulin aspart Sanofi should normally be taken in combination with intermediate-acting or 

long-acting insulin preparations.  

 

 

2. What you need to know before you use Insulin aspart Sanofi 

 

Do not use Insulin aspart Sanofi 

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in 
section 6). 

• If you suspect hypoglycaemia (low blood sugar) is starting (see “Summary of serious and very 
common side effects” in section 4) 

• If the pre-filled pen is dropped, damaged or crushed. 

• If it has not been stored correctly or been frozen (see “How to store Insulin aspart Sanofi” in 
section 5). 

• If the insulin does not appear clear and colourless. 
 



 

38 

If any of these applies, do not use Insulin aspart Sanofi. Talk with your doctor, nurse or pharmacist for 

advice. 

 

Before using Insulin aspart Sanofi 

• 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 the pre-filled pen must not be shared. 

• Insulin aspart Sanofi 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 

Record the brand name (“Insulin aspart Sanofi”) and Lot number (included on the outer cartons and 

labels of each cartridge and pre-filled pen) of the product you are using and provide this information 

when reporting any side effects. 

 

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 Insulin aspart Sanofi 

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). 
 



 

39 

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. 

 

Insulin aspart Sanofi and alcohol 

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. Insulin aspart Sanofi 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 Insulin aspart Sanofi 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 use 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 use a machine. Bear in mind that you could endanger yourself or 

others. 

 

Insulin aspart Sanofi has a rapid onset of effect therefore if hypoglycaemia occurs, you may 

experience it earlier after an injection when compared to soluble human insulin. 

 

Insulin aspart Sanofi contains sodium 

This medicine contains less than 1 mmol (23 mg) sodium per dose, that to say essentially “sodium-

free”. 

 

 

3. How to use Insulin aspart Sanofi 

 

Dose and when to use 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. 

 

Insulin aspart Sanofi is generally used immediately before a meal. Eat a meal or snack within 
10 minutes of the injection to avoid low blood sugar. When necessary, Insulin aspart Sanofi can be 

given soon after a meal (see “How and where to inject below for information”). 

 



 

40 

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 

Insulin aspart Sanofi 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 

Insulin aspart Sanofi is for injection under the skin (subcutaneously). You must never inject yourself 

directly into a vein (intravenously) or muscle (intramuscularly). Insulin aspart Sanofi 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 you inject into the front of your waist (abdomen). 

You should always measure your blood sugar regularly. 

 

How to handle Insulin aspart Sanofi SoloStar pre-filled pen 

Insulin aspart Sanofi SoloStar is a pre-filled disposable pen containing insulin aspart. Each SoloStar 

pen delivers 1-80 units in increments of 1 unit. 

 

Read carefully the instructions for use included in this package leaflet. You must use the pen as 

described in the Instructions for Use.  

 

Always ensure you use the correct pen before you inject your insulin. 

 

If you use more insulin than you should 

If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious 

and very common side effects” in section 4). 

 

If you forget to use your insulin 

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects 

from diabetes” in section 4). 

 

If you stop using your insulin  

Do not stop using 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 “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. 

 

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. 

 



 

41 

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 "Insulin aspart Sanofi with alcohol” 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 Insulin aspart Sanofi 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 up to 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. 

 
Other side effects 

 

Uncommon (may affect up to 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 using 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 



 

42 

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 using 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 (may affect up to 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 to 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. 

 

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 using 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 Insulin aspart Sanofi  

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date 

refers to the last day of that month. 

 

Before the first use store your Insulin aspart Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep 

the pre-filled pen in the outer carton in order to protect from light. 

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


 

43 

 

Keep your Insulin aspart Sanofi pre-filled pen in use at room temperature (below 30°C) for a 

maximum of 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled 

pen should not be stored with the needle attached. Always keep the cap on the pre-filled pen when you 

are not using it in order to protect from light. 

 

Do not use Insulin aspart Sanofi pre-filled pen if the solution is coloured or it has solid pieces in it. 

You must use it only if it looks like water. Check this each time you inject yourself.  

 

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

throw away medicines you no longer use. These measures will help to protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Insulin aspart Sanofi contains  

• The active substance is insulin aspart. One ml of the solution contains 100 units (equivalent to 
3.5 mg) of insulin aspart. Each pre-filled pen (SoloStar) contains 3 ml of solution for injection, 

equivalent to 300 units of insulin aspart. Each pre-filled pen (SoloStar) delivers 1-80 units in 

steps of 1 unit.  

• The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, 
hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric 

acid may have been used to adjust the acidity. 

 
What Insulin aspart Sanofi looks like and contents of the pack  

Insulin aspart Sanofi solution for injection is a clear, colourless, aqueous solution. Each pre-filled pen 

(SoloStar) contains 3 ml. 

 

Only use needles that are compatible for use with Insulin aspart Sanofi. 

 

Insulin aspart Sanofi in pre-filled pen (SoloStar) comes in a pack of 1, 5 or 10 pre-filled pens. Not all 

pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer  

 

Marketing Authorisation Holder: 

sanofi-aventis groupe, 54, rue La Boétie, F - 75008 Paris, France 

 

Manufacturer:  

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 

 

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

Authorisation Holder. 

 

België/Belgique/Belgien 

Sanofi Belgium 

Tél/Tel: +32 (0)2 710 54 00 

 

Lietuva 

UAB « SANOFI-AVENTIS LIETUVA » 

Tel: +370 5 2755224 

 

България 

SANOFI BULGARIA EOOD 

Тел.: +359 (0)2 970 53 00 

 

Luxembourg/Luxemburg 

Sanofi Belgium  

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Magyarország 

SANOFI-AVENTIS Zrt.,  

Tel.: +36 1 505 0050 

 



 

44 

Danmark 

Sanofi A/S 

Tlf: +45 45 16 70 00 

 

Malta 

Sanofi S.p.A. 

Tel: +39 02 39394275 

 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

Tel : 0800 52 52 010 

Tel. aus dem Ausland: +49 69 305 21 131 

 

Nederland 

sanofi-aventis Netherlands B.V. 

Tel: +31 20 245 4000  

Eesti 

sanofi-aventis Estonia OÜ 

Tel: +372 627 34 88 

 

Norge 

sanofi-aventis Norge AS 

Tlf: +47 67 10 71 00 

 

Ελλάδα 

sanofi-aventis AEBE 

Τηλ: +30 210 900 16 00 

 

Österreich 

sanofi-aventis GmbH 

Tel: +43 1 80 185 – 0 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

France 

sanofi-aventis France 

Tél: 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 

 

Portugal 

Sanofi - Produtos Farmacêuticos, Lda 

Tel: +351 21 35 89 400 

 

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36 

 

Ireland 

sanofi-aventis Ireland Ltd. T/A SANOFI 

Tel: +353 (0) 1 403 56 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 48 00 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel: +421 2 33 100 100 

 

Italia 

Sanofi S.p.A. 

Tel: 800 13 12 12 (domande di tipo tecnico)  

800.536389 (altre domande) 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: +358 (0) 201 200 300 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

 

This leaflet was last revised in  

 

 

Other source of information 



 

45 

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

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

  

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


 

46 

Insulin aspart Sanofi solution for injection in pre-filled pen (SoloStar)  

INSTRUCTIONS FOR USE  

 

Read this first 

 

Important information 

 

• Never share your pen – it is only for you. 
• Never use your pen if it is damaged or if you are not sure that it is working properly. 
• Always perform a safety test 
• Always carry a spare pen and spare needles in case they got lost or stop working. 
• Never re-use needles. If you do you might not get your dose (underdosing) or get too much 

(overdosing) as the needle could block. 
 
Learn to inject 

 

• Talk with your doctor, pharmacist or nurse about how to inject, before using your pen. 

• Ask for help if you have problems handling the pen, for example if you have problems with your 
sight. 

• Read all package leaflet information and instructions before using your pen. If you do not follow 
all of these instructions, you may get too much or too little insulin. 

 

Need help? 

 

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or 

call sanofi-aventis number on the front of this leaflet. 

 
Extra items you will need: 

 

• a new sterile needle (see STEP 2). 

• a puncture resistant container for used needles and pens (see Throwing your pen away). 
 

Get to know your pen 

 

 
 

 

* You will not see the plunger until you have injected a few doses. 

 

 

Cartridge holder 

Pen cap 
Rubber seal Insulin scale 

Insulin name Dose window Dose pointer 

Dose selector 

Injection button 

Plunger* 



 

47 

STEP 1: Check your pen 

• Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more 
painful to inject. 

 

1A Check the name and expiry date on the label of your pen. 

• Make sure you have the correct insulin. This is especially important if you have other 
injector pens. 

• Never use your pen after the expiry date. 
 

 
 

 
1B Pull off the pen cap. 

 
 
 

1C Check that the insulin is clear. 

• Do not use the pen if the insulin looks cloudy, coloured or contains particles. 
 

 

 
 
STEP 2: Attach a new needle 

 

• Always use a new sterile needle for each injection. This helps stop blocked needles, 
contamination and infection. 

• Only use needles that are compatible for use with Insulin aspart Sanofi. 
 

 



 

48 

2A Take a new needle and peel off the protective seal. 

 

 
 
2B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten. 

 
 

2C Pull off the outer needle cap. Keep this for later. 

 

 
 

2D  Pull off the inner needle cap and throw away. 

 

 
 

 Handling needles 

• Take care when handling needles – this is to prevent needle injury and cross-infection. 
 

 

STEP 3: Do a safety test 

 

• Always do a safety test before each injection – this is to: 
• check your pen and the needle are working properly. 

• make sure that you get the correct insulin dose. 
 



 

49 

3A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark. 

 
 

3B Press the injection button all the way in. 

• When insulin comes out of the needle tip, your pen is working correctly. 

 
 
If no insulin appears: 

• You may need to repeat this step up to 3 times before seeing insulin. 

• If no insulin comes out after the third time, the needle may be blocked. If this happens: 
- change the needle (see STEP 6 and STEP 2), 
- then repeat the safety test (STEP 3). 

• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen. 

• Never use a syringe to remove insulin from your pen. 
 

If you see air bubbles 

• You may see air bubbles in the insulin. This is normal, they will not harm you. 
 
 
STEP 4: Select the dose 

 

• Never select a dose or press the injection button without a needle attached. This may damage 
your pen. 

 



 

50 

4A  Make sure a needle is attached and the dose is set to ‘0’. 

 
 

4B Turn the dose selector until the dose pointer lines up with your dose. 

• If you turn past your dose, you can turn back down. 

• If there are not enough units left in your pen for your dose, the dose selector will stop at the 
number of units left. 

• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and 
use a new pen to complete your dose. 

 

 
 

How to read the dose window 

 

Even numbers are shown in line with the dose pointer: 

 
Odd numbers are shown as a line between even numbers: 

 
 
Units of insulin in your pen 

• Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in 
steps of 1 unit. Each pen contains more than one dose. 

• You can see roughly how many units of insulin are left by looking at where the plunger is on 
the insulin scale. 

 

 

20 units selected 

21 units selected 



 

51 

STEP 5: Inject your dose 

 

• If you find it hard to press the injection button in, do not force it as this may break 
your pen. See the  section below for help. 

 

5A  Choose a place to inject as shown in the picture  

 

 

  

 

 

 

 

 

 

 

 

5B Push the needle into your skin as shown by your doctor, pharmacist or nurse. 

• Do not touch the injection button yet. 
 

 
 
 
5C Place your thumb on the injection button. Then press all the way in and hold. 

• Do not press at an angle – your thumb could block the dose selector from turning. 

 
 

Upper arms 

Stomach 

Thighs 

Buttocks 



 

52 

 
5D Keep the injection button held in and when you see "0" in the dose window, slowly count to 

10. 

• This will make sure you get your full dose. 
 

 
 
5E After holding and slowly counting to 10, release the injection button. Then remove the 

needle from your skin. 

 

If you find it hard to press the button in: 

• Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3). 

• If you still find it hard to press in, get a new pen. 

• Never use a syringe to remove insulin from your pen. 
 
 
STEP 6: Remove the needle 

 

• Take care when handling needles – this is to prevent needle injury and cross-infection. 
• Never put the inner needle cap back on. 

 

6A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.  

• To reduce the risk of accidental needle injury, never replace the inner needle cap. 

• If your injection is given by another person, or if you are giving an injection to another 
person, special caution must be taken by this person when removing and disposing of the 

needle. 

• Follow recommended safety measures for removal and disposal of needles (contact your 
doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and 

transmission of infectious diseases. 

 

6B Throw away the used needle in a puncture resistant container, or as told by your pharmacist 

or local authority. 

 

 
 
 



 

53 

6C Put the pen cap back on. 

• Do not put the pen back in the fridge. 
 

 

How to store and care for you pen 

• You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not 
soak, wash or lubricate your pen – this may damage it. 

• Remove and throw away your used pen as told by your pharmacist or local authority. 

• For further information on the storage and use of your pen please refer to sections 2 and 5 of 
the package leaflet. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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