Active substanceInsulin GlulisinInsulin Glulisin
Similar drugsTo uncover
Dosage form: & nbsphypodermic solution
Composition:

1 ml of the solution contains:

active ingredient: insulin glulisine 100 ED (3.49 mg);

auxiliary ingredients: metacresol (m-cresol), trometamol (tromethamine), sodium chloride, polysorbate 20, sodium hydroxide, hydrochloric acid, water for injection.

Description:Transparent, colorless or almost colorless liquid.
Pharmacotherapeutic group:Hypoglycemic agent - short-acting insulin analog
ATX: & nbsp

A.10.A.B.06   Insulin Glulisin

Pharmacodynamics:

Insulin glulisin is a recombinant analog of human insulin, which by force of action is equal to the usual human insulin. After subcutaneous administration insulin glulisin begins to act faster and has a shorter duration of action than soluble human insulin. The most important action of insulin and insulin analogues, including insulin glulisin, is the regulation of glucose metabolism. Insulin reduces the concentration of glucose in the blood, stimulating the absorption of glucose by peripheral tissues, especially skeletal muscle and fat tissue, and also inhibiting the formation of glucose in the liver.Insulin inhibits lipolysis in adipocytes, suppresses proteolysis and increases protein synthesis.

Studies conducted in healthy volunteers and patients with diabetes showed that with subcutaneous injection insulin glulisin begins to act faster and has a shorter duration of action than soluble human insulin. With subcutaneous administration, the lowering of the glucose concentration in the blood, the effect of glulisin insulin begins in 10-20 minutes. With intravenous administration, the effects of reducing blood glucose in the blood of insulin glulisin and soluble human insulin are equal in strength. One unit of glulisin insulin has the same glucose-lowering activity as one unit of soluble human insulin. In the Phase I study, in patients with type 1 diabetes mellitus, glucose-lowering profiles of insulin glulisin and soluble human insulin administered subcutaneously at a dose of 0.15 U / kg at different times with respect to the standard 15-minute meal were evaluated. The results of the study showed that insulin glulisin introduced 2 minutes before meals provided the same glycemic control after eating as soluble human insulin, administered 30 minutes before meals.When administered 2 min before meals insulin glulisin provided better glycemic control after eating than soluble human insulin, administered 2 minutes before meals. Insulin Glulisin, administered 15 minutes after the start of food intake, gave the same glycemic control after eating as soluble human insulin administered 2 minutes before meals.

Phase I study with insulin glulisin, insulin lispro and soluble human insulin in a group of obese patients showed that in these patients insulin glulisin retains its fast-response characteristics. In this study, the time to reach 20% of the total AUC was 114 min for glulisin insulin, 121 min for insulin lispro and 150 min for soluble human insulin, a AUC(0-2 h), reflecting also the early glucose-lowering activity, respectively was 427 mg / kg for insulin glulisin, 354 mg / kg for insulin lispro, and 197 mg / kg for soluble human insulin.

Clinical researches

Type 1 diabetes mellitus

In a 26-week phase III clinical trial comparing insulin glulisin with insulin lispro, injected subcutaneously shortly before meals (0-15 min) in patients with type 1 diabetes mellitus using basal insulin insulin glargine, insulin glulisin was comparable with insulin lizpro for glycemic control, which was estimated from a change in the concentration of glycosylated hemoglobin (HbA1c) at the time of the end point of the study in comparison with the outcome. Comparable values ​​of blood glucose concentration determined by self-monitoring were observed. With the introduction of insulin glulisine, unlike the treatment with insulin lyspro, did not require an increase in the dose of basal insulin.

A 12-week clinical phase III study conducted in patients with type 1 diabetes who received basal therapy insulin glargine, showed that the effectiveness of insulin glulisin immediately after meals was comparable to that of insulin glulisin just before meals (0-15 min) or soluble human insulin (30-45 min before meals).

In the population of patients who completed the study protocol, in the group of patients who received food before meals insulin glulisin, a significantly greater decrease in HbA1C compared with the group of patients receiving soluble human insulin.

Diabetes mellitus type 2

A 26-week phase III clinical trial followed by a 26-week follow-up as a safety study was conducted to compare glulisin insulin (0-15 minutes before meals) with soluble human insulin (30-45 minutes before meals), which were administered subcutaneously in patients with type 2 diabetes, except for using insulin-isophane as a basal insulin. The average body mass index of patients was 34.55 kg / m2. Insulin Glulisin showed a greater decrease in the concentration of HbA1C of the initial value compared to soluble human insulin (0.46% for glulisin insulin and 0.30% for soluble human insulin, p = 0.0029). In this study, the majority of patients (79%) mixed their short-acting insulin with insulin-isophane immediately before injection. 58 patients at the time of randomisation used oral hypoglycemic and received instructions to continue taking them at the same (unchanged) dose.

In conducting continuous subcutaneous insulin infusion via pump means (diabetes mellitus type 1) in 59 patients treated with the drug or insulin aspart APIDRA® in both treatment groups was observed low incidence of catheter occlusion (0.08 occlusion per month in the application preparation APIDRA® and 0.15 occlusion per month with insulin aspart), and the frequency of such reactions at the injection site (10.3% with APIDRA® preparation and 13.3% with insulin aspart).

In children and adolescents with type 1 diabetes mellitus, who received basal insulin once a day at night insulin glargine or twice a day, morning and evening, isophane insulin, when comparing the efficacy and safety of insulin glulisine and insulin lispro when administered subcutaneously 15 minutes before a meal, it was shown that glycemic control, the incidence of hypoglycemia, require the intervention of third parties, and and the incidence of severe hypoglycemic episodes were comparable in both treatment groups. However, after 26 weeks of treatment in patients treated with insulin glulizine to achieve glycemic control, comparable to insulin, lyspro,a significantly smaller increase in daily doses of basal insulin, fast acting insulin and total insulin dose was required.

Racial origin and gender

In controlled clinical studies in adults, there was no difference in the safety and efficacy of glulisin insulin in the analysis of subgroups isolated by race.

Pharmacokinetics:

In insulin glulisine, the substitution of the amino acid asparagine of human insulin at position B3 for lysine and lysine at position B29 for glutamic acid promotes faster absorption.

Absorption and bioavailability

The pharmacokinetic concentration-time curves in healthy volunteers and patients with type 1 and type 2 diabetes demonstrated that the absorption of glulisin insulin compared to soluble human insulin was approximately 2 times faster, and the maximum plasma concentration achieved (CmOh) was approximately 2 times greater.

In a study conducted in patients with type 1 diabetes, after subcutaneous administration of insulin glulisin at a dose of 0.15 U / kg, TmOh (the time of the maximum plasma concentration) was 55 minutes, and CmOh was 82 ± 1.3 μED / ml compared to TmOh, which is 82 minutes, and CmOh, 46 ± 1.3 μED / ml, for soluble human insulin. The mean residence time in the systemic bloodstream of insulin glulisin was shorter (98 minutes) than that of soluble human insulin (161 minutes).

In a study in patients with type 2 diabetes mellitus after subcutaneous administration of insulin glulisin at a dose of 0.2 U / kg CmOh was 91 μED / ml with interquartile latitude from 78 to 104 μDU / ml.

With subcutaneous administration of glulisin insulin to the anterior abdominal wall, hip or shoulder region (to the deltoid muscle region), absorption was faster when injected into the anterior abdominal wall area as compared with the administration of the drug to the thigh area. The rate of absorption from the deltoid muscle region was intermediate. The absolute bioavailability of glulisin insulin after subcutaneous administration was approximately 70% (73% of the anterior abdominal wall area, 71 of the deltoid region and 68% of the thigh area) and had low variability in different patients.

Distribution and deduction

The distribution and excretion of insulin glulisin and soluble human insulin after intravenous administration are similar, with distribution volumes of 13 liters and 22 liters and half-lives,which are 13 and 18 minutes respectively.

After subcutaneous administration insulin glulisin is excreted faster than soluble human insulin, with an apparent half-life of 42 minutes, compared to an apparent half-life of soluble human insulin of 86 minutes. In a cross-sectional analysis of studies of insulin glulisin, both in healthy individuals and in individuals with type 1 and type 2 diabetes, the apparent half-life was in the range of 37 to 75 minutes.

Special patient groups

Patients with renal insufficiency

In a clinical study conducted in individuals without diabetes mellitus with a wide range of renal functional status (creatinine clearance> 80 ml / min, 30-50 ml / min, <30 ml / min), the overall rapidity of the insulin glulisin effect persisted . However, the need for insulin in the presence of renal insufficiency can be reduced.

Patients with hepatic insufficiency

In patients with impaired hepatic function, pharmacokinetic parameters were not studied.

Elderly people

There are very limited data on the pharmacokinetics of insulin glulisin in elderly patients with diabetes mellitus.

Children and teens

Pharmacokinetic and pharmacodynamic properties of glulisin insulin have been studied in children (7-11 years) and adolescents (12-16 years old) with type 1 diabetes mellitus. In both age groups insulin glulisin quickly absorbed with TmOh and CmOh similar to those of adults. As in adults when administered immediately before a meal test insulin glulisin provides better control of blood glucose after eating than soluble human insulin. Increased blood glucose after eating (AUC 0-6 hours the area under the curve of the blood glucose concentration (time from 0 to 6 hours) was 641 mg / (h * dL) for insulin glulisin and 801 mg / (h * dL) for soluble human insulin.

Indications:

Diabetes mellitus, requiring insulin treatment, in adults, adolescents and children older than 6 years.

Contraindications:

Hypersensitivity to insulin glulisin or to any of the components of the drug.

Hypoglycemia.

Carefully:

During pregnancy.

Pregnancy and lactation:

Pregnancy

There are no controlled clinical studies on the use of the drug Apidra® in pregnant women.

A limited amount of data obtained from the use of glulisin insulin in pregnant women (reported less than 300 pregnancies) does not indicate its adverse effect on pregnancy, intrauterine fetal development, or on a newborn baby.

Reproductive animal studies did not reveal any differences between insulin glulisin and human insulin in relation to pregnancy, fetal / fetal development, childbirth and postnatal development. Use of the drug Apidra® SoloStar® in pregnant women should be done with caution.

A careful monitoring of the concentration of glucose in the blood and maintenance of glycemic control.

Patients with pre-pregnancy or gestational diabetes mellitus need to maintain glycemic control throughout their entire pregnancy. During the first trimester of pregnancy, the need for insulin can decrease, and during the second and third trimesters, it can usually increase. Immediately after delivery, the need for insulin rapidly decreases.

Breastfeeding period

Unknown, excreted or not insulin glulisin in breast milk.

Women in the period of breastfeeding may need to adjust the dosage regimen of insulin and diet.

Dosing and Administration:

The drug Apidra® SoloStar® should be administered shortly (0-15 minutes) before or soon after eating. The drug Apidra® SoloStar® should be used in treatment regimens that include either medium-term insulin or long-acting insulin or a long-acting insulin analogue. In addition, the drug Apidra® SoloStar® can be used in combination with oral hypoglycemic drugs.

Dosing regimen of the drug Apidra® SoloStar® is selected individually.

Administration of the drug

The drug Apidra® SoloStar® is administered by subcutaneous injection.

Subcutaneous injections of the drug Apidra® SoloStar® should be performed in the area of ​​the anterior abdominal wall, shoulder or thigh. The injection sites within the above-mentioned areas (anterior abdominal wall, thigh or shoulder) should alternate with each new administration of the drug. The absorption rate and, correspondingly, the beginning and duration of the action can be influenced by: the site of injection, physical stress and other changing conditions.Subcutaneous injection into the abdominal wall provides for a somewhat faster absorption than administration to the other abovementioned parts of the body (see Pharmacokinetics section).

Precautions should be taken to ensure that the preparation does not enter the blood vessels directly. After the administration of the drug, massage of the area of ​​administration can not be performed. Patients should be trained in the correct technique of injection.

Mixing with insulin for subcutaneous injection

The drug Apidra® can be mixed with human insulin-isophane. When mixing the drug Apidra® with human insulin-isophane, the Apidra® preparation must be injected into the syringe first. Subcutaneous injection should be performed immediately after mixing.

Mixed above insulin can not be administered intravenously.

The use of Apidra® with a pump device for continuous subcutaneous insulin infusion

The Apidra® preparation can also be administered by a pump device for continuous subcutaneous insulin infusion. If necessary, the Apidra® preparation can be removed from the Apidra® SoloStar® syringe cartridge and beIt is used for insertion with a pump device for continuous subcutaneous insulin infusion.

In this case, the infusion set and the tank used with the Apidra® preparation should be replaced with aseptic rules, at least every 48 hours. These recommendations may differ from the general instructions in the manuals for the use of pump devices. It is important that patients follow the above-mentioned special instructions for the use of the drug Apidra®. Failure to comply with these special instructions for the use of the drug Apidra® can lead to the development of serious adverse events.

When using the Apidra® preparation with a pump device for continuous subcutaneous insulin infusion, it should not be mixed with other insulins or solvents.

Patients to whom Apidra® is administered by continuous subcutaneous infusion should have alternative systems for insulin administration and should be trained to administer insulin by subcutaneous injection (in the event of a breakdown of the pump device used). When using Apidra® with pump devices for continuous subcutaneous insulin infusion,failure of the infusion set or mistakes in handling them can quickly lead to the development of hyperglycemia, ketosis and diabetic ketoacidosis. In the case of hyperglycemia or ketosis or diabetic ketoacidosis, rapid identification and elimination of the causes of their development is required.

It is necessary to strictly follow the instructions for the correct handling of the pre-filled SoloStar® syringe pen (see "Instructions for use and handling of the pre-filled SoloStar® syringe pen").

Special patient groups

Impaired renal function

The need for insulin in renal failure may be reduced.

Impaired liver function

In patients with impaired liver function, the need for insulin may decrease due to reduced ability to gluconeogenesis and slowing down the metabolism of insulin.

Elderly patients

The available data on the pharmacokinetics in elderly patients with diabetes mellitus are inadequate.

Impaired renal function in the elderly can lead to a decrease in the need for insulin.

Children and teens

The drug Apidra ® can be used in children over 6 years and adolescents.Clinical information on the use of the drug in children younger than 6 years is limited.

Side effects:

The undesirable reactions observed were reactions known to this pharmacological class and, therefore, are common to any insulin.

Disorders from the metabolism and nutrition

Hypoglycemia, the most frequent undesirable effect of insulin therapy, can occur if too high doses of insulin are used, exceeding the need for it.

Symptoms of hypoglycemia usually develop suddenly. However, usually neuroleptic neuropsychiatric disorders (fatigue, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) are preceded by symptoms of adrenergic (activation of the sympathetic adrenal system in response to hypoglycemia): hunger, irritability, nervous excitement or tremor, anxiety, pale skin, "cold" sweat, tachycardia, marked palpitation (the faster the hypoglycemia develops and the harder it is, the stronger symptoms of adrenergic counterregulation are expressed).Episodes of severe hypoglycemia, especially recurrent, can lead to damage to the nervous system. Long and pronounced hypoglycemia can threaten the lives of patients, as with the growth of hypoglycemia, even a fatal outcome is possible.

Immune system disorders

Local hypersensitivity reactions to insulin

Local reactions of hypersensitivity may occur (hyperemia, swelling and itching at the injection site of insulin). These reactions usually disappear after a few days or weeks of use. In some cases, these reactions may not be associated with insulin, but are caused by skin irritation caused by antiseptic treatment before injection or incorrect subcutaneous injection (if the correct technique for subcutaneous injection is violated).

Systemic hypersensitivity reactions to insulin

Such reactions to insulin (including insulin glulisin) can, for example, be accompanied by the appearance of rashes all over the body (including accompanied by itching), feelings of tightness in the chest, suffocation, lowering blood pressure, increased heart rate or excessive sweating.Severe cases of generalized allergies, including anaphylactic reactions, can threaten the patient's life.

Disturbances from the skin and subcutaneous tissue

Lipodystrophy

As with any other insulin, lipodystrophy can develop at the injection site, which can slow the absorption of insulin. The development of lipodystrophy can contribute to the violation alternation of places of introduction of insulin, since the introduction of the drug in the same place can contribute to the development of lipodystrophy.

The constant alternation of injection sites within one of the injection areas (thigh, shoulder, front surface of the abdominal wall) can help reduce and prevent the development of this undesirable reaction.

Other

It was reported about the accidental administration of other insulins by mistake, especially long-acting insulin, instead of insulin glulisin.

Overdose:

With an excess of insulin in relation to the need for it, determined by food intake and energy expenditure, hypoglycemia may develop.

There are no specific data on glutamine insulin overdose. However, with its overdose it is possible to develop hypoglycemia.

Episodes of mild hypoglycemia can be stopped by taking glucose or foods containing sugar. Therefore, it is recommended that patients with diabetes always have pieces of sugar, sweets, biscuits or sweet fruit juice.

Episodes of severe hypoglycemia with coma, convulsions and neurological disorders can be stopped by intramuscular or subcutaneous injection of 0.5-1 mg of glucagon or by intravenous administration of a concentrated (20%) solution of dextrose (glucose) by a medical professional.

After restoration of consciousness it is recommended to give the patient carbohydrates inside to prevent the recurrence of hypoglycemia, which is possible after apparent clinical improvement.

After the introduction of glucagon, to establish the cause of this severe hypoglycemia and prevent the development of other similar episodes, the patient should be observed in the hospital.

Interaction:

Studies on pharmacokinetic interactions were not performed. Based on the available empirical knowledge in relation to other similar drugs, the emergence of clinically relevant pharmacokinetic interactions is unlikely.Some drugs can affect glucose metabolism, which may require correction of glulisine insulin doses and especially careful monitoring of treatment.

To substances that can increase the hypoglycemic action of insulin and increase the predisposition to hypoglycemia include: oral hypoglycemic agents, inhibitors angiotensin-converting enzyme, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antimicrobial agents.

To substances that can reduce the hypoglycemic action of insulin, include: glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics (for example, epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, estrogens, gestagens (for example, in hormonal contraceptives), protease inhibitors and atypical antipsychotics (eg, olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts or ethanol can either potentiate or weaken the hypoglycemic action of insulin.Pentamidine may cause hypoglycemia followed by hyperglycaemia.

In addition, under the influence of medicines with sympatholytic activity, such as beta-blockers, clonidine, guanethidine and reserpine, symptoms of reflex adrenergic activation in response to hypoglycemia may be less pronounced or absent.

Compatibility Guidelines

Due to the lack of compatibility studies, insulin glulisin should not be mixed with any other medicines, with the exception of human insulin-isophane.

With the introduction of The infusion pump device Apidra® should not be mixed with solvents and other insulin preparations.

Special instructions:

Transfer of the patient to a new type of insulin or another manufacturer's insulin should be carried out under strict medical supervision, since a change in dosage may be required due to a change in the concentration of insulin, a brand (manufacturer), type of insulin (soluble, insulin-isophane, etc.) insulin (animal origin) and / or mode of production.In addition, correction of concomitant oral hypoglycemic therapy may be required. The use of inadequate insulin doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis - conditions that are potentially life threatening.

Hypoglycaemia

The time through which hypoglycemia develops depends on the rate of onset of the effect of the insulin used and, in this connection, can change with a change in the treatment regimen. Conditions that can change or make less pronounced precursors of hypoglycaemia include: the long existence of diabetes, the intensification of insulin therapy, the presence of diabetic neuropathy, the use of certain medications such as beta-blockers, or the transfer of a patient from animal insulin to human insulin.

Correction of insulin doses may also be required if patients increase physical activity or change their usual eating patterns. Physical exercise performed immediately after a meal can increase the risk of developing hypoglycemia.Compared to soluble human insulin, hypoglycemia may develop earlier after the injection of fast acting insulin analogues.

Uncompensated hypoglycemic or hyperglycaemic reactions can lead to loss of consciousness, coma development or death.

The need for insulin can change with diseases or emotional overload.

Instructions for use and handling of a pre-filled syringe pen SoloStar®

Before the first use, the syringe pen should be held at room temperature for 1-2 hours.

Before use, inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, contains no visible solid particles and resembles water in a consistency.

Empty SoloStar® pen need not be reused and must be destroyed.

To prevent infection, a pre-filled syringe pen should only be used by one patient and not transferred to another person.

Handling of the SoloStar® syringe handle

Carefully read the usage information before using the SoloStar® pen.

Important information on using the syringe pen SoloStar®

Before each use, use caution connect a new needle to the syringe pen and conduct a safety test. Use only needles that are compatible with the SoloStar® syringe handle.

It is necessary to take special precautions to avoid accidents involving the use of a needle and the possibility of infection transmission.

Do not use the SoloStar® pen if it is damaged or if you are not sure that it will work properly.

Always have a spare SoloStar® pen in case you lose or damage your a copy of the SoloStar® pen.

Storage Instruction

Please read the "Storage conditions" section for the storage rules for the SoloStar® pen.

If the SoloStar® pen is stored in the refrigerator, remove it from there 1-2 hours before the proposed injection so that the solution will take up room temperature. The introduction of chilled insulin is more painful.

Used syringe pen SoloStar® must be destroyed.

Caring for the syringe handle SoloStar®

The SoloStar® syringe handle must be protected from dust and dirt. The outer side of the SoloStar® pen can be cleaned by wiping it with a damp cloth.

Do not immerse in liquid, do not rinse or lubricate the SoloStar® syringe, as this can damage it.

Syringe handle SoloStar® precisely doses insulin and is safe in work. It also requires careful handling. Avoid situations in which the SoloStar® pen can be damaged. If you suspect that your copy of the SoloStar® pen can be damaged, use a new syringe pen.

Stage 1. Insulin control

It is necessary to check the label on the SoloStar® syringe pen to ensure that it contains the appropriate insulin. For the preparation of Apidra®, the SoloStar® syringe pen is blue with a dark blue button with a relief ring for injection. After removing the cap of the syringe-pen, monitor the appearance of the insulin contained in it: the insulin solution must be transparent, colorless, free of visible solid particles and resemble water in a consistency.

Stage 2. Connecting the needle

Use only needles that are compatible with the SoloStar® syringe handle.

For each subsequent injection, a new sterile needle. After removing the cap, the needle should be carefully installed on the syringe pen.

Step 3. Performing a safety test

Before each injection, a safety test must be carried out and make sure that the syringe pen and needle work well and air bubbles are removed.

Measure the dose equal to 2 units. The outer and inner needle caps must be removed.

With the needle pen up, gently tap the cartridge with the insulin finger so that all air bubbles are directed toward the needle. Fully press the injection injection button.

If insulin appears at the tip of the needle, it means that the pen and needle work correctly.

If no insulin appears on the tip of the needle, stage 3 can be repeated until insulin appears on the tip of the needle.

Stage 4. Dose selection

The dose can be set to an accuracy of 1 unit from a minimum dose of 1 unit to a maximum dose of 80 units. If you need to enter a dose, exceeding 80 units, two or more injections should be given.The dosage window should indicate "0" after the completion of the safety test. After this, the required dose can be set.

Stage 5. Dosing Introduction

The patient should be informed about the technology injection by a medical professional.

The needle must be inserted under the skin. The injection button must be pressed completely. It is held in this position for another 10 seconds until the needle is removed. Thus, the introduction of the selected of the insulin dose completely.

Stage 6. Extraction and ejection of a needle

In all cases, the needle after each injection should be removed and discarded. This ensures the prevention of contamination and / or infection, air entering the insulin tank and leakage of insulin.

When removing and ejecting a needle, special precautions. Observe the recommended safety measures for removing and disposing of needles (for example, the technique of putting the cap on with one hand) in order to reduce the risk of accidents involving the use of the needle, and to prevent infection.

After removing the needle, close the SoloStar® penwith a lintel.

Effect on the ability to drive transp. cf. and fur:

Hyperglycemia and hypoglycemia, as well as visual disorders that occur during their development, can worsen the ability to concentrate and slow the patient's psychomotor reactions. This may pose a risk when driving vehicles and engaging in other potentially hazardous activities. This is especially dangerous in patients who are weakened or have no symptoms predicting the development of hypoglycemia, or who have frequent episodes of hypoglycemia. This should be taken into account in each specific case to decide whether the patient is able or not to drive and engage in other potentially hazardous activities.

Patients should be advised during the management of vehicles to take precautions in order to avoid the possibility of developing hypoglycemia.

Form release / dosage:

Solution for subcutaneous administration, 100 U / ml.

Packaging:

3 ml of the drug in a cartridge of clear, colorless glass (type I). The cartridge is sealed on one side with a cork and crimped with an aluminum cap, on the other hand - by a plunger.

The cartridge is mounted in a disposable syringe pen SoloStar®. 5 SoloStar® syringe pens along with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Keep out of the reach of children.

The Apidra® SoloStar® syringe can not be cooled before use (the injection of the cooled solution is more painful).

After the start of the use, the disposable syringe Apidra® SoloStar® should be stored at a temperature not higher than 25 ° C in a place inaccessible to children, and protected from light.

Shelf life:

2 years.

After the expiration date, the drug can not be used.

Shelf life of the drug in a disposable syringe pen Apidra® SoloStar® after the first use is 4 weeks. It is recommended to mark the date of the first injection of the drug on the label.

Terms of leave from pharmacies:On prescription
Registration number:LSR-007048/09
Date of registration:07.09.2009 / 04.10.2013
Expiration Date:Unlimited
The owner of the registration certificate:Sanofi-Aventis Deutschland GmbHSanofi-Aventis Deutschland GmbH Germany
Manufacturer: & nbsp
Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
Information update date: & nbsp08.09.2017
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