Instruction for use: Apidra SoloStar

Active substance Insulin glulisine

ATX codeA10AB06 Insulin glulisine

Pharmacological group of substance Calcitonin

Insulins

Nosological classification (ICD-10)

E10 Insulin-dependent diabetes mellitus

Decompensation of carbohydrate metabolism, Diabetes mellitus, Diabetes insulin sugar, Diabetes mellitus type 1, Diabetic ketoacidosis, Insulin-dependent diabetes, Insulin-dependent diabetes mellitus, Coma hyperosmolar non-ketoacidotic, Labile form of diabetes mellitus, Violation of carbohydrate metabolism, Type 1 diabetes mellitus, Type I diabetes mellitus, Insulin-dependent diabetes mellitus, Type 1 diabetes mellitus

Composition

Solution for subcutaneous administration, 100 units / 1 ml 1 ml

active substance:

Insulin glulisine 100 U (3.49 mg)

Auxiliary substances: metacresol (m-cresol); Trometamol (tromethamine); sodium chloride; Polysorbate 20; Sodium hydroxide; Hydrochloric acid; water for injections

Description of dosage form

Transparent, colorless or almost colorless liquid.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

Insulin glulisin is a recombinant analog of human insulin, which by force of action is equal to the normal human insulin. Insulin glulisin starts 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 and proteolysis and increases protein synthesis. Studies conducted in healthy volunteers and patients with diabetes mellitus have shown that when insulin is injected with insulin glulisin begins to act faster and has a shorter duration of action than soluble human insulin. With n / to the introduction of lowering blood glucose in the blood, the effect of glulisin insulin begins in 10-20 minutes. With intravenous administration, the effects of lowering 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, patients with type 1 diabetes mellitus were assessed for glucose-lowering profiles of glulisin insulin and soluble human insulin administered SC at a dose of 0.15 U / kg at different times with respect to the standard 15-minute meal.

The results of the study showed that insulin glulisine, administered 2 minutes before a meal, provided the same glycemic control after meals as the soluble human insulin administered 30 minutes before meals. When administered 2 minutes 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 meals as the soluble human insulin administered 2 minutes before meals.

Obesity. Phase I study, conducted with insulin glulisin, insulin lispro and soluble human insulin in a group of obese patients, demonstrated that in these patients, insulin glulisin retained its fast-acting 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, and AUC (0-2 h), also reflecting early glucose-lowering activity, was 427 Mg / kg for glulisin insulin, 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 administered shortly before meals (0-15 min) in patients with type 1 diabetes using basal insulin Insulin glargine, insulin glulisin was comparable to insulin lyspro for glycemic control, which was estimated from a change in the concentration of glycosylated hemoglobin (HbA1C) at the endpoint of the study compared to the outcome. Comparable values of blood glucose, determined by self-monitoring, were observed. With the introduction of insulin glulisine, unlike the treatment with insulin lizpro, did not require an increase in the dose of basal insulin.

A 12-week Phase III clinical trial in patients with type 1 diabetes treated as basal insulin glargine showed that the effectiveness of insulin glulisin immediately after meals was comparable to that of glulisin insulin just before meals (0 -15 min) or soluble human insulin for 30-45 minutes before meals.

In a population of patients who completed the study protocol, a significantly greater decrease in HbA1C was observed in the group of patients who received pre-meal insulin glulisin compared to the group of patients receiving soluble human insulin.

Type 2 diabetes mellitus. 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 min before meals) with soluble human insulin (30-45 Min before meals), which were administered to patients with type 2 diabetes mellitus, besides using basal 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 from baseline compared to soluble human insulin (-0.46% for glulisin insulin and -0.30% for soluble human insulin, p = 0.0029). In this study, most patients (79%) mixed their short-acting insulin with insulin-isophane immediately before injection. At the time of randomisation, 58 patients used oral hypoglycemic drugs and received instructions to continue their use at the same dose.

When performing continuous infusion of insulin with a pump device (for type 1 diabetes mellitus), in 59 patients treated with Apidra® or insulin aspart, a low incidence of occlusion of the catheter (0.008 occlusions per month with Apidra ® and 0.15 occlusions per month with the use of insulin aspart), and a similar frequency of reactions at the site of administration (10.3% with Apidra® and 13.3% with insulin aspart).

In children and adolescents with type 1 diabetes mellitus, insulin glargine or twice daily in the morning and evening insulin-isophane was administered as basal insulin in the evening, when comparing the efficacy and safety of insulin glulisin and insulin lispro at their n / 15 minutes before meals, glycemic control, the incidence of hypoglycemia requiring third-party intervention, and the incidence of severe hypoglycemic episodes were comparable in both treatment groups. However, after 26 weeks of treatment, patients who received insulin glulisin treatment required a significantly lower increase in daily doses of basal insulin, fast-acting insulin, and total insulin dose to achieve glycemic control comparable to insulin lyspro.

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

Pharmacokinetics

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

Absorption and bioavailability. The pharmacokinetic curves of AUC 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 about 2 times faster, reaching up to twice the C max.

In a study in patients with type 1 diabetes mellitus, after glucosin insulin administration at a dose of 0.15 U / kg, Tmax was 55 min after the insulin administration, and Cmax in plasma was (82 ± 1.3) μED / ml compared to With Tmax of 82 min and Cmax of (46 ± 1.3) μED / ml, for soluble human insulin. The mean residence time in the systemic circulation of glulisin insulin was shorter (98 min) than for normal human insulin (161 min).

In a study in patients with type 2 diabetes mellitus, after glucosin insulin administration at a dose of 0.2 U / kg C max was 91 μED / ml with interquartile latitude from 78 to 104 μED / ml.

With n / to the introduction of glulisin insulin into the anterior abdominal wall, thigh or shoulder (deltoid muscle region), absorption was faster when inserted into the anterior abdominal wall as compared with the introduction of the drug into the thigh. The rate of absorption from the deltoid muscle region was intermediate. The absolute bioavailability of glulisin after the SC administration was approximately 70% (73 - from the anterior abdominal wall area, 71 - from the deltoid muscle region, 68% from the femur region) at different places of administration was similar and had low variability between different patients.

Distribution and elimination. The distribution and excretion of insulin glulisin and soluble human insulin after iv administration are similar to the distribution volumes of 13 and 22 L and T1 / 2 of 13 and 18 minutes, respectively.

After insulin administration, glulisin is excreted faster than soluble human insulin with an apparent T1 / 2 of 42 minutes, compared to the apparent T1 / 2 soluble human insulin of 86 minutes. In a cross-sectional analysis of studies of insulin glulisin in both healthy individuals and in individuals with type 1 and type 2 diabetes, the apparent T1 / 2 was in the range of 37 to 75 minutes.

Special patient groups

Renal insufficiency. In a clinical study conducted in individuals without diabetes mellitus with a wide range of renal functional status (Cl creatinine> 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.

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

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

Children and teenagers. Pharmacokinetic and pharmacodynamic properties of glulisin insulin have been studied in children (7-11 years old) and adolescents (12-16 years old) with type 1 diabetes mellitus. In both age groups, glulisin is rapidly absorbed with Tmax and Cmax, similar to those in adults. As in adults, when administered immediately before a test meal with insulin glulisine provides better control of blood glucose levels after meals, than soluble human insulin. The increase in blood glucose concentration after meal (AUC0-6 h - the area under the curve of blood glucose concentration - time from 0 to 6 h) was 641 mg / h × dL for glulisin insulin and 801 mg / h × dL for soluble human Insulin.

Indications

Diabetes mellitus, requiring insulin treatment, in adults, adolescents and children over 6 years of age.

Contraindications

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

Hypoglycemia.

Caution should be used in pregnant women.

pregnancy and lactation

There is insufficient information on the use of glulisin insulin 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. Animal reproductive studies have not revealed any difference 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 the maintenance of glycemic control are mandatory.

Patients with existing prior to pregnancy or gestational diabetes need throughout pregnancy maintain glycemic control. During I trimester of pregnancy the need for insulin can be reduced, and during trimesters II and III it can usually increase. Immediately after delivery, the need for insulin rapidly decreases.

It is not known whether insulin glulisin is excreted into breast milk. For women during breastfeeding, it may be necessary to adjust the dosage regimen of insulin and diet.

Side effects

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

On the part of metabolism and nutrition: hypoglycemia, the most frequent undesirable effect of insulin therapy, may occur in the case of very high doses of insulin in excess of the need for it.

Symptoms of hypoglycemia usually develop suddenly. However, usually neuropsychiatric disorders due to neuroglycopenia (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 counterregulation (activation of sympathetic adrenal System in response to hypoglycemia): hunger, irritability, nervous excitement or tremor, restlessness, pallor of the skin, cold sweat, tahika Diya expressed palpitations (faster than developing hypoglycaemia and the heavier it is, the signs of adrenergic kontrregulyatsii more pronounced).

Episodes of severe hypoglycemia, especially recurrent, can lead to damage to the nervous system. Long and severe hypoglycemia can endanger the lives of patients, With the growth of hypoglycemia, even a fatal outcome is possible.

Immune system: local hypersensitivity reactions to insulin (redness, swelling and itching at the site of insulin injections). 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 injecting or improperly performing SC injection (if the correct technique for performing SC 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 itching), feelings of tightness in the chest, suffocation, lowering blood pressure, increased pulse or excessive sweating. Severe cases of generalized allergies, including anaphylactic reactions, can endanger the patient's life.

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 be facilitated by the violation of the alternation of insulin injection sites, because The introduction of the drug in the same place may contribute to the development of lipodystrophy. The constant alternation of injection sites within one of the areas of administration (thigh, shoulder, front surface of the abdominal wall) can help reduce and prevent the development of this undesirable reaction.

Other: it was reported that other insulins were accidentally introduced by mistake, especially long-acting insulins, instead of insulin glulisin.

Interaction

Studies on the pharmacokinetic interaction were not conducted. Based on the available empirical knowledge regarding other similar drugs, the appearance of clinically significant pharmacokinetic interaction is unlikely. Some substances 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, angiotensin converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antimicrobials.

To substances that can reduce the hypoglycemic action of insulin, include: GCS, danazol, diazoxide, diuretics, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics (eg epinephrine (adrenaline), salbutamol, terbutaline), thyroid hormones, estrogens, progestins (eg in oral Contraceptive agents), protease inhibitors and antipsychotic drugs (eg olanzapine and clozapine).

Beta-adrenoblockers, clonidine, lithium salts or alcohol can either potentiate or weaken the hypoglycemic action of insulin. Pentamidine may cause hypoglycemia with subsequent hyperglycaemia.

In addition, under the influence of such drugs with sympatholytic activity, like beta adrenoblockers, clonidine, guanethidine and reserpine, symptoms of reflex adrenergic activation may be less pronounced or absent.

Compatibility Guidelines

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

When administered with an infusion pump, the Apidra® SoloStar® preparation should not be mixed with other drugs.

Dosing and Administration

P / c, not for long (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 preparation of Apidra® SoloStar® can be used in combination with oral hypoglycemic agents.

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

Administration of the drug

The drug Apidra® SoloStar® is injected either by injection or by continuous infusion into the subcutaneous fat tissue using a pump system.

The injections of the drug Apidra® SoloStar® should be made in the area of the anterior abdominal wall, shoulder or thigh, and the introduction of the drug by continuous infusion into the subcutaneous fat is produced in the region of the anterior abdominal wall. The injection sites and the infusion site in the above areas (anterior abdominal wall, hip or shoulder) should alternate with each new administration of the drug. The absorption rate and, accordingly, the beginning and duration of the action can be influenced by: the site of injection, physical stress and other changing conditions. A / c the introduction into the abdominal wall provides for a somewhat faster absorption than the introduction into the other abovementioned parts of the body (see the section "Pharmacokinetics").

Precautions should be taken to ensure that the drug 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 proper injection techniques.

Mixing with insulins

The drug Apidra® SoloStar® should not be mixed with any other drug other than human insulin-isophane.

When mixing Apidra® with human insulin-isophane, the Apidra® preparation should be syringed first. S / injection should be done immediately after mixing. Mixed above insulin can not be administered iv.

Pump device for continuous infusion of infusion

When using the drug Apidra® SoloStar® with a pump system for insulin infusion, it should not be mixed with other drugs.

The Apidra® preparation can also be administered with a pump device to conduct a continuous infusion of insulin. If necessary, the Apidra® preparation can be removed from the Apidra® SoloStar® pen syringe cartridge and used for insertion with a pump device for continuous insulin infusion.

The infusion set and reservoir used with the Apidra® preparation must 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 Apidra® with a pump device for continuous insulin infusion, it should not be mixed with other insulins or solvents.

Patients to whom Apidra® is administered by continuous infusion should have alternative systems for insulin administration and should be trained to administer insulin by injection (in the event of a breakdown of the pump device used).

When using Apidra® with pump devices for continuous insulin infusion, disrupting the pump device, malfunctioning infusion set, or mistakes in handling them can quickly lead to 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 pre-filled syringes (see section "Instructions for use and circulation").

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

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, free of visible solids 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

Before using the SoloStar® pen, you should read the instructions for use carefully.

Important information on using the SoloStar® pen

Before each use, it is necessary to carefully connect a new needle to the syringe pen and conduct a safety test. It is necessary to use only needles compatible with SoloStar®.

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

Do not use the SoloStar® pen when it is damaged or if it is not certain that it will work properly.

Always have a spare SoloStar® pen in case of loss or damage to the used specimen.

Storage Instruction

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

The used SoloStar® pen must be destroyed.

Exploitation

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, rinse and lubricate the SoloStar® syringe handle, as this can damage it.

The syringe handle SoloStar® precisely doses insulin and is safe in operation. It also requires careful handling. Avoid situations in which the SoloStar® pen can be damaged. If there is a suspicion that a copy of the SoloStar® pen can be damaged, it is necessary to use a new pen syringe.

Stage 1. Insulin control

It is necessary to check the label on the SoloStar® syringe pen to ensure that it contains the appropriate insulin. After removing the cap of the syringe pen, the appearance of the insulin contained in it is controlled: 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 pen.

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

Stage 3. Safety test

Before each injection, a safety test must be carried out and the syringe and needle should work well and air bubbles be 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 the air bubbles move toward the needle.

Press (fully) on the injection injection button.

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

If the appearance of insulin at the tip of the needle is not observed, then stage 3 is repeated until insulin appears on the tip of the needle.

Stage 4. Dose selection

The dose can be established with an accuracy of 1, from the minimum dose (1 U) to the maximum (80 U). If it is necessary to enter a dose exceeding 80 units, two or more injections should be given.

The dosage window should indicate "0" after the safety test is completed. After that, the required dose can be set.

Stage 5. Dosing Introduction

The patient should be informed about the technique of 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 a selected dose of insulin is ensured completely.

Stage 6. Extraction and ejection of a needle

In all cases, after each injection, the needle 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 discarding the needle, special precautions must be taken. 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® syringe with the cap.

Special patient groups

Impaired renal function. The need for insulin in renal failure may be reduced.

Violation of the function of the liver. 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.

Patients of advanced age. The available data on pharmacokinetics in elderly patients with diabetes mellitus are inadequate. Violation of kidney function in old age can lead to a decrease in the need for insulin.

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

Overdose

Symptoms: with an excess of insulin in relation to the need for it, determined by food intake and energy consumption, hypoglycemia may develop.

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

Treatment: 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 during which the patient loses consciousness can be stopped by intramuscular injection or by injection of 0.5-1 mg of glucagon, which is produced by the person receiving the appropriate instructions, or / in the administration of dextrose ( Glucose) by a medical professional. If the patient does not respond to the administration of glucagon within 10-15 minutes, it is also necessary to administer dextrose IV.

After restoration of consciousness it is recommended to give the patient carbohydrates inside to prevent recurrence of hypoglycemia.

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

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, as. May require a change in dosage due to a change in the concentration of insulin, the brand (manufacturer), the type of insulin (soluble, insulin-isophane, etc.), the type of 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.

Hypoglycemia. The time through which hypoglycemia develops depends on the speed of onset of the effect of the insulin used and, in connection with this, can change with a change in the treatment regimen. Conditions that can change or make less pronounced precursors of hypoglycemia include: the long existence of diabetes mellitus, the intensification of insulin therapy, the presence of diabetic neuropathy, the intake 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 with soluble human insulin after the injection of high-speed insulin analogs, hypoglycemia may develop earlier.

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

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

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.

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

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

Impact on the ability to drive vehicles and engage in other potentially hazardous activities. 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 have weak or absent symptoms that predict the development of hypoglycemia, or there are 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 of issue

Solution for subcutaneous administration, 100 units / ml. In cartridges of 3 ml of transparent colorless glass (type I), mounted in a disposable syringe pen SoloStar®; In a pack of cardboard 5 syringes-pens.

Terms of leave from pharmacies

On prescription.

Storage Conditions

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf Life

2 years.

Do not use after the expiry date printed on the package.