Epaydra solution for injection 100 U/ml Solostar syringe pen 3 ml No. 5

Instructions for use Epaydra solution for injection 100 U/ml Solostar syringe pen 3 ml No. 5

Composition

active ingredient: insulin glulisine;

1 ml of solution contains 100 units of insulin glulisine (product of recombinant DNA technology using Escherichia coli), which is equivalent to 3.49 mg;

1 SoloStar® syringe pen contains 3 ml of solution for injection, equivalent to 300 U of insulin glulisine;

Excipients: m-cresol, sodium chloride, tromethamine, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.

Dosage form

Solution for injection.

Main physicochemical properties: transparent colorless aqueous solution.

Pharmacotherapeutic group

Antidiabetic agents. Insulins and rapid-acting analogues. ATC code A10A B06.

Pharmacological properties

Pharmacodynamics

Insulin glulisine is a recombinant human insulin analogue that is similar in potency to human insulin. Insulin glulisine acts more rapidly and has a shorter duration of action than regular human insulin.

The main action of insulins and their analogues, including insulin glulisine, is to regulate glucose metabolism. Insulins lower blood glucose levels by stimulating peripheral glucose utilization, especially in skeletal muscle and adipose tissue, and by inhibiting glucose synthesis in the liver. Insulin prevents lipolysis in adipocytes, proteolysis, and enhances protein synthesis.

Studies in healthy volunteers and patients with diabetes have shown that insulin glulisine has a faster onset and shorter duration of action than regular human insulin when administered subcutaneously. When insulin glulisine is injected subcutaneously, the onset of glucose lowering begins within 10 to 20 minutes. After intravenous administration, the onset of action is earlier and lasts shorter, and the peak of activity is more pronounced than when administered subcutaneously. When administered intravenously, the blood sugar-lowering effects of insulin glulisine or regular human insulin are equally potent.

One unit of insulin glulisine has the same blood sugar-lowering activity as one unit of regular human insulin.

Dose dependence.

In a study involving 18 men with type 1 diabetes, aged 21 to 50 years, the blood glucose-lowering effect of insulin glulisine was dose-dependent at therapeutic doses of 0.075 to 0.15 U/kg, but less than proportional at doses of 0.3 U/kg or higher, as with human insulin.

The effect of insulin glulisine occurs approximately twice as quickly and stops approximately 2 hours earlier than the effect of regular human insulin.

A phase I study in patients with type 1 diabetes evaluated the glucose-lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 U/kg at different times relative to a 15-minute standard meal. Insulin glulisine administered 2 minutes before a meal provided similar postprandial glycemic control to regular human insulin administered 30 minutes before a meal. When the glucose-lowering effects of insulin glulisine and regular human insulin administered 2 minutes before a meal were compared, insulin glulisine provided better postprandial control than regular human insulin. Administration of insulin glulisine 15 minutes after the start of a meal provided similar glycemic control to regular human insulin administered 2 minutes before a meal.

Adiposity.

A phase I study of insulin glulisine, insulin lispro, and regular human insulin in obese patients demonstrated that insulin glulisine retained its rapid-acting ability in these patients. In this study, the time to 20% of total AUC and AUC (0-2 hours), which are indicators of the early glucose-lowering action of insulins, were 114 min and 427 mg/kg for insulin glulisine, 121 min and 354 mg/kg for insulin lispro, and 150 min and 197 mg/kg for regular human insulin, respectively.

Another phase I study evaluating insulin glulisine and insulin lispro in 80 non-diabetic subjects with a wide range of body mass indices (18–46 kg/m2) demonstrated that rapid onset of action was generally maintained across a wide range of body mass indices (BMI), while the overall glucose-lowering effect decreased with increasing obesity.

The mean total AUC of the glucose infusion rate between 0 and 1 h was 102 ± 75 mg/kg and 158 ± 100 mg/kg, respectively, for insulin glulisine at doses of 0.2 and 0.4 U/kg and 83.1 ± 72.8 mg/kg and 112.3 ± 70.8 mg/kg, respectively, for insulin lispro at doses of 0.2 and 0.4 U/kg. A phase I study in 18 obese patients with type 2 diabetes (BMI 35 to 40 kg/m2) treated with insulin glulisine and insulin lispro [90% CI: 0.81, 0.95 (p ≤ 0.01)] showed that insulin glulisine effectively controlled diurnal postprandial blood glucose fluctuations.

Clinical efficacy and safety.

In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro administered subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus receiving insulin glargine as basal insulin, insulin glulisine provided comparable glycemic control to insulin lispro as measured by changes from baseline in glycosylated hemoglobin (expressed as HbA1c equivalent) at the study endpoint. Comparable self-monitored blood glucose levels were observed. In contrast to insulin lispro, no increase in basal insulin dose was required with insulin glulisine.

A 12-week phase III clinical study in patients with type 1 diabetes receiving insulin glargine as basal insulin showed that the efficacy of insulin glulisine administered immediately after a meal was comparable to that of insulin glulisine administered shortly before a meal (0-15 minutes) or regular insulin (30-45 minutes).

Of the population of patients who met the study protocol, the group of patients who received insulin glulisine before meals had a statistically significant greater reduction in glycosylated hemoglobin compared to the group of patients who received regular insulin.

Type 1 diabetes mellitus – pediatric patients.

A 26-week phase III clinical trial compared insulin glulisine and insulin lispro administered by subcutaneous injection shortly (0-15 minutes) before a meal in children (ages 4-5 years: n = 9; ages 6-7 years: n = 32; and ages 8-11 years: n = 149) and adolescents (ages 12-17 years: n = 382) with type 1 diabetes mellitus receiving insulin glargine or NPH insulin as basal insulin. Insulin glulisine provided comparable glycemic control to insulin lispro as measured by changes from baseline in glycosylated hemoglobin (expressed as HbA1c equivalent) at endpoint and in self-monitored glucose levels.

There is insufficient information regarding the clinical use of Epaydra® in children under 6 years of age.

Type 2 diabetes mellitus – adult patients.

A 26-week phase III clinical study followed by a 26-week safety follow-up study was conducted to compare insulin glulisine (administered 0-15 minutes before a meal) with regular human insulin (administered 30-45 minutes before a meal) administered by subcutaneous injection in patients with type 2 diabetes mellitus also receiving NPH insulin as basal insulin. The patients had a mean body mass index (BMI) of 34.55 kg/m2. Insulin glulisine was shown to be comparable to regular human insulin in terms of changes in glycosylated haemoglobin (expressed as HbA1c equivalent) at the 6-month endpoint compared to baseline (-0.46% for insulin glulisine and -0.30% for regular human insulin, p=0.0029) and at the 12-month endpoint compared to baseline (-0.23% for insulin glulisine and -0.13% for regular human insulin, the difference was not statistically significant). In this study, the majority of patients (79%) mixed their short-acting insulin with NPH insulin immediately before injection, and 58% of patients were taking oral antidiabetic agents at randomisation and were instructed to continue taking them at the same dose.

Race and gender.

In controlled clinical trials in adult patients, insulin glulisine did not demonstrate differences in safety and efficacy across subgroups based on race and gender.

Pharmacokinetics

Faster absorption of insulin glulisine is achieved by replacing the amino acid asparagine at position B3 of human insulin with lysine and the lysine at position B29 with glutamic acid.

In a study in 18 men aged 21 to 50 years with type 1 diabetes, the effect of insulin glulisine was dose-dependent at early, peak and total exposures over the dose range of 0.075 to 0.4 U/kg.

Absorption and bioavailability.

Pharmacokinetic profiles in healthy volunteers and patients with diabetes mellitus (type 1 or 2) demonstrated that the absorption rate of insulin glulisine was approximately twice as high and the maximum concentration was approximately twice as high compared to regular human insulin.

In a study in patients with type 1 diabetes mellitus, after subcutaneous injection of 0.15 U/kg, Tmax for insulin glulisine was 55 min and Cmax was 82 ± 1.3 μU/ml compared to Tmax of 82 min and Cmax of 46 ± 1.3 μU/ml for regular human insulin. The mean systemic residence time of insulin glulisine was shorter (98 min) than that of regular human insulin (161 min).

When insulin glulisine was injected subcutaneously into the abdominal wall, thigh or deltoid muscle, the concentration-time profiles were similar, with absorption being slightly faster in the abdominal wall than in the thigh. Absorption at the deltoid injection site was intermediate between the above (see section 4.2). The absolute bioavailability (70%) of insulin glulisine was similar at the above injection sites and had low inter-individual variability (coefficient of variation 11%). Intravenous bolus administration of insulin glulisine resulted in higher systemic exposure compared to subcutaneous injection, with a Cmax value approximately 40-fold higher.

Adiposity.

Another phase I study of insulin glulisine and insulin lispro in 80 non-diabetic subjects with a wide range of body mass indices (18–46 kg/m2) demonstrated that rapid absorption and overall exposure were generally maintained across a wide range of body mass indices.

The time to reach 10% of total insulin exposure was approximately 5-6 minutes shorter with insulin glulisine.

Distribution and output.

The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration are similar, with volumes of distribution of 13 L and 22 L and half-lives of 13 min and 18 min, respectively.

After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin, with an apparent half-life of 42 minutes for insulin glulisine compared to 86 minutes for regular insulin. In an analysis of data from different studies with insulin glulisine in healthy volunteers or patients with type 1 or type 2 diabetes, the apparent half-life ranged from 37 to 75 minutes (interquartile range).

Insulin glulisine, like human insulin, is poorly bound to blood plasma proteins.

Features of the use of the drug in certain groups of patients

Patients with renal impairment.

In a clinical study in non-diabetic subjects with a wide range of renal function (creatinine clearance > 80 ml/min, 30-50 ml/min, < 30 ml/min), the rapid onset of action of insulin glulisine was generally maintained. However, insulin requirements may be reduced in cases of renal impairment.

Patients with liver dysfunction.

The pharmacokinetic properties of insulin glulisine have not been studied in patients with hepatic impairment.

Elderly patients.

There is a very limited pharmacokinetic database in elderly patients with diabetes.

Children and adolescents.

The pharmacokinetic and pharmacodynamic properties of insulin glulisine in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes are as follows: insulin glulisine is rapidly absorbed in both age groups and has similar Tmax and Cmax values as in adults (see section 4.2). Administration of insulin glulisine immediately before a meal in children and adolescents provides better postprandial glycaemic control compared to regular human insulin, as in adults (see section 4.2). The glucose tolerance (AUC0-6h) is 641 mg h dl-1 for insulin glulisine and 801 mg h dl-1 for regular human insulin.

Preclinical safety data

Preclinical data do not indicate any toxicity (other than that associated with hypoglycemia) that would differ from that seen with regular human insulin or that would be clinically relevant for humans.

Indication

Diabetes mellitus when insulin is required in adults, adolescents and children aged 6 years and over.

Contraindication

Hypersensitivity to insulin glulisine or to any component of the drug. Hypoglycemia.

Interaction with other medicinal products and other types of interactions

Studies on the types of pharmacokinetic interactions have not been performed. Based on empirical knowledge of other similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.

Glucose metabolism is affected by a number of substances and medicinal products. Therefore, this may require adjustment of the insulin glulisine dose and particularly close monitoring of the patient.

Substances that may enhance the glucose-lowering activity and increase the susceptibility to hypoglycemia include oral antidiabetic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antibiotics.

Beta-blockers, clonidine, lithium salts or alcohol may either increase or decrease the blood glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, sometimes accompanied by hyperglycemia.

In addition, under the influence of sympatholytic drugs such as clonidine, guanethidine, reserpine, and beta-blockers, signs of adrenergic feedback regulation may be weakened or even absent.

Application features

Transferring a patient to a new type or brand should be done under close medical supervision. Changes in strength, brand (manufacturer), type of drug (regular, NPH [neutral protamine Hagedorn], lente, long-acting, etc.), origin (animal, human, human insulin analogue), and/or method of manufacture may require a change in dosage. Adjustments in concomitant oral antidiabetic medication regimens may also be necessary.

Patients should be advised to rotate injection sites to reduce the risk of lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsening glycemic control after insulin injections at these sites. Changing the injection site to an intact area of skin has been reported to result in hypoglycemia. Blood glucose monitoring is recommended after changing injection sites, and dose adjustments of antidiabetic medications may be considered.

Hyperglycemia.

The use of inappropriate doses or discontinuation of treatment, especially in patients with insulin-dependent diabetes, may lead to the development of hyperglycemia and diabetic ketoacidosis - conditions that are potentially fatal.

Hypoglycemia.

Hypoglycemia occurs depending on the action profile of the insulins used and may therefore change when switching to a new treatment regimen.

Conditions that may make the early warning symptoms of hypoglycemia atypical or less pronounced include long duration of diabetes, intensification of insulin therapy, diabetic neuropathy, use of medicinal products such as beta-blockers, or transfer from animal-based insulin to human insulin. The need for dose adjustment may also arise if patients increase their physical activity or change their usual diet. Physical exertion immediately after a meal increases the risk of developing hypoglycemia. Hypoglycemia after injection of fast-acting insulin analogues usually occurs earlier than with soluble human insulin. Hypoglycemic or hyperglycemic reactions, if not treated appropriately, may lead to loss of consciousness, coma, or death.

Insulin requirements may change in the presence of other illness or emotional disturbances.

Incorrect administration of other medications.

There have been reports of medication errors where other insulins, including long-acting insulins, have been accidentally injected instead of insulin glulisine. The label should be checked before each injection to avoid the mistaken administration of other insulins instead of insulin glulisine.

Excipients.

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially sodium-free.

Epaydra® contains m-cresol, which may cause allergic reactions.

Combination of Epaydra® with pioglitazone.

Cases of heart failure have been reported with pioglitazone in combination with insulin, particularly in patients at risk of developing heart failure. This should be taken into account when considering the combination of pioglitazone and Epaydra®. Patients should be monitored for signs and symptoms of heart failure, weight gain and oedema when using this combination. Pioglitazone should be discontinued if any worsening of cardiac symptoms occurs.

Handling the SoloStar® pre-filled pen.

Epaydra® in the SoloStar® pre-filled pen can only be used for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is required, the vial should be used. Before using the SoloStar® pen, the instructions for use should be read carefully. The SoloStar® pen should be used in accordance with the recommendations contained in this instruction (see section “Method of administration and dosage”).

Ability to influence reaction speed when driving vehicles or other mechanisms

Patients should be advised to exercise caution and avoid hypoglycemia while driving. This is especially important for those patients who have mild or no warning signs of hypoglycemia and for those patients who have frequent episodes of hypoglycemia. In these circumstances, the appropriateness of driving should be considered.

Use during pregnancy or breastfeeding

Pregnancy

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women.

Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development.

This drug should be used with caution in pregnant women. Glucose levels should be carefully monitored.

Patients with established or gestational diabetes mellitus should maintain adequate metabolic control during pregnancy. Insulin requirements may decrease during the first trimester of pregnancy and usually increase during the second and third trimesters. Insulin requirements decrease rapidly immediately after delivery.

Breast-feeding

It is not known whether insulin glulisine is excreted in human milk, but insulin is generally not excreted in breast milk and is not absorbed after oral administration.

Women who are breastfeeding may need to adjust their insulin dose and diet.

Fertility

Animal reproductive studies with insulin glulisine did not reveal any adverse effects on fertility.

Method of administration and doses

Epaydra® is used in insulin therapy regimens that include intermediate- or long-acting insulin or a basal insulin analogue. This medicinal product can be administered concomitantly with oral antidiabetic agents.

The dose of Epaydra® is selected and adjusted individually.

Special categories of patients.

Patients with renal impairment.

The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in patients with renal impairment (see section 5.2).

Patients with liver dysfunction.

The pharmacokinetic properties of insulin glulisine have not been studied in patients with reduced hepatic function. In patients with impaired hepatic function, insulin requirements may be reduced due to reduced gluconeogenesis and reduced insulin metabolisation.

Elderly patients.

There are limited data on the pharmacokinetics of insulin in elderly patients with diabetes. Decreasing renal function may lead to a decrease in insulin requirements.

Children and adolescents.

There is no reliable clinical information on the use of Epaydra® in children under 6 years of age.

Application.

Epaydra® in the SoloStar® pre-filled pen is for subcutaneous injection only. If administration by syringe, intravenous injection or infusion pump is required, the vial should be used (see section 4.4).

Epaydra® should be administered by subcutaneous injection shortly (0-15 minutes) before or immediately after a meal.

Epaydra® is administered subcutaneously into the abdominal wall, thigh or deltoid muscle. Injection or infusion sites within the injection area (anterior abdominal wall, thigh or deltoid muscle) should be rotated to reduce the risk of lipodystrophy and skin amyloidosis (see sections 4.4 and 4.8 of the instructions). The rate of absorption and, consequently, the onset and duration of action may depend on the specific injection site, the technique used and other variables. Subcutaneous injection into the abdominal wall provides slightly faster absorption than other injection sites (see section 5.2).

Care should be taken to avoid injecting the drug directly into a blood vessel. The injection site should not be massaged after administration. Patients should be instructed in the correct injection procedure.

Mixing with other insulins.

Insulin glulisine should not be mixed with other medicinal products except NPH (neutral protamine Hagedorn) human insulin.

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

Inspect the cartridge before use. It should only be used if the solution is clear, colorless, free of visible particles, and has the consistency of water. As Epaydra® is a solution, it does not need to be resuspended before use.

Empty pens cannot be reused and must be disposed of properly.

Important information about using the SoloStar® syringe pen:

Use a new needle for each injection that is compatible only with the SoloStar® pen. Do not select a dose or press the injection button unless the needle is attached to the pen. Perform a safety test before each injection. The pen is for your personal use and should not be shared with others. If someone else is giving you the injection, that person must take special precautions to prevent needle stick injuries and transmission of infection. Do not use the SoloStar® pen if it is damaged or if you are not sure whether it is working properly. Always carry a spare SoloStar® pen in case your current SoloStar® pen is lost or damaged.

Storage instructions.

Carefully read the information on storing your SoloStar® pen.

If your SoloStar® pen is stored in the refrigerator, remove it from the refrigerator 1 to 2 hours before injecting the medicine to allow it to warm to room temperature. Injecting cold insulin is more painful.

The used SoloStar® syringe pen must be disposed of in accordance with established regulations.

Operation.

Keep your SoloStar® syringe pen away from dust and dirt.

You can clean the outside of your SoloStar® pen by wiping it with a damp cloth.

Do not immerse, rinse, or lubricate the pen as this may damage it.

The SoloStar® syringe pen is designed for precise and safe operation.

It should be used with care. Avoid situations where the SoloStar® pen may be damaged. If you suspect that the SoloStar® pen is damaged, use a new pen.

Stage 1. Insulin control.

Carefully read the information on the SoloStar® pen label to make sure you are injecting the correct insulin. The SoloStar® pen with Epaydra® is blue, the injection button is dark blue with a raised ring at the top. Remove the pen cap. Check the appearance of the insulin. Epaydra® is a clear, colorless solution with no visible solid particles and has the same consistency as water with insulin. Do not use the SoloStar® pen if the insulin is cloudy, colored, or has foreign particles.

Stage 2. Attaching the needle.

Always use a new sterile needle for each injection. This will help prevent contamination and possible needle blockage. Only needles that are compatible with the SoloStar® pen should be used.

Remove the protective label from the needle container. Align the needle with the pen and then hold it in line until it is attached (screwed on or pushed on, depending on the type of needle). If the needle is not aligned with the pen when attached, it may damage the rubber seal and cause fluid leakage or needle breakage.

Stage 3. Safety test.

In all cases, perform a safety test before each injection. This ensures that you receive an accurate dose by:

Check that the pen and needle are working properly; Remove any air bubbles. Measure a dose of 2 units by turning the dose selector. Remove the outer needle cap and save it to put on the needle used after the injection. Remove the inner needle cap and throw it away. Place the pen with the needle pointing upwards. Tap the insulin reservoir gently with your fingertips to make any air bubbles rise towards the needle. Press the injection button all the way in. Check that insulin appears at the tip of the needle.

If insulin comes out of the needle tip, the pen and needle are working properly. You can do the safety test several times until insulin appears.

If insulin does not appear, check for air bubbles and repeat the safety test more than twice before removing them. If insulin does not appear, this may be due to a blocked needle. Remove the needle and repeat the test. If insulin does not appear after changing the needle, your SoloStar® pen may be damaged. Do not use it.

Stage 4. Dose selection.

You can set the dose in increments of 1 unit (from a minimum dose of 1 unit to a maximum dose of 80 units). If you need to inject a dose greater than 80 units, you will need to inject 2 or more injections.

Check that the dose window shows “0” after the safety test is complete. Select the dose you need (in the example below, the selected dose is 30 units). If you have set a dose that is higher than the required dose, you must return the dose selector to its original position. Do not press the injection button while turning the selector, otherwise insulin will leak out. You will not be able to turn the dose selector to a number of units that is higher than the amount left in the syringe pen. Do not try to force the dose selector to turn. In this case, you must either inject the remaining insulin and complete the dose you need with a new SoloStar® syringe pen, or use a new SoloStar® syringe pen to inject the full dose.

Follow the injection technique that your doctor has shown you. Insert the needle into the skin. Inject the dose by pressing the injection button all the way in one direction. After injection, the dose window should read “0”. Leave the injection button pressed in. Slowly count to 10 before removing the needle from the skin. This will ensure that the full dose is delivered.

Stage 6. Removal and disposal of the needle.

In all cases, remove the needle after each injection and store the pen without the needle attached. This helps prevent:

contamination and/or infection; air entering the insulin reservoir and insulin leaking out, which may result in incorrect dosing. Replace the outer needle cap on the needle and use it to unscrew the needle from the pen. Special care must be taken when removing and discarding the needle. To reduce the risk of needle-related accidents, never replace the inner needle cap. If the injection was given by another person, special precautions should be taken when removing and disposing of the needle by the same person. Follow recommended safety precautions for removing and disposing of needles (e.g. one-handed capping technique) to reduce the risk of needle-related accidents and the transmission of infectious diseases. Dispose of the needle carefully (as instructed by your doctor). In all cases, put the cap back on the pen and store the pen until your next injection.

Children

There is insufficient data on the clinical use of Epaydra® in children under 6 years of age.

Overdose

Hypoglycemia can occur as a result of excessive insulin action relative to the amount of food consumed and energy expenditure.

There are no specific data on overdose with insulin glulisine. However, hypoglycemia may develop gradually.

Mild hypoglycemic episodes can be treated by oral administration of glucose or foods high in sugar. Therefore, a diabetic patient is advised to always carry a few pieces of sugar, candy, cookies, or sugary fruit juice with him.

Sugar substitutes cannot be used to treat hypoglycemic conditions!

Severe hypoglycaemic episodes in which the patient loses consciousness can be treated by glucagon (0.5-1 mg) intramuscularly or subcutaneously, which can be done by a suitably trained person, or by intravenous glucose, which should be done by a healthcare professional. Glucose is also administered intravenously if the patient's condition does not improve within 10-15 minutes after glucagon administration.

When the patient regains consciousness, oral administration of carbohydrates is recommended to prevent recurrence of hypoglycemia.

After a glucagon injection, the patient should be examined in a hospital to identify the cause of severe hypoglycemia and prevent similar attacks.

Adverse reactions

The most common side effect of insulin therapy is hypoglycemia, which occurs as a result of using a larger dose of insulin than required.

Relevant adverse reactions demonstrated during clinical trials are listed below by system organ class and in decreasing order of frequency: very common (≥ 1/10); common (≥ 1/100 - < 1/10); uncommon (≥ 1/1,000 - < 1/100); rare (≥ 1/10,000 - < 1/1,000); very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).

Within each group, adverse events are presented in order of decreasing seriousness.

MedDRA system organ class	Very often	Often	Infrequently	Rarely	Unknown
Metabolic and nutritional disorders	Hypoglycemia
Skin and subcutaneous tissue disorders		Injection site reactions, local hypersensitivity reactions		Lipodystrophy	Skin amyloidosis
Violation Specifications Characteristics Active ingredient Insulin glulisine Adults Can ATC code A DIGESTIVE SYSTEM AND METABOLISM AGENTS; A10 ANTIDIABETIC DRUGS; A10A INSULIN AND ITS ANALOGUES; A10A B Insulins and analogues for injection, fast-acting; A10A B06 Insulin glulisine Country of manufacture Germany Diabetics Can Dosage 100 U/ml Drivers With caution For allergies Can For children From the age of 6 Form Cartridges and syringe pens Method of application Injections Nursing With caution as prescribed by a doctor Pregnant With caution Primary packaging pieces Producer Sanofi Quantity per package 5 cartridges Trade name Epidaurus Vacation conditions By prescription Reviews There are no reviews for this product. + Add review Write a review Epaydra solution for injection 100 U/ml Solostar syringe pen 3 ml No. 5 My mark: Continue There are no reviews for this product, be the first to leave your review. Answers & questions Add your question and we will answer as soon as possible. + Ask a question Ask a question Add your question and we will answer as soon as possible. * Your question Continue No questions about this product, be the first and ask your question. You are watched new Best-seller Hit Allerveg spray against dust mites 400 ml In stock 0 935.78 грн. Add to Cart new Hit Rofitis solution for infusions bottle 400 ml In stock 0 308.75 грн. Add to Cart new Hit Kotex Super Deo daily pads No. 52 In stock 0 125.40 грн. Add to Cart new Hit Sold out ElenSee cosmetic bath salt sea with pine needles 700 g Распродано 0 52.30 грн. new Hit Mask Sulsena anti-acne sachet 10 ml No. 1 In stock 0 45.36 грн. Add to Cart new Hit Ketonal Duo hard capsules 150 mg blister No. 20 In stock 0 274.37 грн. Add to Cart new Hit Herbal tea bronchodilator bag 1.5 g No. 20 In stock 0 71.40 грн. Add to Cart new Hit Arederma Atopic body cream with probiotics 250 ml In stock 0 366.20 грн. Add to Cart new Hit Dentissimo Parodontal toothbrush soft bristles In stock 0 188.96 грн. Add to Cart new Hit Sold out Flexivin Advance film-coated tablets No. 30 Распродано 0 431.30 грн.