Apidra SoloStar solution of subcutaneous injection 100ME ml3 ml N5шпр
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Active ingredients
Insulin glulisine
Release form
Solution
Composition
The solution for SC injection is clear, colorless or almost colorless. 1 ml insulin glulisine 100 U (3.49 mg) Excipients: metacresol (m-cresol), trometamol, sodium chloride, polysorbate 20, sodium hydroxide, hydrochloric acid, water for i.
Pharmacological effect
Insulin glulisine is a recombinant analogue of human insulin, which is equal in strength to normal human insulin. Insulin glulisine 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 glulisine, is the regulation of glucose metabolism. Insulin lowers the concentration of glucose in the blood by stimulating glucose uptake by peripheral tissues, especially skeletal muscle and adipose tissue, as well as inhibiting the formation of glucose in the liver. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis and increases protein synthesis. Studies conducted in healthy volunteers and patients with diabetes mellitus showed that insulin glulisine starts to act faster and has a shorter duration of action than soluble human insulin. When s / c administration hypoglycemic effect of insulin glulisine begins after 10-20 minutes. With a / in the introduction of the effects of lowering blood glucose insulin glulisine and soluble human insulin are equal in strength. One unit of insulin glulisine has the same glucose-lowering activity as one unit of soluble human insulin. In a phase I study, patients with type 1 diabetes mellitus evaluated the glucose-lowering profiles of insulin glulisine and soluble human insulin, administered subcutaneously at a dose of 0.15 U / kg at different times relative to the standard 15-minute food intake. The results of the study showed that insulin glulisine, administered 2 minutes before a meal, provided the same glycemic control after a meal as soluble human insulin, administered 30 minutes before a meal. When administered 2 minutes before a meal, insulin glulisine provided better glycemic control after a meal than soluble human insulin, administered 2 minutes before a meal. Insulin glulisine, administered 15 minutes after the start of a meal, gave the same glycemic control after a meal as soluble human insulin, administered 2 minutes before a meal.A phase I study of insulin glulisine, lizpro insulin and soluble human insulin in a group of obese patients demonstrated that insulin glulisine retains its fast-acting characteristics in these patients. In this study, the time to reach 20% of the total AUC was 114 min for insulin glulisine, 121 min for insulin lispro and 150 min for soluble human insulin, and AUC (0-2 h), also reflecting early glucose lowering activity, respectively, was 427 mg / kg for insulin glulisine, 354 mg / kg for insulin lispro, and 197 mg / kg for soluble human insulin. Clinical studies Type 1 diabetes mellitus In a 26-week clinical trial of phase III, in which insulin glulisine was compared with lispro insulin administered subcutaneously shortly before a meal (for 0-15 minutes) to patients with type 1 diabetes mellitus, using basal insulin insulin glargine, insulin glulisine was comparable to lispro insulin in relation to glycemic control, which was assessed by the change in glycosylated hemoglobin concentration (HbA1C) at the time of the end point of the study compared to the outcome. Observed comparable values of blood glucose, determined by self-control. With the introduction of insulin glulisine in contrast to treatment with insulin lispro 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 insulin glargine as basal therapy showed that the effectiveness of administering insulin glulisine directly after a meal was comparable to that of administering insulin glulisine directly before a meal (for 0 -15 min) or soluble human insulin (30-45 minutes before meals). In the population of patients who completed the study protocol, in the group of patients who received insulin glulisine before meals, there was a significantly greater decrease in HbA1C compared to the group of patients who received soluble human insulin. Type 2 diabetes mellitus A 26-week clinical trial of phase III followed by a 26-week follow-up safety study was conducted to compare insulin glulisine (0-15 minutes before a meal) with soluble human insulin (30-45 minutes meals), which were administered s / c to patients with type 2 diabetes, besides receiving insulin-isophane as basal insulin.The average body mass index of the patients was 34.55 kg / m2. Insulin glulisine showed a greater decrease in the concentration of HbA1C from the initial value compared with soluble human insulin (-0.46% for insulin glulisine and -0.30% for soluble human insulin, p = 0.0029). In this study, the majority of patients (79%) mixed their short-acting insulin with isophane insulin just before the injection. 58 patients at the time of randomization used oral hypoglycemic drugs and were instructed to continue taking them in the same (unchanged) dose. When conducting continuous s / c infusion of insulin using a pump device (for type 1 diabetes) in 59 patients treated with the drug Apidra. or insulin aspart, in both treatment groups, there was a low frequency of catheter occlusion (0.08 occlusions per month with the use of the drug Apidra. and 0.15 occlusions per month with the use of insulin aspart), as well as a similar frequency of reactions at the injection site (10.3% with the use of the drug Apidra. and 13.3% when using insulin aspart). In children and adolescents with type 1 diabetes, who as the basal insulin 1 time / day in the evening was administered insulin glargine or 2 times / day in the morning and evening insulin isophane, when comparing the efficacy and safety of insulin treatment with glulisine and insulin lispro with their p / for administration 15 minutes before a meal, it was shown that glycemic control, the incidence of hypoglycemia, requiring intervention by third parties, and the frequency of severe hypoglycemic episodes were comparable in both treatment groups. At the same time, after 26 weeks of treatment in patients treated with insulin glulisine to achieve glycemic control comparable to lispro insulin, a significantly smaller increase in daily doses of basal insulin, fast acting insulin and total insulin dose was required Racial origin and sex In controlled clinical studies in adults not differences in the safety and efficacy of insulin glulisine in the analysis of subgroups identified by gender by gender were shown.
Indications
- diabetes mellitus requiring insulin treatment in adults, adolescents and children over 6 years old.
Use during pregnancy and lactation
There are no controlled clinical studies on the use of the drug Apidra. in pregnant women. The limited amount of data obtained for pregnant women (fewer than 300 outcomes of pregnancies were reported) who received insulin glargine do not indicate its adverse effects on the course of pregnancy, fetal development or the newborn child. Reproductive animal studies did not reveal any differences between insulin glulisine and human insulin regarding the course of pregnancy, fetal / fetal development, childbirth and postnatal development. The use of the drug Apidra. SoloStar in pregnant women should be carried out with caution. Careful monitoring of blood glucose and maintenance of glycemic control is essential. Patients with pre-pregnancy or gestational diabetes need to maintain glycemic control throughout the pregnancy. During the first trimester of pregnancy, the need for insulin may decrease, and during the second and third trimesters, it can usually increase. Immediately after delivery, the need for insulin is rapidly reduced. It is not known whether insulin glulisine is excreted in breast milk. In women during breastfeeding, it may be necessary to adjust the insulin dosage regimen and diet.
Side effects
On the part of the metabolism: hypoglycemia, the most frequent undesirable effect of insulin therapy, can occur when using too high doses of insulin, exceeding the need for it. Symptoms of hypoglycemia usually occur suddenly. However, neuroglycopenia (feeling tired, unusual fatigue or weakness, diminished ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) usually precedes the symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): feeling of hunger, irritability, nervous agitation or tremor, anxiety, pallor of the skin, cold sweat, tachika pd, marked palpitations (the faster hypoglycemia develops and the harder it is, the more pronounced the symptoms of adrenergic counterregulation). Episodes of severe hypoglycemia, especially repeated, can lead to damage to the nervous system.Prolonged and severe hypoglycemia can threaten the lives of patients, because with an increase in hypoglycemia, even fatal outcome is possible. Local hypersensitivity reactions to insulin: local hypersensitivity reactions 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 of it before the injection or improper conducting of the s / c injection (in case of violation of the correct technique of s / c injection). Systemic hypersensitivity reactions to insulin: possible - a rash all over the body, sometimes accompanied by itching, feeling of tightness in the chest, feeling of suffocation, decrease in blood pressure, increased heart rate, and profuse sweating. Severe cases of generalized allergy, including anaphylactic reactions, can be life-threatening. On the part of the skin and subcutaneous fat: perhaps - lipodystrophy (disruption of the alternation of insulin injections in any of the areas / administration of the drug in the same place can slow insulin absorption). Constant alternation of injection sites within one of the injection areas (hip, shoulder, anterior surface of the abdominal wall) helps to reduce and prevent the development of lipodystrophy. Other: Accidental injections of other insulins have been reported by mistake, especially long-acting insulins, instead of insulin glulisine.
special instructions
On the part of the metabolism: hypoglycemia, the most frequent undesirable effect of insulin therapy, can occur when using too high doses of insulin, exceeding the need for it. Symptoms of hypoglycemia usually occur suddenly. However, neuroglycopenia (feeling tired, unusual fatigue or weakness, diminished ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) usually precedes the symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): feeling of hunger, irritability, nervous agitation or tremor, anxiety, pallor of the skin, cold sweat, tachika pd, marked palpitations (the faster hypoglycemia develops and the harder it is, the more pronounced the symptoms of adrenergic counterregulation).Episodes of severe hypoglycemia, especially repeated, can lead to damage to the nervous system. Prolonged and severe hypoglycemia can threaten the lives of patients, because with an increase in hypoglycemia, even fatal outcome is possible. Local hypersensitivity reactions to insulin: local hypersensitivity reactions 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 of it before the injection or improper conducting of the s / c injection (in case of violation of the correct technique of s / c injection). Systemic hypersensitivity reactions to insulin: possible - a rash all over the body, sometimes accompanied by itching, feeling of tightness in the chest, feeling of suffocation, decrease in blood pressure, increased heart rate, and profuse sweating. Severe cases of generalized allergy, including anaphylactic reactions, can be life-threatening. On the part of the skin and subcutaneous fat: perhaps - lipodystrophy (disruption of the alternation of insulin injections in any of the areas / administration of the drug in the same place can slow insulin absorption). Constant alternation of injection sites within one of the injection areas (hip, shoulder, anterior surface of the abdominal wall) helps to reduce and prevent the development of lipodystrophy. Other: Accidental injections of other insulins have been reported by mistake, especially long-acting insulins, instead of insulin glulisine.