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The solution for the p/to the introduction
1 ml contains insulin glulisine 100 IU (3.49 mg),excipients: metacresol (m-cresol), trometamol, sodium chloride, Polysorbate 20, sodium hydroxide, hydrochloric acid, water d/and.
5 syringe pens of 3 ml.
Apidra Solostar has a hypoglycemic effect.
Diabetes mellitus, requiring insulin treatment, in adult patients.
Hypersensitivity to insulin glulisine or to any component of the drug, hypoglycemia.
Application of pregnancy and breastfeeding
There is not enough information on the use of insulin glulisine in pregnant women. Reproductive animal studies have not revealed any differences between insulin glulisine and human insulin in relation to pregnancy, embryonal/fetal development, parturition and postnatal development.In appointing the drug Apidra Solostar pregnant women should be careful. Required careful monitoring of glucose levels in the blood. Patients with pre-pregnancy or gestational diabetes is necessary during pregnancy to maintain optimal metabolic control. During the first trimester of pregnancy, insulin requirements may decrease, and during the second and third trimester it is, as a rule, may increase. Immediately after birth the need for insulin decreases rapidly. Nursing mothers may require correction doses of insulin and diet.
Method of application and doses
N/a, shortly (for 0-15 min) before or soon after a meal. The drug Apidra Solostar should be used in treatment regimens, including or insulin average duration or long acting insulin or insulin analogue long-acting. In addition, the drug Apidra Solostar may be used in combination with oral hypoglycemic agents. The dosage regimen of the drug Apidra Solostar selected individually.
Hypoglycemia is the most frequent undesirable effect of insulin therapy that may occur in the case of too high doses of insulin, greater than the need for it.
Observed in clinical trials adverse reactions related to drug administration are listed below by organ system and in decreasing order of frequency of occurrence. When describing the frequency of occurrence of the following criteria are used: very common – >,, 10%, frequently >,, 1% and <,, 10=”” -=””>,, 0.1% and <,, 1=”” -=””>,, 0.01% and <,, 0=”” 1=”” -=”” 01=”” br=””>,From the metabolic: very often – hypoglycemia. Symptoms of hypoglycemia usually occur suddenly. Usually, however, neuropsychiatric disorders on the background of neuroglycopenia (feeling tired, unusual tiredness or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion, or loss of, sudorozhny syndrome) is preceded by symptoms of adrenergic kontrrevolyutsiei (activation of the sympathoadrenal system in response to hypoglycemia): hunger, irritability, nervous agitation or tremor, anxiety, paleness, “cold” sweat, tachycardia, pronounced heartbeat (the faster developing hypoglycemia and how is it heavier, the more pronounced symptoms of adrenergic contraregulatory).
Bouts of severe hypoglycemia, particularly recurring may lead to damage to the nervous system. Episodes of prolonged and pronounced hypoglycemia could threaten patients ‘ lives, since the increase of hypoglycemia may even result in death.
Local reactions: often – local hypersensitivity reactions (redness, swelling and itching at the injection site). These reactions are usually transient and disappear with continued treatment, rare – lipodystrophy (as a result of a breach of alternating places of insulin in any of the areas /introduction of the drug in the same place/).
Allergic reactions: sometimes – urticaria, feeling of tightness in the chest, bronchospasm, allergic dermatitis, itching. Severe cases of generalized allergic reactions (including anaphylaxis) can be life-threatening.
Transfer the patient to a new type of insulin or insulin from another manufacturer should be under strict medical supervision because you may need a dosage adjustment due to changes in the concentration of insulin, brand (manufacturer), type of insulin (soluble insulin-isophane, etc.), type of insulin (animal origin) and/or method of production. In addition, you may need to adjust concomitant oral hypoglycemic therapy. The use of inadequate doses of insulin or discontinuation of treatment, especially in patients with diabetes mellitus type 1 can lead to the development of hyperglycemia and diabetic ketoacidosis – States that are potentially life-threatening.
Studies on pharmacokinetic interactions have not been conducted. On the basis of existing empirical knowledge in relation to other similar drugs the occurrence of clinically significant pharmacokinetic interaction is unlikely. Some substances can affect the metabolism of glucose, which may require correction doses of insulin glulisine and particularly careful monitoring of treatment. Substances that can increase the hypoglycemic action of insulin and increase susceptibility to hypoglycaemia include: oral hypoglycaemic agents, angiotensin converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoksifen, salicylates and sulfa antibiotics. Substances that can reduce hypoglycemic effect of insulin include: corticosteroids, danazol, diazoxide, diuretics, isoniazid, fenotiazina derivatives, somatropin, sympathomimetic agents (e.g. epinephrine (adrenaline), salbutamol, terbutaline), thyroid hormones, estrogens, progestins (e.g. in oral contraceptives), protease inhibitors and antipsychotic medications (e.g. olanzapine and clozapine).
Symptoms: there are no specific data on overdose of insulin glulisine, possible development of hypoglycemia of varying severity.
Treatment: episodes of mild hypoglycemia can be relieved with the intake of glucose or food containing sugar. It is therefore recommended that patients with diabetes constantly had lumps of sugar, sweets, biscuits or sugary fruit juice. Episodes of severe hypoglycemia, during which the patient loses consciousness, can be cropped in/m or p/to the introduction 0.5-1 mg glukagona or on/in the introduction dekstrozy (glucose). If the patient does not respond to the introduction of glucagon within 10-15 min, you must also enter the dextrose/in. After regaining consciousness, it is recommended to give the patient the carbohydrates orally to prevent recurrence of hypoglycemia. After injection of glucagon to determine the cause of this severe hypoglycaemia and prevent other similar episodes the patient should be observed in hospital.
The drug should be stored out of the reach of children, protected from light place at temperature from 2° to 8°C, do not freeze!