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indications:
Diabetes that requires insulin therapy. Diabetes in pregnant women.
Composition:
1 vial (10 ml) contains 1000 IU and one pen cartridge (3 ml) contains 300 IU. human biphasic insulin (50% soluble insulin and 50% isophane insulin).
Action:
The preparation is a two-phase suspension of human insulin obtained by bacterial recombinant DNAE. colicontaining 50% soluble insulin and 50% isophane insulin. Insulin reduces blood Glucose, exerts an anabolic effect, increases Glucose transport into cells and enhances glycogen synthesis in muscle tissue and liver, reduces glycogenolysis and gluconeogenesis, increases lipogenesis in the liver and adipose tissue, inhibits lipolysis, increases amino acid uptake and protein synthesis. After subcutaneous administration, the onset of action occurs within 30 minutes of administration, the maximum effect - between 2 and 8 hours, and the duration of action is up to 24 hours and depends on the dose.
Contraindications:
Hypoglycemia. Hypersensitivity to insulin or other components of the preparation, unless it is part of the desensitization program. Do not use intravenously.
Precautions:
Changing the type or brand of insulin used may result in the need to modify the dosage - strict medical supervision is advisable. In patients who have improved glycemic control significantly, the warning symptoms of hypoglycaemia may be less pronounced or not appear at all. Other situations that may change or diminish the early warning symptoms of hypoglycaemia: the period after the change of animal-derived insulin to human long-term diabetes, diabetic neuropathy, the concomitant use of certain drugs (eg beta-blockers). Inadequate dosing or discontinuation of treatment may lead to hyperglycaemia and ketoacidosis (especially in insulin dependent diabetes mellitus). The insulin requirement may change significantly in the case of diseases of the pancreas, adrenal glands, pituitary gland, thyroid gland, kidney and liver disorders. Insulin requirements may be increased during high-fever, severe infection, gastrointestinal diseases and disorders, including nausea, vomiting, diarrhea, slow gastric emptying and malabsorption, as well as in emotional disorders. Dose modification may also be necessary in the event of a change in the patient's physical activity or diet.
Pregnancy and lactation:
The preparation can be used during pregnancy. During pregnancy, diabetic patients are advised to monitor the level of diabetes mellitus. The demand for insulin usually decreases in the first trimester and increases during the second and third trimester of pregnancy, after childbirth it quickly decreases. In patients with breastfeeding diabetes, dosage and / or diet may need to be adjusted because lactation is less demanding during pregnancy than pre-pregnancy, and 6 to 9 months after the initial requirement.
Side effects:
The most common side effect is hypoglycaemia. Severe hypoglycaemia may lead to unconsciousness and / or convulsions, and in extreme cases even to death. Common: local allergic reaction (erythema, edema, itching). Uncommon: Lipodystrophy at the injection site. Very rare: Systemic signs of hypersensitivity (rash, shortness of breath, wheezing, low blood pressure, accelerated pulse, sweating).
Dosage:
Individually, according to the patient's need for insulin. The preparation can be used in classical insulin therapy, the most common algorithm is 1, 2 or 3 injections per day. The product is administered subcutaneously in the abdominal tissue of the abdomen, buttocks, thigh or upper arm. Injection sites should be changed within the same area. The preparation can be given by intramuscular injection, but it is not recommended. The preparation may be used in combination with oral antidiabetic agents, e.g. Metformin or glimepiride.