Instruction for use: Berlinsulin H Basal U-40

ATX Code A10AB01 Human insulin

Active substance: Insulin-isophan [human semisynthetic]

Pharmacological group

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

E11 Non-insulin-dependent diabetes mellitus

Acetonuric diabetes, Decompensation of carbohydrate metabolism, Diabetes insulin-independent sugar, Diabetes sugar type 2, Type 2 Diabetes, Non-insulin-dependent diabetes, Non-insulin dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Insulin resistance, Insulin resistant diabetes mellitus, Coma lactobacillus diabetic, Violation of carbohydrate metabolism, Type 2 diabetes mellitus, Diabetes mellitus type II, Diabetes mellitus in adulthood, Diabetes mellitus in old age, Diabetes insulin-independent, Diabetes mellitus type 2, Sugar insulin-independent diabetes type II

Composition and form of release

1 ml of the suspension for injection contains human insulin 40 ED (unit of action) and protamine sulfate 0.14 mg (corresponding to 0.108 mg protamine base); In bottles of 10 ml, in a box of 1 pc.

pharmachologic effect

Pharmacological action - hypoglycemic.

Enhances the absorption of glucose by tissues, facilitates its penetration into cells, stimulates neoglycogenesis.

Clinical Pharmacology

The action begins 30-45 minutes after the injection, reaches a maximum after 2-10 hours and lasts 18-20 hours.

indications

All forms of diabetes mellitus (type I and II), intolerance to other insulin preparations.

Contraindications

Absolute: hypoglycemia, intravenous (intravenous) administration.

Relative: allergic reactions of immediate type to insulin preparations (in the anamnesis).

pregnancy and lactation

During pregnancy and during lactation, it may be necessary to adjust the dosage of insulin and diet. In the I-th trimester, the need is reduced, from the fourth month it increases and after the delivery often decreases again quickly.

Side effects

Hypoglycemic conditions (up to coma), transient edema, refraction of the lens, lipodystrophy, hyperemia (at the injection site), allergic reactions.

Interaction

Strengthening the effect (reducing the need for insulin) is possible with the intake of alcohol, alpha and beta adrenoblockers, amphetamine, anabolic steroids, clofibrate, cyclophosphamide, fenfluramine, ifosfamide, MAO inhibitors (monoamine oxidase), methyldopa, tetracyclines and trophosphamide; Weakening (increase in the need for insulin) - chlorprotixen, diazoxide, heparin, steroid contraceptives, glucocorticoids, lithium salts, nicotinic acid, phenolphthalein, phenothiazines, phenytoin, thiazide diuretics, thyroid hormones, sympathomimetics, tricyclic antidepressants. Reserpine, salicylates alter (increase or decrease) the level of lipoglycemia. Symptoms of hypoglycemia mask beta-blockers and clonidine. Reduces the tolerability of alcohol.

Dosing and Administration

SC, usually appoint 1 injection; At a dose exceeding 50 units (unit of action), 2 injections per day are prescribed. The dose is administered for 30-45 minutes before the first breakfast and before dinner. In special cases, enter in / m (intramuscularly) (can not be administered intravenously).

Overdose

It is manifested by hypoglycemia: the sudden appearance of sweat, palpitation, tremor, hunger, excitement, paresthesia in the mouth, pallor, headache, drowsiness, timidity, depression, irritability, movement uncertainty, speech and vision impairment. With severe hypoglycemia - loss of consciousness, cold sweat, high turgor of the eyeball tissues, convulsions like Jackson, right up to the epistatus; The Babinsky reflex.

Therapy: with mild hypoglycemia - the intake of sugar; In severe cases, 1-2 mg glucagon or glucose (40-80 ml 40% solution, iv) should be administered in / m.

Precautionary measures

With increased sensitivity to insulin of animal origin, it is necessary to check the tolerability of human insulin (skin test). With an allergic reaction of an immediate type to protamine sulfate, it is recommended to switch to insulin that does not contain protamine. With each injection, the injection site is changed.

It is necessary to protect the drug from freezing.

storage Conditions

In a cool 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.