Instruction for use: Ultratard HM

ATX Code A10AE01 Human insulin

Active substance Insulin biphasic [human biosynthetic]

Pharmacological group

Insulins

Nosological classification (ICD-10)Z31.1 Artificial insemination

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 biosynthetic human zinc-insulin crystalline 40 or 100 IU (international unit); In bottles of 10 ml.

Characteristic

Human biosynthetic zinc-insulin-suspension of long-acting.

pharmachologic effect

Pharmacological action - hypoglycemic.

Interacts with a specific receptor of the plasma membrane and penetrates into the cell, which activates the phosphorylation of cellular proteins, stimulates glycogen synthase, pyruvate dehydrogenase, hexokinase, inhibits fat lipase and lipoprotein lipase. In combination with a specific receptor facilitates the penetration of glucose into cells, enhances its assimilation by tissues and promotes conversion into glycogen. Increases the glycogen reserve in muscles, stimulates the synthesis of peptides.

Clinical Pharmacology

The effect develops 4 hours after SC administration, reaches a maximum after 8-24 hours and lasts for 28 hours. In insulin-dependent diabetes mellitus it is used as a basal insulin in combination with short-acting insulin. With non-insulin-dependent diabetes mellitus, it can be used both for monotherapy and in combination with fast-acting insulin.

Indications

Diabetes mellitus type I, type II diabetes mellitus (with resistance to sulfonylureas and biguanide derivatives, intercurrent diseases, operations and post-operation period, during pregnancy).

Contraindications

Hypoglycemia, insulinoma.

Side effects

Hypoglycemia, rarely hyperemia and lipodystrophy at injection sites.

Interaction

The effect is enhanced by acetylsalicylic acid, alcohol, alpha and beta adrenoblockers, amphetamine, anabolic steroids, clofibrate, cyclophosphamide, fenfluramine, fluoxetine, ifosfamide, MAO inhibitors, methyldopa, tetracyclines, tritokvaline, triphosphamide, weaken - chlorprotixen, diazoxide, diuretics Thiazides), glucocorticoids, heparin, hormonal contraceptives, isoniazid, lithium carbonate, nicotinic acid, phenothiazines, sympathomimetics, tricyclic antidepressants.

Dosing and Administration

P / to, the dose is determined individually. Before use, the contents of the vial are gently mixed. When transferring patients from highly purified pig insulin to human, the dose remains the same. When transferred from bovine or mixed (porcine / bovine) insulin, the dose can be reduced by 10%, except when the initial dose is less than 0.6 U / kg body weight. At a daily dose exceeding 0.6 U / kg of body weight, the drug must be administered as two injections in different places. Patients receiving a daily dose of 100 units or more, at the time of changing insulin, it is advisable to hospitalize.

Overdose

It is characterized by hypoglycemia (sudden sweat, palpitation, tremor, hunger, excitement, irritability, paresthesia in the mouth, pallor, headache, drowsiness, movement uncertainty, speech and vision impairment, depression) or coma (loss of consciousness, cold sweat, tension of tissues Eyeball, convulsions like Jackson, right up to convulsions, Babinsky's reflex).

Treatment: the intake of sugar (if the patient is conscious), sc, v / m, iv injection of 1 mg glucagon or IV glucose.

Precautionary measures

Do not use a solution that does not have the inherent dull white flocculent consistency. It should be borne in mind that when translated into human insulin, the ability to drive a car may temporarily deteriorate.

storage Conditions

At a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life

2.5 years.

Do not use after the expiry date printed on the package.