Instruction for use: Insuman Comb 15 GT

ATX CodeA10AD01 Human insulin

Active substance Cetrorelix 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

Composition and form of release

1 ml of suspension for injection of Insuman Comb 15 GT, 25 GT and 50 GT contains 100 IU of insulin, including, respectively, 15, 25 and 50 IU neutral insulin solution and 85, 75 and 50 IU crystalline insulin protamine, or 40 ME insulin, incl. Respectively, 6, 10 and 20 IU of a neutral insulin solution and 34, 30 and 20 IU crystalline insulin protamine; In bottles of 5 (100 IU / ml) or 10 ml (40 IU / ml), in a cardboard bundle 5 pcs.

1 cartridge for syringe-pens OptiPen (Insuman Comb 25 Gt) contains 3 ml of suspension for injection with insulin activity of 100 IU / ml, incl. 25 IU / ml neutral insulin solution and 75 IU / ml crystalline insulin protamine; In a cardboard bundle 5 pcs.

Characteristic

Identical in structure to human insulin and obtained by genetic engineering.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

Eliminates the deficiency of endogenous insulin.

Clinical Pharmacology

Different drugs differ in the percentage of neutral insulin and crystalline protamine insulin, which causes quantitative differences in their pharmacodynamics. Insuman Comb 15/85 is characterized by a rapid onset (after 30-45 minutes) and an average duration (11-20 hours) of action, Insuman Comb 25 GT, respectively, 30-60 min and 12-19 h, Insuman Comb 50/50 - 30 Min (with a maximum effect in 1-1.5 hours) and 10-16 hours, respectively. The duration of action depends on the dose and on the individual characteristics of the patient.

Indications

Type 2 diabetes mellitus in patients who had not previously received insulin; Pregnant women, in case of intolerance to other insulin-containing drugs; A labile form of diabetes mellitus associated with the presence of a high titer of antibodies to insulin (other than Insuman's Comb 50 Gt); When transplanting islet cells of the pancreas. Type 2 diabetes mellitus with resistance to oral hypoglycemic agents, during surgical operations, with the addition of concomitant diseases, with ineffectiveness of diet therapy during pregnancy.

Contraindications

Hypersensitivity, hypoglycemia.

Side effects

Associated with the effect on carbohydrate metabolism: hypoglycemia (pallor, sweating, palpitation, sleep disorders, tremor), hypoglycemic precoma and coma; Neurological disorders (rarely); Local reactions: lipodystrophy at the site of administration (with prolonged use); Allergic reactions.

Interaction

The effect is enhanced: ACE inhibitors, acetylsalicylic acid, cibenzoline, fibrates, disopyramide, fenfluramine, oral hypoglycemic agents, pentoxifylline, phenoxybenzamine, propoxyphene, somatostatin, sulfonamides, amphetamine, anabolic steroids, cyclophosphamide, fenfluramine, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, tetracyclines , Tritavalin, triphosphamide; Weaken: barbiturates, diuretics, danazol, doxazosin, estrogens and progestogens, corticosteroids, glucocorticoids, diazoxide, heparin, isoniazid, nicotinic acid, phenolphthalein, phenothiazine derivatives, phenytoin, sympathomimetics.

In patients simultaneously receiving clonidine, reserpine and lithium salts, both attenuation and enhancement of action can be observed. Reduces the tolerance of alcohol. Beta-adrenoblockers, clonidine, guanethidine, reserpine may mask the symptoms of hypoglycemia. Can be mixed with human insulin, with the exception of insulin, intended for pump injection.

Dosing and Administration

The injection site is changed every time. The dose is set individually. Adults who receive the drug for the first time start with a dose of 8-24 IU 1 time per day. In patients with high sensitivity to insulin, a dose of less than 8 IU / day may be sufficient, with a lower dose of more than 24 IU / day. The maximum single dose is 40 IU (the excess of this dose is allowed only in exceptional cases). Insuman Comb 15 GT and Insuman Comb 25 GT are usually administered 30-45 minutes before meals, Insuman Comb 50 GT - for 20-30 minutes. Insulin-dependent diabetes mellitus is usually prescribed Insuman Comb 15 GT and Insuman Comb 25 GT.

Overdose

It is manifested by hypoglycemia of varying severity.

Treatment: glucose inside (if the patient is conscious). In case of unconsciousness, enter / in glucose or glucagon in / m (p / k).

Precautionary measures

IV introduction is absolutely unacceptable. As a rule, the dose should be reduced by replacing insulin with animal origin with Insuman Comb.

Storage conditions

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.