Expiration date: 10/2024

The composition and form of issue:

Protafan HM

Suspension for subcutaneous injection. 1 ml contains:

insulin-isophane [human genetic engineering] 100 IU (3.5 mg)

1 IU corresponds to 0,035 mg of anhydrous human insulin 

excipients: zinc chloride, glycerin (glycerol) metacresol phenol sodium hydrogen phosphate dihydrate Protamine sulphate sodium hydroxide and/or hydrochloric acid (to adjust pH) water for injections 

10 ml in glass vials in carton of 1 vial.

Protafan HM Penfill

Suspension for subcutaneous injection. 1 ml contains:

insulin-isophane [human genetic engineering] 100 IU (3.5 mg)

1 IU corresponds to 0,035 mg of anhydrous human insulin 

excipients: zinc chloride, glycerin (glycerol) metacresol phenol sodium hydrogen phosphate dihydrate Protamine sulphate sodium hydroxide and/or hydrochloric acid (to adjust pH) water for injections 

for 3 ml glass cartridges Penfill in blister packs of 5 cartridges in cardboard pack 1 blister.

Feature:

Monocomponent biosynthetic human isophane insulin suspension medium duration of action.

Pharmacological action:

Interacts with the specific receptor plazmaticescoy membranes and enters the cell where it activates the phosphorylation of cellular protein stimulates glikiencintetazu, piruvatdegidrogenzu, geksokinazou, ingibiruet lipazu adipose tissue and lipoproteinlipazou. In tandem with the specific receptor facilitates entry of glucose into cells, increases absorption by tissues and promotes the enzyme. Increases the glycogen stores in the muscles, stimulates the synthesis of peptides.

Clinical pharmacology:

The effect is a 1.5 h after s/to the introduction, reaches its maximum after 4-12 hours and lasts for 24 h protafan Hm Penfill in insulin-dependent diabetes mellitus is used as basal insulin in combination with short-acting insulin, with insulin — like monotherapy and in combination with rapid acting insulins.

Indications:

Diabetes mellitus type I, diabetes type II (resistance to the sulfonylureas, interkurrentnykh diseases, and operations in the postoperative period, pregnancy).

Contraindications:

Hypoglycemia, insulinoma.

Side effects:

Hypoglycemic condition, allergic reactions, lipodystrophy (long-term use).

Drug interactions:

Hypoglycemic effect increase acetylsalicylic acid, alcohol, alpha - and beta-blockers, amphetamine, anabolic steroids, clofibrate, cyclophosphamide, fenfluramine, fluoxetine, ifosfamide, MAO inhibitors, methyldopa, tetracyclines, tritoqualine, trofosfamide weaken — chlorprothixene, diazoxide, diuretics (especially thiazides), glucocorticoids, heparin, hormonal contraceptives, isoniazid, lithium carbonate, nicotinic acid, phenothiazines, sympathomimetics, tricyclic antidepressants.

Method of application and dose:

Protafan HM

Protafan HM Penfill

N/a. the Dose is selected individually, taking into account the patient's needs. Usually the need for insulin varies from 0.3 to 1 IU/kg/day. The daily insulin requirement may be higher in patients with insulinrezistentnost (e.g. in puberty, and in patients with obesity) and lower in patients with residual endogenous insulin production. In addition, the doctor determines how many injections a day to the patient one or more. Protafan Hm can be administered both as monotherapy and in combination with insulin rapid or short-acting. If necessary, intensive insulin therapy the suspension may be used as basal insulin (injection is carried out in the evening and/or morning), in combination with insulin rapid or short-acting injections which have to be timed to meals.

If patients with diabetes achieved optimal glycemic control, complications of diabetes they have, as a rule, appear later. In this regard, the aim should be to optimize metabolic control, in particular by conducting thorough monitoring of glucose levels in the blood.

The drug is usually injected s/C in the thigh area. If it is convenient, the injection can be made also in the anterior abdominal wall, the gluteal region or the deltoid region of the shoulder. When the drug is administered in the thigh area, there is a slow absorption than when administered in the region of the anterior abdominal wall. If the injection is drawn in the fold of skin, it minimizes the risk of accidental/m injection.

It is necessary to change the injection site within the anatomical region to prevent the development of lipodystrophy.

Suspension of insulin in any circumstances you cannot enter.

Dose adjustment

If the kidney damage or liver the need for insulin is reduced.

Overdose:

Symptoms: hypoglycemia (cold sweat, palpitations, tremor, hunger, excitement, irritability, paleness, headache, drowsiness, lack of movement, impaired speech and vision, depression). Severe hypoglycemia can cause temporary or permanent dysfunction of the brain, coma and death.

Treatment: sugar, or glucose inside (if the patient is conscious), n/a, in/m or/in — glukagon or/in — glucose.

Precautions:

You should not use the drug if mixing suspension is not fully homogeneous.

Storage conditions:

Used, the bottle should be stored at room temperature not above 30 °C for 6 weeks. Protect from direct heat and sunlight.

Insulin
Protaphane
HM
(Insulin-isophane)