Protafan HM, 100 me/ml suspension 10 ml

Protaphan HM has hypoglycemic action.

It interacts with specific receptor of plasma membrane and penetrates into cell, where it activates phosphorylation of cellular proteins, stimulates glycogen synthetase, pyruvate dehydrogenase, hexokinase, inhibits lipase of fat tissue and lipoproteinlipase. In complex with specific receptor it facilitates glucose penetration into cells, enhances its uptake by tissues and promotes conversion into glycogen. It increases the stock of glycogen in the muscles and stimulates the synthesis of peptides.

The effect develops 1.5 hours after p/u injection, reaches a maximum after 4-12 hours and lasts 24 hours. Protafan NM Penfill in insulin-dependent diabetes is used as basal insulin in combination with short-acting insulin, in insulin-independent – both for monotherapy and in combination with fast-acting insulins.

Indications

Type 1 diabetes, Type 2 diabetes

Type I diabetes, Type II diabetes (with resistance to sulfonylurea derivatives, intercurrent diseases, surgery and in the postoperative period, pregnancy.)

Composition

Active ingredient:

Isophene insulin (human genetically engineered);

Auxiliary substances:

Zinc chloride;

Glycerin (glycerol);

methacresol;

phenol;

sodium hydrophosphate dihydrate;

Protamine sulfate;

Sodium hydroxide and/or hydrochloric acid (for pH adjustment);

Injectable water

How to take, the dosage

Subcutaneously. The drug is intended for subcutaneous administration. Suspensions of insulin cannot be injected intravenously.

The dose of the drug is adjusted individually, taking into account the needs of the patient. Usually the requirement for insulin is 0.3 to 1 IU/kg/day. The daily requirement of insulin may be higher in patients with insulin resistance (e.g., during puberty and in obese patients) and lower in patients with residual endogenous insulin production.

Protaphan^® NM may be used either in monotherapy or in combination with rapid-acting or short-acting insulin.

Protaphan^® NM is usually injected subcutaneously, in the thigh area. If it is convenient, injections may also be given in the anterior abdominal wall, gluteal region, or in the deltoid region of the shoulder. When injecting the drug into the thigh area, slower absorption is noted than when injecting into other areas. If the injection is made into a retracted skin fold, the risk of accidental intramuscular injection is minimized.

The needle must stay under the skin for at least 6 seconds to ensure complete administration of the dose. The injection sites within the anatomical region need to be changed constantly to prevent lipodystrophy.

Protafan^® NM Penfill^® is designed for use with Novo Nordisk insulin injection systems and NovoFine^® or NovoTwist^® needles. Detailed recommendations for use and administration should be followed.

Dose adjustment

Companion diseases, especially those with infection and fever, usually increase the body’s need for insulin. Dose adjustment of the drug may also be necessary if the patient has concomitant kidney, liver, adrenal, pituitary, or thyroid disorders. A dose adjustment may also be necessary in case of changes in physical activity or in the patient’s usual diet. Dose adjustments may be necessary when changing from one type of insulin to another.

Interaction

Hypoglycemic effect is enhanced by acetylsalicylic acid, alcohol, alpha- and beta-adrenoblockers, amphetamine, anabolic steroids, clofibrate, cyclophosphamide, fenfluramine, fluoxetine, ifosfamide, MAO inhibitors, methyldopa, tetracyclines, tritoqualine, triphosphamide, attenuate – chlorprotixene, diazoxide, diuretics (especially thiazides), glucocorticoids, heparin, hormonal contraceptives, isoniazid, lithium carbonate, nicotinic acid, phenothiazines, sympathomimetics, tricyclic antidepressants.

Contraindications

Hypoglycemia, insulinoma.

Side effects

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

Overdose

Symptoms: development of hypoglycemia (cold sweat, palpitations, tremors, hunger, agitation, irritability, pallor, headache, drowsiness, uncertainty of movements, speech and vision disorders, depression). Severe hypoglycemia can lead to temporary or permanent impairment of brain function, coma and death.

Treatment: sugar or glucose solution orally (if the patient is conscious), n/a, intravenous or intravenous – glucagon or intravenous – glucose.