Instruction for use: Hemofil M

Dosage form: Lyophilizate for the preparation of a solution for intravenous administration

Active substance: Coagulation factor VIII

ATX

B02BD02 Coagulation factor VIII

Pharmacological group:

Coagulants (including factors of blood coagulation), hemostatics

The nosological classification (ICD-10)

D66 Hereditary factor VIII deficiency: Congenital insufficiency of factor VIII; Hemophilia; Hemophilia A; Hemophilia classical; Deficiency of antihemophilic factor of blood VIII; Deficiency of the coagulation factor VIII; Inhibitory form of hemophilia A; Bleeding at hemophilia A; Hereditary hemophilia; Hereditary anomalies of antihemophilic factor VIII; Failure factor VIII; Insufficiency of coagulation factor VIII; Acquired hemophilia; Coagulopathies are hereditary

R58 Bleeding, not elsewhere classified: Abdominal apoplexy; Hemorrhagia; Haemorrhage of the esophagus; Hemorrhage; Generalized bleeding; Diffuse bleeding; Diffuse bleeding; Prolonged bleeding; Blood loss; Blood loss during surgical interventions; Bleeding during surgery and in the postoperative period; Bleeding during labor; Bleeding and haemorrhage in hemophilia B; Bleeding from the gums; Bleeding intraoperative abdominal; Bleeding against a background of coumarin anticoagulants; Hepatic hepatitis; Bleeding in hemophilia A; Bleeding at hemophilia A; Bleeding with inhibitory forms of hemophilia A and B; Bleeding due to leukemia; Bleeding in patients with leukemia; Bleeding; Bleeding due to portal hypertension; Bleeding due to hyperfibrinolysis; Drug bleeding; Local bleeding; Local bleeding due to activation of fibrinolysis; Massive blood loss; Acute blood loss; Parenchymal hemorrhage; Hepatic bleeding; Postoperative hemorrhage; Kidney bleeding; Vascular-platelet hemostasis; Traumatic bleeding; Threatening bleeding; Chronic blood loss

Composition and release form

1 bottle with a sterile, pyrogen-free, lyophilisate for the preparation of the injection solution contains a blood coagulation factor VIII 220-450, 451-849, 850-1240 or 1240-1700 IU, complete with a solvent - water for injection in 10 ml bottles, with a double-sided needle And a filter needle; In a cardboard box 1 set.

Pharmachologic effect

Mode action - hemostatic, replenishing deficiency of coagulation factor VIII.

Replenishes the deficit of an anti-hemophilic factor.

Indications for Hemofil M

Hemophilia A (classical), hemostasis disorders caused by circulating inhibitors of factor VIII (if their level does not exceed 10 Bethesda ED / ml).

Contraindications

Hypersensitivity.

Side effects

Rarely - nausea, febrile conditions, chills, hives.

Dosing and Administration

• IV, at a rate of 2-3 ml / min. The dosage regimen is set individually under the control of the coagulation factor VIII activity. With joint, muscle and tissue bleedings, the level of activity of factor VIII is increased to 10-20% (duration of treatment is not less than 2-3 days); Removal of the tooth or small operations - not less than 30% (5 days), gastrointestinal bleeding - at least 30-50% (10-14 days); Extensive surgical interventions or intracranial hemorrhages - no less than 60% (2-3 weeks). The initial dose (IU) is calculated as the product of the desired increase in factor VIII (%) content per body weight (kg), the maintenance dose being half the initial dose. For prolonged prevention of bleeding in severe haemophilia A - 12-25 IU / kg every 2-3 days.

Storage conditions of the drug Hemofil M

At a temperature of 2-30 ° C (do not freeze). Avoid freezing liquid for reconstitution

Keep out of the reach of children.

Shelf life of Hemofil M

2 years 6 months.

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