Instruction for use: Octavi

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 vial of 510-770 mg of lyophilized powder for the preparation of the injection solution contains a fraction of human plasma enriched with a coagulation factor VIII and having an activity of 250 IU (with a total protein content of 1-5 mg, Octavi 250), 500 IU (protein 2 -10 mg; Octavi 500) or 1000 IU (protein 4-20 mg; Octavi 1000); Complete with a solvent (water for injection) in 10 ml vials. The package also contains 1 disposable syringe per 10 ml, 1 needle with two ends, 1 filter needle, 1 set for infusion and 2 tampons moistened with alcohol.

Characteristic

Lyophilized human blood coagulation factor VIII.

Pharmachologic effect

Mode action - Hemostatic.

Replenishes the deficiency of the coagulation factor VIII.

Indications for Octavi

Insufficiency of coagulation factor VIII, incl. Haemophilia A; Violations of hemostasis caused by antibodies to factor VIII.

Contraindications

Not.

Side effects

Increase in body temperature, development of antibodies to factor VIII, hypervolemia, hemolysis, reduction of resistance to infectious diseases, allergic, incl. Anaphylactic reactions.

Dosing and Administration

IV, Slowly (pre-dissolve in the attached solvent). The dose and course are set individually. When calculating the dose, it is recommended to take into account that 1 IU of factor VIII per 1 kg of body weight increases the level of factor VIII in the blood by 1-2% and during 12 hours the activity of factor VIII decreases by 15%. With hemorrhages in joints, muscles and small bleeding in tissues, the level of factor VIII is increased by 10-20% (course of treatment 2-3 days); With bleeding in the oral cavity, removal of teeth, small operations, the level should not fall below 30% (course of treatment 5 days); With gastrointestinal bleeding, a drop in the level of factor VIII should not be lower than 30-50% (course of treatment 10-14 days); At complex operations or intracranial hemorrhages - below 60% (course of treatment 2-3 weeks). For long-term prophylaxis of bleeding in severe hemophilia A, 12-25 IU / kg is administered every 2-3 days (if necessary, the dose is increased and the intervals are shortened).

Storage conditions of the drug Octavi

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

Keep out of the reach of children.

Shelf life of Octavi

2 years.

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