Instruction for use: Octanine

Dosage form: Lyophilizate for the preparation of a solution for infusions

Active substance: Antihemophilic factor IX

ATX

B02BD04 Antihemophilic factor IX

Pharmacological group:

Coagulants (including factors of blood coagulation), hemostatics

The nosological classification (ICD-10)

D67 Hereditary factor IX deficiency: Congenital factor IX deficiency; Congenital deficiency of the coagulation factor IX; Hemorrhagic syndrome with factor IX deficiency; Hemophilia B; Hemophilia B with a factor IX inhibitor; Hemophilia B in children; Deficiency of the coagulation factor IX; Inhibitory form of hemophilia; Inhibitory form of hemophilia B; Coagulopathies are hereditary; Bleeding and haemorrhage in hemophilia B; Bleeding with acquired or congenital deficiency of factor IX; Hereditary hemophilia

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 with 280-500 mg of lyophilized powder for the preparation of the injection solution contains a fraction of human plasma enriched with coagulation factor IX and having an activity of 250 IU (with a total protein content of not more than 10 mg, Octanine 250), 500 IU (protein, no more than 20 mg; octanine 500) or 1000 IU (protein not more than 40 mg; octanine 1000); In a set with a solvent (water for injection), in bottles of 10 ml. 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 factor IX of blood clotting.

Pharmachologic effect

Mode of action - hemostatic.

Replenishes the deficiency of the coagulation factor IX.

Indications of preparation Octanine

Prevention and treatment of bleeding and hemorrhage in hemophilia B (congenital deficiency of the coagulation factor IX), acquired factor IX deficiency.

Contraindications

Acute thrombosis, acute myocardial infarction.

Side effects

Decrease in resistance to infectious diseases, the formation of antibodies to factor IX, allergic, incl. Anaphylactic reactions.

Dosing and Administration

• IV, slowly (pre-dissolve in the attached solvent). The dose is set individually. For emergency cases it is recommended to take into account that the primary administration in a dose of 1 IU / kg of body weight leads to an increase in the concentration of factor IX in the blood by 0.5-1%, subsequent administration at this dose by 1-1.5%. With bleeding in the oral cavity, removal of teeth and other small operations, the recommended level of factor IX should not fall below 30%, with gastrointestinal bleeding - not lower than 30-50%, with intracranial hemorrhages or large operations - not less than 60%. For the long-term prevention of bleeding in severe cases of hemophilia B, the recommended dose is 18-30 IU / kg once a week or 9-15 IU / kg 2 times a week.

Precautionary measures

• In DIC-syndrome (even with suspicion) should be used only after the termination of the process.

Storage conditions of the drug Octanine

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of Octanine

2 years.

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