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Instructions

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Instruction for use: Kryobulin TIM 3

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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 lyophilized powder for the preparation of the injection solution contains antihemophilic globulin A in purified, concentrated and stabilized form 250, 500 or 1000 IU, complete with water for injections (bottles of 10, 20 and 40 ml). The content of factor VIII per 1 mg of protein is from 1.25 to 2.5 IU. The product contains 17.5 mg of glucose in 1 ml of reconstituted solution. The plasma used to produce the drug undergoes mandatory testing for ALT, as well as the absence of HBsAg, anti-HCV, HIV-1 and HIV-2 antibodies.

Pharmachologic effect

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

Indications for Kryobulin TIM 3

Disorders of hemostasis against congenital or acquired (inhibitory form of hemophilia A) factor VIII deficiency.

Contraindications

Not identified.

Side effects

Nausea, vomiting, allergic reactions (fever, urticaria), activation of the factor VIII inhibitor.

Dosing and Administration

IV (solution is prepared before injection), with a speed of no more than 5 ml / min. The dose depends on the degree of deficiency of factor VIII. Introduction 1ME / kg increases the level of the factor in the plasma by 1% (first dose) or 2% (repeated dose).

Storage conditions of the drug Kryobulin TIM 3

At a temperature of 2-8 C.

Keep out of the reach of children.

Shelf life of Kryobulin TIM 3

2 years (6 months at room temperature not higher than 25 C).

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

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