Instruction for use: Koate-HP

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)

D65-D69 Blood clotting disorders, purpura and other hemorrhagic conditions: Hyperfibrinolysis; Hypocoagulation; Increased vascular permeability; Hemorrhagic syndrome

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

Composition and release form

1 bottle with lyophilized powder for the preparation of the injectable solution contains anti-hemophilic factor VIII (human) 250, 500, 1000 or 1500 IU; Complete with a solvent in ampoules of 5 or 10 ml respectively, as well as with a bilateral needle, needle-filter and infusion set.

Pharmachologic effect

Mode action - Replenishing deficiency of coagulation factor VIII.

Pharmacodynamics

Provides an increase in the level of factor VIII in blood plasma and temporarily corrects the coagulation defect.

Indications for Koate-HP

Hemophilia A (treatment and prevention of bleeding).

Contraindications

Not.

Side effects

Allergic reactions.

Dosing and Administration

IV. For the prevention of spontaneous bleeding or with mild bleeding - 10 IU / kg. With moderate bleeding and minor surgery, 15-25 IU / kg followed by a maintenance dose of 10-15 IU / kg every 8-12 hours. In case of acute bleeding that threatens life or involves vital structures, 40-50 IU / kg, followed by a maintenance dose of 20-25 IU / kg every 8-12 hours. If a significant surgical procedure is performed, 40-50 IU / kg for 1 hour before the procedure and 20-25 IU / kg after 5 hours After the first dose

Precautionary measures

Careful monitoring of the blood formula should be carried out in patients with blood group A, B or AB (to identify early signs of anemia). When pregnancy is used only in case of emergency.

Storage conditions of the drug Koate-HP

At a temperature of 2-8 ° C (do not freeze). For short-term storage (up to 6 months) - at a temperature of up to 25 ° C.

Keep out of the reach of children.

Shelf life of Koate-HP

2 years.

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