Instruction for use: Immunate

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

Composition and release form

1 bottle with lyophilized powder for the preparation of the injection solution contains clotting factor VIII 250, 500 or 1000 IU, complete with water for injection in vials of 5 and 10 ml, and a set of accessories for dissolution and administration (syringes and needles); In the box 1 set.

Pharmachologic effect

Mode action - hemostatic.

Replenishes the deficiency of endogenous coagulation factor VIII in the blood plasma, normalizes hemocoagulation in patients with its deficiency.

Indications for Immunate

Bleeding due to congenital or acquired factor VIII deficiency: hemophilia A, inhibitory form of hemophilia A, acquired factor VIII deficiency associated with the spontaneous appearance of an appropriate inhibitor (treatment and prevention), vWF disease with factor VIII deficiency.

Contraindications

Hypersensitivity.

Side effects

Hemolysis, the formation of antibodies that inhibit factor VIII in the blood, allergic reactions.

Dosing and Administration

• IV, by drop or stream infusion (Injection rate not more than 2 ml / min), dissolve 250-500 IU in 5 ml and 1000 IU in 10 ml of water for injection immediately before injection. To calculate the effective therapeutic dose, determine the level of factor VIII in the plasma and use the formula-dose (ME) = body weight (kg) x the desired increase in factor VIII (%) x 0.5. Enter at intervals of 8-12 hours; With severe hemophilia A - 10-50 IU / kg at intervals of 2-3 days, with the inhibitory form of hemophilia, the dosage is calculated individually, based on coagulation assays; For the prevention of bleeding during surgery - 1 hour before surgery, in the case of a major intervention - before surgery and every 8 hours of the first postoperative day.

Precautionary measures

Do not mix with other medications. During pregnancy and during breast-feeding are used only in case of acute necessity. When allergy signs appear, treatment should be stopped and antihistamine or anti-shock therapy initiated. The appointment of large doses especially requires mandatory monitoring of patients with blood groups A, B and AB for the timely detection of hemolysis.

Special instructions

For the infusion use a disposable system with an adequate filter. The solution must be consumed quickly and not reused.

Storage conditions of the drug Immunate

At a temperature of 2-8 ° C. Within the indicated period, it can be stored at room temperature (up to 25 ° C) for 6 months.

Keep out of the reach of children.

Shelf life of Immunate

2 years.

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