Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
FACTOR VIII; VON WILLEBRAND FACTOR
KAMADA LTD, ISRAEL
B02BD06
POWDER FOR SOLUTION FOR INJECTION
FACTOR VIII 500 IU/VIAL; VON WILLEBRAND FACTOR 1300 IU/VIAL
I.V
Required
BIO PRODUCTS LABORATORY LIMITED, UK
VON WILLEBRAND FACTOR AND COAGULA-TION FACTOR VIII IN COMBINATION
VON WILLEBRAND FACTOR AND COAGULA-TION FACTOR VIII IN COMBINATION
Treatment and prophylaxis of bleeding with haemophilia A (congenital factor VIII deficiency).
2013-12-31
1 Product Data Sheet OPTIVATE HIGH PURITY FACTOR VIII AND VON WILLEBRAND FACTOR CONCENTRATE 1. NAME OF THE MEDICINAL PRODUCT: Optivate 500 IU, powder for solution for injection Optivate 1000 IU, powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Optivate is a concentrate of human coagulation factor VIII with associated von Willebrand Factor (VWF) (the natural stabiliser for FVIII). There are no added proteins as stabilisers. Optivate 500 IU Each vial contains nominally 500 IU human coagulation factor VIII. Optivate contains approximately 100 IU/ml of human coagulation factor VIII after reconstitution. Optivate 1000 IU Each vial contains nominally 1000 IU human coagulation factor VIII. Optivate contains approximately 100 IU/ml of human coagulation factor VIII after reconstitution. The factor VIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Optivate is approximately 800 IU/mg protein when VWF is discounted and approximately 43 IU/mg protein when the presence of VWF is considered in the calculation. The VWF potency (IU) is measured according to Ristocetin Cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand Factor concentrate (WHO). The label on each vial states the assayed amounts of factor VIII and VWF Ristocetin Cofactor activities. Produced from the plasma of human donors. Excipient with known effect: Optivate contains approximately 320 mmol/1 (7.4 mg/ml) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM: Powder and solvent for solution for injection. Powder: White or pale yellow powder. Solvent: Clear colourless liquid. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dosage and duration of the su Izlasiet visu dokumentu