Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
FACTOR VIII
DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR VIII 500 IU/VIAL
I.V
Required
OCTAPHARMA AG, SWITZERLAND
COAGULATION FACTOR VIII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand's disease.
2021-02-28
_1/13 _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OCTANATE 500 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Octanate 500 contains nominally 500 IU human coagulation factor VIII per vial. The product contains approximately 50 IU* per ml human coagulation factor VIII when reconstituted with 10 ml of the supplied solvent. Produced from the plasma of human donors. The product contains approximately ≤ 30 IU per ml von Willebrand factor (VWF:RCo). *The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity is ≥ 100 IU/mg protein. Produced from the plasma of human donors. Excipient with known effect: Sodium up to 1.75 mmol (40 mg) per dose. Sodium concentration after reconstitution: 125 – 175 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white or pale yellow, also appearing as a friable solid. The solvent is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. _2/13 _ POSOLOGY The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, and on the patient’s clinical condition. The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current World Health Organisation (WHO) international standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in Baca dokumen lengkapnya