Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HUMAN PLASMAFRAKTION (FACTOR VIII)
Octapharma Limited
500 International Unit
Pdr for Soln for Injection
2004-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octanate 500 IU Powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Octanate 500 IU 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 the supplied solvent (10 ml for 500 IU/vial). The product contains approximately 30 IU per ml von Willebrand factor (VWF:RCo). This medicinal product contains up to 1.75 mmol sodium (40 mg) per dose for 500 IU/vial. To be taken into consideration by patients on a controlled sodium diet. For a full list of excipients, see section 6.1. *The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Octanate is 100 IU/mg protein. 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. 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 Read the complete document