Land: Israël
Taal: Engels
Bron: Ministry of Health
FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR
CSL BEHRING LTD., ISRAEL
B02BD07
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
FACTOR VIII (HUMAN) 500 IU / 10 ML; VON WILLEBRAND FACTOR 1200 IU / 10 ML
I.V
Required
CSL BEHRING GMBH, GERMANY
COAGULATION FACTOR XIII
COAGULATION FACTOR XIII
Congenital and acquired deficiency of blood clotting factor VIII: severe or moderate haemophilia, prophylaxis during operation, Von Willebrands disease.
2014-02-28
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 19/11/2014 םש רישכת תילגנאב רפסמו :םושירה HAEMATE-P 250 I.U. ( 113 53 22360 00 ), HAEMATE-P 500 I.U. ( 113 51 22459 00 ) HAEMATE-P 1000 I.U ( 113 52 22460 00 ) םש לעב םושירה GENMEDIX דבלב תורמחהה טורפל דעוימ הז ספוט ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Prophylaxis_ _[…]_ _Prophylaxis_ _[…]_ _Previously untreated patients _ The safety and efficacy of Haemate in previously untreated patients have not yet been established. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _HAEMOPHILIA A_ The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the exposure to anti-haemophilic factor VIII, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days. patients treated with human coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. In patients with high levels of inhibitor, therapy may not be effective and other therapeutic options should be considered. See also section “4.8 Undesirable effects". _HAEMOPHILIA A_ _Inhibitors_ The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which ar Lees het volledige document
FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT HAEMATE ® P 250 IU FVIII / 600 IU VWF Powder and solvent for solution for injection or infusion HAEMATE ® P 500 IU FVIII / 1200 IU VWF Powder and solvent for solution for injection or infusion HAEMATE ® P 1000 IU FVIII / 2400 IU VWF Powder and solvent for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial Haemate P 250 IU FVIII / 600 IU VWF contains nominally: 250 IU human coagulation factor VIII (FVIII). 600 IU human von Willebrand factor (VWF). After reconstitution with 5 ml water for injections, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF. One vial Haemate P 500 IU FVIII / 1200 IU VWF contains nominally: 500 IU human coagulation factor VIII (FVIII). 1200 IU human von Willebrand factor (VWF). After reconstitution with 10 ml water for injections, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF. One vial Haemate P 1000 IU FVIII / 2400 IU VWF contains nominally: 1000 IU human coagulation factor VIII (FVIII). 2400 IU human von Willebrand factor (VWF). After reconstitution with 15 ml water for injections, the solution contains 66.6 IU/ml of FVIII and 160 IU/ml of VWF. The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific FVIII activity of Haemate P is approximately 2 - 6 IU of FVIII/mg protein. 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 specific VWF activity of Haemate P is approximately 5 - 17 IU of VWF:RCo/mg protein. Haemate P is produced from the plasma of human donors. Excipient with known effect: Sodium: Haemate P 250 IU FVIII / 600 IU VWF and Haemate P 500 IU FVIII / 1200 IU VWF – approximately 113 mmol/l (2.6 mg/ml) Haemate P 1000 IU FVIII / 2400 IU VWF – approximately 150 mmol/l (3.5 mg/ml) For the full list of excipients, see section 11 (Description). 3. PHARMACEUTICAL FORM Powder and solvent for s Lees het volledige document