Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII
Takeda Malaysia Sdn Bhd
Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII
1Units Units; 5 ml 1 Units mL
Takeda Manufacturing Austria AG
_IMMUNATE _ 50 IU/ML HUMAN COAGULATION FACTOR VIII (HUMAN VON WILLEBRAND FACTOR) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What _IMMUNATE _ is used for 2. How _IMMUNATE _ works _3._ _ _ Before you use _IMMUNATE _ _4._ _ _ How to use _IMMUNATE _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _IMMUNATE _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _IMMUNATE IS _USED FOR _IMMUNATE _ is used for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency, haemophilia A with factor VIII inhibitor, acquired factor VIII deficiency due to spontaneous development of factor VIII inhibitor). _IMMUNATE _ is also used for the treatment of bleeding in patients with von Willebrand’s disease with factor VIII deficiency. HOW _IMMUNATE WORKS _ _ _ _IMMUNATE _ is a coagulation factor VIII / von Willebrand factor complex made from human plasma. The coagulation factor VIII in _IMMUNATE _ replaces the factor VIII which is lacking or is not functioning properly in haemophilia A. Haemophilia A is a sex-linked, hereditary blood coagulation defect due to reduced factor VIII levels. This results in severe bleeding in joints, muscles and inner organs, either spontaneously or as a consequence of accidental or surgical traumata. The administration of _IMMUNATE _ temporarily corrects the factor VIII deficiency and reduces the bleeding tendency. In addition to its role as a Factor VIII protecting protein, von Willebrand Factor (VWF) mediates platelet adhesion to sites of vascular injury and plays a role in platelet aggregation. BEFORE YOU USE _IMMUNATE _ _ _ _When you must not use it _ Do not take _IMMUNATE _ if you are allergic to human coagulation factor VIII or any of the other ingredients of this medicine. See the end of this leaflet for a complete list of ingredients in _IMMUNATE. _ If you are unsure about this, ask your doctor. _Before you start use it _ _ _ _When allergic Lire le document complet
Black Black Dieline Technical Info Item Number: Profile: Artwork Dimensions/Size: Graphics House: Date: OPTIONAL: Artwork Approver outside the Shire Management System: Role: Name: Signature: Date: Version: Technical Specification: 0750095 2 0402115_1_PIL_Drwg 435 x 270 mm 103988904 / 401937462 / SGK München 16Jun2020 0402115 750095 CODE ITF 2/5 DATAMATRIX CODE NA RSS / GS1-128 CODE NA PHARMACODE NA CODE 3 OF 9 NA GTIN / EAN-13 CODE NA BODY TEXT SIZE 9 pt FRONT BACK 1. NAME OF THE MEDICINAL PRODUCT IMMUNATE 50 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances: Human coagulation Factor VIII/ Human von Willebrand Factor Each vial contains nominally 250 IU human coagulation factor VIII1 and 190 IU human von Willebrand factor 2 (VWF:RCo). Immunate 250 IU FVIII/190 IU VWF contains approximately 50 IU/ml of human coagulation factor VIII and 38 IU/ml human von Willebrand factor after reconstitution. The potency of factor VIII (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Immunate is 70 ± 30 IU FVIII/mg protein 3 . The potency of VWF (IU) is determined using the European Pharmacopoeia ristocetin co-factor assay (VWF:RCo). Produced from the plasma of human donors. Excipients with known effect: 1 vial contains approx. 9.8 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White or pale yellow powder or friable solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency, haemophilia A with factor VIII inhibitor, acquired factor VIII deficiency due to spontaneous development of factor VIII inhibitor). Von Willebrand’s disease with factor VIII deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physician experienced in the treatment of haemostatic disorders. Posology DOSAGE IN HAEMOP Lire le document complet