البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
rFVIII (OCTOCOG ALFA)
Takeda Malaysia Sdn Bhd
rFVIII (OCTOCOG ALFA)
5 ml
Baxalta Belgium Manufacturing S.A.
_ADVATE_ 250, 500, 1000, 1500 IU OCTOCOG ALFA (RECOMBINANT HUMAN COAGULATION FACTOR VIII) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _ADVATE_ is used for 2. How _ADVATE _ works 3. Before you use _ADVATE _ 4. How to use _ADVATE _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ADVATE _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ADVATE IS_ USED FOR _ADVATE_ is used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). HOW _ADVATE WORKS_ _ADVATE _ contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly. BEFORE YOU USE _ADVATE_ _When you must not use it _ _ _ Do not take _ADVATE _ if you: • are allergic to octocog alfa or any of the other ingredients of this medicine. See the end of this leaflet for a complete list of ingredients in _ADVATE._ • Are allergic to mouse or hamster proteins. If you are unsure about this, ask your doctor. _Before you start to use it _ Talk to your doctor before using _ADVATE._ You should tell your doctor if you have been previously treated with Factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again. Inhibitors are blocking antibodies against factor VIII that reduce the efficacy of _ADVATE_ to prevent or control bleeding. Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with _ADVATE_ , tell your doctor immediately. There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to _ADVATE_ . You should be aware of the early signs of allergic reactions such as rash, hiv اقرأ الوثيقة كاملة
Technical Info Dieline NA NA NA CODE 3 OF 9 DATAMATRIX CODE RSS / GS1-128 CODE BODY TEXT SIZE 8.0 pt NA CODE ITF 2/5 3139 PHARMACODE NA GTIN / EAN-13 CODE BACK Black TECHNICAL SPECIFICATION: ARTWORK DIMENSIONS/SIZE: ITEM NUMBER: FRONT LE-07-50075 VERSION: 2 PROFILE: 0400374_1_PIL_Drwg LE0400374 310 x 446 mm GRAPHICS HOUSE: SGK Redmond DATE: 06JUN2020 OPTIONAL: Artwork Approver outside the Shire Management System: ROLE: NAME: SIGNATURE: DATE: PANTONE 259 C Swatch Swatch Black Swatch Swatch Swatch 1. NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4,000‑10,000 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human‑ or animal‑derived protein in the cell culture process, purification or final formulation. Excipients with known effect: 0.45 mmol sodium (10 mg) per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection White to off‑white friable powder. Solvent: Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ADVATE does not contain von Willebrand Factor 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 and with r اقرأ الوثيقة كاملة