देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Albutrepenonacog Alfa
DKSH MALAYSIA SDN. BHD.
Albutrepenonacog Alfa
6 ml
CSL Behring GmbH
IDELVION ® Albutrepenonacog alfa (250IU, 500IU, 1000IU, 2000IU) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What IDELVION is used for 2. How IDELVION works 3. Before you use IDELVION 4. How to use IDELVION 5. While you are using it 6. Side effects 7. Storage and Disposal of IDELVION 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IDELVION IS USED FOR IDELVION is used in children and adults with hemophilia B to control and prevent bleeding episodes. Your healthcare provider may give you IDELVION when you have surgery. IDELVION can reduce the number of bleeding episodes when used regularly (prophylaxis). HOW IDELVION WORKS IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX. The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)). Factor IX is involved in blood clotting. Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed. IDELVION works by replacing factor IX in haemophilia B patients to enable their blood to clot. BEFORE YOU USE IDELVION - _When you must not use it _ _ _ If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients listed below. _ _ - _Before you start use it _ Talk to your doctor, pharmacist or nurse before using IDELVION. • Allergic (hypersensitivity) reactions are possible. The product contains traces of hamster proteins (see also “When you must not use it”). If symptoms of allergic reactions occur, you should stop using the medicine immediately and contact your doctor. Your doctor should inform you of the early signs of hypersensitivity reactions. These include hives, generalised skin rash, tightness of the chest, wheezing, low blood pressure (hypotension), and anaphylaxis (a serious allergic reaction that cau पूरा दस्तावेज़ पढ़ें
1. NAME OF THE MEDICINAL PRODUCT IDELVION 250IU powder and solvent for solution for injection IDELVION 500IU powder and solvent for solution for injection IDELVION 1000IU powder and solvent for solution for injection IDELVION 2000IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial IDELVION contains nominally 250/500/1000/2000 IU of the active substance, recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections (250/500/1000 IU) the solution contains 100/200/400 IU/ml of albutrepenonacog alfa. When reconstituted with 5 ml water for injections (2000 IU) the solution contains 400 IU/ml of albutrepenonacog alfa. The potency (International Units [IU]) is determined using an in-vitro activated partial thromboplastin time (aPTT)-based one-stage clotting assay calibrated against the World Health Organization (WHO) International Standard for factor IX concentrate. Albutrepenonacog alfa is a purified protein produced by recombinant DNA technology, generated by the genetic fusion of recombinant albumin to recombinant coagulation factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation factor IX enables the protein to be produced as a single recombinant protein and assures product homogeneity by avoiding chemical conjugation. The recombinant factor IX portion is identical to the Thr148 allelic form of plasma-derived factor IX. The cleavable linker between the recombinant factor IX and albumin molecules is derived from the endogenous “activation peptide” in native factor IX. Excipient with known effect: Sodium approximately 75 mmol/l (1.7243 g/l). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Pale yellow to white powder and clear, colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IDELVION is indicated in children पूरा दस्तावेज़ पढ़ें