Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Rurioctocog alfa pegol
Takeda Malaysia Sdn Bhd
Rurioctocog alfa pegol
2 ml
Baxalta US Inc
_ADYNOVATE_ 250, 500, 750, 1000, 1500, 2000, 3000IU ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _ADYNOVATE_ is used for 2. How _ADYNOVATE _ works 3. Before you use _ADYNOVATE_ 4. How to use _ADYNOVATE _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ADYNOVATE_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ADYNOVATE IS_ USED FOR _ADYNOVATE_ is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you _ADYNOVATE _ when you have surgery. _ADYNOVATE_ can reduce the number of bleeding episodes when used regularly (prophylaxis). _ADYNOVATE_ is not used to treat von Willebrand disease. HOW _ADYNOVATE WORKS_ _ADYNOVATE, _ a PEGylated form of recombinant antihemophilic factor ( _ADVATE_ ), temporarily replaces the missing coagulation factor VIII needed for effective hemostasis in congenital hemophilia A patients. _ADYNOVATE_ exhibits an extended terminal half-life through pegylation of the parent molecule, _ADVATE_ , which reduces binding to the physiological factor VIII clearance receptor (LRP1). BEFORE YOU USE _ADYNOVATE_ _When you must not use it _ _ _ You should not use _ADYNOVATE _ if you: • are allergic to any ingredients in _ADYNOVATE_ or _ADVATE_ . See the end of this leaflet for a complete list of ingredients in _ADYNOVATE._ • are allergic to mice or hamster protein. If you are unsure about this, ask your doctor. _Before you start to use it _ You should tell your healthcare provider if you: • Have or have had any medical problems. • Have any allergies, including allergies to mice or hamsters. • Are breastfeeding. It is not known if _ADYNOVATE_ passes into your milk and if it can harm your baby. • Are pregnant or planning to become pregnant. It is not known if _ADYNOVATE_ may harm your unborn baby. • Have been told Soma hati kamili
FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT ADYNOVATE 250IU powder and solvent for solution for injection ADYNOVATE 500IU powder and solvent for solution for injection ADYNOVATE 750IU powder and solvent for solution for injection ADYNOVATE 1000IU powder and solvent for solution for injection ADYNOVATE 1500IU powder and solvent for solution for injection ADYNOVATE 2000IU powder and solvent for solution for injection ADYNOVATE 3000IU powder and solvent for solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION ADYNOVATE 250IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol ADYNOVATE 500IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol. ADYNOVATE 750IU powder and solvent for solution for injection Each vial contains nominally 750 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol. ADYNOVATE 1000IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol ADYNOVATE 1500IU powder and solvent for solution for injection Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol ADYNOVATE 2000IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol ADYNOVATE 3000IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol 1 INDICATIONS AND USAGE ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management • Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use ADYNOV Soma hati kamili