Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NONACOG ALFA (RECOMBINANT COAGULATION FACTOR IX)
PFIZER (MALAYSIA) SDN. BHD.
NONACOG ALFA (RECOMBINANT COAGULATION FACTOR IX)
1 mcg/mL; 1 Units; 1 Units
Wyeth Farma, S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BENEFIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Nonacog alfa (250 IU, 500 IU, 1000 IU or 2000 IU) 1 WHAT IS IN THIS LEAFLET 1. What BeneFIX is used for 2. How BeneFIX works 3. Before you use BeneFIX 4. How to use BeneFIX 5. While you are using it 6. Side Effects 7. Storage and Disposal of BeneFIX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BENEFIX IS USED FOR BeneFIX is an injectable medicine that is used to help control and prevent bleeding episodes including those people with haemophilia B (a hereditary bleeding disorder caused by a lack of blood clotting factor IX). BeneFIX is also used to help control and reduce bleeding in surgical settings. HOW BENEFIX WORKS BeneFIX contains active ingredient nonacog alfa (recombinant coagulation factor IX). People who are born with haemophilia B (also known as Christmas disease) lack sufficient factor IX to control bleeding. BeneFIX works by replacing factor IX to enable their blood to clot. BEFORE YOU USE BENEFIX - _When you must not use it_ Do not take BeneFIX - If you are hypersensitive (allergic) to nonacog alfa or to any of the other ingredients of the medicine (listed in Product Description). - If you are allergic to hamster protein. - _Before you start to use it_ Tell your doctor, pharmacist or nurse: - If you have a symptoms or history of allergic reaction like difficulty breathing, shortness of breath, swelling, hives, itching, chills, flushing, tightness of the chest, wheezing, faintness, low blood pressure and blurred vision. - If you suffer from liver disease or if you have recently had surgery or you are known to have coagulation disorder, there is an increased risk for blood clotting (coagulation) complications. _Pregnancy and lactation_ If you are pregnant, planning for pregnancy or breast-feeding ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breast-feeding, BeneFIX should only be given if it is clearly indi Read the complete document
Pfizer Confidential 1 1. NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection. BeneFIX 500 IU powder and solvent for solution for injection. BeneFIX 1000 IU powder and solvent for solution for injection. BeneFIX 2000 IU powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 200 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 400 IU nonacog alfa. Excipients: For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM White/almost white powder and clear and colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION BeneFIX Coagulation Factor IX (Recombinant), is indicated for the control and prevention of hemorrhagic episodes and for routine prophylaxis in patients with hemophilia B (congenital factor IX deficiency or C Read the complete document