البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SIROLIMUS
PFIZER (MALAYSIA) SDN. BHD.
SIROLIMUS
30Tablet Tablets; 100Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ RAPAMUNE _®_ Sirolimus (1 mg) 1 WHAT IS IN THIS LEAFLET 1. What Rapamune is used for 2. How Rapamune works 3. Before you use Rapamune 4. How to use Rapamune 5. While you are using it 6. Side Effects 7. Storage and Disposal of Rapamune 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT RAPAMUNE IS USED FOR Rapamune is a medicine used to prevent rejection (anti-rejection medicine) in people who have received a kidney transplant. Rejection is when your body’s immune system recognizes the new organ as a “foreign” threat and attacks it. You will be determined if you have a low to moderate immunological risk or high immunological risk. IF YOU BELONG TO LOW TO MODERATE IMMUNOLOGICAL RISK, you will be asked to take Rapamune initially in a regimen with cyclosporine and corticosteroids. Cyclosporine will be withdrawn 2 to 4 months after transplantation, and the Rapamune dose will be increased to reach recommended blood concentrations. IF YOU BELONG TO HIGH IMMUNOLOGIC RISK (defined as Black transplant recipients and/or repeat kidney transplant recipients who lost a previous transplant for immunologic reason and/or individuals with high- panel reactive antibodies (PRA; peak PRA level > 80%), you will be asked to take Rapamune in combination with tacrolimus and corticosteroids or cyclosporine and corticosteroids for the first year following transplantation. Whether these combinations are safe and effective in high-risk renal transplant patients have not been studied beyond one year. Therefore, after the first year following transplantation, any adjustments to these regimens will be considered on the basis of your clinical status. HOW RAPAMUNE WORKS Rapamune inhibits the activation and increase in the number or amount of a type of white blood cell called T- lymphocyte. Your body produces T- lymphocytes to fight against infection or foreign substances which have entered the body. Rapamune also inhibits antib اقرأ الوثيقة كاملة
WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES MAY RESULT FROM IMMUNOSUPPRESSION INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA MAY RESULT FROM IMMUNOSUPPRESSION. ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF RENAL TRANSPLANT PATIENTS SHOULD USE RAPAMUNE FOR PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING RENAL TRANSPLANTS. PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE PATIENT. THE SAFETY AND EFFICACY OF RAPAMUNE (SIROLIMUS) AS IMMUNOSUPPRESSIVE THERAPY HAVE NOT BEEN ESTABLISHED IN LIVER OR LUNG TRANSPLANT PATIENTS, AND THEREFORE, SUCH USE IS NOT RECOMMENDED. LIVER TRANSPLANTATION – EXCESS MORTALITY, GRAFT LOSS, AND HEPATIC ARTERY THROMBOSIS (HAT) THE USE OF RAPAMUNE IN COMBINATION WITH TACROLIMUS WAS ASSOCIATED WITH EXCESS MORTALITY AND GRAFT LOSS IN A STUDY IN _DE NOVO_ LIVER TRANSPLANT PATIENTS. MANY OF THESE PATIENTS HAD EVIDENCE OF INFECTION AT OR NEAR THE TIME OF DEATH. IN THIS AND ANOTHER STUDY IN _DE NOVO_ LIVER TRANSPLANT PATIENTS, THE USE OF RAPAMUNE IN COMBINATION WITH CYCLOSPORINE OR TACROLIMUS WAS ASSOCIATED WITH AN INCREASE IN HAT; MOST CASES OF HAT OCCURRED WITHIN 30 DAYS POST-TRANSPLANTATION AND MOST LED TO GRAFT LOSS OR DEATH. LUNG TRANSPLANTATION – BRONCHIAL ANASTOMOTIC DEHISCENCE CASES OF BRONCHIAL ANASTOMOTIC DEHISCENCE, MOST FATAL, HAVE BEEN REPORTED IN _ DE NOVO_ LUNG TRANSPLANT PATIENTS WHEN RAPAMUNE HAS BEEN USED AS PART OF AN IMMUNOSUPPRESSIVE REGIMEN. 1. NAME OF THE MEDICINAL PRODUCT Rapamune 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sirolimus is a white to off-white powder. It is insoluble in water but freely soluble in benzyl alcohol, chloroform, acet اقرأ الوثيقة كاملة