Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLATE MOFETIL
UNIMED SDN BHD
MYCOPHENOLATE MOFETIL
100Capsule Capsules; 50Capsule Capsules
Strides Pharma Science Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ REFRAT Mycophenolate Mofetil Capsules USP 250mg / Tablets USP 500mg 1 WHAT IS IN THIS LEAFLET 1. What Refrat Capsule/ Tablet is used for 2. How Refrat Capsule/ Tablet works 3. Before you use Refrat Capsule/ Tablet 4. How to take Refrat Capsule/ Tablet 5. While you are using Refrat Capsule/ Tablet 6. Side Effects 7. Storage and Disposal of Refrat Capsule/ Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT REFRAT CAPSULE/ TABLET IS USED FOR Refrat is used to prevent your body rejecting a transplanted organ; i.e. kidney, heart or liver. Refrat is indicated for induction and maintenance treatment of lupus nephritis (inflammation of the kidney caused by systemic lupus erythematosus (SLE)), a disease of the immune system. Refrat is used together with other medicines: • Cyclosporine • corticosteroids. HOW REFRAT CAPSULE/ TABLET WORKS Refrat contains mycophenolate mofetil, This belongs to a group of medicines called “immune - suppressants”. This medication works by lowering your body's immune system activity. BEFORE YOU USE REFRAT CAPSULE/ TABLET _-When you must not take it _ DO NOT TAKE REFRAT IF: • you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Refrat If you are not sure, talk to your doctor or pharmacist before taking Refrat. BEFORE YOU START TO TAKE IT Take special care with Refrat Talk to your doctor straight away before taking Refrat if: • you have a sign of infection such as a fever or sore throat • you have any unexpected bruising or bleeding • you have ever had a problem with your digestive system such as a stomach ulcer • you have increased risk for cancer especially skin cancer. Taking Refrat with food and drink Taking food and drink has no effect on your treatment with Refrat. Pregnancy, contraception and breast- feeding Pregnancy If you are pregnant, do not take Refrat. This is because Refrat may harm your unborn baby. • Olvassa el a teljes dokumentumot
D3 PROPOSED PACKAGE INSERT REFRAT MYCOPHENOLATE MOFETIL CAPSULES USP 250MG REFRAT MYCOPHENOLATE MOFETIL TABLETS USP 500MG COMPOSITION: Each capsule contains Mycophenolate Mofetil 250mg Each film coated tablet contains Mycophenolate Mofetil 500mg PRODUCT DESCRIPTION: 250mg: White to off white blend of Mycophenolate Mofetil filled in size 1 hard gelatin capsules with ivory Cap and ivory body printed “SAL” on cap & “726” on body in black. 500mg: Pinkish brown coloured, capsule shaped, film coated tablets with “SAL” engraved on one side and engraved “725” on other side. PHARMACOLOGY: Mycophenolate mofetil, the 2-morpholinoethyl ester of mycophenolic acid (MPA), is an immunosuppressive agent. Mycophenolate mofetil is a prodrug that has little pharmacologic activity until hydrolyzed in vivo to mycophenolic acid (MPA), the pharmacologically active metabolite. MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation in to DNA. MPA has more potent cytostatic effects on lymphocytes than on other cells. PHARMACOKINETICS: ABSORPTION Mycophenolate mofetil is well absorbed following oral administration, having an absolute bioavailability of approximately 94% (based on mycophenolic acid and. undergoes complete presystemic metabolism to the active metabolite, MPA. Mycophenolate mofetil can be measured systemically during intravenous infusion; however, after oral administration it is below the limit of quantitation (0.4 µ g/mL). Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil administered at doses of 1.5 g twice daily to renal transplant patients. However, MPA C max was decreased by 40% in the presence of food. DISTRIBUTION Secondary increases in plasma MPA concentration are usually observed at approximately 6-12 hours post-dose, consistent with enterohepatic recirculation. At clinically relevant concentrations, MPA is 97% bo Olvassa el a teljes dokumentumot