Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLATE MOFETIL
HOVID BERHAD
MYCOPHENOLATE MOFETIL
60 Tablets
CONCORD BIOTECH LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MOFECON 500 (MYCOPHENOLATE MOFETIL 500MG TABLETS) MYCOPHENOLATE MOFETIL (500MG) 1 WHAT IS IN THIS LEAFLET 1. What Mofecon is used for 2. How Mofecon works 3. Before you use Mofecon 4. How to use Mofecon 5. While you are using Mofecon 6. Side effects 7. Storage and Disposal of Mofecon 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT MOFECON IS USED FOR Mofecon is indicated to prevent the body from rejecting a transplanted organ in patients receiving kidney, heart or liver transplants in combination with drugs like ciclosporin and corticosteroids. Mofecon is used for treatment of kidney inflammation, lupus nephritis and it should be used together with other medicine known as corticosteroids. HOW MOFECON WORKS Mofecon belongs to a drug class “immunosuppressant”. It reduces immune response from your body. BEFORE YOU USE MOFECON _ _ _- When you must not use it _ Do not take Mofecon • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients listed at the end of this leaflet. • If you are a woman who could be pregnant and not using effective contraception • If you are pregnant or planning to become pregnant or think you may be pregnant • If you are breast-feeding If you are not sure, talk to your doctor or pharmacist before taking Mofecon. _- Before you start to use it _ Tell your doctor straight away before start using Mofecon: • If you are pregnant or planning to become pregnant • If you are breast-feeding or plan to breast-feed • If you are a sexually active man • If you are allergic to any other medicines, foods, dyes or preservatives • If you have any other health problems, especially the following: - a history of sun spots or skin cancers. - a history of low blood counts of neutrophils (a type of white blood cell). - a history of serious stomach or bowel problems (such as ulcers or bleeding). -kidney disease. -rare heredit Lestu allt skjalið
MOFECON TM 500 (MYCOPHENOLATE MOFETIL 500 MG TABLETS) VIMOF06-var (MY SIN) DESCRIPTION Lavender-colored, caplet-shaped, film-coated tablet, debossed with “C4” on one side and plain on the other side. COMPOSITION Each tablet contains: Mycophenolate mofetil 500mg _Excipients:_ Microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, indigo carmine aluminium lake, black iron oxide. PHARMACODYNAMICS Mycophenolate mofetil is an immunosuppressive agent. Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the _de novo_ pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on _ de novo_ synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells. PHARMACOKINETICS ABSORPTION AND DISTRIBUTION Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of Mofecon is correlated with MPA concentration. Food had no effect on the extent of absorption of mycophenolate mofetil. There is a significant amount of enterohepatic recirculation for mycophenolate mofetil. MPA at clinically relevant concentrations is 97% bound to plasma albumin. BIOTRANSFORMATION AND ELIMINATION MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG). _ In _ _vivo_, MPAG is converted back to free MPA via enterohepatic recirculation. A minor acylglucuronide (AcMPAG) is also formed. AcMPAG is pharmacologically active and is suspected to be responsible for some Lestu allt skjalið