Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLIC ACID (AS SODIUM SALT)
HOVID BERHAD
MYCOPHENOLIC ACID (AS SODIUM SALT)
60 Tablets
CONCORD BIOTECH LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MOFECON-GR (MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS) MYCOPHENOLIC ACID (AS MYCOPHENOLATE SODIUM) (180, 360 MG) 1 WHAT IS IN THIS LEAFLET 1. What Mofecon-GR is used for 2. How Mofecon-GR works 3. Before you use Mofecon-GR 4. How to use Mofecon-GR 5. While using Mofecon-GR 6. Side effects 7. Storage and Disposal of Mofecon- GR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT MOFECON-GR IS USED FOR Mofecon-GR belong to the class of drugs known as immunosuppressants. Immunosuppressants reduce your body’s response to anything that it sees as “foreign” – which includes transplant organs. HOW MOFECON-GR WORKS Mofecon-GR is used to prevent your body from rejecting a transplanted kidney. Mofecon-GR is used together with other medicines containing ciclosporin and corticosteroids. BEFORE YOU USE MOFECON-GR Mofecon-GR will only be prescribed for you by a doctor experienced in transplantation medicine. Follow your doctor’s instructions carefully. They might differ from the general information contained in this leaflet. _- When you must not use it _ Do not take Mofecon-GR: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine • If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription as mycophenolate causes birth defects and miscarriage. • If you are pregnant or planning to become pregnant or think you may be pregnant • If you are not using effective contraception • If you are breast-feeding. If any of the above apply to you, talk to your doctor or pharmacist before taking Mofecon-GR. _-Pregnancy and breast-feeding _ If you are pregnant or breast-feeding, planning to have a baby or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Doctor will explain to you about the risks in case of pregnancy and alt Đọc toàn bộ tài liệu
VIMOFxx-09 (MY) MOFECON-GR 360 (MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360MG) DESCRIPTION MOFECON−GR 360 (MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360 MG): Pink to light pink colored, enteric coated, ovaloid biconvex tablet, debossed with “C 2” on one side and plain on other side. COMPOSITION MOFECON−GR 360 (MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360 MG): Each enteric coated tablet contains: Mycophenolic acid 360 mg _Excipients:_ Microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, triethyl citrate, sodium bicarbonate, iron oxide yellow, iron oxide red, sodium lauryl sulfate. PHARMACODYNAMICS Mycophenolic acid (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 utilize salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells. PHARMACOKINETICS ABSORPTION Following oral administration, mycophenolate sodium is extensively absorbed. Consistent with its enteric coated design, the time to maximal concentration (T max ) of MPA was approximately 1.5-2 hours. DISTRIBUTION The volume of distribution at steady state for MPA is 50 litres. Both mycophenolic acid and mycophenolic acid glucuronide are highly protein bound. The free MPA concentration may increase under conditions of decreased protein binding sites (uraemia, hepatic failure, hypoalbuminaemia, concomitant use of drugs with high protein binding). This may put patients at increased risk of MPA-related adverse effects. BIOTRANSFORMATION MPA is metabolised principally by glucuronyl transferase to form the phenolic glucuronide of MPA, mycophenolic acid glucuronide (MPAG). MPAG is the pr Đọc toàn bộ tài liệu