Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Mycophenolate mofetil 500mg;
Douglas Pharmaceuticals Limited
Mycophenolate mofetil 500 mg
500 mg
Film coated tablet
Active: Mycophenolate mofetil 500mg Excipient: Croscarmellose sodium Hyprolose Magnesium stearate Microcrystalline cellulose Opadry purple 03B50110 Povidone Purified talc
Blister pack, PVC/PVDC/aluminium foil, 50 tablets
Prescription
Prescription
Concord Biotech Limited
for the prophylaxis of acute organ rejection in patients receiving allogeneic renal transplants.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium foil - 50 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVDC/aluminium - 100 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture
2006-06-22
CONSUMER MEDICINE INFORMATION MYACCORD MYCOPHENOLATE MOFETIL 250 MG CAPSULES AND 500 MG TABLETS WHAT IS IN THIS LEAFLET • This leaflet answers some if not all of the common questions about MYACCORD capsules and tablets. • It will not have all the available information. • It does not take the place of talking to your doctor or pharmacist. • Your doctor has weighed the risks of you taking MYACCORD against its benefits before prescribing it for you. • If you have any concerns about taking this medicine do ask your doctor or pharmacist. • Keep this leaflet with the medicine. You may need to read it again. WHAT IS MYACCORD USED FOR • MYACCORD contains the active ingredient mycophenolate mofetil which belongs to a group of medicines called immunosuppressants. It is these immunosuppressants that are used to prevent rejection of transplanted organs, and work by stopping your immune system from reacting to the transplanted organ. • MYACCORD may be used together with other medicines known as ciclosporin and corticosteroids. • At times your doctor may have prescribed MYACCORD for some other purpose. • If in doubt, do ask your doctor if you have any questions about MYACCORD. • This medicine is available only with a doctor's prescription. BEFORE YOU TAKE MYACCORD _WHEN YOU MUST NOT TAKE IT _ • The medicine should not be taken if: 1. the package is torn or shows signs of tampering 2. the expiry date printed on the pack has passed. The medicine may not work as well if you take it after the expiry date has passed. 3. you have had an allergic reaction to MYACCORD or any ingredients listed at the end of this leaflet. Allergic r Lestu allt skjalið
DATA SHEET MYACCORD Mycophenolate mofetil Immunosuppressant; inosine monophosphate dehydrogenase (IMPDH) inhibitor PHARMACEUTICAL FORM ORAL ADMINISTRATION Myaccord is supplied as capsules and tablets. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Mycophenolate mofetil (MMF). _ _ _ORAL ADMINISTRATION _ Each capsule contains 250 mg mycophenolate mofetil. Each tablet contains 500 mg mycophenolate mofetil. Do not halve tablet. Dose equivalence when the tablet is divided has not been established. APPEARANCE _Myaccord capsules 250 mg_: Light blue/peach, hard gelatin capsules with ‘MMF’ on the cap and ‘250’ on the body containing white to off white powder. _Myaccord tablets 500 mg:_ Purple coloured, capsule shaped, biconvex, film coated tablets engraved ‘AHI’ on one side and ‘500’ on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Myaccord is indicated for the prophylaxis of acute organ rejection in patients receiving allogeneic renal transplants. Myaccord is indicated for the prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants. In the treated population, MMF improved survival in the first year after transplantation. Myaccord is indicated for the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants. Myaccord should be used concomitantly with ciclosporin and corticosteroids. DOSAGE AND METHOD OF ADMINISTRATION Do not halve tablet. Dose equivalence when the tablet is divided has not been established. STANDARD DOSAGE _STANDARD DOSAGE FOR PROPHYLAXIS OF RENAL REJECTION _ _Adults_ A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g/day of mycophenolate mofetil demonstrated an overall better safety profile compared Lestu allt skjalið