Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Mycophenolate mofetil 250mg;
Roche Products (NZ) Ltd
Mycophenolate mofetil 250 mg
250 mg
Capsule
Active: Mycophenolate mofetil 250mg Excipient: Croscarmellose sodium Gelatin Magnesium stearate Povidone Pregelatinised maize starch
Blister pack, 10 x10 strips White opaque PVC, 100 capsules
Prescription
Prescription
Roche Ireland Ltd
CellCept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. CellCept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.
Package - Contents - Shelf Life: Blister pack, 10 x10 strips White opaque PVC - 100 capsules - 36 months from date of manufacture stored at or below 25°C
1994-12-19
CellCept ® 20210329 1 _ _ CONSUMER MEDICINE INFORMATION CELLCEPT ® MYCOPHENOLATE MOFETIL 250 MG CAPSULES 500 MG TABLETS 500 MG POWDER FOR SOLUTION FOR INFUSION 200 MG/ML ORAL SUSPENSION (WHEN RECONSTITUTED) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CellCept capsules, tablets, infusion and oral suspension. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CellCept against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CELLCEPT IS USED FOR CellCept contains the active ingredient mycophenolate mofetil. CellCept belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent rejection of transplanted organs, and work by stopping your immune system from reacting to the transplanted organ. CellCept may be used together with other medicines known as cyclosporin and corticosteroids. Your doctor, however, may have prescribed CellCept for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CELLCEPT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CELLCEPT _WHEN YOU MUST NOT TAKE IT _ CellCept ® 20210329 2 _ _ DO NOT TAKE CELLCEPT IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO CELLCEPT OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET Symptoms of an allergic reaction include swelling, itching, rash, breathing difficulties. 2. YOU ARE PREGNANT CellCept is harmful to an unborn baby when taken by a pregnant woman. There have been cases of miscarriage and severe birth defects reported in patients exposed to CellCept during pregnancy. You must tell your doctor if you are pregnant or plan to become pregnant. 3. YOU ARE BREASTFEEDING CellCept may pass into human breast milk and could cause serious side Les hele dokumentet
NEW ZEALAND DATA SHEET Cellcept 210120 _ _ _ _ _ _ 1 _ _ 1. PRODUCT NAME CellCept 250 mg hard capsules CellCept 500mg film-coated tablets CellCept 500 mg powder for infusion. CellCept 200 mg/mL powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CellCept 250 mg hard capsules - each capsule contains 250mg of mycophenolate mofetil CellCept 500mg film-coated tablets - each tablet contains 500mg mycophenolate mofetil CellCept 500 mg powder for infusion - each vial contains 500 mg mycophenolate mofetil (as hydrochloride salt) CellCept 200 mg/mL powder for oral suspension – each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. 5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CellCept capsules are oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body. CellCept tablets are lavender coloured capsule-shaped, engraved with "CellCept 500" on one side and "Roche" on the reverse. CellCept powder for infusion is a sterile lyophilised white to off-white powder. CellCept 200 mg/mL powder for oral suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CellCept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. CellCept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants. Cellcept 210120 2 _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The initial dose of CellCept should be given as soon as clinically feasible following transplantation. Intravenous administration is recommended in those patients unable to take oral medication. However, oral administration should be initiated as soon as possible. ADULTS RENAL TRANSPLANTATION The recommended dose in renal transplant patients is 1 g administered orally or intravenously twice daily (2 g daily dose). CARDIAC TRANSPLANTATION The recommended do Les hele dokumentet