País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 500 mg
Sandoz Pty Ltd
Mycophenolate mofetil
Tablet, film coated
Excipient Ingredients: hyprolose; hypromellose; povidone; purified talc; titanium dioxide; croscarmellose sodium; macrogol 400; iron oxide red; iron oxide black; microcrystalline cellulose; magnesium stearate
Oral
150, 50
(S4) Prescription Only Medicine
Mycophenolate Sandoz is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. . Mycophenolate Sandoz is indicated for the prophylaxis of organ rejection in paediatric patients (6 to 18 years) receiving allogeneic renal transplants.
Visual Identification: Lavender colored, capsule-shaped, film-coated, biconvex tablet, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2008-12-08
MYCOPHENOLATE SANDOZ ® 1 MYCOPHENOLATE SANDOZ ® _mycophenolate mofetil capsules and tablets _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mycophenolate Sandoz. 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT MYCOPHENOLATE SANDOZ IS USED FOR Mycophenolate Sandoz contains the active ingredient mycophenolate mofetil. Mycophenolate Sandoz belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent rejection of transplanted organ and works by stopping your immune system from reacting to the transplanted organ. There are many different types of medicines used to prevent rejection of a transplanted organ. Mycophenolate Sandoz may be used together with other medicines known as ciclosporin and corticosteroids. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. Mycophenolate Sandoz is not addictive. BEFORE YOU TAKE MYCOPHENOLATE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • mycophenolate mofetil, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT. Mycophenolate Sandoz is harmful to an unborn baby when taken Leer el documento completo
220223-Mycophenolate Sandoz-pi Page 1 of 32 AUSTRALIAN PRODUCT INFORMATION MYCOPHENOLATE SANDOZ ® (MYCOPHENOLATE MOFETIL) 1 NAME OF THE MEDICINE Mycophenolate mofetil (MMF) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Mycophenolate Sandoz ® 250 mg capsules contains 250 mg mycophenolate mofetil. Each Mycophenolate Sandoz ® 500 mg tablets contains 500 mg mycophenolate mofetil. MMF is a white to off-white crystalline powder. For the full list of excipients, see Section 6.1 List of excipients. _Not all strengths may be marketed in Australia. _ 3 PHARMACEUTICAL FORM Mycophenolate Sandoz 250 mg capsules – Blue opaque cap with orange opaque body, containing white to off white coloured powder. Mycophenolate Sandoz 500 mg tablets – Capsule shaped, lavender coloured, film-coated biconvex tablet, plain on both sides. _Not all strengths may be marketed in Australia. _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Mycophenolate Sandoz is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Mycophenolate Sandoz is indicated for the prophylaxis of organ rejection in paediatric patients (6 to 18 years) receiving allogeneic renal transplants. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The initial dose of Mycophenolate Sandoz should be given as soon as clinically feasible following transplantation. _ADULTS _ _Renal Transplantation: _ The recommended dose in renal transplant patients is 1 g twice daily (2 g daily dose). _Cardiac Transplantation: _ The recommended dose in cardiac transplant patients is 1.5 g administrated orally twice daily (3 g daily dose). _Hepatic Transplantation: _ The recommended dose in hepatic transplant patients is 1 g twice daily (2 g daily dose) followed by 1.5 g twice daily (3 g daily dose). 220223-Mycophenolate Sandoz-pi Page 2 of 32 _Other Transplants: _ The recommended dose in other transplants is 2 to 3 g per day depending on the level of immunosuppression required. _CHILDREN (6-18 YEARS) _ The recommended dose for renal transplant Leer el documento completo