Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 500 mg
Pharmacor Pty Ltd
Mycophenolate mofetil
Tablet, film coated
Excipient Ingredients: povidone; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hyprolose; purified talc; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake
Oral
50 tablets, 150 tablets
(S4) Prescription Only Medicine
Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Prophylaxis of organ rejection in paediatric patients (with a body surface area > 1.5 m2) receiving allogeneic renal transplants.
Visual Identification: Purple colored, capsule shaped, biconvex, film coated tablets debossed 'AHI' on one side and '500' on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-12-16
Pc-Mycophenolate 500 (V 02) Page 1 of 5 PC-MYCOPHENOLATE 500 _Mycophenolate mofetil _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pc- mycophenolate 500. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Pc- mycophenolate 500 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 need to read it again. WHAT PC-MYCOPHENOLATE 500 IS USED FOR Pc-mycophenolate 500 contains the active ingredient mycophenolate mofetil. Pc-mycophenolate 500 belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent the rejection of a transplanted organs and work 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 Pc-mycophenolatePc- mycophenolate 500 may be used together with other medicines known as cyclosporin and corticosteroids. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PC- MYCOPHENOLATE 500 HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Pc-mycophenolate 500 for another reason. Pharmacor Mycophenolate 500 is not addictive This medicine is available only with a doctor’s prescription. Pc-mycophenolate BEFORE YOU TAKE PC- MYCOPHENOLATE 500 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PC-MYCOPHENOLATE 500 IF: 1. YOU HAVE HAD AN ALLERGIC TO:Pc- mycophenolate 500 or any ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of face, lips, tongue or other parts of the body rash, itching, hives on the skin 2. YOU ARE PREGNANT Pc-mycophenolate 500 is harmful to an unborn baby when taken by a pregnant woman. Lue koko asiakirja
PC- Mycophenolate 500 (V-02) 1 AUSTRALIAN PRODUCT INFORMATION PC-MYCOPHENOLATE 500 (MYCOPHENOLATE MOFETIL) TABLETS 1 NAME OF THE MEDICINE Mycophenolate mofetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pc-Mycophenolate 500 contains mycophenolate mofetil 500 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Pc-Mycophenolate 500 are purple coloured, capsule shaped, biconvex, film coated tablets debossed ‘AHI’ on one side and ‘500’ on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Prophylaxis of organ rejection in paediatric patients (2-18 years) receiving allogeneic renal transplants. 4.2 D OSE AND METHOD OF ADMINISTRATION The initial dose of Pc-Mycophenolate 500 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 dose in cardiac transplant patients is 1.5 g administrated orally or intravenously twice daily (3 g daily dose). _HEPATIC TRANSPLANTATION _ The recommended dose in hepatic transplant patients is 1 g administrated intravenously twice daily (2 g daily dose) followed by 1.5 g administered orally twice daily (3 g daily dose). PC- Mycophenolate 500 (V-02) 2 _OTHER TRANSPLANTS _ The recommended dose in other transplants is 2 to 3 g per day depending on the level of immunosuppression required. _PAEDIATRICS (2 TO 18 YEARS) _ The recommended dose of for renal transplant patients is 600mg/m 2 of mycophenolate mofetil (MMF) administered orally twice daily (up to a maximum of 2 g daily.) Pc-Mycophenolate 500 may be administered in combination with ciclosporin and corticosteroids Lue koko asiakirja