국가: 몰타
언어: 영어
출처: Medicines Authority
MYCOPHENOLIC ACID
Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands
L04AA06
MYCOPHENOLIC ACID 180 mg
GASTRO-RESISTANT TABLET
MYCOPHENOLIC ACID 180 mg
POM
IMMUNOSUPPRESSANTS
Withdrawn
2013-08-07
PACKAGE LEAFLET Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER AXYMPA 180MG GASTRO-RESISTANT TABLETS Mycophenolic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Axympa is and what it is used for 2. What you need to know before you take Axympa 3. How to take Axympa 4. Possible side effects 5. How to store Axympa 6. Contents of the pack and other information 1. WHAT AXYMPA IS AND WHAT IT IS USED FOR Axympa contains a substance called mycophenolic acid. This belongs to a group of medicines called immunosuppressants. Axympa is used to stop the body’s immune system from rejecting a kidney transplant. It is used together with other medicines containing ciclosporin and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXYMPA WARNING Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy, breast-feeding and fertility”. DO NOT TAKE AXYMPA • if you are allergic to mycophenolic 전체 문서 읽기
Page 1 of 17 1 NAME OF THE MEDICINAL PRODUCT Axympa 180mg gastro-resistant tablets Axympa 360mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Axympa 180 mg gastro-resistant tablets: Each gastro-resistant tablet contains 180 mg mycophenolic acid (as mycophenolate sodium). Excipient(s) with known effect≥ Each tablet contains 13.9 mg (0.61 mmol) sodium Axympa 360 mg gastro-resistant tablets: Each gastro-resistant tablet contains 360 mg mycophenolic acid (as mycophenolate sodium). Excipient(s) with known effect≥ Each tablet contains 27.9 mg (1.21 mmol) sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet 180 MG: Lime Green colored, round shaped, biconvex bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side Note: Diameter of the tablet is 10.80 ± 0.2 mm 360 MG: Peach colored, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side with black ink and plain on the other side. Note: Length and Width of the tablet is 17.50 ± 0.2 mm and 10.35 ± 0.2 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Axympa is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Axympa should be initiated and maintained by appropriately qualified transplant specialists. POSOLOGY The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This dose of mycophenolate sodium corresponds to 1 g mycophenolate mofetil administered twice daily (2 g daily dose) in terms of mycophenolic acid (MPA) content. Page 2 of 17 For additional information about the corresponding therapeutic doses of mycophenolate sodium and mycophenolate mofetil, see sections 4.4 and 5.2. In _de novo_ patients, Axympa should be initiated within 72 hours following transplantation. Paediatric population Insufficient data are availa 전체 문서 읽기