Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
mycophenolate mofetil
Teva B.V.
L04AA06
mycophenolate mofetil
Immunosuppressants
Graft Rejection
Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Revision: 27
Authorised
2008-02-21
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYFENAX 250 MG HARD CAPSULES mycophenolate mofetil 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. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Myfenax is and what it is used for 2. What you need to know before you take Myfenax 3. How to take Myfenax 4. Possible side effects 5. How to store Myfenax 6. Contents of the pack and other information 1. WHAT MYFENAX IS AND WHAT IT IS USED FOR Myfenax is a medicine that is used to suppress immune activity. The active substance in this medicine is called mycophenolate mofetil. Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used in combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYFENAX 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, contraception and breast-feeding”. DO NOT TAKE MYFENAX, Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Myfenax 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) The capsule body is caramel opaque, printed with ‘250’ axially in black ink. The capsule cap is light blue opaque printed ‘M’ axially in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and maintained by appropriately qualified transplant specialists. Posology _Use in renal transplant _ Adults Treatment should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose). Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m 2 administered orally twice daily (up to a maximum of 2 g daily). Capsules should only be prescribed to patients with a body surface area of at least 1.25 m 2 . Patients with a body surface area of 1.25 to 1.5 m 2 may be prescribed mycophenolate mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater than 1.5 m 2 may be prescribed mycophenolate mofetil capsules at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction. Paediatric population < 2 years There are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dosage recommen Aqra d-dokument sħiħ