देश: स्वीडन
भाषा: स्वीडिश
स्रोत: Läkemedelsverket (Medical Products Agency)
mykofenolatmofetil
2care4 ApS
L04AA06
mycophenolate mofetil
250 mg
Kapsel, hård
natriumlaurilsulfat Hjälpämne; propylenglykol Hjälpämne; mykofenolatmofetil 250 mg Aktiv substans
Receptbelagt
Avregistrerad
2018-02-28
Mycophenolate mofetil, SE/H/0790/001, 20.01.20 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYKOFENOLATMOFETIL ACTAVIS 250 MG CAPSULES, HARD 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mykofenolatmofetil Actavis is and what it is used for 2. What you need to know before you take Mykofenolatmofetil Actavis 3. How to take Mykofenolatmofetil Actavis 4. Possible side effects 5. How to store Mykofenolatmofetil Actavis 6. Contents of the pack and other information 1. WHAT MYKOFENOLATMOFETIL ACTAVIS IS AND WHAT IT IS USED FOR Mykofenolatmofetil Actavis contains mycophenolate mofetil. - This belongs to a group of medicines called “immunosuppressants”. Mykofenolatmofetil Actavis is used to prevent your body rejecting a transplanted organ. - A kidney, heart or liver. Mykofenolatmofetil Actavis should be used together with other medicines: - Ciclosporin and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYKOFENOLATMOFETIL ACTAVIS 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 पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mykofenolatmofetil Actavis 250 mg capsules, hard 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 Capsules, hard Light blue/peach, size 1 hard capsule, 18.9 mm ± 0.5 mm in length, imprinted with MMF on cap and 250 on body, containing white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mykofenolatmofetil Actavis 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 mak पूरा दस्तावेज़ पढ़ें