国: イスラエル
言語: 英語
ソース: Ministry of Health
MYCOPHENOLATE MOFETIL
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AA06
CAPSULES
MYCOPHENOLATE MOFETIL 250 MG
PER OS
Required
HOFFMANN LA ROCHE, SWITZERLAND
MYCOPHENOLIC ACID
MYCOPHENOLIC ACID
Prophylaxis of rejection in renal allograft recepients, and in patients reciving allogenic cardiac transplants. Cellcept should be used concomitantly with cyclosporin and corticosteroids.Allogenic hepatic transplant.
2023-06-30
CellCept PL version 9 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 198 This medicine is dispensed with a doctor’s prescription only CELLCEPT ® 250 MG Capsules CELLCEPT ® 500 MG Tablets COMPOSITION: Each capsule contains: Each film-coated tablet contains: Mycophenolate mofetil 250 mg Mycophenolate mofetil 500 mg *For information on the inactive ingredients and allergens, see section 2 “Before using the medicine” and section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your illness only. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. IMPORTANT INFORMATION FOR YOUR REVIEW Warning: Mycophenolate causes miscarriages and birth defects. Do not begin treatment with CELLCEPT in women of child-bearing age, who do not have a negative pregnancy test before starting treatment. Follow the contraception instructions given to you by the attending doctor. Before taking the preparation, consult the doctor again if you did not fully understand the instructions. For further information, see section “Special warnings regarding use of this medicine” and “Pregnancy, contraception and breast-feeding” section. 1. WHAT IS THE MEDICINE INTENDED FOR? CELLCEPT is used, in combination with cyclosporine and corticosteroids, to prevent rejection of a transplanted organ in kidney, heart or liver transplant recipients. THERAPEUTIC GROUP Immunosuppressants. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are allergic to mycophenolate mofetil, mycophenolic acid, or to any of the other ingredients contained in the medicine )for the list of inactive ingredients, see section 6 - “Further Information”(. You are a woman of child-bearing age and you have not provided a negative preg 完全なドキュメントを読む
1 CellCept PI version 10 CELLCEPT ® MYCOPHENOLATE MOFETIL Capsules 250 mg and Tablets 500 mg 1. NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules. CellCept 500 mg film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg mycophenolate mofetil. Each tablet contains 500 mg mycophenolate mofetil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CellCept 250 mg capsules: Capsules, hard oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" on the capsule body. CellCept 500 mg film coated tablets: Lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and “ROCHE" on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of rejection in renal allograft recepients, and in patients receiving allogenic cardiac transplants. Cellcept should be used concomitantly with cyclosporin and corticosteroids. Allogenic hepatic transplant. 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). 2 _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). Tablets should only be prescribed to patients with a body surface area greater than 1.5 m 2 , at a dose of 1 g twice daily (2 g daily dose). As some a 完全なドキュメントを読む