Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
MYCOPHENOLATE MOFETIL
HOFFMANN-LA ROCHE LIMITED
L04AA06
MYCOPHENOLIC ACID
200MG
POWDER FOR SUSPENSION
MYCOPHENOLATE MOFETIL 200MG
ORAL
175 ML
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0128158003; AHFS:
APPROVED
2000-05-09
_ _ _ _ _Pr_ _CELLCEPT® mycophenolate mofetil _ _Page 1 of 85_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CELLCEPT ® mycophenolate mofetil Capsules – 250 mg Film-Coated Tablets – 500 mg Powder for Oral Suspension – 200 mg/mL (when reconstituted) PR CELLCEPT ® I.V. mycophenolate mofetil for injection (as hydrochloride) – 500 mg/vial Manufacturer’s Standard Immunosuppressive Agent Hoffmann-La Roche Ltd. 7070 Mississauga Road Mississauga, Ontario L5N 5M8 Date of Initial Authorization: December 31, 1995 Date of Revision: July 8, 2021 Submission Control Number: 248429 www.rochecanada.com CellCept ® is a registered trade-mark of Syntex Pharm AG, used under license © Copyright 1995-2021, Hoffmann-La Roche Limited. _ _ _ _ _ _ _Pr_ _CELLCEPT® mycophenolate mofetil _ _Page 2 of 85_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Immune 06-2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics .......................................................................................................... 5 1.2 Geriatrics........................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION........................................................... Belgenin tamamını okuyun