Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ISOTRETINOIN
HOFFMANN-LA ROCHE LIMITED
D10BA01
ISOTRETINOIN
40MG
CAPSULE
ISOTRETINOIN 40MG
ORAL
30
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0115751002; AHFS:
APPROVED
2001-04-02
_Pr_ _ACCUTANE™ ROCHE_ _®_ _ (isotretinoin) _ _Page 1 of 36_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACCUTANE™ ROCHE ® isotretinoin Capsule, USP 10 mg, 40 mg Retinoid for Treatment of Acne ATC Code: D10BA01 Hoffmann-La Roche Limited 7070 Mississauga Road Mississauga, ON L5N 5M8 www.rochecanada.com Date of Initial Approval: December 02, 1982 Date of Revision: August 21, 2019 Submission Control No: 226870 ACCUTANE™ ROCHE ® trade-mark of Hoffmann-La Roche Limited © Copyright 1982 – 2019 Hoffmann-La Roche Limited _ _ _Pr_ _ACCUTANE™ ROCHE_ _®_ _ (isotretinoin) _ _Page 2 of 36_ RECENT MAJOR LABEL CHANGES ADVERSE REACTIONS, Clinical Trial Adverse Reaction [8.2] Nov-2016 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS ................................................................................................................. 4 1.1 Pediatrics ............................................................................................................... 4 1.2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................ 6 4.1 Dosing Considerations ........................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment ....................................................... 7 4.3 Administration ...... Olvassa el a teljes dokumentumot