国: カナダ
言語: 英語
ソース: Health Canada
ELIGLUSTAT (ELIGLUSTAT TARTRATE)
SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
A16AX10
ELIGLUSTAT
84MG
CAPSULE
ELIGLUSTAT (ELIGLUSTAT TARTRATE) 84MG
ORAL
14/56
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0158970001; AHFS:
APPROVED
2017-04-21
CERDELGA (eliglustat capsules)_ _ _ _ _ _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr CERDELGA™ Eliglustat capsules 84 mg eliglustat (as eliglustat tartrate), for oral administration Various Alimentary Tract and Metabolism Product Sanofi Genzyme, a division of sanofi-aventis Canada Inc. 1755 Steeles Avenue WestToronto, ON M2R 3T4 Date of Initial Authorization: APR 21, 2017 Date of Revision: NOV 29, 2023 Submission Control Number: 275984 RECENT MAJOR LABEL CHANGES Not Applicable TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................ 4 1.1 Pediatrics ................................................................................................................. 4 1.2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.4 Administration ......................................................................................................... 9 4.5 Missed Dose ............................................................................................................ 9 5 OVERDOSAGE ......................................................... 完全なドキュメントを読む