国: カナダ
言語: 英語
ソース: Health Canada
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
PRO DOC LIMITEE
N06DA04
GALANTAMINE
16MG
CAPSULE (EXTENDED RELEASE)
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
ORAL
30/100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0144660004; AHFS:
CANCELLED POST MARKET
2023-07-10
_GALANTAMINE ER _ _Page 1 of 64_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR GALANTAMINE ER galantamine hydrobromide extended release capsules Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral House Standard Cholinesterase Inhibitor PRO DOC LTÉE 2925 Boul. Industriel Laval, Québec H7L 3W9 Date of Initial Authorization: DEC 03, 2013 Date of Revision: FEB 25, 2022 Submission Control Number: 261429 _GALANTAMINE ER _ _Page 2 of 64_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 02/2022 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 ....................................................................... 4 1 INDICATIONS ................................................................................................................... 4 1.1 Pediatrics ....................................................................................................................... 4 1.2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 4 4.1 Dosing Considerations .................................................................................................. 4 4.2 Recommended Dose and Dosage Adjustment ............................................................. 5 4.4 Administration .............................................................................................................. 6 4.5 Missed Dose ......... 完全なドキュメントを読む