Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
PHARMASCIENCE INC
N06DA04
GALANTAMINE
24MG
CAPSULE (EXTENDED RELEASE)
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
ORAL
30/100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0144660005; AHFS:
APPROVED
2012-12-14
_pms-GALANTAMINE ER _ _Page 1 of 64_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-GALANTAMINE ER galantamine hydrobromide extended release capsules Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral House Standard Cholinesterase Inhibitor PHARMASCIENCE INC. 6111 Royalmount Avenue, Suite #100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of Initial Authorization: DEC 14, 2012 Date of Revision: JAN 28, 2022 Submission Control Number: 256025 _pms-GALANTAMINE ER _ _Page 2 of 64_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 01/2022 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...................................................................................................... Baca dokumen lengkap