PMS-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

MAH:

PHARMASCIENCE INC

ATC_code:

N06DA04

INN:

GALANTAMINE

dosage:

16MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0144660004; AHFS:

authorization_status:

APPROVED

authorization_date:

2012-12-14

SPC

_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......................................................................................................