PMS-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Disponible des:

PHARMASCIENCE INC

Codi ATC:

N06DA04

Designació comuna internacional (DCI):

GALANTAMINE

Dosis:

16MG

formulario farmacéutico:

CAPSULE (EXTENDED RELEASE)

Composición:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-12-14

Fitxa tècnica

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