GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Verfügbar ab:

PRO DOC LIMITEE

ATC-Code:

N06DA04

INN (Internationale Bezeichnung):

GALANTAMINE

Dosierung:

16MG

Darreichungsform:

CAPSULE (EXTENDED RELEASE)

Zusammensetzung:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100

Verschreibungstyp:

Prescription

Therapiebereich:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2023-07-10

Fachinformation

_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
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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
.........