GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Boleh didapati daripada:

PRO DOC LIMITEE

Kod ATC:

N06DA04

INN (Nama Antarabangsa):

GALANTAMINE

Dos:

8MG

Borang farmaseutikal:

CAPSULE (EXTENDED RELEASE)

Komposisi:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0144660002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2023-07-10

Ciri produk

_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
.........