MAR-TOPIRAMATE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

TOPIRAMATE

Boleh didapati daripada:

MARCAN PHARMACEUTICALS INC

Kod ATC:

N03AX11

INN (Nama Antarabangsa):

TOPIRAMATE

Dos:

100MG

Borang farmaseutikal:

TABLET

Komposisi:

TOPIRAMATE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0132938002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2014-11-10

Ciri produk

_MAR-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
MAR-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite#112
Ottawa, Ontario
K2E 1A2
Submission Control Number: 271273
Date of Initial Authorization:
NOV 10, 2014
Date of Revision:
FEB
02, 2023
_ _
_ _
_ _
_MAR-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
02/2023
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
02/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
02/2023
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
..............................................................................
5
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................. 5
4.4
Administration
.......................................................................................