MAR-TOPIRAMATE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TOPIRAMATE

Sẵn có từ:

MARCAN PHARMACEUTICALS INC

Mã ATC:

N03AX11

INN (Tên quốc tế):

TOPIRAMATE

Liều dùng:

100MG

Dạng dược phẩm:

TABLET

Thành phần:

TOPIRAMATE 100MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2014-11-10

Đặc tính sản phẩm

_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
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_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
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2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................. 5
4.4
Administration
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