JAMP-TOPIRAMATE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TOPIRAMATE

可用日期:

JAMP PHARMA CORPORATION

ATC代码:

N03AX11

INN（国际名称）:

TOPIRAMATE

剂量:

100MG

药物剂型:

TABLET

组成:

TOPIRAMATE 100MG

给药途径:

ORAL

每包单位数:

30/100/500

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2015-01-06

产品特点

_JAMP-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
JAMP-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
JAN 06, 2015
Date of Revision:
APR 20, 2023
Submission Control Number: 273323
_ _
_ _
_ _
_JAMP-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
04/2023
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
04/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
04/2023
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
.......................................................................................