MINT-TOPIRAMATE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TOPIRAMATE

Доступно од:

MINT PHARMACEUTICALS INC

АТЦ код:

N03AX11

INN (Међународно име):

TOPIRAMATE

Дозирање:

100MG

Фармацеутски облик:

TABLET

Састав:

TOPIRAMATE 100MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS ANTICONVULSANTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2008-08-19

Карактеристике производа

_MINT-TOPIRAMATE (topiramate) _
_Page 1 of 78_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-TOPIRAMATE
topiramate tablets, USP tablets, 25 mg, 100 mg and 200 mg, oral
Antiepileptic/Migraine Prophylaxis
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
August 19, 2008
Date of Revision:
November 28, 2023
Submission Control Number: 278199
_MINT-TOPIRAMATE (topiramate) _
_Page 2 of 78_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
09/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Teratogenic Risk
11/2023
7 WARNINGS AND PRECAUTIONS, Information for
Patients, Fetal Toxicity
11/2023
7.1.1 Pregnant Women
11/2023
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
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4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................