APO-TOPIRAMATE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TOPIRAMATE

MAH:

APOTEX INC

ATC_code:

N03AX11

INN:

TOPIRAMATE

dosage:

100MG

pharmaceutical_form:

TABLET

composition:

TOPIRAMATE 100MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2006-04-19

SPC

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_APO-TOPIRAMATE (topiramate tablets) _
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_Page 1 of 88 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 50 mg, 100 mg and 200 mg, oral
Apotex Standard
Antiepileptic / Migraine Prophylaxis
APOTEX INC.
Date of Initial Authorization:
150 Signet Drive
APR 19, 2006
Toronto, Ontario
M9L 1T9
Date of Revision:
NOV 17, 2023
Submission Control Number: 277804
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_APO-TOPIRAMATE (topiramate tablets) _
_ _
_Page 2 of 88 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
04/2022
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
03/2023
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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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
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