AG-TOPIRAMATE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TOPIRAMATE

Disponível em:

ANGITA PHARMA INC.

Código ATC:

N03AX11

DCI (Denominação Comum Internacional):

TOPIRAMATE

Dosagem:

100MG

Forma farmacêutica:

TABLET

Composição:

TOPIRAMATE 100MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANTICONVULSANTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2018-05-22

Características técnicas

_AG-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
MAY 22, 2018
Date of Revision:
MAY 31, 2023
Submission Control Number: 275331
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_ AG-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
05/2023
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
05/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
05/2023
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...............................................................
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
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5
4.2
Recommended Dose and Dosage Adjustment
................................................. 5
4.4
Administration
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7