TEVA-TOPIRAMATE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TOPIRAMATE

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

N03AX11

Designación común internacional (DCI):

TOPIRAMATE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

TOPIRAMATE 100MG

Vía de administración:

ORAL

Unidades en paquete:

60

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2011-04-04

Ficha técnica

_TEVA-TOPIRAMATE (Topiramate Tablets) _
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_Page 1 of 85 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, Oral
Teva Standard
Antiepileptic/Migraine Prophylaxis
Teva Canada Limited
30 Novopharm Court
Toronto, ON
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
May 6, 2011
Date of Revision:
Nov 22, 2023
Submission Control Number: 278124
_TEVA-TOPIRAMATE (Topiramate Tablets) _
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_Page 2 of 85 _
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RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
03/2022
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
10/2022
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
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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
.