IPG-TOPIRAMATE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

TOPIRAMATE

Prieinama:

MARCAN PHARMACEUTICALS INC

ATC kodas:

N03AX11

INN (Tarptautinis Pavadinimas):

TOPIRAMATE

Dozė:

100MG

Vaisto forma:

TABLET

Sudėtis:

TOPIRAMATE 100MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS ANTICONVULSANTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2016-04-21

Prekės savybės

_IPG-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
IPG-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite#112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
AUG 29, 2014
Date of Revision:
DEC 20, 2022
Submission Control Number: 267040
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_IPG-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
01/2022
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
01/2022
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
12/2022
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
............................................................. 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....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................ 5
4.4
Administration
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7
4.5
Missed D