AG-TOPIRAMATE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TOPIRAMATE

Tilgængelig fra:

ANGITA PHARMA INC.

ATC-kode:

N03AX11

INN (International Name):

TOPIRAMATE

Dosering:

100MG

Lægemiddelform:

TABLET

Sammensætning:

TOPIRAMATE 100MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTICONVULSANTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2018-05-22

Produktets egenskaber

_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