MINT-TOPIRAMATE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TOPIRAMATE

Dostupno od:

MINT PHARMACEUTICALS INC

ATC koda:

N03AX11

INN (International ime):

TOPIRAMATE

Doziranje:

25MG

Farmaceutski oblik:

TABLET

Sastav:

TOPIRAMATE 25MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTICONVULSANTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0132938001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2008-08-19

Svojstava lijeka

_MINT-TOPIRAMATE (topiramate) _
_Page 1 of 78_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-TOPIRAMATE
topiramate tablets, USP tablets, 25 mg, 100 mg and 200 mg, oral
Antiepileptic/Migraine Prophylaxis
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
August 19, 2008
Date of Revision:
November 28, 2023
Submission Control Number: 278199
_MINT-TOPIRAMATE (topiramate) _
_Page 2 of 78_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
09/2022
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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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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4
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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