JAMP-TOPIRAMATE TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TOPIRAMATE

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

N03AX11

INN (Alþjóðlegt nafn):

TOPIRAMATE

Skammtar:

100MG

Lyfjaform:

TABLET

Samsetning:

TOPIRAMATE 100MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30/100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

MISCELLANEOUS ANTICONVULSANTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2015-01-06

Vara einkenni

_JAMP-Topiramate (Topiramate Tablets) Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
JAMP-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
JAN 06, 2015
Date of Revision:
APR 20, 2023
Submission Control Number: 273323
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_JAMP-Topiramate (Topiramate Tablets) Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Serious Skin
Reactions
04/2023
7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis
04/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
04/2023
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...............................................................
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
..............................................................................
5
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................. 5
4.4
Administration
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