GLN-TOPIRAMATE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
28-08-2018
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Aktiva substanser:
TOPIRAMATE
Tillgänglig från:
GLENMARK PHARMACEUTICALS CANADA INC.
ATC-kod:
N03AX11
INN (International namn):
TOPIRAMATE
Dos:
100MG
Läkemedelsform:
TABLET
Sammansättning:
TOPIRAMATE 100MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS ANTICONVULSANTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0132938002; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2018-07-17
Produktens egenskaper
_Page 1 of 73 _
PRODUCT MONOGRAPH
PR
GLN-TOPIRAMATE
Topiramate Tablets
25, 100 and 200 mg
Antiepileptic/Migraine Prophylaxis
Glenmark Pharmaceuticals Canada Inc.
500 King St. West, 3
rd
Floor
Toronto, Ontario
M5V 1L9
Date of Preparation:
August 28, 2018
Submission Control No.: 218267
_Page 2 of 73 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
19
DRUG INTERACTIONS
.................................................................................................
36
DOSAGE AND ADMINISTRATION
.............................................................................
44
OVERDOSAGE
...............................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 48
STORAGE AND STABILITY
.........................................................................................
51
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 51
PART II: SCIENTIFIC INFORMATION
..............................................................................
52
PHARMACEUTICAL INFORMATION
.........................................................................
53
CLINICAL TRIALS
.........................................................................................................
54
DETAILED PHARMACOLOGY
........................................................
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