NU-TOPIRAMATE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TOPIRAMATE

MAH:

NU-PHARM INC

ATC_code:

N03AX11

INN:

TOPIRAMATE

dosage:

100MG

pharmaceutical_form:

TABLET

composition:

TOPIRAMATE 100MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

authorization_status:

CANCELLED (UNRETURNED ANNUAL)

authorization_date:

2018-03-28

SPC

Page 1 of 70
PRODUCT MONOGRAPH
Pr
NU-TOPIRAMATE
TOPIRAMATE TABLETS
25 MG, 50 MG, 100 MG AND 200 MG
ANTIEPILEPTIC/MIGRAINE PROPHYLAXIS
NU-PHARM INC.
DATE OF REVISION:
50 MURAL STREET, UNITS 1 & 2
AUGUST 8, 2011
RICHMOND HILL, ON
CANADA
L4B 1E4
CONTROL # 148177
Page 2 of 70
TABLE OF CONTENTS
PART I: HEALTH PROFFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
4
ADVERSE
REACTIONS.......................................................................................................
12
DRUG INTERACTIONS
.......................................................................................................
34
DOSAGE AND ADMINISTRATION
...................................................................................
41
OVERDOSAGE......................................................................................................................
45
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
45
STORAGE AND
STABILITY...............................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 48
PART II: SCIENTIFIC INFORMATION
.............................................................................
49
PHARMACEUTICAL
INFORMATION...............................................................................
49
CLINICAL TRIALS
...............................................................................................................
49
DETAILED PHARMACOLOGY
..............