DOM-TOPIRAMATE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TOPIRAMATE

متاح من:

DOMINION PHARMACAL

ATC رمز:

N03AX11

INN (الاسم الدولي):

TOPIRAMATE

جرعة:

100MG

الشكل الصيدلاني:

TABLET

تركيب:

TOPIRAMATE 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTICONVULSANTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2005-09-14

خصائص المنتج

PRODUCT MONOGRAPH
Pr
Dom-TOPIRAMATE
Topiramate Tablets, House Standard
25 mg, 100 mg and 200 mg
Antiepileptic/Migraine Prophylaxis
DOMINION PHARMACAL
Date of Revision:
6111 Royalmount Ave., Suite 100
August 23, 2019
Montréal, Québec
H4P 2T4
Control No.: 229734
Dom-TOPIRAMATE Product Monograph
Page 2 of 74
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
.........................................................................................................
20
DRUG INTERACTIONS
..........................................................................................................
38
DOSAGE AND ADMINISTRATION
......................................................................................
46
OVERDOSAGE
........................................................................................................................
49
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
50
STORAGE AND STABILITY
.................................................................................................
53
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 53
PART II: SCIENTIFIC INFORMATION
...............................................................................
54
PHARMACEUTICAL INFORMATION
.................................................................................
54
CLINICAL TRIAL
...........................................................................