RAN-GABAPENTIN CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

GABAPENTIN

متاح من:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC رمز:

N02BF01

INN (الاسم الدولي):

GABAPENTIN

جرعة:

100MG

الشكل الصيدلاني:

CAPSULE

تركيب:

GABAPENTIN 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTICONVULSANTS

ملخص المنتج:

Active ingredient group (AIG) number: 0125929001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2023-02-06

خصائص المنتج

Page 1 of 33
PRODUCT MONOGRAPH
PR
RAN™-GABAPENTIN
Gabapentin Capsules, Mfr. Std
100 mg, 300 mg, and 400 mg
Antiepileptic Agent
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision
126 East Drive
June 17, 2020
Brampton, Ontario
L6T 1C1
Submission Control No.: 239409
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
17
STORAGE AND STABILITY
.................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
...................................