RAN-GABAPENTIN CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GABAPENTIN

MAH:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC_code:

N02BF01

INN:

GABAPENTIN

dosage:

300MG

pharmaceutical_form:

CAPSULE

composition:

GABAPENTIN 300MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0125929003; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2023-02-06

SPC

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
...................................