RAN-GABAPENTIN CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

GABAPENTIN

Доступно од:

RANBAXY PHARMACEUTICALS CANADA INC.

АТЦ код:

N02BF01

INN (Међународно име):

GABAPENTIN

Дозирање:

100MG

Фармацеутски облик:

CAPSULE

Састав:

GABAPENTIN 100MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS ANTICONVULSANTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2023-02-06

Карактеристике производа

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