RAN-GABAPENTIN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

GABAPENTIN

Saatavilla:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-koodi:

N02BF01

INN (Kansainvälinen yleisnimi):

GABAPENTIN

Annos:

400MG

Lääkemuoto:

CAPSULE

Koostumus:

GABAPENTIN 400MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0125929002; AHFS:

Valtuutuksen tilan:

MARKETED

Valtuutus päivämäärä:

2009-01-07

Valmisteyhteenveto

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