RAN-GABAPENTIN CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

GABAPENTIN

Boleh didapati daripada:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

N02BF01

INN (Nama Antarabangsa):

GABAPENTIN

Dos:

300MG

Borang farmaseutikal:

CAPSULE

Komposisi:

GABAPENTIN 300MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2023-02-06

Ciri produk

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