DOM-GABAPENTIN CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

GABAPENTIN

Disponibbli minn:

DOMINION PHARMACAL

Kodiċi ATC:

N02BF01

INN (Isem Internazzjonali):

GABAPENTIN

Dożaġġ:

100MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

GABAPENTIN 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2001-04-04

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
Pr DOM-GABAPENTIN
Gabapentin Capsules, House Standard
100 mg, 300 mg and 400 mg
Gabapentin Tablets, USP
600 mg and 800 mg
Antiepileptic Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
August 11, 2017
Submission Control No.: 207318
_ _
_Dom-GABAPENTIN Product Monograph _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOG