DOM-GABAPENTIN CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GABAPENTIN

Mevcut itibaren:

DOMINION PHARMACAL

ATC kodu:

N02BF01

INN (International Adı):

GABAPENTIN

Doz:

100MG

Farmasötik formu:

CAPSULE

Kompozisyon:

GABAPENTIN 100MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2001-04-04

Ürün özellikleri

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