DOM-GABAPENTIN CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

GABAPENTIN

Commercializzato da:

DOMINION PHARMACAL

Codice ATC:

N02BF01

INN (Nome Internazionale):

GABAPENTIN

Dosaggio:

100MG

Forma farmaceutica:

CAPSULE

Composizione:

GABAPENTIN 100MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2001-04-04

Scheda tecnica

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
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_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