DOM-GABAPENTIN CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GABAPENTIN

Pieejams no:

DOMINION PHARMACAL

ATĶ kods:

N02BF01

SNN (starptautisko nepatentēto nosaukumu):

GABAPENTIN

Deva:

100MG

Zāļu forma:

CAPSULE

Kompozīcija:

GABAPENTIN 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2001-04-04

Produkta apraksts

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