PRO-GABAPENTIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

GABAPENTIN

Beszerezhető a:

PRO DOC LIMITEE

ATC-kód:

N02BF01

INN (nemzetközi neve):

GABAPENTIN

Adagolás:

600MG

Gyógyszerészeti forma:

TABLET

Összetétel:

GABAPENTIN 600MG

Az alkalmazás módja:

ORAL

db csomag:

100/500

Recept típusa:

Prescription

Terápiás terület:

MISCELLANEOUS ANTICONVULSANTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0125929004; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2014-01-03

Termékjellemzők

_Page 1 of 35_
_Pro-Gabapentin (Gabapentin Tablets USP, 600 mg and 800 mg)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-GABAPENTIN
GABAPENTIN TABLETS
TABLETS, 600 MG AND 800 MG, ORAL
USP
Antiepileptic Agent
Pro Doc Ltée.
2925 Boulevard Industriel
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NO.: 279698
Date of
Initial
Authorization:
JUL 17, 2008
Date of Revision:
OCT
20, 2023
_ _
_Pro-Gabapentin (Gabapentin Tablets USP, 600 mg and 800 mg) _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
10-2023
7.1 Special Populations, 7.1.1 Pregnant Women, Neonatal withdrawal
syndrome
10-2023
_ _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES ......................................................................................2
TABLE OF CONTENTS ........................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1 INDICATIONS ................................................................................................................4
1.1 Pediatrics
..................................................................................................................
4
1.2 Geriatrics
...................................................................................................................
4
2 CONTRAINDICATIONS ...............................................................................................4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...............................................4
4 DOSAGE AND ADMINISTRATION ...........................................................................4
4.1 Dosing Considerations
...........................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
.................................................. 5
4.4 Admini