PRO-GABAPENTIN CAPSULE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

GABAPENTIN

Beszerezhető a:

PRO DOC LIMITEE

ATC-kód:

N02BF01

INN (nemzetközi neve):

GABAPENTIN

Adagolás:

300MG

Gyógyszerészeti forma:

CAPSULE

Összetétel:

GABAPENTIN 300MG

Az alkalmazás módja:

ORAL

db csomag:

100/500

Recept típusa:

Prescription

Terápiás terület:

MISCELLANEOUS ANTICONVULSANTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0125929003; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2008-07-17

Termékjellemzők

_PRO-GABAPENTIN page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRO-GABAPENTIN
Gabapentin Capsules
Capsules, 100 mg, 300 mg and 400 mg, oral
House Standard
Antiepileptic Agent
PRO DOC LTÉE
2529 boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Approval:
JUL 17, 2008
Date of Revision:
JAN 02, 2024
Submission Control No: 278367
_PRO-GABAPENTIN page 2 of 39 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
01/2024
7.1 Special Populations, 7.1.1 Pregnant Women, Neonatal
withdrawal syndrome
01/2024
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
..............................................................................................
5
4.1
Dosing Considerations
.........................................................................................................
5
4.2
Recommended Dose and Dosage