Ország: Kanada
Nyelv: angol
Forrás: Health Canada
GABAPENTIN
PRO DOC LIMITEE
N02BF01
GABAPENTIN
100MG
CAPSULE
GABAPENTIN 100MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929001; AHFS:
APPROVED
2008-07-17
_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 Olvassa el a teljes dokumentumot