Land: Kanada
Språk: engelska
Källa: Health Canada
TOPIRAMATE
MARCAN PHARMACEUTICALS INC
N03AX11
TOPIRAMATE
100MG
TABLET
TOPIRAMATE 100MG
ORAL
30/100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0132938002; AHFS:
APPROVED
2014-11-10
_MAR-Topiramate (Topiramate Tablets) Page 1 of 79_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MAR-TOPIRAMATE Topiramate Tablets Tablets, 25 mg, 100 mg and 200 mg, oral USP Antiepileptic/Migraine Prophylaxis Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite#112 Ottawa, Ontario K2E 1A2 Submission Control Number: 271273 Date of Initial Authorization: NOV 10, 2014 Date of Revision: FEB 02, 2023 _ _ _ _ _ _ _MAR-Topiramate (Topiramate Tablets) Page 2 of 79 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Serious Skin Reactions 02/2023 7 WARNINGS AND PRECAUTIONS, Metabolic Acidosis 02/2023 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 02/2023 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 4 DOSAGE AND ADMINISTRATION .............................................................................. 5 4.1 Dosing Considerations ..................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................. 5 4.4 Administration ....................................................................................... Läs hela dokumentet