Land: Kanada
Sprache: Englisch
Quelle: Health Canada
TOPIRAMATE
DOMINION PHARMACAL
N03AX11
TOPIRAMATE
100MG
TABLET
TOPIRAMATE 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0132938002; AHFS:
APPROVED
2005-09-14
PRODUCT MONOGRAPH Pr Dom-TOPIRAMATE Topiramate Tablets, House Standard 25 mg, 100 mg and 200 mg Antiepileptic/Migraine Prophylaxis DOMINION PHARMACAL Date of Revision: 6111 Royalmount Ave., Suite 100 August 23, 2019 Montréal, Québec H4P 2T4 Control No.: 229734 Dom-TOPIRAMATE Product Monograph Page 2 of 74 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 20 DRUG INTERACTIONS .......................................................................................................... 38 DOSAGE AND ADMINISTRATION ...................................................................................... 46 OVERDOSAGE ........................................................................................................................ 49 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 50 STORAGE AND STABILITY ................................................................................................. 53 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 53 PART II: SCIENTIFIC INFORMATION ............................................................................... 54 PHARMACEUTICAL INFORMATION ................................................................................. 54 CLINICAL TRIAL ........................................................................... Lesen Sie das vollständige Dokument