Țară: Canada
Limbă: engleză
Sursă: Health Canada
TOPIRAMATE
RANBAXY PHARMACEUTICALS CANADA INC.
N03AX11
TOPIRAMATE
25MG
TABLET
TOPIRAMATE 25MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0132938001; AHFS:
CANCELLED POST MARKET
2020-11-03
_ _ _ _ _Page 1 of 67_ PRODUCT MONOGRAPH PR RAN™-TOPIRAMATE Topiramate Tablets, USP 25 mg, 100 mg and 200 mg Antiepileptic/Migraine Prophylaxis Ranbaxy Pharmaceuticals Canada Inc. Date of Revision: 2680 Matheson Blvd. E., Suite 200 June 29, 2015 Mississauga, Ontario L4W 0A5 Submission Control No.: 184894 RAN trademark owned by Sun Pharmaceutical Industries Ltd. _ _ _ _ _Page 2 of 67_ 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 ..................................................................................................19 DRUG INTERACTIONS ..................................................................................................35 DOSAGE AND ADMINISTRATION ..............................................................................42 OVERDOSAGE ................................................................................................................46 ACTION AND CLINICAL PHARMACOLOGY ............................................................46 STORAGE AND STABILITY ..........................................................................................49 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................49 PART II: SCIENTIFIC INFORMATION ...............................................................................50 PHARMACEUTICAL INFORMATION ..........................................................................50 CLINICAL TRIALS ................................................................................................... Citiți documentul complet