Држава: Канада
Језик: Енглески
Извор: Health Canada
SOTALOL HYDROCHLORIDE
VALEANT CANADA LP / VALEANT CANADA S.E.C.
C07AA07
SOTALOL
160MG
TABLET
SOTALOL HYDROCHLORIDE 160MG
ORAL
100/500
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0113778001; AHFS:
CANCELLED POST MARKET
2014-07-30
_ _ _Rylosol Product Monograph – November 25, 2005 _ _Page 1 of 30_ PRODUCT MONOGRAPH Pr RYLOSOL Sotalol Hydrochloride 80 mg, 160 mg, 240 mg Tablets BP Anti-arrhythmic Valeant Canada limitée/Limited 4787, Levy Street Montreal, Quebec H4R 2P9 Date of Preparation: November 25, 2005 Revision: June 14, 2006 Submission Control No: 102836 _ _ _Rylosol Product Monograph – November 25, 2005 _ _Page 2 of 30_ 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..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION..............................................................................14 OVERDOSAGE ................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 STORAGE AND STABILITY..........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION..........................................................................20 CLINICAL TRIALS.................................................................................... Прочитајте комплетан документ