Ország: Kanada
Nyelv: angol
Forrás: Health Canada
OXYBUTYNIN CHLORIDE
PATRIOT A DIVISION OF JANSSEN INC
G04BD04
OXYBUTYNIN
15MG
TABLET (EXTENDED-RELEASE)
OXYBUTYNIN CHLORIDE 15MG
ORAL
100/500
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692005; AHFS:
CANCELLED PRE MARKET
2017-08-03
_~db5_Oa6c04dba162b402eafecbbb371927dc1.doc _ _ _ _ _ _ _ _ _ _1 of _27_ _ PRODUCT MONOGRAPH PR PAT-OXYBUTYNIN CHLORIDE ER oxybutynin chloride Extended-release Tablets, USP 5 mg, 10 mg and 15 mg Anticholinergic/Antispasmodic Agent Patriot, a division of Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.patriot-canada.ca Date of Preparation: January 24, 2014 Submission Control No: 170994 All trademarks used under license. © 2014 Patriot, a Division of Janssen Inc. _~db5_Oa6c04dba162b402eafecbbb371927dc1.doc _ _ _ _ _ _ _ _ _ _2 of _27_ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................12 ACTION AND CLINICAL PHARMACOLOGY ............................................................12 STORAGE AND STABILITY ..........................................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................16 PHARMACEUTICAL INFORMATION ....................... Olvassa el a teljes dokumentumot