Land: Kanada
Tungumál: enska
Heimild: Health Canada
OXYBUTYNIN CHLORIDE
JANSSEN INC
G04BD04
OXYBUTYNIN
15MG
TABLET (EXTENDED-RELEASE)
OXYBUTYNIN CHLORIDE 15MG
ORAL
100
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692005; AHFS:
CANCELLED PRE MARKET
2017-08-03
_Ditropan XL_apm.doc _ _ _ _1 of _ 26 _ _ PRODUCT MONOGRAPH PR DITROPAN XL * oxybutynin chloride Extended-release Tablets, USP 5 mg, 10 mg and 15 mg Anticholinergic/Antispasmodic Agent This Product Monograph is the exclusive property of Janssen-Ortho Inc. It may not be copied in whole or in part without the written permission of Janssen-Ortho Inc. Janssen-Ortho Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen-ortho.com Date of Revision: March 03, 2009 SUBMISSION CONTROL NUMBER: 126559 * All trademark rights used under license © 2009 JANSSEN-ORTHO Inc. _Ditropan XL_apm.doc _ _ _ _2 of _ 26 _ _ 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 ................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ............................................................12 STORAGE AND STABILITY..........................................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................15 Lestu allt skjalið