Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
OXYBUTYNIN CHLORIDE
JANSSEN INC
G04BD04
OXYBUTYNIN
5MG
TABLET
OXYBUTYNIN CHLORIDE 5MG
ORAL
100
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692001; AHFS:
CANCELLED POST MARKET
2006-08-04
_E:\DIT062306A.PRI.doc _ _Page 1 of 19 _ PRODUCT MONOGRAPH PR DITROPAN * oxybutynin chloride tablets, USP, 5 mg oxybutynin chloride syrup, USP, 1 mg/mL 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 Date of Preparation: February 13, 2002 Date of Revision: December 20, 2006 Submission Control No: 108761 * All trademark rights used under license © 2006 JANSSEN-ORTHO Inc. _E:\DIT062306A.PRI.doc _ _Page 2 of 19 _ 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....................................................................................................6 DRUG INTERACTIONS ....................................................................................................8 DOSAGE AND ADMINISTRATION................................................................................9 OVERDOSAGE ..................................................................................................................9 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY..........................................................................................11 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................11 PART II: SCIENTIFIC INFORMATION ........................................................... Đọc toàn bộ tài liệu