Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
OXYBUTYNIN CHLORIDE
TEVA CANADA LIMITED
G04BD04
OXYBUTYNIN
5MG
TABLET
OXYBUTYNIN CHLORIDE 5MG
ORAL
100/500/1000
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692001; AHFS:
APPROVED
2014-06-12
PRODUCT MONOGRAPH PR TEVA-OXYBUTYNIN oxybutynin chloride tablets, USP, 5 mg Anticholinergic/Antispasmodic Agent Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Revision: September 21, 2021 Submission Control No: 251700 2 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 STORAGE AND STABILITY .................................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 12 PART II: SCIENTIFIC INFORMATION ........................................................................... 13 PHARMACEUTICAL INFORMATION .................................................................... 13 CLINICAL TRIALS ................................................................................................... 14 DETAILED PHARMACOLOGY ............................................................................... 14 TOXICOLOGY........................................................................................................... 15 REFERENCES ........................................................ Přečtěte si celý dokument