DITROPAN XL TABLET (EXTENDED-RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

OXYBUTYNIN CHLORIDE

Tilgjengelig fra:

JANSSEN INC

ATC-kode:

G04BD04

INN (International Name):

OXYBUTYNIN

Dosering :

15MG

Legemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensetning:

OXYBUTYNIN CHLORIDE 15MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

Antimuscarinics

Produkt oppsummering:

Active ingredient group (AIG) number: 0114692005; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2017-08-03

Preparatomtale

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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.
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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