DITROPAN XL TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

OXYBUTYNIN CHLORIDE

Saatavilla:

JANSSEN INC

ATC-koodi:

G04BD04

INN (Kansainvälinen yleisnimi):

OXYBUTYNIN

Annos:

10MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

OXYBUTYNIN CHLORIDE 10MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Antimuscarinics

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0114692004; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2022-09-15

Valmisteyhteenveto

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PRODUCT MONOGRAPH
PR
DITROPAN XL
®
oxybutynin chloride
Extended-release Tablets, USP
5 mg and 10 mg
Anticholinergic/Antispasmodic Agent
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 12, 2019
Submission Control No: 223169
All trademarks used under license.
© 2019 Janssen 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
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS
.........................................