DITROPAN XL TABLET (EXTENDED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

OXYBUTYNIN CHLORIDE

Prieinama:

JANSSEN INC

ATC kodas:

G04BD04

INN (Tarptautinis Pavadinimas):

OXYBUTYNIN

Dozė:

5MG

Vaisto forma:

TABLET (EXTENDED-RELEASE)

Sudėtis:

OXYBUTYNIN CHLORIDE 5MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

Antimuscarinics

Produkto santrauka:

Active ingredient group (AIG) number: 0114692001; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2022-09-15

Prekės savybės

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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
.........................................