PAT-OXYBUTYNIN CHLORIDE ER TABLET (EXTENDED-RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OXYBUTYNIN CHLORIDE

Fáanlegur frá:

PATRIOT A DIVISION OF JANSSEN INC

ATC númer:

G04BD04

INN (Alþjóðlegt nafn):

OXYBUTYNIN

Skammtar:

10MG

Lyfjaform:

TABLET (EXTENDED-RELEASE)

Samsetning:

OXYBUTYNIN CHLORIDE 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

Antimuscarinics

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2018-07-30

Vara einkenni

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PRODUCT MONOGRAPH
PR
PAT-OXYBUTYNIN CHLORIDE ER
oxybutynin chloride
Extended-release Tablets, USP
5 mg, 10 mg and 15 mg
Anticholinergic/Antispasmodic Agent
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.patriot-canada.ca
Date of Preparation:
January 24, 2014
Submission Control No: 170994
All trademarks used under license.
© 2014 Patriot, a Division of 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
.......................