PAT-OXYBUTYNIN CHLORIDE ER TABLET (EXTENDED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

OXYBUTYNIN CHLORIDE

Boleh didapati daripada:

PATRIOT A DIVISION OF JANSSEN INC

Kod ATC:

G04BD04

INN (Nama Antarabangsa):

OXYBUTYNIN

Dos:

15MG

Borang farmaseutikal:

TABLET (EXTENDED-RELEASE)

Komposisi:

OXYBUTYNIN CHLORIDE 15MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

Antimuscarinics

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2017-08-03

Ciri produk

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