PAT-OXYBUTYNIN CHLORIDE ER TABLET (EXTENDED-RELEASE)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

OXYBUTYNIN CHLORIDE

Dostupné s:

PATRIOT A DIVISION OF JANSSEN INC

ATC kód:

G04BD04

INN (Mezinárodní Name):

OXYBUTYNIN

Dávkování:

5MG

Léková forma:

TABLET (EXTENDED-RELEASE)

Složení:

OXYBUTYNIN CHLORIDE 5MG

Podání:

ORAL

Jednotky v balení:

100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

Antimuscarinics

Přehled produktů:

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

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2018-07-30

Charakteristika produktu

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