DITROPAN SYRUP 1MG/ML

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OXYBUTYNIN CHLORIDE

Fáanlegur frá:

JANSSEN INC

ATC númer:

G04BD04

INN (Alþjóðlegt nafn):

OXYBUTYNIN

Skammtar:

1MG

Lyfjaform:

SYRUP

Samsetning:

OXYBUTYNIN CHLORIDE 1MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

473ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

Antimuscarinics

Vörulýsing:

Active ingredient group (AIG) number: 0114692002; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2007-02-21

Vara einkenni

_E:\DIT062306A.PRI.doc _
_Page 1 of 19 _
PRODUCT MONOGRAPH
PR
DITROPAN
*
oxybutynin chloride tablets, USP, 5 mg
oxybutynin chloride syrup, USP, 1 mg/mL
Anticholinergic/Antispasmodic Agent
This Product Monograph is the exclusive property of Janssen-Ortho Inc.
It may not be copied in whole or in part without the written
permission of Janssen-Ortho Inc.
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Date of Preparation:
February 13, 2002
Date of Revision:
December 20, 2006
Submission Control No: 108761
* All trademark rights used under license
© 2006 JANSSEN-ORTHO Inc.
_E:\DIT062306A.PRI.doc _
_Page 2 of 19 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND
ADMINISTRATION................................................................................9
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND
STABILITY..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...........................................................