OXYBUTYNIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
08-03-2021
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Werkstoffen:
OXYBUTYNIN CHLORIDE
Beschikbaar vanaf:
APOTEX INC
ATC-code:
G04BD04
INN (Algemene Internationale Benaming):
OXYBUTYNIN
Dosering:
5MG
farmaceutische vorm:
TABLET
Samenstelling:
OXYBUTYNIN CHLORIDE 5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
Antimuscarinics
Product samenvatting:
Active ingredient group (AIG) number: 0114692001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2021-03-10
Productkenmerken
Page 1 of 23
PRODUCT MONOGRAPH
PR
OXYBUTYNIN
Oxybutynin Chloride Tablets 5 mg, USP
PR
OXYBUTYNIN SYRUP
Oxybutynin Chloride Syrup 1 mg / mL, USP
ANTICHOLINERGIC / ANTISPASMODIC AGENT
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF PREPARATION:
April 15,1997
DATE OF REVISION:
March 8, 2021
Submission Control number #244366
Page 2 of 23
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
......................................................................................................................
9
DOSAGE AND ADMINISTRATION
....................................................................................................
9
OVERDOSAGE
.................................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
11
STORAGE AND STABILITY
...............................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................................
12
PART II: SCIENTIFIC INFORMATION
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