OXYBUTYNIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
08-03-2021
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Aktiv ingrediens:
OXYBUTYNIN CHLORIDE
Tilgjengelig fra:
APOTEX INC
ATC-kode:
G04BD04
INN (International Name):
OXYBUTYNIN
Dosering :
5MG
Legemiddelform:
TABLET
Sammensetning:
OXYBUTYNIN CHLORIDE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
100/500
Resept typen:
Prescription
Terapeutisk område:
Antimuscarinics
Produkt oppsummering:
Active ingredient group (AIG) number: 0114692001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2021-03-10
Preparatomtale
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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