APO-OXYBUTYNIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

OXYBUTYNIN CHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

G04BD04

INN (Nome Internazionale):

OXYBUTYNIN

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

OXYBUTYNIN CHLORIDE 5MG

Via di somministrazione:

ORAL

Confezione:

100 & 500 TABLETS

Tipo di ricetta:

Prescription

Area terapeutica:

Antimuscarinics

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-01-25

Scheda tecnica

Page 1 of 23
PRODUCT MONOGRAPH
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Tablets 5 mg, USP
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Syrup 1 mg / mL, USP
ANTICHOLINERGIC / ANTISPASMODIC AGENT
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9 DATE OF PREPARATION:
April 18,1995 DATE OF REVISION:
January 24, 2022
Submission Control number #259986
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
......................................................................................................................
8
DOSAGE AND ADMINISTRATION
....................................................................................................
9
OVERDOSAGE
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10
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
10
STORAGE AND STABILITY
...............................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................................
12
PART II: SCIENTIFIC INFORMATION
.........................................................................