UROMAX TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

OXYBUTYNIN CHLORIDE

Saatavilla:

PURDUE PHARMA

ATC-koodi:

G04BD04

INN (Kansainvälinen yleisnimi):

OXYBUTYNIN

Annos:

10MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

OXYBUTYNIN CHLORIDE 10MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Antimuscarinics

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0114692004; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2013-08-01

Valmisteyhteenveto

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_Page 1 of 26_
PRODUCT MONOGRAPH
Pr
UROMAX
®
Oxybutynin Chloride
Controlled Release Tablets – 5, 10 and 15 mg
Anticholinergic-Antispasmodic
ATC: G04BD04
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
DATE OF REVISION:
October 16, 2013
SUBMISSION CONTROL NO: 167196
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_Page 2 of 26_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.................................................