DITROPAN XL TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

OXYBUTYNIN CHLORIDE

Dostupno od:

JANSSEN INC

ATC koda:

G04BD04

INN (International ime):

OXYBUTYNIN

Doziranje:

5MG

Farmaceutski oblik:

TABLET (EXTENDED-RELEASE)

Sastav:

OXYBUTYNIN CHLORIDE 5MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

Antimuscarinics

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2022-09-15

Svojstava lijeka

_Non-223169 DITROPAN XL - APM_.doc _
_ _
_1 of _26_ _
PRODUCT MONOGRAPH
PR
DITROPAN XL
®
oxybutynin chloride
Extended-release Tablets, USP
5 mg and 10 mg
Anticholinergic/Antispasmodic Agent
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 12, 2019
Submission Control No: 223169
All trademarks used under license.
© 2019 Janssen Inc.
_Non-223169 DITROPAN XL - APM_.doc _
_ _
_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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS
.........................................