DURAGESIC 25 PATCH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENTANYL

Available from:

JANSSEN INC

ATC code:

N02AB03

INN (International Name):

FENTANYL

Dosage:

25MCG

Pharmaceutical form:

PATCH

Composition:

FENTANYL 25MCG

Administration route:

TRANSDERMAL

Units in package:

5

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0123302014; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-11-24

Summary of Product characteristics

_Duragesic.apm.doc _
_Page 1 of 40_
PRODUCT MONOGRAPH
N
DURAGESIC
* 12
N
DURAGESIC
* 25
N
DURAGESIC
* 50
N
DURAGESIC
* 75
N
DURAGESIC
* 100
fentanyl transdermal system
Opioid Analgesic
This Product Monograph is the exclusive property of Janssen-Ortho Inc.
It may not be copied in whole or in part without the written
permission of Janssen-Ortho Inc.
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen-ortho.com
Distribution Site:
Markham, Ontario
L3R 0T5
Date of Revision:
April 30, 2009
Submission Control No: 127971
* All trademark rights used under license
© 2009 JANSSEN-ORTHO Inc
.
_Duragesic.apm.doc _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND
ADMINISTRATION..............................................................................16
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND
STABILITY..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................