CO FENTANYL PATCH
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-08-2017
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Active ingredient:
FENTANYL
Available from:
COBALT PHARMACEUTICALS COMPANY
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:
2018-05-17
Summary of Product characteristics
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_CO _FENTANYL_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
N
_CO_ FENTANYL
Fentanyl Transdermal Patches (Matrix)
12 mcg/h
25 mcg/h
37 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
Cobalt Pharmaceuticals Company
Date of Revision:
6733 Mississauga Road, Suite 400
August 23, 2017
Mississauga, Ontario
L5N 6J5
Submission Control No.: 208560
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_CO _FENTANYL_ _
_Page 2 of 49_
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
..........................................................................................................
14
DRUG
INTERACTIONS
...........................................................................................................
17
DOSAGE
AND
ADMINISTRATION
.......................................................................................
18
OVERDOSAGE
.........................................................................................................................
25
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
26
STORAGE
AND
STABILITY...................................................................................................
28
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 29
PART II: SCIENTIFIC INFORMATION
................................................................................
31
PHARMACE
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