PMS-FENTANYL MTX PATCH
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-12-2020
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Active ingredient:
FENTANYL
Available from:
PHARMASCIENCE INC
ATC code:
N02AB03
INN (International Name):
FENTANYL
Dosage:
100MCG
Pharmaceutical form:
PATCH
Composition:
FENTANYL 100MCG
Administration route:
TRANSDERMAL
Units in package:
5 PATCHES/BOX
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0123302012; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2023-06-05
Summary of Product characteristics
PRODUCT MONOGRAPH
N PMS-FENTANYL MTX
Fentanyl Transdermal System
12 mcg/h
25 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave., Suite 100
December 29, 2020
Montreal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No.: 242156
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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
..........................................................................................................
17
DRUG
INTERACTIONS
...........................................................................................................
20
DOSAGE
AND
ADMINISTRATION
.......................................................................................
22
OVERDOSAGE
.........................................................................................................................
28
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
29
STORAGE
AND
STABILITY...................................................................................................
32
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
32
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 33
PART II: SCIENTIFIC INFORMATION
................................................................................
35
PHARMACEUTICAL
INFORMATION
........................
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