TEVA-FENTANYL PATCH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENTANYL

Available from:

TEVA CANADA LIMITED

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:

APPROVED

Authorization date:

2006-07-04

Summary of Product characteristics

_ _
_TEVA-FENTANYL (12, 25, 50, 75 and 100 mcg/h) _
_ Page 1 of 60_
PRODUCT MONOGRAPH
N
TEVA-FENTANYL
FENTANYL TRANSDERMAL SYSTEM
PATCH, 12 MCG/H, 25 MCG/H, 50 MCG/H, 75 MCG/H AND 100 MCG/H
Opioid Analgesic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
June 10, 2022
Submission
Control No: 257888
_ _
_TEVA-FENTANYL (12, 25, 50, 75 and 100 mcg/h) _
_ Page 2 of 60_
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............................................................................................
18
DRUG INTERACTIONS
............................................................................................
21
DOSAGE AND ADMINISTRATION
.........................................................................
23
OVERDOSAGE
.........................................................................................................
30
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
31
STORAGE AND STABILITY
....................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
................................................................... 34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 35
PART II: SCIENTIFIC INFORMATION
..........................................................................
37
PHARMACEUTICAL INFORMATION
.....................................................................
37
CLINICAL TRIALS
......................