TEVA-FENTANYL PATCH

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FENTANYL

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

N02AB03

DCI (Dénomination commune internationale):

FENTANYL

Dosage:

25MCG

forme pharmaceutique:

PATCH

Composition:

FENTANYL 25MCG

Mode d'administration:

TRANSDERMAL

Unités en paquet:

5

Type d'ordonnance:

Narcotic (CDSA I)

Domaine thérapeutique:

OPIATE AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-07-04

Résumé des caractéristiques du produit

_ _
_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
......................