TEVA-FENTANYL PATCH

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FENTANYL

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

N02AB03

INN (Nama Internasional):

FENTANYL

Dosis:

50MCG

Bentuk farmasi:

PATCH

Komposisi:

FENTANYL 50MCG

Rute administrasi :

TRANSDERMAL

Unit dalam paket:

5

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0123302011; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-07-04

Karakteristik produk

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