ABSTRAL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FENTANYL (FENTANYL CITRATE)

Tersedia dari:

PALADIN LABS INC.

Kode ATC:

N02AB03

INN (Nama Internasional):

FENTANYL

Dosis:

200MCG

Bentuk farmasi:

TABLET

Komposisi:

FENTANYL (FENTANYL CITRATE) 200MCG

Rute administrasi :

SUBLINGUAL

Unit dalam paket:

10/30

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0123302017; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-06-29

Karakteristik produk

_ _
_ABSTRAL Product Monograph _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
N
ABSTRAL
®
Fentanyl citrate sublingual tablets
100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg fentanyl as
fentanyl citrate
Opioid Analgesic
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, Quebec H4M 2P2
Date of Preparation:
March 8, 2018
Version 7.0
Submission Control No: 210630
_ _
®
Registered trademark of Strakan International Limited
_ _
_ _
_ABSTRAL Product Monograph Page 2 of 64_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...........................................................