ABSTRAL TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FENTANYL (FENTANYL CITRATE)

Boleh didapati daripada:

PALADIN LABS INC.

Kod ATC:

N02AB03

INN (Nama Antarabangsa):

FENTANYL

Dos:

200MCG

Borang farmaseutikal:

TABLET

Komposisi:

FENTANYL (FENTANYL CITRATE) 200MCG

Laluan pentadbiran:

SUBLINGUAL

Unit dalam pakej:

10/30

Jenis preskripsi:

Narcotic (CDSA I)

Kawasan terapeutik:

OPIATE AGONISTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-06-29

Ciri 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
...........................................................