ABSTRAL TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FENTANYL (FENTANYL CITRATE)

Fáanlegur frá:

PALADIN LABS INC.

ATC númer:

N02AB03

INN (Alþjóðlegt nafn):

FENTANYL

Skammtar:

100MCG

Lyfjaform:

TABLET

Samsetning:

FENTANYL (FENTANYL CITRATE) 100MCG

Stjórnsýsluleið:

SUBLINGUAL

Einingar í pakka:

10/30

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0123302012; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2018-06-29

Vara einkenni

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