ABSTRAL TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FENTANYL (FENTANYL CITRATE)

Pieejams no:

PALADIN LABS INC.

ATĶ kods:

N02AB03

SNN (starptautisko nepatentēto nosaukumu):

FENTANYL

Deva:

100MCG

Zāļu forma:

TABLET

Kompozīcija:

FENTANYL (FENTANYL CITRATE) 100MCG

Ievadīšanas:

SUBLINGUAL

Vienības iepakojumā:

10/30

Receptes veids:

Narcotic (CDSA I)

Ārstniecības joma:

OPIATE AGONISTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2018-06-29

Produkta apraksts

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