ABSTRAL TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
08-03-2018
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Aktiva substanser:
FENTANYL (FENTANYL CITRATE)
Tillgänglig från:
PALADIN LABS INC.
ATC-kod:
N02AB03
INN (International namn):
FENTANYL
Dos:
200MCG
Läkemedelsform:
TABLET
Sammansättning:
FENTANYL (FENTANYL CITRATE) 200MCG
Administreringssätt:
SUBLINGUAL
Enheter i paketet:
10/30
Receptbelagda typ:
Narcotic (CDSA I)
Terapiområde:
OPIATE AGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0123302017; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2018-06-29
Produktens egenskaper
_ _
_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
...........................................................
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