ABSTRAL TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

FENTANYL (FENTANYL CITRATE)

Disponível em:

PALADIN LABS INC.

Código ATC:

N02AB03

DCI (Denominação Comum Internacional):

FENTANYL

Dosagem:

200MCG

Forma farmacêutica:

TABLET

Composição:

FENTANYL (FENTANYL CITRATE) 200MCG

Via de administração:

SUBLINGUAL

Unidades em pacote:

10/30

Tipo de prescrição:

Narcotic (CDSA I)

Área terapêutica:

OPIATE AGONISTS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2018-06-29

Características técnicas

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