XARELTO Trousse
Land: Kanada
Språk: franska
Källa: Health Canada
Produktens egenskaper
(SPC)
13-09-2018
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Aktiva substanser:
Rivaroxaban; Rivaroxaban
Tillgänglig från:
BAYER INC
ATC-kod:
B01AF01
INN (International namn):
RIVAROXABAN
Dos:
15MG; 20MG
Läkemedelsform:
Trousse
Sammansättning:
Rivaroxaban 15MG; Rivaroxaban 20MG
Administreringssätt:
Orale
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
Direct Factor Xa Inhibitors
Produktsammanfattning:
Numéro de groupe d'ingrédients actifs (GIA) :0256950001; AHFS:
Bemyndigande status:
ANNULÉ APRÈS COMMERCIALISATION
Tillstånd datum:
2018-12-01
Produktens egenskaper
_XARELTO_
_Product Monograph Page 1 of 97_
PRODUCT MONOGRAPH
PR
XARELTO
®
rivaroxaban tablets
2.5 mg, 10 mg, 15 mg and 20 mg
Anticoagulant
(ATC Classification: B01AF01)
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
Canada
http://www.bayer.ca
Date of Revision:
September 13, 2018
Submission Control No: 211611
2018, Bayer Inc.
® TM see www.bayer.ca/tm-mc
All other trademarks are the property of their respective owners.
_XARELTO_
_Product Monograph Page 2 of 97_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.....................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................3
INDICATIONS AND CLINICAL
USE.....................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS.........................................................................................4
ADVERSE
REACTIONS.........................................................................................................11
DRUG INTERACTIONS
.........................................................................................................26
DOSAGE AND
ADMINISTRATION.....................................................................................30
OVERDOSAGE
.......................................................................................................................36
ACTION AND CLINICAL PHARMACOLOGY
...................................................................38
STORAGE AND
STABILITY.................................................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
1
...................................................45
PART II : SCIENTIFIC INFORMATION
..........................................................................47
PHARMACEUTICAL
INFORMATION..........................
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