XARELTO KIT
Land: Kanada
Språk: engelska
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:
KIT
Sammansättning:
RIVAROXABAN 15MG; RIVAROXABAN 20MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
Direct Factor Xa Inhibitors
Produktsammanfattning:
Active ingredient group (AIG) number: 0256950001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2018-12-01
Produktens egenskaper
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_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 18, 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 INFORMAT
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