XARELTO KIT

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

RIVAROXABAN; RIVAROXABAN

Tilgjengelig fra:

BAYER INC

ATC-kode:

B01AF01

INN (International Name):

RIVAROXABAN

Dosering :

15MG; 20MG

Legemiddelform:

KIT

Sammensetning:

RIVAROXABAN 15MG; RIVAROXABAN 20MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

Direct Factor Xa Inhibitors

Produkt oppsummering:

Active ingredient group (AIG) number: 0256950001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-12-01

Preparatomtale

_ _
_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