XARELTO Trousse

Negara: Kanada

Bahasa: Prancis

Sumber: Health Canada

Bahan aktif:

Rivaroxaban; Rivaroxaban

Tersedia dari:

BAYER INC

Kode ATC:

B01AF01

INN (Nama Internasional):

RIVAROXABAN

Dosis:

15MG; 20MG

Bentuk farmasi:

Trousse

Komposisi:

Rivaroxaban 15MG; Rivaroxaban 20MG

Rute administrasi :

Orale

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

Direct Factor Xa Inhibitors

Ringkasan produk:

Numéro de groupe d'ingrédients actifs (GIA) :0256950001; AHFS:

Status otorisasi:

ANNULÉ APRÈS COMMERCIALISATION

Tanggal Otorisasi:

2018-12-01

Karakteristik produk

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