PRO-RIVAROXABAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RIVAROXABAN

Tersedia dari:

PRO DOC LIMITEE

Kode ATC:

B01AF01

INN (Nama Internasional):

RIVAROXABAN

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

RIVAROXABAN 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0152487004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-11-01

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-RIVAROXABAN
Rivaroxaban Tablets
Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral
House standard
Anticoagulant
(ATC Classification: B01AF01)
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control Number: 276861
Date of Initial Authorization:
AUG 30, 2023
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TABLE OF CONTENTS
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TABLE OF
CONTENTS........................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................................4
1 INDICATIONS
................................................................................................................................4
1.1
Pediatrics
.......................................................................................................................................
5
1.2
Geriatrics
.......................................................................................................................................
5
2 CONTRAINDICATIONS
...................................................................................................................5
4 DOSAGE AND ADMINISTRATION
...................................................................................................6
4.1
Dosing Considerations
...................................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..............................................................................
8
4.4
Administration
.............................................................................................................................
13
4.