PRO-RIVAROXABAN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Osta kohe

Laadi alla Toote omadused (SPC)
30-08-2023

Toimeaine:

RIVAROXABAN

Saadav alates:

PRO DOC LIMITEE

ATC kood:

B01AF01

INN (Rahvusvaheline Nimetus):

RIVAROXABAN

Annus:

2.5MG

Ravimvorm:

TABLET

Koostis:

RIVAROXABAN 2.5MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-11-01

Toote omadused

                                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
_PRO-RIVAROXABAN _
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
......................................................................................................2
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.
                                
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