EDURANT TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE)

Dostupné z:

JANSSEN INC

ATC kód:

J05AG05

INN (Medzinárodný Name):

RILPIVIRINE

Dávkovanie:

25MG

Forma lieku:

TABLET

Zloženie:

RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0152944001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2014-09-08

Súhrn charakteristických

_Approved Product Monograph 1.docx _
_EDMS-RIM-818666 v8.0 _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EDURANT
®
rilpivirine as rilpivirine hydrochloride
Tablets, 25 mg Oral
Human Immunodeficiency Virus (HIV) non-nucleoside reverse
transcriptase inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
July 20, 2011
Date of Revision:
January 20, 2023
Submission Control Number: 267245
All trademarks used under license
© 2023 Janssen Inc.
_Approved Product Monograph 1.docx _
_EDMS-RIM-818666 v8.0_
Page 2 of 44
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization
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......................................................................................................
4
1.2
Geriatrics
......................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
..................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment............................................... 5
4.4
Administration
...................................................................................