INTELENCE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ETRAVIRINE

Saatavilla:

JANSSEN INC

ATC-koodi:

J05AG04

INN (Kansainvälinen yleisnimi):

ETRAVIRINE

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

ETRAVIRINE 100MG

Antoreitti:

ORAL

Kpl paketissa:

120

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152450001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2008-03-27

Valmisteyhteenveto

_Approved Product Monograph 1.docx _
_EDMS-RIM-1139595 v6.0 _
_Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
INTELENCE
®
etravirine tablets
tablets, 100 mg, 200 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:
March 27, 2008
Date of Revision:
MAR 28, 2024
M
Control Number: 280475
All trademarks used under license.
© 2024 Janssen Inc.
_Approved Product Monograph 1.docx _
_EDMS-RIM-1139595 v6.0 _
_Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
1 Indications
03/2024
1 Indications, 1.1 Pediatrics
03/2024
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
03/2024
4 Dosage and Administration, 4.4 Administration
10/2022
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 a