INTELENCE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ETRAVIRINE

Mevcut itibaren:

JANSSEN INC

ATC kodu:

J05AG04

INN (International Adı):

ETRAVIRINE

Doz:

200MG

Farmasötik formu:

TABLET

Kompozisyon:

ETRAVIRINE 200MG

Uygulama yolu:

ORAL

Paketteki üniteler:

60

Reçete türü:

Prescription

Terapötik alanı:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0152450002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2011-11-14

Ürün özellikleri

_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