INTELENCE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ETRAVIRINE

Mevcut itibaren:

JANSSEN INC

ATC kodu:

J05AG04

INN (International Adı):

ETRAVIRINE

Doz:

25MG

Farmasötik formu:

TABLET

Kompozisyon:

ETRAVIRINE 25MG

Uygulama yolu:

ORAL

Paketteki üniteler:

120

Reçete türü:

Prescription

Terapötik alanı:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0152450003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2023-08-08

Ürün özellikleri

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_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
Pr
INTELENCE
®
etravirine tablets
tablets, 25 mg, 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:
October 14, 2022
Submission Control Number: 264392
All trademarks used under license.
© 2022 Janssen Inc.
_ _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
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
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
..................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment............................................... 5
4.4
Administration
...............................................................................................
6
4.5
Missed Dose
......................................................................