PREZISTA TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Tersedia dari:

JANSSEN INC

Kode ATC:

J05AE10

INN (Nama Internasional):

DARUNAVIR

Dosis:

600MG

Bentuk farmasi:

TABLET

Komposisi:

DARUNAVIR (DARUNAVIR ETHANOLATE) 600MG

Rute administrasi :

ORAL

Unit dalam paket:

60

Jenis Resep:

Prescription

Area terapi:

HIV PROTEASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0151656003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2009-03-12

Karakteristik produk

_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 1 of 93_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PREZISTA
®
darunavir tablets 75 mg, 150 mg, 600 mg, 800 mg
darunavir oral suspension 100 mg/mL
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
July 27, 2006
Date of Revision:
March 3, 2023
Submission Control Number: 268362
© 2023 Janssen Inc.
All trademarks used under license
_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 2 of 93_
_ _
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
4.5
Missed Dose
........