PREZISTA SUSPENSION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Dostupné s:

JANSSEN INC

ATC kód:

J05AE10

INN (Mezinárodní Name):

DARUNAVIR

Dávkování:

100MG

Léková forma:

SUSPENSION

Složení:

DARUNAVIR (DARUNAVIR ETHANOLATE) 100MG

Podání:

ORAL

Jednotky v balení:

200ML

Druh předpisu:

Prescription

Terapeutické oblasti:

HIV PROTEASE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0151656007; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2013-11-19

Charakteristika produktu

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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:
Jul 27, 2006
Date of Revision:
October 14, 2022
Submission Control Number: 264786
© 2022 Janssen Inc.
All trademarks used under license
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_Page 2 of 93_
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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
....................................................................................................
8
5
OVERDOSAGE
...............................................