PREZISTA TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Disponible des:

JANSSEN INC

Codi ATC:

J05AE10

Designació comuna internacional (DCI):

DARUNAVIR

Dosis:

300MG

formulario farmacéutico:

TABLET

Composición:

DARUNAVIR (DARUNAVIR ETHANOLATE) 300MG

Vía de administración:

ORAL

Unidades en paquete:

120

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0151656001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2011-07-27

Fitxa tècnica

_PREZISTA_
_®_
_ (darunavir) – Product Monograph _
_NON_PRZ 2012 04 SNDS 800 mg_PREZ02152012CPM.NC.doc _
_Page 1 of 77 _
PRODUCT
MONOGRAPH
PR
PREZISTA
®
darunavir tablets 75 mg, 150 mg, 400 mg, 600 mg, 800 mg
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Date of Preparation:
July 27, 2006
Date of Revision:
September 28, 2012
www.janssen.ca
Submission Control No: 154695
© JANSSEN Inc. 2012
All trademarks used under license.
_PREZISTA_
_®_
_ (darunavir) – Product Monograph _
_NON_PRZ 2012 04 SNDS 800 mg_PREZ02152012CPM.NC.doc _
_Page 2 of 77 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
31
OVERDOSAGE
.......................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 34
STORAGE AND STABILITY
.................................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................