PREZISTA TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Disponible depuis:

JANSSEN INC

Code ATC:

J05AE10

DCI (Dénomination commune internationale):

DARUNAVIR

Dosage:

300MG

forme pharmaceutique:

TABLET

Composition:

DARUNAVIR (DARUNAVIR ETHANOLATE) 300MG

Mode d'administration:

ORAL

Unités en paquet:

120

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2011-07-27

Résumé des caractéristiques du produit

_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
..........................................