PREZISTA TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Prieinama:

JANSSEN INC

ATC kodas:

J05AE10

INN (Tarptautinis Pavadinimas):

DARUNAVIR

Dozė:

300MG

Vaisto forma:

TABLET

Sudėtis:

DARUNAVIR (DARUNAVIR ETHANOLATE) 300MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

120

Recepto tipas:

Prescription

Gydymo sritis:

HIV PROTEASE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2011-07-27

Prekės savybės

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