PREZISTA TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Доступна с:

JANSSEN INC

код АТС:

J05AE10

ИНН (Международная Имя):

DARUNAVIR

дозировка:

300MG

Фармацевтическая форма:

TABLET

состав:

DARUNAVIR (DARUNAVIR ETHANOLATE) 300MG

Администрация маршрут:

ORAL

Штук в упаковке:

120

Тип рецепта:

Prescription

Терапевтические области:

HIV PROTEASE INHIBITORS

Обзор продуктов:

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

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2011-07-27

Характеристики продукта

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