PREZISTA TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DARUNAVIR (DARUNAVIR ETHANOLATE)

제공처:

JANSSEN INC

ATC 코드:

J05AE10

INN (국제 이름):

DARUNAVIR

복용량:

300MG

약제 형태:

TABLET

구성:

DARUNAVIR (DARUNAVIR ETHANOLATE) 300MG

관리 경로:

ORAL

패키지 단위:

120

처방전 유형:

Prescription

치료 영역:

HIV PROTEASE INHIBITORS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2011-07-27

제품 특성 요약

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