PAT-DARUNAVIR TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DARUNAVIR (DARUNAVIR ETHANOLATE)

제공처:

PATRIOT A DIVISION OF JANSSEN INC

ATC 코드:

J05AE10

INN (International Name):

DARUNAVIR

복용량:

75MG

약제 형태:

TABLET

구성:

DARUNAVIR (DARUNAVIR ETHANOLATE) 75MG

관리 경로:

ORAL

패키지 단위:

480

처방전 유형:

Prescription

치료 영역:

HIV PROTEASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0151656004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2012-11-19

제품 특성 요약

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_Page 1 of 78 _
PRODUCT
MONOGRAPH
PR
PAT-DARUNAVIR
darunavir tablets 75 mg, 150 mg, 400 mg, 600 mg, 800 mg
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Date of Preparation:
November 30, 2012
www.patriot-canada.ca
Submission Control No: 159996
© JANSSEN Inc. 2012
All trademarks used under license.
Draft Date: Oct 26, 2012
_ _
_Page 2 of 78 _
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
.....................................................................................
32
OVERDOSAGE
.......................................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 35
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
.............................