PAT-DARUNAVIR TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
13-12-2012
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Aktiv bestanddel:
DARUNAVIR (DARUNAVIR ETHANOLATE)
Tilgængelig fra:
PATRIOT A DIVISION OF JANSSEN INC
ATC-kode:
J05AE10
INN (International Name):
DARUNAVIR
Dosering:
800MG
Lægemiddelform:
TABLET
Sammensætning:
DARUNAVIR (DARUNAVIR ETHANOLATE) 800MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30
Recept type:
Prescription
Terapeutisk område:
HIV PROTEASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0151656006; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2020-03-12
Produktets egenskaber
_ _
_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
.............................
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