PAT-DARUNAVIR TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Διαθέσιμο από:

PATRIOT A DIVISION OF JANSSEN INC

Φαρμακολογική κατηγορία (ATC):

J05AE10

INN (Διεθνής Όνομα):

DARUNAVIR

Δοσολογία:

75MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DARUNAVIR (DARUNAVIR ETHANOLATE) 75MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

480

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HIV PROTEASE INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2012-11-19

Αρχείο Π.Χ.Π.

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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
.............................