AGENERASE CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

AMPRENAVIR

Verfügbar ab:

GLAXOSMITHKLINE INC

ATC-Code:

J05AE05

INN (Internationale Bezeichnung):

AMPRENAVIR

Dosierung:

150MG

Darreichungsform:

CAPSULE

Zusammensetzung:

AMPRENAVIR 150MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

240

Verschreibungstyp:

Prescription

Therapiebereich:

HIV PROTEASE INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0143241002; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2008-05-27

Fachinformation

_DCTM/498/510/131-2005-06-21-pm-pristine--agenerase-capsules.doc _
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_J_
_Appendix E - Product Monograph Template - Standard _
_Page 1 of 33_
PRODUCT MONOGRAPH
Pr
AGENERASE™
amprenavir
50 mg and 150 mg capsules
Antiretroviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
October 30, 2001
Date of Revision:
June 27, 2005
Submission Control No: 097413
_©_
_ 2005 GlaxoSmithKline Inc. All Rights Reserved _
_™ AGENERASE used under license by GlaxoSmithKline Inc. _
_ _
_ _
_Appendix E - Product Monograph Template - Standard _
_Page 2 of 33_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND
STABILITY..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC