AGENERASE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMPRENAVIR

Disponible depuis:

GLAXOSMITHKLINE INC

Code ATC:

J05AE05

DCI (Dénomination commune internationale):

AMPRENAVIR

Dosage:

150MG

forme pharmaceutique:

CAPSULE

Composition:

AMPRENAVIR 150MG

Mode d'administration:

ORAL

Unités en paquet:

240

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2008-05-27

Résumé des caractéristiques du produit

_DCTM/498/510/131-2005-06-21-pm-pristine--agenerase-capsules.doc _
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_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