AGENERASE CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

AMPRENAVIR

Disponible des:

GLAXOSMITHKLINE INC

Codi ATC:

J05AE05

Designació comuna internacional (DCI):

AMPRENAVIR

Dosis:

50MG

formulario farmacéutico:

CAPSULE

Composición:

AMPRENAVIR 50MG

Vía de administración:

ORAL

Unidades en paquete:

480

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0143241001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2008-05-27

Fitxa tècnica

_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