AGENERASE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMPRENAVIR

Available from:

GLAXOSMITHKLINE INC

ATC code:

J05AE05

INN (International Name):

AMPRENAVIR

Dosage:

50MG

Pharmaceutical form:

CAPSULE

Composition:

AMPRENAVIR 50MG

Administration route:

ORAL

Units in package:

480

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2008-05-27

Summary of Product characteristics

_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. _
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_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