AGENERASE CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

AMPRENAVIR

Dostępny od:

GLAXOSMITHKLINE INC

Kod ATC:

J05AE05

INN (International Nazwa):

AMPRENAVIR

Dawkowanie:

150MG

Forma farmaceutyczna:

CAPSULE

Skład:

AMPRENAVIR 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

240

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HIV PROTEASE INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2008-05-27

Charakterystyka produktu

_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