AGENERASE LIQUID

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

AMPRENAVIR

Mevcut itibaren:

GLAXOSMITHKLINE INC

ATC kodu:

J05AE05

INN (International Adı):

AMPRENAVIR

Doz:

15MG

Farmasötik formu:

LIQUID

Kompozisyon:

AMPRENAVIR 15MG

Uygulama yolu:

ORAL

Paketteki üniteler:

240 ML

Reçete türü:

Prescription

Terapötik alanı:

HIV PROTEASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0143241003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2008-05-27

Ürün özellikleri

_DCTM/498/510/131-2005-06-21-pm-pristine-agenerase-oral-solution.doc _
_ _
_Appendix E - Product Monograph Template - Standard _
_Page 1 of 33_
PRODUCT MONOGRAPH
Pr
AGENERASE™
amprenavir
15 mg/mL oral solution
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..................................................................................................10
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND
STABILITY..........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
.