AGENERASE LIQUID

Land: Kanada

Språk: engelska

Källa: Health Canada

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Ladda ner Produktens egenskaper (SPC)
15-07-2005

Aktiva substanser:

AMPRENAVIR

Tillgänglig från:

GLAXOSMITHKLINE INC

ATC-kod:

J05AE05

INN (International namn):

AMPRENAVIR

Dos:

15MG

Läkemedelsform:

LIQUID

Sammansättning:

AMPRENAVIR 15MG

Administreringssätt:

ORAL

Enheter i paketet:

240 ML

Receptbelagda typ:

Prescription

Terapiområde:

HIV PROTEASE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2008-05-27

Produktens egenskaper

                                _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
.
                                
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