ZOVIRAX 800 TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ACYCLOVIR

Tilgængelig fra:

GLAXOSMITHKLINE INC

ATC-kode:

J05AB01

INN (International Name):

ACYCLOVIR

Dosering:

800MG

Lægemiddelform:

TABLET

Sammensætning:

ACYCLOVIR 800MG

Indgivelsesvej:

ORAL

Enheder i pakken:

50

Recept type:

Prescription

Terapeutisk område:

NUCLEOSIDES AND NUCLEOTIDES

Produkt oversigt:

Active ingredient group (AIG) number: 0115506005; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2011-08-03

Produktets egenskaber

_2008-09-10/131-prisitne-english-zovirax.doc _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Acyclovir Tablets USP, 200, 400, and 800 mg
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
September 10, 2008
SUBMISSION CONTROL NUMBER: 123012
_©_
_ 2008 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_ ZOVIRAX, WELLSTAT PAC and ZOSTAB PAC are registered trademarks,
GlaxoSmithKline Inc. _
_2008-09-10/131-prisitne-english-zovirax.doc _
_ _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL
INFORMATION..........................