ZOVIRAX 400 TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ACYCLOVIR

Dostopno od:

GLAXOSMITHKLINE INC

Koda artikla:

J05AB01

INN (mednarodno ime):

ACYCLOVIR

Odmerek:

400MG

Farmacevtska oblika:

TABLET

Sestava:

ACYCLOVIR 400MG

Pot uporabe:

ORAL

Enote v paketu:

56

Tip zastaranja:

Prescription

Terapevtsko območje:

NUCLEOSIDES AND NUCLEOTIDES

Povzetek izdelek:

Active ingredient group (AIG) number: 0115506004; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2014-02-20

Lastnosti izdelka

_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..........................