ZOVIRAX 800 TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ACYCLOVIR

MAH:

GLAXOSMITHKLINE INC

ATC_code:

J05AB01

INN:

ACYCLOVIR

dosage:

800MG

pharmaceutical_form:

TABLET

composition:

ACYCLOVIR 800MG

administration_route:

ORAL

units_in_package:

50

prescription_type:

Prescription

therapeutic_area:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2011-08-03

SPC

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