ZOVIRAX 400 TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ACYCLOVIR

Dostępny od:

GLAXOSMITHKLINE INC

Kod ATC:

J05AB01

INN (International Nazwa):

ACYCLOVIR

Dawkowanie:

400MG

Forma farmaceutyczna:

TABLET

Skład:

ACYCLOVIR 400MG

Droga podania:

ORAL

Sztuk w opakowaniu:

56

Typ recepty:

Prescription

Dziedzina terapeutyczna:

NUCLEOSIDES AND NUCLEOTIDES

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2014-02-20

Charakterystyka produktu

_2008-09-10/131-prisitne-english-zovirax.doc _
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_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..........................