ZOVIRAX TAB 200MG TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ACYCLOVIR

Disponible desde:

GLAXOSMITHKLINE INC

Código ATC:

J05AB01

Designación común internacional (DCI):

ACYCLOVIR

Dosis:

200MG

formulario farmacéutico:

TABLET

Composición:

ACYCLOVIR 200MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

NUCLEOSIDES AND NUCLEOTIDES

Resumen del producto:

Active ingredient group (AIG) number: 0115506002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2016-01-11

Ficha técnica

_2014-11-10/131-pristine-pm-zovirax.doc _
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_Page 1 of 38_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Acyclovir Tablets USP, 200 mg
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
November 10, 2014
Submission Control No: 177766
_©_
_2014 GlaxoSmithKline Inc. All Rights Reserved _
_ZOVIRAX is a registered trademark of GlaxoSmithKline Inc. _
_2014-11-10/131-pristine-pm-zovirax.doc _
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_Page 2 of 38_
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
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................