ZOVIRAX SUSPENSION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ACYCLOVIR

Disponible des:

GLAXOSMITHKLINE INC

Codi ATC:

J05AB01

Designació comuna internacional (DCI):

ACYCLOVIR

Dosis:

200MG

formulario farmacéutico:

SUSPENSION

Composición:

ACYCLOVIR 200MG

Vía de administración:

ORAL

Unidades en paquete:

125ML

tipo de receta:

Prescription

Área terapéutica:

NUCLEOSIDES AND NUCLEOTIDES

Resumen del producto:

Active ingredient group (AIG) number: 0115506003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2001-08-07

Fitxa tècnica

_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
May 30, 2016
Submission Control No: 191703
_©_
_2016 GlaxoSmithKline Inc. All Rights Reserved _
_ZOVIRAX is a registered trademark of GlaxoSmithKline Inc. _
_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
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................15
DETALIL