ZOVIRAX SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ACYCLOVIR

Disponible depuis:

GLAXOSMITHKLINE INC

Code ATC:

J05AB01

DCI (Dénomination commune internationale):

ACYCLOVIR

Dosage:

200MG

forme pharmaceutique:

SUSPENSION

Composition:

ACYCLOVIR 200MG

Mode d'administration:

ORAL

Unités en paquet:

125ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDES AND NUCLEOTIDES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2001-08-07

Résumé des caractéristiques du produit

_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