ZOVIRAX OPHTHALMIC OINTMENT

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ACICLOVIR

Disponível em:

GLAXO SMITH KLINE (ISRAEL) LTD

Código ATC:

S01AD03

Forma farmacêutica:

OPHTALMIC OINTMENT

Composição:

ACICLOVIR 3 %W/W

Via de administração:

OCULAR

Tipo de prescrição:

Required

Fabricado por:

JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP (JHSGP), CANADA

Grupo terapêutico:

ACICLOVIR

Área terapêutica:

ACICLOVIR

Indicações terapêuticas:

Indicated for the treatment of herpes simplex keratitis.

Data de autorização:

2014-05-31

Folheto informativo - Bula

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Características técnicas

_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in_
_June 2014_
ZOVIRAX
™ OPHTHALMIC OINTMENT
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zovirax Ophthalmic Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir 3.0% W/W
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic Ointment
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of herpes simplex keratitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration to the eye.
ADULTS:
1cm ribbon of ointment should be placed inside the lower conjunctival
sac five
times a day at approximately four hourly intervals, omitting the night
time application.
Treatment should continue for at least 3 days after healing is
complete.
CHILDREN:
As for adults
USE IN THE ELDERLY:
As for adults.
4.3
CONTRA-INDICATIONS
Zovirax Ophthalmic Ointment is contra-indicated in patients with a
known
hypersensitivity to aciclovir or valaciclovir, or any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be informed that transient mild stinging immediately
following
application may occur.
Patients should avoid wearing contact lenses when using Zovirax
Ophthalmic Ointment.
4.5
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
No clinically significant interactions have been identified.
4.6.
FERTILITY, PREGNANCY AND BREAST-FEEDING
_PREGNANCY _
A post-marketing aciclovir pregnancy registry has documented pregnancy
outcomes in
women exposed to any formulation of Zovirax. The registry findings
have not shown an
increase in the number of birth defects described amongst Zovirax
exposed subjects
compared with the general population, and any birth defects showed no
uniqueness or
consistent pattern to suggest a common cause.
Systemic administration of aciclovir in internationally accepted
standard tests did not
produce embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-