ZOVIRAX OPHTHALMIC OINTMENT

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

ACICLOVIR

Dostupno od:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC koda:

S01AD03

Farmaceutski oblik:

OPHTALMIC OINTMENT

Sastav:

ACICLOVIR 3 %W/W

Administracija rute:

OCULAR

Tip recepta:

Required

Proizveden od:

JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP (JHSGP), CANADA

Terapijska grupa:

ACICLOVIR

Područje terapije:

ACICLOVIR

Terapijske indikacije:

Indicated for the treatment of herpes simplex keratitis.

Datum autorizacije:

2014-05-31

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_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-