ZOVIRAX OPHTHALMIC OINTMENT 3% ww

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

ACYCLOVIR

Prieinama:

GLAXOSMITHKLINE PTE LTD

ATC kodas:

S01AD03

Dozė:

3% w/w

Vaisto forma:

OINTMENT

Sudėtis:

ACYCLOVIR 3% w/w

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

Prescription Only

Pagaminta:

Jubilant Hollisterstier General Partnership

Autorizacija statusas:

ACTIVE

Leidimo data:

1988-05-14

Pakuotės lapelis

_ZOVIRAX_™ OPHTHALMIC OINTMENT
ACICLOVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ophthalmic ointment containing 3% w/w aciclovir.
PHARMACEUTICAL FORM
Ophthalmic ointment.
CLINICAL PARTICULARS
INDICATIONS
_ZOVIRAX _ophthalmic ointment is indicated for the treatment
of _herpes simplex _keratitis.
DOSAGE AND ADMINISTRATION
The dosage for all age groups is the same.
A 10mm ribbon of the ointment should be placed inside the lower
conjunctival sac five times a 
day at approximately four hourly intervals.
Treatment should continue for at least 3 days after healing.
CONTRAINDICATIONS
_ZOVIRAX _ophthalmic ointment is contra-indicated in patients known
to be hypersensitive to 
aciclovir or valaciclovir.
WARNINGS AND PRECAUTIONS
Patients should be informed that transient mild
stinging immediately following application may 
occur.
Patients should avoid wearing contact lenses when using 
_ZOVIRAX _ophthalmic ointment.
INTERACTIONS
No clinically significant interactions have been identified.
Singapore proposed PI_clean
PREGNANCY AND LACTATION
The use of
_ZOVIRAX _ophthalmic ointment should be considered only when the
potential benefits 
outweigh the possibility of unknown risks. 
A post-marketing acyclovir 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 amongst aciclovir 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 product 
embryotoxic  or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed
but only following such high 
subcutaneous doses that maternal toxicity was produced.
The clinical relevance of these findings 
is uncertain.
Limited human data show

Prekės savybės

_ZOVIRAX_™ OPHTHALMIC OINTMENT
ACICLOVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ophthalmic ointment containing 3% w/w aciclovir.
PHARMACEUTICAL FORM
Ophthalmic ointment.
CLINICAL PARTICULARS
INDICATIONS
_ZOVIRAX_
ophthalmic ointment is indicated for the treatment of
_herpes simplex_
keratitis.
DOSAGE AND ADMINISTRATION
The dosage for all age groups is the same.
A 10mm ribbon of the ointment should be placed inside the lower
conjunctival sac five times a
day at approximately four hourly intervals.
Treatment should continue for at least 3 days after healing.
CONTRAINDICATIONS
_ZOVIRAX _
ophthalmic ointment is contra-indicated in patients known to be
hypersensitive to
aciclovir or valaciclovir.
WARNINGS AND PRECAUTIONS
Patients should be informed that transient mild stinging immediately
following application may
occur.
Patients should avoid wearing contact lenses when using
_ZOVIRAX_
ophthalmic ointment.
INTERACTIONS
No clinically significant interactions have been identified.
Singapore proposed PI_clean
PREGNANCY AND LACTATION
The use of
_ZOVIRAX_
ophthalmic ointment should be considered only when the potential
benefits
outweigh the possibility of unknown risks.
A post-marketing acyclovir 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 amongst aciclovir 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 product
embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed but
only following such high
subcutaneous doses that maternal toxicity was produced. The clinical
relevance of these findings
is uncertain.
Limited human data show that the drug does pass into breast milk
following systemic
administration. However, the dosage recei