ZOVIRAX

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

ACICLOVIR

Saadav alates:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

ACICLOVIR

Annus:

5 %

Ravimvorm:

KRIM

Ühikuid pakis:

DUS, 1 TUBE @ 2 G

Valmistatud:

GLAXO OPERATIONS UK LTD - England

Loa andmise kuupäev:

2018-01-24

Toote omadused

Page 1 of 3
_ZOVIRAX _CREAM
ACICLOVIR
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream containing 5% w/w aciclovir.
2. PHARMACEUTICAL FORM
Cream.
3. CLINICAL PARTICULARS
3.1. INDICATIONS
_ZOVIRAX_ Cream is indicated for the treatment of herpes simplex virus
infections of the skin including
initial and recurrent genital herpes and herpes labialis.
3.2. DOSAGE AND ADMINISTRATION
Adults and children:
_ZOVIRAX_ Cream should be applied five times daily at approximately
four hourly intervals omitting the
night time application.
_ZOVIRAX_ Cream should be applied to the lesions or impending lesions
as early as possible after the
start of an infection. It is particularly important to start treatment
of recurrent episodes during the
prodromal period or when the lesions first appear. Treatment should be
continued for 5 days. If
healing has not occurred treatment may be continued for up to 10 days.
3.3. CONTRAINDICATIONS
_ZOVIRAX_ Cream is contra-indicated in patients known to be
hypersensitive to aciclovir, valaciclovir,
propylene glycol or any of the excipients of _ZOVIRAX_ Cream.
3.4. WARNINGS AND PRECAUTIONS
_ZOVIRAX_ Cream is not recommended for application to mucous
membranes, such as in the mouth,
eye or vagina, as it may be irritant. Particular care should be taken
to avoid accidental introduction
into the eye.
3.5. INTERACTIONS
No clinically significant interactions have been identified.
3.6. PREGNANCY AND LACTATION
A post-marketing aciclovir pregnancy registry has documented pregnancy
outcomes in women
exposed to any formulation of _ ZOVIRAX_. The birth defects described
amongst _ ZOVIRAX_ exposed
subjects have not shown any uniqueness or consistent pattern to
suggest a common cause.
The use of _ ZOVIRAX_ Cream should be considered only when the
potential benefits outweigh the
possibility of unknown risks.
Systemic administration of aciclovir
in
internationally
accepted standard tests did not produce
embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities w