ZOVIRAX I.V.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACICLOVIR

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AB01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

ACICLOVIR 250 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Therapeutic group:

ACICLOVIR

Therapeutic area:

ACICLOVIR

Therapeutic indications:

Zovirax I.V. is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised.Zovirax I.V. is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.Zovirax I.V. is indicated for the treatment of Varicella zoster infections.Zovirax I.V. is indicated for the treatment of herpes encephalitis.Zovirax I.V. is indicated for the treatment of Herpes simplex infections in the neonate and infant up to 3 months of age.

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
ZOVIRAX I.V.
POWDER FOR PREPARATION OF A SOLUTION FOR INFUSION
Each vial contains: aciclovir 250 mg/vial.
For the list of inactive and allergenic ingredients in the
preparation, see section
2 – “Important information about some of the ingredients of the
medicine” and
section 6 – “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Zovirax I.V. is indicated:
•
for the treatment of
Herpes simplex
infections in immunocompromised pa-
tients and for the treatment of severe initial genital herpes in
non-immuno-
compromised patients.
•
for the prophylaxis of
Herpes simplex
infections in immunocompromised
patients.
•
for the treatment of chickenpox (
Varicella zoster
).
•
to treat inflammation of the brain caused by the herpes virus (herpes
en-
cephalitis).
•
for the treatment of
Herpes simplex
infections in neonates and infants up to
3 months of age.
THERAPEUTIC GROUP: Zovirax I.V. belongs to a group of medicines called
antivirals.
Zovirax I.V. contains a medicine called aciclovir. It works by killing
or stopping
the growth of viruses.
2. BEFORE USING THE MEDICINE
DO NOT USE ZOVIRAX I.V. IF:
•
you are sensitive (allergic) to aciclovir or valaciclovir or to any of
the addi-
tional ingredients contained in the medicine (listed in section 6).
Do not take Zovirax I.V. if this applies to you. If you are not sure,
refer to the
physician or pharmacist before taking Zovirax.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
Before treatment with Zovirax I.V., tell the physician or pharmacis

Summary of Product characteristics

ZOVIRAX I.V.
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zovirax I.V.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg aciclovir in each vial
Excipients with known effect:
Sodium hydroxide
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Intravenous injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zovirax
I.V.
is
indicated
for
the
treatment
of
_Herpes _
_simplex_
infections
in
immunocompromised
patients
and
severe
initial
genital
herpes
in
the
non-
immunocompromised.
Zovirax
I.V.
is
indicated
for
the
prophylaxis
of
_Herpes _
_simplex_
infections
in
immunocompromised patients.
Zovirax I.V. is indicated for the treatment of
_Varicella zoster_
infections.
Zovirax I.V. is indicated for the treatment of herpes encephalitis.
Zovirax I.V. is indicated for the treatment of
_Herpes simplex _
infections in the neonate
and infant up to 3 months of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration:
_ _
Slow intravenous infusion over 1 hour.
A course of treatment with Zovirax I.V. usually lasts 5 days, but this
may be adjusted
according to the patient's condition and response to therapy.
Treatment for herpes
encephalitis usually lasts 10 days. Treatment for neonatal herpes
infections usually lasts
14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for
disseminated
or central nervous system disease.
The duration of prophylactic administration of Zovirax I.V. is
determined by the
duration of the period at risk.
Dosage in adults:
Patients with
_Herpes simplex_
(except herpes encephalitis) or
_Varicella zoster _
infections
should be given Zovirax I.V. in doses of 5 mg/kg body weight every 8
hours provided
renal function is not impaired (see Dosage in renal impairment).
Immunocompromised patients with
_Varicella zoster_
infections or patients with herpes
encephalitis should be given Zovirax I.V. in doses of 10 mg/kg body
weight every 8
hours provided renal function is not impaired (see Dosage in renal
impairment).
In obese patients dosed