Zovirax IV for Infusion 250 mg, Powder for solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-01-2021
Summary of Product characteristics
(SPC)
20-01-2021
Active ingredient:
Aciclovir
Available from:
GlaxoSmithKline (Ireland) Limited
ATC code:
J05AB; J05AB01
INN (International Name):
Aciclovir
Dosage:
250 milligram(s)
Pharmaceutical form:
Powder for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir
Authorization status:
Marketed
Authorization date:
1983-05-03
Patient Information leaflet
(GSK LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX
® IV FOR INFUSION 250 MG
POWDER FOR SOLUTION FOR INFUSION
ACICLOVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zovirax is and what it is used for
2
What you need to know before you have Zovirax
3
How to have Zovirax
4
Possible side effects
5
How to store Zovirax
6
Contents of the pack and other information
1 What Zovirax is and what it is used for
Zovirax IV for Infusion 250 mg Powder for solution for infusion
(called ‘Zovirax’ in this leaflet) contains a medicine
called aciclovir. This belongs to a group of medicines called
antivirals. It works by stopping the growth of viruses.
Zovirax IV can be used to:
treat recurring chicken-pox and shingles in people whose immune system
works well
treat severe first cases of genital herpes in people whose immune
system works well
treat primary and recurring chickenpox and shingles in people whose
immune systems work less well, which
means their bodies are less able to fight infections
treat and stop cold sores and genital herpes in people whose immune
systems work less well, which means
their bodies are less able to fight infections
prevent herpes simplex infections in people whose immune systems work
less well, which means their bodies
are less able to fight infections
treat inflammation of the brain. This can rarely be caused by the
virus responsible for cold sore infection and
genital herpes.
2 WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOVIRAX
DO NOT HAVE ZOVIRAX IF:
you are allergic (hypersensitive) to aciclovir or valaciclovir or any
of the other ingredients (listed in Section 6).
Do not ha
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Summary of Product characteristics
Health Products Regulatory Authority
19 January 2021
CRN009Z6V
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax IV for Infusion 250 mg, Powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg aciclovir (as the sodium salt).
The quantity after reconstitution is 25 mg aciclovir per mL.
Each vial contains 28.03 mg of sodium.
The quantity of sodium after reconstitution in 10 mL of water for
injection is approximately 2.789 mg/mL.
The quantity of sodium after reconstitution in 10 mL of NaCl (0.9 %
w/v) is approximately 6.403 mg/mL.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
A white to off white freeze-dried sterile powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax IV is indicated for:
NON-IMMUNOCOMPROMISED PATIENTS
IMMUNOCOMPROMISED PATIENTS
Severe initial genital herpes
Herpes simplex infection
Recurrent varicella zoster virus infection Primary and recurrent
varicella zoster infection
Prophylaxis of herpes simplex infection
Herpes simplex encephalitis
Herpes simplex encephalitis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The required dose of Zovirax IV should be administered by slow
intravenous infusion over 1 hour.
A course of treatment with Zovirax IV 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 usually lasts 14
days for mucocutaneous (skin-eye-mouth) infections and 21 days for
dissemination or central nervous system disease.
The duration of prophylactic administration of Zovirax IV 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 IV in doses of 5
mg/kg body weight every 8 hours provided renal function is not
impaired (see Dosage in renal impairment).
Immunocompromised pati
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