Zovirax I.V. 250mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aciclovir sodium

Available from:

GlaxoSmithKline UK Ltd

ATC code:

J05AB01

INN (International Name):

Aciclovir sodium

Dosage:

250mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030201; GTIN: 5010706003200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX® I.V. 250 MG AND 500 MG
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed
in this leaflet. See section 4.
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 I.V. (called ‘Zovirax’ in this leaflet) contains a
medicine called aciclovir. This belongs to a group of
medicines called antivirals. It works by killing or stopping the
growth of viruses.
Zovirax can be used to:
•
treat chickenpox
•
treat severe cases of genital herpes
•
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
•
treat serious virus infections in children up to 3 months of age. This
can rarely be caused by the virus
responsible for cold sore infection and genital herpes.
•
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 to aciclovir or valaciclovir or any of the other
ingredients of this medicine (listed in Section
6).
Do not take Zovirax if the above applies to you. If you are not sure,
talk to your doctor or pharmacist before
having Zovirax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before having Zovirax if:
•

Summary of Product characteristics

OBJECT 1
ZOVIRAX IV 250MG
Summary of Product Characteristics Updated 01-Apr-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Zovirax
®
I.V. 250 mg
Zovirax
®
I.V. 500 mg
2. Qualitative and quantitative composition
250 mg aciclovir or 500 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 inimmunocompromised
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