ACICLOVIR CLARIS 25 Mg/Ml Concentrate for Soln for Inf

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

ACICLOVIR

Disponible desde:

Claris Lifesciences (UK) Limited

Código ATC:

J05AB01

Designación común internacional (DCI):

ACICLOVIR

Dosis:

25 Mg/Ml

formulario farmacéutico:

Concentrate for Soln for Inf

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors

Estado de Autorización:

Authorised

Fecha de autorización:

2013-03-27

Información para el usuario

1/11
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ACICLOVIR
The name of your medicine is Aciclovir 25 mg/ml Concentrate for
solution for infusion,
which will be referred to as Aciclovir throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT ACICLOVIR IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR
3.
HOW TO USE ACICLOVIR
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ACICLOVIR
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ACICLOVIR IS AND WHAT IT IS USED FOR
Aciclovir contains a medicine called aciclovir,This belongs to a group
of medicines
called antivirals. It works by killing or stopping the growth of
viruses.
Aciclovir can be used to:

treat severe cases of genital herpes

treat chickenpox

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 USE ACICLOVIR
DO NOT USE ACICLOVIR :
If you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this
medicine(listed in Section 6).
Do not take Aciclovir if the above applies to yo

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir 25mg/ml Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 25 mg aciclovir as aciclovir sodium
Each vial of 10 ml of solution contains 250 mg aciclovir (sodium salt
formed_ in situ_)
Each vial of 20 ml of solution contains 500 mg aciclovir (sodium salt
formed_ in situ_)
Excipient(s) with known effect:
Each ml of solution contains 2.67 mg of sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless solution, free from visible particles
pH of the solution is between 10.70 and 11.70 and osmolarity of the
solution is 353.01 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aciclovir is indicated for the treatment of Herpes simplex infections
in immunocompromised patients and severe initial
genital herpes in the non-immunocompromised.
Aciclovir is indicated for the prophylaxis of Herpes simplex
infections in immunocompromised patients.
Aciclovir is indicated for the treatment of Varicella zoster
infections .
Aciclovir is indicated for the treatment of herpes encephalitis.
Aciclovir 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 Aciclovir 25 mg/ml Concentrate for solution
for infusion 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 Aciclovir 25 mg/ml
Concentrate for solution for infusion is determined
by the duration of the period at risk.
Dosage in adults:
Patients with Herpes simplex (e