Aciclovir 250mg Powder for Solution for Infusion
1. Name of the medicinal product
Aciclovir 250mg Powder for Solution for Infusion
2. Qualitative and quantitative composition
Each vial contains 250mg of aciclovir as the sodium salt

For a full list of excipients, see section 6.1

3. Pharmaceutical form
Powder for solution for infusion.

White powder.

4. Clinical particulars
4.1 Therapeutic indications
Aciclovir for infusion is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised.

Aciclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.

Aciclovir for infusion is indicated for the treatment of Varicella zoster infections.

Aciclovir for infusion is indicated for the treatment of herpes encephalitis.

Aciclovir for infusion is indicated for the treatment of Herpes simplex infections in the neonate and infant up to three months of age.

4.2 Posology and method of administration
Route of administration: Slow intravenous infusion over one hour.

A course of treatment with aciclovir for infusion usually lasts five days, but this may be adjusted according to the patient's condition and response to therapy. Treatment for herpes encephalitis usually lasts ten days. Treatment for neonatal herpes 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 for infusion is determined by the duration of the period at risk.

Dosage

Dosage in adults:

Patients with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given aciclovir for infusion in doses of 5mg/kg bodyweight every eight 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 aciclovir for infusion in doses of 10mg/kg bodyweight every eight hours provided renal function is not impaired (see Dosage in renal impairment).

In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see 5.2 Pharmacokinetic properties). Consideration should therefore be given to dosage reduction in obese patients and especially in those with renal impairment or the elderly.

Dosage in children:

The dose of aciclovir for infusion for children aged between three months and 12 years is calculated on the basis of body surface area.

Children three months of age or older with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given aciclovir for infusion in doses of 250 mg per square metre of body surface area every eight hours if renal function is not impaired.

In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, aciclovir for infusion should be given in doses of 500 mg per square metre body surface area every eight hours if renal function is not impaired.

The dosage of aciclovir for infusion in neonates and infants up to three months of age is calculated on the basis of bodyweight.

The recommended regimen for infants treated for known or suspected neonatal herpes is aciclovir 20 mg/kg body we