SALACLOVIR POWDER FOR SOLUTION FOR INFUSION 250MG/VIAL [SIN14645P]

Product Info

SALACLOVIR POWDER FOR SOLUTION FOR INFUSION 250MG/VIAL

[SIN14645P]

4.1 Therapeutic indications
SALACLOVIR is indicated in non-immunocompromised patients for the treatment of

• Severe initial genital herpes.

• Varicella zoster virus infection.

• Herpes simplex encephalitis.

SALACLOVIR is indicated in immunocompromised patients for the treatment of

• Herpes simplex infection.

• Varicella zoster infection.

• Prophylaxis of herpes simplex infection.

• Herpes simplex encephalitis.

4.2 Posology and method of administration
Posology
A course of treatment with SALACLOVIR usually lasts 5 days, but this may be adjusted according to the patient’s condition and response to therapy.
Treatment for herpes simplex encephalitis and neonatal Herpes simplex infection usually lasts 10 days.
The duration of prophylactic administration of SALACLOVIR is determined by the duration of the period at risk.

Adults
Obese patients should be dosed at the recommended adult dose using ideal body weight rather than actual body weight.

Special populations
Paediatric population
The dose of SALACLOVIR in neonates and infants up to 3 months of age is calculated on the basis of body weight. Although its use in neonatal herpes is still experimental, doses of 10 mg/kg have been employed.
The dose of SALACLOVIR for children aged between 3 months and 12 years is calculated on the basis of body surface area.
Children, 3 months of age or older, with herpes simplex (except herpes simplex encephalitis) or varicella zoster infections should be given SALACLOVIR in doses of 250 mg per square metre of body surface area every 8 hours.
In immunocompromised children with varicella zoster infections or children with herpes simplex encephalitis, this medicinal product should be given in doses of 500 mg per square metre of body surface area every 8 hours if renal function is not impaired.
Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.

Elderly patients
The possibility of renal impairment in the elderly must be considered and the dose should be adjusted accordingly (see “Patients with renal impairment” below). Adequate hydration should be maintained.

Patients with renal impairment
Caution is advised when administering aciclovir i.v. for infusion to patients with impaired renal function. Adequate hydration should be maintained.

The following modifications in dose are recommended:

Method of administration
SALACLOVIR is intended for intravenous use.
The required dose of SALACLOVIR should be administered by slow intravenous infusion over a one-hour period.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to valaciclovir – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.