ight IV every eight hours for 21 days for disseminated and CNS disease, or for 14 days for disease limited to the skin and mucous membranes.
Infants and children with impaired renal function require an appropriately modified dose, according to the degree of impairment (see Dosage in renal impairment).
Dosage in the elderly:
The possibility of renal impairment in the elderly must be considered. In the elderly, total aciclovir body clearance declines in parallel with creatinine clearance. Special attention should be given to dosage reduction in elderly patients with impaired creatinine clearance.
Adequate hydration should be maintained.
Dosage in renal impairment:
Caution is advised when administering aciclovir for infusion to patients with impaired renal function. Adequate hydration should be maintained.
Dosage adjustment for patients with renal impairment is based on creatinine clearance, in units of ml/min for adults and adolescents and in units of ml/min/1.73m2 for infants and children less than 13 years of age. The following adjustments in dosage are suggested:
Dosage adjustments in adults and adolescents:
Creatinine Clearance
Dosage
25 to 50 ml/min:
The dose recommended above (5 or 10 mg/kg bodyweight) should be given every 12 hours.
10 to 25 ml/min:
The dose recommended above (5 or 10 mg/kg bodyweight) should be given every 24 hours.
0 (anuric) to 10 ml/min:
In patients receiving continuous ambulatory peritoneal dialysis (CAPD) the dose recommended above (5 or 10 mg/kg bodyweight) should be halved and administered every 24 hours. In patients receiving haemodialysis the dose recommended above (5 or 10 mg/kg bodyweight) should be halved and administered every 24 hours and after dialysis.
Dosage adjustments in infants and children:
Creatinine Clearance
Dosage
25 to 50 ml/min/1.73m2:
The dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight (should be given every 12 hours).
10 to 25 ml/min/1.73m2:
The dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be given every 24 hours.
0(anuric) to 10 ml/min/1.73m2:
In patients receiving continuous ambulatory peritoneal dialysis (CAPD) the dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be halved and administered every 24 hours.
In patients receiving haemodialysis the dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be halved and administered every 24 hours and after dialysis.
Administration
The required dose of aciclovir for infusion should be administered by slow intravenous infusion over a one-hour period.
After reconstitution aciclovir for infusion may be administered by a controlled-rate infusion pump.
Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for administration by infusion.
For instructions on reconstitution and dilution of the product before administration see section 6.6.
4.3 Contraindications
Aciclovir for infusion is contraindicated in patients known to be hypersensitive to aciclovir and valaciclovir, or to any of the excipients.
4.4 Special warnings and pre