Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Adequate hydration should be maintained in patients given i.v. or high oral doses of aciclovir.
Intravenous doses should be given by infusion over one hour to avoid precipitation of aciclovir in the kidney; rapid or bolus injection should be avoided.
The risk of renal impairment is increased by use with other nephrotoxic drugs. Care is required if administering i.v. aciclovir with other nephrotoxic drugs.


Use in patients with renal impairment and in elderly patients:
Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2 Posology and method of administration). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects.
In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8 Undesirable effects). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (see section 5.1).
In patients receiving Zovirax I.V. at higher doses (e.g. for herpes encephalitis) specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairment.
Reconstituted Zovirax I.V. has a pH of approximately 11 and should not be administered by mouth. Product contains sodium (28.03 mg sodium per vial). To be taken into consideration by patients on a controlled sodium diet.

Zovirax I.V. contains no antimicrobial preservative. Reconstitution and dilution should therefore be carried out under full aseptic conditions immediately before use and any unused solution discarded. The reconstituted or diluted solutions should not be refrigerated.
Other warnings and precautions
The labels shall contain the following statements:
For intravenous infusion only
Keep out of the reach and sight of children
Store below 25°C
Prepare immediately prior to use
Discard unused solution


Excipients
This medicinal product contains 28.03 mg sodium per vial, equivalent to 1.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.


Effects on Driving

4.7   Effects on ability to drive and use machines
Aciclovir i.v. for infusion is generally used in an in-patient hospital population and information on ability to drive and operate machinery is not usually relevant. There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery.