Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Medovir powder for solution for infusion is indicated for the treatment and prophylaxis of herpes simplex infections in immunocompromised patients, and severe initial genital herpes in non-immunocompromised. It is indicated for the treatment of Varicella zoster infections and herpes encephalitis. It is indicated for the treatment of herpes simplex infection in the neonate and infants up to three months old.
Herpes simplex or Varicella zoster infection: 5mg/kg body weight, every eight hours.
Immunocompromised patients with Varicella zoster infection or patients with herpes encephalitis: 10mg/kg body weight, every eight hours (unless renally impaired).
Immunocompromised patients with Varicella zoster infection, or herpes encephalitis: 500mg/m² body surface area, every eight hours.
Dosage for neonates and children up to 3 months of age is calculated on body weight. For Herpes simplex infection, 10mg/kg body weight, every eight hours, usual duration of therapy is ten days.
Together with creatinine clearance, total aciclovir body clearance declines. Adequate hydration of such patients must be maintained. Attention should be paid to the need for dosage reduction, especially in such patients with renal impairment.
Caution should be exercised in administration. Children with renal impairment also require a modified dose according to the degree of renal impairment. The dosage adjustments recommended are:
| Creatinine Clearance | Dose |
|---|---|
| 25ml – 50ml/min | 5mg or 10mg/kg body weight, or 500mg/m², every twelve hours |
| 10ml – 25ml/min | 5mg or 10mg/kg body weight, or 500mg/m², every twenty four hours |
| 0ml – 10ml/min | - patients on continuous ambulatory peritoneal dialysis, 2.5mg or 5mg/kg body weight, or 250mg/m², every twenty four hours - patients receiving haemodialysis, 2.5mg or 5mg/kg body weight, or 250mg/m², every twenty four hours and after dialysis |
The usual duration of treatment is five days; this can be adjusted according to the condition and response of the patient. Treatment of neonatal Herpes simplex infection and of herpes encephalitis lasts ten days.
Following reconstitution (see section 6.6), the required dose can be administered by slow intravenous infusion over a one hour time period.
The reconstituted solution may be further diluted (aciclovir concentration not more than 5mg/ml or 0.5%w/v) for administration by infusion. In adults it is recommended infusion bags of 100ml be used, even if the aciclovir concentration is below 0.5%w/v. If concentration would be more than 0.5% w/v, it is necessary to use a second bag. In children and neonates, where infusion fluid volume should be minimized, it is recommended to add 2ml reconstituted solution (aciclovir 100mg) to 20ml infusion fluid, giving a final concentration of aciclovir 5mg/ml.
Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have been ingested overdoes of up to 20g of aciclovir on a single occasion, usually without toxic effects. Accidental, repeated overdoses of oral aciclovir over several days have been associated with gastrointestinal effects (such as nausea or vomiting) and neurological effects (headache and confusion)
Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.
Patients should be observed closely for signs of toxicity. Hemodialysis significantly enhances the removal of aciclovir from the blood and may therefore, be considered a management option in the vent of symptomatic overdose.
It is considered oral doses of up to 5g would not have adverse effects. Ingestion of an entire tube of cream would not be anticipated to cause severe effects. Overdose greater than 5g should require close observation of the patient. Treatment should be symptomatic and supportive. Aciclovir is dialyzable by haemodialysis.
36 months.
Following dilution, the solution is stable for up to 12 hours at room temperature. Solutions should not be refrigerated.
Store below 25°C, in the original package. Do not refrigerate or freeze.
Use immediately after reconstitution.
For storage conditions after dilution of the medicinal product, see section 6.3.
Medovir powder for solution for infusion is supplied in type I clear glass vials, sealed with a rubber stopper and aluminium overcap. Cartons of 1, 10, 50 or 100 vials are available.
Not all pack sizes may be marketed.
Carry out reconstitution and dilution under aseptic conditions immediately prior to use. Any unused solution must be discarded.
For reconstitution either sterile Water for Injection B.P or sterile Sodium chloride Intravenous Injection B.P (0.9%) may be used.
To reconstitute add 10ml to the 250mg vial or 20ml to the 500mg vial. This gives a solution of aciclovir 25mg/ml. Shake the vial well to ensure complete solution. The resulting solution should be further diluted with a suitable infusion fluid to give a final aciclovir concentration of no more than 5mg/ml (0.5%).
Suitable infusion fluids include:
Following dilution, the solution is stable for up to 12 hours at room temperature. Solutions should not be refrigerated.
If any visible turbidity or crystallization appears in the solution during preparation or infusion, it should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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