AMBISOME FOR INJECTION 50 mg/vial

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** AmBisome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes. An in-line membrane filter may be used for the intravenous infusion of AmBisome; provided **THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1.0 MICRON**. **NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.** Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended initial dose of AmBisome for each indication for adult and pediatric patients is as follows:  Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events. Doses recommended for visceral leishmaniasis are presented below:  **For immunocompetent patients** who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful. **For immunocompromised patients** who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended. For additional information see **DESCRIPTION OF CLINICAL STUDIES** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.