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AMBISOME FOR INJECTION 50 MG/VIAL [SIN12021P]
Active ingredients: AMBISOME FOR INJECTION 50 MG/VIAL
Last updated 26 October 2025
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Product Info
AMBISOME FOR INJECTION 50 MG/VIAL
[SIN12021P]
Product information
Active Ingredient and Strength | AMPHOTERICIN B - 50 MG/VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | GILEAD SCIENCES, INC. - UNITED STATES |
Registration Number | SIN12021P |
Licence Holder | GILEAD SCIENCES SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J02AA01 |
INDICATIONS AND USAGE
AmBisome is indicated for the following:
Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
See DOSAGE AND ADMINISTRATION for recommended doses by indication.
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.
CONTRAINDICATIONS
AmBisome is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.