4.1 Therapeutic indications
AmBisome is indicated in adults and children aged 1 month to 18 years old for:
• the treatment of severe systemic and/or deep mycoses
• the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children
• the empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause.
Infections successfully treated with AmBisome include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis.
AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).