Leaflet AMBISOME 50mg concentrate for dispersion for infusion

Indicated for: fungal infections

Route of administration: infusion

Substance: amphotericin B (antifungal)

ATC: J02AA01 (Antiinfectives for systemic use | Antimycotics for systemic use | Antibiotics)

Precautions:
Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Amphotericin B is an antifungal medication used to treat severe and potentially life-threatening fungal infections. It is effective against a wide range of fungi, including Candida, Aspergillus, and Cryptococcus, and is used in systemic or invasive infections such as cryptococcal meningitis or invasive aspergillosis.

This medication works by binding to ergosterol in the fungal cell membrane, leading to the destruction of fungal cells. It is available as an injectable solution and is administered intravenously, usually in a hospital setting under strict medical supervision.

Amphotericin B can cause significant side effects, including fever, chills, nausea, vomiting, kidney damage, and electrolyte imbalances. For this reason, its use is reserved for severe cases, and patients require close monitoring during treatment.

Liposomal formulations of amphotericin B are better tolerated and have an improved safety profile, making them preferred in certain situations.

General data about AMBISOME 50mg

  • Substance: amphotericin B
  • Date of latest medicines list: 01-12-2021
  • Product code: W68165001
  • Pharmaceutical form: concentrate for dispersion for infusion
  • Quantity: 10
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: GILEAD SCIENCES IRELAND UC - IRLANDA
  • Holder: GILEAD SCIENCES IRELAND UC - IRLANDA
  • Number: 661/2021/01

Concentrations available for amphotericin B

  • 50mg
  • 50mg/5ml
  • 5mg/ml