Leaflet AMBISOME 50mg powder for 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)

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 last drug list: 01-05-2026
  • Commercial code: W70550001
  • Pharmaceutical form: powder for concentrate for dispersion for infusion
  • Quantity: 10
  • Product type: generic
  • Price: 10459.31 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: GILEAD SCIENCES IRELAND UC - IRLANDA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 966/2024/01

Concentrations available for amphotericin B

  • 50mg
  • 50mg/5ml
  • 5mg/ml

Compensation lists for AMBISOME 50mg Unifarm

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment

Price

Copayment

Patient

10459.31 RON

7294.34 RON

3164.97 RON