AMBISOME 50mg powder for concentrate for infusion dispersion medication leaflet

J02AA01 amphotericin B • 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: 01-06-2025

Commercial code: W70598001

Concentration: 50mg

Pharmaceutical form: powder for concentrate for infusion dispersion

Quantity: 10

Product type: generic

Price: 9203.22 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: GILEAD SCIENCES IRELAND UC - IRLANDA

Holder: GILEAD SCIENCES (GSR) S.R.L. - ROMANIA

Number: 975/2024/01

Shelf life: 4 years

Concentrations available for amphotericin B

50mg, 50mg/5ml, 5mg/ml

Compensation lists for AMBISOME 50mg GILEAD

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

Price

Copayment

Patient

9203.22 RON

9203.22 RON

0.00 RON