AMBISOME Powder for solution for infusion (2019)
Active ingredients: Amphotericin B
Product Name and Form
AmBisome 50 mg Powder for solution for infusion.
Sterile, powder for solution for infusion.
Yellow lyophilised cake or powder.
Qualitative and Quantitative Composition
Each vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes. After reconstitution, the concentrate contains 4 mg/mL amphotericin B.
Excipient with known effect: For a full list of excipients, see section 6.1.
Hydrogenated soy phosphatidylcholine
Disodium succinate hexahydrate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Pack sizes and Marketing
AmBisome is presented in 15 ml, 20 ml or 30 ml sterile, Type I glass vials. The closure consists of a grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap. Single-dose vials are packed ten per carton with 10 filters. Not all pack sizes may be marketed.
Gilead Sciences International Ltd, Granta Park, Abington, Cambridge, CB21 6GT
11 September 1998/24 September 2004