AmBisome 50 mg Powder for solution for infusion.
AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. After reconstitution, the product is an injectable intended to be administered by intravenous infusion.
Each vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes. After reconstitution, the concentrate contains 4 mg/mL amphotericin B.
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)
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 Limited
11 September 1998/24 September 2004.