SPC, UK: AmBisome Powder for solution for infusion (2012)

Product Name and Form

AmBisome 50 mg Powder for solution for infusion.

Pharmaceutical form

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.

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.

For a full list of excipients, see section 6.1.

List of excipients

Hydrogenated soy phosphatidylcholine
Cholesterol
Distearoylphosphatidylglycerol
Alpha tocopherol
Sucrose
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.

Marketing authorization holder
Authorization dates

Gilead Sciences International Limited
Granta Park
Abington
Cambridge
CB21 6GT

11 September 1998/24 September 2004.

Marketing authorization number:

PL: 16807/0001