Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Gilead Sciences International Ltd, Granta Park, Abington, Cambridge, CB21 6GT
AmBisome 50 mg Powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Sterile, powder for solution for infusion. Yellow lyophilised cake or powder. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Amphotericin B |
Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. The molecule is thought to act by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules. |
| List of Excipients |
|---|
|
Hydrogenated soy phosphatidylcholine |
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
PL: 16807/0001
11 September 1998/24 September 2004
| Drug | Countries | |
|---|---|---|
| AMBISOME | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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