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AMBISOME Powder for solution for infusion (2019)

Active ingredients: Amphotericin B

Product Name and Form

AmBisome 50 mg Powder for solution for infusion.

Pharmaceutical form

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.

Chemical substance
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
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 Ltd, Granta Park, Abington, Cambridge, CB21 6GT

11 September 1998/24 September 2004

Marketing authorization number:

PL: 16807/0001