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Amphotericin B

Amphotericin B is a mixture of polyenes active against a wide variety of fungi e.g. Aspergillus, Candida and Cryptococcus species.

Indication: Used in the treatment of severe, invasive, potentially life-threatening fungal infections (mycosis) typically in immunocompromised patients.

 

Applications: Administered intravenously as a colloidal complex with sodium deoxycholate or as a liposomal formulation. The low germ and endotoxin content makes Xellia’s amphotericin B particularly suitable for parenteral use.

 

Product grades

Non-sterile

Compliance

Ph. Eur.

USP

JP

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

Other Health Authorities

Regulatory documentation

EU Drug Master File (DMF)

Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

0.1 kgA*

0.5 kgA*

1 kgA*

Packaging material

Primary: Polyethylene bag, with plastic seal

Secondary: Two polyethylene bags, heat sealed

Tertiary: Aluminum container

Shelf life

2 years

Storage conditions

Below 8°C (46°F)

* Kilogram Activity