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Daptomycin

Daptomycin* is a lipopeptide antibiotic active against Gram-positive bacteria such as Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp.equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

 

Indication:Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of Gram-positive bacteria in adult and pediatric patients and in the treatment of patients with Staphylococcus aureus (including MRSA-methicillin- resistant strains) bacteremia, as well as right-sided endocarditis.

Application: Administered systemically as intravenous infusion or injection.

Product grades

Non-sterile

Compliance

No monograph for daptomycin in either Ph. Eur. or USP available

Manufacturing site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Release site

Xellia Pharmaceuticals Ltd., Budapest, Hungary

Site registered

EU GMP issued by Hungarian National Institute of Pharmacy

US FDA

Regulatory documentation

US Drug Master File (DMF)

EU Drug Master File (DMF)

Packaging sizes

Packaging size can be discussed with your Sales Representative

Packaging material

Primary: Aluminum foil bag (laminated with polyethylene on the inner side and polyester on outer side) and heat-sealed

Secondary: Primary bag placed into second identical bag also heat-welded and labeled

Shelf life

3 years

Storage conditions

Below -20 °C (- 4°F)

*Products protected by valid patents are not offered for sale in countries, where the sale of such products constitutes a patent infringement.