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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 recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA)

Regulatory documentation

US Drug Master File (DMF)

EU Drug Master File (DMF)

China Drug Master File (CDMF)

DMF also available in other selected countries outside EU/US/China

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 labelled

Shelf life

3 years

Storage conditions

Store in a freezer (-20±5°C / 5 to -13°F)