Our products / FDFs
Daptomycin vials
Daptomycin is a lipopeptide antibacterial agent active against gram-positive bacteria.
Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of gram-positive bacteria such as Staphylococcus aureus (including MRSA-methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae supsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible isolates only).
Additionally used for bloodstream infections (bacteremia), including patients with right-sided infective endocarditis caused by Staphylococcus aureus.
Application: Administered as intravenous infusions or injections.
Downloadables
Dosage form
Lyophilized vials
Strength
350 mg
500 mg
Batch size
350 mg
EU: 32150 vials
US: 32150 and 40000 vials
500 mg
EU: 22000 vials
US: 33400, 42000 and 53500 vials
Packaging sizes
1 vial/pack
Shelf life
36 months
Storage conditions
Between 2-8°C (36-46°F)
Compliance
No monograph for daptomycin in either Ph. Eur. or USP available
Manufacturing site
CMO for Xellia Pharmaceuticals ApS
Xellia Pharmaceuticals ApS, Copenhagen, Denmark (for US only)
Release site
CMO for Xellia Pharmaceuticals ApS
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered
EU GMP issued by Danish Medicines Agency
US FDA
Other health authorities
Regulatory documentation
EU dossier
US dossiers
RoW (Rest of the World) dossier
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