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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.

Dosage form

Lyophilized vials

Strength

350 mg

500 mg

Compliance

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

Manufacturing site

CMO for Xellia Pharmaceuticals ApS

Release site

CMO for Xellia Pharmaceuticals ApS

Site registered

EU GMP issued by Medicines and Healthcare products Regulatory Agency

US FDA

Other health authorities

Batch size

350 mg

500mg

EU: 32150 vials

US: 32150 vials

EU: 22000 vials

US: 33400 and 53500 vials

Regulatory documentation

EU dossier

US dossiers

RoW** dossier

Packaging sizes

1 vial/pack

Shelf life

36 months

Storage conditions

Between 2-8°C (36-46°F)

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

* * Rest of the World