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Colistimethate sodium dry-filled vials

Colistimethate sodium is a prodrug of colistin which is a mixture of polypeptide antibiotics active against gram-negative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Indication: Used in the treatment of patients with serious infections due to selected aerobic gram-negative pathogens with limited treatment options.

Application: Administered intrathecally, by intraventricular administration, or as intravenous infusion.

Dosage form

Dry-filled (powder dosed) vials

Strength

1 MIU (Million International Units)

2 MIU (Million International Units)

3 MIU (Million International Units)

Batch size

1 MIU vials

600000 vials

2 MIU vials

400000 vials

3 MIU vials

200000 vials

Packaging sizes

Labelled vials

1 vial/pack
10 vials/pack
30 vials/pack

Possibility for different packaging configuration can be discussed with your Sales Representative

Un-labelled vials

150 vials/pack

Possibility for different packaging configuration can be discussed with your Sales Representative

Shelf life

36 months

Storage conditions

Below 25°C (77°F)

Compliance

No monograph for colistimethate sodium vials in Ph. Eur. available

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency

Other health authorities

Regulatory documentation

EU dossier

RoW (Rest of the World) dossier

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