Finished dosage products
High-quality intravenous anti-infectives designed for reliability in the most demanding clinical settings.
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