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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, intraventricularly or as intravenous infusion.

 

Dosage form

Dry-filled (powder dosed) vials

Strength

1 MIU*

2 MIU*

3 MIU*

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

Batch size

1 MIU* vials

2 MIU* vials

3 MIU* vials

575000 vials

400000 vials

400000 vials

Regulatory documentation

EU dossier

RoW** dossier

Packaging sizes

Labelled vials

Un-labelled vials

1 vial/pack

10 vials/pack

30 vials/pack

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)

* Million Internation Units

** Rest of the World