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Colistimethate sodium lyophilized 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 especially Pseudomonas aeruginosa.

Indication: Used in the treatment of acute or chronic infections due to sensitive strains of Gram-negative pathogens. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa.

Application: Administered systemically as intramuscular injections and intravenous injections or infusions.

 

Dosage form

Lyophilized vials

Strength

150 mg colistin base activity*

Compliance

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

USP monograph for colistimethate for injection available

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency

US FDA

Batch size

80500 vials

Regulatory documentation

US dossier

RoW** dossier

Packaging sizes

1 vial/pack

6 vials/pack

10 vials/pack

12 vials/pack

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

Shelf life

RoW: 36 months

US: 24 months

Storage conditions

Between 15-25°C (59-77°F) depending on territory

* Equivalent to ~4.5 Million International Units

** Rest of the World