Our products / FDFs
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.
Downloadables
Dosage form
Lyophilized vials
Strength
150 mg colistin base activity (equivalent to ~4.5 Million International Units)
Batch size
80500 vials
Packaging sizes
1 vial/pack
10 vials/pack
12 vials/pack
Possibility for different packaging configuration can be discussed with your Sales Representative
Shelf life
RoW (Rest of the World): 36 months
US: 24 months
Storage conditions
Between 15-25°C (59-77°F) depending on territory
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
Regulatory documentation
US dossier
RoW (Rest of the World) dossier
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