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 |
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Strength |
150 mg colistin base activity* |
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Compliance |
No monograph for colistimethate sodium vials in Ph. Eur. available USP monograph for colistimethate for injection available |
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Manufacturing site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Release site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Site registered |
EU GMP issued by Danish Medicines Agency US FDA |
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Batch size |
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Regulatory documentation |
US dossier RoW** dossier |
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Packaging sizes |
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Shelf life |
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Storage conditions |
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* Equivalent to ~4.5 Million International Units
** Rest of the World
