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 |
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Strength |
1 MIU* 2 MIU* 3 MIU* |
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Compliance |
No monograph for colistimethate sodium vials in Ph. Eur. 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 Other health authorities |
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Batch size |
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Regulatory documentation |
EU 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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* Million International Units
** Rest of the World
