Colistimethate Sodium is a derivative of colistin (polymyxin E) that is a mixture of polypeptide antibiotics active against Gramnegative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Indication: Used in the treatment of acute or chronic infections due to sensitive strains of Gram-negative pathogens.
Application: Administered systemically as intramuscular injections and intravenous injections or infusions. Colistimethate sodium can also be administered by inhalation or mixed with bone cement, as well used in ophthalmic formulations.
Product grades |
Sterile, micronized Sterile, non-micronized Non-sterile, non-micronized | |||||||
Compliance |
Ph. Eur. USP |
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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 Other Health Authorities |
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Regulatory documentation |
EU Drug Master File (DMF) Certificate of Suitability (CEP) US Drug Master File (DMF) Letter of Access (LoA) |
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