Colistimethate sodium is a prodrug of colistin (polymyxin E) 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 acute or chronic infections due to sensitive strains of Gram-negative pathogens, especially in patients with limited treatment options.
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 as used in ophthalmic formulations.
Product grades |
Sterile, micronized Sterile, non-micronized Non-sterile, non-micronized | |||||||
Compliance |
Ph. Eur. USP |
|||||||
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 Other health authorities |
|||||||
Regulatory documentation |
EU Drug Master File (DMF)/Certificate of Suitability (CEP) US Drug Master File (DMF) Letter of Access (LoA) |
|||||||
Packaging sizes |
|
|||||||
Packaging material |
|
|||||||
Shelf life |
| |||||||
Storage conditions |
| |||||||
*Billion Of Units
