Colistimethate Sodium is a derivative 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, intraventricularly or as intravenous injection or infusion.
Dosage form |
Dry filled (powder dosed) vials |
|||||||
Strength |
1 MIU* 2 MIU* 3 MIU* |
|||||||
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 Other Health Authorities |
|||||||
Batch size |
|
|||||||
Regulatory documentation |
EU dossier RoW* dossier |
|||||||
Packaging sizes |
|
|||||||
Shelf life |
| |||||||
Storage conditions |
| |||||||
* Million Internation Units
** Rest of the world
