Polymyxin B Sulfate is a mixture of the sulfates of polypeptide antibiotics active against Gram-negative bacteria.
Indication: Used in the treatment of patients with acute urinary, meningeal or blood-stream infections due to susceptible strains such as Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Aerobacter aerogenes or Klebsiella pneumoniae.
Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops or subconjunctival injections.
Dosage form |
Lyophilized vials |
||
Strength |
500 000 units/vial |
||
Compliance |
USP |
||
Manufacturing site |
CMO for Xellia Pharmaceuticals ApS |
||
Release site |
CMO for Xellia Pharmaceuticals ApS |
||
Site registered |
EU GMP issued by Medicines and Healthcare products Regulatory Agency US FDA Other Health Authorities |
||
Batch size |
|
||
Regulatory documentation |
EU dossier RoW* dossier |
||
Packaging sizes |
|
||
Shelf life |
| ||
Storage conditions |
| ||
* Rest of the world
