Polymyxin B Sulfate is mixture of the sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other serious Gram-negative bacteria.
Indication: Used in the treatment of patients with acute urinary, meningeal or blood stream infections due to Pseudomonas aeruginosa and other serious Gram-negative pathogens. It is often used in combined products for local treatment of skin, ear and eye infections.
Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops or subconjunctival injections.
Product grades |
Sterile, micronized Sterile, non-micronized Non-sterile, 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 |
Certificate of Suitability (CEP) EU Drug Master File (DMF) US Drug Master File (DMF) Letter of Access (LoA) |
||||||||||||
Packaging sizes |
|
||||||||||||
Packaging material |
|
||||||||||||
Shelf life |
| ||||||||||||
Storage conditions |
|