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Polymyxin B vials

Polymyxin B 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

65000 vials

Regulatory documentation

US dossier

RoW* dossier

Packaging sizes

1 vial/pack

10 vials/pack

Shelf life

24 months

Storage conditions

Between 15-30°C (59-86°F)

* Rest of the World