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Polymyxin B vials

Polymyxin B is a mixture of the sulfates of polypeptide antibiotics active against almost all gram-negative bacteria except the Proteus group.

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

Batch size

65000 vials

Packaging sizes

1 vial/pack
10 vials/pack
25 vials/pack

Shelf life

RoW (Rest of the World): 36 months

US: 24 months

Storage conditions

Between 15-25 °C (59-77°F)

Compliance

USP

Manufacturing site

CMO for Xellia Pharmaceuticals ApS

Release site

CMO for Xellia Pharmaceuticals ApS

Site registered

US FDA

Other health authorities

Regulatory documentation

US dossier

RoW (Rest of the World) dossier

Polymyxin B vial has a boxed warning for use by intrathecal or intramuscular route of administration, where patients must be hospitalized and under constant supervision by physician. In addition, there is risk of nephrotoxicity and neurotoxicity. The safety data on usage in pregnancy is lacking. For further information, including boxed warning, please reach out to us here.

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