Our products / FDFs
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.
Downloadables
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.
Want to hear more about our products?