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Bacitracin vials

Bacitracin is comprised of a polypeptide complex and bacitracin A is the major component in this complex active against a variety of Gram-positive bacteria and a few Gram-negative bacteria, however only staphylococcal infections qualify for the systemic therapy.

Indication: The use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.

Application: Administered systemically as intramuscular injections.

 

Dosage form

Lyophilized vials

Strength

50 000 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

35000 vials

17000 vials

Regulatory documentation

US dossier

Packaging sizes

1 vial/pack

10 vials/pack

Shelf life

24 months

Storage conditions

Between 2-8°C (36-46°F)