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 |
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Strength |
50 000 units/vial |
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Compliance |
USP |
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Manufacturing site |
CMO for Xellia Pharmaceuticals ApS |
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Release site |
CMO for Xellia Pharmaceuticals ApS |
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Site registered |
EU GMP issued by Medicines and Healthcare products Regulatory Agency US FDA Other Health Authorities |
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Batch size |
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Regulatory documentation |
US dossier |
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Packaging sizes |
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Shelf life |
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Storage conditions |
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