Polymyxin B sulfate is a mixture of sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other Gram-negative bacteria.
Indication: Used in the treatment of acute urinary, meningeal or blood stream infections due to Pseudomonas aeruginosa and other Gram-negative pathogens causing serious infections when less potentially toxic drugs are ineffective or contraindicated. It is often used as a combination drug product for the local treatment of skin, ear and eye infections.
Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops or subconjunctival injections.
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Sterile, micronized Sterile, non-micronized Non-sterile, micronized Non-sterile, non-micronized | |||||||||||||
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Ph. Eur. USP |
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Manufacturing site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Release site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Site registered |
EU GMP issued by Danish Medicines Agency US FDA Other health authorities |
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Regulatory documentation |
EU Drug Master File (DMF)/Certificate of Suitability (CEP) US Drug Master File (DMF) Letter of Access (LoA) |
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