Polymyxin B sulfate is a mixture of sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other gram-negative bacteria except the Proteus group.
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, eye and vaginal infections.
Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops, ear drops, intravaginal capsules or subconjunctival injections.
Product grades |
Sterile, micronized Sterile, non-micronized Non-sterile, micronized Non-sterile, non-micronized | |||||||||||||
Compliance |
Ph. Eur. USP CP |
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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) China Drug Master File (CDMF) Japan Drug Master File (JDMF) DMF also available in other selected countries outside EU/US/China/Japan |
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