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Polymyxin B sulfate

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.

Product grades

Sterile, micronized Sterile, non-micronized Non-sterile, micronized Non-sterile, non-micronized

Compliance

Ph. Eur.

USP

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency

US FDA

Other health authorities

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Sterile

Non-sterile

Micronized

Non-micronized

Micronized

Non-micronized

5 BOU*

10 BOU*

10 BOU*

5 BOU*

10 BOU*

25 BOU*

10 BOU*

Packaging material

Primary: Aluminum containers with PE insert and polypropylene lid

Secondary: Polystyrene

Shelf life

Sterile for US only: 24 months

Sterile & Non-sterile (Ph. Eur./USP grade for ROW): 5 years

Storage conditions

Below 25°C (77°F)

*Billion Of Units