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Polymyxin B Sulfate

Polymyxin B Sulfateis mixture of the sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other serious Gram-negative bacteria.

Indication: Used in the treatment of patients with acute urinary, meningeal or blood stream infections due to Pseudomonas aeruginosa and other serious Gram-negative pathogens. It is often used in combined products for 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

Certificate of Suitability (CEP)

EU Drug Master File (DMF)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Sterile

Non-sterile

Micronized

Non-Micronized

Micronized

Non-Micronized

1 BOU*

5 BOU*

10 BOU*

1 BOU*

10 BOU*

1 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: 24 months

Non-sterile: 5 years non-sterle

USP grade for ROW and EP grade: 5 years

Storage conditions

Below 25°C (77°F)

* BOU = Billions of units.