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Colistimethate Sodium

Colistimethate Sodium is a derivative of colistin (polymyxin E) that is a mixture of polypeptide antibiotics active against Gramnegative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Indication: Used in the treatment of acute or chronic infections due to sensitive strains of Gram-negative pathogens.

 

Application: Administered systemically as intramuscular injections and intravenous injections or infusions. Colistimethate sodium can also be administered by inhalation or mixed with bone cement, as well used in ophthalmic formulations.

Product grades

Sterile, micronized Sterile, non-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, Micronized

Sterile, Non-Micronized

Non-sterile, Non-Micronized

10 BOU*

100 BOU*

10 BOU*

15 BOU*

65 BOU*

100 BOU*

10 BOU*

15 BOU*

65 BOU*

100 BOU*

Packaging material

Primary: Almuinum containers with polyethylene insert and polypropylene lid

Secondary: Polystyrene

Shelf life

5 years

Storage conditions

Below 25°C (77°F)