Xelia Colistimethate Sodium lyophilized vials 150 mg

Xelia Colistimethate Sodium Lyophilized Vials 150 Mg is a derivative of colistin, which is a mixture of polypeptide antibiotics active against Gram-negative microorganisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and especially Pseudomonas aeruginosa.

Functions: Antibiotic, Disinfectant

Dosage Form: Injectables, Powder & Powder Blends

Certifications & Compliance: GMP

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Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features

Dosage form : Lyophilized vials
Strength : 150 mg colistin base activity*
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

Applications & Uses

Applications

Administered systemically as intramuscular injections and intravenous injections or infusions.

Properties

Physical Form

Regulatory & Compliance

Certifications & Compliance
Compliance

No monograph for colistimethate sodium vials in Ph. Eur. available
USP monograph for colistimethate for injection available

Regulatory documentation

US dossier
RoW** dos

Packaging & Availability

Packaging Type
Batch size

80500 vials

Packaging sizes

1 vial/pack
6 vials/pack
10 vials/pack
12 vials/pack

Storage & Handling

Shelf-life

RoW: 36 months
US: 24 months

Storage conditions

Between 20-25°C (68-77°F)