Xelia Colistimethate Sodium dry-filled vials 1 miu, 2 miu

Xelia Colistimethate Sodium Dry-filled Vials 1 Miu, 2 Miu is a derivative of colistin which is a mixture of polypeptide antibiotics active against Gram-negative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and 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 : Dry-filled (powder dosed) vials
Strength: 1 MIU* , 2 MIU* , 3 MIU*
Manufacturing site : Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site : Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered : EU GMP issued by Danish Medicines Agency, Other health authorities

Applications & Uses

Applications

Administered intrathecally, intraventricularly or as intravenous injection or infusion.

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

EU dossier
RoW** dossier

Packaging & Availability

Packaging Type
Batch size

1 MIU* vials: 575000 vials 
2 MIU* vials: 400000 vials
3 MIU* vials: 400000 vials

Packaging sizes

Labeled vials
1 vial/pack
10 vials/pack
30 vials/pack
Un-labeled vials
150 vials/pack

Storage & Handling

Shelf-life

36 months

Storage conditions

Below 25°C (77°F)