Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
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
- Markets
- Applications
- Dosage Form
- Applications
Administered systemically as intramuscular injections and intravenous injections or infusions.
Properties
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)