Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
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
- Markets
- Applications
- Dosage Form
- Applications
Administered intrathecally, intraventricularly or as intravenous injection or infusion.
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
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)