Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Xydalba 500 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white to pale yellow powder. |
Each vial contains dalbavancin hydrochloride equivalent to 500 mg dalbavancin.
After reconstitution each ml contains 20 mg dalbavancin.
The diluted solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin (see section 6.6).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dalbavancin |
Dalbavancin is a bactericidal lipoglycopeptide. Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall synthesis by binding to the terminal D-alanyl-D-alanine of the stem peptide in nascent cell wall peptidoglycan, preventing cross-linking (transpeptidation and transglycosylation) of disaccharide subunits resulting in bacterial cell death. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.
Each pack contains 1 vial.
Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
EU/1/14/986/001
Date of first authorisation: 19 February 2015
| Drug | Countries | |
|---|---|---|
| XYDALBA | Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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