XYDALBA Powder for concentrate for solution for infusion Ref.[8445] Active ingredients: Dalbavancin

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstraße, 67061 Ludwigshafen, Germany

Product name and form

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.

Qualitative and quantitative composition

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)
Lactose monohydrate
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.

Each pack contains 1 vial.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstraße, 67061 Ludwigshafen, Germany

Marketing authorization dates and numbers

EU/1/14/986/001

Date of first authorisation: 19 February 2015
Date of latest authorisation: 05 December 2019

Drugs

Drug Countries
XYDALBA Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom
 
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