Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Nabriva Therapeutics Ireland DAC, Alexandra House, Office 225/227, The Sweepstakes, Ballsbridge, Dublin 4, D04 C7H2, Ireland
Xenleta 150 mg concentrate and solvent for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate and solvent for solution for infusion. The concentrate is a colourless solution. The solvent is a colourless solution. |
Each vial of concentrate contains lefamulin acetate equivalent to 150 mg of lefamulin in 15 mL of normal saline (0.9% sodium chloride), to be diluted to a final concentration of 0.6 mg/mL.
Excipients with known effect:
This medicinal product contains 1,055 mg sodium per dose, equivalent to 52.75% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lefamulin |
Lefamulin is a pleuromutilin antibacterial agent. It inhibits bacterial protein synthesis by interacting with the A- and P- sites of the peptidyl transferase centre (PTC) in the central part of domain V of the 23S rRNA of the 50S ribosomal subunit, preventing correct positioning of the tRNA. |
| List of Excipients |
|---|
|
Concentrate: Sodium chloride Solvent: Citric acid |
One pack contains:
Type I glass, closed with a stopper (chlorobutyl rubber) and sealed with a flip off cap, 2 vials with 15 mL concentrate.
Polypropylene (PP) infusion bags, 2 bags with 250 mL solvent.
Nabriva Therapeutics Ireland DAC, Alexandra House, Office 225/227, The Sweepstakes, Ballsbridge, Dublin 4, D04 C7H2, Ireland
EU/1/20/1457/001
Date of first authorisation: 27 July 2020
| Drug | Countries | |
|---|---|---|
| XENLETA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.