Recarbrio

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imipenem / cilastatin / relebactam

Authorised
This medicine is authorised for use in the European Union.

Overview

Recarbrio is an antibiotic for treating adults with the following infections:

  • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught while on a ventilator, which is a machine that helps a patient to breathe);
  • infection that has spread into the blood (bacteraemia) as a likely complication of hospital-acquired pneumonia or ventilator-associated pneumonia;
  • infections caused by bacteria classed as aerobic Gram-negative bacteria when other treatments might not work.

Official guidance on the appropriate use of antibiotics should be considered when using the medicine.

Recarbrio contains the active substances imipenem, cilastatin and relebactam.

This EPAR was last updated on 18/05/2021

Authorisation details

Product details
Name
Recarbrio
Agency product number
EMEA/H/C/004808
Active substance
  • imipenem monohydrate
  • cilastatin sodium
  • relebactam monohydrate
International non-proprietary name (INN) or common name
  • imipenem
  • cilastatin
  • relebactam
Therapeutic area (MeSH)
Gram-Negative Bacterial Infections
Anatomical therapeutic chemical (ATC) code
J01DH56
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
13/02/2020
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

22/04/2021 Recarbrio - EMEA/H/C/004808 - P46/003

Contents

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Pharmacotherapeutic group

  • Antibacterials for systemic use

  • Carbapenems

Therapeutic indication

Recarbrio is indicated for:
- Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).
- Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
- Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

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