Recarbrio
imipenem / cilastatin / relebactam
Table of contents
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.
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List item
Recarbrio : EPAR - Medicine overview (PDF/162.99 KB) (updated)
First published: 26/02/2020
Last updated: 19/02/2021 -
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List item
Recarbrio : EPAR - Risk-management-plan summary (PDF/1.62 MB)
First published: 26/02/2020
Last updated: 18/01/2021
Authorisation details
Product details | |
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Name |
Recarbrio
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Agency product number |
EMEA/H/C/004808
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Gram-Negative Bacterial Infections
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Anatomical therapeutic chemical (ATC) code |
J01DH56
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Additional 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 | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
13/02/2020
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Contact address |
Product information
16/11/2020 Recarbrio - EMEA/H/C/004808 - II/0001
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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Antibacterials for systemic use
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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.