Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
imipenem monohydrate, cilastatin sodium, relebactam monohydrate
Merck Sharp & Dohme B.V.
J01DH56
imipenem, cilastatin, relebactam
Carbapenems, Antibacterials for systemic use,
Gram-Negative Bacterial Infections
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.
Revision: 5
Authorised
2020-02-13
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFOR MATION FOR THE USER RECARBRIO 500 MG/500 MG/250 MG POWDER FOR SOLUTION FOR INFUSION imipenem/cilastatin/relebactam This medicine is subjec t to additiona l moni toring. This will allo w quick identification of new sa fety information. You can he lp by reporting any side effects you may get. See the end of section 4 for how to repor t side effects. READ AL L OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MED ICINE BECAUSE IT CONTAINS IM PORTANT INFORMATION FOR YOU. Kee p this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If you get any side effects, t alk to your doctor or nurse. This includes any possible s ide effects not listed in th is leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Recarbrio is and what it is used for 2. What you need to k now before you are given Recarbrio 3. How you are given Recarbrio 4. Possible side effec ts 5. How to store Recarbrio 6. Contents of th e pa ck and other information 1. WHAT RECARBRIO IS AND WHAT IT IS US ED FOR Recarbrio is an antibiotic. It contains the a ctive substances imipenem, ci last atin, and rele bactam. Recarbrio is used in adults to treat: certain bacterial infections of the lungs (p neumonia) inf ections of the bloo d associated with the infection s of the lung mentioned above infections caused by bact eria that other antibiotics m ay not be able to kill Recarbrio is used in patients 18 years or older. 2. WHAT YOU NEE D TO KNOW BEFORE YOU ARE GIVEN RECARBRIO YOU SHOULD N OT BE GIVEN RECARBRIO IF: you are allergic t o imipenem, cilastatin, relebactam or any of t he other ingredients of this medicine (listed in section 6) you are allergic to carbapenem antibiotics you ever had a severe allergic reaction to penicillin antibiotics or cephalospor in antibiotics You s hould not be given Recarbrio if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Recarbrio. WARNINGS Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adve rse reactions. See section 4.8 for how to report adverse reactions . 1. NAME OF THE MEDICINAL PROD UCT Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains imipenem monohydrate eq uivalent to 500 mg imipenem, cilastatin sodium equivalent to 500 mg cilastatin, and relebactam mon ohydrate equivalent to 250 mg relebactam. Excipient(s) with known effect The total amount of sodium in each vial is 37.5 mg (1.6 mmol). For the full list of excipients, see section 6.1. 3. PHARMAC EUTICAL FORM Powder for solution for infusion. A white to light yellow powder. 4. CLINIC AL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Re carbrio is indicated for : T reatment of hospital-acquired pneumonia (HAP) , including ventilator associated pneumonia (VAP), in adult s (see sections 4.4 and 5.1). Treatment of bacteraemia that occurs in associatio n with, or is suspected to be associated with HAP or VAP, in adults. T reatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1). Considerat ion should be given to official guidance on the appropriate us e of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTR ATION It is recommended th at Recarbrio sho uld be used to treat infections due to aerobic Gram-negative organisms in adult patient s with limited treatment options only after consultation wit h a physician with appropriate experien ce in t he management of inf ectious diseases . Posology Table 1 shows the recommend ed intravenous dos e for patients with a cre atinine clearance (CrCl) ≥ 90 mL/min (see sections 4.4 and 5.1). 3 TABLE 1: RECOMMENDED I NTRAVENOUS DOSE FOR P ATIENTS WITH A CREATININE CLEARANCE (CRCL) ≥ 90 ML/MIN 1,2 TYPE OF INFECTIO Olvassa el a teljes dokumentumot