国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
CEFTOBIPROLE MEDOCARIL SODIUM
Basilea Medical Ltd. c/o Cox Costello & Horne Limited
J01DI01
CEFTOBIPROLE MEDOCARIL SODIUM
500 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Other cephalosporins
Authorised
2017-09-29
Package leaflet: Information for the user Adaluzis 500 mg powder for concentrate for solution for infusion Ceftobiprole 䊲 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects Read all of this leaflet carefully before you start using this medicine because it contains important information for you. – Keep 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, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Adaluzis is and what it is used for 2. What you need to know before you use Adaluzis 3. How to use Adaluzis 4. Possible side effects 5. How to store Adaluzis 6. Contents of the pack and other information 1. What Adaluzis is and what it is used for Adaluzis is an antibiotic medicine that contains the active substance ceftobiprole medocaril sodium. It belongs to a group of medicines called ‘cephalosporin antibiotics’. Adaluzis is used to treat adults with infections of the lungs called ‘pneumonia’. Adaluzis works by killing certain bacteria, which can cause serious lung infections. 2. What you need to know before you use Adaluzis Do not use Adaluzis: – if you are allergic to ceftobiprole medocaril sodium or any of the other ingredients of this medicine (listed in section 6), – if you are allergic to other cephalosporin or beta-lactam antibiotics, – if you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem. Do not use Adaluzis if any of the above applies to you. If you are not sure, talk to your doctor or nurse before being given Adaluzis. Warnings and precautions Talk to your doctor or nurse before using Adaluzis: – if you have kidney problems (your doctor may need to lower your dose of this medicine 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 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 adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Adaluzis 500mg Powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ceftobiprole (as 666.6 mg of ceftobiprole medocaril sodium). After reconstitution, each mL of concentrate contains 50 mg of ceftobiprole (as 66.7 mg of ceftobiprole medocaril sodium). Excipient(s) with known effect: Each vial contains approximately 1.3 mmol (29 mg) sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White, yellowish to slightly brownish, cake to broken cake or powder. The pH of the reconstituted solution is between 4.5 and 5.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adaluzis is indicated for the treatment of the following infections in adults (see sections 4.4, 5.1): - Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP) - Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Adaluzis is 500 mg administered as a 2-hour intravenous infusion every 8 hours. For CAP, a switch to an appropriate oral antibiotic may be considered after completion of at least 3 days of intravenous ceftobiprole medocaril sodium treatment, depending on the patient’s clinical response. _Paediatric population_ The safety and efficacy of Adaluzis in children aged birth to < 18 years have not yet been established. Adaluzis is not recommended for use in children or adolescents below 18 years of age. _Elderly patients_ No dose adjustment is necessary in elderly patients, except in cases of moderate to severe r 完全なドキュメントを読む