Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
eravacycline
PAION Deutschland GmbH
J01AA
eravacycline
Antibacterials for systemic use,
Infection; Bacterial Infections
Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 7
Authorised
2018-09-20
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XERAVA 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION eravacycline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 Xerava is and what it is used for 2. What you need to know before you are given Xerava 3. How you will be given Xerava 4. Possible side effects 5. How to store Xerava 6. Contents of the pack and other information 1. WHAT XERAVA IS AND WHAT IT IS USED FOR WHAT XERAVA IS Xerava is an antibiotic medicine that contains the active substance eravacycline. It belongs to a group of antibiotics called ‘tetracyclines’ which work by stopping the growth of certain infectious bacteria. WHAT XERAVA IS USED FOR Xerava is used to treat adults with a complicated infection in the abdomen. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN XERAVA YOU MUST NOT RECEIVE XERAVA - if you are allergic to eravacycline or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following: Anaphylactic reactions Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics. These can develop suddenly and can potentially be life-threatening. SEEK URGENT MEDICAL ATTENTION if you suspect you have an anaphylactic reaction whilst receiving Xerava. Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing c Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xerava 50 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg eravacycline. After reconstitution, each mL contains 10 mg eravacycline. After further dilution, 1 mL contains 0.3 mg eravacycline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). Pale yellow to dark yellow cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1). 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 regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days. _Strong CYP3A4 inducers _ In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5). _ _ _Elderly (≥ 65 years old) _ No dose adjustment is required in elderly patients (see section 5.2). _ _ _Renal impairment _ No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis. Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2). _ _ _Hepatic impairment _ No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2). _ _ _Paediatric population _ The safety and efficacy of Xerava in children and adolescents less than 18 years of age have not been established. No data are available. Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6). 3 Method of administration Intravenous use. Xerava is administered only by intravenous infusion over approximately 1 hour (see section 4.4). For instructions on reconstitution Olvassa el a teljes dokumentumot