Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
telavancin
Theravance Biopharma Ireland Umited
J01XA03
telavancin
Antibacterials for systemic use,
Pneumonia, Bacterial; Cross Infection
Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 10
Withdrawn
2011-09-02
25 B. PACKAGE LEAFLET Medicinal product no longer authorised 26 PACKAGE LEAFLET: INFORMATION FOR THE USER VIBATIV 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION VIBATIV 750 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION telavancin 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 ARE GIVEN 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 pharmacist. - If you get any side effects, talk your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What VIBATIV is and what it is used for 2. What you need to know before you use VIBATIV 3. How to use VIBATIV 4. Possible side effects 5. How to store VIBATIV 6. Contents of the pack and other information 1. WHAT VIBATIV IS AND WHAT IT IS USED FOR VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group. VIBATIV is used to treat adult patients with infections of the lungs that have developed in the hospital, including patients on artificial ventilation, when these infections are known or suspected to be caused by bacteria called methicillin-resistant _Staphylococcus aureus_ (MRSA). It is only used when the bacteria that cause these infections can be killed with telavancin. VIBATIV can only be used when other antibiotics are not suitable. If you also have other bacteria that cause your infection, your doctor may prescribe other antibiotics in addition to VIBATIV. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIBATIV DO NOT USE VIBATIV - if you are allergic (hypersensitive) to telavancin or any of the other ingredients of VIBATIV (listed in section 6) - If you suffer from severe kidney problems, or receive hae Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VIBATIV 250 mg powder for concentrate for solution for infusion Each vial contains 250 mg telavancin (as hydrochloride). VIBATIV 750 mg powder for concentrate for solution for infusion Each vial contains 750 mg telavancin (as hydrochloride). After reconstitution, each ml contains 15 mg of telavancin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion A white to pale pink, whole or fragmented cake 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant _Staphylococcus aureus_ (MRSA). VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 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 _Adults_ The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days. Special populations _ _ _Elderly patients _ Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function (see sections 4.3 and 5.2). Medicinal product no longer authorised 3 _Renal impairment_ Patients with renal impairment should receive an initial dose according to calculated or measured creatinine clearance as presented in t Lesen Sie das vollständige Dokument