البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
DAPTOMYCIN
Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece
J01XX09
DAPTOMYCIN 500 mg
POWDER FOR SOLUTION FOR INJECTION/INFUSION
DAPTOMYCIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2019-10-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZEPRAXEN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION daptomycin 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Zepraxen is and what it is used for 2. What you need to know before you are given Zepraxen 3. How Zepraxen is given 4. Possible side effects 5. How to store Zepraxen 6. Contents of the pack and other information 1. WHAT ZEPRAXEN IS AND WHAT IT IS USED FOR The active substance in Zepraxen powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Zepraxen is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used to treat infections in the blood when associated with skin infection. Zepraxen is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called _Staphylococcus aureus. _ It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection. Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Zepraxen. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEPRAXEN YOU SHOULD NOT BE GIVEN ZEPRAXEN If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6). If this a اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zepraxen 350 mg powder for solution for injection/infusion Zepraxen 500 mg powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zepraxen 350 mg powder for solution for injection/infusion Each vial contains 350 mg daptomycin. One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution. Zepraxen 500 mg powder for solution for injection/infusion Each vial contains 500 mg daptomycin. One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. A pale yellow to light brown lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zepraxen is indicated for the treatment of the following infections (see sections 4.4 and 5.1). - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). - Adult patients with right-sided infective endocarditis (RIE) due to _Staphylococcus aureus_ . It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. See sections 4.4 and 5.1. - Adult and paediatric (1 to 17 years of age) patients with _Staphylococcus aureus_ bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram-positive bacteria only (see section 5.1). In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, Zepraxen should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Clinical studies in patient اقرأ الوثيقة كاملة