Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
DAPTOMYCIN
Melita Pharm, S.L. C/Roma, 6-10, 08023 - Barcelona,, Spain
J01XX09
DAPTOMYCIN 350 mg
POWDER FOR SOLUTION FOR INJECTION/INFUSION
DAPTOMYCIN 350 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2017-09-29
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAPTOMYCIN MELITA PHARM 350 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 Daptomycin Melita Pharm is and what it is used for 2. What you need to know before you are given Daptomycin Melita Pharm 3. How Daptomycin Melita Pharm is given 4. Possible side effects 5. How to store Daptomycin Melita Pharm 6. Contents of the pack and other information 1. WHAT DAPTOMYCIN MELITA PHARM IS AND WHAT IT IS USED FOR The active substance in Daptomycin Melita Pharm powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Daptomycin Melita Pharm 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. Daptomycin Melita Pharm 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 bacterium called _Staphyloccocus aureus_ and to treat infections in the blood caused by the same bacterium when associated with skin or 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 Daptomycin Melita Pharm. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN MELITA PHARM YOU SHOULD NOT BE GIVEN DAPTOMYCIN MELITA PHARM If you are allergic to daptomycin or to sodium hydroxid Baca dokumen lengkap
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Daptomycin Melita Pharm 350 mg powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. A pale yellow to light brown lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daptomycin Melita Pharm 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, Daptomycin Melita Pharm 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 patients employed infusion of daptomycin over 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects. However, when compared with the Baca dokumen lengkap