Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
daptomycin
Pfizer Europe MA EEIG
J01XX09
daptomycin
Antibacterials for systemic use,
Soft Tissue Infections; Skin Diseases, Bacterial
Daptomycin is indicated for the treatment of the following infections.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 isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.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. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 13
Authorised
2017-03-22
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAPTOMYCIN HOSPIRA 350 MG POWDER FOR SOLUTION FOR INJECTION/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 Hospira is and what it is used for 2. What you need to know before you are given Daptomycin Hospira 3. How Daptomycin Hospira is given 4. Possible side effects 5. How to store Daptomycin Hospira 6. Contents of the pack and other information 1. WHAT DAPTOMYCIN HOSPIRA IS AND WHAT IT IS USED FOR The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Daptomycin Hospira 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. Daptomycin Hospira 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 Daptomycin Hospira. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN HOSPIRA YOU SHOULD NOT BE GIVEN DAPTOMYCIN HOSPIRA If Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Daptomycin Hospira 350 mg powder for solution for injection/infusion Daptomycin Hospira 500 mg powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Daptomycin Hospira 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 for injection. Daptomycin Hospira 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 injection. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Daptomycin Hospira 350 mg powder for solution for injection/infusion Powder for solution for injection/infusion. A light yellow to light brown lyophilised cake or powder. Daptomycin Hospira 500 mg powder for solution for injection/infusion Powder for solution for injection/infusion. A light yellow to light brown lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daptomycin 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. 3 Daptomycin is active against Gram positive bacteria only (see section 5.1). In mixed infec Прочетете целия документ