Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
DAPTOMYCIN
Clonmel Healthcare Ltd
J01XX09
DAPTOMYCIN
500 Milligram
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
daptomycin
Not Marketed
2017-07-14
What is in this leaflet 1. What Daptomycin Clonmel is and what it is used for 2. What you need to know before you are given Daptomycin Clonmel 3. How Daptomycin Clonmel is given 4. Possible side effects 5. How to store Daptomycin Clonmel 6. Contents of the pack and other information 1. What Daptomycin Clonmel is and what it is used for The active substance in Daptomycin Clonmel powder for solution for injection or infusion is daptomycin. Daptomycin is an antibiotic that can stop the growth of certain bacteria. What is it used for? Daptomycin Clonmel 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 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 _Staphylococcus 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 antibiotics while you are receiving treatment with Daptomycin Clonmel. 2. What you need to know before you are given Daptomycin Clonmel You must not be given Daptomycin Clonmel • 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 applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice. Warnings and precautions Talk to your doctor or nurse before you are given Daptomycin Clonmel: • if you have, or have previously had kidney problems. Your doctor may need to change the dose of Daptomycin Clonmel (see section 3 of this leaflet) • occasionally, patients receiving Daptomycin Clonmel may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to conti Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daptomycin Clonmel 500 mg powder for solution for Injection or Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Daptomycin Clonmel 500 mg Powder for solution for infusion or injection: Each vial contains 500 mg daptomycin. This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’. 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 or infusion A pale yellow to light brown lyophilised cake or powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daptomycin Clonmel is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Adult and paediatric (2 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 patients with_ Staphylococcus aureus_ bacteraemia (SAB) when associated with RIE or 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 Clonmel 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 same doses Прочитајте комплетан документ