Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TEICOPLANIN
Generics (UK) Limited
J01XA02
TEICOPLANIN
200 Milligram
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
teicoplanin
Not Marketed
2017-11-10
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEICOPLANIN 100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION TEICOPLANIN 200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION TEICOPLANIN 400 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION teicoplanin 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Teicoplanin is and what it is used for 2. What you need to know before you are given Teicoplanin 3. How Teicoplanin is given 4. Possible side effects 5. How to store Teicoplanin 6. Contents of the pack and other information 1. WHAT TEICOPLANIN IS AND WHAT IT IS USED FOR Teicoplanin contains the active substance teicoplanin, which is an antibiotic. It works by killing the bacteria that cause infections in your body. Teicoplanin is used in adults and children (including newborn babies) to treat bacterial infections of: - the skin and underneath the skin (sometimes called soft tissue) - the bones and joints - the lung - the urinary tract - the heart (sometimes called endocarditis) - the abdominal wall (peritonitis) - the blood, when caused by any of the conditions listed above Teicoplanin can be used to treat some infections caused by the _Clostridium difficile_ bacteria in the gut. For this, the solution is taken by mouth. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TEICOPLANIN YOU MUST NOT BE GIVEN TEICOPLANIN if you are allergic to teicoplanin or any of th Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 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 Teicoplanin 200 mg Powder for Solution for Injection/Infusion or Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg teicoplanin equivalent to not less than 200,000 IU. After reconstitution, the solution will contain 200 mg teicoplanin in 3.0 mL. Excipient(s) with known effect Each 200 mg vial contains approximately 11.6 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion or oral solution. White to off-white lyophilised powder or cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teicoplanin is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1): complicated skin and soft tissue infections, bone and joint infections, hospital acquired pneumonia, community acquired pneumonia, complicated urinary tract infections, infective endocarditis, peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD), bacteraemia that occurs in association with any of the indications listed above. Teicoplanin is also indicated as an alternative oral treatment for_ Clostridium difficile_ infection-associated diarrhoea and colitis. Where appropriate, teicoplanin should be administered in combination with other antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function. H E A L T H P R O D U C T S R E G U Διαβάστε το πλήρες έγγραφο