Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Teicoplanin
Noridem Enterprises Limited
J01XA; J01XA02
Teicoplanin
200 milligram(s)
Powder and solvent for solution for injection/infusion
For injection/infusion or oral solution
Bt x 1 vial x 200 mg + 1 ampoule x 3 ml solvent
Product subject to prescription which may not be renewed (A)
DEMO S.A.
Glycopeptide antibacterials
Glycopeptide antibacterials; teicoplanin
It is indicated in adults and in children from birth for the parenteral treatment of the following infections : 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.
Marketed
2015-05-22
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER TEICOPLANIN 200 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION TEICOPLANIN 400 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION TEICOPLANIN 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 to use Teicoplanin 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 is an antibiotic. It contains a medicine called ‘teicoplanin’. 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 ‘ _Clostridioides difficile’_ bacteria in the gut. For this, the solution is taken by mouth. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TEICOPLANIN. DO NOT USE TEICOPLANIN IF: - you are allergic to teicoplanin or any of the other ingredients of this medicine, (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are given Teicoplanin if: • you are allergic to an antibiotic called ‘vancomycin’ • you have had a flushing of your up Citiți documentul complet
Health Products Regulatory Authority 13 October 2022 CRN00D6JQ Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teicoplanin 200 mg Powder and Solvent 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 solutions will contain 200 mg teicoplanin in 3.0 mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection/infusion or oral solution. Powder: White to off white powder. Solvent: clear, colourless liquid. 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 _Clostridioides 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. Measurement of serum concentrations Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration h Citiți documentul complet