देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Teicoplanin
Hikma Farmacêutica (Portugal) S.A.
J01XA; J01XA02
Teicoplanin
200 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Glycopeptide antibacterials; teicoplanin
Not marketed
2018-04-06
PACKAGE LEAFLET: INFORMATION FOR THE USER TEICOPLANIN HIKMA 200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION TEICOPLANIN HIKMA 400 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION Teicoplanin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Hikma is and what it is used for 2. What you need to know before you take Teicoplanin Hikma 3. How to take Teicoplanin Hikma 4. Possible side effects 5. How to store Teicoplanin Hikma 6. Contents of the pack and other information 1. WHAT TEICOPLANIN HIKMA IS AND WHAT IT IS USED FOR Teicoplanin Hikma is an antibiotic. It contains a medicine called ‘teicoplanin’. It works by killing the bacteria that cause infections in your body. Teicoplanin Hikma 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 Hikma 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 TAKE TEICOPLANIN HIKMA DO NOT TAKE TEICOPLANIN HIKMA: • 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 taking Teicoplanin Hikma: • if you are allergic to an antibiotic called ‘vancomycin’ • if पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 11 April 2023 CRN00CT70 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teicoplanin Hikma 200mg 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 solutions will contain 200 mg of teicoplanin in 3.0 ml and 400 mg in 3.0 ml. Excipient(s) with known effect: 10 mg of sodium per vial For a full list of excipients, see section 6.1.p 3 PHARMACEUTICAL FORM Powder for solution for Injection/infusion or oral solution. White to yellowish lyophilized powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teicoplanin Hikma 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 Hikma 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 पूरा दस्तावेज़ पढ़ें