Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TEICOPLANINE 200 mg/flacon
TEICOPLANINE 200 mg/flacon
Poeder en oplosmiddel voor oplossing voor injectie, Poeder en oplosmiddel voor oplossing voor infusie
NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE
Intraveneus gebruik, Intramusculair gebruik, Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEICOPLANINE SUN 200 MG, POEDER EN OPLOSMIDDEL VOOR OPLOSSING VOOR INJECTIE/INFUSIE OF ORALE OPLOSSING TEICOPLANINE SUN 400 MG, POEDER EN OPLOSMIDDEL VOOR OPLOSSING VOOR INJECTIE/INFUSIE OF ORALE OPLOSSING teicoplanin 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, pharmacist 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, 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 SUN is and what it is used for 2. What you need to know before you are given Teicoplanin SUN 3. How to use Teicoplanin SUN 4. Possible side effects 5. How to store Teicoplanin SUN 6. Contents of the pack and other information 1. WHAT TEICOPLANIN SUN IS AND WHAT IT IS USED FOR Teicoplanin SUN is an antibiotic. It contains the active substance teicoplanin. It works by killing the bacteria that cause infections in your body. Teicoplanin SUN 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 SUN can be used to treat some infections caused by _'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 SUN DO NOT USE TEICOPLANIN SUN: - if you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS 2 TAL Đọc toàn bộ tài liệu
V001 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Teicoplanine SUN 200 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing Teicoplanine SUN 400 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each powder 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. Each powder vial contains 400 mg teicoplanin equivalent to not less than 400,000 IU. After reconstitution, the solution will contain 400 mg teicoplanin in 3.0 ml. For the full list of excipients, see section 6.1. Excipient with known effect This medicinal product contains 9.45 mg sodium per vial, equivalent to 0.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection/infusion or oral solution Powder for solution for injection/infusion or oral solution: White-ivory spongy lyophilized powder. Solvent: Clear, colourless and odourless liquid 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teicoplanin SUN 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 SUN 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 MET Đọc toàn bộ tài liệu