Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Cefuroxime Sodium
Fresenius Kabi Deutschland GmbH
J01DC; J01DC02
Cefuroxime Sodium
750 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefuroxime
Marketed
2009-08-21
1 UK-IE V006 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME 750 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFUROXIME 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 or pharmacist. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Cefuroxime is and what it is used for 2. What you need to know before you use Cefuroxime 3. How to use Cefuroxime 4. Possible side effects 5. How to store Cefuroxime 6. Contents of the pack and other information 1. WHAT CEFUROXIME IS AND WHAT IT IS USED FOR Cefuroxime is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called _cephalosporins. _ CEFUROXIME IS USED TO TREAT INFECTIONS of: • the lungs or chest • the urinary tract • the skin and soft tissue • the abdomen Cefuroxime is also used: • to prevent infections during surgery. Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxime during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CEFUROXIME YOU MUST NOT BE GIVEN CEFUROXIME: • IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS or any of the other ingredients of Cefuroxime (listed in section 6). • if you have ever had a severe allergic ( _hypersensitive_ ) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). • if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after treatment with cefuroxime or any other cephalosporin antibiotics. → TELL YOUR DOCTOR BEFORE you start on Cefuroxime if you think that this applies to you. You must not be given Cefuroxime. 2 UK-IE V006 . WARNINGS AND PRECAUTIONS Talk to your docto Прочитайте повний документ
Health Products Regulatory Authority 20 November 2023 CRN00DL69 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 750 mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 750 mg of cefuroxime (as 789 mg cefuroxime sodium). Excipients with known effect: Each vial contains 40.63 mg of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion White to cream coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Kabi is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1). Community acquired pneumonia. Acute exacerbations of chronic bronchitis. Complicated urinary tract infections, including pyelonephritis. Soft-tissue infections: cellulitis, erysipelas and wound infections. Intra-abdominal infections (see section 4.4). Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section). In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Table 1. Adults and children _≥ _40 kg_ INDICATION DOSAGE Community acquired pneumonia and acute exacerbations of chronic bronchitis 750 mg every 8 hours (intravenously or intramuscularly) Soft-tissue infections: cellulitis, erysipelas and wound infections. Intra-abdominal infections Complicated urinary tract infections, including pyelonephritis 1.5 g every 8 hours (intravenously or intramuscularly) Severe infections 750 mg every 6 hours (intravenously) 1.5 g every 8 hours (intravenously) Health Prod Прочитайте повний документ