País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Cefuroxime sodium
Stravencon Ltd
J01DC; J01DC02
Cefuroxime sodium
750 milligram(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefuroxime
Not marketed
2015-08-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME 250 MG POWDER FOR SOLUTION FOR INJECTION CEFUROXIME 750 MG POWDER FOR SOLUTION FOR INJECTION CEFUROXIME 1500 MG POWDER FOR SOLUTION FOR INJECTION OR 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 nurse. - If you get any of the 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 are given Cefuroxime . 3. How Cefuroxime is given. 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 the 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 Stravencon during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME YOU MUST NOT BE GIVEN CEFUROXIME: • IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS • if you have ever had a severe allergic (_hypersensitive_) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). è TELL YOUR DOCTOR BEFORE you start on Cefuroxime if you think that this applies to you. You must not be given Cefuroxime. TAKE SPECIAL CARE WITH CEFUROXIME You must look out for certain symptoms such as allergic reactions, skin rashes, gastrointestinal disorders such as diarrhoea or fung Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 750 mg Powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefuroxime sodium equivalent to 750mg of cefuroxime. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 750 mg powder for solution for injection. White or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime is indicated for the treatment of 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 treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with 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_ _40kg_ Cefuroxime strength Amount of sodium per vial 750 mg 41.4 mg 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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leer el documento completo