Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Cefuroxime Sodium
Flynn Pharma Limited
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
2000-06-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME 750MG & 1.5G POWDER FOR INJECTION/INFUSION Cefuroxime The name of your medicine is Cefuroxime 750mg & 1.5g Powder for Injection/Infusion, which will be referred to as Cefuroxime Injection throughout this document. 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 or nurse. - 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 Injection is and what it is used for 2. What you need to know before you are given Cefuroxime Injection 3. How Cefuroxime Injection is given 4. Possible side effects 5. How to store Cefuroxime Injection 6. Contents of the pack and other information 1. WHAT CEFUROXIME INJECTION IS AND WHAT IT IS USED FOR Cefuroxime injection 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 INJECTION IS USED TO TREAT INFECTIONS OF: - the lungs or chest - the urinary tract - the skin and soft tissue - the abdomen Cefuroxime Injection is also used: - to prevent infections during surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME INJECTION YOU MUST NOT BE GIVEN CEFUROXIME INJECTION: - IF YOU ARE ALLERGIC (_HYPERSENSITIVE_) TO ANY CEPHALOSPORIN antibiotics or any other ingredients of Cefuroxime Injection (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 Injection if you think that this Preberite celoten dokument
Health Products Regulatory Authority 22 May 2023 CRN00DKCN Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 750 mg Powder for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 750mg cefuroxime (as sodium salt). Excipients with known effects: Each vial contains 40.6 mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for suspension for injection/Powder for solution for injection or infusion Vials containing a white or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime 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 Health Products Regulatory Authority 22 May 2023 CRN00DKCN Page 2 of 14 Complicated urinary tract infections, including pyelonephritis 1.5 g every 8 hours (intravenously or intramuscularly) Severe infections 750 Preberite celoten dokument