Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Cefuroxime sodium
GlaxoSmithKline (Ireland) Limited
J01DC; J01DC02
Cefuroxime sodium
1.5 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefuroxime
Marketed
1978-08-21
Reason for update: UKIE TII WS - Excipients Update, M3 Harmonisation and GDS v33 updates Market: Ireland Agency Approval Date: Text Date: 14/07/2020 Text Issue and Draft No.: Issue 8 draft 4 PACKAGE LEAFLET: INFORMATION FOR THE USER ZINACEF 250 mg powder for solution or suspension for injection 750 mg powder for solution or suspension for injection 1.5g 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 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 Zinacef is and what it is used for 2. What you need to know before you are given Zinacef 3. How Zinacef is given 4. Possible side effects 5. How to store Zinacef 6. Contents of the pack and other information 1. WHAT ZINACEF IS AND WHAT IT IS USED FOR Zinacef 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._ ZINACEF IS USED TO TREAT INFECTIONS OF : the lungs or chest the urinary tract the skin and soft tissue the abdomen Zinacef 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 Zinacef during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZINACEF YOU MUST NOT BE GIVEN ZINACEF: IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS or any of the other ingredients of Zinacef (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). Reason for update: UKIE TII WS - Excipients Update, M3 Harmonisation and GDS v33 updates Mark Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 16 December 2021 CRN009WWR Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zinacef 1.5 g Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1.5 g of cefuroxime (as cefuroxime sodium). Each vial contains 83 mg of sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to cream powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zinacef 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) Health Products Regulatory Authority 16 December 2021 CRN009WWR Page 2 of 11 1.5 g every 8 hours (intravenously) Surg Lesen Sie das vollständige Dokument