Land: Malta
Språk: engelska
Källa: Medicines Authority
Venus Pharma GmbH Am Bahnhof 1-3, Werne, D 59368, Germany
J01DC02
CEFUROXIME 750 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
CEFUROXIME 750 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFUROXIME VENUS PHARMA 750 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFUROXIME VENUS PHARMA 1500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFUROXIME (AS CEFUROXIME SODIUM) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Cefuroxime Venus Pharma is and what it is used for 2. What you need to know before you are given Cefuroxime Venus Pharma 3. How Cefuroxime Venus Pharma is given 4. Possible side effects 5. How to store Cefuroxime Venus Pharma 6. Contents of the pack and other information 1. WHAT CEFUROXIME VENUS PHARMA IS AND WHAT IT IS USED FOR Cefuroxime Venus Pharma 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 VENUS PHARMA IS USED TO TREAT INFECTIONS OF : • the lungs or chest • the urinary tract • the skin and soft tissue • the abdomen Cefuroxime Venus Pharma 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 this medicine during your treatment. 2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME VENUS PHARMA YOU MUST NOT BE GIVEN CEFUROXIME VENUS PHARMA: • IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS or any of the other ingredients of this medicine (listed in section 6). • if you have ever had a severe allergic ( _hypersensitive_ ) reaction to any Läs hela dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime Venus Pharma 750 mg powder for solution for injection or infusion Cefuroxime Venus Pharma 1500 mg powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefuroxime Venus Pharma 750 mg powder for solution for injection or infusion Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 750 mg Each vial of cefuroxime sodium contains approximately 39 mg sodium. Cefuroxime Venus Pharma 1500 mg powder for solution for injection or infusion Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 1500 mg Each vial of cefuroxime sodium contains approximately 78 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion White or almost white, slightly hygroscopic 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 2 • 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 intramuscu Läs hela dokumentet