Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Cefotaxime sodium
Wockhardt UK Limited
J01DD; J01DD01
Cefotaxime sodium
500 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; cefotaxime
Marketed
2003-09-19
PACKAGE LEAFLET: INFORMATION FOR THE USER Cefotaxime 500mg powder for solution for injection or infusion Cefotaxime 1g powder for solution for injection or infusion Cefotaxime 2g powder for solution for injection or infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. Keep this leaflet. You may need to read it again while you are receiving your treatment. If you have any further questions, please ask your doctor or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is cefotaxime 500mg, 1g or 2g powder for solution for injection or infusion. In the rest of this leaflet it is called cefotaxime for injection. IN THIS LEAFLET: 1. What cefotaxime for injection is and what it is used for 2. Before you are given cefotaxime for injection 3. How cefotaxime for injection should be given 4. Possible side effects 5. How to store cefotaxime for injection 6. Further information 1. WHAT CEFOTAXIME FOR INJECTION IS AND WHAT IT IS USED FOR Cefotaxime belongs to a group of medicines called cephalosporins which are antibiotics. These medicines work by killing bacteria that cause infections. Cefotaxime for injection is used for the treatment of a range of serious bacterial infections including infections of the blood stream (septicaemia), bones (osteomyelitis), the heart valves (endocartitis), the membranes covering the brain (meningitis) and the lining of the abdomen (peritonitis), and to prevent and treat infections following surgical operations. 2. BEFORE YOU ARE GIVEN CEFOTAXIME FOR INJECTION CEFOTAXIME FOR INJECTION SHOULD NOT BE GIVEN IF: You are allergic to cefotaxime or any other cephalosporin. You have previously had a severe allergic reaction to penicillin or any other beta-lactam antibiotic If any of the above app read_full_document
Health Products Regulatory Authority 13 November 2019 CRN009G5D Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefotaxime 500mg Powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefotaxime sodium equivalent to 500 mg of cefotaxime Each gram of cefotaxime contains approximately 48 mg (2.09mmol) of sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. (Powder for injection or infusion). White to slightly yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, including : osteomyelitis, septicaemia, bacterial endocarditis, meningitis, and peritonitis. and other serious bacterial infections suitable for parenteral antibiotic therapy. 2. Cefotaxime may be used for pre-operative prophylaxis in patients undergoing surgical procedures, that may be classified as contaminated or potentially so. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefotaxime may be administered intravenously_,_ by bolus injection or by infusion, or by intramuscular injection. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. _Adults:_ The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. In severe infections dosage may be increased up to 12g daily given in three or four divided doses. For infections caused by sensitive _Pseudomonas_ species daily doses of greater than 6g will usually be read_full_document