Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
CEFUROXIME SODIUM
Actavis Group PTC ehf
J01DC02
CEFUROXIME SODIUM
750 Base Milligrams
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins
Authorised
2010-11-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME ACTAVIS 250 MG POWDER FOR SOLUTION FOR INJECTION CEFUROXIME ACTAVIS 750 MG POWDER FOR SOLUTION FOR INJECTION CEFUROXIME ACTAVIS 1.5 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION Cefuroxime READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Cefuroxime Actavis is and what it is used for 2. Before you are given Cefuroxime Actavis 3. How Cefuroxime Actavis is given 4. Possible side effects 5. How to store Cefuroxime Actavis 6. Further information 1. WHAT CEFUROXIME ACTAVIS IS AND WHAT IT IS USED FOR Cefuroxime belongs to a group of antibiotics called cephalosporins. Antibiotics are used to kill the bacteria or ‘germs’ that cause infections. Cefuroxime is a powder which is made into a solution to be given by injection into a vein or into a muscle. Cefuroxime Actavis is given for the treatment of infections including infections of the chest and kidneys. A doctor may also give it to you before an operation to protect you from infection. 2. BEFORE YOU ARE GIVEN CEFUROXIME ACTAVIS DO NOT USE CEFUROXIME ACTAVIS: if you are allergic (hypersensitive) to cefuroxime (see section 6 for a list of the ingredients). if you have had an allergic reaction to antibiotics such as penicillin or cephalosporins (an allergic reaction may inclu Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Actavis 750 mg powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefuroxime sodium equivalent to 750 mg cefuroxime. Each 750 mg vial contains approximately 42 mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. Cefuroxime is white to faintly yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime is indicated for the treatment of the following infections when caused by susceptible organisms. Respiratory tract infections: acute exacerbation of chronic bronchitis, hospital acquired pneumonia, severe community acquired pneumonia. Upper urinary tract infections: pyelonephritis. Peri-operative prophylaxis against infection in abdominal, orthopaedic and cardiac surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Usual dosage for adolescents (aged 12 years to 17 years), adults and the elderly:_ The dosage is 1.5 g/day to 6 g/day. In most infections a sufficient dose is 750 mg every 8 hours. In more severe infections the dose should be increased to 1.5 g every 8 hours by intravenous injection. If necessary, the dosage frequency can be increased to every 6 hours up to total daily dose of 6 g. _Prophylaxis_ The usual dose is 1.5 g intravenously with induction of anaesthesia for abdominal and orthopaedic operations, but may be supplemented with two 750 mg intramuscular doses eight and sixteen hours later. In cardiac operations, the usual dose is 1.5 g intravenously with induction of anaesthesia continuing with 750 mg intramuscularly three times daily for a further 24 hours to 48 hou Прочитайте повний документ