Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
CEFOTAXIME SODIUM
Teva Pharma B.V.
J01DD01
CEFOTAXIME SODIUM
500 Milligram
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins
Authorised
2006-11-10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFOTAXIME 500 MG POWDER FOR SOLUTION FOR INJECTION CEFOTAXIME 1000 MG POWDER FOR SOLUTION FOR INJECTION CEFOTAXIME 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, nurse or pharmacist. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cefotaxime is and what it is used for 2. What you need to know before you take Cefotaxime 3. How to take Cefotaxime 4. Possible side effects 5. How to store Cefotaxime 6. Contents of the pack and other information 1. WHAT CEFOTAXIME IS AND WHAT IT IS USED FOR CEFOTAXIME 500 MG POWDER FOR SOLUTION FOR INJECTION AND CEFOTAXIME 1000 MG POWDER FOR SOLUTION FOR INJECTION CONTAIN CEFOTAXIME. Cefotaxime belongs to a group of drugs called antibiotics, which are used to treat bacterial infections. Cefotaxime is used to treat infections of the following: Chest (respiratory tract) Kidneys, bladder and urethra (the tube that carries urine from the bladder) Skin and soft tissues Abdomen, such as peritonitis Cefotaxime is also used to treat a type of sexually transmitted disease called gonorrhoea. Cefotaxime can also be used to treat other infections, such as meningitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFOTAXIME DO NOT USE Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefotaxime 500 mg Powder for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefotaxime sodium equivalent to 500 mg cefotaxime. 3 PHARMACEUTICAL FORM Powder for solution for injection. White or slightly yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of the following severe infections when known or thought very likely to be due to organisms that are susceptible to cefotaxime (see section 5.1) Infections of the lower respiratory tract Infections of the kidneys and other upper urinary tract infections Infections of the skin and soft tissue Genital infections caused by gonococci, particularly when penicillin has failed or is unsuitable Intra-abdominal infections (including peritonitis) (cefotaxime should be used in combination with another antibiotic that can provide anaerobic cover in the treatment of intra-abdominal infections) Acute Meningitis Consideration should be given to official local guidance on the appropriate use of antibiotics when using cefotaxime. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefotaxime sodium may be administered intravenously by bolus injection or intramuscularly. Cefotaxime 500 mg and 1000 mg are suitable for i.v. and i.m. injection. The intramuscular method of administration is reserved to exceptional clinical situations and should undergo a risk- benefit assessment! It is recommended that no more than 4 ml is injected unilaterally. If the daily dose exceeds 2000 mg cefotaxime or if cefotaxime is injected more frequently than twice per day, the i.v. route is recommended. Intramuscular administration of cefotaxime reconstituted with lidocaine should not be administrated to children in the first year of age. DOSAGE WITH Prečítajte si celý dokument