Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
CEFOTAXIME
Sandoz GmbH
CEFOTAXIME
1 Grams
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
V020: CDS updates, Nat. phase 04/07/2013 MS PACKAGE LEAFLET: INFORMATION FOR THE USER CEFOTAXIME 0.5 G POWDER FOR SOLUTION FOR INJECTION CEFOTAXIME 1 G POWDER FOR SOLUTION FOR INJECTION CEFOTAXIME 2 G POWDER FOR SOLUTION FOR INJECTION Cefotaxime 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. If you get any side effects, talk to your doctor. 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 use Cefotaxime 3. How to use 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 The active ingredient in this medicine is cefotaxime. Cefotaxime is an antibiotic. Cefotaxime belongs to a group of antibiotics called ‘cephalosporins’. It is suitable for the treatment of bacterial infections such as: lung infections (lower respiratory tract), bladder and kidney infections (urinary tract), skin infections and infections of the layers (soft tissue) beneath the skin, genital tract infections (including gonorrhoea which is a sexually transmitted disease), abdominal infections (peritonitis), brain infections (meningitis). V020: CDS updates, Nat. phase 04/07/2013 MS 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CEFOTAXIME DO NOT USE CEFOTAXIME: if you are allergic (hypersensitive) to cefotaxime or any other cephalosporin type of antibiotic. if you have ever had an severe allergic reaction to pen Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefotaxime 1g Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 g vial contains 1 g cefotaxime (as cefotaxime sodium). Sodium content: 48 mg/vial. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. Description: Sterile, crystalline, white to slightly yellow powder for solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefotaxime is indicated for the treatment of the following severe infections when known or thought very likely to be due to bacteria that are susceptible to cefotaxime (see section 5.1): Bacterial pneumonia Complicated infections of the kidneys and upper urinary tract Severe infections of the skin and soft tissue Genital infections including Gonorrhea Intra-abdominal infections (such as peritonitis) (see section 4.2) Acute bacterial meningitis Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefotaxime may be administered by intravenous bolus injection, by intravenous infusion, or by intramuscular injection, after reconstitution of the solution according to the directions given below. Dosage and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition. Therapy may be started before the result of sensitivity tests are known. Cefotaxime has synergistic effects with aminoglycosides. _ADULTS AND CHILDREN OVER 12 YEARS:_ The usual dose in adults is 2 to 6 g daily. The daily dosage should be divided. Izlasiet visu dokumentu