Kraj: Malta
Język: angielski
Źródło: Medicines Authority
CEFOTAXIME SODIUM
Villerton Invest S.A. Rue Edward Steichen 14, 2540, Luxembourg
J01DD01
CEFOTAXIME SODIUM 1/4.4 g/ml
SOLUTION FOR INJECTION/INFUSION
CEFOTAXIME SODIUM 1/4.4 g/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2019-07-16
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFOTAXIME SODIUM FOR INJECTION 500MG, 1G READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. In this leaflet: 1. What Cefotaxime Injection is and what it is used for. 2. Before you are given Cefotaxime Injection. 3. How Cefotaxime Injection is given. 4. Possible side effects. 5. How to store Cefotaxime Injection 6. Further information. The name of your medicine is “Cefotaxime sodium for injection” (referred to AS CEFOTAXIME INJECTION throughout this leaflet). 1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR Cefotaxime is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin. Cefotaxime kills bacteria and it can be used to treat infections of the: • Kidneys and bladder • Blood (septicaemia) • Skin and flesh immediately under the skin • Bones • Heart valves • Brain (meningitis) • Abdomen (peritonitis) • Some sexually transmitted infections (gonorrhoea) It can also be used to prevent and treat infections following surgical operations. 2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION YOU SHOULD NOT BE GIVEN CEFOTAXIME INJECTION IF: • you are allergic (hypersensitive) to cefotaxime • you are allergic to any similar antibiotics (known as “cephalosporins”) • you have ever had a serious allergic reaction when given penicillin or similar antibiotics • you are allergic to lidocaine Tell your doctor or nurse if any of the above apply to you. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION You must tell the doctor or nurse if any of the foll Przeczytaj cały dokument
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefotaxime Sodium for Injection 500mg, 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefotaxime (as cefotaxime sodium) per vial Diluent to be added Final concentration of solution 500 mg 2 ml 500 mg/2.2 ml 1 g 4 ml 1 g/4.4 ml A quantity of cefotaxime sodium equivalent to 1 g cefotaxime contains approximately 50 mg (2.2 mmol) of sodium For excipients see 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. Vials containing a white to slightly yellow powder, which when dissolved in Water for Injections forms a straw coloured solution. The intensity of the colour of the solution may vary but this does not indicate differences in potency or safety. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. Cefotaxime sodium is indicated for the treatment of the following severe infections when known or thought very likely to be due to organisms that are susceptible to cefotaxime. ▪ Infections of the lower respiratory tract ▪ Infections of the kidneys and urinary tract Page 2 of 18 ▪ 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) ▪ Lyme-borreliosis (especially stages II and III) ▪ Acute Meningitis in case of gram-negative microorganisms in combination with another suitable antibiotic ▪ Sepsis in case of gram-negative microorganism in combination with another suitable antibiotic ▪ Endocarditis in case of gram-negative microorganism in combination with another suitable antibiotic Peri-operative prophylaxis in surgical procedures such as colorectal, gastrointestinal, prostatic, urogenital and gynaecological surgery in patients who have a definite risk of post-operative infections. Cefotaxime should be used in combination with another antibiotic that can provide anaerobi Przeczytaj cały dokument