البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
CEFUROXIME SODIUM
Dr. Friedrich Eberth Arzneimittel GmbH Am Bahnhof 2, Ursensollen 92289, Germany
J01DC02
CEFUROXIME SODIUM 1500 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
CEFUROXIME SODIUM 1500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2016-06-10
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER Cefuroxime Dr. Eberth 1500 mg powder for solution for injection/infusion Cefuroxime 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Cefuroxime Dr. Eberth is and what it is used for 2. What you need to know before you are given Cefuroxime Dr. Eberth 3. How Cefuroxime Dr. Eberth is given 4. Possible side effects 5. How to store Cefuroxime Dr. Eberth 6. Contents of the pack and other information 1. WHAT CEFUROXIME DR. EBERTH IS AND WHAT IT IS USED FOR Cefuroxime Dr. Eberth is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins _._ CEFUROXIME DR. EBERTH IS USED TO TREAT INFECTIONS of: the lungs or chest the urinary tract the skin and soft tissue the abdomen. Cefuroxime Dr. Eberth is also used: to prevent infections during surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME DR. EBERTH YOU MUST NOT BE GIVEN CEFUROXIME DR. EBERTH: IF YOU ARE ALLERGIC (hypersensitive) to CEFUROXIME SODIUM or ANY CEPHALOSPORIN ANTIBIOTICS . if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). TELL YOUR DOCTOR BEFORE you start on Cefuroxime Dr. Eberth if you think that this applies to you. You must not be given Cefuroxime Dr. Eberth. WARNINGS AND PRECAUTIONS Page 2 of 7 Talk to your doctor or nurse before Cefuroxime Dr. Eberth is given to you. You must look out for certain symptoms such as allergic reactions and gastrointestinal disorders such as diarrhoea while you are being given Cef اقرأ الوثيقة كاملة
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Cefuroxime Dr. Eberth 750 mg Powder for solution for injection/infusion Cefuroxime Dr. Eberth 1500 mg Powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefuroxime sodium equivalent to750 mg cefuroxime and 1500 mg cefuroxime resp. The total quantity of sodium per vial is as follows: strength Amount of sodium per vial 750 mg 1.8 mmol corresponding to 40.7 mg sodium 1500 mg 3.6 mmol corresponding to 81.4 mg sodium 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion White to light yellow powder . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Dr. Eberth is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1). • Community acquired pneumonia. • Acute exacerbations of chronic bronchitis. • Complicated urinary tract infections, including pyelonephritis. • Soft-tissue infections: cellulitis, erysipelas and wound infections. • Intra-abdominal infections (see section 4.4). • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section). In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Table 1: Adults and children _ ≥ _40 kg_ INDICATION DOSAGE Community acquired pneumonia and acute exacerbations of chronic bronchitis 750 mg every 8 hours (intravenously or intramuscularly) Soft-tissue infections: cellulitis, erysipelas and wound infections Intra-abdominal infections Complicated urinary tract infections, including pyelonephritis 1.5 g every 8 hours (in اقرأ الوثيقة كاملة