Country: Malta
Language: English
Source: Medicines Authority
DALI Pharma GmbH Brehmstrasse 56, 40239, Dusseldorf,, Germany
J01DC02
CEFUROXIME SODIUM 1500 mCi
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
CEFUROXIME SODIUM 1500 mCi
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-30
1 PACKAGE LEAFLET Page 2 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFUROXIME DALI PHARMA, 750 MG, POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFUROXIME DALI PHARMA, 1500 MG, POWDER FOR SOLUTION FOR INJECTION OR INFUSION _Cefuroximum _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. − 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, or nurse This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cefuroxime Dali Pharma is and what it is used for 2. What you need to know before you use Cefuroxime Dali Pharma 3. How to use Cefuroxime Dali Pharma 4. Possible side effects 5. How to store Cefuroxime Dali Pharma 6. Contents of the pack and other information 1. WHAT [INVENTED NAME IS AND WHAT IT IS USED FOR Cefuroxime Dali Pharma is an antibiotic used in adults, adolescents and children. It works by killing bacteria that cause infections and which are sensitive to the active substance cefuroxime (as cefuroxime sodium). It belongs to a group of medicines called cephalosporins _._ CEFUROXIME DALI PHARMA IS USED TO TREAT INFECTIONS OF: • the lungs or chest • the urinary tract • the skin and soft tissue • the abdomen Cefuroxime Dali Pharma is also used: • To prevent infections during surgery. Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to cefuroxime during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CEFUROXIME DALI PHARMA INVENTED NAME MUST NOT BE GIVEN: • IF YOU ARE ALLERGIC TO CEFUROXIME SODIUM OR ANY CEPHALOSPORIN ANTIBIOTICS or any of the other ingredients of Cefuroxime Dali Pharma (listed in section 6). • if you hav Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 13 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefuroxime (Cefuroximum) as cefuroxime sodium. 1 vial contains 750 mg (as cefuroxime sodium). 1 vial contains 1500 mg (as cefuroxime sodium). Cefuroxime Dali Pharma strength Amount of sodium per vial 750 mg 40.6 mg 1500 mg 81.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White or almost white powder. After the addition of an appropriate amount of water or other suitable solvent, an off white suspension is formed for intramuscular use or a yellowish solution for intravenous administration.. The prepared solution has pH of 4.0 - 9.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Dali Pharma is indicated for the treatment of the infections listed below in adults, adolescents 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 guidelines on the appropriate use of antibiotics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Table 1. Adults, adolescents and children ≥ 40 kg _ _ _ Page 3 of 13 INDICATION DOSAGE Community acquired pneumonia and acute exac Read the complete document