Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Ceftazidime
Wockhardt UK Limited
J01DD; J01DD02
Ceftazidime
1 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; ceftazidime
Marketed
2004-12-17
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTAZIDIME 1 G POWDER FOR SOLUTION FOR INJECTION CEFTAZIDIME 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION 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. - This medicine has been prescribed to 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of the medicine is ceftazidime 1g powder for solution for injection and ceftazidime 2g powder for solution for injection or infusion. In the rest of this leaflet it is called ceftazidime for injection. WHAT IS IN THIS LEAFLET 1. What ceftazidime for injection is and what it is used for 2. What you need to know before you take ceftazidime for injection 3. How to take ceftazidime for injection 4. Possible side effects 5. How to store ceftazidime for injection 6. Contents of the pack and other information 1. WHAT CEFTAZIDIME IS AND WHAT IT IS USED FOR Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins. CEFTAZIDIME IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF: • the lungs or chest • the lungs and bronchi in patients suffering from cystic fibrosis • the brain (_meningitis_) • the ear • the urinary tract • the skin and soft tissues • the abdomen and abdominal wall (_peritonitis_) • the bones and joints. Ceftazidime can also be used: • to prevent infections during prostate surgery in men • to treat patients with low white blood cell counts (_neutropenia_) who have a fever due to a bacterial infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFTAZIDIME FOR INJECTION DO N Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftazidime 1g Powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftazidime 1g (as pentahydrate). Excipient with known effect Each gram of ceftazidime contains approximately 52mg (2.26mmol) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection (Powder for injection). White to cream coloured, crystalline powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftazidime is indicated for the treatment of the infections listed below in adults and children including neonates (from birth). Nosocomial pneumonia Broncho-pulmonary infections in cystic fibrosis Bacterial meningitis Chronic suppurative otitis media Malignant otitis externa Complicated urinary tract infections Complicated skin and soft tissue infections Complicated intra-abdominal infections Bone and joint infections Peritonitis associated with dialysis in patients on CAPD. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing trans- urethral resection of the prostate (TURP). The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1). Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum of activity. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lue koko asiakirja