Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Ceftazidime
Hikma Farmacêutica (Portugal) S.A.
J01DD; J01DD02
Ceftazidime
500 milligram(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; ceftazidime
Not marketed
2014-09-12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION CEFTAZIDIME 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFTAZIDIME 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION Ceftazidime 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. PA1217/012/001 PA1217/012/002 PA1217/012/003 WHAT IS IN THIS LEAFLET 1. What Ceftazidime is and what it is used for 2. What you need to know before you use Ceftazidime 3. How to use Ceftazidime 4. Possible side effects 5. How to store Ceftazidime 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 new-born 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 USE CEFTAZIDIME DO NOT USE CEFTAZIDIME: - if you are allergic (hypersensitive) to ceftazidime or any of the other ingredients of this medicine (listed in section 6). - if you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidime. WARNINGS AND PRECAUTIONS Talk to y Læs hele dokumentet
Health Products Regulatory Authority 01 March 2022 CRN00CQN8 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftazidime 500 mg powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftazidime 500 mg (as pentahydrate). Excipient(s) with known effect: Ceftazidime 500 mg powder for solution for injection contains 26 mg (1.13 mmol) of sodium per vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 500 mg: Powder for solution for injection White or pale-yellow 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Health Læs hele dokumentet