Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
CEFTAZIDIME
Clonmel Healthcare Ltd
CEFTAZIDIME
1 Grams
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-08-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftazidime 1 g powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1165 mg ceftazidime pentahydrate corresponding to 1 g ceftazidime Excipient with known effect: 51.2 mg (2.23 mmol) of sodium/vial of powder for solution for injection or infusion For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. The powder is white or off-white. 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 woul Pročitajte cijeli dokument