Country: Malta
Language: English
Source: Medicines Authority
CEFTAZIDIME
Glaxo Operations UK Limited
J01DD02
CEFTAZIDIME
POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 1 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-02-01
1 Only marketed product strengths and pack sizes will be shown. 1 Information for the Healthcare Professional FORTUM® FOR INJECTION 3 G, 2 G, 1 G AND 500 MG CEFTAZIDIME DOSAGE AND ADMINISTRATION INFORMATION ONLY Please refer to the Summary of Product Characteristics for further information • POSOLOGY AND METHOD OF ADMINISTRATION _General dosage recommendations: _ Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity and type of infection and the age, weight and renal function of the patient. _Adults and children > 40 kg _ The adult dosage range for ceftazidime is 1 to 9 g per day 8 or 12-hourly (im or iv). In the majority of infections, 1 g 8-hourly or 2 g 12-hourly should be given. In urinary tract infections and in many less serious infections, 500 mg or 1 g 12-hourly is usually adequate. In very severe infections, especially immunocompromised patients, including those with neutropenia, 2 g 8 or 12-hourly or 3 g 12-hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 g (from the 1 g vial) should be given at the induction of anaesthesia. A second dose should be considered at the time of catheter removal. _Elderly _ In view of the reduced clearance of ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 g in those over 80 years of age. _Cystic fibrosis _ In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used. In adults with normal renal function 9 g/day has been used. _Infants > 2 months and children < 40 kg _ The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given Read the complete document
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fortum for Injection Ceftazidime (as pentahydrate) (INN) Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fortum for Injection: Vials contain 1g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime). 3. PHARMACEUTICAL FORM Powder for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fortum 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 f Read the complete document