Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
CEFTAZIDIME AS PENTAHYDRATE
NEOPHARM (ISRAEL) 1996 LTD
J01DD02
POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME AS PENTAHYDRATE 1000 MG/VIAL
I.V, I.M
Required
LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL
CEFTAZIDIME
Ceftazidime is indicated for the treatment of the infections listed below in adults and children includingneonates (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 regarding the appropriate use of antibacterial agents
2021-05-31
1 SUMMARY OF PRODUCTS CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ceftazidime Fresenius 1 g Ceftazidime Fresenius 2 g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ceftazidime Fresenius 1000 mg powder for solution for injection Each vial contains 1000 mg of ceftazidime (as Ceftazidime pentahydrate) Ceftazidime Fresenius 2000 mg powder for solution for injection or infusion Each bottle contains 2000 mg of ceftazidime (as Ceftazidime pentahydrate) Excipients with known effect: This medicinal product contains 2.3 mmol (52 mg) sodium for 1000 mg Ceftazidime. This medicinal product contains 4.6 mmol (104 mg) sodium for 2000 mg Ceftazidime. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ceftazidime Fresenius 1000 mg: Powder for solution for IV or IM injection. Ceftazidime Fresenius 2000 mg: Powder for solution for IV or IM injection or infusion. 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. 2 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 Đọc toàn bộ tài liệu