País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CEFTAZIDIME PENTAHYDRATE
Martindale Pharmaceuticals Ltd
CEFTAZIDIME PENTAHYDRATE
2 Grams
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftazidime 2 g Powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2330 mg of ceftazidime pentahydrate, equivalent to 2 g of ceftazidime Excipient: each 2 g vial of powder contains 242 mg of sodium carbonate This medicinal product contains 4.57 mmol (or 105 mg) of sodium per vial For a 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 treatment of the following bacterial infections when they are caused by ceftazidime- sensitive bacteria, and only if beta-lactam-antibiotics with a narrower spectrum cannot be used: - Nosocomial pneumonia - Bronchopulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa - Meningitis caused by aerobic gram-negative microorganisms Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the degree of severity of the infection, sensitivity and type of infection, and on the age, weight and renal function of the patient. _WITH NORMAL RENAL FUNCTION_ AGE GROUP INFECTION NORMAL DOSE Adults Most indications 1 g every 8 hours (3 g/day) or 2 g every 12 hours (4 g/day) Nosocomial pneumonia and infections in patients with neutropaenia 2 g every 8 hours (6 g/day) Bronchopulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa 100-150 mg/kg/day, divided into 3 doses; 9 g/day must not be exceeded Infants and children aged over two months Most indications 30-100 mg/kg/day, divided into 2 or 3 doses IRISH MEDICINES BOARD _______________________ Llegiu el document complet