Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PIPERACILLIN SODIUM STERILE, TAZOBACTAM SODIUM STERILE
Fresenius Kabi Limited
J01CR05
PIPERACILLIN SODIUM STERILE, TAZOBACTAM SODIUM STERILE
4/0.5 Grams
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors
Authorised
2008-11-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt). One vial of powder for solution for infusion contains 9.7 mmol (224 mg) of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piperacillin/Tazobactam is indicated for the treatment of the following infections in adults and children over 2 years of age (see sections 4.2 and 5.1): ADULTS AND ADOLESCENTS - Severe pneumonia including hospital-acquired and ventilator-associated pneumonia - Complicated urinary tract infections (including pyelonephritis) - Complicated intra-abdominal infections - Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Piperacillin/tazobactam may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. CHILDREN 2 TO 12 YEARS OF AGE - Complicated intra-abdominal infections Piperacillin/tazobactam may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dose and frequency of Piperacillin/Tazobactam depends on the severity and localisation of the infection and expected pathogens. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document