FORMULATION: 4g/500 mg Powder for Injection Antibacterial For nosocomial pneumonia and bacterial infections in neutropenic patient: recommended dose is a 4 g piperacillin / 500 mg tazobactam administered every 6 hours. This regimen may also be applicable to treat patie ts with other other indicated infection when particularly severe. The following table summaries the treatment frequency and the recommended dos for adult and adolescent patients by indication or condition: Each vial contains Piperacillin (as sodium salt) equivalent to 4g and Tazobactam (as sodium salt) equivalent to 4g/500 mg INDICATIONS: Piperacillin/Tazobactam 500 mg powder for solution or infusion is indicated for treatment of the following infections in adults and children over 2 years of age Adults and adolescents

• Severe pnemonia 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 its suspected to be associated with any of the infections li ted above. Piperacillin/ Tazobactam maybe used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. Children aged 2-12 years

• Complicated inta-abdominal infections

Piperacillin/Tazobactam maybe used in the management of neuthropenic children with fever suspected to be due to a bacterial infection. Consideration should be given to official guidance on the appropriate use of an anti- bacterial agents. DOSAGE: The dose and frequency of Piperacillin/Tazobactam depends on the severity and localisation of the infection and expected pathogens. Adult and Adolescent patients Infections The usual dose is 4 g piperacillin / 500 mg tazobactam given every 8 hours Renal impairment The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly). Creatinine cleaance

• (ml/min) Recommended dose
• > 40 No dose adjustment necessary
• 20-40 Maximum dose suggested 4 g / 0.5 g every 8 hours
• < 20 Maximum dose suggested 4 g / 0.5 g every 12 hours
• For patients on haemodialysis, one additional dose of pipacillin / tazobactam 2g/250mg should be administered following each dialysis period because haemodialysis removes 30%-50% of piperacillin in 4 hours.

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