Dosage and route of administration. The use of Fetcroja is recommended for the treatment of patients with limited treatment options only after consultation with a physician with appropriate experience in the treatment of infectious diseases. Dosage Recommended dose of Fetcroja1 for patients with a creatinine clearance (CrCl) ≥90 ml/min2: Normal renal function (CrCl ≥90 to <120 ml/min), dose 2 g, every 8 hours, duration in accordance with the site of infection3 Augmented renal clearance (CrCl ≥120 ml/min), dose 2 g, every 6 hours, duration in accordance with the site of infection3 1To be used in combination with antibacterial agents active against anaerobic pathogens and/or Gram-positive pathogens when these are known or suspected to be contributing to the infectious process. 2Calculated using the Cockcroft-Gault formula. 3e.g., for complicated urinary tract infections, including pyelonephritis, and for complicated intra-abdominal infections, the recommended treatment duration is 5 to 10 days. For hospital-acquired pneumonia, including ventilator-associated pneumonia, the recommended treatment duration is 7 to 14 days. Treatment up to 21 days may be necessary. Special populations Renal impairment Recommended dose of Fetcroja for patients with a CrCl <90 ml/min1: Mild renal impairment (CrCl ≥60 to <90 ml/min) dose 2 g, every 8 hours Moderate renal impairment (CrCl ≥30 to <60 ml/min) dose 1.5 g, every 8 hours Severe renal impairment (CrCl ≥15 to <30 ml/min) dose 1 g, every 8 hours End-stage renal disease (CrCl <15 ml/min) dose 0.75 g, every 12 hours Patients on intermittent haemodialysis2 dose 0.75 g, every 12 hours 1Calculated using the Cockcroft-Gault formula. 2As cefiderocol is removed by haemodialysis, administer cefiderocol as soon as possible after completion of the haemodialysis session on haemodialysis days. Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2). Elderly population No dose adjustment is necessary (see section 5.2). Paediatric population The safety and efficacy of Fetcroja in children under 18 years of age has not yet been established. No data are available. Method of administration Intravenous route. Fetcroja is administered by intravenous infusion over 3 hours. To consult instructions on reconstitution and dilution of the medicine before administration, see section 6.6. If combined treatment with another medicinal product and Fetcroja is unavoidable, administration must not occur in the same syringe or in the same infusion solution. It is recommended to adequately flush the intravenous lines between the administration of different medicinal products. DISPENSING AND REIMBURSEMENT CONDITIONS MEDICINAL PRODUCT SUBJECT TO MEDICAL PRESCRIPTION. Hospital diagnosis. Medicinal product included in the pharmaceutical presentation of the Sistema Nacional de Salud. PRESENTATION, NATIONAL CODE AND PRICE. Fetcroja 1 G powder for concentrate for solution for infusion 10 vials. N.C. 728609. PVL 1,500 € PVP VAT: 1,618.15 €. Check Price financed by Sistema Nacional de Salud.
▼This medicinal product is subject to additional monitoring. Reporting of any suspected adverse reactions associated with this medicinal product is a priority.
