Dosage: The recommended dosage is 1 vial where each vial contains 2000 mg ceftazidime and 500 mg avibactam. Treatment is repeated every 8 hours. For patients with renal impairment, see dosage adjustments, renal impairment as follows. (See Table 11.)
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For cUTI including pyelonephritis, the total duration of treatment could be increased to 14 days for patients with bacteraemia.
The duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Dosage adjustments: Renal impairment: No dosage adjustment is required in patients with mild renal impairment (estimated creatinine clearance (CrCL) ≥51 ≤80 mL/min).
Dosage adjustment of Zavicefta is recommended in patients with moderate and severe renal impairment and end-stage renal disease. Table 12 shows the recommended dose adjustments for patients with estimated CrCL ≤50 mL/min. For patients with changing renal function, CrCL should be monitored at least daily and the dosage of Zavicefta adjusted accordingly. (see Use in renal impairment under Precautions, Pharmacology: Pharmacodynamics: Clinical trials and Pharmacokinetics: Renal impairment under Actions). (See Table 12.)
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Hepatic impairment: No dosage adjustment is required in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Close clinical monitoring for safety and efficacy is advised.
Haemodialysis: Both ceftazidime and avibactam are haemodialyzable; thus, Zavicefta should be administered after haemodialysis on haemodialysis day.
Haemofiltration: There is insufficient data to make specific dosage adjustment recommendations for patients undergoing continuous veno-venous haemofiltration.
Peritoneal dialysis: There is insufficient data to make specific dosage adjustment recommendations for patients undergoing peritoneal dialysis.
Elderly: No dosage adjustment is required in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric patients: Safety and efficacy in children and adolescents below 18 years of age have not been established. No data are available.
Method of administration: Zavicefta is administered by intravenous infusion over 120 minutes in an infusion volume of 100 mL.
The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use. The reconstituted solution is pale yellow solution and free of particles.
Standard aseptic techniques should be used for solution preparation and administration. 1. Introduce the syringe needle through the vial closure and inject 10 mL of sterile water for injections.
2. Withdraw the needle and shake the vial to give a clear solution.
3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the vial closure to relieve the internal pressure.
4. Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately. Reduced doses may be achieved by transfer of an appropriate volume of the resultant solution to an infusion bag, based upon ceftazidime and avibactam content of 167.3 mg/mL and 41.8 mg/mL, respectively. A dose of 1000 mg/250 mg or 750 mg/187.5 mg is achieved with 6.0 mL or 4.5 mL aliquots, respectively.
Note: To preserve product sterility, it is important that the gas relief needle is not inserted through the vial closure before the product is dissolved.
Vials of ceftazidime/avibactam powder should be reconstituted with 10 mL of sterile water for injections, followed by shaking until the content dissolves.
An infusion bag may contain any of the following: sodium chloride 9 mg/mL (0.9%); dextrose 50 mg/mL (5%); sodium chloride 4.5 mg/mL and dextrose 25 mg/mL (0.45% sodium chloride and 2.5% dextrose); Lactated Ringer's solution.
A 100 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements. The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Product is for single use in one patient only. Discard any residue.