Use ceftazidime-avibaktam for the treatment of patients with Gram-negative aerobic infections with a limited choice of antibiotic therapy should only after consultation with a physician with relevant experience in the treatment of infectious diseases (see section "Special instructions").
The contents of one vial of Zawietseft (2000 mg of ceftazidime + 500 mg of avibactam) are administered intravenously in the form of a 100 ml infusion at a constant rate for 120 minutes every 8 hours if the estimated CC is ≥ 51 ml / min. (cm."Preparation of a solution for infusions" further in the text of the section, as well as sections "Pharmacodynamics" and "Special instructions").
The following duration of therapy is recommended:
- complicated intra-abdominal infections1,2 - 5-14 days;
- complicated urinary tract infections, including pyelonephritis2 - 5-10 days3;
- Hospital pneumonia, including pneumonia associated with mechanical ventilation2 - 7-14 days;
- infections caused by aerobic Gram-negative microorganisms in patients with limited choice of antibiotic therapy1,2 - duration of therapy depends on the severity of the infection, causative agent, clinical and bacteriological response to treatment4.
1 With the confirmed or expected involvement of anaerobic pathogens in the infectious process, the drug should be used in combination with metronidazole.
2 With the confirmed or suspected involvement of gram-positive pathogens, the drug should be used in combination with an antibacterial drug effective against these microorganisms.
3 This duration of therapy may include intravenous therapy with Zawietseft's preparation followed by a transition to the appropriateantibacterial preparation inside.
4 The experience of using Zawietzfta for more than 14 days is very limited.
Special patient groups
Patients of advanced age (≥65 years)
Correction of dose in elderly patients is not required. Correction of the dose is required in case of renal dysfunction (see section "Pharmacokinetics").
Patients with impaired renal function
Patients with mild renal dysfunction (assessed by CK> 51 ml / min - ≤ 80 ml / min.) Do not need dose adjustment (see section "Pharmacokinetics").
Table 2 provides recommendations for correcting the dose of the drug in patients with an estimated CK ≤ 50 ml / min. (see the sections "Pharmacokinetics" and "Special instructions").
Table 2. Recommended dosage regimen of the Zawietzeft drug in patients with assessed CK ≤ 50 ml / min.1
| Estimated CK (ml / min)2 | Dosing regimen2 | Frequency of administration | Duration of infusion |
| 31-50 | 1000 mg + 250 mg | every 8 hours | 2 hours |
| 16-30 | 750 mg + 187.5 mg | every 12 hours | 2 hours |
| 6-15 | 750 mg + 187.5 mg | every 24 hours | 2 hours |
| Terminal stage of renal failure, including patients on hemodialysis3 | 750 mg + 187.5 mg | every 48 hours | 2 hours |
1 The QC was calculated by the Cockcroft-Gault formula.
2 Dosing recommendations are based on the modeling of pharmacokinetics.
3 Ceftazidime and aviabactam are excreted in hemodialysis (see sections "Pharmacokinetics" and "Overdose"). On the days of hemodialysis, Zawietseft should be administered after the end of the session.
Hemofiltration
There is insufficient data to give specific recommendations for dose adjustment in patients receiving continuous venovenous hemofiltration.
Peritoneal dialysis
There is insufficient data to give specific recommendations for dose adjustment in patients receiving peritoneal dialysis.
Patients with impaired hepatic function
Correction of the dose in patients with impaired liver function is not required (see the section "Pharmacokinetics"). A thorough clinical observation is recommended to assess safety and efficacy.
Children
Safety and efficacy in children and adolescents under the age of 18 years have not been established.
Preparation of a solution for infusions
Powder for the preparation of concentrate for solution for infusion should be dissolved with sterile water for injection. When preparing and injecting the solution, standard aseptic techniques should be used.
1 Insert the 10 ml of sterile water for injection into the vial through the syringe needle inserted into the vial.
2 Then remove the needle and shake the bottle until a clear solution is obtained.The resulting concentrate is a pale yellow solution that is free of visible particles.
3 Then insert the syringe needle (to reduce internal pressure) into the vial plug. Do not insert the needle to lower the internal pressure before dissolving the powder to maintain the sterility of the preparation.
The resulting concentrate should be immediately used for the preparation of a solution for infusions. The concentration of ceftazidime and avibactam in the resulting concentrate is 167.3 mg / ml and 41.8 mg / ml, respectively. Immediately transfer the resulting concentrate to an infusion bottle containing one of the following compatible infusion liquids:
- 0.9% solution of sodium chloride,
- 5% dextrose solution,
- 0.45% sodium chloride solution and 2.5% dextrose solution.
- Ringer's lactate solution.
To apply a dose of ceftazidime-avibactam at a dose of 2000 mg + 500 mg, the whole concentrate obtained (approximately 12 ml) is transferred to a vial of compatible infusion fluid. To obtain a reduced dose of ceftazidime-avibaktam 1000 mg + 250 mg, 6 ml of concentrate should be transferred to the infusion bottle, and 4.5 ml of concentrate for the dose of 750 mg + 187.5 mg.
The infusion solution can be prepared by adding the concentrate to a vial of infusion fluid of 100 ml,taking into account the peculiarities and limitations of fluid administration in patients.
The time from the beginning of the dissolution of the powder to the completion of the preparation of the infusion solution should not exceed 30 minutes.
Each bottle is for single use.
Unused product or waste must be disposed of in accordance with local regulations.