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- How is ZAVICEFTA dosed in adults? Are there any adjustments for patients with renal or hepatic impairment?
- Does the dose of ZAVICEFTA need to be adjusted across different adult patient groups?
- Should the dose of ZAVICEFTA be increased in difficult-to-treat infections such as HAP/VAP in adults?
- What is the recommended dose of ZAVICEFTA in the treatment of secondary bacteraemia associated with cIAI, cUTI and HAP/VAP in adults?
- Can ZAVICEFTA be given by prolonged infusion in adults?
- Is ZAVICEFTA stable for extended infusion or home IV therapy in adults?
- Can ZAVICEFTA be used in adult patients undergoing haemodialysis?
- Can ZAVICEFTA be used during pregnancy?
- Can ZAVICEFTA be used during breast-feeding?
- What is the preparation and administration guidance for ZAVICEFTA?
- What is reason for the changes in the storage conditions of ZAVICEFTA?
- What are the changes in the in-use storage condition for ZAVICEFTA?
- Are there any changes to the in-use storage condition for ZAVICEFTA in infusion syringes?
- What are the new in-use storage conditions for ZAVICEFTA?
- How much ceftazidime and avibactam does 1 mL of reconstituted solution contain?
- What are the general storage requirements of ZAVICEFTA?
- For adult patients, the recommended dosage is 2000 mg of ceftazidime and 500 mg of avibactam infused over 2 hours q8h, for 5 to 14 days in the treatment of cIAI (in combination with metronidazole); for 5 to 10 days in the treatment of cUTI, including pyelonephritis; and for 7 to 14 days in the treatment of HAP, including VAP
- Dosage adjustments are required for patients with moderate or more severe renal impairment (see table). Neurological sequelae, such as tremor, myoclonus, non-convulsive status epilepticus, convulsion, encephalopathy and coma, have been reported occasionally with the use of ceftazidime, particularly in patients with renal impairment when the dose has not been reduced
- Close monitoring of estimated CrCl is advised in some patients with impaired renal function, particularly early in the course of the infection when CrCl estimated from serum creatinine can change quickly, and the ZAVICEFTA dose should be adjusted accordingly
- In patients receiving haemodialysis, ZAVICEFTA should be given after haemodialysis, as both ceftazidime and avibactam are readily cleared by haemodialysis
- Dosage adjustment is not currently considered necessary for patients with hepatic impairment
cIAI, complicated intra-abdominal infection; CrCl, creatinine clearance; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; q8h, every 8 hours; VAP, ventilator-associated pneumonia.
ZAVICEFTA SPC
- Subgroup simulation for individual Phase III patients showed that the dosage regimen was robust, with high target attainment (>95%) against MICs ≤8 mg/L achieved regardless of older age, obesity, augmented renal clearance or severity of infection1
- No dosage adjustment is required in elderly patients2
- No dosage adjustment is required in patients with mild renal impairment (estimated CrCl ≥51–≤80 mL/min)2
- Dosage adjustments are required in patients with moderate or more severe renal impairment2
- No dosage adjustment is required in patients with hepatic impairment2
- No. The recommended dose of ZAVICEFTA is the same across all indications1
- The clinical efficacy of ZAVICEFTA in the Phase III clinical trials demonstrated the efficacy of the 2000 mg/500 mg dose2–4
- Unlike for some other β-lactam/β-lactamase inhibitor combinations, the same dose of ZAVICEFTA was used in the REPROVE trial, which demonstrated efficacy in HAP/VAP,2 as in the Phase III clinical trials in cIAI and cUTI and in bacteraemia associated with cIAI, cUTI and HAP/VAP3,4
- Extensive PK/PD modelling was carried out to determine the optimum dose of ceftazidime and avibactam5,6
- Both ceftazidime and avibactam penetrate human bronchial ELF to the same extent, with drug concentrations approximately 30% of those measured in plasma; the concentration–time profiles are similar for ELF and plasma1
Merdjan H, et al. Clin Drug Investig 2015;35:307–17.
- Dose recommendations are unchanged from the current dosing information for cIAI, cUTI and HAP/VAP1
- The recommended dosage of ZAVICEFTA is 2 g/0.5 g (ceftazidime/avibactam) administered q8h, infused over 2 hours, and is consistent across all indications,2 as per the clinical development programme for ZAVICEFTA, which included patients with secondary bacteraemia1,2
- No dosage adjustments are required in the elderly, patients with mild renal impairment (estimated CrCl ≥51–≤80 mL/min) or those with hepatic impairment2
- ZAVICEFTA is administered by intravenous infusion over 2 hours in an appropriate infusion volume
- The recommended dosage of ZAVICEFTA in patients with end-stage renal disease, including those on haemodialysis, is ceftazidime 750 mg and avibactam 187.5 mg administered q48h by IV infusion
- Ceftazidime and avibactam are removed by haemodialysis. Dosing of ZAVICEFTA on haemodialysis days should occur after completion of haemodialysis
- There are no clinical data in pregnant women; therefore, ZAVICEFTA should only be used during pregnancy if the potential benefit outweighs the possible risk
- Ceftazidime is excreted in human milk in small quantities, but it is unknown whether avibactam is excreted in human milk. Therefore, a risk to newborns/infants cannot be excluded
- A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZAVICEFTA therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman
- ZAVICEFTA is supplied as a dry powder, which must be reconstituted and subsequently diluted using aseptic techniques, before IV infusion. The reconstituted vial should be used immediately
- The powder in the vial should be reconstituted with 10 mL of sterile water for injection, followed by shaking until the content dissolves, and must not be mixed with other medicinal products, except when further diluting in a 100 mL infusion bag, which may contain any of the following:
- Sodium chloride 9 mg/mL (0.9%) solution for injection
- Dextrose 50 mg/mL (5%) solution for injection
- Sodium chloride 4.5 mg/mL (0.45%) and dextrose 25 mg/mL (2.5%) solution for injection
- Lactated Ringer’s solution for injection
- ZAVICEFTA diluted to a ceftazidime concentration of 8 mg/mL demonstrated greater in-use stability than when diluted to a ceftazidime concentration of 40 mg/mL and this is reflected in different maximum in-use storage conditions.
- The in-use storage conditions for ZAVICEFTA in infusion bags are summarised below:
- The in-use storage conditions for ZAVICEFTA in infusion syringes are summarised below:
- After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam
- ZAVICEFTA does not require any special storage conditions but should be kept in the original package to protect it from light
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PP-BCP-NOR-0001 juni 2023
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