ZAVICEFTA® (CEFTAZIDIME AND AVIBACTAM)| Paediatric Dosing

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Prescribing Information

Paediatric Dosing

ZAVICEFTA (ceftazidime/avibactam) provides dosing options to treat paediatric patients from birth to <18 years¹

Zavicefta is administered by intravenous infusion over 120 minutes in an appropriate infusion volume (see section 6.6 of SmPC).

Dosage in paediatric patients with creatinine clearance (CrCL) > 50 mL/min/1.73 m²

(Please refer to Zavicefta Summary of Product Characteristics for full dosing information)

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Recommended dose for paediatric patients aged 2 years to < 18 years with estimated CrCL^* ≤ 50 mL/min/1.73 m²

^* CrCL estimated using the Schwartz bedside formula.

^#To be used in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process.

^† To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.

^‡ The total treatment duration shown may include intravenous Zavicefta followed by appropriate oral therapy.

^§ There is very limited experience with the use of Zavicefta for more than 14 days.

^¶There is limited experience with the use of Zavicefta in paediatric patients 3 months to < 6 months (see section 5.2 of SmpC).

^|| Ceftazidime/avibactam is a combination product in a fixed 4:1 ratio and dosage recommendations are based on the ceftazidime component only (see section 6.6 of SmPC).

^**Paediatric patients studied from 3 to 12 months of age were full term (≥37 weeks gestation).

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Recommended dose for paediatric patients less than 3 months of age^**

^#To be used in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process.

* To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.

^¤ The total treatment duration shown may include intravenous Zavicefta followed by appropriate oral therapy.

^† There is very limited experience with the use of Zavicefta for more than 14 days.

^|| Ceftazidime/avibactam is a combination product in a fixed 4:1 ratio and dosage recommendations are based on the ceftazidime component only (see section 6.6 of SmPC).

^‡Preterm defined as < 37 weeks gestation.

^§Postmenstrual age.

^¶ Dose recommendations for patients 26 to < 31 weeks PMA are based on pharmacokinetic modelling only (see section 5.2).

** Patients with serum creatinine at or below the upper limit of normal for age.

Dosage in paediatric patients with CrCl ≤ 50 mL/min/1.73 m²

Scroll left to view table

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Recommended dose for paediatric patients aged 2 years to < 18 years with estimated CrCL^* ≤ 50 mL/min/1.73 m²

^* CrCL estimated using the Schwartz bedside formula.

^# Dose recommendations are based on pharmacokinetic modelling (see section 5.2 of SmPC).

^† Ceftazidime and avibactam are removed by haemodialysis (see sections 4.9 and 5.2 of SmPC). Dosing of Zavicefta on haemodialysis days should occur after completion of haemodialysis.

^|| Ceftazidime/avibactam is a combination product in a fixed 4:1 ratio and dosage recommendations are based on the ceftazidime component only (see section 6.6 of SmPC).

Recommended dose for paediatric patients aged 3 months to < 2 years with estimated

CrCL^* ≤ 50 mL/min/1.73 m²

* Calculated using the Schwartz bedside formula.

^# Dose recommendations are based on pharmacokinetic modelling (see section 5.2 of SmPC).

^||Ceftazidime/avibactam is a combination product in a fixed 4:1 ratio and dosage recommendations are based on the ceftazidime component only (see section 6.6 of SmPC).

^†Paediatric patients studied from 3 to 12 months of age were full term (≥ 37 weeks gestation).

There is insufficient information to recommend a dosage regimen for paediatric patients aged 3 months to < 2 years of age that have a CrCL < 16 mL/min/1.73 m².

There is insufficient information to recommend a dosage regimen for paediatric patients from birth to 3 months of age with signs of renal impairment.

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Prescribing information

Zavicefta® (avibactam sodium, ceftazidime pentahydrate) 2g/0.5g powder for concentrate for
solution for infusion)

Recommended dose for paediatric patients from 3 months of age with estimated

CrCL^*> 50 mL/min/1.73 m²

Type of infection	Age Group**	Dose of ceftazidime/avibactam^\|\|	Frequency	Infusion time	Duration of treatment
cIA^#,^† OR cUTI including pyelonephritis^† OR HAP/VAP^† OR Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†	6 months to < 18 years	50 mg/kg/12.5 mg/kg to a maximum of 2 g/0.5 g	Every 8 hours	2 hours	cIAI: 5 – 14 days cUTI^‡: 5 – 14 days HAP/VAP: 7 – 14 days LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§
Every 8 hours	2 hours
3 months to < 6 months^¶	40 mg/kg/10 mg/kg	Every 8 hours	2 hours

Type of infection

Age Group**

Dose of ceftazidime/avibactam^||

Frequency

Infusion time

Duration of treatment

cIA^#,^†

cUTI including pyelonephritis^†

HAP/VAP^†

Infections due to aerobic Gram‑negative organisms in patients with limited treatment options (LTO)^#^,†

6 months to < 18 years

50 mg/kg/12.5 mg/kg

to a maximum of

2 g/0.5 g

Every 8 hours

2 hours

cIAI: 5 – 14 days

cUTI^‡: 5 – 14 days

HAP/VAP: 7 – 14 days

LTO: Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress^§

Every 8 hours

2 hours

3 months to < 6 months^¶

40 mg/kg/10 mg/kg

Every 8 hours

2 hours

Abbreviations:

cIAI, complicated intra-abdominal infection; CrCl, creatinine clearance; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; LTO, limited treatment options; SmPC, Summary of Product Characteristics; VAP, ventilator-associated pneumonia.

References:

ZAVICEFTA. Summary of Product Characteristics.

Dosing

Legal Category: S1A

Further information available upon request

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