Zavicefta Dosage/Direction for Use

Posology: Dosage in Adults with creatinine clearance (CrCL >50 mL/min): Table 11 shows the recommended intravenous dose for adults with estimated creatinine clearance (CrCL) >50 mL/min (see Precautions and Pharmacology: Pharmacodynamics under Actions). (See Table 11.)

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Dosage in paediatric patients with creatinine clearance (CrCL) >50 mL/min/1.73 m²: Table 12 shows the recommended intravenous doses for paediatric patients with estimated creatinine clearance (CrCL) >50 mL/min/1.73 m² (see Precautions and Pharmacology: Pharmacodynamics under Actions). (See Table 12.)

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Special populations: Elderly: No dosage adjustment is required in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dosage adjustment is required in patients with mild renal impairment (estimated CrCL >50-≤80 mL/min) (see Pharmacology: Pharmacokinetics under Actions).
Table 13 shows the recommended dose adjustments for adults with estimated CrCL ≤50 mL/min (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Dosage in adults with creatinine clearance (CrCL) ≤50 mL/min: See Table 13.

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Table 14 and Table 15 shows the recommended dose adjustments for paediatric patients with estimated CrCL ≤50 mL/min/1.73 m² according to different age groups (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Dosage in paediatric patients ≥2 years of age with CrCl ≤50 mL/min/1.73 m²: See Table 14.

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Dosage in paediatric patients <2 years of age with CrCl ≤50 mL/min/1.73 m²: See Table 15.

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There is insufficient information to recommend a dosage regimen for paediatric patients <2 years of age that have a CrCL <16 mL/min/1.73 m².
Hepatic impairment: No dosage adjustment is required in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric patients: The safety and efficacy in paediatric patients <3 months old have not been established. No data are available.
Method of administration: Intravenous use.
Zavicefta is administered by intravenous infusion over 120 minutes in an appropriate infusion volume (see Instructions for use, handling and disposal under Cautions for Usage).
For instructions on reconstitution and dilution of the medicinal product before administration, see Instructions for use, handling and disposal under Cautions for Usage.