Ceftobiprole medocaril
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Zevtera · Reconstitution and dilution
- Preparation
- Select the diluent and final concentration by age. For patients 12 years and older, reconstitute with 10 mL sterile water for injection or 5% dextrose, then dilute to 2.67 mg/mL as directed.
- Administration and handling
- For ages 3 months to under 12 years, reconstitute with 10 mL of 5% dextrose and follow Table 5 for the 5.33 mg/mL infusion. Concentrations refer to ceftobiprole medocaril sodium.
Product and source details
La Jolla Pharmaceutical Company · NDA218275
Product NDC: 68547-578
SPL effective 2026-10-13 | SPL version 7. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.