Four-factor prothrombin complex concentrate
Reconstitution onlyFull monograph review pending
U.S. label preparation
Kcentra · Reconstitution only
- Preparation
- Use the sterile water supplied in the kit: 20 mL for the nominal 500-unit vial or 40 mL for the nominal 1,000-unit vial.
- Administration and handling
- Calculate the administered volume from the actual factor IX potency printed on the vial. This entry applies to Kcentra only.
Product and source details
CSL Behring GmbH · BLA125421
Product NDC: 63833-386, 63833-387
SPL effective 2023-05-16 | SPL version 13. 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.