Fibrinogen, human-chmt (Fesilty)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Fesilty · Reconstitution only
- Preparation
- Reconstitute the nominal 1 g vial with the supplied 50 mL sterile water and transfer device. Use the actual fibrinogen amount printed on the vial to calculate the dose.
- Administration and handling
- Use an infusion pump. Section 2.3 gives the age-specific initial rates, including newborns. Do not exceed 5 mL/min.
- Manufacturer's storage limits
- Keep at room temperature and use within 4 hours after dissolution. A compounding beyond-use date requires a separate assessment.
Product and source details
Grifols USA LLC · BLA125833
Product NDC: 13533-502
SPL effective 2026-08-20 | SPL version 5. 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.