Plasminogen, human-tvmh (Ryplazim)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Ryplazim · Reconstitution only
- Preparation
- Add 12.5 mL sterile water for injection to each 68.8 mg vial for a final 5.5 mg/mL. Gently swirl and draw up the calculated volume from the required number of vials.
- Administration and handling
- Use the specified 5 micron syringe disc filter. Infuse over 10 to 30 minutes (approximately 5 mL/min).
- Manufacturer's storage limits
- Administer within 3 hours of reconstitution and keep at room temperature. A compounding beyond-use date requires a separate assessment.
Product and source details
Prometic Biotherapeutics, Inc. · BLA125659
FDA original approval 2021-06-04. 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.