Velmanase alfa-tycv (Lamzede)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Lamzede · Reconstitution only
- Preparation
- Add 5 mL sterile water for injection per vial, yielding 2 mg/mL. Allow the labeled settling time, then gently tilt and roll.
- Administration and handling
- Use the syringe and infusion system described in section 2.5. The saline used to clear the line is a separate step.
Product and source details
Chiesi USA, Inc. · BLA761278
Product NDC: 10122-180
SPL effective 2023-02-21 | SPL version 1. 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.