Terlipressin
Reconstitution onlyFull monograph review pending
U.S. label preparation
Terlivaz · Reconstitution only
- Preparation
- Add 5 mL of 0.9% sodium chloride to the 0.85 mg vial. The label expresses the resulting strength as 0.85 mg per 5 mL.
- Administration and handling
- Give the prescribed dose by slow IV bolus over 2 minutes. See the boxed warning on respiratory failure.
Product and source details
Keenova Hospital Products Inc. · NDA022231
Product NDC: 43825-200
SPL effective 2026-10-23 | SPL version 8. 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.