Ustekinumab-srlf (Imuldosa)
Dilution requiredFull monograph review pending
U.S. label preparation
Imuldosa · Dilution required
- Preparation
- Adult IV induction for inflammatory bowel disease. Use the 130 mg/26 mL IV vial. For each vial needed, remove 26 mL from a 250 mL bag of 0.9% sodium chloride and replace it with 26 mL of concentrate. Final volume is 250 mL.
- Administration and handling
- Mix gently and infuse over at least 1 hour using a sterile low protein-binding 0.2 micron in-line filter. Subcutaneous presentations have separate instructions.
Product and source details
Accord BioPharma Inc. · BLA761364
Product NDC: 69448-019
SPL effective 2026-06-17 | SPL version 10. 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.