How Supplied
Each XYNTHA SOLOFUSE Kit contains: one plunger rod for assembly, one sterile infusion set, two alcohol swabs, one bandage, one gauze pad, one vented sterile cap, and one package insert. The drug product, diluents for injection and the rest of components included within the XYNTHA 250, 500, 1000, 2000, or 3000 International Units kit are free from natural rubber and natural rubber latex.
XYNTHA SOLOFUSE is supplied in a kit that includes the XYNTHA lyophilized powder containing nominally 250, 500, 1000, 2000 or 3000 IU and 4 mL 0.9 % Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe:
XYNTHA SOLOFUSE KitNominal Strength | Fill Size Color Indicator | Kit NDC # |
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250 International Units | Yellow | 58394-022-03 |
500 International Units | Blue | 58394-023-03 |
1000 International Units | Green | 58394-024-03 |
2000 International Units | Red | 58394-025-03 |
3000 International Units | Gray | 58394-016-03 |
Actual factor VIII activity in International Units is stated on the label of each XYNTHA SOLOFUSE.