How Supplied
Each XYNTHA Vial Kit contains: one prefilled diluent syringe containing 4 mL 0.9% Sodium Chloride with plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, one gauze pad, and one package insert. The drug product, diluents for injection and the rest of components included within the XYNTHA 250, 500, 1000, or 2000 International Units kit are free from natural rubber and natural rubber latex.
XYNTHA is supplied in kits that include single-use vials containing nominally 250, 500, 1000, or 2000 International Units lyophilized powder per vial:
XYNTHA Vial KitNominal Strength | Fill Size Color Indicator | Vial Kit NDC # |
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250 International Units | Yellow | 58394-012-01 |
500 International Units | Blue | 58394-013-01 |
1000 International Units | Green | 58394-014-01 |
2000 International Units | Red | 58394-015-01 |
Actual factor VIII activity in International Units is stated on the label of each XYNTHA vial.