16 HOW SUPPLIED/STORAGE AND HANDLING
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:
| Nominal Strength | Fill Size Color Indicator | Kit NDC # |
|---|---|---|
| 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.
Storage and Handling
Product as Packaged for Sale:
- Store XYNTHA SOLOFUSE under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label.
- Within the expiration date, XYNTHA SOLOFUSE also may be stored at room temperature not to exceed 25°C (77°F) for up to 3 months.
- Clearly record the starting date at room temperature storage in the space provided on the outer carton. At the end of the 3-month period, immediately use or discard the product. Do not put the product back into the refrigerator.
- Do not use XYNTHA SOLOFUSE after the expiration date stated on the label or after 3 months when stored at room temperature, whichever is earlier.
- Do not freeze. (Freezing may damage the XYNTHA SOLOFUSE.)
- During storage, avoid prolonged exposure of XYNTHA SOLOFUSE to light.
- Store the reconstituted solution at room temperature prior to administration. Administer XYNTHA SOLOFUSE within 3 hours after reconstitution or after removal of the grey rubber tip cap from the product.