16 HOW SUPPLIED/STORAGE AND HANDLING
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:
|Nominal Strength||Fill Size Color Indicator||Vial Kit NDC #|
|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.
Storage and Handling
- Store XYNTHA 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 also may be stored at room temperature not to exceed 25°C (77°F) for up to 3 months.
- After room temperature storage, XYNTHA can be returned to the refrigerator until the expiration date. Do not store XYNTHA at room temperature and return it to the refrigerator more than once.
- 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, discard, or return the product to refrigerated storage. The diluent syringe may be stored at 2° to 25°C (36° to 77°F).
- Do not use XYNTHA after the expiration date.
- Do not freeze. (Freezing may damage the prefilled diluent syringe.)
- During storage, avoid prolonged exposure of XYNTHA vial to light.
- Store the reconstituted solution at room temperature prior to administration. Administer XYNTHA within 3 hours after reconstitution.