Product Name: Xyntha

Formulation & Concentration: [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]

Manufacturer: Pfizer

Indications
“XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with Hemophilia A (congenital factor VIII deficiency or classic Hemophilia). XYNTHA™ does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease. XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for surgical prophylaxis in patients with Hemophilia A.”

Vial Size NDC #
250 IU 58394-012-01
500 IU 58394-013-01
1000 IU 58394-014-01
2000 IU 58394-015-01
3000 IU 58394-016-03

Size
4ml

Shelf Life
36 Months

Storage
“Product as Packaged for Sale: (1) 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™ may also 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. (2) The starting date at room temperature storage should be clearly recorded in the space provided on the outer carton. At the end of the 3-month period, the product must be used immediately, discarded, or returned to refrigerated storage. The diluent syringe may be stored at 2° to 25°C (36° to 77°F). (3) Do not use XYNTHA™ after the expiration date. (4) Do not freeze to prevent damage to the prefilled diluent syringe. (5) During storage, avoid prolonged exposure of XYNTHA™ vial to light. Product After Reconstitution: Administer XYNTHA™ within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.”

Full Prescribing Information:
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