KCENTRA

Prothrombin Complex Concentrate (Human)

CSL Behring

Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor de ciency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:

• acute major bleeding or
• need for an urgent surgery/invasive procedure. (1)

Three years, up to the expiration date

Prior to Reconstitution Kcentra is for single use only. Contains no preservatives. Store Kcentra between 2-25°C (36-77°F), this includes room temperature, not to exceed 25°C (77°F). Do not freeze. Kcentra is stable for 36 months from the date of manufacture, up to the expiration date on the carton and vial labels. Do not use Kcentra beyond the expiration date on the vial label and carton. Store the vial in the original carton to protect it from light. After Reconstitution Kcentra must be used within 4 hours following reconstitution. Reconstituted Kcentra can be stored at 2-25°C. If cooled, the solution should be warmed to 20-25°C prior to administration. Do not freeze. Discard partially used vials.