BALFAXAR- prothrombin complex concentrate (human) powder, for solution

Octapharma

BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.

Store BALFAXAR for up to 36 months at 2°C to 25°C (36°F to 77°F) from the date of manufacture. Do not freeze.

Do not use beyond the expiration date on the vial label and carton.

Store the vial in the original package to protect it from light.

Reconstitute the BALFAXAR powder only directly before use. Use the solution immediately after reconstitution. However, if it is not administered immediately, the reconstituted solution can be stored for up to 8 hours at room temperature (20°C to 25°C; 68°F to 77°F), provided sterility of the stored product is maintained. Discard partially used vials.