CSL Behring

ZEMAIRA is indicated for chronic augmentation and maintenance therapy for adults with alpha₁-proteinase inhibitor (A₁-PI) deficiency and emphysema. The effect of augmentation therapy with ZEMAIRA or any A₁-PI product on pulmonary exacerbations and progression of emphysema in A₁-PI deficiency has not been demonstrated in randomized, controlled clinical studies.

ZEMAIRA is not indicated for lung disease patients in whom severe A₁-PI deficiency has not been established.

• Check the expiration date on the vial label and carton. Do not use ZEMAIRA after the expiration date. • Reconstitute prior to use according to the instructions provided below.

• Reconstitute ZEMAIRA using aseptic technique to maintain product sterility.

• Total reconstitution time for a 1g vial should be obtained within 5 minutes.

• Total reconstitution time for a 4g or 5g vial should be obtained within 10 minutes.

• Inspect the reconstituted solution prior to administration. The solution should be clear, colorless to slightly yellow, and free from visible particles.

• Reconstituted ZEMAIRA may be stored at room temperature. Do not freeze the reconstituted solution.