Generic Name and Formulations:
Alpha1-proteinase inhibitor (human) 1000mg/vial; pwd for IV infusion after reconstitution; preservative-free.

Company:
CSL Behring, LLC

Indications for ZEMAIRA:
For chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.

Adult:
Give by IV infusion at a rate of 0.08mL/kg/min. 60mg/kg once weekly. Monitor infusion rates and clinical state closely during infusion.

Children:
Not established.

Contraindications:
History of anaphylaxis or severe systemic response to A1-PI products. Selective IgA deficiencies who have known antibodies against IgA.

Warnings/Precautions:
Contains human plasma; monitor for possible infection transmission. Risk of circulatory overload. Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions:
Asthenia, inj site pain, dizziness, headache, paresthesia, pruritus; hypersensitivity reactions (discontinue if occur).

How Supplied:
Single-use vial—1 (w. diluent + vented transfer device)