ZEMAIRA SUMMARY
Alpha1-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.
Zemaira™ is indicated for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.
Zemaira™ increases antigenic and functional (ANEC) serum levels and lung epithelial lining fluid levels of A1-PI.
Clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with Zemaira™ are not available.
Safety and effectiveness in pediatric patients have not been established.
Zemaira™ is not indicated as therapy for lung disease patients in whom severe congenital A1-PI deficiency has not been established.
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