alpha1-proteinase inhibitor


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alpha1-proteinase inhibitor

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Alpha 1-Proteinase Inhibitor (Human), GLASSIA[TM] is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency.
Important Safety Information PROLASTIN, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy of individuals having congenital deficiency of alpha1- PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema.
Prolastin(R), Alpha1-Proteinase Inhibitor (Human) is a sterile, stable, lyophilized preparation of purified human AAT prepared from pooled human plasma of healthy donors by a modification of the cold ethanol fractionation process.
Food and Drug Administration (FDA) for use as chronic augmentation and maintenance therapy in adults with alpha1-proteinase inhibitor deficiency (Alpha-1), a life threatening genetic disorder, which clinically manifests as emphysema.
The SFF will be used for final container filling, freeze-drying, and pasteurization of all products manufactured in Clayton including Prolastin(R), Alpha1-Proteinase Inhibitor (Human), used in the treatment of genetic emphysema, Gamimune(R) N, Immune Globulin Intravenous (Human), indicated for patients with immune deficiencies, and Koate(R)-DVI Antihemophilic Factor (Human), used to treat hemophilia.
Alpha1-proteinase inhibitor (A1PI) deficiency is inherited and affects nearly 100,000 people in the United States who lack a sufficient amount of this critical blood protein.