New Product - Prolastin-C
Prolastin-C (alpha1-proteinase inhibitor (human)) is produced from pooled human plasma using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography and cation exchange chromatography. The intended theoretical goal of alpha1-proteinase inhibitor (alpha1-PI) intravenous infusion is to provide protection to the lower respiratory tract by correcting the imbalance between neutrophil elastase and protease inhibitors. Prolastin-C is indicated to increase serum alpha1-PI levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (FEV1 < 80%). The data for clinical efficacy of Prolastin-C is derived from changes in the biomarkers alpha-1 anti-protease level and CT lung density. Efficacy on FEV1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. Clinical trials have only included patients who were not smoking. Prolastin-C is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity. Prolastin-C is available as a lyophilised powder for injection containing 1000 mg of alpha1-proteinase inhibitor (human) with 20 mL solvent in packs of 1’s.
Copyright © MIMS Australia Pty Ltd. All rights reserved.
Level 2, 1 Chandos Street
St Leonards NSW 2065
Phone: 1800 800 629