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You are here: Home » Products Listed by Brand » McKesson Products » Drug Reference (A's) » Alpha 1-Proteinase Inhibitor


Alpha1-Proteinase Inhibitor (Human), ProlastinÒ is a sterile, stable, lyophilized preparation of purified human Alpha1-Proteinase Inhibitor (alpha1-PI) also known as alpha1-antitrypsin. Prolastin is intended for use in therapy of congenital alpha1-antitrypsin deficiency.

Prolastin is prepared from pooled human plasma of normal donors by modification and refinements of the cold ethanol method of Cohn.1 Part of the fractionation may be performed by another licensed manufacturer. In order to reduce the potential risk of transmission of infectious agents Prolastin has been heat treated in solution at 60±0.5 °C for not less than 10 hours. However, no procedure has been found to be totally effective in removing viral infectivity from plasma fractionation products.

The specific activity of Prolastin is ³0.35 mg functional alpha1-PI mg protein and when reconstituted, as directed the concentration of alpha1 PI is ³20 mg mL. When reconstituted Prolastin has a pH of 6.6- 7.4 a sodium content of 100-210 mEq-L a chloride content of 60-180 mEq/L a sodium phosphate content of 0.015- 0.025 M, a polyethylene glycol content of not more than (NMT) 5 ppm, and NMT 0.1% sucrose. Prolastin contains small amounts of other plasma proteins including alpha2 plasmin inhibitor, alpha1-antichymotrypsin, C1- esterase inhibitor, haptoglobin, antithrombin III, alpha1-lipoprotein albumin and IgA. 1

Each vial of Prolastin contains the labeled amount of functionally active alpha1-PI in milligrams per vial (mg/vial), as determined by capacity to neutralize porcine pancreatic elastase.1 Prolastin contains no preservative and must be administered by the intravenous route.

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