BUMINATE 25%, Albumin (Human), 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 25 g of albumin and is prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ± 15 mEq/L. This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 25%, Albumin (Human), 25% Solution is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.
The likelihood of the presence of viable hepatitis viruses has been minimized
by heating the product for 10 hours at 60°C. This procedure has been shown
to be an effective method of inactivating hepatitis virus in albumin solutions
even when those solutions were prepared from plasma known to be infective.1-3
1. Gellis SS, Neefe JR, Stokes J Jr, et al: Chemical, clinical and immunological
studies on the products of human plasma fractionation. XXXVI. Inactivation of
the virus of homologous serum hepatitis in solutions of normal human serum albumin
by means of heat. J Clin Invest 27:239-244, 1948
2. Gerety RJ, Aronson DL: Plasma derivatives and viral hepatitis. Transfusion
3. Murray R, Diefenbach WCL, Geller H, et al: Problem of reducing danger of
serum hepatitis from blood and blood products. NY State J Med 55:1145-1150,
Last reviewed on RxList: 1/20/2009
This monograph has been modified to include the generic and brand name in many instances.