Buminate 25%

DRUG DESCRIPTION

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 60C. 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



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