Albuked

Generic name:albumin (human)
Dosage form: injection
Drug class:Plasma expanders

Medically reviewed by Drugs.com. Last updated on Aug 1, 2020.

Albuked Description

Albumin (Human) 25%, USP (Albuked™ 25) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration.

Albuked 25 is a 25% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 25 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Albuked 25 must be administered intravenously.

Each vial of Albuked 25 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(11-14) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 25 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.

Albuked - Clinical Pharmacology

Each 20 mL vial of Albuked 25 supplies the oncotic equivalent of approximately 100 mL citrated plasma; 50 mL supplies the oncotic equivalent of approximately 250 mL citrated plasma.

When administered intravenously to an adequately hydrated subject, the oncotic (colloid osmotic) effect of 20 mL Albuked 25 is such that it will draw approximately a further 70 mL of fluid from the extravascular tissues into the circulation within 15 minutes,(1) thus increasing the total blood volume and reducing both hemoconcentration and whole blood viscosity. Accordingly, the main clinical indications are for hypoproteinemic stat...