Clinical Information
Gen. Code and Des.
6331 albumin human INTRAVEN VIAL 25 %
GCN and Des.
25060 albumin human INTRAVEN VIAL 25 %
Strength
25%
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
16000000 BLOOD DERIVATIVES
Active Ingredients
2027 albumin human
Inactive Ingredients
18822 rubber, unspecified
ALBUKED albumin human solution
KEDRION BIOPHARMA, INC.
DESCRIPTION
Albumin (Human) 5%, USP (Albuked? 5) 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 is 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 sodium caprylate and 0.004 acetyltryptophan. The aluminum content of the product is not more than 200 ?g/L. The approximate sodium content of the product is 145 mEq/L. Albuked is clear, slightly viscous, almost colorless to pale yellow, amber or green.
Each vial of Albuked is heat-treated at 60?C for 10 hours against the possibility of transmitting the hepatitis viruses.
CLINICAL PHARMACOLOGY
Albuked is oncotically equivalent volume for volume to normal human plasma.
When administered intravenously to an adequately hydrated subject, the oncotic (colloid osmotic) effect of Albuked is to expand the circulating blood volume by an amount approximately equal to the volume infused. It is primarily used in the treatment of shock associated with hemorrhage, surgery, trauma, burns, bacteremia, renal failure, and cardiovascular collapse.
Albumin is transport protein and it may be useful in severe jaundice in hemolytic disease of the newborn. This could also be of importance in acute liver failure where albumin might serve the dual role of supporting plasma oncotic pressure, as well as binding excessive plasma bilirubin.
CONTRAINDICATIONS
Certain patients, e.g., those with history of congestive cardiac failure, renal insufficiency or stabilized chronic anemia, are at special risk of developing circulatory overload. history of allergic reaction to albumin is specific contraindication for usage.
STORAGE
Store at room temperature not exceeding 30?C (86?F). Do not freeze. Do not use after expiration date.
