Recommended Topic Related To:

Buminate 5%

"The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less fre"...

Buminate 5%

BUMINATE 5%
Albumin (Human), USP, 5% Solution

This bottle contains 12.5 g albumin from venous plasma in saline and is osmotically equivalent to an equal volume of normal human plasma. It has been stabilized with sodium caprylate and sodium acetyltryptophanate and heated for 10 hours at 60°C. The sodium content is 145 ±15 mEq/L. Contains no preservative. Store at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. See attached directions for use.

Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Single dose container. Discard partially used bottle.

The patient and physician should discuss the risks and benefits of this product.

DRUG DESCRIPTION

BUMINATE 5%, Albumin (Human), 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 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 has been stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ±15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 5%, Albumin (Human), 5% 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 reduced 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

BUMINATE 5%, Albumin (Human), 5% Solution contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient's blood group.

References

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 22:347-351, 1982

3. Murray R, Diefenbach WCL, Geller H, etat Problem of reducing danger of serum hepatitis from blood and blood products. NY State J Med 55:1145-1150, 1955

Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.