Recommended Topic Related To:

Albuminar

"Nov. 28, 2012 -- Many pork chops and ground pork products in the U.S. may be tainted with antibiotic-resistant bacteria, including one that the USDA does not look for, a Consumer Reports study shows.

The new report also found"...

Albuminar

Albuminar®-25
[albumin (Human)] USP, 25%

DRUG DESCRIPTION

Albumin (Human) 25%, Albuminar®-25 (albumin human) is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.

The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.

Albumin (Human) 25%, Albuminar®-25 (albumin human) is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.

Albumin (Human) 25%, Albuminar®-25 (albumin human) , is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albumin (Human) 25%, Albuminar®-25 (albumin human) , pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus), and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albumin (Human) 5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 (albumin human) with the following results.1

Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)
Virus Albumin (Human) 5%, Albuminar®-5
HIV-1 >5.44, >6.38 and >6.31
BVDV >6.01, >6.76 and >6.55
PrV >7.30, >7.68 and >7.63
EMC >7.38, >7.97 and >7.97
Virus Albumin (Human) 25%, Albuminar®-25
HIV-1 >5.50, >6.57 and >6.64
BVDV >5.99, >5.81 and >5.32
PrV >7.32, >7.20 and >7.42
EMC >7.10, >7.89 and >7.87

1. Data on file.

Last reviewed on RxList: 7/21/2008
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.


Weight Loss Wisdom

Get tips, recipes and inspiration.

Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations