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 |
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