ALBUMINAR-25 (albumin- human solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)

Available from:

CSL Behring LLC

INN (International Name):

Albumin Human

Composition:

Albumin Human 25 g in 100 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated. Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance. Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained. ALBUMINAR® -25 may be contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Product summary:

ALBUMINAR® -25 is supplied as a 25% solution. Each product presentation includes a package insert and the components listed in Table 2 below. Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ALBUMINAR-25- ALBUMIN (HUMAN) SOLUTION
CSL BEHRING LLC
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ALBUMIN (HUMAN) USP, 25%
ALBUMINAR -25
R ONLY
DESCRIPTION
Albumin (Human) 25%, ALBUMINAR -25 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.
All Source Plasma used in the manufacture of this product was tested
by FDA-licensed Nucleic Acid
Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive
(negative).
ALBUMINAR -25 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.
ALBUMINAR -25 is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of ALBUMINAR -25
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 ALBUMINAR -25 with the results provided in Table 1.
TABLE 1. VIRAL REDUCTION STUDIES FOR
ALBUMINAR -5 AND ALBUMINAR -25
Pasteurization (60°C for 10 hours)