Albuminar-20

ALBUMINAR-20- albumin human solution
CSL Behring LLC

Rx only

DESCRIPTION

Albuminar® -20, Albumin (Human) 20% 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 0.016 M sodium acetyltryptophanate and 0.016 M sodium caprylate and heated at 60°C for 10 hours.

All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used in the manufacture of this product and found to be nonreactive (negative). The aim of the HBV test is to detect low levels of viral material, however, the significance of a nonreactive (negative) result has not been established.

Albuminar® -20 is a solution containing in each 100 mL 20 grams of human albumin, osmotically equivalent to 400 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® -20 is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albuminar® -20, 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 Albuminar® -5, Albumin (Human) 5% and Albuminar® -25, Albumin (Human) 25% with the following results. 1

Pasteurization (60°C for 10 hours) Viral Reduction Studies (log10 reduction)
Virus Albuminar® -5, Albumin (Human) 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 Albuminar® -25, Albumin (Human) 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

CLINICAL PHARMACOLOGY

Albuminar® -20 is active osmotically and is therefore important in regulating the volume of circulating blood. When injected intravenously, 50 mL of 20% albumin draws approximately 140 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity. The degree of volume expansion is dependent on the initial blood volume. When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours. In individuals with normal blood volume, it usually lasts only a few hours.

Albumin (Human), unlike whole blood or plasma, is considered free of the danger of viral hepatitis because it is heated at 60°C for 10 hours. Albuminar® -20 may be given in conjunction with other parenteral fluids such as saline, dextrose or sodium lactate. It is convenient to use since no cross-matching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

Albuminar-20 Indications and Usage

SHOCK

Albuminar® -20 is indicated in the emergency treatment of shock due to burns, trauma, operations and infections, in the treatment of injuries of such severity that shock, although not immediately present, is likely to ensue 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.

BURNS

Albuminar® -20 is indicated in conjunction with adequate infusions of crystalloid to counteract hemoconcentration and the loss of protein, electrolytes and water that usually follow severe burns. Because of changes in permeability, little administered albumin is likely to be retained intravascularly in the first 12 hours after a major burn. However, an optimum regimen for the use of colloid, electrolytes and water in the treatment of burns has not been established.

HYPOPROTEINEMIA

Albuminar® -20 may be used in acutely hypoproteinemic patients in the presence or absence of edema.

CONTRAINDICATIONS

Albuminar® -20 is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

WARNINGS

Infusion of protein-containing solutions such as Albuminar® -20 that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar® -20, which are normal saline and 5% dextrose.

Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

Albuminar® -20 is made from human plasma. Products made from human plasma may contain infectious agents such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. The manufacturing procedure for Albuminar® -20 includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar® -20 is pasteurized in the final container at 60.0 +/- 0.5°C for 10-11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures.) Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

PRECAUTIONS

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