Albuminar-20

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

1. Data on file.

NDC 0053-7695-34

20%

100 mL

Albuminar®-20
Albumin (Human)
USP 20%

For Intravenous Administration Only.

20 g in 100 mL solution osmotically equivalent to 400 mL of plasma.

Do not use if turbid

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

Applies to albumin human: intravenous solution

Dermatologic

Dermatologic side effects have included urticaria, skin rash, pruritus, edema, and erythema.[Ref]

Nervous system

Nervous system side effects have included headache, chills, and febrile reactions.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting and increased salivation.[Ref]

Respiratory

Respiratory side effects have included bronchospasm.[Ref]

Some side effects of Albuminar-20 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.