Albuminar-5

Generic name:albumin human
Dosage form: injection
Drug class:Plasma expanders

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

Rx only

Albuminar-5 Description

Albumin (Human) 5%, Albuminar®-5 is a sterile solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is heated at 60°C for 10 hours and stabilized with 0.004 M sodium acetyltryptophanate and 0.004 M sodium caprylate.

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.

Each 50 mL vial of 5% solution contains 2.5 grams of albumin in normal saline. Each 250 mL bottle of 5% solution contains 12.5 grams of albumin in normal saline. Each 500 mL bottle of 5% solution contains 25 grams of albumin in normal saline. The 5% solution is osmotically equivalent to citrated plasma. The pH of the solution is adjusted to 6.9 ± 0.5 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®-5 is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albuminar®-5 pasteurization of the final container at 60ºC 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 conduct...