RX ITEM-Buminate 5% Sol 6X500ml by ASD Healthcare

BUMINATE- albumin human injection, solution
Baxter Healthcare Corporation

DESCRIPTION

BUMINATE 20% in 50 and 100 mL glass bottles is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 20 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.016M) and sodium caprylate (0.016M). The sodium content is 145 � 15 mEq/L. This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 20% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.



The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60�C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1-3

CLINICAL PHARMACOLOGY

Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating the volume of circulating blood.4-6 Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6

BUMINATE 20% is osmotically equivalent to approximately four times its volume of human plasma. When injected intravenously, 20% albumin will draw about three times its volume of additional fluid into the circulation within 15 minutes, except when the patient is markedly dehydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and duration of volume expansion depends upon the initial blood volume. In patients with decreased blood volume, the effect of infused albumin can persist for many hours; however, in patients with normal blood volume, the duration will be shorter.7-9

Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extra cellular compartments; more than 60% is located in the extravascular fluid compartment. The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5

The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mm Hg.4

BUMINATE 20% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 � 0.5�C for 10 � 11 hours. This process accomplishes both purification of albumin and reduction of viruses.

In vitro studies demonstrate that the manufacturing process for BUMINATE 20% provides for effective viral reduction. These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for BUMINATE 20% using human immunodeficiency virus, type 1 (HIV-1) both as a target virus and model for HIV-2 and other lipid-enveloped RNA viruses; bovine viral diarrhea virus (BVDV), a model for lipid-enveloped RNA viruses, such as hepatitis C virus (HCV); West Nile Virus (WNV), a target virus and model for other similar lipid-enveloped RNA viruses; pseudorabies virus (PRV), a model for other lipid-enveloped DNA viruses such as hepatitis B virus (HBV); mice minute virus (MMV), models for non-enveloped DNA viruses such as human parvovirus B 1910 ; and hepatitis A virus (HAV), a target virus and a model for other non-enveloped RNA viruses.

Buminate 5% Sol 6X500ml by ASD Healthcar
NDC No. 00944-0491-02 UPC/GTIN No. 3-09440-49102-8 MPN 11007 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

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ALBUMIN HUMAN INTRAVEN IV
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