Rx Item-Flexbumin 25% Solution 12X100Ml Bag By Baxalta

FLEXBUMIN- albumin human solution
Baxter Healthcare Corporation

DESCRIPTION

FLEXBUMIN 20% in 50 and 100 mL GALAXY plastic container is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 20g 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 (0.016 M) 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. FLEXBUMIN 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

The GALAXY plastic container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

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

FLEXBUMIN 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 extracellular 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

FLEXBUMIN 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.

RX ITEM-Flexbumin 25% Solution 12X100Ml
NDC 00944-0493-02 UPC/GTIN No.3-09440-49302-2 Mfg.Part No.27199

Flexbumin 25% Solution 12X100Ml Bag By B
BRAND: FLEXBUMIN NDC: 00944-0493-02,944049302 UPC: 3-09440-49302-2,309440493022 BAXALTA HEALTH CARE

ALBUMIN HUMAN INTRAVEN IV
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