Albumin (Human), 5% Solution, Buminate® 5% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and has been stabilized with 0.004 M sodium acetyltryptophanate and 0.004 M sodium caprylate. The sodium content is 145 ± 15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. Albumin (Human), 5% Solution, Buminate 5% 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 reduced 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
Albumin (Human), 5% Solution, Buminate 5% contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient' blood group.
Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating and increasing blood volume. 4,5,6 It is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation. 5,6 Albumin (Human), 5% Solution, Buminate 5% is osmotically equivalent to an equal volume of normal human plasma and will increase circulating plasma volume by an amount approximately equal to the volume infused. The degree and duration of volume expansion depends upon the initial blood volume. With patients treated for diminished blood volume, the effect of infused albumin may last for many hours. In patients with normal blood volumes, the hemodilution lasts for a shorter period. 7,8
Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments. 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
There is no valid reason for use of albumin as an intravenous nutrient.
A history of allergic reactions to albumin is a specific contraindication to the use of this product.
Albumin (Human), 5% Solution, Buminate 5% is also contraindicated in severely anemic patients and in patients with cardiac failure.
Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
Certain components used in the packaging of this product contain natural rubber latex.
Albumin (Human), 5% Solution, Buminate 5% may be given rapidly to individuals with reduced plasma volume with the following exception: if a patient has a history of cardiac or circulatory disease, Albumin (Human), 5% Solution, Buminate 5% should be administered slowly (5 to 10 mL per minute) to avoid too rapid a rise in the blood pressure.
Patients should always be carefully monitored in order to guard against the possibility of circulatory overload.
When Albumin (Human), 5% Solution, Buminate 5% is used following injuries or surgery, the quick rise in blood pressure which follows administration makes it necessary to monitor the patient to detect and treat severed blood vessels that may not have bled at a lower blood pressure.
Animal reproduction studies have not been conducted with Albumin (Human), 5% Solution. It is not known whether Albumin (Human), 5% Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human), 5% Solution should be given to a pregnant woman only if clearly needed.
The use of Albumin (Human), 5% Solution in children has not been associated with any special or specific hazard, if the dose is appropriate for the child's body weight.
Untoward reactions to Albumin (Human), 5% Solution are extremely rare, although nausea, fever, chills or urticaria may occasionally occur. Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time.
Albumin (Human), 5% Solution, Buminate 5% must be administered intravenously. It may be administered either in conjunction with or combined with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate.
The volume of the total dose and the rate of infusion depends on the patient' condition and response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.
Albumin (Human), 5% Solution, Buminate 5% is supplied in 250 mL and 500 mL bottles.
Store Albumin (Human), 5% Solution, Buminate 5% at room temperature, not to exceed 30 °C (86 °F). Avoid freezing to prevent damage to the bottle.
©Copyright 1977, 1979, 1980, 1983, 1985, 1988, 1989, 1990, 1993, 1998
Baxter Healthcare Corporation. All rights reserved.
Baxter Healthcare Corporation
Hyland Division
Glendale, CA 91203 USA
U.S. License No. 140 Revised January 1998