BUMINATE 5% SUMMARY
BUMINATE 5%, Albumin (Human), 5% Solution, 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. 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 has been stabilized with sodium acetyltryptophanate and 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. BUMINATE 5%, Albumin (Human), 5% Solution, is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.
BUMINATE 5% Solution is indicated for the following:
- Hypovolemia
Hypovolemia is a possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Its effectiveness in reversing hypovolemia depends largely upon its colloid osmotic pressure. Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a longer intravascular half-life than crystalloid solutions.9
When the hypovolemia is long-standing and hypoalbuminemia exists accompanied by adequate hydration or edema, treatment with BUMINATE 25%, Albumin (Human), 25% Solution, is preferable.4,6
When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. - Hypoalbuminemia
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General
Hypoalbuminemia is another possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Hypoalbuminemia can result from one or more of the following:5
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Inadequate production (malnutrition, burns, major injury, infections, etc.)
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Excessive catabolism (burns, major injury, pancreatitis, etc.)
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Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
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Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than administration of albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore adequate plasma albumin levels. In these cases, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful. -
Burns
In conjunction with appropriate crystalloid therapy, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful for treatment of protein deficits after the initial 24-hour period following extensive burns.4
- Miscellaneous Indications
BUMINATE 5%, Albumin (Human), 5% Solution, may be indicated prior to or during cardiopulmonary bypass surgery, though the data do not indicate a clear-cut advantage over crystalloid solutions.4,6,10
There is no valid reason for use of albumin as an intravenous nutrient.
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