Plasbumin Solution
NDC Package 13533-690-25

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Albumin (human)

Albumin Human

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Intravenous - Administration within or into a vein or veins.

Emergency Treatment of Hypovolemic ShockPlasbumin-5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Plasbumin-5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin®-25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Plasbumin-25 is used, appropriate additional crystalloid should be administered.(1)Crystalloid solutions in volumes several times greater than that of Plasbumin-5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1)Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1)Burn TherapyAn optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Plasbumin-25 may be preferred for this purpose.(1)Cardiopulmonary Bypass(1)With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.Acute Liver Failure(1)In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.Sequestration of Protein Rich Fluids(2)This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.Situations in Which Albumin Administration is Not Warranted(1)In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.

Grifols Usa, Llc

Plasma Derivative

BLA101138

BLA - A product marketed under an approved Biologic License Application.

09-26-1994

12-31-2026

N

No