Plasbumin Albumin (Human) 2.5 g/50mL Solution

INDICATIONS AND USAGE Emergency Treatment of Hypovolemic Shock Plasbumin-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 Therapy An 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.

DOSAGE AND ADMINISTRATION Plasbumin-5 should always be administered by intravenous infusion. The choice between the use of Plasbumin-5 and Albumin (Human) 25%, USP (Plasbumin ® -25) depends upon whether the patient requires primarily volume (Plasbumin-5) or primarily colloid osmotic activity (Plasbumin-25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases. [1] When the oncotic pressure drops below this level, the patient should be treated with Plasbumin-25 together with diuretics.

This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia. The volume administered and the speed of administration should be adapted to the response of the individual patient. A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use.

These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. Hypovolemic Shock The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.

In neonates or infants, Plasbumin-5 may be given in large amounts. [7] The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight. Burns After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL). [1] This is best achieved by the intravenous administration of Plasbumin, usually as Plasbumin-25.

The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administra­tion of albumin should not be considered as a source of nutrition. Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.