ALBUMIN (HUMAN)
5% SOLUTION (Baxter Healthcare)


Description

Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The solution is approximately isotonic and isooncotic with human plasma. The effective oncotic pressure of the solution depends largely on its albumin content. Sodium bicarbonate is used to adjust the pH to 6.9 ± 0.5. The sodium content of the solution ranges between 130 and 160 meq/L. 0.08 millimole sodium caprylate/g albumin and 0.08 millimole sodium N- acetyltryptophanate/g albumin are added as stabilizers to prevent denaturation during heating. The solution has been heat-treated at 60°C for 10 hours for inactivation of hepatitis viruses.

Clinical Pharmacology

Albumin is a very soluble, globular protein (MW 66,500) accounting for 70-80% of the colloid osmotic pressure of plasma. Albumin (Human) 5% is an effective and long acting agent for plasma volume expansion. The rationale for this is the Starling concept of the capillary balance of hydrostatic and oncotic pressure gradients across the capillary walls as the determinant of the fluid-i.e., volume-distribution between the intravascular and interstitial compartments (10). Albumin is distributed throughout the extracellular water; more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g. Albumin has a half life of 15-20 days in the circulation (2,7) with a turnover of approximately 15 g per day.

When injected intravenously, Albumin (Human) 5% will increase the circulating plasma volume by an amount approximately equal to the amount infused. The additional fluid will reduce the hemoconcentration and decrease blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. In patients with diminished blood volume, the effect of infused Albumin (Human) may persist many hours. The hemodilution lasts for a much shorter time when albumin is administered to individuals with normal blood volume.

Albumin is a transport protein which binds naturally occurring therapeutic and toxic materials in the circulation. The binding properties of albumin may, in special circumstances, provide an indication for its clinical use. For such purposes, however, Albumin (Human) 25% should be used.

Indications and Usage

Conditions For Which Albumin (Human) 5% Is Recommended:

Shock

The definitive treatment of major hemorrhage is the transfusion of red blood cells for restoring the normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume should, as an emergency measure, be supported by Albumin (Human) 5% or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with Albumin (Human).

Burns

Apart from damage to the respiratory tract, the development of burn shock is the most life-threatening event in the immediate care of the burned patient. An optimum regimen for the use of Albumin (Human), electrolytes, and fluid in the treatment of burns has not been established. Therapy during the first 24 hours after a severe burn is usually directed at the administration of large volumes of crystalloid solutions and lesser amounts of Albumin (Human) to maintain an adequate plasma volume. For continuation of therapy beyond 24 hours, larger amounts of Albumin (Human) and lesser amounts of crystalloid are generally used (12).

Conditions For Which Albumin (Human) 5% May Be Useful:

Pancreatitis and Peritonitis

Albumin (Human) 5% may be useful in the early therapy of shock associated with acute hemorrhagic pancreatitis and peritonitis. It has been found that the correction of the blood volume deficit and adequate fluid therapy are mandatory in the acute stage of pancreatitis and peritonitis when there is loss of fluid into the peritoneal cavity or the retroperitoneal space (1).

Conditions For Which Albumin (Human) 5% Is Usually Not Recommended:

Postoperative albumin loss

It is now recognized that intraoperative damage to capillary walls, e.g., by blunt handling and sharp dissection of tissue, leads to substantial postoperative losses of circulating albumin, over and above those due to bleeding. However, this internal redistribution rarely causes clinically significant hypovolemia or adversely affects wound healing, and treatment of this condition with Albumin (Human) 5% is usually not indicated.

Hypoproteinemia with an oncotic deficit

In subacute or chronic hypoproteinemia, efforts should always be made to determine the underlying cause and to improve circulating protein levels by dietary means. Most commonly, such states are due to protein-calorie malnutrition, defective absorption in gastrointestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism after operation or in sepsis, and abnormal renal losses of albumin in chronic kidney disease. In all these situations, the circulating plasma volume is usually maintained by the renal retention of sodium and water, but this is associated with tissue edema due to the hypoalbuminemia and with an oncotic deficit. Though relief of the basic pathology is the definitive therapy for restoration of the plasma protein level, Albumin (Human) is effective in the rapid correction of an oncotic deficit occurring in the aforementioned acute complications of chronic hypoproteinemia. For this purpose, however, Albumin (Human) 25% is the preferable therapeutic agent, possibly in conjunction with a diuretic. It is emphasized that whereas Albumin (Human) may be needed to treat the acute complications of chronic hypoproteinemia, it is NOT indicated for treatment of the chronic disease itself.

Contraindications

The use of Albumin (Human) is contraindicated in patients with a history of an incompatibility reaction to such preparations (see Adverse Reactions ). In addition, the Albumin (Human) may be contraindicated in patients with cardiac failure, pulmonary edema or severe anemia because of the risk of acute circulatory overload. Also, Albumin (Human) has been reported to contain trace amounts of aluminum (4,5). Accumulations of aluminum in patients with chronic renal insufficiencies has led to toxic manifestations such as hypercalcemia, vitamin D-refractory osteodystrophy, anemia, and severe progressive encephalopathy (5,6,13). Therefore, when large volumes of Albumin (Human) are contemplated for administration to such patients, serious consideration of these potential risks relative to the anticipated benefits should be given.

Warnings

Albumin (Human) is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to our U.S. distributor at (800) 423-2862. The physician should discuss the risks and benefits of this product with the patient.

ALBUMIN (HUMAN) 5% MUST NOT BE USED IF THE SOLUTION IS TURBID.

ALBUMIN (HUMAN) 5% MUST BE INFUSED IMMEDIATELY AND WITHOUT INTERRUPTION AFTER PERFORATION OF THE R/C BOTTLE. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED. PARTIALLY USED BOTTLES MUST BE DISCARDED. ALBUMIN (HUMAN) 5% MUST NOT BE GIVEN THROUGH INFUSION SETS WHICH HAVE ALREADY BEEN USED OR ARE INTENDED FOR SIMULTANEOUS INFUSION OF PROTEIN HYDROSYLATE OR SOLUTIONS CONTAINING ALCOHOL.

Precautions

Adequate precautions should be taken against circulatory overload; this can be done, for example, by measurement of the pulmonary wedge pressure. Special caution is indicated in patients with stabilized chronic anemia or renal insufficiency.

The rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may not have bled at the lower blood pressure.

Certain components used in the packaging of this product contain natural rubber latex.

PREGNANCY CATEGORY C. Albumin (Human) 5% -- Animal reproduction studies have not been conducted with Albumin (Human) 5%. It is also not known whether Albumin (Human) 5% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albumin (Human) 5% should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Though very rare, adverse reactions such as chills, fever, tachycardia, hypotension, urticaria, skin rash and nausea may occur (3,8,9,11). These symptoms may disappear if the infusion is slowed or stopped for a short period of time. If necessary, the intravenous administration of 50 to 200 mg of prednisolone may be useful (9).

Dosage and Administration

Upon administration of Albumin (Human) 5% there is a rapid increase of the plasma volume about equal to the volume infused. The initial dose for adults is 250 to 500 mL. The quantity given may be increased to a total of 0.5 g albumin per pound of body weight (i.e., 10 mL/pound), but administration should be monitored by careful observation of the patient. The rate of infusion and the total volume administered are determined by the condition and the response of the patient. A rate of 1-2 mL per minute is usually suitable in the absence of overt shock, whereas the capacity of the administration set is the only limit in the exsanguinated patient. During resuscitation, constant monitoring of the patient provides the guidelines for treatment. For children, a dose of 10 to 15 mL per pound of body weight is usually adequate and close surveillance of the small patient is essential. In severely injured or septic patients, administration of Albumin (Human) 5% should always be guided by an appropriate hemodynamic monitoring of the patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

To prepare Albumin (Human) 5% for administration, remove outer seal to expose central portion of rubber stopper, cleanse stopper with germicidal solution and follow directions for use of intravenous injection set.

Albumin (Human) 5% must be administered INTRAVENOUSLY. The venipuncture site should not be infected or traumatized, and should be prepared with standard aseptic technique. The solution is compatible with whole blood or packed red blood cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. By contrast, it should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. It is ready for use as contained in the bottle and may be given without regard to the blood group of the recipient.

Only clear solutions of a light yellowish color should be administered.

How Supplied

Puncture vial containing 50 mL of Albumin (Human) 5%.

Puncture vial containing 250 mL of Albumin (Human) 5%.

Puncture vial containing 500 mL of Albumin (Human) 5%.

The package may be supplied with an intravenous injection set.

STORAGE

Albumin (Human) 5% can be stored for 3 years at a temperature not exceeding 30°C (86°F).

Protect from freezing.

References

  1. CLOWES, G.H.A., Jr., VUCINIC, M., and WEIDNER, M.G.: Ann. Surg. 163, 866 (1996).
  2. JANEWAY, C.A. In: Sgouris, J.T. and Rene A. (eds.): Proceedings of the Workshop on Albumin, DHEW Publication No. (NIH) 76-925, U.S. Government Printing Office, Washington, D.C., p. 3-21 (1976).
  3. LOWENSTEIN, E. In: Sgouris, J.T. and Rene A. (eds.): Proceedings of the Workshop on Albumin, DHEW Publication No. (NIH) 76-925, U.S. Government Printing Office, Washington, D.C., p. 302 (1976).
  4. MAHARAJ, D., FELL, G.S., BOYCE, B.F., NG, J.P., SMITHE, G.D., BOULTON-JONES, J.M., CUMMING, R.L., and DAVIDSON, J.F.: Brit. Med. J. 295, 693-696 (1987).
  5. MILLINER, D.S., SHINABERGER, J.H., SHUMAN, P., and COBURN, J.W.: N. Engl. J. Med. 312, 165-167 (1985).
  6. OTT, S.M., MALONEY, N.A., KLEIN, G.L., ALFREY, A.C., AMENT, M.E., COBURN, J.W., and SHERRAND, D.J.: Ann. of Inter. Med. 98, 910-914 (1983).
  7. PETERS, T., Jr., In: Putnam, F.W. (ed.): Plasma Proteins, 2nd Edition, Vol. 1, Academic Press, New York, p. 133-181 (1975).
  8. RING, J. and MESSMER, K.: Lancet 1, 466 (1977).
  9. RING, J., SEIFERT, J., LOB, G., COULIN, K., and BRENDEL, W.: W. Klin, Wschr. 52, 595 (1974).
  10. STARLING, E.H.: J. Physiol. (London) 19, 312 (1896).
  11. TULLIS, J.L.: J.A.M.A. 237, 355 (1977).
  12. TULLIS, J.L.: J.A.M.A. 237, 460 (1977).
  13. WILLIS, M.R., and SAVORY, J.A.: Lancet 2, 29-34 (1983).

IMMUNO-U.S., INC.

1200 Parkdale Road

Rochester, MI 48307 USA

Distributed in Canada By:

IMMUNO (Canada) LTD.

U.S. License No. 850              Canadian License No. 227

Rev. April, 1998

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