Drug: Buminate 5%

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 is 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. 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 BUMINATE 5%, Albumin (Human), 5% Solution contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient's blood group. References 1. Gellis SS, Neefe JR, Stokes J Jr, et al: Chemical, clinical and immunological studies on the products of human plasma fractionation. XXXVI. Inactivation of the virus of homologous serum hepatitis in solutions of normal human serum albumin by means of heat. J Clin Invest 27:239-244, 1948 2. Gerety RJ, Aronson DL: Plasma derivatives and viral hepatitis. Transfusion 22:347-351, 1982 3. Murray R, Diefenbach WCL, Geller H, etat Problem of reducing danger of serum hepatitis from blood and blood products. NY State J Med 55:1145-1150, 1955 Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

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Untoward reactions to BUMINATE 5%, 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. Read the Buminate 5% (albumin (human) 5% solution) Side Effects Center for a complete guide to possible side effectsLearn More »

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BUMINATE 5%, Albumin (Human), 5% Solution 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's condition and response. Recommended Dosages Hypovolemia Although the volume of BUMINATE 5%, Albumin (Human), 5% Solution administered must be individualized, the initial dose should be 250 to 500 mL for older children and adults and 12 to 20 mL per kilogram of body weight for infants and young children. It may be repeated after 30 minute intervals if the response is not adequate. Hypoalbuminemia Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia. When using the patient's serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to 100 mL per kilogram of body weight.5,6 Daily dose should not exceed 2 g of albumin per kilogram of body weight. Burns When BUMINATE 5%, Albumin (Human), 5% Solution is administered after the first 24 hours following burns, an initial dose of 500 mL is recommended. Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  1. Remove cap from bottle to expose center portion of rubber stopper.
  2. Clean stopper with germicidal solution.
Administration Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.

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No information provided. Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 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
  1. Inadequate production (malnutrition, burns, major injury infections, etc.)
  2. Excessive catabolism (burns, major injury, pancreatitis, etc.)
  3. Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
  4. 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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A history of allergic reactions to albumin is a specific contraindication to the use of this product. BUMINATE 5%, Albumin (Human), 5% Solution is also contraindicated in severely anemic patients and in patients with cardiac failure. Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

BUMINATE 5%, Albumin (Human), 5% Solution is supplied in 250 mL and 500 mL bottles. Storage Store BUMINATE 5%, Albumin (Human), 5% Solution at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. References 4. Tullis JL: Albumin, 1. Background and use, and 2. Guidelines for clinical use. JAMA 237:355-360,460-463, 1977 5. Peters T Jr: Serum albumin, in The Plasma Proteins, 2nd ed, Vol 1. Putnam FW (ed). New York, Academic Press, 1975, pp 133-181 6. Finlayson JS: Albumin products. Sem Thromb Hemostas 6:85-120, 1980 9. Shoemaker WC, Schluchter M, Hopkins JA, et al: Comparison of the relative effectiveness of colloids and crystalloids in emergency resuscitation. Am J Surg 142:73-83, 1981 10. Lowenstein E, Hallowell P, Bland JHL: Use of colloid and crystalloid solutions in open heart surgery: Physiological basis and clinical results, in Proceedings of the Workshop on Albumin. Sgouris JT, Rene A (eds.) DHEW Publication No. (NIH) 76-925, Washington DC, U.S. Government Printing Office, 1976, pp 195-210 To enroll in the confidential, industry-wide Patient Notification System, call 1-888-UPDATE U (1-888-873-2838). Baxter Healthcare Corporation, Westlake Village, CA 91362 USA. Revised September 2002. FDA rev date: n/a Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Certain components used in the packaging of this product contain natural rubber latex. BUMINATE 5%, Albumin (Human), 5% Solution 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, BUMINATE 5%, Albumin (Human), 5% Solution 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 BUMINATE 5%, Albumin (Human), 5% Solution 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. Pregnancy-Category C Animal reproduction studies have not been conducted with BUMINATE 5%, Albumin (Human), 5% Solution. It is not known whether BUMINATE 5%, Albumin (Human), 5% Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BUMINATE 5%, Albumin (Human), 5% Solution should be given to a pregnant woman only if clearly needed. Pediatric Use The use of BUMINATE 5%, 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. Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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