Prescription Drugs

CLINICAL PHARMACOLOGY Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating and increasing blood volume.4,5,6 It is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6 BUMINATE 5%, Albumin (Human), 5% Solution is osmotically equivalent to an equal volume of normal human plasma and will increase circulating plasma volume by an amount approximately equal to the volume infused. The degree and duration of volume expansion depends upon the initial blood volume. With patients treated for diminished blood volume, the effect of infused albumin may last for many hours. In patients with normal blood volumes, the hemodilution lasts for a shorter period.7,8 Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments. The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5 The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mm Hg.4 BUMINATE 5%, Albumin (Human), 5% Solution is manufactured by the modified Cohn-Oncley cold ethanol fractionation process which includes a series of cold-ethanol precipitation, centrifugation and/or filtration of human plasma followed by pasteurization of the final product at 60 ± 0.5°C for 10 - 11 hours. This process accomplishes both purification of albumin and the reduction of viruses. In vitro studies demonstrate that the manufacturing process for BUMINATE 5%, Albumin (Human), 5% Solution provides for significant viral reduction. These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for BUMINATE 5%, Albumin (Human), 5% Solution using human immunodeficiency virus, type 1 (HlV-1) both as a relevant and model virus for HIV-2 and other enveloped RNA viruses; bovine viral diarrheal virus (BVD), a model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); porcine parvovirus (PPV), a model for non-lipid enveloped DNA viruses such as human parvovirus B19; hepatitis A virus (HAV), a relevant virus and a model for non-lipid enveloped RNA viruses. These studies indicate that specific manufacturing steps for BUMINATE 5%, Albumin (Human), 5% Solution are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation at each step is different, the overall manufacturing process of BUMINATE 5%, Albumin (Human), 5% Solution is robust in reducing viral load. Table 1 Summary of Viral Reduction Factor for Each Virus and Processing Step Process Step Viral Reduction Factor (log10) Lipid Enveloped Non-lipid Enveloped BVD HIV-1 PRV HAV PPV Step 1: Processing of cryo-poor plasma to Fraction I+II+III centrifugate 1.2±0.0 5.8±0.0 4.6±0.5 1.9±0.8 1.4±0.1 Step 2: Processing of Fraction I+II+III centrifugate to Fraction IV1 centrifugate 2.8±0.5 NCM 3.4±0.4 1.9±0.7 (1.2±0.3)* Step 3: Processing of Fraction IV1 centrifugate to Fraction IV4 centrifugate/ filter press filtrate† > 2.4±0.1/ > 2.4±0.1 > 4.4±0.5/ > 4.5±0.5 > 4.8±0.1/ > 4.8±0.1 3.8±0.1/ 2.9±0.2 2.2±0.3/ 2.0±0.3 Step 4: Processing of Fraction IV4 centrifugate/ filter press filtrate to Fraction IV4 Cuno 70C filtrate†† > 1.6±0.2/ > 1.7±0.1 NCM > 4.1±0.5/ > 4.4±0.1 4.7±0.1/ 4.6±0.1 2.3±0.3/ 3.0±0.8 Step 5: Processing of Fraction V suspension to Cuno 90LP filtrate (0.2±0.2)* > 5.0±0.5 > 4.6±0.0 4.2±0.4 3.4±0.5 Step 6: Pasteurization > 4.9±0.1 > 5.1±0.3 > 5.3±0.1 5.3±0.4 NT Cumulative Reduction Factor**, log10 >12.9/13.0 > 20.3/20.4 > 26.8/27.1 21.8/20.8 9.3/9.8 NT Not tested. NCM No virus reduction claim made at this step. * Since the reduction factor of < 1.0 is within the variability limit of the assay, these values are not included in the computation of the cumulative reduction factor. † Two reduction factors indicate the two liquid-solid separation options available at this step. †† Two reduction factors indicate the two starting materials at this step. ** Two cumulative reduction factors derived from the use of the two liquid-solid separation options available at Step 3. 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 7. Janeway CA: Berenberg W, Hutchins G: Indications and uses of blood, blood derivatives and blood substitutes. Med Clin N Amer 29:10691094, 1945 8. Janeway CA, Gibson ST, Woodruff LM, et al: Chemical, clinical and immunological studies on the products of human plasma fractionation. VII. Concentrated human serum albumin. J Clin Invest 23:465-490, 1944

CLINICAL PHARMACOLOGY Albumin (Human) 25%, Albuminar®-25 (albumin (human)) is active osmotically and is therefore important in regulating the volume of circulating blood. When injected intravenously, 50 mL of 25% albumin draws approximately 175 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity. The degree of volume expansion is dependent on the initial blood volume. When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours. In individuals with normal blood volume, it usually lasts only a few hours. Albumin, unlike whole blood or plasma, is considered free of the danger of homologous serum hepatitis. Albumin (Human) 25%, Albuminar®-25 (albumin (human)) may be given in conjunction with other parenteral fluids such as saline, dextrose or sodium lactate. It is convenient to use since no crossmatching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

BUMINATE 5% Albumin (Human), USP, 5% Solution This bottle contains 12.5 g albumin from venous plasma in saline and is osmotically equivalent to an equal volume of normal human plasma. It has been stabilized with sodium caprylate and sodium acetyltryptophanate and heated for 10 hours at 60°C. The sodium content is 145 ±15 mEq/L. Contains no preservative. Store at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. See attached directions for use. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Single dose container. Discard partially used bottle. The patient and physician should discuss the risks and benefits of this product. DESCRIPTION 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

Find Lowest Prices on Albuminar®-25 [albumin (Human)] USP, 25% DESCRIPTION Albumin (Human) 25%, Albuminar®-25 (albumin human) is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours. The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established. Albumin (Human) 25%, Albuminar®-25 (albumin human) is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia. Albumin (Human) 25%, Albuminar®-25 (albumin human) , is to be administered by the intravenous route. The heat treatment step employed in the manufacture of Albumin (Human) 25%, Albuminar®-25 (albumin human) , pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus), and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albumin (Human) 5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 (albumin human) with the following results.1 Pasteurization (60° C for 10 hours) Viral Reduction Studies (log10 reduction) Virus Albumin (Human) 5%, Albuminar®-5 HIV-1 >5.44, >6.38 and >6.31 BVDV >6.01, >6.76 and >6.55 PrV >7.30, >7.68 and >7.63 EMC >7.38, >7.97 and >7.97 Virus Albumin (Human) 25%, Albuminar®-25 HIV-1 >5.50, >6.57 and >6.64 BVDV >5.99, >5.81 and >5.32 PrV >7.32, >7.20 and >7.42 EMC >7.10, >7.89 and >7.87 1. Data on file.

INDICATIONS 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 Inadequate production (malnutrition, burns, major injury infections, etc.) Excessive catabolism (burns, major injury, pancreatitis, etc.) Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.) 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. DOSAGE AND ADMINISTRATION 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. Remove cap from bottle to expose center portion of rubber stopper. 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. HOW SUPPLIED 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

INDICATIONS Shock- Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated. Burns - Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance. Hypoproteinemia with or without edema- Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained. DOSAGE AND ADMINISTRATION Albumin (Human) 25%, Albuminar®-25 (albumin (human)) may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 200 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma. When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume. In the treatment of shock the amount of albumin and duration of therapy must be based on the responsiveness of the patient as indicated by blood pressure, degree of pulmonary congestion, and hematocrit. The initial dose may be followed by additional albumin within 15-30 minutes if the response is deemed inadequate. If there is continued loss of protein, it may be desirable to give packed red blood cells. In the treatment of burns an optimal regimen involving use of albumin, crystalloids, electrolytes and water has not been established. Suggested therapy during the first 24 hours includes administration of large volumes of crystalloid solution to maintain an adequate plasma volume. Continuation of therapy beyond 24 hours usually requires more albumin and less crystalloid solution to prevent marked hemoconcentration and maintain electrolyte balance. Duration of treatment varies depending upon the extent of protein loss through renal excretion, denuded areas of skin and decreased albumin synthesis. Attempts to raise the albumin level above 4.0 g/100 mL may only result in an increased rate of catabolism. In the treatment of hypoproteinemia, 200 to 300 mL of 25% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of 25% albumin should not be given faster than 100 mL in 30 to 45 minutes to avoid circulatory embarrassment. If slower administration is desired, 200 mL of 25% albumin may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL of this dextrose solution an hour. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. HOW SUPPLIED Albumin (Human), Albuminar®-25 (albumin (human)) is supplied as a 25% solution in: 20 mL vials containing 5 grams of albumin (NDC 0053-7680-01) 50 mL vials containing 12.5 grams of albumin (NDC 0053-7680-32) 100 mL vials containing 25 grams of albumin (NDC 0053-7680-33) Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Bibliography Finlayson, J.S.: Albumin Products. Seminars in Thrombosis and Hemostasis 6:85-120, 1980. Tullis, J.L.: Albumin. JAMA 237: 355-360 and 460-463, 1977. Rudolph, A.M.: Pediatrics. 18th ED., p. 1839, Appleton and Lange, 1987. Manufactured by: ZLB Behring LLC, Kankakee, IL 60901, USA. Revised August, 2004. FDA Rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

PATIENT INFORMATION Some viruses, such as parvovirus B19 or hepatitis A are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women, or immune-compromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (community acquired) sources.

OVERDOSE No information provided. CONTRAINDICATIONS 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.

OVERDOSE NO INFORMATION PROVIDED. CONTRAINDICATIONS Albumin (Human) 25%, Albuminar®-25 (albumin (human)) may be contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

SIDE EFFECTS 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. DRUG INTERACTIONS No information provided.

SIDE EFFECTS Allergic or pyrogenic reactions are characterized primarily by fever and chills; rash, nausea, vomiting, tachycardia and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional ALBUMIN (HUMAN) USP, ALBUTEIN® ,material from a different lot should be used. ALBUTEIN® , particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema. DRUG INTERACTIONS No information provided.

WARNINGS Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. BUMINATE 5%, Albumin (Human), 5% Solution 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 (See DESCRIPTION). Despite these measures, such products can still potentially transmit disease. Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. 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 Baxter Healthcare Corporation at 1-800-423-2862. The physician should discuss the risks and benefits of this product with the patient. PRECAUTIONS 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.

WARNINGS Infusion of protein-containing solutions such as Albuminar®-25 (albumin (human)) that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar®-25 (albumin (human)) , which are normal saline and 5% dextrose. Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered. Albumin (Human) 25%, Albuminar®-25 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 during manufacture. The manufacturing procedure for Albumin (Human) 25%, Albuminar®-25 (albumin (human)) includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar®-25 (albumin (human)) is pasteurized in the final container at 60.0 +/- 0.5°C for 10-11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures.) Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to ZLB Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient. Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. PRECAUTIONS General If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 25%, Albuminar®-25 (albumin (human)) should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired - 200 mL of albumin solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour. If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient's clinical state should be monitored closely during infusion. Pregnancy Category C- Animal reproduction studies have not been conducted with Albumin (Human) 25%, Albuminar®-25 (albumin (human)) . It is also not known whether Albuminar®-25 (albumin (human)) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar®-25 (albumin (human)) should be given to a pregnant woman only if clearly needed. Pediatric Use - No clinical studies using Albumin (Human) 25%, Albuminar®-25 (albumin (human)) have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) 25%, Albuminar (albumin (human)) ®-25 in the same manner as adults.