Albutein

Normal human serum albumin

Albutein 5%, 20% and 25% solution is a sterile aqueous solution for single dose IV administration containing 5%, 20% and 25% human albumin (weight/volume), respectively. Albutein is prepared by alcohol fractionation method from pooled human plasma obtained from venous blood. Albutein is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate/g albumin. Albutein 5% solution is osmotically and isotonically equivalent to an equal volume of normal human plasma. Albutein 20% and 25% is osmotically equivalent to 4 and 5 times its volume of normal human plasma, respectively. Albutein 5%, 20% and 25% solution contains 130-160 mEq sodium ion/L and has a pH 6.9±0.5. Albutein contains no preservatives. Albutein is heated at 60°C for 10 hrs. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis.

Pharmacology: There are no known cases of viral hepatitis, which have resulted from the administration of Albutein. Albumin is a highly soluble, globular protein (molecular weight 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma. Albutein 5% solution supplies the oncotic equivalent of approximately its volume of human plasma. Albutein 20% and 25% solutions supply the oncotic equivalent of approximately 4 and 5 times its volume of human plasma respectively. Albutein 5% will increase the circulating plasma volume by an amount approximately equal to the volume infused. This extra fluid reduces hemoconcentration and decreases blood volume. Albutein 20% and 25% will increase the circulating plasma volume by an amount approximately 2.5 and 3.5 times, respectively, the volume infused within 15 min, if the recipient is adequately hydrated. This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hrs. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.
Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation. The binding properties of albumin may, special circumstances provide an indication for its clinical use. For such purposes, however, the 25% solution should be used.
Albumin is distributed throughout the extracellular water and >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; it has a circulating life span of 15-20 days, with a turnover of approximately 15 g/day.

Treatment of hypovolemic shock.
Albutein 5%: In conditions in which there is severe hypoalbuminemia. However, unless the pathologic condition responsible for the hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic or supportive relief.
As an adjunct in hemodialysis and in cardiopulmonary bypass procedures.
Albutein 20% and 25%: As an adjunct in hemodialysis for patients or for those who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.
In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established.
Conditions in which Albumin 20% and 25% solution may be indicated:
Adult respiratory distress syndrome (ARDS).
Major injury or surgery resulting in increased albumin loss or inadequate synthesis.
Acute nephrosis not responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.
Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.
Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is no valid reason for the use of albumin as an IV nutrient.
In those conditions in which the colloid requirement is high and there is less need for fluid, albumin should be administered as a 25% solution.
Children: Albumin (human) USP 20% solution is indicated in conjunction with exchange transfusion in the treatment of neonatal hyperbilirubinemia.
The pediatric use of Albutein has not been clinically evaluated. Therefore, physicians should weigh the risks and benefits of the use of Albumin (human) in the pediatric population.

Administer IV. The total dosage will vary with the individual.
Adults: An initial infusion of 500 mL (Albutein 5%) or 100 mL (Albutein 20%/25%) is suggested. Additional amounts may be administered as clinically indicated.
In the treatment of patient in shock wih greatly reduced blood volume, Albutein may be administered as rapidly as necessary in order to improve the clinical condition as restore normal blood volume. This may be repeated in 15-30 min if the initial dose fails to prove adequate. In patient with a slightly low or normal blood volume, the rate of administration should be 1-2 and 1 mL/min for Albutein 5% and Albutein 20%/25%, respectively.
If dilution of Albutein 20%/25% is clinically desirable, compatible diluents include sterile 0.9% Sodium Chloride solution or sterile 5% Dextrose in Water.
Children: The pediatric use of Albutein has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose ¼-½ the adult dose may be administered or dosage may be calculated on the basis of 0.6-1 g/kg body weight (Albutein 5%: 12-20 mL; Albutein 20%: 3-5 mL and Albutein 25%: 2.4-4 mL). The usual rate of administration in children should be ¼ the adult rate.
Albutein 20%/25%: For jaundiced infants suffering from hemolytic disease of the newborn, the appropriate dose for binding of free serum bilirubin is 1 g/kg of body weight which may be adminsitered during the procedure.
Administration: Albutein (250 and 500 mL with Administration Set):
Flip off plastic cap on the top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile IV equipment as follows:
Close clamp on administration set (delivers approximately 15 and 19 drops/mL for Albutein 5% and Albutein 20%/25%).
With bottle upright, thrust piercing pin straight through stopper center. Do not twist or angle.
Immediately invert bottle to automatically establish proper fluid level in drip chamber (half full).
Attach infusion set to administration set, open clamp and allow solution to expel air from tubing and needle, then close clamp.
Make venipuncture and adjust flow.
Discard all administration equipment after use. Discard any unused contents.
Albutein 20% and 25% (When Administration Set is not Used):
Flip off plastic cap on the top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile IV equipment as follows:
Using aseptic technique, attach filter needle to a sterile disposable plastic syringe.
Insert filter needle into Albutein vial.
Aspirate Albutein from the vial into the syringe.
Remove and discard the filter needle from the syringe.
Attach desired size needle to syringe.
Discard all administration equipment after use. Discard any unused contents.

Patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume; patients with a history of allergic reactions to Albutein.

Albutein is made from pooled human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases, including a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). Although no cases of transmission of viral diseases or CJD have ever been identified for albumin, the risk of infectious agents cannot be totally eliminated. All infections thought by a physician possibly to have been transmitted by Albutein should be reported to the manufacturer at 1-323-225-9735. The physician should weigh the risks and benefits of the use of Albutein and should discuss these with the patient.
Albutein should not be used if they appear turbid or if there is sediment in the bottle. Do not begin administration >4 hrs after the container has been entered. Discard unused portion.
Albutein 20% and 25%: Following reports that there exists a risk of potentially fatal hemodialysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human), if dilution is required, acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Albutein should be administered with caution to patients with low cardiac reserve.
Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure. Patients with marked dehydration require administration of additional fluids. Albutein may be administered with the usual dextrose and saline IV solutions. However, solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Albutein since these combinations may cause the proteins to precipitate.
Use in pregnancy: Animal reproduction studies have not been conducted with Albumin (Human). It is also not known whether Albumin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human) should be given to pregnant woman only if clearly needed.

Use in pregnancy: Animal reproduction studies have not been conducted with Albumin (Human). It is also not known whether Albumin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human) should be given to pregnant woman only if clearly needed.

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 Albutein, material from a different lot should be used.
Albutein, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

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

Albutein is stable for 3 years providing storage temperature does not exceed 30°C. Protect from freezing.

Intravenous & Other Sterile Solutions

B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

P₁S₁S₃