Plasbumin 5 (Albumin)

PLASBUMIN®-5

Bayer

Albumin (Human)

Plasma Substitute/Blood Derivative

Action And Clinical Pharmacology: Albumin (human) 5% is oncotically equivalent volume for volume to normal human plasma.

When administered i.v. to an adequately hydrated subject, the oncotic (colloid osmotic) effect of Albumin (Human) 5% is to expand the circulating blood volume by an amount approximately equal to the volume infused. It is primarily used in the treatment of shock associated with hemorrhage, surgery, trauma, burns, bacteremia, renal failure, and cardiovascular collapse.

Albumin is a transport protein and it may be useful in severe jaundice in hemolytic disease of the newborn. This could also be of importance in acute liver failure where albumin might serve the dual role of supporting plasma oncotic pressure, as well as binding excessive plasma bilirubin.

Indications And Clinical Uses: Emergency Treatment of Hypovolemic Shock: Albumin (human) 5% is iso-oncotic with normal plasma and on i.v. 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; but where there is an oncotic deficit, the 25% solution may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If the 25% solution is used, appropriate additional crystalloid should be administered.

Crystalloid solutions in volumes several times greater than that of Albumin (Human) 5% may be effective in treating shock in younger individuals who have no pre-existing illness at the time of the incident. Older patients, especially those with pre-existing 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.

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.

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. Albumin (human) 25% may be preferred for this purpose.

Cardiopulmonary Bypass: 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/100 mL in the patient.

Acute Liver Failure: 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: 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: 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.

Contra-Indications: Certain patients, e.g., those with a history of congestive cardiac failure, renal insufficiency or stabilized chronic anemia, are at special risk of developing circulatory overload. A history of allergic reaction to albumin is a specific contraindication for usage.

Manufacturers’ Warnings In Clinical States: Solutions which are turbid or which have been frozen should not be used. Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded. Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. The 5% solution contains no preservative.

Precautions: General: Patients should always be monitored carefully in order to guard against the possibility of circulatory overload. The 5% solution is iso-oncotic with normal plasma and will not tend to aggravate tissue dehydration. Appropriate additional crystalloids should be administered, if required by the patient, to maintain normal fluid balance.

In hemorrhage, the administration of albumin should be supplemented by the transfusion of whole blood to treat the relative anemia associated with hemodilution. When circulating blood volume has been reduced, hemodilution following the administration of albumin persists for many hours. In patients with a normal blood volume, hemodilution lasts for a much shorter period. The rapid rise in blood pressure, which may follow the administration of a colloid with positive oncotic activity, necessitates careful observation to detect and treat severed blood vessels which may not have bled at the lower blood pressure.

Drug Interactions: Albumin (human) 5% is compatible with whole blood and packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for i.v. use. It should not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.

Pregnancy: Animal reproduction studies have not been conducted with albumin (human) 5%. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Children: Safety and effectiveness in the pediatric population have not been established.

Adverse Reactions: Adverse reactions to albumin are rare. Such reactions may be allergic in nature or be due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse and blood pressure. tag_DosageDosage

Dosage And Administration: Albumin (human) 5% should always be administered by i.v. infusion. The choice between the use of 5% and 25% solutions depends upon whether the patient requires primarily volume (5% solution) or primarily colloid osmotic activity (25% solution). Below a serum oncotic level of 20 mmHg (equal to a total serum protein concentration of 5.2 g/100 mL) there is evidence which suggests that the risk of complications increases. When the oncotic pressure drops below this level, the patient should be treated with the 25% solution 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.

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, albumin (human) 5% may be given in large amounts. 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/100 mL with a plasma oncotic pressure of 20 mmHg (equivalent to a total plasma protein concentration of 5.2 g/100 mL). This is best achieved by the i.v. administration of albumin (human), usually as the 25% solution. 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. Long-term administration of albumin should not be considered as a source of nutrition.

Other dosage recommendations are given under Indications.

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.

Availability And Storage: Each vial of sterile, aqueous solution for i.v. administration contains albumin (human) 5%, USP: 2.5 g (in 50 mL), 12.5 g (in 250 mL), 25 g (in 500 mL). Also contains sodium caprylate 0.004 M, and acetyltryptophan 0.004 M and is buffered with sodium carbonate. Preservative-free. Vials of 50 (pediatric size), 250 and 500 mL.

Each vial is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

Store at room temperature not exceeding 30°C. Do not use after expiration date. Do not freeze.

PLASBUMIN®-5 Bayer Albumin (Human) Plasma Substitute/Blood Derivative

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