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Plasbumin-5 (Albumin (Human))
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Pharmacology
Albumin (human) 5% is oncotically (colloid osmotic) equivalent volume for volume to normal human plasma.
When administered i.v. to an adequately hydrated subject, the oncotic 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.
Albumin (human) 5% is oncotically (colloid osmotic) equivalent volume for volume to normal human plasma.
When administered i.v. to an adequately hydrated subject, the oncotic 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
Albumin (human) 5% Is Oncotically (colloid Osmotic) Equivalent Volume For Volume To Normal Human Plasma.
When Administered I.v. To An Adequately Hydrated Subject, The Oncotic 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.
Albumin (human) 5% Is Oncotically (colloid Osmotic) Equivalent Volume For Volume To Normal Human Plasma.
When Administered I.v. To An Adequately Hydrated Subject, The Oncotic 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.
Contraindications
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.
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.
Safety Information / Warning
Plasbumin-5 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. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitisC. 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 Bayer Inc. at 1-800-622-2937 ext. 5425.
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering to the patient.
Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4hours 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.
Plasbumin-5 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. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitisC. 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 Bayer Inc. at 1-800-622-2937 ext. 5425.
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering to the patient.
Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4hours 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 manyhours. 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 , CategoryC: 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.
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 manyhours. 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 , CategoryC: 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.
Side Effects / Adverse Effects
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.
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.
Overdose
Information not available
Information not available
Recommended Dosage
Albumin (human) 5% should always be administered by i.v. infusion. The choice between the use of5% 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 of20mmHg (equal to a total serum protein concentration of5.2g/100mL) 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 10to 20mL/kg equivalent to 0.5to 1.0g albumin/kg body weight.
Burns: After a burn injury (usually beyond 24hours) 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 of2.5±0.5g/100mL with a plasma oncotic pressure of20mmHg (equivalent to a total plasma protein concentration of5.2g/100mL). 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.
Albumin (human) 5% should always be administered by i.v. infusion. The choice between the use of5% 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 of20mmHg (equal to a total serum protein concentration of5.2g/100mL) 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 10to 20mL/kg equivalent to 0.5to 1.0g albumin/kg body weight.
Burns: After a burn injury (usually beyond 24hours) 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 of2.5±0.5g/100mL with a plasma oncotic pressure of20mmHg (equivalent to a total plasma protein concentration of5.2g/100mL). 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.
Supplied / Packaging
Each vial of sterile, aqueous solution for i.v. administration contains albumin (human) 5%, USP: 2.5g (in 50mL), 12.5g (in 250mL), 25g (in 500mL). Also contains sodium caprylate 0.004M, and acetyltryptophan 0.004M and is buffered with sodium carbonate. Preservative-free. Vials of 50 (pediatric size), 250and 500mL.
Each vial is heat-treated at60°C for 10hours against the possibility of transmitting the hepatitis viruses.
Store at room temperature not exceeding30°C. Do not use after expiration date. Do not freeze.
Each vial of sterile, aqueous solution for i.v. administration contains albumin (human) 5%, USP: 2.5g (in 50mL), 12.5g (in 250mL), 25g (in 500mL). Also contains sodium caprylate 0.004M, and acetyltryptophan 0.004M and is buffered with sodium carbonate. Preservative-free. Vials of 50 (pediatric size), 250and 500mL.
Each vial is heat-treated at60°C for 10hours against the possibility of transmitting the hepatitis viruses.
Store at room temperature not exceeding30°C. Do not use after expiration date. Do not freeze.
Search for a drug
Brand Name
Plasbumin-5
Plasbumin-5
Generic Name
Albumin (Human)
Albumin (Human)
General Indications
Plasma Substitute/Blood Derivative
Plasma Substitute/Blood Derivative
