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Plasbumin-25 (Albumin (Human))
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Pharmacology
Each 20mL vial of albumin (human) 25% supplies the oncotic (colloid osmotic) equivalent of approximately 100mL citrated plasma; 50mL supplies the oncotic equivalent of approximately 250mL citrated plasma.
When administered i.v.to an adequately hydrated subject, the oncotic effect of20mL albumin (human) 25% is such that it will draw approximately a further 70mL of fluid from the extravascular tissues into the circulation within 15minutes, thus increasing the total blood volume and reducing both hemoconcentration and whole blood viscosity. Accordingly, the main clinical indications are for hypoproteinemic states involving reduced oncotic pressure, with or without accompanying edema. Albumin (human) 25% can also be used as a plasma volume expander.
Albumin is a transport protein and it may be useful in severe hemolytic disease in the neonate who is awaiting exchange transfusion. The infused albumin may reduce the level of free bilirubin in the blood.
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.
Each 20mL vial of albumin (human) 25% supplies the oncotic (colloid osmotic) equivalent of approximately 100mL citrated plasma; 50mL supplies the oncotic equivalent of approximately 250mL citrated plasma.
When administered i.v.to an adequately hydrated subject, the oncotic effect of20mL albumin (human) 25% is such that it will draw approximately a further 70mL of fluid from the extravascular tissues into the circulation within 15minutes, thus increasing the total blood volume and reducing both hemoconcentration and whole blood viscosity. Accordingly, the main clinical indications are for hypoproteinemic states involving reduced oncotic pressure, with or without accompanying edema. Albumin (human) 25% can also be used as a plasma volume expander.
Albumin is a transport protein and it may be useful in severe hemolytic disease in the neonate who is awaiting exchange transfusion. The infused albumin may reduce the level of free bilirubin in the blood.
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
Each 20mL Vial Of Albumin (human) 25% Supplies The Oncotic (colloid Osmotic) Equivalent Of Approximately 100mL Citrated Plasma; 50mL Supplies The Oncotic Equivalent Of Approximately 250mL Citrated Plasma.
When Administered I.v.to An Adequately Hydrated Subject, The Oncotic Effect Of20mL Albumin (human) 25% Is Such That It Will Draw Approximately A Further 70mL Of Fluid From The Extravascular Tissues Into The Circulation Within 15minutes, Thus Increasing The Total Blood Volume And Reducing Both Hemoconcentration And Whole Blood Viscosity. Accordingly, The Main Clinical Indications Are For Hypoproteinemic States Involving Reduced Oncotic Pressure, With Or Without Accompanying Edema. Albumin (human) 25% Can Also Be Used As A Plasma Volume Expander.
Albumin Is A Transport Protein And It May Be Useful In Severe Hemolytic Disease In The Neonate Who Is Awaiting Exchange Transfusion. The Infused Albumin May Reduce The Level Of Free Bilirubin In The Blood.
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.
Each 20mL Vial Of Albumin (human) 25% Supplies The Oncotic (colloid Osmotic) Equivalent Of Approximately 100mL Citrated Plasma; 50mL Supplies The Oncotic Equivalent Of Approximately 250mL Citrated Plasma.
When Administered I.v.to An Adequately Hydrated Subject, The Oncotic Effect Of20mL Albumin (human) 25% Is Such That It Will Draw Approximately A Further 70mL Of Fluid From The Extravascular Tissues Into The Circulation Within 15minutes, Thus Increasing The Total Blood Volume And Reducing Both Hemoconcentration And Whole Blood Viscosity. Accordingly, The Main Clinical Indications Are For Hypoproteinemic States Involving Reduced Oncotic Pressure, With Or Without Accompanying Edema. Albumin (human) 25% Can Also Be Used As A Plasma Volume Expander.
Albumin Is A Transport Protein And It May Be Useful In Severe Hemolytic Disease In The Neonate Who Is Awaiting Exchange Transfusion. The Infused Albumin May Reduce The Level Of Free Bilirubin In The Blood.
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 an allergic reaction to albumin is a specific contraindication to 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 an allergic reaction to albumin is a specific contraindication to usage.
Safety Information / Warning
Plasbumin-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. 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.
As with any hyperoncotic protein solution likely to be administered in large volumes, severe hemolysis and acute renal failure may result from the inappropriate use of Sterile Water for Injection as a diluent for Plasbumin-25. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Please refer to the Dosage for recommended diluents.
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. Albumin (human) 25% contains no preservative.
Plasbumin-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. 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.
As with any hyperoncotic protein solution likely to be administered in large volumes, severe hemolysis and acute renal failure may result from the inappropriate use of Sterile Water for Injection as a diluent for Plasbumin-25. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Please refer to the Dosage for recommended diluents.
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. Albumin (human) 25% contains no preservative.
Precautions
General: Patients should always be monitored carefully in order to guard against the possibility of circulatory overload. Albumin (human) 25% is hyperoncotic, therefore, in the presence of dehydration, albumin must be given with or followed by addition of fluids.
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) 25%, USP is compatible with whole blood, packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for i.v. use. It should, however, not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.
Pregnancy , Category C: Animal reproduction studies have not been conducted with albumin (human) 25%. 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. Albumin (human) 25% is hyperoncotic, therefore, in the presence of dehydration, albumin must be given with or followed by addition of fluids.
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) 25%, USP is compatible with whole blood, packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for i.v. use. It should, however, not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.
Pregnancy , Category C: Animal reproduction studies have not been conducted with albumin (human) 25%. 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 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 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) 25% should always be administered by i.v. infusion. If sodium restriction is required, it may be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% dextrose in water.
Hypovolemic Shock: For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
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 of 2.5±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) 25%. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema: Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the i.v. administration of albumin (human) 25% must be considered purely symptomatic or supportive (see Indications, Situations in which albumin administration is not warranted). The usual daily dose of albumin for adults is 50to 75g and for children 25g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of albumin (human) 25% should not exceed 2mL/min, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under Indications.
Preparation for Administration: Remove seal to expose stopper. Always swab stopper top immediately with a 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) 25% should always be administered by i.v. infusion. If sodium restriction is required, it may be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% dextrose in water.
Hypovolemic Shock: For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.
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 of 2.5±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) 25%. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.
Hypoproteinemia With or Without Edema: Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the i.v. administration of albumin (human) 25% must be considered purely symptomatic or supportive (see Indications, Situations in which albumin administration is not warranted). The usual daily dose of albumin for adults is 50to 75g and for children 25g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of albumin (human) 25% should not exceed 2mL/min, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.
Other dosage recommendations are given under Indications.
Preparation for Administration: Remove seal to expose stopper. Always swab stopper top immediately with a 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) 25%, USP: 5g (in 20mL), 12.5g (in 50mL), 25g (in 100mL). The solution also contains sodium caprylate 0.02M and acetyltryptophan 0.02M and is buffered with sodium carbonate. Preservative-free. Vials of20, 50 and 100mL.
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) 25%, USP: 5g (in 20mL), 12.5g (in 50mL), 25g (in 100mL). The solution also contains sodium caprylate 0.02M and acetyltryptophan 0.02M and is buffered with sodium carbonate. Preservative-free. Vials of20, 50 and 100mL.
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.
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Brand Name
Plasbumin-25
Plasbumin-25
Generic Name
Albumin (Human)
Albumin (Human)
General Indications
Plasma Substitute/Blood Derivative
Plasma Substitute/Blood Derivative
