Flexbumin
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Questions & Answers
Side Effects & Adverse Reactions
Allergic /Anaphylactic Reactions
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, implement standard medical treatment for shock.
Transmission of Infectious Agents
FLEXBUMIN 5% 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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hypovolemia
The effectiveness of FLEXBUMIN 5% in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective with patients who are well hydrated. When the hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% albumin is preferable to 5% protein solutions.4,6 Use 5% protein solutions or dilute 25% albumin with crystalloid solutions in the absence of adequate or excessive hydration. Administer compatible red blood cells or whole blood as quickly as possible when blood volume deficit is the result of hemorrhage.
Hypoalbuminemia
General
Hypoalbuminemia can result from one or more of the following:5
(1) Inadequate production (malnutrition, burns, major injury, infections, etc.)
(2) Excessive catabolism (burns, major injury, pancreatitis, etc.)
(3) Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
(4) Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed.
There is no valid reason for use of albumin as an intravenous nutrient. 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 albumin solutions.
Occasionally, hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements can fail to restore serum albumin levels. FLEXBUMIN 5% is indicated in these cases.
Burns
An optimum regimen for the use of albumin, electrolytes and fluid in the early treatment of burns has not been established, however, in conjunction with appropriate crystalloid therapy, FLEXBUMIN 5% is indicated for treatment of oncotic deficits after the initial 24 hour period following extensive burns and to replace the protein loss which accompanies any severe burn.4,6
Cardiopulmonary Bypass Surgery
FLEXBUMIN 5% is indicated during cardiopulmonary bypass surgery as a component of the pump prime.6
History
There is currently no drug history available for this drug.
Other Information
FLEXBUMIN 5% in 250 mL GALAXY plastic container is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5g of albumin and was 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 stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M). The sodium content is 145 ± 15 mEq/L. This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 5% 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 minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and 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 FLEXBUMIN 5% contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient’s blood group.
The GALAXY plastic container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
Sources
Flexbumin Manufacturers
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Baxter Healthcare Corporation
![Flexbumin (Albumin Human) Injection, Solution [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Flexbumin | Baxter Healthcare Corporation
FLEXBUMIN 5% must be administered intravenously.
• Do not use if turbid. • Do not begin administration more than 4 hours after the container has been entered. • Monitor hemodynamic parameters in patients receiving FLEXBUMIN 5% and check for the risk of hypervolemia and cardiovascular overload.[see Precautions] Hypervolemia can occur if the dosage and rate of infusion are not adjusted, giving consideration to the solution concentration and the patient’s clinical status. • Do not dilute with Sterile Water for Injection as this can cause hemolysis in recipients [see Contraindications]. • Do not mix with other medicinal products including blood and blood components. FLEXBUMIN 5% can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The volume of the total dose and the rate of infusion depend on the patient’s condition and response. • Do not mix with protein hydrolysates or solutions containing alcohol since these combinations can cause the proteins to precipitate. • Do not add supplementary medication. • Record the name and batch number of the product to maintain a link between the patient and the product. • Discard unused portion.Recommended Dosages
Hypovolemia
The dosage of FLEXBUMIN 5% must be individualized. Initial dosage range for older children and adults is 250 to 500 mL and for infants and young children 12 to 20 mL per kilogram body weight. Repeat after 30 minute intervals if the response is not adequate.
Upon administration of additional albumin or if hemorrhage occurs, hemodilution, and a relative anemia can occur. Supplemental administration of compatible red blood cells or compatible whole blood may be required to treat this condition.
Burns
The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. An initial dose of 500 mL is recommended after the first 24 hours following burns.
Hypoalbuminemia
Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. Consider total body albumin deficit when determining the amount of albumin necessary to reverse the hypoalbuminemia. Calculate the body albumin compartment to be 80 to 100 mL per kilogram of body weight when using the patient’s serum albumin concentration to estimate the deficit.5,6 Do not exceed a daily dose of 2 g of albumin per kilogram of body weight.
Preparation for Administration
• Check the GALAXY container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility can be impaired. • Do not add supplementary medication. • Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. FLEXBUMIN 5% is a transparent or slightly opalescent solution, which may have a greenish tint or may vary from a pale straw to an amber color. Do not use unless solution is clear of particulate matter and seal is intact.CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Administration:
1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. Make certain that the administration set contains an adequate filter (15-micron or smaller). -
Baxter Healthcare Corporation
Flexbumin | Baxter Healthcare Corporation
FLEXBUMIN 25% must be administered intravenously.
• Do not use if turbid. • Do not begin administration more than 4 hours after the container has been entered. • Monitor hemodynamic parameters in patients receiving FLEXBUMIN 25% and check for the risk of hypervolemia and cardiovascular overload.[see Precautions]. Hypervolemia can occur if the dosage and rate of infusion are not adjusted, giving consideration to the solution concentration and the patient’s clinical status. • Do not dilute with Sterile Water for Injection as this can cause hemolysis in recipients [see Contraindications]. • Do not mix with other medicinal products including blood and blood components. FLEXBUMIN 25% can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The addition of four volumes of normal saline or 5% glucose to 1 volume of FLEXBUMIN 25% gives a solution which is approximately isotonic and isosmotic with citrated plasma. • Do not mix with protein hydrolysates or solutions containing alcohol since these combinations can cause the proteins to precipitate. • Do not add supplementary medication. • Record the name and batch number of the product in order to maintain a link between the patient and the batch of the product. • Discard unused portion. Recommended DosagesHypovolemic Shock
The dosage of FLEXBUMIN 25% must be individualized. Initial dosage range for adults is 100 to 200 mL and for children 2.5 to 5 mL per kilogram body weight. Repeat after 15 to 30 minutes if the response is not adequate. Administer albumin replacement in the form of 5% Albumin (Human) in patients with significant plasma volume deficits.
Upon administration of additional albumin or if hemorrhage occurs, hemodilution and anemia can occur. Supplemental administration of compatible red blood cells or compatible whole blood may be required to treat this condition.
Burns
The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. Determine the appropriate dose according to the patient’s condition and response to treatment when FLEXBUMIN 25% is administered after the first 24 hours following burns.
Hypoalbuminemia
Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. Consider total body albumin deficit when determining the amount of albumin necessary to reverse the hypoalbuminemia. Calculate the body albumin compartment to be 80 to 100 mL per kg of body weight when using the patient’s serum albumin concentration to estimate the deficit.5,6 Do not exceed a daily dose of 2 g of albumin per kilogram of body weight.
Hemolytic Disease of the Newborn
Administer FLEXBUMIN 25% prior to or during exchange transfusion at a dose of 1 g per kilogram body weight.12
Preparation for Administration • Check the GALAXY container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility can be impaired. • Do not add supplementary medication. • Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. FLEXBUMIN 25% is a transparent or slightly opalescent solution, which may have a greenish tint or may vary from a pale straw to an amber color. Do not use unless solution is clear of particulate matter and seal is intact.CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Administration: 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container.3. 3. Attach administration set. Refer to complete directions accompanying set. Make certain that the administration set contains an adequate filter (15-micron or smaller). -
Baxter Healthcare Corporation
Flexbumin | Baxter Healthcare Corporation
FLEXBUMIN 20% must be administered intravenously.
• Do not use if turbid. • Do not begin administration more than 4 hours after the container has been entered. • Monitor hemodynamic parameters in patients receiving FLEXBUMIN 20% and check for the risk of hypervolemia and cardiovascular overload.[see Precautions]. Hypervolemia can occur if the dosage and rate of infusion are not adjusted, giving consideration to the solution concentration and the patient’s clinical status. • Do not dilute with Sterile Water for Injection as this can cause hemolysis in recipients [see Contraindications]. • Do not mix with other medicinal products including blood and blood components. FLEXBUMIN 20% can be used concomitantly with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate when deemed medically necessary. The addition of four volumes of normal saline or 5% glucose to 1 volume of FLEXBUMIN 20% gives a solution which is approximately isotonic and isosmotic with citrated plasma. • Do not mix with protein hydrolysates or solutions containing alcohol since these combinations can cause the proteins to precipitate. • Do not add supplementary medication. • Record the name and batch number of the product in order to maintain a link between the patient and the batch of the product. • Discard unused portion. Recommended DosagesHypovolemic Shock
The dosage of FLEXBUMIN 20% must be individualized. Initial dosage range for adults is 125 to 250 mL and for children 3 to 6 mL per kilogram body weight. Repeat after 15 to 30 minutes if the response is not adequate. Administer albumin replacement in the form of 5% Albumin (Human) in patients with significant plasma volume deficits.
Upon administration of additional albumin or if hemorrhage occurs, hemodilution and anemia can occur. Supplemental administration of compatible red blood cells or compatible whole blood may be required to treat this condition.
Burns
The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. Determine the appropriate dose according to the patient’s condition and response to treatment when FLEXBUMIN 20% is administered after the first 24 hours following burns.
Hypoalbuminemia
Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. Consider total body albumin deficit when determining the amount of albumin necessary to reverse the hypoalbuminemia. Calculate the body albumin compartment to be 80 to 100 mL per kg of body weight when using the patient’s serum albumin concentration to estimate the deficit.5,6 Do not exceed a daily dose of 2 g of albumin per kilogram of body weight.
Hemolytic Disease of the Newborn
Administer FLEXBUMIN 20% prior to or during exchange transfusion at a dose of 1 g per kilogram body weight.12
Preparation for Administration • Check the GALAXY container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility can be impaired. • Do not add supplementary medication. • Visually inspect parenteral drug product for particulate matter and discoloration prior to administration. FLEXBUMIN 20% is a transparent or slightly opalescent solution, which may have a greenish tint or may vary from a pale straw to an amber color. Do not use unless solution is clear of particulate matter and seal is intact.CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Administration: 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container.3. Attach administration set. Refer to complete directions accompanying set. Make certain that the administration set contains an adequate filter (15-micron or smaller).
![Flexbumin (Albumin Human) Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bdb4e167-27a2-4b50-b245-43df9cd535cb&name=image-01.jpg)
![Flexbumin (Albumin Human) Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98b96ee2-86d2-4056-bdda-4d75d72d891f&name=image-01.jpg)
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