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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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
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 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.
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
There is currently no drug history available for this drug.
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.