FLEXBUMIN [Albumin (Human)]

The information contained in this page is intended for U.S. healthcare professionals only.

Indications & Usage FLEXBUMIN 5%, Albumin (Human), USP, 5% Solution

FLEXBUMIN 5% [Albumin (Human)] 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.

FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.

Indications & Usage FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution

FLEXBUMIN 25% [Albumin (Human)] 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.

FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, adult respiratory distress syndrome (ARDS), and nephrosis, and for use during cardiopulmonary bypass surgery as a component of the pump prime, and hemolytic disease of the newborn (HDN).

Important Risk Information for FLEXBUMIN 5%

  • FLEXBUMIN 5% is contraindicated in patients with a history of allergic reactions to human albumin and any of the excipients, severe anemia, and heart failure.
  • Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
  • Do not dilute with Sterile Water for injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human). Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
  • FLEXBUMIN 5% is made from human blood. It carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD) and theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD).
  • FLEXBUMIN 5% must be administered intravenously. FLEXBUMIN 5% should be administered slowly (5 to 10 mL/min) to avoid too rapid a rise in the blood pressure. More rapid administration can cause circulatory overload and pulmonary edema.
  • Monitor blood pressure in trauma patients and postoperative patients resuscitated with FLEXBUMIN 5% in order to detect rebleeding secondary to clot disruption.
  • In post marketing experience anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions, headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension, flushing, pulmonary edema, dyspnea, vomiting, nausea, urticaria, rash, pruritus, pyrexia and chills have been reported.

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.

Important Risk Information for FLEXBUMIN 25%

  • FLEXBUMIN 25% is contraindicated in patients with a history of allergic reactions to human albumin and any of the excipients, severe anemia, and heart failure.
  • Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered.
  • Do not dilute with Sterile Water for injection as this can cause hemolysis. There exists a risk of potentially fatal hemolysis and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human) in concentrations of 20% or higher. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
  • FLEXBUMIN 25% is made from human blood. It carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD) and theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD).
  • FLEXBUMIN 25% must be administered intravenously at a rate not to exceed 1 mL/min to patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema.
  • Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with FLEXBUMIN 25% in order to detect rebleeding secondary to clot disruption.
  • In post marketing experience anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions, headache, dysgeusia, myocardial infarction, atrial fibrillation, tachycardia, hypotension, flushing, pulmonary edema, dyspnea, vomiting, nausea, urticaria, rash, pruritus, pyrexia and chills have been reported.

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.

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