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Human Albumin Baxalta

Active Ingredient:
Human Plasma Protein
Origin:
EU

Human Albumin Baxalta (Human Plasma Protein)

Human Albumin Baxalta is a sterile solution for injection that contains human plasma protein (human albumin) as the active ingredient. The product is supplied in an unspecified strength and is intended for intravenous administration. It is classified as a plasma volume expander and is available by prescription in the European Union. The formulation is derived from pooled human plasma and is used to support patients with low plasma protein levels.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Human Albumin Baxalta is indicated for clinical situations that require rapid restoration of intravascular volume or plasma protein concentration.

  • Treatment of hypovolemia due to acute blood loss, surgery, or trauma.
  • Management of hypoalbuminemia associated with chronic liver disease, nephrotic syndrome, or malnutrition.
  • Supportive care for patients with extensive burns to maintain oncotic pressure.
  • Resuscitation in shock states where plasma expansion is needed.
  • Adjunct therapy during plasma exchange procedures.
  • Prevention of circulatory collapse in patients undergoing major abdominal or cardiac surgery.

How It Works

  • Human Albumin Baxalta works by increasing the oncotic pressure of the plasma compartment. Albumin molecules bind water and small solutes, drawing fluid from the interstitial space into the vascular lumen. This shift expands intravascular volume and helps restore normal plasma protein concentrations. The effect is mediated through the albumin’s natural role in maintaining colloid osmotic balance and transporting endogenous substances.

Side Effects

Adverse reactions to Human Albumin Baxalta are generally related to the infusion process or to the protein source.

Common

  • Mild fever or chills during or shortly after infusion.
  • Headache or dizziness.
  • Nausea, vomiting, or abdominal discomfort.
  • Transient hypertension or hypotension.
  • Localized erythema or swelling at the injection site.
  • Mild rash or pruritus at distant sites.

Serious

  • Anaphylactic or severe allergic reactions, including urticaria and bronchospasm.
  • Acute hemolysis or renal impairment.
  • Volume overload leading to pulmonary edema.
  • Thromboembolic events such as deep vein thrombosis.
  • Transmission of infectious agents (theoretical risk despite screening).
  • Severe hypotension requiring vasopressor support.

These events are typically identified during monitoring and may resolve with appropriate medical management.

Precautions & Warnings

When prescribing Human Albumin Baxalta, clinicians should evaluate patient history and monitor for conditions that could be aggravated by plasma volume expansion.

  • Assess for fluid overload, congestive heart failure, or severe renal disease before administration.
  • Verify that the patient has no known hypersensitivity to albumin or any component of the solution.
  • Use caution in patients with active infection or sepsis, as volume expansion may affect hemodynamics.
  • Monitor vital signs and fluid balance during and after infusion, especially in critically ill individuals.
  • Adjust dose or infusion rate in patients with pulmonary hypertension or compromised cardiac function.
  • Consider the risk of electrolyte disturbances, particularly hypernatremia, when large volumes are infused.

Avoid Interactions

Human Albumin Baxalta may interact with other intravenously administered agents, and certain combinations require avoidance or careful monitoring.

Avoid

  • Concurrent use with other plasma expanders (e.g., hydroxyethyl starch) due to risk of volume overload.
  • Simultaneous infusion of high‑dose diuretics that may precipitate rapid intravascular volume shifts.
  • Administration with blood products containing incompatible antibodies.

Use with caution

  • Co‑administration with vasopressors; monitor blood pressure closely.
  • Use alongside nephrotoxic drugs; assess renal function regularly.
  • Combination with anticoagulants; observe for bleeding tendencies.
  • Overlap with other colloid solutions; adjust total colloid load.

Frequently Asked Questions

Human Albumin Baxalta is used as a plasma volume expander to increase intravascular volume and restore plasma protein levels in conditions such as hypovolemia and hypoalbuminemia.

It is commonly given for acute blood loss, major surgery, severe burns, shock, and chronic conditions that cause low albumin levels, such as liver disease or nephrotic syndrome.

The product is supplied as a sterile solution for injection and is administered intravenously under medical supervision.

Use in children should be based on clinical judgment and dosing guidelines provided by the prescribing information; it is not specifically contraindicated but requires careful monitoring.

Vital signs, fluid balance, and signs of allergic reaction should be monitored before, during, and after the infusion, especially in critically ill patients.

The product is derived from pooled human plasma that undergoes rigorous screening and viral inactivation; however, a theoretical risk of infectious disease transmission remains.

Infusion should be stopped immediately, and appropriate medical treatment such as antihistamines, corticosteroids, or epinephrine should be administered according to standard anaphylaxis protocols.

Contraindications include known hypersensitivity to albumin or any component of the formulation and conditions where rapid plasma expansion could be harmful, such as uncontrolled heart failure.

Human Albumin Baxalta is a natural plasma protein that restores oncotic pressure, whereas synthetic colloids are man‑made substances that may have different safety profiles and metabolic pathways.

Concurrent administration is possible, but compatibility and timing should be managed by the healthcare team to avoid volume overload and ensure appropriate monitoring.

The solution should be stored according to the manufacturer’s instructions, typically refrigerated between 2 °C and 8 °C, and protected from light.

The product information provided refers to the European Union market; approval status in other regions should be verified with local regulatory authorities.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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