Europe — EMA
Human Albumin Baxalta (Human Serum Albumin)
Human Albumin Baxalta is a prescription IV solution of human serum albumin used to treat hypovolemia and hypoalbuminemia by restoring plasma oncotic pressure.
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What is Human Serum Albumin?
Human Albumin Baxalta is a sterile solution for injection that contains human serum albumin as the active ingredient. It is supplied in a standard concentration for intravenous administration and is marketed in the European Union as a prescription‑only plasma protein product. The preparation is used to restore plasma oncotic pressure and to support volume expansion in patients with hypovolemia or hypoalbuminemia under careful medical supervision.
What is Human Serum Albumin used for?
Human Albumin Baxalta is indicated for clinical situations where restoration of plasma volume or albumin concentration is required.
- Treatment of hypovolemia due to acute blood loss, burns, or surgery. - Management of hypoalbuminemia associated with liver disease, nephrotic syndrome, or malnutrition. - Support during major fluid shifts in critical care or perioperative settings. - Adjunct therapy for patients undergoing renal dialysis with low serum albumin. - Volume expansion in patients with sepsis or severe infections when albumin replacement is indicated.
What are the side effects of Human Serum Albumin?
Adverse reactions to Human Albumin Baxalta are generally infrequent but may occur during or after infusion.
Common: - Mild fever or chills. - Transient hypotension or hypertension. - Nausea, vomiting, or abdominal discomfort. - Localized rash or urticaria at the infusion site.
Serious: - Severe anaphylactic or anaphylactoid reactions. - Acute hemolysis or renal impairment. - Pulmonary edema or fluid overload. - Thromboembolic events such as deep vein thrombosis.
What precautions apply to Human Serum Albumin?
Before using Human Albumin Baxalta, clinicians should evaluate patient history and monitor specific parameters to reduce risk.
- Assess for known hypersensitivity to albumin or blood products. - Verify baseline serum albumin and fluid status to avoid overload. - Use caution in patients with heart failure, renal insufficiency, or pulmonary disease. - Monitor vital signs and urine output during infusion. - Adjust infusion rate if signs of hypotension or allergic reaction appear. - Avoid use in patients with uncontrolled sepsis unless albumin replacement is clinically justified.
What does Human Serum Albumin interact with?
Human Albumin Baxalta may interact with other agents that affect fluid balance or immune response.
Avoid: - Concurrent administration of large-volume crystalloid solutions that may exacerbate fluid overload. - Simultaneous use of other plasma expanders without clear clinical indication.
Use with caution: - Diuretics, which may alter intravascular volume during albumin therapy. - Vasopressors, as rapid changes in blood pressure can occur. - Anticoagulants, because volume expansion may affect coagulation parameters. - Immunosuppressive agents, which could mask allergic reactions.



