Europe — EMA
Human Albumin Baxalta (Human Serum Albumin)
Human Albumin Baxalta is a prescription intravenous albumin solution used to expand plasma volume and treat hypoalbuminemia in EU patients.
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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. Provided as an intravenous albumin solution, it is manufactured for the European market and classified as a plasma protein used as a volume expander. The product is prescription‑only and is used when rapid restoration of circulatory volume or correction of low serum albumin is needed clinically.
What is Human Serum Albumin used for?
Human Albumin Baxalta is employed in clinical settings where plasma volume expansion or albumin replacement is required.
- Treatment of hypovolemia associated with acute blood loss or dehydration. - Management of shock, including septic or hemorrhagic shock. - Support for patients with extensive burns to maintain intravascular volume. - Correction of hypoalbuminemia in liver disease, nephrotic syndrome, or chronic malnutrition. - Adjunct therapy during renal dialysis when low albumin contributes to fluid shifts. - Perioperative volume management in major surgery.
What are the side effects of Human Serum Albumin?
Adverse reactions to Human Albumin Baxalta are generally infrequent but can range from mild to severe.
Common: - Transient fever or chills. - Mild hypotension or hypertension. - Headache. - Nausea or vomiting. - Local irritation at the infusion site.
Serious: - Anaphylactic or severe allergic reactions. - Acute hemolysis. - Volume overload leading to pulmonary edema. - Thromboembolic events. - Renal dysfunction.
What precautions apply to Human Serum Albumin?
Clinicians should evaluate patient history and clinical status before administering Human Albumin Baxalta to minimize risk.
- Assess for known hypersensitivity to human albumin or any component of the solution. - Use caution in patients with congestive heart failure or pulmonary edema due to risk of volume overload. - Monitor fluid balance and electrolytes during and after infusion. - Avoid rapid infusion rates that may provoke cardiovascular instability. - Evaluate renal and hepatic function, as impairment may affect albumin metabolism. - Consider the potential for increased intracranial pressure in patients with head trauma.
What does Human Serum Albumin interact with?
Human Albumin Baxalta may interact with other therapies that influence fluid balance, coagulation, or immune response.
Avoid: - Concurrent administration of other volume expanders (e.g., synthetic colloids) without careful monitoring. - Use with drugs that have a high risk of anaphylaxis, such as certain antibiotics or contrast agents, without pre‑medication.
Use with caution: - Diuretics, which may exacerbate intravascular volume shifts. - Vasopressors, as combined effects on blood pressure require close observation. - Anticoagulants, because changes in plasma protein levels can alter drug binding. - Immunosuppressants, due to potential modulation of immune reactions.



