Europe — EMA
Human Albumin Baxalta (Human Serum Albumin)
Human Albumin Baxalta is a sterile IV solution of human serum albumin used as a volume expander and plasma protein replacement for hypovolemia, shock, burns, and hypoalbuminemia.
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What is Human Serum Albumin?
Human Albumin Baxalta is a sterile solution for injection containing human serum albumin as the active ingredient. It is supplied in an unspecified strength and is marketed in the European Union. The product is classified as an albumin and is prescribed as a volume expander and plasma protein replacement for intravenous administration. It is available only by prescription and is intended for use under the supervision of a qualified health professional.
What is Human Serum Albumin used for?
Human Albumin Baxalta is used clinically to restore and maintain intravascular volume in conditions where plasma protein loss or deficiency occurs. It is commonly administered intravenously in acute care settings to address fluid shifts and low albumin levels.
- Treatment of hypovolemia associated with trauma, surgery, or dehydration. - Management of shock where rapid plasma expansion is required. - Supportive care for patients with extensive burns to replace lost plasma proteins. - Correction of hypoalbuminemia in chronic liver disease or nephrotic syndrome. - Volume replacement during massive transfusion protocols. - Adjunct therapy in plasma exchange procedures.
What are the side effects of Human Serum Albumin?
Adverse reactions to Human Albumin Baxalta are generally infrequent but may occur following intravenous administration.
Common: - Transient fever or chills. - Mild hypotension or hypertension. - Headache or dizziness. - Nausea or vomiting.
Serious: - Anaphylactic or severe allergic reaction. - Acute hemolysis. - Volume overload leading to pulmonary edema.
What precautions apply to Human Serum Albumin?
When prescribing Human Albumin Baxalta, clinicians should evaluate patient history and monitor for potential complications.
- Assess for known hypersensitivity to human albumin or blood products. - Use caution in patients with congestive heart failure or renal impairment due to risk of fluid overload. - Monitor fluid balance and weight in individuals receiving large volumes. - Avoid rapid infusion rates that may provoke cardiovascular instability. - Evaluate coagulation status in patients with bleeding disorders. - Consider the risk of infection transmission in immunocompromised patients.
What does Human Serum Albumin interact with?
Human Albumin Baxalta may interact with other intravenously administered agents, influencing efficacy or safety.
Avoid: - Concurrent administration with other volume expanders that may cause excessive plasma volume. - Simultaneous infusion of high‑dose diuretics that could exacerbate electrolyte disturbances.
Use with caution: - Co‑administration with vasopressors; monitor hemodynamic response. - Infusion alongside blood products; observe for compatibility and transfusion reactions. - Use with nephrotoxic drugs; assess renal function closely.



