Europe — EMA
Humani Albumin Baxalta (Human Serum Albumin)
Humani Albumin Baxalta is an EU‑marketed human serum albumin solution for injection used as a plasma volume expander.
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What is Human Serum Albumin?
Humani Albumin Baxalta is a sterile solution for injection that contains human serum albumin as its active ingredient. Marketed in the European Union, this plasma‑derived product is supplied without a specified strength label and is administered intravenously under prescription. It belongs to the albumin drug class and is used as a plasma volume expander to restore intravascular oncotic pressure and to support circulatory stability in patients with hypoalbuminemia.
What is Human Serum Albumin used for?
Humani Albumin Baxalta is employed in clinical situations where rapid expansion of plasma volume is required and where albumin deficiency contributes to fluid shifts.
- Treatment of hypovolemia associated with burns, major surgery, or traumatic injury. - Volume replacement in patients with severe hypoalbuminemia or liver disease. - Support of circulatory stability during liver transplantation procedures. - Management of nephrotic syndrome when oncotic pressure is markedly reduced. - Use as a carrier protein in investigational drug formulations.
What are the side effects of Human Serum Albumin?
Adverse reactions to Humani Albumin Baxalta vary in frequency and severity.
Common: - Mild fever or chills - Headache - Nausea or vomiting - Transient hypertension or flushing
Serious: - Anaphylactic or severe allergic reactions - Volume overload leading to pulmonary edema - Hemolysis or transfusion‑related acute lung injury - Thromboembolic events such as deep‑vein thrombosis - Acute renal dysfunction or failure
What precautions apply to Human Serum Albumin?
Humani Albumin Baxalta should be used with careful clinical assessment and monitoring.
- Assess cardiac and renal function before infusion to avoid volume overload. - Monitor vital signs and fluid balance during and after administration. - Use caution in patients with known hypersensitivity to human albumin or plasma products. - Avoid rapid infusion rates that may precipitate hypotension or pulmonary edema. - Consider risk of infection transmission inherent to plasma‑derived products. - Adjust dosage in patients with severe burns or extensive capillary leak syndrome.
What does Human Serum Albumin interact with?
Potential drug interactions may modify the safety profile of Humani Albumin Baxalta.
Avoid: - Concurrent use of other colloid volume expanders without medical supervision. - Simultaneous administration of high‑dose diuretics that could exacerbate intravascular depletion.
Use with caution: - Anticoagulants and antiplatelet agents, due to possible alteration of bleeding risk. - ACE inhibitors or ARBs, which may affect blood pressure regulation. - Nephrotoxic medications, as added volume may stress compromised kidneys. - Other plasma‑derived products, which could increase the risk of immune reactions.



