Europe — EMA
Human Albumin Biotest
Human Albumin Biotest is an EU‑approved intravenous human serum albumin solution used for plasma volume expansion and hypoalbuminemia management.
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What is Human Serum Albumin?
Human Albumin Biotest 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 as a prescription‑only plasma protein product. The preparation is used to expand intravascular volume by restoring colloid osmotic pressure, and it is administered intravenously under medical supervision. It is typically stored refrigerated and prepared according to aseptic technique before infusion.
What is Human Serum Albumin used for?
Human Albumin Biotest is indicated for clinical situations where plasma volume expansion or albumin replacement is required.
- Treatment of hypovolemia associated with trauma, surgery, or fluid loss. - Management of shock and severe burns to restore circulatory volume. - Correction of hypoalbuminemia in liver disease, nephrotic syndrome, or chronic illness. - Support during major surgical procedures to maintain oncotic pressure. - Adjunct therapy in patients with plasma protein loss during extracorporeal circulation.
What are the side effects of Human Serum Albumin?
Adverse reactions to Human Albumin Biotest are generally infrequent but may occur during or after infusion.
Common: - Mild fever or chills. - Transient hypotension or hypertension. - Headache or dizziness. - Nausea or mild gastrointestinal discomfort.
Serious: - Anaphylactic or severe allergic reactions. - Acute hemolysis or renal impairment. - Volume overload leading to pulmonary edema.
What precautions apply to Human Serum Albumin?
Before administering Human Albumin Biotest, clinicians should evaluate patient history and monitor specific parameters to reduce risk.
- Assess for known hypersensitivity to human albumin or any component of the formulation. - Evaluate fluid status and cardiac function, especially in patients with heart failure or renal insufficiency. - Monitor vital signs and urine output during infusion to detect early signs of volume overload. - Use caution in patients with active infection, as albumin may affect immune response. - Adjust dose or infusion rate in patients with severe hypoalbuminemia or coagulopathy. - Avoid rapid bolus administration; prefer controlled infusion rates.
What does Human Serum Albumin interact with?
Human Albumin Biotest can interact with other medications or solutions administered intravenously; awareness of these interactions helps maintain safety.
Avoid: - Co‑administration with incompatible solutions such as calcium‑containing fluids that may precipitate. - Simultaneous infusion of high‑dose diuretics that could exacerbate intravascular volume shifts. - Use with blood products that have differing osmolarity without proper mixing protocols.
Use with caution: - Concurrent vasopressor therapy, as rapid volume changes may alter hemodynamic response. - Anticoagulants, because changes in plasma volume can affect coagulation monitoring. - Renal replacement therapies, where albumin removal may reduce therapeutic effect.
Frequently asked questions
What is the primary clinical purpose of Human Albumin Biotest?+
How is Human Albumin Biotest administered to patients?+
Can Human Albumin Biotest be used during major surgery?+
What are common adverse reactions observed with albumin infusion?+
When should clinicians avoid using Human Albumin Biotest?+
Is there a risk of volume overload with Human Albumin Biotest?+
What monitoring is recommended during infusion of Human Albumin Biotest?+
Are there any special storage requirements for Human Albumin Biotest?+
Can Human Albumin Biotest interact with anticoagulant therapy?+
What should be considered when using Human Albumin Biotest in patients with liver disease?+
Is Human Albumin Biotest approved for over‑the‑counter sale?+
What is the ATC classification for Human Albumin Biotest?+
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