Europe — EMA
Humanalbumin Kedrion
Humanalbumin Kedrion is a prescription human albumin solution for injection used as a plasma volume expander to treat hypovolemia, shock, burns, and hypoalbuminemia.
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What is Human Albumin Solution?
Humanalbumin Kedrion is a human albumin solution for injection, supplied as a sterile solution with an unspecified strength. The product contains purified human albumin, a plasma protein used as a volume expander. It is marketed in the European Union and requires a prescription. Humanalbumin Kedrion is administered intravenously and is indicated for hypovolemia, shock, burns, and hypoalbuminemia where intravascular volume restoration is needed, clinically and effectively.
What is Human Albumin Solution used for?
Humanalbumin Kedrion is employed as a plasma volume expander in clinical settings where rapid restoration of circulatory volume is required.
- Treatment of hypovolemia due to fluid loss, hemorrhage, or dehydration. - Management of circulatory shock associated with trauma, sepsis, or anaphylaxis. - Supportive care for patients with extensive burns to maintain intravascular oncotic pressure. - Correction of hypoalbuminemia in liver disease, nephrotic syndrome, or malnutrition. - Adjunct therapy during major surgery to prevent intra‑operative hypotension. - Volume expansion in patients with severe pancreatitis to improve microcirculatory flow. - Use in renal replacement therapy to counteract albumin loss during dialysis.
What are the side effects of Human Albumin Solution?
Adverse reactions to Humanalbumin Kedrion are generally infrequent but may occur during or after infusion, and they can range from mild, transient symptoms to rare, life‑threatening events.
Common: - Mild fever or chills. - Transient hypotension or hypertension. - Headache or dizziness. - Nausea or vomiting. - Localized erythema or urticaria at the infusion site. - Mild pruritus or skin rash. - Flushing or warmth sensation. - Slight increase in serum creatinine.
Serious: - Anaphylactic or severe allergic reactions. - Acute hemolysis. - Pulmonary edema due to rapid volume overload. - Thromboembolic events. - Sepsis related to contaminated product. - Disseminated intravascular coagulation. - Acute renal failure secondary to volume overload. - Cardiogenic pulmonary edema in patients with compromised cardiac function.
What precautions apply to Human Albumin Solution?
When using Humanalbumin Kedrion, clinicians should assess patient risk factors and monitor clinical status to minimize potential complications.
- Verify indication and ensure benefit outweighs risk of volume overload. - Assess baseline fluid balance, cardiac function, and pulmonary status before infusion. - Use the lowest effective volume and infuse at a controlled rate. - Monitor vital signs, especially blood pressure and heart rate, during and after administration. - Observe for signs of allergic reaction or anaphylaxis throughout the infusion. - Adjust dosage in patients with renal or hepatic impairment. - Avoid use in patients with known hypersensitivity to human albumin.
What does Human Albumin Solution interact with?
Humanalbumin Kedrion may interact with other therapies that affect fluid balance, coagulation, or immune response, requiring careful consideration.
Avoid: - Concurrent administration of other volume expanders (e.g., synthetic colloids) that may cause excessive intravascular volume. - Use with blood products containing incompatible antibodies. - Concurrent infusion of hypertonic saline solutions, which can cause rapid shifts in osmolarity.
Use with caution: - Diuretics, which may alter the intended volume expansion effect. - Vasopressors, as combined therapy can affect hemodynamic stability. - Anticoagulants, because changes in plasma protein levels can modify drug binding. - Immunosuppressants, due to potential additive risk of infection. - Renal replacement therapies, as albumin may be removed during dialysis, affecting dosing. - Chemotherapeutic agents that are highly protein bound, since albumin infusion can alter their free concentrations.
Frequently asked questions
What is Humanalbumin Kedrion and how is it supplied?+
How does Humanalbumin Kedrion differ from synthetic colloid volume expanders?+
In which clinical situations is Humanalbumin Kedrion indicated?+
What is the mechanism by which Humanalbumin Kedrion expands intravascular volume?+
What monitoring is recommended during Humanalbumin Kedrion infusion?+
Can Humanalbumin Kedrion be used in patients with heart failure?+
What are the common adverse reactions associated with Humanalbumin Kedrion?+
How should an allergic reaction to Humanalbumin Kedrion be managed?+
Are there any contraindications for Humanalbumin Kedrion?+
How does Humanalbumin Kedrion interact with diuretics or vasopressors?+
What storage conditions are required for Humanalbumin Kedrion?+
Is Humanalbumin Kedrion approved for use in the United States?+
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