Europe — EMA
Human Albumin Kedrion
Human Albumin Kedrion is a prescription intravenous solution used as a plasma volume expander for hypovolemia, shock, burns, and hypoalbuminemia.
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What is Human Albumin Solution?
Human Albumin Kedrion is a sterile solution for injection that contains human albumin as the active ingredient. It is supplied as a plasma-derived protein solution without a specified concentration, intended for intravenous administration. The product is manufactured in the European Union and is available by prescription only. It is used as a plasma volume expander to help restore and maintain intravascular fluid balance in patients with low blood volume.
What is Human Albumin Solution used for?
Human Albumin Kedrion is indicated for clinical situations where rapid plasma volume expansion is required. It is commonly employed in the management of hypovolemia, shock, extensive burns, and hypoalbuminemia.
- Treatment of hypovolemia due to trauma, surgery, or dehydration. - Management of circulatory shock when fluid resuscitation is needed. - Support of patients with severe burns to replace lost plasma proteins. - Correction of hypoalbuminemia associated with liver disease or nephrotic syndrome. - Volume expansion during major surgical procedures or cardiac bypass.
What are the side effects of Human Albumin Solution?
Adverse reactions to Human Albumin Kedrion are generally infrequent but can range from mild to severe.
Common: - Fever, chills, or rigors occurring during or shortly after the infusion. - Headache, light‑headedness, or transient dizziness that resolves without intervention. - Nausea, vomiting, or mild abdominal discomfort. - Localized urticaria, pruritus, or erythema at the infusion site.
Serious: - Anaphylaxis or severe hypersensitivity reaction characterized by bronchospasm, hypotension, or angio‑edema. - Acute renal failure or hemolysis manifested by sudden rise in serum creatinine or hemoglobinuria. - Volume overload resulting in pulmonary edema, hypertension, or congestive heart failure.
What precautions apply to Human Albumin Solution?
Before using Human Albumin Kedrion, clinicians should assess patient history and monitor specific clinical parameters to reduce risk.
- Verify absence of known hypersensitivity to albumin or any plasma‑derived products. - Assess fluid status and avoid administration in patients with uncontrolled heart failure or severe pulmonary edema. - Monitor blood pressure, central venous pressure, and urine output during and after infusion. - Use caution in patients with renal impairment, liver disease, or coagulopathy. - Adjust dose or infusion rate in neonates, infants, and elderly patients. - Ensure appropriate viral inactivation and screening of the plasma source.
What does Human Albumin Solution interact with?
Human Albumin Kedrion may interact with other therapies that affect fluid balance, coagulation, or immune response.
Avoid: - Avoid concurrent administration with high‑dose diuretics that may precipitate rapid intravascular volume depletion. - Do not mix with incompatible solutions such as those containing calcium chloride or potassium phosphate.
Use with caution: - Use with caution when combined with other plasma expanders (e.g., hydroxyethyl starch) to prevent excessive volume expansion. - Caution is advised when administering together with anticoagulants, as albumin can alter plasma protein binding. - Monitor closely when given alongside immunosuppressive agents, because albumin may affect drug distribution.
Frequently asked questions
What is Human Albumin Kedrion and how is it supplied?+
In which clinical conditions is Human Albumin Kedrion indicated?+
How does Human Albumin Kedrion increase intravascular volume?+
What are the common side effects of Human Albumin Kedrion?+
What serious adverse reactions should be reported with Human Albumin Kedrion?+
Who should not receive Human Albumin Kedrion?+
How should fluid status be monitored during Human Albumin Kedrion infusion?+
Can Human Albumin Kedrion be used together with diuretics?+
What precautions are needed for patients with heart failure receiving Human Albumin Kedrion?+
How is Human Albumin Kedrion stored before administration?+
Is Human Albumin Kedrion safe for use in pregnant women?+
What is the route of administration for Human Albumin Kedrion?+
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