GNH USA

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.

Human Albumin Solution

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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?+
Human Albumin Kedrion is a prescription‑only sterile solution for injection that contains human albumin as the active ingredient and is administered intravenously.
In which clinical conditions is Human Albumin Kedrion indicated?+
It is indicated for hypovolemia, circulatory shock, extensive burns, hypoalbuminemia, and for volume expansion during major surgery or cardiac bypass.
How does Human Albumin Kedrion increase intravascular volume?+
The albumin molecules raise plasma oncotic pressure, pulling water from the interstitial space into the bloodstream, thereby expanding circulating blood volume.
What are the common side effects of Human Albumin Kedrion?+
Common adverse effects include fever, chills, headache, dizziness, nausea, mild abdominal discomfort, and localized urticaria or itching at the infusion site.
What serious adverse reactions should be reported with Human Albumin Kedrion?+
Serious reactions to report are anaphylaxis, severe hypersensitivity, acute renal failure or hemolysis, and volume overload leading to pulmonary edema or heart failure.
Who should not receive Human Albumin Kedrion?+
Patients with known hypersensitivity to albumin or plasma products, uncontrolled heart failure, or severe pulmonary edema should not receive the product.
How should fluid status be monitored during Human Albumin Kedrion infusion?+
Clinicians should monitor blood pressure, central venous pressure, urine output, and weight changes throughout and after the infusion.
Can Human Albumin Kedrion be used together with diuretics?+
Concurrent use with high‑dose diuretics should be avoided because it may cause rapid intravascular volume depletion.
What precautions are needed for patients with heart failure receiving Human Albumin Kedrion?+
Fluid status must be carefully assessed, infusion rates should be reduced, and patients should be monitored for signs of volume overload.
How is Human Albumin Kedrion stored before administration?+
The solution should be stored according to the manufacturer’s instructions, typically refrigerated between 2 °C and 8 °C, and protected from light.
Is Human Albumin Kedrion safe for use in pregnant women?+
The pregnancy safety category is unknown; use only if the potential benefit justifies the potential risk to the fetus.
What is the route of administration for Human Albumin Kedrion?+
Human Albumin Kedrion is administered intravenously as a sterile solution for injection.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Human Albumin Solution
Route
Intravenous Use
Manufacturer
Kedrion S.P.A.
Origin
EU

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