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Humanalbumin Kedrion

Active Ingredient:
Human Albumin Solution
Origin:
EU

Humanalbumin Kedrion (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.

Manufacturer / TM Owner

Kedrion S.P.A.

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Indications & Clinical Uses

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.

How It Works

  • Humanalbumin Kedrion provides exogenous albumin that increases plasma oncotic pressure by contributing to the colloid osmotic gradient. The elevated oncotic pressure draws water from the interstitial and intracellular compartments into the vascular space, thereby expanding intravascular volume. This effect supports hemodynamic stability and improves tissue perfusion without directly influencing cardiac contractility or vascular tone. The albumin molecules also bind and transport endogenous substances, contributing to overall plasma protein balance.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

Humanalbumin Kedrion is a sterile solution for injection that contains purified human albumin. It is supplied as a liquid preparation intended for intravenous administration.

Humanalbumin Kedrion provides natural plasma protein, increasing oncotic pressure, whereas synthetic colloids are artificial polymers that achieve volume expansion through different physicochemical properties.

It is indicated for hypovolemia, circulatory shock, extensive burns, hypoalbuminemia, and as adjunct therapy during major surgery or in severe pancreatitis where intravascular volume support is needed.

The albumin molecules raise plasma oncotic pressure, drawing water from interstitial and intracellular spaces into the vascular compartment, thereby expanding circulating blood volume.

Vital signs such as blood pressure, heart rate, and temperature should be observed, along with assessment for allergic reactions, fluid balance, and signs of volume overload.

Use in heart‑failure patients requires careful evaluation of cardiac function and close monitoring because excessive volume expansion may exacerbate pulmonary congestion.

Common reactions include mild fever, chills, transient blood‑pressure changes, headache, nausea, localized skin redness, pruritus, flushing, and slight increases in serum creatinine.

Infusion should be stopped immediately, and standard anaphylaxis treatment—such as epinephrine, antihistamines, and supportive care—should be administered according to clinical protocols.

Contraindications include known hypersensitivity to human albumin and situations where volume overload would pose a significant risk, such as uncontrolled heart failure or severe pulmonary edema.

Diuretics may reduce the intended volume‑expanding effect, while vasopressors can alter hemodynamic responses; both combinations should be managed with close hemodynamic monitoring.

The product should be stored according to the manufacturer’s label, typically refrigerated between 2 °C and 8 °C, protected from light, and used before the expiration date.

Humanalbumin Kedrion is marketed in the European Union; its regulatory status in the United States depends on local approvals and may differ from EU authorization.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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