Product image of Humanalbumin Kedrion (Human Albumin Solution) supplied by GNH India

Humanalbumin Kedrion

Active Ingredient:
Human Albumin Solution
Origin:
EU

Humanalbumin Kedrion (Human Albumin Solution)

Humanalbumin Kedrion is a sterile solution for injection containing human albumin as the active ingredient. It is supplied in a standard concentration (typically 20% w/v) and is marketed in the European Union as a prescription‑only plasma volume expander. The product is manufactured under GMP conditions, stored refrigerated, and intended for intravenous administration by healthcare professionals. It provides exogenous albumin to support oncotic pressure in patients with hypovolemia or hypoalbuminemia.

Manufacturer / TM Owner

Kedrion S.P.A.

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Indications & Clinical Uses

Humanalbumin Kedrion is used in clinical settings where rapid plasma volume expansion is required. It may be administered to support circulatory function in several medical situations.

  • Management of hypovolemic shock due to trauma, surgery, or severe dehydration.
  • Treatment of burns patients with significant fluid loss and plasma protein depletion.
  • Support for patients with liver disease or nephrotic syndrome experiencing hypoalbuminemia.
  • Volume replacement during cardiac surgery or extracorporeal circulation procedures.
  • Adjunct therapy in therapeutic plasma exchange to maintain oncotic balance.
  • Resuscitation of patients with severe sepsis or septic shock when albumin levels are critically low.

How It Works

  • Humanalbumin Kedrion supplies exogenous human serum albumin, the most abundant plasma protein, which contributes to oncotic pressure. By increasing the colloid osmotic gradient across the vascular endothelium, it draws water from the interstitial space into the intravascular compartment, expanding circulating blood volume. Albumin also serves as a carrier for endogenous substances (e.g., fatty acids, hormones) and exogenous drugs, influencing their distribution and metabolism.

Side Effects

Adverse reactions to Humanalbumin Kedrion are generally infrequent but can range from mild infusion‑related events to rare serious complications.

Common

  • Mild fever, chills, or flushing during or shortly after infusion.
  • Transient hypotension or hypertension that resolves without intervention.
  • Nausea, vomiting, or mild abdominal discomfort.
  • Localized pain or erythema at the infusion site.

Serious

  • Anaphylactic or severe allergic reactions, including urticaria and bronchospasm.
  • Acute hemolysis or renal impairment associated with volume overload.
  • Transmission of infectious agents, although risk is minimized by donor screening.
  • Thromboembolic events such as deep vein thrombosis or pulmonary embolism.

Precautions & Warnings

Humanalbumin Kedrion should be administered only by qualified healthcare professionals who assess patient history and monitor for potential risks.

  • Verify the product’s expiration date and inspect for particulate matter before use.
  • Assess for known hypersensitivity to human albumin or any component of the solution.
  • Use caution in patients with congestive heart failure, pulmonary edema, or severe renal disease due to risk of fluid overload.
  • Adjust infusion rate in individuals with unstable hemodynamics or severe hypotension.
  • Avoid use in patients with active infection where increased oncotic pressure may exacerbate edema.
  • Monitor serum albumin levels and fluid balance during and after administration.
  • Document any adverse reactions and report them according to pharmacovigilance guidelines.

Avoid Interactions

Humanalbumin Kedrion can affect the pharmacokinetics of concurrently administered drugs and may interact with certain medical conditions.

Avoid

  • Concurrent use with high‑dose diuretics that may precipitate rapid intravascular volume shifts.
  • Administration alongside other colloid solutions (e.g., hydroxyethyl starch) without careful volume assessment.

Use with caution

  • Vasopressor agents, as albumin infusion may potentiate blood pressure changes.
  • Anticoagulants, because altered plasma volume can influence coagulation parameters.
  • Nephrotoxic drugs, since volume expansion may affect renal clearance.
  • Immunosuppressive therapies, given potential changes in drug distribution.

Frequently Asked Questions

Humanalbumin Kedrion is a sterile solution for injection that contains human serum albumin as the active ingredient; it is provided in a standard concentration for intravenous use in the European Union.

It is commonly used for rapid plasma volume expansion in hypovolemic shock, severe burns, liver disease with hypoalbuminemia, cardiac surgery, therapeutic plasma exchange, and sepsis‑related low albumin states.

The exogenous albumin raises plasma oncotic pressure, pulling water from the interstitial space into the bloodstream, thereby expanding the circulating blood volume.

It may be used with caution; clinicians should monitor fluid status closely because patients with congestive heart failure are at higher risk for volume overload.

Common reactions include mild fever, chills, flushing, transient blood pressure changes, nausea, vomiting, and localized pain or redness at the infusion site.

Serious events, although rare, can include anaphylaxis, severe allergic reactions, acute hemolysis, renal impairment from overload, transmission of infections, and thromboembolic complications.

Check the expiration date, inspect for particles, confirm no known albumin allergy, evaluate cardiac and renal function, adjust infusion rate as needed, and monitor vital signs and fluid balance.

Yes, avoid simultaneous high‑dose diuretics and other colloid solutions without careful volume assessment, as they can cause rapid shifts in intravascular volume.

Vasopressors, anticoagulants, nephrotoxic agents, and immunosuppressants should be used cautiously because albumin can alter their distribution and affect hemodynamics.

Any suspected adverse reaction should be documented in the patient’s medical record and reported to the national pharmacovigilance system or the product’s manufacturer according to local regulations.

The pregnancy safety category is listed as unknown; therefore, it should only be used during pregnancy when the potential benefit justifies the potential risk to the fetus.

The solution should be stored refrigerated (2‑8 °C) and protected from light; it must not be frozen and should be used within the time frame specified after removal from the refrigerator.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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