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Human Albumin Grifols

Active Ingredient:
Human Serum Albumin
Origin:
EU

Human Albumin Grifols (Human Serum Albumin)

Human Albumin Grifols is a human serum albumin solution for intravenous administration, supplied as a sterile liquid preparation. It contains purified human serum albumin derived from pooled plasma and is marketed in the European Union as a volume expander. The product restores plasma oncotic pressure, supports intravascular volume, and helps manage conditions linked to low albumin levels. It is classified as a plasma protein and is given under medical supervision.

Manufacturer / TM Owner

Instituto Grifols, S.A.

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Indications & Clinical Uses

Human Albumin Grifols is indicated for clinical situations where plasma volume expansion or albumin replacement is required, particularly in critically ill or peri‑operative patients.

  • Treatment of hypovolemia due to fluid loss, trauma, or surgery.
  • Management of circulatory shock when rapid intravascular volume support is needed.
  • Adjunct therapy for extensive burns to replace protein loss and maintain oncotic pressure.
  • Correction of hypoalbuminemia associated with liver disease, nephrotic syndrome, or malnutrition.
  • Support during cardiac or vascular surgery to improve hemodynamic stability.
  • Therapeutic support in severe sepsis or septic shock when hypoalbuminemia contributes to vascular leakage.

How It Works

  • Human Albumin Grifols works by increasing the concentration of albumin in the plasma, which raises the oncotic (colloid) pressure within the vascular compartment. The elevated oncotic pressure draws water from the interstitial space into the intravascular space, expanding circulating blood volume. Albumin also serves as a carrier protein for endogenous substances and drugs, contributing to the maintenance of fluid balance and vascular integrity.

Side Effects

Adverse reactions to Human Albumin Grifols are generally infrequent but may occur shortly after the start of infusion or later during therapy.

Common

  • Transient fever, chills, or rigors occurring shortly after the start of infusion.
  • Mild headache or nausea that usually resolves without intervention.
  • Localized urticaria, pruritus, or erythema at the infusion site.
  • Slight fluctuations in blood pressure, presenting as either a brief rise or mild hypotension.

Serious

  • Anaphylactic or severe allergic reactions, which may include bronchospasm, angioedema, or hypotensive shock.
  • Volume overload leading to pulmonary edema, particularly in patients with pre‑existing cardiac or renal impairment.
  • Hemolytic or thrombotic complications such as deep‑vein thrombosis or disseminated intravascular coagulation.

Precautions & Warnings

Before using Human Albumin Grifols, clinicians should evaluate patient history and clinical status to minimize risk.

  • Assess cardiac function and avoid use in uncontrolled heart failure or severe left‑ventricular dysfunction.
  • Evaluate renal function and monitor fluid balance to prevent overload in renal insufficiency.
  • Verify absence of known hypersensitivity to human albumin or any plasma‑derived product before infusion.
  • Use caution in individuals with IgA deficiency, as they may develop anti‑IgA antibodies that can trigger reactions.
  • Monitor hemodynamic status during and after infusion, especially in patients after major surgery or trauma.
  • Adjust dosage or discontinue therapy if signs of pulmonary edema, hypertension, or severe allergic response appear.

Avoid Interactions

Human Albumin Grifols may interact with certain medications or solutions, requiring attention to avoid incompatibility or altered therapeutic effect.

Avoid

  • Do not mix with calcium‑ or phosphate‑containing solutions, as precipitation may occur.
  • Avoid simultaneous infusion with high‑dose loop diuretics that can cause rapid intravascular volume shifts.
  • Concurrent administration with drugs that are highly albumin‑bound (e.g., warfarin, phenytoin) may alter free‑drug concentrations.

Use with caution

  • Use cautiously with anticoagulants, as changes in plasma protein binding can affect anticoagulant activity.
  • Monitor patients receiving vasopressors, because albumin infusion may potentiate pressor effects.
  • In individuals with pre‑existing hypervolemia or heart failure, closely track fluid balance to prevent overload.

Frequently Asked Questions

Human Albumin Grifols is a sterile liquid preparation of purified human serum albumin intended for intravenous infusion. It is supplied as a solution for injection and is marketed in the European Union as a prescription‑only plasma protein product.

It is commonly used for hypovolemia, circulatory shock, extensive burns, hypoalbuminemia due to liver disease or nephrotic syndrome, and to support hemodynamic stability during major cardiac or vascular surgery.

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

Common adverse reactions include transient fever, chills, mild headache, nausea, localized urticaria or pruritus at the infusion site, and brief changes in blood pressure.

Serious reactions can include anaphylaxis or severe allergic responses, pulmonary edema from volume overload, and hemolytic or thrombotic events such as deep‑vein thrombosis.

Clinicians should assess cardiac and renal function, confirm no hypersensitivity to albumin or plasma products, consider IgA deficiency, and monitor hemodynamic parameters throughout the infusion.

Use with caution; patients with uncontrolled heart failure are at higher risk for volume overload and should be closely monitored for signs of pulmonary edema.

Safety data are limited; the product should only be used during pregnancy when clearly indicated and after weighing potential benefits against risks.

The solution should be stored at controlled room temperature, protected from light, and used before the expiration date indicated on the vial or bag.

It should not be mixed with calcium‑ or phosphate‑containing solutions due to the risk of precipitation, and compatibility with other fluids should be verified before co‑administration.

Vital signs, especially blood pressure and heart rate, should be monitored continuously. Fluid balance, signs of allergic reaction, and respiratory status should also be observed.

It may affect the free concentration of highly albumin‑bound drugs such as warfarin and phenytoin, and it should be used cautiously with anticoagulants and vasopressors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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