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Humani Albumin Baxalta

Active Ingredient:
Human Serum Albumin
Origin:
EU

Humani Albumin Baxalta (Human Serum Albumin)

Humani Albumin Baxalta is a sterile solution for injection that contains human serum albumin as its active ingredient. Marketed in the European Union, this plasma‑derived product is supplied without a specified strength label and is administered intravenously under prescription. It belongs to the albumin drug class and is used as a plasma volume expander to restore intravascular oncotic pressure and to support circulatory stability in patients with hypoalbuminemia.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Humani Albumin Baxalta is employed in clinical situations where rapid expansion of plasma volume is required and where albumin deficiency contributes to fluid shifts.

  • Treatment of hypovolemia associated with burns, major surgery, or traumatic injury.
  • Volume replacement in patients with severe hypoalbuminemia or liver disease.
  • Support of circulatory stability during liver transplantation procedures.
  • Management of nephrotic syndrome when oncotic pressure is markedly reduced.
  • Use as a carrier protein in investigational drug formulations.

How It Works

  • Human serum albumin, the primary protein in plasma, exerts its effect by increasing colloid osmotic (oncotic) pressure within the vascular compartment. When administered intravenously, the albumin molecules remain largely intravascular, drawing water from the interstitial space into the bloodstream and thereby expanding plasma volume. In addition, albumin binds endogenous substances such as fatty acids, hormones, and drugs, contributing to transport and buffering functions that support hemodynamic stability.

Side Effects

Adverse reactions to Humani Albumin Baxalta vary in frequency and severity.

Common

  • Mild fever or chills
  • Headache
  • Nausea or vomiting
  • Transient hypertension or flushing

Serious

  • Anaphylactic or severe allergic reactions
  • Volume overload leading to pulmonary edema
  • Hemolysis or transfusion‑related acute lung injury
  • Thromboembolic events such as deep‑vein thrombosis
  • Acute renal dysfunction or failure

Precautions & Warnings

Humani Albumin Baxalta should be used with careful clinical assessment and monitoring.

  • Assess cardiac and renal function before infusion to avoid volume overload.
  • Monitor vital signs and fluid balance during and after administration.
  • Use caution in patients with known hypersensitivity to human albumin or plasma products.
  • Avoid rapid infusion rates that may precipitate hypotension or pulmonary edema.
  • Consider risk of infection transmission inherent to plasma‑derived products.
  • Adjust dosage in patients with severe burns or extensive capillary leak syndrome.

Avoid Interactions

Potential drug interactions may modify the safety profile of Humani Albumin Baxalta.

Avoid

  • Concurrent use of other colloid volume expanders without medical supervision.
  • Simultaneous administration of high‑dose diuretics that could exacerbate intravascular depletion.

Use with caution

  • Anticoagulants and antiplatelet agents, due to possible alteration of bleeding risk.
  • ACE inhibitors or ARBs, which may affect blood pressure regulation.
  • Nephrotoxic medications, as added volume may stress compromised kidneys.
  • Other plasma‑derived products, which could increase the risk of immune reactions.

Frequently Asked Questions

Humani Albumin Baxalta is a sterile solution for injection that contains human serum albumin, a plasma‑derived protein used to expand intravascular volume.

It is administered intravenously by a healthcare professional, typically as an infusion over a period determined by the clinical situation.

It is used when rapid plasma volume expansion is needed, such as in hypovolemia from burns, surgery, trauma, severe hypoalbuminemia, liver transplantation, and certain nephrotic syndromes.

The albumin increases colloid osmotic pressure in the bloodstream, drawing fluid from the interstitial space into the vascular compartment and thereby expanding plasma volume.

Common adverse effects include mild fever, chills, headache, nausea, transient hypertension, and flushing.

Serious reactions may include anaphylaxis, volume overload with pulmonary edema, hemolysis, thromboembolic events, and acute renal dysfunction.

Clinicians should evaluate cardiac and renal function, monitor vital signs and fluid balance, and be cautious in patients with known hypersensitivity or severe capillary leak.

Yes, concurrent use of other colloid volume expanders and high‑dose diuretics should be avoided unless medically justified.

Anticoagulants, ACE inhibitors/ARBs, nephrotoxic drugs, and other plasma‑derived products should be used with caution due to potential additive effects.

Yes, it is classified as a prescription‑only (Rx) product and must be administered under medical supervision.

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

The pregnancy safety category is not established; use in pregnancy should be considered only if the potential benefit justifies the potential risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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