Product image of Human Rabies Immunoglobulin Bio Products Laboratory (Human Rabies Immunoglobulin) supplied by GNH India

Human Rabies Immunoglobulin Bio Products Laboratory

Active Ingredient:
Human Rabies Immunoglobulin
Origin:
EU

Human Rabies Immunoglobulin Bio Products Laboratory (Human Rabies Immunoglobulin)

Human Rabies Immunoglobulin Bio Products Laboratory, containing human rabies immunoglobulin, is supplied as a sterile injectable solution of unspecified strength. It is manufactured in the European Union and intended for passive immunization against rabies virus exposure. The product provides immediate antibodies to neutralize the virus while the recipient’s own immune response develops after vaccination. It is used under medical supervision in clinical post‑exposure prophylaxis protocols.

Manufacturer / TM Owner

Bio Products Laboratory

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Indications & Clinical Uses

Human Rabies Immunoglobulin is indicated for passive immunization in individuals who have potentially been exposed to rabies virus.

  • Immediate provision of rabies‑neutralizing antibodies after a bite or scratch from a suspected rabid animal.
  • Use in conjunction with active rabies vaccination as part of a complete post‑exposure prophylaxis regimen.
  • Administration when the wound is severe, deep, or located near the central nervous system.
  • Use for patients who cannot receive the vaccine due to contraindications, as a temporary protective measure.
  • Application in cases where the timing of vaccine initiation is delayed.

How It Works

  • Human rabies immunoglobulin consists of purified polyclonal IgG antibodies derived from pooled human plasma that have high affinity for the rabies virus glycoprotein. After intramuscular or infiltrative administration, the antibodies circulate systemically and bind to viral particles at the site of inoculation, preventing attachment to neuronal receptors and blocking retrograde transport along peripheral nerves. This passive neutralization provides immediate protection until active immunity from vaccination develops.

Side Effects

Adverse reactions to human rabies immunoglobulin are generally infrequent but can vary in severity, ranging from mild local discomfort to rare systemic events that require medical attention.

Common

  • Injection site pain, redness, or swelling.
  • Mild fever or chills.
  • Headache or fatigue.
  • Nausea or gastrointestinal discomfort.
  • Localized itching or rash at the injection site.

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing, hives, or hypotension.
  • Serum sickness–like illness presenting with fever, rash, arthralgia.
  • Neurological symptoms such as peripheral neuropathy or aseptic meningitis.
  • Renal impairment or acute kidney injury.
  • Coagulation abnormalities (e.g., thrombocytopenia).

Precautions & Warnings

Human rabies immunoglobulin should be administered with consideration of specific precautions to ensure safety and optimal efficacy.

  • Verify the product’s expiration date and integrity before use.
  • Assess the patient for known hypersensitivity to human immunoglobulins or blood‑derived products.
  • Avoid intravascular injection; administer only by the recommended intramuscular or wound‑infiltration routes.
  • Observe the patient for at least 30 minutes after administration for signs of an allergic reaction.
  • Do not exceed the recommended volume at a single injection site to prevent tissue necrosis.
  • Document the lot number and batch information for traceability.

Avoid Interactions

When co‑administered with other agents, human rabies immunoglobulin may interact in ways that affect safety or efficacy, requiring attention to specific drug combinations.

Avoid

  • Live attenuated vaccines administered concurrently, as passive antibodies can diminish the vaccine’s immunogenic response.
  • High‑dose intravenous immunoglobulin products, which may increase the risk of hyperviscosity or renal complications.

Use with caution

  • Anticoagulants or antiplatelet agents, because injection‑site bleeding may be prolonged.
  • Monoclonic antibodies targeting immune pathways, which could alter the clearance of the immunoglobulin.
  • Renal‑impairing medications, as the combined protein load may stress kidney function.
  • Vaccines requiring a strong cellular response (e.g., hepatitis B), as passive antibodies may interfere with antigen presentation.

Frequently Asked Questions

Human rabies immunoglobulin is a sterile preparation of purified polyclonal IgG antibodies derived from pooled human plasma that have high affinity for the rabies virus.

It should be given as soon as possible, ideally within 24 hours of the exposure, and before the first dose of the rabies vaccine.

The immunoglobulin provides immediate passive antibodies, while the vaccine stimulates the patient’s own immune system to produce active, long‑term protection.

Yes, it can be administered to children of any age when indicated, using weight‑based dosing as recommended by clinical guidelines.

Common reactions include pain, redness or swelling at the injection site, mild fever, chills, headache, fatigue, nausea, and localized itching.

Signs of anaphylaxis (difficulty breathing, hives, low blood pressure), serum‑sickness‑like illness, neurological symptoms, renal impairment, or severe bleeding should be treated as emergencies.

Contraindications include known hypersensitivity to human immunoglobulin products or any component of the formulation.

The skin should be cleaned with an appropriate antiseptic, and the injection should be performed using aseptic technique in the recommended muscle or wound‑infiltration site.

Patients should be observed for at least 30 minutes for allergic reactions and monitored for any signs of systemic adverse events during the post‑exposure period.

It can be co‑administered with the rabies vaccine, but live attenuated vaccines should be given at a different time to avoid interference with immune response.

The immunoglobulin should be stored in a refrigerator between 2 °C and 8 °C, protected from light, and used before the expiration date printed on the label.

Passive antibodies may affect serologic testing for rabies antibodies, potentially leading to false‑positive results if testing is performed shortly after administration.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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