Product image of Immunoglobuline Humaine De L'hepatite B Lfb (Human Hepatitis B Immunoglobulin) supplied by GNH India

Immunoglobuline Humaine De L'hepatite B Lfb

Active Ingredient:
Human Hepatitis B Immunoglobulin
Origin:
EU

Immunoglobuline Humaine De L'hepatite B Lfb (Human Hepatitis B Immunoglobulin)

Human Hepatitis B Immunoglobulin, the active ingredient in Immunoglobuline Humaine De L'hepatite B Lfb, is an immunoglobulin presented as a sterile injectable solution for intramuscular use. It provides passive immunity to prevent hepatitis B virus infection in at‑risk individuals.
GNH India supplies Immunoglobuline Humaine De L'hepatite B Lfb as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and clinics worldwide.

Manufacturer / TM Owner

Lfb Biomedicaments

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Indications & Clinical Uses

Human Hepatitis B Immunoglobulin is used within the antiviral and hepatitis B prophylaxis pathway to prevent HBV infection and recurrence.

  • Post‑exposure prophylaxis: provides immediate passive immunity to avert hepatitis B infection after potential exposure.
  • Liver transplantation: prevents recurrence of hepatitis B in recipients of HBV‑positive donor livers.
  • Neonatal protection: administered to newborns of HBsAg‑positive mothers to block perinatal transmission of hepatitis B.

How It Works

  • Human Hepatitis B Immunoglobulin supplies high‑titer anti‑HBs antibodies that bind circulating hepatitis B virus particles, neutralising them and blocking entry into hepatocytes. The passive antibodies also facilitate viral clearance by opsonisation and complement activation, delivering immediate but temporary protection until active immunity can develop.

Side Effects

Human Hepatitis B Immunoglobulin may cause adverse reactions following intramuscular administration.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the injection site.
  • Fever: transient low‑grade temperature elevation.
  • Headache: occasional mild headache.
  • Fatigue: short‑term tiredness.
  • Nausea: mild gastrointestinal upset.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Serum sickness‑like reaction: fever, rash, arthralgia occurring days after administration.
  • Thrombocytopenia: reduced platelet count, potentially leading to bleeding.
  • Guillain‑Barré syndrome: rare demyelinating neuropathy.
  • Severe local tissue necrosis: extensive tissue damage at injection site.

Precautions & Warnings

Human Hepatitis B Immunoglobulin should be used with careful clinical assessment.

  • Serology assessment: confirm HBV status and anti‑HBs titres before administration.
  • Allergy screening: avoid in patients with known hypersensitivity to human immunoglobulins.
  • Monitor reactions: observe for signs of anaphylaxis or serum sickness after injection.
  • Caution in immunocompromised: efficacy may be reduced; monitor virologic response.
  • Do not inject intravenously: intended for intramuscular use only.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Human Hepatitis B Immunoglobulin can interact with other therapies, influencing safety or efficacy.

Major Interactions (Avoid)

  • Concurrent blood products: may increase risk of volume overload.
  • Live vaccines: immunoglobulin may diminish vaccine efficacy.
  • Serologic testing: can interfere with hepatitis B surface antigen assays.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: potential for altered bleeding risk.
  • Immunosuppressants: may affect immunoglobulin clearance and response.
  • Other vaccines: schedule administration to avoid reduced immunogenicity.

Frequently Asked Questions

Immunoglobuline Humaine De L'hepatite B provides passive immunity against hepatitis B virus. It is indicated for post‑exposure prophylaxis after potential HBV contact, for preventing HBV recurrence after liver transplantation, and for protecting newborns of hepatitis B‑positive mothers.

The product contains high‑titer anti‑HBs antibodies that bind to circulating hepatitis B virus particles. By neutralising the virus and blocking its entry into liver cells, the antibodies prevent infection and assist the immune system in clearing the virus.

The specific dose and schedule are determined by the prescribing clinician based on the patient’s HBV exposure risk, weight, and clinical situation. Healthcare professionals should follow local guidelines and product labeling when prescribing.

Safety data in pregnancy and lactation are limited. The product should be used only if the potential benefit justifies any possible risk to the fetus or infant, and the decision should be made by the treating physician.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and import documentation.

Human Hepatitis B Immunoglobulin offers immediate passive immunity, unlike hepatitis B vaccines which require time to induce active immunity. Compared with other immunoglobulin preparations, it provides a standardized high anti‑HBs titre, making it suitable for rapid protection in high‑risk settings.

Store the product at 2‑8 °C in a refrigerator. Keep it in the original packaging, protect from light, and do not freeze or shake the vial. Allow the vial to reach room temperature before administration if required by the label.

The immunoglobulin is given by intramuscular injection, typically into the deltoid or gluteal muscle. The exact injection site and volume are determined by the prescriber, and aseptic technique must be followed.

Serious adverse reactions include anaphylaxis, serum‑sickness‑like reactions, severe thrombocytopenia, and Guillain‑Barré syndrome. Immediate medical attention is required if any signs of severe allergic reaction or neurological symptoms develop after injection.

Patients with a known hypersensitivity to human immunoglobulin preparations or any component of the formulation should not receive the product. It is also contraindicated for intravascular administration and should be avoided in individuals with uncontrolled severe asthma or severe allergic disorders without appropriate precautions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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