Description:
Hepatitis B Immunoglobulin (HBIG) combined with the Hepatitis B vaccine is a preventive treatment used for individuals who have been exposed to the Hepatitis B virus (HBV) or those at high risk of exposure. The immunoglobulin provides immediate passive protection by supplying antibodies, while the vaccine induces long-term active immunity by stimulating the immune system to produce its own antibodies.

Prescription:

• Prescription required.

Dosage:

• Post-exposure Prophylaxis:
  A single dose of Hepatitis B Immunoglobulin (HBIG) is administered immediately following exposure, along with the first dose of the Hepatitis B vaccine.
• Pre-exposure Prophylaxis:
  The vaccination schedule typically involves 3 doses of the Hepatitis B vaccine over 6 months. The specific dose of HBIG will be determined based on the individual’s weight and medical condition.

The dosage may vary based on age, weight, and health conditions, and it is important to follow the exact instructions from the healthcare provider.

Therapeutic Category:

• Vaccine / Immunoglobulin / Immunization

Active Ingredients/Composition:

• Hepatitis B Immunoglobulin (HBIG): Contains antibodies derived from human plasma, specifically designed to neutralize the Hepatitis B virus.
• Hepatitis B Vaccine (recombinant): Contains HBsAg (Hepatitis B surface antigen) which induces the production of protective antibodies against the Hepatitis B virus.

Variant:

• Available as injectable solution or combined vaccine-immunoglobulin formulations.

Consume Type:

• Injection: Administered intramuscularly (IM) or intravenously (IV) by a healthcare professional.

Directions/Usage:

1. Post-exposure:
   • Administer HBIG as soon as possible, within 24 hours of exposure to the Hepatitis B virus.
   • Follow up with the Hepatitis B vaccine as per the recommended schedule.
2. Pre-exposure (for high-risk individuals):
   • Complete the full vaccination course (3 doses over 6 months).
3. The exact method of administration should be determined by a healthcare provider, and it should only be used under professional medical guidance.

Common Side Effects:

• Pain or redness at the injection site
• Fever
• Fatigue
• Headache
• Muscle or joint aches
• Rash (in rare cases)
• Allergic reactions (e.g., hives, swelling, difficulty breathing)

Serious side effects are rare but should be monitored, and immediate medical attention should be sought if any severe allergic reactions occur.

Package Type:

• Vials or pre-filled syringes, depending on the manufacturer and formulation.

Storage Advice:

• Store in a refrigerator (2–8°C) and protect from light.
• Do not freeze.
• The vaccine and immunoglobulin must be kept in their original packaging until use.

Safety Advice:

• Only administer under the supervision of a healthcare professional.
• Individuals allergic to any components of the vaccine or immunoglobulin should not receive it.
• Not recommended during pregnancy unless deemed absolutely necessary by a doctor.
• Always follow the prescribed vaccination schedule for effective immunity.
• Inform the healthcare provider of any medical conditions such as previous reactions to vaccines, immune disorders, or other vaccinations.

Product Substitutes:

• Hepatitis B Vaccine (monovalent)
• Hepatitis B Immunoglobulin (HBIG)
• Engerix-B (Hepatitis B vaccine)
• HBVAXPRO (Hepatitis B vaccine)

Manufacturer/Marketer:

• GlaxoSmithKline

Country of Origin:

• United States