Engerix-B Injection 10mcg/0.5ml

Recommended use

• Neonates and children up to 19 years of age: 10 mcg of antigen protein in 0.5 ml.
• Adults 19 years of age and older: 20 mcg of antigen in 1 ml.

Immunization schedule for the Hepatitis B Vaccine (rDNA

Standard Schedule:

• First dose: Selected date.
• Second dose: 1 month after the first dose.
• Third dose: 6 months after the first dose.

Accelerated Schedule:

• First dose: Selected date.
• Second dose: 1 month after the first dose.
• Third dose: 2 months after the first dose.
• Fourth dose: 12 months after the first dose.

Neonates born to hepatitis B surface antigen-positive mothers:

• First dose: At birth with hepatitis B immunoglobulin injection at a separate site.
• Second dose: 1 month after the first dose.
• Third dose: 2 months after the first dose.
• Fourth dose: 12 months after the first dose.

Patients with renal insufficiency (including those on hemodialysis), aged 16 and older:

• 4 doses of 40 mcg each:
  • First dose: Selected date.
  • Second dose: 1 month after the first dose.
  • Third dose: 2 months after the first dose.
  • Fourth dose: 6 months after the first dose.

Common side effects of the Hepatitis B Vaccine (rDNA)

• >10%: Pain, pruritus, erythema, burning, nodules, fatigue, headache, fever, vertigo.
• 1-10%: Lightheadedness, flushing, insomnia, irritability, arthralgia, constipation, pruritus, lupus-like syndrome, lymphadenopathy, tachycardia.

Contraindications for the Hepatitis B Vaccine (rDNA

• Confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens.
• Hypersensitivity reactions to eggs, as some vaccines are prepared in egg cultures.
• Severe immunodeficiency.
• Malignant disease is treated with chemotherapy or radiotherapy and for at least 6 months after stopping treatment.
• Patients with compromised immune systems (e.g., high-dose systemic corticosteroids, immunosuppressants, or HIV positive).

Interactions with other medications

The vaccine response may be reduced when used concurrently with immunosuppressants such as corticosteroids or antineoplastics.

Regarding the use of the Hepatitis B Vaccine (rDNA) during pregnancy and lactation

• Pregnancy: Adequate human data are not available. Use only when clearly needed and when the potential benefits outweigh the risks to the fetus.
• Lactation: Adequate data are not available. Administer only when needed and when the benefits outweigh the risks.

Precautions when administering the Hepatitis B Vaccine (rDNA)

• Ensure any alcohol or disinfectant used for skin cleansing has evaporated before vaccination to avoid inactivation of the vaccine.
• Use during lactation is not well-studied; consider the benefits versus risks.
• For pregnant women, use only when the potential benefits outweigh the possible risks.

Storage:

Store the vaccine between 2-8°C, protected from light. Do not freeze. Keep out of the reach of children.