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.