RECOMBINANT HEPATITIS B VACCINE
Recombinant Hepatitis B vaccine (Gene-HBvax)

COMPOSITION:
1 ml of vaccine contains:
– Purified Hepatitis B surface antigen ≈ 20 µg
– Aluminum hydroxide (calculated as aluminum) ……. ≤ 600 µg
– Thimerosal ……………………… ≤ 0.012% (w/v)

0.5 ml of vaccine contains:
– Purified Hepatitis B surface antigen ≈ 10 µg
– Aluminum hydroxide (calculated as aluminum) ……. ≤ 300 µg
– Thimerosal ……………………… ≤ 0.012% (w/v)

INDICATIONS:
■ Prevention of Hepatitis B for all individuals at risk, specifically:

• Group of healthy individuals at high risk:
  – Healthcare workers (physicians, dentists, surgeons, nurses, attendants…);
  – Hospital staff frequently exposed to blood;
  – Laboratory personnel;
  – Families with members infected with Hepatitis B virus, especially infants born to mothers carrying HBsAg and HBeAg.
• Group of patients:
  – Patients requiring frequent blood transfusions or blood products that may be contaminated with Hepatitis B virus;
  – Immunocompromised patients;
  – Patients with chronic nephritis and/or undergoing hemodialysis treatment.
• Other groups:
  – Administrative staff, military personnel, prisoners;
  – Homosexual men, drug addicts and intravenous drug users;
  – Residents and travelers to regions with high incidence such as the Mediterranean, Central Europe, South America, Africa, and Asian countries.

CONTRAINDICATIONS:
• Individuals hypersensitive to any component of the vaccine;
• Suffering from congenital diseases;
• Fatigue, high fever, or systemic reactions with ongoing infections;
• Cardiac, renal, or hepatic diseases;
• Diabetes mellitus or malnutrition;
• Leukemia and malignancies in general;
• Hypersensitivity disorders.

ADVERSE REACTIONS:
• The most commonly observed reactions are pain, swelling, and redness at the injection site, similar to any other adsorbed vaccines. These reactions are usually mild and disappear within 2 days after injection.
• Less common systemic reactions such as fever, headache, nausea, dizziness, and fatigue may also occur in some individuals after vaccination, though the causal relationship with the vaccine has not been established.

DRUG INTERACTIONS:
• Gene-HBvax can be administered together with Hepatitis B immune globulin (HBIG) but at different injection sites. HBIG must be given together with Hepatitis B vaccine in the following cases:
– Risk of exposure to blood infected with Hepatitis B virus (needles, scalpels, etc.);
– Infants born to mothers positive for HBsAg and HBeAg should be given the vaccine (preferably within 24 hours after birth).

• Gene-HBvax can be administered with other vaccines (diphtheria–pertussis–tetanus, poliomyelitis, BCG) but separate syringes and different injection sites must be used.

PRECAUTIONS / WARNINGS:
• Epinephrine must be readily available for use in rare cases of anaphylactic shock.
• It is recommended not to vaccinate pregnant women or breastfeeding women. However, pregnant women at high risk of Hepatitis B virus infection may also receive this vaccine.
• The vaccine does not protect individuals who are already infected with Hepatitis B at the time of vaccination.
• Do not inject Gene-HBvax into the gluteal region or intradermally.
• Strictly do not inject this vaccine intravenously.
• Hemodialysis patients and individuals with compromised immune systems may require additional doses after the primary vaccination.
• Do not use the vaccine if it has been frozen.

ROUTE OF ADMINISTRATION AND DOSAGE:
• Route of administration:
Hepatitis B vaccine must be administered intramuscularly. Adults: inject into the deltoid muscle. Children: inject into the anterolateral thigh. Exceptionally, the vaccine may be given subcutaneously for patients with bleeding disorders. Shake the vial thoroughly before injection.

• Dosage:
  – Adults: 20 µg / dose / 1 ml (over 10 years old)
  – Children: 10 µg / dose / 0.5 ml (10 years old and under)
• Vaccination schedule: Apply one of the two basic schedules as follows:
  (1) First dose: at the initial visit
    Second dose: 1 month after the first dose
    Third dose: 2 months after the first dose
    Booster: 1 year after the first dose

Or (2) First dose: at the initial visit
  Second dose: 1 month after the first dose
  Third dose: 6 months after the first dose
  Booster: 5 years after the first dose

OVERDOSAGE:
Avoid overdose.

STORAGE:
Store and transport at +2°C to +8°C. Do not freeze.

PRESENTATION:
Box of 10 vials × 1 ml
Box of 10 vials × 0.5 ml

SHELF LIFE:
36 months from the date of manufacture.