Hepa-B 1ml

Indications

Hepa-B is indicated for the active immunization against infections caused by all known subtypes of the Hepatitis B virus. Since Hepatitis D (resulting from the delta virus) cannot occur without a Hepatitis B infection, the Hepa-B vaccine is expected to provide protection against Hepatitis D as well.

Immunization is recommended for individuals of all ages, particularly those at heightened risk of exposure to the Hepatitis B virus, including:

• Newborns of infected mothers, who may contract the virus at birth.
• Children, adolescents, and adults can become infected through:
  • Contact with blood and body fluids due to cuts, bites, or sores.
  • Exposure to contaminated objects such as toothbrushes, razors, or diabetes monitoring devices.
  • Unprotected sexual contact with an infected individual.
  • Sharing needles for drug injections.
  • Accidental needlestick injuries.
  • Household contact with Hepatitis B-positive individuals.
  • Residents and staff in facilities for individuals with developmental disabilities.
  • Patients undergoing kidney dialysis.
  • Travelers to regions where Hepatitis B is endemic.
  • Individuals with HIV.
  • Patients with hemophilia, thalassemia, sickle cell anemia, or cirrhosis.

Additional at-risk groups include military personnel, morticians, embalmers, prisoners, and first responders (police and fire department personnel) who may encounter exposure through their duties.

Always consult a registered healthcare professional before using this medication.

Composition

Each 0.5 ml dose contains more than 10 mcg of hepatitis B surface antigen, adsorbed onto Aluminium Hydroxide gel, which is equivalent to 0.25 mg of Al3+.

Each 1 ml dose contains more than 20 mcg of hepatitis B surface antigen, adsorbed onto Aluminium Hydroxide gel, which is equivalent to 0.5 mg of Al3+.

Description

Hepa-B is a non-infectious recombinant DNA hepatitis B vaccine. It is a sterile suspension of the purified hepatitis B surface antigen, derived from genetically engineered yeast cells (Saccharomyces cerevisiae). These cells carry the gene coding for HBsAg. The expressed HBsAg protein undergoes several purification steps before being formulated as a suspension adsorbed onto aluminium hydroxide. Notably, no human-derived substances are utilized in its production.

Dosage

• For Neonates, Infants, and Children (up to 19 years): The recommended dose is more than 10 mcg of antigen protein in 0.5 ml.
• For Adults (19 years and older): The recommended dose is more than 20 mcg of antigen in 1 ml.

Primary Immunization Schedule for All Ages

The standard immunization regimen consists of three doses:

• First Dose: Administered on a chosen date.
• Second Dose: Administered one month after the first dose.
• Third Dose: Administered six months after the first dose.

Alternatively, an accelerated schedule can be adopted, consisting of four doses:

• First Dose: Administered on a chosen date.
• Second Dose: Administered one month after the first dose.
• Third Dose: Administered two months after the first dose.
• Fourth Dose: Administered twelve months after the first dose.

The accelerated schedule provides quicker protection and is designed to enhance patient compliance.

For neonates born to hepatitis B surface antigen-positive mothers, a total of four doses of 10 mcg are recommended:

• First Dose: Administered at birth alongside hepatitis B immunoglobulin (at a separate injection site).
• Second Dose: Administered one month after the first dose.
• Third Dose: Administered two months after the first dose.
• Fourth Dose: Administered twelve months after the first dose.

For travelers departing within one month, adults over 18 years should follow this regimen:

• First Dose: Administered on a chosen date.
• Second Dose: Administered seven days after the first dose.
• Third Dose: Administered twenty-one days after the first dose.
• Fourth Dose: Administered twelve months after the first dose.

For individuals with renal insufficiency (including hemodialysis patients), the recommended schedule is four doses of 40 mcg:

• First Dose: Administered on the appropriate date.
• Second Dose: Administered one month after the first dose.
• Third Dose: Administered two months after the first dose.
• Fourth Dose: Administered six months after the first dose.

Immunization schedules and booster doses may need adjustments for those with low antibody concentrations.

Booster vaccinations: For individuals with normal immune status who have been vaccinated, the necessity for booster doses of the Hepatitis B vaccine has not been conclusively established. However, booster doses are advised for hemodialysis patients and other immunocompromised individuals.

Always consult a registered healthcare professional before using this medication.

Administration

Method of Administration: The Hepatitis B vaccine is intended for intramuscular injection only; it should not be administered intravenously. For adults and children, the vaccine should be injected intramuscularly into the deltoid muscle, while in children under 1 year, it should be injected into the anterolateral aspect of the thigh.

Preparation for Administration: Shake the vaccine gently before use to achieve a homogeneous, turbid white suspension—avoid vigorous shaking. Inspect the vaccine visually for any particulate matter or discoloration prior to administration. If any abnormalities are present, do not administer the vaccine. The vaccine is ready to use; no dilution is required.

Co-Administration: The Hepatitis B vaccine can be administered simultaneously with other vaccines, including Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps, and Rubella (MMR), Haemophilus influenzae b, Hepatitis A, and BCG vaccines, at different sites and with separate syringes. However, it should not be mixed with other vaccines or medications in the same syringe.

Always consult a registered healthcare professional before using this medication.

Contraindications

Hypersensitivity to any component of the vaccine, including yeast, constitutes a contraindication. This vaccine is also contraindicated for individuals who have had prior hypersensitivity reactions to any Hepatitis B virus-containing vaccine.

Side Effects

Hepa-B is generally well tolerated, with most recipients experiencing only mild reactions post-vaccination. Common reactions are typically localized at the injection site (such as redness, swelling, and tenderness). Systemic reactions, including malaise, headache, diarrhea, vomiting, muscle pain, and elevated temperature, are reported less frequently. In very rare instances, allergic reactions (such as itching, rash, and hives) may occur.

Pregnancy & Lactation

The impact of Hepatitis B on fetal development or reproductive capacity remains unestablished. The vaccine should only be administered during pregnancy in cases of high infection risk. Adequate data on its use during lactation is lacking; therefore, it should be given to nursing mothers only if absolutely necessary.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin.

Storage Conditions

Store the vaccine out of reach of children at temperatures between +2°C to +8°C. Ensure transportation occurs within this temperature range. Protect the vaccine from light and avoid freezing.