Hepa-B 0.5ml

Indications

Hepa-B is intended for the active immunization against infections caused by all known subtypes of the Hepatitis B virus. Since Hepatitis D (associated with the delta virus) cannot occur without Hepatitis B infection, vaccination with Hepa-B is also expected to provide protection against Hepatitis D.

Vaccination is advisable for individuals of all ages, particularly those who may be at increased risk of exposure to the Hepatitis B virus, including:

• Newborns born to infected mothers, who are at risk of infection at birth.
• Children, adolescents, and adults, who may become infected through:
  • Contact with blood and bodily fluids through skin abrasions such as bites, cuts, or sores.
  • Contact with contaminated objects, such as toothbrushes, razors, or diabetes monitoring devices.
  • Engaging in unprotected sexual activities with an infected individual.
  • Sharing needles during drug use.
  • Accidental needle stick injuries.
  • Living with individuals infected with Hepatitis B.
  • Residents and staff in facilities for individuals with developmental disabilities.
  • Patients undergoing kidney dialysis.
  • Travelers to areas where Hepatitis B is prevalent.
  • Individuals with HIV infection.
  • Patients with hemophilia, thalassemia, sickle cell anemia, or cirrhosis.

Additional groups at risk include military personnel, morticians, embalmers, inmates, and first responders such as police and fire department personnel who may come into contact with the virus during their work.

Consult a registered healthcare professional before taking any medication.

Composition

Each 0.5 ml dose contains over 10 mcg of hepatitis B surface antigen adsorbed on Aluminum Hydroxide gel, equivalent to 0.25 mg of Al3+.

Each 1 ml dose contains over 20 mcg of hepatitis B surface antigen adsorbed on Aluminum Hydroxide gel, equivalent to 0.5 mg of Al3+.

Description

Hepa-B is a non-infectious recombinant DNA vaccine designed to protect against Hepatitis B. It consists of a sterile suspension of the purified surface antigen obtained from genetically engineered yeast cells (Saccharomyces cerevisiae), which express the gene coding for HBsAg. The HBsAg protein undergoes extensive purification and is formulated as a suspension adsorbed on aluminum hydroxide. No human-derived substances are involved in its production.

Dosage

For neonates, infants, and children up to 19 years: The recommended dose of Hepatitis B vaccine (rDNA) is over 10 mcg of antigen protein in 0.5 ml.

For adults aged 19 and older: The recommended dose is over 20 mcg of antigen in 1 ml.

Primary Immunization Schedule for All Ages:
The standard immunization schedule involves three doses of the vaccine:

• First Dose: Administered on the selected date.
• Second Dose: 1 month after the first dose.
• Third Dose: 6 months after the first dose.

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

• First Dose: On the 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.

The accelerated schedule allows for quicker protection and improves patient compliance.

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

• First Dose: At birth, along with Hepatitis B immunoglobulin injection (administered 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.

For travelers departing within 1 month, adults over 18 years should follow this schedule:

• First Dose: On the selected date.
• Second Dose: 7 days after the first dose.
• Third Dose: 21 days after the first dose.
• Fourth Dose: 12 months after the first dose.

For individuals with renal insufficiency (including hemodialysis patients), the schedule for adults and children over 16 years consists of four doses of 40 mcg:

• First Dose: At the appropriate time.
• Second Dose: 1 month after the first dose.
• Third Dose: 2 months after the first dose.
• Fourth Dose: 6 months after the first dose.

Immunization schedules and booster doses may need to be adjusted for those with low antibody concentrations.

Booster Vaccinations:
For individuals with normal immune status who have been vaccinated, the need for booster doses of the Hepatitis B vaccine has not been clearly established. However, booster doses are advised for patients undergoing hemodialysis or those who are immunocompromised.

Consult a registered healthcare professional before taking any medication.

Administration

Method of Administration: Hepatitis B vaccine is intended for intramuscular injection only. It should not be administered intravenously. The vaccine should be given intramuscularly in the deltoid muscle for adults and children or in the anterolateral thigh for children under 1 year.

Preparation for Administration: Prior to use, the vaccine should be shaken gently to achieve a uniform turbid white suspension. Do not shake vigorously. Visually inspect the vaccine for any particulate matter or discoloration before administration; if any irregularities are found, do not use the vaccine. It should be administered as supplied without dilution.

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

Consult a registered healthcare professional before taking any medication.

Contraindications

Hypersensitivity to any component of the vaccine, including yeast, constitutes a contraindication. This vaccine is not suitable for individuals who have had prior hypersensitivity reactions to any Hepatitis B-containing vaccine.

Side Effects

Hepa-B is generally well tolerated. Most individuals may experience mild reactions post-vaccination, typically localized to the injection site (such as redness, swelling, and tenderness). Systemic reactions (including malaise, headaches, diarrhea, vomiting, muscle pain, and fever) are less common. In rare instances, allergic reactions (like itching, rashes, and hives) may occur.

Pregnancy & Lactation

The impact of Hepatitis B vaccination on fetal development or reproductive capacity has not been thoroughly studied. It should be administered during pregnancy only in cases of high infection risk. Data regarding its use during lactation and comprehensive animal reproduction studies are insufficient. It may be given to nursing mothers if deemed necessary.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin.

Storage Conditions

Keep out of reach of children. Store at temperatures between +2°C and +8°C. Ensure transportation occurs within this temperature range. Protect from light and do not freeze.