Hepa-B For Pediatric Vaccine 0.5ml

Uses:

To prevent Hepatiis B virus For active immunization against the, Hepatitis B infection

Composition

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

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

Pharmacology

Hepatitis B vaccines are utilized for active immunization against hepatitis B infection. These vaccines work by introducing the hepatitis B surface antigen (HBsAg) into the body. The HBsAg is adsorbed onto aluminum hydroxide or a similar adsorbent. When administered, the vaccine stimulates the immune system to produce antibodies against the HBsAg, thereby providing immunity and protecting the individual from future hepatitis B infections.

Tolerability and Reactions

Hepatitis B vaccine is generally well tolerated. Most recipients experience some reactions upon vaccination, which are typically mild and short-lived. These reactions primarily include local reactions at the injection site, such as erythema (redness), induration (hardening), and tenderness. Systemic reactions, such as malaise (general discomfort), headache, diarrhea, vomiting, myalgia (muscle pain), and elevated temperature, are reported less commonly. In very rare cases, allergic-type reactions, such as pruritus (itching), rash, and urticaria (hives), may occur.

Dosage Guidelines

Neonates, Infants, and Children up to 19 Years of Age:

• Recommended Dose: >10 mcg of antigen protein in 0.5 ml.

Adults 19 Years of Age and Older:

• Recommended Dose: >20 mcg of antigen in 1 ml.

Primary Immunization Schedule for All Ages

Standard Schedule (3 doses):

1. First Dose: On the elected date.
2. Second Dose: 1 month after the first dose.
3. Third Dose: 6 months after the first dose.

Accelerated Schedule (4 doses):

1. First Dose: On the elected date.
2. Second Dose: 1 month after the first dose.
3. Third Dose: 2 months after the first dose.
4. Fourth Dose: 12 months after the first dose.

This accelerated schedule provides quicker protection and is expected to enhance patient compliance.

Neonates Born to Hepatitis B Surface Antigen-Positive Mothers (4 doses of 10 micrograms):

1. First Dose: At birth with Hepatitis B immunoglobulin injection (at a separate site).
2. Second Dose: 1 month after the first dose.
3. Third Dose: 2 months after the first dose.
4. Fourth Dose: 12 months after the first dose.

Travelers Departing Within 1 Month (Adults over 18 Years):

1. First Dose: On the elected date.
2. Second Dose: 7 days after the first dose.
3. Third Dose: 21 days after the first dose.
4. Fourth Dose: 12 months after the first dose.

Renal Insufficiency (Including Hemodialysis Patients) - Adults and Children Over 16 Years (4 doses of 40 micrograms):

1. First Dose: On the appropriate date.
2. Second Dose: 1 month after the first dose.
3. Third Dose: 2 months after the first dose.
4. Fourth Dose: 6 months after the first dose.

The immunization schedule and booster doses may need to be adjusted for individuals with low antibody concentrations.

Booster Vaccinations

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

Administration:

Method of Administration:

• Route: Intramuscular injection only.
• Do Not: Inject intravenously.
• Injection Sites:
  • Adults and Children (over 1 year): Deltoid muscle.
  • Children (under 1 year): Anterolateral aspect of the thigh.

Preparation for Administration:

1. Shake Well: Shake the vaccine well before use to obtain a homogenous, turbid white suspension. Avoid vigorous shaking.
2. Visual Inspection: Inspect the vaccine visually for any particulate matter and discoloration before administration. Do not use the vaccine if these conditions are present.
3. Usage: Use the vaccine as supplied without any dilution.

Co-Administration:

• Simultaneous Administration: Hepatitis B vaccine can be administered concurrently with other vaccines, such as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae b, Hepatitis A, and BCG vaccines. Administer these vaccines at separate sites using separate syringes.
• Do Not Mix: Do not mix the Hepatitis B vaccine with other vaccines or medicinal products in the same syringe.

Interaction

Reduced response to vaccination when used concurrently with immunosuppressants such as corticosteroids or antineoplastics.

Contraindications

Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any Hepatitis B virus-containing vaccine.

Pregnancy & Lactation

The effect of Hepatitis B on fetal development or reproduction capacity has not been evaluated. However, it should only be used during pregnancy when there is a high risk of infection. Adequate human data on use during lactation and adequate animal reproduction studies are not available. It may be administered to nursing mothers only if needed.

Precautions & Warnings

If any alcohol or disinfectant is used for cleansing the skin it should be allowed to evaporate before vaccination otherwise inactivation of live vaccines may occur. Lactation: not known if excreted in breast milk

Storage Conditions:

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Protect from light. Do not freeze.