Hepa-B Injection 20 mcg/ml is a recombinant DNA (rDNA) hepatitis B vaccine designed to provide active immunization against Hepatitis B virus (HBV) infection. Hepatitis B is a potentially serious liver infection caused by the HBV, which can lead to chronic liver disease, cirrhosis, and hepatocellular carcinoma. Hepa-B Injection stimulates the immune system to produce protective antibodies against the virus without causing the disease itself. It is suitable for individuals of all ages, including infants, children, adolescents, and adults who are at risk of HBV exposure.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Indications

Hepa-B Injection 20 mcg/ml is indicated for:

• Active immunization against hepatitis B virus in individuals at risk of infection, including:

  • Newborns of HBV-infected mothers

  • Healthcare and laboratory personnel

  • Patients undergoing hemodialysis or frequent blood transfusions

  • Travelers to endemic regions

  • Individuals with chronic liver disease or other immunocompromised conditions

• Prevention of HBV infection in unvaccinated adults and children

Immunization should be administered under the guidance of a healthcare professional.

Therapeutic Class

• Vaccines

• Immunobiologicals

Composition

Each 1 ml of Hepa-B Injection contains:

• Hepatitis B surface antigen (HBsAg, recombinant DNA) – 20 mcg

• Additional excipients include aluminum hydroxide as an adjuvant and preservatives to ensure stability and effectiveness.

Pharmacology

Hepa-B Injection contains recombinant HBsAg produced in yeast cells using recombinant DNA technology. Upon administration:

• The antigen stimulates the immune system to produce hepatitis B surface antibodies (anti-HBs)

• These antibodies provide protective immunity against HBV

• The vaccine induces a long-lasting immunologic memory, enabling the body to respond quickly to future exposures to the virus

The vaccine does not contain live virus and cannot cause hepatitis B infection. Protective antibody levels are typically achieved after completing the full vaccination schedule.

Dosage & Administration

Standard Dosage Schedule:

• Infants, Children, and Adolescents: 0.5 ml per dose via intramuscular injection into the anterolateral thigh (infants) or deltoid muscle (older children and adolescents)

  • Schedule: 0, 1, and 6 months

• Adults: 1.0 ml per dose via intramuscular injection into the deltoid

  • Schedule: 0, 1, and 6 months

Alternative Schedule: Accelerated schedules may be used in specific circumstances, such as for travelers or healthcare workers, as directed by a healthcare provider.

Administration Guidelines:

• Administer intramuscularly only; do not inject intravenously or subcutaneously.

• Shake well before use.

• Use a new sterile needle and syringe for each injection.

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Contraindications

• Hypersensitivity to any component of the vaccine, including yeast proteins

• Severe acute illness or infection (temporary postponement until recovery)

Side Effects

Hepa-B Injection is generally well tolerated. Common side effects include:

• Pain, redness, or swelling at the injection site

• Mild fever, fatigue, headache, or malaise

• Rarely, allergic reactions such as rash or urticaria

Serious adverse reactions are extremely uncommon.

Precautions & Warnings

• Ensure appropriate resuscitation equipment is available in case of rare anaphylactic reactions.

• Immunocompromised individuals may require additional doses to achieve protective antibody levels.

• Co-administration with other vaccines is generally safe but should follow recommended immunization guidelines.

Pregnancy & Lactation

• Pregnancy: Can be administered if clinically indicated; no evidence of harm to mother or fetus.

• Lactation: Safe to administer; the vaccine does not pass into breast milk in clinically significant amounts.

Storage Conditions

• Store at 2°C–8°C in a refrigerator.

• Do not freeze.

• Protect from light and use before the expiration date.

• Keep out of reach of children.