Introduction
The Euvax-B IM Injection 10 mcg/0.5 ml is a recombinant DNA vaccine designed to prevent infection caused by the hepatitis B virus (HBV). It is produced using recombinant DNA technology, where genes encoding hepatitis B surface antigens are inserted into yeast cells, which then produce the vaccine antigen. This vaccine is used as a preventive measure to protect against hepatitis B infection, a serious liver disease that can lead to chronic hepatitis, cirrhosis, and liver cancer.
Uses
The Euvax-B IM Injection 10 mcg/0.5 ml is used for:
- Primary Prevention: To protect individuals from contracting hepatitis B virus infection.
- Prevention in High-Risk Populations: Recommended for newborns, healthcare workers, individuals with chronic liver disease, and those at higher risk of exposure to HBV.
- Public Health: Part of routine childhood immunization schedules and vaccination programs to reduce the incidence of hepatitis B in the community.
| Brand Name | Euvax-B |
|---|---|
| Type | IM Injection |
| Weight | 10 mcg/0.5 ml |
| Generic | Hepatitis B Vaccine [rDNA] |
| Manufacturer | Sanofi Bangladesh Ltd. |
| Available in | English বাংলা |
Mechanism of Action
The vaccine works by stimulating the immune system to produce antibodies against the hepatitis B virus. The recombinant vaccine contains a small amount of hepatitis B surface antigen (HBsAg) which, once administered, prompts the immune system to recognize and attack the virus if exposed in the future. This creates an immunological memory that helps the body mount a defense against the virus.
How Long Does It Take to Work?
Immunity typically develops about 1 to 2 weeks after completing the full vaccination series. For individuals receiving the three-dose series, the full protective effect is generally achieved within 4 to 6 weeks after the third dose. Full protection requires completion of the entire vaccination regimen.
Absorption
The Euvax-B IM Injection 10 mcg/0.5 ml is administered intramuscularly, usually into the deltoid muscle of the upper arm. After injection, the vaccine components are absorbed into the bloodstream, where they stimulate the immune response.
Route of Elimination
The components of the Euvax-B IM Injection 10 mcg/0.5 ml are not metabolized or eliminated by the body in a conventional sense. The hepatitis B surface antigens in the vaccine do not persist in the body, as they are used to trigger an immune response, and are gradually broken down and cleared by normal immune processes.
Dosage
Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is >10 mcg of antigen protein in 0.5 ml.Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is >20 mcg of antigen in 1 ml.
Primary immunization schedule for all ages:
The usual immunization schedule consists of 3 doses of vaccine-
- First dose: at elected date
- Second dose: 1 month after first dose
- Third dose: 6 months after first dose
- First dose: at elected date
- Second dose: 1 month after first dose
- Third dose: 2 months after first dose
- Fourth dose: 12 months after first dose
Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:
- First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
- Second dose: 1 month after first dose
- Third dose: 2 months after first dose
- Fourth dose: 12 months after first dose
- First dose: at elected date
- Second dose: 7 days after first dose
- Third dose: 21 days after first dose
- Fourth dose: 12 months after first dose
- First dose: at the appropriate date
- Second dose: 1 month after first dose
- Third dose: 2 months after first dose
- Fourth dose: 6 months after first dose
Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses of
Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.
The standard dosage schedule for the Euvax-B IM Injection 10 mcg/0.5 ml includes:
- For Infants and Children: Three doses are given. The initial dose is administered at birth, followed by the second dose at 1 to 2 months, and the third dose at 6 to 18 months.
- For Adults: Three doses are typically administered at 0, 1, and 6 months.
- For High-Risk Individuals: The dosage schedule may vary based on specific risk factors and recommendations from healthcare providers.
Administration
The vaccine is administered via intramuscular injection, preferably into the deltoid muscle of the upper arm in older children and adults, or the thigh in infants. It should be injected slowly and gently to minimize discomfort.
Side Effects
Common side effects include:
- Pain, redness, or swelling at the injection site.
- Mild fever or irritability.
- Fatigue or headache.
Rare but serious side effects may include severe allergic reactions such as anaphylaxis. Immediate medical attention should be sought if signs of an allergic reaction occur.
Toxicity
The Euvax-B IM Injection 10 mcg/0.5 ml is generally considered safe and non-toxic when administered according to recommended guidelines. Overdose or inappropriate administration is unlikely, given the vaccine’s precise dosing and administration protocols.
Precautions
Precautions include:
- Ensure the recipient is not allergic to any component of the vaccine, including yeast or other vaccine ingredients.
- Monitor for any signs of allergic reactions following administration.
- Consult a healthcare provider before administering the vaccine to individuals with severe immunodeficiency or other significant health concerns.
Interaction
The Euvax-B IM Injection 10 mcg/0.5 ml can be administered concurrently with other vaccines, including routine childhood vaccines, without compromising efficacy. However, it should be administered in different sites if given simultaneously.
Disease Interaction
Patients with acute or chronic illness, including fever or immunosuppressive conditions, should consult their healthcare provider. The vaccine may still be administered, but a delay might be recommended for severe acute illness.
Drug Interaction
There are no significant drug interactions associated with the Euvax-B IM Injection 10 mcg/0.5 ml. It can be safely administered alongside most medications. However, patients should inform their healthcare provider of all medications and health conditions prior to vaccination.
Food Interactions
There are no known food interactions with the Euvax-B IM Injection 10 mcg/0.5 ml. Food intake does not affect the vaccine’s efficacy or safety.
Pregnancy Use
The Euvax-B IM Injection 10 mcg/0.5 ml is generally considered safe during pregnancy, especially if the risk of hepatitis B exposure is high. It is important to consult a healthcare provider for a personalized recommendation.
Lactation Use
The vaccine is safe for use during lactation. It does not affect breastfeeding or pose any risk to the nursing infant.
Acute Overdose
Acute overdose is unlikely with the Euvax-B IM Injection 10 mcg/0.5 ml, as it is administered in controlled doses. In the rare event of an overdose, the vaccine’s components are generally well-tolerated and do not pose a significant risk. Consult a healthcare provider for guidance if an overdose occurs.
Contraindication
Contraindications include:
- Severe allergic reaction to any component of the vaccine.
- History of severe allergic reactions to previous doses of the hepatitis B vaccine.
Use Direction
Follow the recommended vaccination schedule for the Euvax-B IM Injection 10 mcg/0.5 ml. Ensure the vaccine is administered by a qualified healthcare professional, and complete the full series to ensure adequate protection against hepatitis B.
Storage Conditions
Store the Euvax-B IM Injection 10 mcg/0.5 ml in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the vaccine in its original packaging to protect it from light and maintain its efficacy.
Volume of Distribution
The concept of volume of distribution is less applicable to vaccines like Euvax-B IM Injection 10 mcg/0.5 ml, as it primarily acts locally at the injection site and within the immune system rather than distributing throughout the body.
Half Life
The half-life of the vaccine components is not typically applicable as the vaccine’s effectiveness relies on the immune response rather than the pharmacokinetics of the vaccine itself.
Clearance
The Euvax-B IM Injection 10 mcg/0.5 ml does not have a traditional clearance rate. The vaccine’s components are used to stimulate an immune response and are gradually metabolized and cleared by normal immune processes.
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