Engerix-B thiomersal-free vaccine

Uses

The best way to prevent hepatitis B is by getting the hepatitis B vaccine. The hepatitis B vaccine is safe and effective and is usually given as 3-4 shots over a six month period.

Hepatitis B vaccination is recommended for:

• All infants, starting with the first dose of hepatitis B vaccine at birth.
• All children and adolescents younger than 19 years old who have not been vaccinated.
• People whose sex partners have hepatitis B.
• Sexually active persons who are not in a long-term, mutually monogamous relationship.
• Persons seeking evaluation or treatment for a sexually transmitted disease.
• Men who have sexual contact with other men.
• People who share needles, syringes, or other drug-injection equipment.
• People who have close household contact with someone infected with the hepatitis B virus.
• Health care and public safety workers at risk for exposure to blood or blood-contaminated body fluids on the job.
• People with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients.
• Residents and staff of facilities for developmentally disabled persons.
• Travelers to regions with moderate or high rates of hepatitis B.
• People with chronic liver disease.
• People with HIV infection.
• People with diabetes 19 through 59 years old, and considered for people with diabetes 60 years or older.
• Anyone who wishes to be protected from hepatitis B virus infection.

For Children and Adolescents

All children should get their first dose of hepatitis B vaccine at birth and complete the vaccine series by 6-18 months old. Hepatitis B vaccine is recommended for all babies so that they will be protected from a serious but preventable disease. Babies and young children are at much greater risk for developing a chronic infection if infected, but the vaccine can prevent this.

All children and adolescents younger than 19 years old who have not yet gotten the vaccine should also be vaccinated. "Catch-up" vaccination is recommended for children and adolescents who were never vaccinated or who did not get the entire vaccine series. Learn more about catching up on vaccines in the Who and When section.

For Adults

Any adult who is at risk for hepatitis B virus infection or who wants to be vaccinated should talk to a health professional about getting the vaccine series.

Dosage

Engerix-B thiomersal-free vaccine 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 pg 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

Or Accelerated schedule consists of 4 doses of vaccine-

• 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

Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.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

For travellers departing within 1 month, adult over 18 years:

• 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

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.

Method of administration:

• Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously.
• This should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.

Preparation for administration:

• The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously.
• The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
• The vaccine should be used as supplied; no dilution is necessary.

Side Effects

Abdominal pain and GI disturbance, and musculoskeletal and joint pain and inflammation. Dizziness and sleep disturbance. CV effects include occasional hypotension and, rarely, tachycardia. Dysuria, visual disturbances and earache.

Precaution

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.

Interaction

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

Pregnancy & Breastfeeding use

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Previous confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens. Hypersensitivity. Vaccines prepared in egg cultures are contraindicated in patients with hypersensitivity reactions to egg. Severe immunodeficiency. Malignant disease being treated with chemotherapy or radiotherapy and for at least 6 mth after stopping treatment. Patients with compromised immune system such as those on high-dose systemic corticosteroids, immunosuppressants or HIV positive.

Special Warning

Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms:

• First dose: at appropriate date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 6 months after first dose

Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.

Storage Condition

Store at 2-8° C. Do not freeze

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