Engerix-B

Hepatitis B (rDNA) vaccine (adsorbed)

Active immunization against HBV infection caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV. Can be expected that hepatitis D will also be prevented by immunisation (does not occur in absence of hepatitis B infection).

IM (deltoid-adult & childn); (anterolateral thigh-young childn, infant, neonate). Adult ≥20 yr 20 mcg dose. Neonate, infant & childn ≤19 yr 10 mcg dose. Primary immunization 3 doses at 0, 1 & 6 mth gives optimal protection at mth 7 or an accelerated schedule at 0, 1 & 2 mth administered w/ a 4th dose at 12 mth. Patient ≥20 yr Rapid immunization 3 doses at 0, 7 & 21 days administered w/ a 4th dose 12 mth after 1st dose. Patient 11-15 yr w/ low risk of hepatitis B infection 20 mcg at 0 & 6 mth. Patient w/ renal insufficiency & those undergoing hemodialysis ≥16 yr 4 double doses (2 x 20 mcg) at 1, 2 & 6 mth after 1st dose; ≤15 yr including neonate 10 mcg at 0, 1, 2 & 12 mth or 0, 1 & 6 mth. Known or presumed exposure to HBV Administer 1st dose w/ HBIg (separate inj site) at 0, 1, 2 & 12 mth. Neonate born of HBV-carrier mothers 10 mcg starting at birth following either the 0, 1, 2 & 12 mth or 0, 1 & 6 mth schedule. Haemodialysis & other immunocompromised patient Booster doses are recommended.

Hypersensitivity to any component of the vaccine, or after previous Engerix-B administration.

Postpone vaccination in patients w/ acute severe febrile illness. Do not administer in the buttock region, intradermally or intravascularly. Exceptionally the vaccine may be administered SC in patients w/ thrombocytopenia or bleeding disorders. Syncope (fainting) can occur. Immune response to HBV vaccine may vary due to a number of factors including older age, male gender, obesity, smoking habits & route of administration. Patients w/ renal insufficiency including patients undergoing haemodialysis, HIV infected & persons w/ impaired immune system may require additional doses. Appropriate medical treatment & supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Protective immune response may not be elicited in all vaccinees. The potential risk of apnoea & the need for resp monitoring for 48-72 hr should be considered when administering the primary immunization series to very premature infants (born ≤28 wk of gestation) & particularly for those w/ a previous history of resp immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Pregnancy & lactation.

Irritability; pain & redness at inj site, fatigue. Appetite loss; headache, drowsiness; GI symptoms (eg nausea, vomiting, diarrhoea, abdominal pain); swelling & induration at inj site; malaise, fever (≥37.5°C).

Different inj vaccines should always be administered at different inj sites.

Vaccines, Antisera & Immunologicals

J07BC - Hepatitis vaccines ; Used for active immunizations.

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