Engerix-B

Active immunization against HBV infection caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV.

IM in the deltoid region in adult & childn or in the anterolateral thigh in neonates, infants & young childn. Adult ≥20 yr 20 mcg dose. Childn ≤19 yr, infant & neonate 10 mcg dose. Primary immunization 0, 1 & 6 mth or accelerated schedule of 0, 1 & 2 mth, 4th dose to be administered at 12 mth. Adult ≥20 yr travelling to high endemic areas 3 IM given at 0, 7 & 21 days, 4th dose is recommended 12 mth after 1^st dose. Childn 11-15 yr 20 mcg vaccine may be administered at 0, 6 mth schedule when there is low risk of HBV infection & when completion of 2-dose vaccination course can be assured. If both conditions cannot be assured (eg, patients undergoing haemodialysis, travellers to endemic regions & close contacts of infected subjects), 3-dose or the accelerated schedule of 10 mcg vaccine should be used. Renal insufficiency & undergoing haemodialysis ≥16 yr 4 double dose at elected date, 1, 2 & 6 mth from date of 1^st dose, ≤15 yr, including neonate 10 mcg at 0, 1, 2 & 12 mth or 0, 1 & 6 mth. Known or presumed HBV exposure 0, 1, 2-12 mth, 1^st dose can be administered simultaneously w/ HBIg. Neonate born of HBV-carrier mother 10 mcg starting at birth & 1 of 2 immunization schedules have to be followed. Use either at 0, 1, 2 & 12 mth or 0, 1 & 6 mth schedule. When available, HBIg should be given simultaneously. Haemodialysis & other immunocompromised patient Recommended for booster dose.

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

Do not administer intravascularly; in the buttock or intradermally. Postpone vaccination in patients w/ acute severe febrile illness. Immune response to HBV vaccine may vary due to a number of factors including older age, male gender, obesity, smoking habits & route of administration. Consider additional doses in adults >40 yr; patients w/ renal insufficiency including undergoing haemodialysis, HIV-infection & impaired immunity. May not prevent unrecognised hepatitis B infection at the time of vaccination. Does not prevent infection caused by other pathogens known to infect the liver eg, hepatitis A, C & E virus. Syncope (fainting) can occur. Protective immune response may not be elicited in all vaccinees. Potential risk of apnoea; consider resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & 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. Loss of appetite; headache, drowsiness; GI symptoms (eg, nausea, vomiting, diarrhoea, abdominal pain); inj site swelling & induration, malaise, fever (≥37.5°C).

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

Vaccines, Antisera & Immunologicals

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

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