vaccine, hepatitis b




Concise Prescribing Info
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.
Dosage/Direction for Use
IM 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 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.
Hypersensitivity. Do not administer intravascularly.
Special Precautions
Postpone vaccination in patients w/ acute severe febrile illness. Possible infection. Consider additional doses in adults >40 yr; patients undergoing hemodialysis, HIV-infected patients, impaired immunity. Syncope may occur. Should be administered SC in patients w/ thrombocytopenia or bleeding disorders. Do not administer intradermally or in the buttock. Consider resp monitoring for 48-72 hr in very premature infants (born ≤28 wk of gestation) particularly those w/ history of resp immaturity. Pregnancy & lactation.
Adverse Reactions
Irritability; pain & redness at inj site, fatigue. Appetite loss; headache, drowsiness; GI symptoms (eg nausea, vomiting, diarrhea, abdominal pain); swelling & induration at inj site; malaise, fever (≥37.5°C).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Engerix-B vaccine (inj) 10 mcg/0.5 mL
Engerix-B vaccine (inj) 20 mcg/mL
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