Engerix-B

Engerix-B

hepatitis b vaccine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Hepatitis B (rDNA) vaccine (adsorbed)
Indications/Uses
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
A 0, 1 & 6 mth schedule gives optimal protection. An accelerated schedule, w/ immunisation at 0, 1 & 2 mth, will confer quick protection but requires 4th dose at 12 mth. Adult & childn ≥16 yr 20 mcg IM in the deltoid region. Neonate, infant & childn ≤15 yr 10 mcg IM in the anterolateral thigh. Adult ≥18 yr requiring rapid induction of protection eg, person travelling to areas of high endemicity & who commence a course of vaccination against HBV w/in 1 mth prior to departure A schedule of 3 IM inj given at 0, 7 & 21 days may be used; 4th dose is recommended 12 mth after the 1st 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. Patient w/ renal insufficiency & undergoing haemodialysis ≥16 yr 4 double doses (2 x 20 mcg) at elected date, 1, 2 & 6 mth from date of 1st dose; ≤15 yr & neonates 10 mcg at either 0, 1, 2, & 12 mth or the 0, 1, 6 mth schedule. Known or presumed exposure to HBV 1st dose can be administered simultaneously w/ HBIg at separate inj site at 0, 1, 2-12 mth immunisation schedule. Neonate born of mother who is HBV carrier 10 mcg to start at birth w/ either 0, 1, 2 & 12 mth or the 0, 1 & 6 mth schedule. When available, HBIg should be given simultaneously.
Contraindications
Hypersensitivity to any component of the vaccine, or after previous Engerix-B administration.
Special Precautions
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. 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.
Adverse Reactions
Irritability; pain & redness at inj site, fatigue. Appetite lost; headache, drowsiness; GI symptoms; swelling at inj site, malaise, inj site reactions (eg, induration), fever (≥37.5°C).
Drug Interactions
Can be given concomitantly w/ DTP, DT &/or polio vaccines; HPV vaccine; MMR vaccine, H. influenzae b vaccine, hepatitis A vaccine, BCG. Different inj vaccines should always be administered at different inj sites.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Form
Engerix-B vaccine (inj) 10 mcg/0.5 mL
Packing/Price
1's
Form
Engerix-B vaccine (inj) 20 mcg/mL
Packing/Price
1's
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