Engerix-B

Engerix-B

hepatitis b vaccine

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per 0.5 mL 10-mcg dose vaccine HBsAg 10 mcg, adsorbed on Al hydroxide hydrated 0.25 mg Al3+. Per 1 mL 20-mcg dose vaccine HBsAg 20 mcg, adsorbed on Al hydroxide hydrated 0.5 mg Al3+.
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
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 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. Renal insufficiency & undergoing haemodialysis ≥16 yr 4 double dose at elected date, 1, 2 & 6 mth from date of 1st 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, 1st 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.
Contraindications
Hypersensitivity to any component of the vaccine, or after previous Engerix-B administration.
Special Precautions
Do not administer intravascularly; in the buttock or intradermally. Postpone vaccination in subjects w/ acute severe febrile illness. Patients >40 yr additional doses may be considered. Patients undergoing haemodialysis, HIV infected, impaired immune system, adequate anti-HBs Ab titres may not be obtained after primary course, therefore administration of additional doses required. Does not prevent infection caused by other pathogens known to infect the liver eg, hepatitis A, C & E virus. Syncope (fainting) can occur. A 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. Renal insufficiency eg, undergoing haemodialysis. Pregnancy & lactation.
Adverse Reactions
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).
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 pre-filled inj 10 mcg/0.5 mL
Packing/Price
(syringe) 1's
Form
Engerix-B pre-filled inj 20 mcg/1 mL
Packing/Price
1's
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