Engerix-B

Engerix-B

hepatitis b vaccine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
HBsAg, recombinant DNA produced in yeast cells
Indications/Uses
Active immunisation against HBV infection caused by all known subtypes in subjects considered at risk of exposure to HBV.
Dosage/Direction for Use
IM Adult ≥20 yr 20 mcg dose. Neonate, infant & childn up to & including 19 yr 10 mcg dose. Childn 11-15 yr 20 mcg at 0, 6 mth or 3-dose accelerated schedule of 10 mcg. Renal insufficiency/undergoing hemodialysis ≥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 1st dose at 0, 1, 2-12 mth. Neonate born of HBV-carrier mother 10 mcg starting at birth at 0, 1, 2 & 12 mth or 0, 1 & 6 mth.
Contraindications
Hypersensitivity to the vaccine or after previous inj.
Special Precautions
Anaphylactic reactions. Not to be inj intravascularly, intradermally or into buttocks. Not for protection against infection caused by other pathogens infecting the liver eg, hepatitis A, C & E virus. Postpone vaccination in patients w/ acute severe febrile illness. Syncope. Resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & w/ previous history of resp immaturity. Patients w/ HIV infection & impaired immune system. Renal insufficiency eg, haemodialysis. Pregnancy & lactation.
Adverse Reactions
Irritability; inj site pain & redness, 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 vaccine 10 mcg/0.5 mL
Packing/Price
1's
Form
Engerix-B vaccine 20 mcg/mL
Packing/Price
1's
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