Engerix-B

Engerix-B

hepatitis b vaccine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Hepatitis B (rDNA) vaccine (adsorbed)
Indications/Uses
Active immunisation 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 Inj in deltoid region in adults & childn, or in anterolateral thigh in neonates, infants & young childn. Primary immunisation schedule: 0, 1 & 6 mth. Accelerated schedule: 0, 1 & 2 mth followed by 4th dose at 12 mth. Adult ≥20 yr requiring rapid induction of protection eg, person travelling to areas of high endemicity & who commence a course of vaccination against hepatitis B w/in 1 mth prior to departure 20 mcg at 0, 7, 21 days followed by 4th dose at 12 mth after 1st dose. Childn ≤19 yr, infant & neonate born of HBV-carrier mother 10 mcg at 0, 1, 2 & 12 mth, or at 0, 1 & 6 mth. Patients 11-15 yr 20 mcg as 2-dose course (0 & 6 mth) for patients w/ low risk of hepatitis B infection, or 10 mcg as 3-dose or accelerated schedule for patients undergoing haemodialysis, travelers to endemic regions & close contacts of infected subjects. Renal insufficiency including patients undergoing haemodialysis ≥16 yr Two 20 mcg at 1, 2 & 6 mth from 1st dose, ≤15 yr including neonates 10 mcg at 0, 1, 2 & 12 mth, or at 0, 1 & 6 mth. Known or presumed HBV exposure Administer 1st dose simultaneously w/ hepatitis B Ig at separate inj site at 0, 1, 2-12 mth. Haemodialysis & other immunocompromised patient Recommended for booster dose.
Contraindications
Known or previous hypersensitivity.
Special Precautions
Postpone administration in patients suffering from acute severe febrile illness. Not to be administered in the buttock, intradermally or intravascularly. Not for preventing infection caused by other liver-infecting pathogens eg, hepatitis A, C & E virus. May not prevent hepatitis B in the presence of unrecognised infection at time of immunisation. Syncope. Male; obese; smoking. Consider additional doses in adults >40 yr; patients w/ renal insufficiency including undergoing hemodialysis, HIV-infection & impaired immunity. Pregnancy & lactation. Potential risk of apnoea & need for 48-72 hr resp monitoring in very premature infants (≤28 wk gestation) & those w/ history of resp immaturity. Elderly.
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 susp for inj 10 mcg/0.5 mL
Packing/Price
0.5 mL x 1's
Form
Engerix-B susp for inj 20 mcg/mL
Packing/Price
1 mL x 1's
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