Hepatitis B Vaccines

Indications & Dose:

Active immunization against hepatitis B (HBV) infection.

DOSE 

Administration: This is for i.m. use only.

In adults the injection should be given in the deltoid region.

In neonates and infants: the injection should be given in anterolateral thigh. Dose for adults and children above 10 years is 20mcg and for neonates, infants and children below 10 years the dose is 10mcg. Three doses are given as: first dose on elected date, second dose one month later and third dose 6-8 months after the first dose. For rapid immunization the third dose can be given two months after the first dose and a fourth booster dose at 12 months.

0r

Adult Dose vaccine-A 20 microgram dose (in 1.0 ml suspension is recommended for adults 20 years of age and older. Paediatric Dose vaccine-A 10 microgram dose(in 0.5m1 suspension) is recommended for neonates, infants and children upto and including age of 19 years. Primary Immunization: A series of 3 intramuscular injections is required to achieve optimal protection. e.g, at 0, 1 and 2 months or 0, 1 and 6 months. The vaccine should be injected in the deltoid region in adults and children or in the antereo lateral thigh in neonates, infants and young children. Rapid Immunization: When a more rapid induction of protection is required in adults, a schedule of 3 intramuscular injections is recommended at 0,7 and 21 days. Booster dose: The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established. Thus a booster dose is not recommended in these circumstances. For haemodialysis and other immunocompromised patients, booster doses are recommended. The booster dose is well tolerated as primary vaccination course. Refer to full prescribing information for special dosing recommendations, including regimens for neonates born of mothers who are FIB carriers, persons with known or presumed exposure to HBV or those who are immunocompromised. Reduction in the incidence of hepatocellular carcinoma in children-. This vaccine can be administered at the same time as DTP, DT and/or OPV.measles-mumps-rubella, Haemophilus influenzae type b, hepatitis A and BCG vaccines. When available, hepatitis B immune globulins (HBIg) should be given simultaneously with This drug at a separate injection site as this may increase the protective efficacy. Different injectables vaccines should always be administered at different injection sites. This drug may be used to complete a primary immunization course started either with plasma — derived or with other genetically-engineered hepatitis B vaccines, or as a booster dose in subjects who have previously received a primary immunization course with plasma —derived or with other genetically —engineered hepatitis B vaccines. 

Contraindications:

Known hypersensitivity to any constituent of the vaccine, or signs of hypersensitivity after previous administration.

Side Effects:

Cautions:

Precautions:

Administration of Engerix TM -B should be postponed in subjects suffering from severe febrile illness. The effectiveness of EngerixTM -B may be reduced in patients with existing (unrecognized) hepatitis B infection or in persons over 40 years of age. Patients with impaired immune system or those on hemodialysis may require additional doses. As with all injectable vaccines medical treatment should be available in case of rare anaphylactie reactions. Engerix TM-B should not be administered intravenously. Engerix TM-B should not be administered in the buttock or intradermally since this may result in a lower immune response.

Pregnancy and Lactation: Adequate human data on use during pregnancy and lactation is not available nor any adequate animal reproduction studies available with all medicines use should be avoided during pregnancy or in nursing mothers unless considered essential by the physician.

UNDESIRABLE EFFECT: Commonly redness, swelling and tenderness at the injection site, Rarely: fatigue, fever, malaise, influenza like symptoms; dizziness, headache, paresthesia, nausea, vomiting, diarrhea, abdominal pain, abnormal LFT, artharalgia, myalgia,rash,pruritis,utricaria. Very rarely: anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness: syncope,hypotension: paralysis, neuropathy, fleuritis (including Guillain Barre Syndrome), opticneuritisandmultiplesclerosis), encephalitis, encephalopathy, meningitis, convulaions; thrombocytopenia; arthritis; bronchospasm like symptoms angioedema erythemamutiforme; vasculitis lymphadenopathy .

Interaction:

Warnings:

Adverse Effects:

Mild local tenderness at infection site, local inflammatory reaction (swelling, heat, redness, induration, pain); fever, malaise, fatigue, headache, dizziness, faintness, leg cramps, myalgia, arthralgia, nausea, vomiting, urticaria, diarrhea, rash, pruritus; possibility of subcutaneous nodules following SC injections; hypersensitivity. 

PREGNANT PATIENTS

* It’s unknown whether drug can harm foetus; use only when potential risk from exposure to hepatitis B infection outweighs potential risk of adverse drug effect.

BREAST-FEEDING PATIENTS

* It isn’t known whether drug appears in breast milk

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: