Presentation and Status in Health Basket
1 X 10 mcg / 0.5 ml
1 X 20 mcg / 0.5 ml
20 μg dose vaccine: The 20 μg dose vaccine (in 1.0 ml suspension) is intended for use in subjects 16 years of age and above.
10 μg dose vaccine: The 10 μg dose vaccine (in 0.5 ml suspension) is intended for use in subjects up to and including 15 years of age, including neonates. In children aged 10 to 15 years, the adult dose of 20 μg can be employed if low compliance is anticipated, since a higher percentage of vaccinees with protective antibody levels (> 10 IU/l) is obtained after two injections at this dosage.
Primary Immunisation schedules: All subjects: Two primary immunisation schedules can be recommended: A 0, 1, 6 months schedule which gives optimal protection at month 7 and produces high antibody concentrations. An accelerated schedule, with immunisation at 0, 1 and 2 months, which will confer protection more quickly and is expected to provide better patient compliance. With this schedule, a fourth dose should be administered at 12 months to assure long term protection as antibody concentrations after the third dose are lower than those obtained after the 0, 1, 6 months schedule. In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.
Subjects 18 years of age and above: In exceptional circumstances in adults, where an even more rapid induction of protection is required, e.g. persons travelling to areas of high endemicity and who commence a course of vaccination against hepatitis B within one month prior to departure, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose.
Patients with renal insufficiency including patients undergoing haemodialysis, 16 years of age and above: The primary immunisation schedule for patients, with renal insufficiency including patients undergoing haemodialysis is four double doses (2 x 20 μg) at elected date, 1 month, 2 months and 6 months from the date of the first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody concentrations remain equal to or higher than the accepted protective level of 10 IU/l. Patients with renal insufficiency including patients undergoing haemodialysis up to and including 15 years of age, including neonates: Patients with renal insufficiency, including patients undergoing haemodialysis, have a reduced immune response to hepatitis B vaccines. Either the 0, 1, 2 and 12 months or the 0, 1, 6 months schedule of the Pediatric Hepatitis B vaccine (10 μg) can be used. Based on adult experience, vaccination with a higher dosage of antigen may improve the immune response. Consideration should be given to serological testing following vaccination. Additional doses of vaccine may be needed to ensure a protective anti-HBs level ≥ 10 IU/l.
Known or presumed exposure to HBV: In circumstances where exposure to HBV has recently occurred (eg needlestick with contaminated needle) the first dose of this vaccine can be administered simultaneously with HBIg which, however, must be given at a separate injection site. The 0, 1, 2-12 months immunisation schedule should be advised.
Neonates born of mothers who are HBV carriers: The immunisation with the pediatric Hepatitis B vaccine (10 μg) of these neonates should start at birth, and two immunisation schedules have been followed. Either the 0, 1, 2 and 12 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response. When available, hepatitis B immune globulins (HBIg) should be given simultaneously with Engerix B Pediatric Dose at a separate injection site as this may increase the protective efficacy. These immunisation schedules may be adjusted to accommodate local immunisation practices with regard to the recommended age of administration of other childhood vaccines.
Booster dose: Current data do not support the need for booster vaccination among immunocompetent subjects who have responded to a full primary vaccination course. (Lancet 2000, 355:561). However, in immunocompromised subjects (eg subjects with chronic renal failure, haemodialysis patients, HIV positive subjects), boosters should be administered to maintain anti-HBs antibody concentrations equal or higher than the accepted protective level of 10 IU/l. For these immunocompromised subjects, post-vaccination testing every 6-12 months is advised. National recommendations on booster vaccination should be considered.
Method of administration: This product should be injected intramuscularly in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Active immunization against Hepatitis B virus infection
Hepatitis B vaccine should not be administered to subjects with known hypersensitivity to the active substances or to any of the excipients or to subjects having shown signs of hypersensitivity after previous Hepatitis B vaccine administration. As with other vaccines, the administration of this vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for immunisation.
Syncope (fainting) can occur following, or even before any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases.
The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E viruses.
As with any vaccine, a protective immune response may not be elicited in all vaccinees. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Hepatitis B vaccine. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the HB vaccination should thus be considered on a case by case basis by the physician. In HIV infected patients, as also in patients with renal insufficiency including patients undergoing haemodialysis and persons with an impaired immune system, adequate anti-HBs antibody concentrations may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
Hepatitis B vaccine should not be administered in the buttock or intradermally since this may result in a lower immune response. Hepatitis B vaccine should under no circumstances be administered intravenously. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants born < 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
In one clinical study conducted in adults with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations. In one clinical study conducted in children with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, drowsiness, irritability, loss of appetite and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations.
Nervous system disorders: Common: drowsiness, headache (headache is very common in children).
Gastrointestinal disorders: Common: gastrointestinal symptoms (such as nausea, vomiting, diarrhoea, abdominal pain).
Metabolism and nutrition disorders: Common: appetite lost.
General disorders and administration site conditions: Very common: pain and redness at injection site, fatigue. Common: fever (> 37.5°C), malaise, swelling at injection site, injection site reaction (such as induration)
Psychiatric disorders: Very common: irritability.
See prescribing information for full details.
The simultaneous administration of Hepatitis B vaccine and a standard dose of HBIg does not result in lower anti-HBs antibody concentrations provided that they are administered at separate injection sites. Hepatitis B vaccine can be given concomitantly with Haemophilus influenzae b, BCG, hepatitis A, polio, measles, mumps, rubella, diphtheria, tetanus and pertussis vaccines.
Hepatitis B vaccine can be given concomitantly with Human Papillomavirus (HPV) vaccine. Administration of Hepatitis B vaccine at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 97.9% for concomitant vaccination and 100% for Hepatitis B vaccine alone. Different injectable vaccines should always be administered at different injection sites. Hepatitis B vaccine may be used to complete a primary immunisation course started either with plasma-derived or with other genetically-engineered hepatitis B vaccines, or, if it is desired to administer a booster dose, it may be administered to subjects who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines.
Pregnancy and Lactation
Pregnancy: The effect of the HBsAg on foetal development has not been assessed. However, as with all inactivated viral vaccines one does not expect harm for the foetus. This product should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus.
Lactation: The effect on breastfed infants of the administration to their mothers has not been evaluated in clinical studies, as information concerning the excretion into the breastmilk is not available.
No contra-indication has been established.
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdose were similar to those reported with normal vaccine administration.