Hepatitis b vaccine
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Suspension for injection containing 40micrograms/ml hepatitis B virus surface antigen, recombinant (HBsAg), adsorbed on amorphous aluminium hydroxyphosphate sulfate.
HBsAg is produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3).
Active immunisation against hepatitis B virus infection caused by all known subtypes in dialysis and predialysis adult patients.
It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection only occurs in the presence of hepatitis B infection.
At risk individuals who require immunisation are determined on the basis of official recommendations.
The following populations are considered to be at risk:
Parenteral drug abusers
Individuals who frequently change sexual partners
Close family contacts of a case or carrier
Infants born to mothers who had hepatitis B during pregnancy
Infants born to mothers who are positive for the hepatitis B surface antigen, with/without hepatitis B e-antigen
Individuals with haemophilia, those receiving regular blood transfusions or blood products, and carers responsible for administering these products
Individuals with chronic renal failure, including those on haemodialysis, and carers for these patients who are negative for the hepatitis B surface antigen
Individuals with chronic liver disease
Healthcare personnel, including trainees, who have direct contact with blood and tissues
Individuals with an occupational risk, such as morticians and embalmers
Staff and patients of day care or residential accommodation for patients with severe learning difficulties
Inmates of custodial institutions
Travellers to areas where there is a high prevalence of hepatitis B, who have an increased risk of developing the disease, or who plan to remain in the area for lengthy periods
Families adopting children from countries where there is a high prevalence of hepatitis B.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
A course of vaccination should include at least three doses to ensure maximum protection.
The basic immunisation schedule for dialysis and pre-dialysis patients
After the first dose, subsequent doses should be given after 1 month and 6 months.
A booster dose may be required if the antibody level against hepatitis B virus surface antigen (anti-HBs) is less than 10 iu/litre.
Additional Dosage Information
Recommendations for known or presumed exposure to hepatitis B virus (e.g. needle-stick with contaminated needle)
Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
The first dose of the vaccine should be initiated within 7 days of exposure and can be given simultaneously with hepatitis B immunoglobulin, although different injection sites should be used.
Subsequent doses should be given, if indicated by the serological status of the patient, according to the recommended immunisation schedule.
In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.
This vaccine may be used to complete a primary immunisation course or as a booster dose in individuals who have previously received a different hepatitis vaccine.
This vaccine can be administered with hepatitis B immunoglobulin or concomitantly with other vaccines, using separate injection sites and syringes.
For intramuscular administration.
The deltoid muscle is the preferred site for injection.
In patients with thrombocytopenia or bleeding disorders the vaccine may be given subcutaneously.
Before use, the vaccine should be well shaken to obtain a white, slightly opaque suspension.
In the absence of compatibility studies, this product must not be mixed with other medicinal products.
Precautions and Warnings
For hepatitis B vaccine administration, regular antibody testing should be done in haemodialysis patients.
Hepatitis B has a long incubation period. It is therefore possible for unrecognised hepatitis B infection to be present at the time of immunisation. This vaccine may not prevent hepatitis B infection in such cases.
Infection caused by hepatitis A, hepatitis C, hepatitis E and other pathogens affecting the liver, will not be prevented by this vaccine. It can be anticipated that hepatitis D infection will be prevented by immunisation with this vaccine as hepatitis D infection only occurs in the presence of hepatitis B infection.
Appropriate medical facilities should be readily available in the case of an anaphylactic reaction to the vaccine.
Sensitisation reactions may occur due to the potential traces of formaldehyde and potassium thiocyanate in the vaccine. These substances are used during the manufacturing process.
Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.
Note that response to the vaccine may be reduced in the following populations: males, elderly, obese, smokers and those suffering with chronic, underlying diseases. The serological status of these patients should therefore be monitored. This patient population may require additional doses of vaccine, but see the caveats under Revaccination of non-responders in the Dosage section.
Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section .
Pregnancy and Lactation
The Green Book recommends that hepatitis B vaccine should be given in pregnancy where there is a definite risk of infection, particularly if the pregnant woman is in a high-risk category.
UK licensed product information stresses that the effects of the hepatitis B vaccine on foetal development have not been assessed. However, together with the Green Book (2006), Schaefer (2007) and Briggs (2011) , it agrees that the risks to the foetus are likely to be negligible because the vaccine is inactivated.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
The Green Book recommends that hepatitis B vaccine should be given to breastfeeding mothers when there is a definite risk of infection. Hale (2010) also states no data are available on the use of hepatitis B vaccine in breastfeeding women, but it is unlikely to produce untoward effects on a breastfeeding infant.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
Local pain (injection site)
Erythema at injection site
Induration (injection site)
CNS demyelinating event
Elevation of liver enzymes
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
BNF for Children (2011-2012) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Immunisation against infectious disease (The Green Book) November 2006.
Available at: https://immunisation.dh.gov.uk/gb-individual-current-chapters/
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: HBVAXPRO 40mcg. Sanofi Pasteur MSD. Revised August 2011.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Hepatitis A vaccine. Last revised: April 3, 2012
Last accessed: June 20, 2012.
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