INFORMATION FOR CONSUMERS
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This leaflet answers some common questions about H-B-VAX II. It does not contain all the available information. It does not take the place of talking to your doctor.
All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given H-B-VAX II against the benefits they expect it will have for you.
If you have any concerns about being given this vaccine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
H-B-VAX II is a vaccine used to help prevent hepatitis B. The vaccine can be given to newborns, infants, children, teenagers and adults.
Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It can be caught by coming into contact with an infected person's blood, semen, vaginal secretions, saliva or other body fluids. For example, if these infected fluids enter your blood stream through a cut in your skin, you could become infected. Other situations that could lead to infection include:
People who have hepatitis B may not look or feel sick when infected. In fact, a person could be infected by the virus six weeks to six months before symptoms occur. Some people develop mild, flu-like symptoms. Others may become very ill and extremely tired, develop yellowing of the skin and/or eyes (also called jaundice), dark urine and other symptoms that require hospitalisation.
Most people recover completely from the HBV infection. However, there are some people, particularly children, who may not have symptoms but continue to carry the virus in their blood. They are called chronic carriers. These chronic carriers are infectious and can spread the disease to others throughout their lives.
Babies who are infected with the HBV at birth, almost always go on to become chronic carriers. The infection at birth is silent, and the babies appear healthy and continue to remain healthy for many years. However, after 30, 40 or 50 years they can become unwell and develop the symptoms described above.
All chronic carriers run the risk of developing serious liver disease, such as cirrhosis (scarring of the liver) or liver cancer.
There is no specific treatment for hepatitis B. Therefore, vaccination is the best way to help protect against infection and possible serious longterm disease.
H-B-VAX II works by causing your body to produce its own protection by making disease-fighting substances (antibodies) to fight the HBV. If a vaccinated person comes into contact with HBV, the body is usually ready, and produces antibodies to destroy the virus. However, as with all vaccines, 100% protection against hepatitis B cannot be guaranteed.
Because hepatitis B infection can go undetected for a long period of time, it is possible that an individual may already be infected at the time the vaccine is given. The vaccine may not prevent hepatitis B in these individuals.
H-B-VAX II will not protect against hepatitis caused by other agents or viruses (such as hepatitis A, hepatitis C, hepatitis D, hepatitis E).
Do not have H-B-VAX II if:
If you are not sure whether you should have H-B-VAX II, talk to your doctor.
Tell your doctor if:
If you have not told your doctor about any of the above, tell them before you are given H-B-VAX II.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
H-B-VAX II may not work as well as it should if you or your child are taking medicines that decrease the immune system, such as corticosteroids (eg. prednisone) or cyclosporin.
Your doctor will advise you if you are taking any of these or other medicines that decrease the immune system. Your doctor will decide whether or not to give the vaccine. You may need to be given a higher dose of H-B-VAX II than normal.
Your doctor will decide on the dose of H-B-VAX II that you will be given. This depends on your age and other factors, such as if you are undergoing dialysis.
H-B-VAX II is given as an injection, usually into your upper arm muscle by a doctor or trained nurse. For babies, the vaccine may be given into the upper thigh muscle.
For some people with bleeding problems, the vaccine may need to be given under the skin (subcutaneously). The vaccine should not be injected directly into veins (intravenously).
H-B-VAX II is generally given as a total of three doses over six months. Each dose is given on a separate visit. The schedule is:
For babies born to mothers infected with HBV, the first dose of H-B-VAX II should be given at birth, or as soon thereafter as possible. In addition to the H-B-VAX II an injection of hepatitis B immune globulin is also given.
It is important to return at the scheduled dates for the follow-up doses.
The duration of protective effect of H-B-VAX II is unknown. Therefore, it is not known whether a booster dose will be necessary.
If you miss a scheduled dose, talk to your doctor and arrange another visit as soon as possible.
Keep your follow-up appointments with your doctor or clinic.
It is important to have your follow-up doses of H-B-VAX II at the appropriate times to make sure the vaccine has the best chance of providing protection against the hepatitis B virus.
Be careful driving or operating machinery until you know whether H-B-VAX II has affected you.
H-B-VAX II should not normally interfere with your ability to drive a car or operate machinery. However, H-B-VAX II may cause dizziness or light-headedness in some people. Make sure you know how you react to H-B-VAX II before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
H-B-VAX II helps protect most people from hepatitis B, but it may have unwanted adverse effects in a few people. All medicines and vaccines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.
Ask your doctor or pharmacist to answer any questions you may have.
These are the more common adverse effects that may occur in children aged 0-10 years. For the most part these have been mild.
These are the more common adverse effects of H-B-VAX II. For the most part these have been mild.
These are serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare.
As with all vaccines given by injection, there is a very small risk of a serious allergic reaction.
These are serious adverse effects. If you have them, you may have had a serious allergic reaction to H-B-VAX II. You may need urgent medical attention or hospitalisation. Most of these adverse effects occur within the first few hours of vaccination.
Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible adverse effects. You may not experience any of them.
H-B-VAX II is usually stored in the doctor's surgery or clinic, or at the pharmacy. However if you need to store H-B-VAX II:
H-B-VAX II comes in glass vials as a slightly white liquid. Three different vaccine doses are available:
The active ingredient of H-B-VAX II is the surface protein of the hepatitis B virus, derived from genetically engineered yeast cells. The vaccine is not infectious, and will not give you the hepatitis B virus.
H-B-VAX II is made without any human blood or blood products, or any other substances of human origin. It does not contain any infectious material.
H-B-VAX II is supplied in New Zealand by:
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND.
Tel: 0800 500 673
This leaflet was prepared in August 2002.
CP-HB2-0202(120802)
®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA