INFORMATION FOR CONSUMERS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
In this leaflet, HAVRIX refers to the use of both HAVRIX 1440 for adults and HAVRIX Junior for children.
This leaflet answers some of the common questions about HAVRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having HAVRIX against the expected benefits.
If you have any concerns about HAVRIX talk to your doctor, nurse or pharmacist.
Keep this leaflet with this vaccine. You may need to read it again.
HAVRIX is a vaccine used to prevent hepatitis A infection. The vaccine works by causing the body to produce its own protection (antibodies) against this disease.
Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus.
The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Hepatitis A is very common in many parts of the world, and the risk of infection is greatest in those areas where hygiene and sanitation are poor. Such areas include Asia, India, Africa, Central and South America, the Pacific Islands, the Middle East, and the Mediterranean basin. HAVRIX is recommended for all travellers to these areas, including people in the armed forces.
Hepatitis A occurs in New Zealand, but is not common. Some groups of people however, are at risk of exposure to the disease and should be vaccinated.
There is no specific treatment for hepatitis A. Therefore vaccination is the best way to protect against infection in the longer term.
Immunoglobulin protects you from hepatitis A straight away but is only effective for a short time (8-12 weeks).
HAVRIX will not protect against hepatitis caused by other agents or viruses (such as hepatitis B, hepatitis C or hepatitis E). If a person if already infected with the hepatitis A virus at the time of vaccination, HAVRIX may not prevent the disease in these people.
If you are not sure whether HAVRIX should be given, talk to your doctor or nurse.
Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if HAVRIX is to be given with another vaccine or medicine.
HAVRIX Junior is recommended for use in children 2 to 15 years of age. HAVRIX is not recommended in children under 1 years of age, as information on use is limited.
Information on use of HAVRIX in the elderly is limited.
The doctor or nurse will give HAVRIX as an injection. If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.
For adults and children aged 16 years and over: the HAVRIX 1440 dose is 1mL.
For adolescents and children aged 2 to 15 years: the HAVRIX Junior dose is 0.5mL
HAVRIX will be injected into the upper arm muscle in adults and older children, and into the thigh muscle in infants. For some people with bleeding problems, the dose may need to be given under the skin (subcutaneously).
The vaccine should never be given intravenously.
HAVRIX is generally given as a single dose on an elected date.
If travelling overseas, HAVRIX should be given at least 2 weeks before departure. This is so the body has time to respond to the vaccine. If there is a risk of hepatitis A infection occurring before immunity develops, human immunoglobulin may need to be given at the same time as HAVRIX.
After one dose of HAVRIX, protection from hepatitis A lasts for at least 1 year. A second boostering dose, given 6 to 12 months after the first dose, gives longer term protection. It is not known how long booster dose protection lasts. Your doctor will advise on the need for booster dosing.
If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.
Keep your visits with the doctor or clinic. It is important HAVRIX doses are given at the correct times. This will ensure the best effect of the vaccine in protecting you (or your child) against hepatitis A.
Be careful driving or operating machinery until you know how HAVRIX affects you. HAVRIX should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or light-headedness. Make sure you know how you react to HAVRIX before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or light-headed.
Tell your doctor, nurse or pharmacist as soon as possible if you (or your child) do not feel well during or after having had a dose of HAVRIX.
HAVRIX helps protect most people from hepatitis A, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Most unwanted effects with HAVRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.
Tell your doctor if you notice any of the following that are troublesome or ongoing after vaccination:
As with all vaccines given by injection there is a very small risk of serious allergic reaction. Contact your doctor immediately or go to the casualty department of your nearest hospital if any of the following happens:
Allergy to HAVRIX is rare. Any such severe reactions will usually occur within the first few hours of vaccination.
Other side effects not listed above, can also occur during or soon after a dose of HAVRIX. Check with your doctor or nurse if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
HAVRIX is usually stored at the doctor's clinic or surgery, or at the pharmacy. But if you need to store HAVRIX always:
Ask your pharmacist what to do with any left over HAVRIX that has expired or has not been used.
HAVRIX comes in glass vials or prefilled syringes. It is a white, slightly milky liquid.
The active ingredient of HAVRIX is the killed hepatitis A virus. Two different vaccine strengths are available:
Inactive ingredients in the vaccine are: aluminium hydroxide, 2-phenoxyethanol, polysorbate 20, amino acids for injection, phosphate salts, sodium chloride, and water. Very small amounts of formaldehyde may also be present.
The vaccine is not infectious, and will not give you hepatitis A.
HAVRIX does not contain human blood or blood products, or any other substances of human origin.
HAVRIX is only available if prescribed by a doctor.
The vaccine comes in the following:
HAVRIX 1440 - monodose vials in packs of 1 and 10 (AUST R 53163) and prefilled syringes in packs of 1
HAVRIX Junior - monodose vials in packs of 1 and 10 (AUST R 57802) and prefilled syringes in packs of 1
Distributed In New Zealand by:
GlaxoSmithKline
Private Bag 106600
Downtown Auckland
Ph: (09) 367 2900
Fax (09) 367 2910
This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.
Date of Preparation: 04/01, Version 1