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Havrix Junior Monodose (Hepatitis A Vaccine)

What Havrix Junior Monodose is and what it is used for

Havrix Junior Monodose is a vaccine containing the hepatitis A virus. It is used to boost the body’s immune system to stop infection from hepatitis A.

How Havrix Junior Monodose works

The virus is not alive so this vaccine cannot cause hepatitis A infection.

When your child is given Havrix Junior Monodose their body will make antibodies (the body’s natural defence system) against the hepatitis A virus.

After 2 to 4 weeks, these antibodies will have been produced and will protect your child against hepatitis A infection.

To ensure long term protection, your child should receive a second (booster) vaccination 6 to 12 months after their first dose. As long as the booster is given within 3 years, they should still be fully protected. Once the booster vaccination is given, they are not expected to need an additional dose of Havrix.

Having this vaccine will only protect against hepatitis A and not against any other type of hepatitis virus or any other illness that can cause hepatitis (inflammation of the liver).

Some general information on hepatitis A infection is given at the end of this leaflet.

Before having Havrix Junior Monodose

Havrix Junior Monodose should not be given if:

  • your child is allergic (hypersensitive) to any of the ingredients of Havrix (listed in section 6)
  • your child is allergic to any other hepatitis A vaccine, any antibiotic, or neomycin; an antibiotic used to treat skin infections
  • your child is aged 16 years or over
  • if your child has a high temperature (fever).

Do not give your child Havrix if any of the above apply to them. If you are not sure, talk to their doctor, nurse or pharmacist before they have Havrix.

Take special care with Havrix Junior Monodose

Check with the doctor, nurse or pharmacist before Havrix Junior Monodose is given if:

  • your child is on dialysis for a kidney problem
  • your child already has the hepatitis A virus or is living with someone who has caught the hepatitis A virus recently
  • you have any problem with the way their body fights disease (immunosuppression).

If any of the above apply to your child, Havrix Junior Monodose can still be given, but your child may not develop enough antibodiesafter a single injection to protect them against infection.

In these cases, the doctor or nurse may decide that extra doses of = Havrix Junior Monodose should be given and may take a blood test to measure the antibody levels in the blood before or after the vaccine is given.

Sometimes, an antibody injection will be given to try and protect your child until the vaccine starts to work. This can be given at the same time as they have the vaccine but will be injected into the opposite arm.

Using other medicines or vaccines

Please tell your doctor or nurse if your child is taking, about to be given or has recently taken, any other medicine. Havrix Junior Monodose can be given at the same time as most other routine childhood vaccines. These vaccines will be given at different injection sites.

In particular talk to your doctor if:

  • your child is taking a medicine that can affect the way in which their body fights disease. Your child should not have Havrix if they are taking this type of medicine

Pregnancy and breastfeeding

Women who are pregnant may sometimes be vaccinated. If they are over 16, they should not receive the Havrix Junior Monodose, but should have the Havrix Monodose vaccine instead.

Talk to their doctor or nurse if the person to be vaccinated thinks they are, or that they might be, pregnant.

Talk to their doctor or nurse if the person to be vaccinated is breastfeeding. It is sometimes possible to have the vaccine if they are breast-feeding.

How Havrix Junior Monodose is given

A single dose of 0.5 ml is injected into the muscle in the upper arm.

The first dose of vaccine should protect your child from infection with hepatitis A virus within 2 to 4 weeks. Protection should last for at least 1 year.

To ensure that protection continues for at least 10 years, a second (booster) dose of the vaccine should be given 6 to 12 months after the first injection.

Having two doses within 1 year is the best way to ensure protection, and that protection will last for at least 10 years.

If the date for the booster injection is missed but a second dose is given within 3 years of the first dose, protection against hepatitis A infection should still continue for at least 10 years.

If a second dose is not given within 3 years of the first dose, the doctor may decide that vaccination should start again, with 2 doses of vaccine within 1 year.

Possible side effects

Like all vaccines, Havrix Junior Monodose can cause side effects, although not everybody gets them.

If your child has any of the following side effects or symptoms, talk to their doctor straight away, they may need urgent medical treatment:

Allergic reaction, the signs may include: difficulty breathing, tightness in the throat, rapidly spreading rashes, very fast heartbeat, dizziness and loss of consciousness due to very low blood pressure. These are very rare. Should these reactions happen they will usually start very soon after the injection has been given to your child.

Very rarely some people have experienced fits (convulsions) after having Havrix.

Problems with their nerves, signs may include: pins and needles, loss of feeling or numbness, problems moving their arms or legs or difficulty with walking and moving about. These are extremely rare. Seek medical help straight away if any of the above happen after leaving the clinic.

The most common side effects are:

  • mild soreness
  • redness or hardness at the site of the injection. These should last only a few days.

Less commonly the person who has had the vaccine may generally feel unwell or experience:

  • rash
  • high temperature (fever)
  • tiredness
  • headache
  • sickness
  • diarrhoea
  • loss of appetite.

Occasionally blood tests to see how their liver is working can become abnormal for a short time.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell their doctor, nurse or pharmacist.

How to store Havrix Junior Monodose

Keep out of the reach and sight of children.

Store between 2°C and 8°C in a refrigerator.

Do not freeze.

Store in the original package with this leaflet.

Do not use after the expiry date which is stated on the label and carton.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of vaccine no longer required.

Further information

What Havrix Junior Monodose contains

The active ingredient is inactivated hepatitis A virus. Each 0.5 ml dose of the vaccine contains 720 ELISA units of hepatitis A viral protein.

The other ingredients are aluminium hydroxide, polysorbate 20, amino acids for injection, disodium phosphate, monopotassium phosphate, sodium chloride, potassium chloride and water for injections.

What Havrix Junior Monodose looks like and contents of the pack

Havrix Junior Monodose is a cloudy white injectable liquid vaccine in a pre-filled syringe that contains a single 0.5 ml dose.

The vaccine is available in packs of 1 or 10 pre-filled syringes

General information on hepatitis A

Hepatitis A virus causes an infection of the liver. You can catch the virus by eating or drinking contaminated food or water. The virus is present in the bowel movement (motion) of infected people, even when they may have no signs of the infection. You can catch hepatitis A infection in any country but the risk is highest in places and countries where sanitation and food and water hygiene are poor.

After catching the virus, it can be up to 6 weeks before signs of illness are seen. Some people have the virus and never get ill but they can still infect other people during this time.

The main signs of the illness include sickness, yellowing of the skin and eyes (jaundice), fever and headache. These signs are all due to an inflammation of the liver while it is infected with the virus.

Most patients get better, usually after a couple of weeks or months, but a few people may take up to a year to make a full recovery. While recovering, people affected with hepatitis A may be unable to work. They may not be able to drink alcohol and may need to avoid certain foods according to their doctors’ advice. Severe complications are very rare but sometimes the liver stops working and hospital care is needed until the infection gets better.

There are many other types of virus that can cause hepatitis. The signs may be the same as in hepatitis A infection but the viruses are not always caught through food and drink.

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