The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 46602/0023.
AVAXIM Junior, suspension for injection in pre-filled syringe
AVAXIM® Junior, suspension for injection in pre-filled syringe
Hepatitis A vaccine
1. What Avaxim Junior is and what it is used for
2. What you need to know before you use Avaxim Junior
3. How to use Avaxim Junior
4. Possible side effects
5. How to store Avaxim Junior
6. Contents of the pack and other information
Avaxim Junior is a vaccine. Vaccines are used to protect against infectious diseases.
This vaccine helps to protect against hepatitis A infection.
Hepatitis A infection is caused by a virus that attacks the liver.
Talk to your doctor or nurse before Avaxim Junior is given, if you or your child have:
Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
The vaccine may not work properly if you are already infected with the hepatitis A virus at the time of vaccination.
As with all vaccines, Avaxim Junior may not fully protect all people who are vaccinated.
Please tell your doctor, nurse or pharmacist if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.
You or your child can be given this vaccine at the same time as any of the below. However, they must be given in different parts of the body (for example another arm or leg). They must not be mixed in the same syringe:
If there is any chance that you or your child is pregnant, tell your doctor or nurse. They will advise whether to delay the vaccination.
You or your child can be given this vaccine during breast-feeding.
This vaccine is unlikely to have any effect on the ability to drive or use machines.
However, no studies on this have been performed.
The vaccine will be given by a doctor or nurse who has been trained to give vaccines. They will also be able to deal with any very rare severe allergic reaction to the injection.
Protection against hepatitis A will start within 2 weeks after injection of the first dose of vaccine.
If you need long-term protection against hepatitis A, you might need a second dose – depending on official recommendations.
This is called a booster injection.
Like all medicines, Avaxim Junior can cause side effects, although not everybody gets them.
Serious allergic reactions (anaphylactic reactions, including shock) can always happen, even if it is very rare.
Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you or your child experience allergic reactions that can be life threatening. The symptoms usually appear very soon after the injection and may include:
People who have had the side effects below had them during the first few days after the vaccination and did not need treatment.
The side effects happen less often after the second dose than after the first dose.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data
If you or your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep out of the sight and reach of children.
Do not use the vaccine after the expiry date which is stated on the carton and syringe label after EXP. The expiry date refers to the last day of that month.
Do not use the vaccine if there are unexpected particles in it.
Do not dispose of vaccines via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer required.
These measures will help to protect the environment.
The active ingredient is:
Hepatitis A virus GBM strain (inactivated) 1,2 . . . . . . . . . . . . 80 EU3
1 produced in human diploid (MRC-5) cells
2 adsorbed on aluminium hydroxide hydrated (0.15 milligram Al3+)
3 ELISA Unit.
The other ingredients are:
* Medium 199 Hanks (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts (including potassium), vitamins and other components.
The inactivated hepatitis A vaccine is a cloudy and whitish suspension.
The vaccine is presented as a suspension for injection in pre-filled syringe (0.5 ml of inactivated hepatitis A virus) with or without an attached needle (pack size of 1 or 10) or with 1 or 2 needles provided separately. All pack sizes may not be marketed.
The Marketing Authorisation Holder:
The manufacturer responsible for batch release is Sanofi Pasteur at one of the following manufacturing sites:
This medicinal product is authorised in the Member States of the EEA under the following names:
Avaxim Junior - Sweden, Denmark, Germany, Greece, Italy, Spain, and United Kingdom.
This leaflet was last revised in