AVAXIM JUNIOR Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Avaxim Junior, injectable suspension in pre-filled syringe

Hepatitis A vaccine (inactivated, adsorbed)

Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to others, as it may harm them.
• If you or your child experience any side effects, consult your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Avaxim Junior and what is it used for
2. What you need to know before you start using Avaxim Junior
3. How to use Avaxim Junior
4. Possible side effects
5. Storage of Avaxim Junior
6. Contents of the pack and further information

1. What is Avaxim Junior and what is it used for

What is Avaxim Junior

Avaxim Junior is a vaccine. Vaccines are used to protect against infectious diseases.

What Avaxim Junior is used for

This vaccine helps protect against hepatitis A infection.

• It is used in children from 1 year to 15 years of age.

Hepatitis A is an infection caused by a virus that attacks the liver.

• It can be caught through food or drinks that contain the virus.
• Symptoms include yellowing of the skin and eyes (jaundice) and general feeling of being unwell.

How Avaxim Junior works

• When you receive an injection of Avaxim Junior, your body's natural defenses will produce protection against hepatitis A infection.
• This vaccine protects against hepatitis A - but it cannot cause hepatitis A infection.
• This vaccine will not protect against other viruses that attack the liver (such as hepatitis B, hepatitis C, or hepatitis E viruses).

2. What you need to know before you start using Avaxim Junior

Do not use Avaxim Junior if you or your child:

• are allergic to the active substance or any of the other ingredients of Avaxim Junior (listed in section 6).
• are allergic to neomycin. This is an antibiotic used during vaccine production - it may be present in the vaccine in small amounts.
• have had an allergic reaction after a previous dose of Avaxim Junior
• are ill with a high temperature. You should delay vaccination until you or your child recover.

Warnings and precautions

Consult your doctor or nurse before starting to use Avaxim Junior if you or your child have:

• a poor or weakened immune system due to:

• corticosteroids, cancer medicines, radiotherapy, or other treatments that can weaken the immune system. Your doctor or nurse may want to wait until your treatment is finished before vaccination.
• HIV infection (human immunodeficiency virus) or any disease that weakens the immune system. It is recommended to administer the vaccine, although it may not protect in the same way as people with a non-weakened immune system.

• haemophilia or other conditions where bruising or bleeding can occur easily.
• jaundice (yellowing of the skin and eyes) in the past or have lived in an area where hepatitis A is common. You or your child may need to have a test to check if you have had hepatitis A infection before.
• fainted after a previous injection.

Fainting can occur (mainly in adolescents) after any injection with a needle, or even before.

If you are already infected with the hepatitis A virus at the time of using the vaccine, vaccination may not be effective.

As with all vaccines, Avaxim Junior may not fully protect all people who are vaccinated.

Other medicines and Avaxim Junior

Tell your doctor, nurse, or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This vaccine can be given to you or your child at the same time as any of the following, but in different parts of the body (e.g. in the other arm or leg) and not mixed in the same syringe:

• vaccines (such as vaccines against diphtheria, tetanus, pertussis, Haemophilus influenzaetype b, poliomyelitis, measles, mumps, and rubella).
• antibodies obtained from blood donors (immunoglobulins) - the vaccine may have less effect if given at the same time as the antibodies. However, you are likely to be protected against hepatitis A infection.

Pregnancy and breastfeeding

If you or your daughter might be pregnant, consult your doctor or nurse before using this vaccine. They will decide whether vaccination should be delayed or not.

You or your child can receive this vaccine during breastfeeding.

Driving and using machines

It is unlikely that this vaccine will have any effect on the ability to drive or use machines.

However, no studies have been developed.

Avaxim Junior contains ethanol, phenylalanine, potassium, and sodium.

• Avaxim Junior contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will have no noticeable effect.
• Avaxim Junior contains 10 micrograms of phenylalanine in each 0.5 ml dose, which is equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• Avaxim Junior contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, so it is considered essentially "potassium-free" and "sodium-free".

3. How to use Avaxim Junior

The vaccine will be administered by a doctor or nurse, who have been trained in the use of the vaccine and who are used to treating severe allergic reactions that may occur rarely after injection.

When protection begins

Protection against hepatitis A will begin within 2 weeks after the first dose of the vaccine is given.

Long-term protection

If you need long-term protection against hepatitis A, you will need a second dose depending on official recommendations. This dose is called a booster dose.

• The second dose is given preferably between 6 months and 10 years after the first dose of the vaccine.
• Avaxim Junior can be given as a booster dose if you or your child have received a first dose of a different hepatitis A vaccine.

How to administer the vaccine

• The vaccine must be injected into the muscle in the upper outer part of the arm. In young children, it can be injected into the outer part of the thigh.
• If you or your child have a bleeding disorder, the injection can be given under the skin.
• Avaxim Junior will not be administered in the buttocks of you or your child.

4. Possible side effects

Like all medicines, Avaxim Junior can cause side effects, although not everybody gets them.

Severe allergic reactions

Severe allergic reactions (anaphylactic reactions including shock) can always occur, even though this is very rare.

Contact your doctor or a healthcare professional immediately or go immediately to the emergency department of the nearest hospital if you or your child experience life-threatening allergic reactions.Symptoms usually appear soon after the injection and may include:

• difficulty breathing, blue discoloration of the tongue or lips
• dizziness (low blood pressure) and possible fainting
• rapid heartbeat and weak pulse, cold skin
• swelling of the face and neck
• itching and rash

Other side effects

People who had the following side effects had them in the first few days after vaccination and did not need treatment. Side effects occur less frequently after the second dose than after the first dose.

Very common:may affect more than 1 in 10 people

• pain at the injection site
• abnormal crying (in babies)
• general feeling of being unwell
• headache

Common:may affect up to 1 in 10 people

• loss of appetite
• irritability, difficulty sleeping (insomnia)
• stomach pain, diarrhea, nausea, vomiting
• muscle or joint pain
• reactions at the injection site such as redness, swelling, or bruising
• fever
• feeling tired or sleepy

Uncommon:may affect up to 1 in 100 people

• rash with or without itching

Frequency not known:cannot be estimated from the available data

• fainting in response to the injection
• seizures (convulsions) with or without fever
• swollen lymph nodes

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Avaxim Junior

Keep this medicine out of the sight and reach of children.

Do not use the vaccine after the expiry date stated on the carton and on the label of the syringe after EXP. The expiry date is the last day of the month shown.

Do not use this vaccine if there are any foreign particles in the suspension.

• Store in a refrigerator at 2°C to 8°C.
• Do not freeze. If frozen, the vaccine must be discarded.
• Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Avaxim Junior

The active substance is:

Hepatitis A virus strain GBM (inactivated) 1, 2……80EU3

1 produced in human diploid cells (MRC-5)

2 adsorbed on hydrated aluminum hydroxide (0.15 milligrams of Al3+)

3 ELISA Unit.

The other ingredients are:

• 2-phenoxyethanol
• anhydrous ethanol
• formaldehyde

Hanks' 199 medium*

• water for injections
• polysorbate 80
• hydrochloric acid and sodium hydroxide for pH adjustment

*Hanks' 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts (including potassium), vitamins, and other components.

Appearance of Avaxim Junior and contents of the pack

The hepatitis A vaccine (inactivated, adsorbed) is a turbid, white suspension.

The vaccine is presented as a suspension for injection in a pre-filled syringe (0.5 ml of inactivated hepatitis A virus) with or without a fixed needle (pack sizes of 1 or 10) or with 1 or 2 separate needles. Not all presentations are marketed.

Marketing authorisation holder and manufacturer

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer responsible for batch release is:

Sanofi Winthrop Industrie - 1541 avenue Marcel Mérieux - 69280 Marcy l’Etoile - France

Sanofi Winthrop Industrie - Voie de l’Institut – Parc Industriel d’Incarville B.P 101 - 27100 Val de Reuil - France

Sanofi-Aventis Zrt. Bdg. DC5 - Campona Utca 1. Budapest XXII - 1225 Budapest – Hungary

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicine is authorised in the Member States of the European Economic Area under the following names:

AVAXIM Junior – Sweden, Denmark, Germany, Greece, Italy, Spain, and United Kingdom.

Date of last revision of this leaflet:07/2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/