AVAXIM INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AVAXIM, injectable suspension in pre-filled syringe

Hepatitis A vaccine (inactivated, adsorbed)

Read the entire leaflet carefully before you are vaccinated, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Avaxim is and what it is used for

2. What you need to know before receiving Avaxim

3. How to use Avaxim

4. Possible side effects

5. How to store Avaxim

6. Contents of the pack and other information

1. What Avaxim is and what it is used for

Avaxim is a vaccine. Vaccines are used to protect you against infectious diseases. This vaccine helps protect against hepatitis A infection in individuals aged 16 years and older.

Hepatitis A is an infection caused by a virus that affects the liver. It can be contracted from food or drinks contaminated with the virus. Symptoms include jaundice (yellowing of the skin) and general malaise.

When you receive an injection of Avaxim, your body's natural defenses will produce protection against hepatitis A infection.

2. What you need to know before using Avaxim

Do not use Avaxim:

• If you are allergic:
  • to the active substance or any of the components of Avaxim (listed in section 6).
  • to neomycin, an antibiotic used during vaccine production which may be present in the vaccine in small amounts.
  • to Avaxim.

If you are ill and have a high temperature, you should delay your vaccination until you recover.

Warnings and precautions

Talk to your doctor or nurse before using Avaxim if you have:

• Liver disease.

• A weakened immune system due to:

• corticosteroids, cytotoxic medicines, radiotherapy, or other treatments that may weaken the immune system. Your doctor or nurse may wish to wait until your treatment is completed.

• HIV infection (human immunodeficiency virus) or any other condition that weakens the immune system. Vaccination is recommended, although it may not protect you as effectively as in individuals with a normal immune system.

  • Haemophilia or other conditions where bruising or bleeding may occur easily.

Fainting may occur after, or even before, any injection with a needle, particularly in adolescents. Therefore, inform your doctor or nurse if you or your child has previously fainted following an injection.

This vaccine will not protect you against other viruses that attack the liver (such as hepatitis B virus, hepatitis C virus, or hepatitis E virus).

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

The vaccine cannot cause the infection it protects against.

As with any vaccine, not all individuals receiving Avaxim will be fully protected against hepatitis A infection.

Use of other vaccines, medicines, and Avaxim

This vaccine may be administered at the same time as the following vaccines, but in different parts of the body (e.g. the other arm or leg), and must not be mixed in the same syringe:

• Typhoid polysaccharide vaccine
• Yellow fever vaccine
• Immunoglobulins (antibodies obtained from blood donors)

Avaxim may be less effective if administered simultaneously with immunoglobulins. However, it is very likely that you will still be protected against hepatitis A infection.

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

Pregnancy and breastfeeding

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

This vaccine may be used 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 conducted.

Avaxim contains ethanol, phenylalanine, potassium, and sodium.

Avaxim contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine is unlikely to have noticeable effects.

Avaxim contains 10 micrograms of phenylalanine in each 0.5 ml dose, equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare inherited disorder in which phenylalanine accumulates because the body cannot process it properly.

Avaxim contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, and is therefore considered essentially "potassium-free" and "sodium-free".

3. How to use Avaxim

The vaccine will be administered by a doctor or nurse who has been trained in the use of the vaccine and is experienced in managing rare severe allergic reactions following injection.

Dosage

Avaxim is administered as a 0.5 ml injection for individuals aged 16 years and older.

You will be protected against hepatitis A approximately 14 days after receiving the first single dose of Avaxim. This protection will last up to 36 months.

If you require longer-term protection against hepatitis A, you will need a second dose (booster) of inactivated hepatitis A vaccine.

The second dose should preferably be administered between 6 and 12 months after the primary vaccination, but may also be given up to 36 months after the primary dose.

This booster dose will protect you against hepatitis A for at least 10 years.

Avaxim may be given as a booster dose if you previously received a first dose of a different hepatitis A vaccine (including vaccines protecting against both hepatitis A and typhoid fever).

Method of administration

The doctor or nurse must shake the syringe immediately before use and check that the liquid is whitish and cloudy, with no foreign particles present.

Avaxim must be injected into the muscle of the upper outer arm. If you have a blood disorder, the injection may be given under the skin. The doctor or nurse must not inject the vaccine into the skin or into a blood vessel.

Avaxim must not be administered into the buttocks.

4. Possible adverse effects

Like all medicines and vaccines, Avaxim may have adverse effects, although not everyone experiences them.

Severe allergic reactions

Although extremely rare, serious and even life-threatening allergic reactions (anaphylactic reactions, including shock) may occur.

If you experience an allergic reaction, contact your doctor or healthcare professional immediately or go to the nearest hospital emergency department.

Allergic reactions may occur immediately or several days after vaccination, and symptoms may include:

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

Other adverse effects

Very common adverse reactions (reported in more than 1 in 10 people):

• mild pain at the injection site
• general feeling of weakness (asthenia)

Common adverse reactions (reported in less than 1 in 10 people but more than 1 in 100 people):

• headache
• nausea and vomiting
• loss of appetite
• diarrhoea and/or stomach pain (abdominal pain)
• muscle and joint pain (myalgia, arthralgia)
• mild fever

Uncommon adverse reactions (reported in less than 1 in 100 people but more than 1 in 1,000 people):

• redness (erythema) at the injection site

Rare adverse reactions (reported in less than 1 in 1,000 people but more than 1 in 10,000 people):

• lumps at the injection site (injection site nodule)
• mild and temporary changes in blood test parameters measuring liver function (increased transaminases)

Not known (frequency cannot be estimated from available data):

• collapse as a response to the injection
• rashes which in some cases have caused lumps and itching (including urticaria)
• swollen lymph nodes

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Avaxim

Keep this vaccine 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 refers to the last day of the month indicated.

Do not use this vaccine if foreign particles are visible in suspension.

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

Do not freeze. If frozen, the vaccine must be discarded.

Keep in the original packaging to protect from light. Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Avaxim

• The active substance is

• Inactivated hepatitis A virus, strain GBM (1,2)............160 EU

1 produced on human diploid cells (MRC-5)

2 adsorbed on aluminium hydroxide, hydrated (0.3 milligrams of Al3+)

• The other components are

• 2-phenoxyethanol

• anhydrous ethanol

• formaldehyde

• Hanks' Medium*

• water for injections

• polysorbate 80

• hydrochloric acid and sodium hydroxide for pH adjustment.

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

Presentation of the product and contents of the pack

The inactivated hepatitis A vaccine is a white, slightly opaque suspension.

The vaccine is supplied 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, 5, 10 or 20), or with 1 or 2 separate needles (pack sizes of 1 or 10).

Not all presentations are marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer

The manufacturer responsible for batch release is:

Sanofi Winthrop Industrie - 1541 avenue Marcel Mérieux - Marcy l’Etoile 69280 - 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 medicinal product is authorised in the European Economic Area member states under the following names:

Avaxim – Austria, Belgium, Germany, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom.

Date of the most recent review of this summary: July 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/