AVAXIM Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

AVAXIM, suspension for injection in pre-filled syringe

Hepatitis A vaccine (inactivated, adsorbed)

Read all of this leaflet carefully before you are 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 vaccine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to 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 and what is it used for
2. What you need to know before you use Avaxim
3. How to use Avaxim
4. Possible side effects
5. Storage of Avaxim

1. Contents of the pack and other information

1. What is Avaxim and what is it used for

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

Hepatitis A is an infection caused by a virus that attacks the liver. It can be caught from food or drinks that contain the virus. Symptoms include jaundice (yellowing of the skin) and general feeling of being unwell.

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 you use Avaxim

Do not use Avaxim:

• If you are allergic:
• to the active substance or any of the other ingredients of Avaxim (listed in section 6).
• to neomycin, an antibiotic used during vaccine production and 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 have recovered.

Warnings and precautions

Tell your doctor or nurse before using Avaxim if you have:

• Liver disease.
• A weakened immune system due to:

• corticosteroids, cytotoxic drugs, radiotherapy, or other treatments that can weaken the immune system. Your doctor or nurse may want to wait until your treatment is finished.
• HIV infection or any disease that weakens the immune system. It is recommended to administer the vaccine even if it may not protect you as well as people with a normal immune system.
• Hemophilia or other conditions where bruising or bleeding can occur easily.

Fainting can occur after any injection, especially in adolescents. Tell your doctor or nurse if you or your child have fainted after a previous injection.

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

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

The vaccine cannot cause the infection it is meant to protect against.

As with any vaccine, not everyone who receives Avaxim will be fully protected against hepatitis A infection.

Using other vaccines or medicines and Avaxim

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

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

Avaxim may not work if given at the same time as immunoglobulins. However, you will likely still be protected against hepatitis A infection.

Tell 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 may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this vaccine. They will decide whether vaccination should be delayed or not.

It is possible to use this vaccine during breastfeeding.

Driving and using machines

It is unlikely that this vaccine will affect your 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) per 0.5 ml dose. The small amount of alcohol in this medicine is unlikely to have any noticeable effects.

Avaxim contains 10 micrograms of phenylalanine per 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 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 used to treating severe allergic reactions that may occur after injection

Dosage

Avaxim is administered by injection of 0.5 ml of vaccine for people aged 16 years and older.

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

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

The second dose is preferably given between 6 to 12 months after the primary immunization but can also be given up to 36 months after.

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

Avaxim can be given as a booster dose if you have received a first dose of a different hepatitis A vaccine (including vaccines that protect against hepatitis A and typhoid fever).

Method of administration

The doctor or nurse should shake the syringe immediately before use and check that the liquid is white and cloudy, and that there are no foreign particles.

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

Avaxim should not be administered in the buttocks.

4. Possible side effects

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

Severe allergic reactions

Although very rare, these severe allergic reactions or even life-threatening reactions (anaphylactic reactions, including shock) can occur.

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

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

• difficulty breathing, blue 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 side effects

Very common side effects (reported in more than 1 in 10 people):

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

Common side effects (reported in less than 1 in 10 people but more than 1 in 100 people)

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

Uncommon side effects (reported in less than 1 in 100 people but more than 1 in 1,000 people)

• redness (erythema) at the injection site

Rare side effects (reported in less than 1 in 1,000 people but more than 1 in 10,000 people)

• lumps at the injection site (nodule at the injection site)
• mild and temporary changes in liver function tests (increased transaminases)

Unknown frequency (cannot be estimated from the available data):

• fainting as a response to the injection

• rashes that have sometimes caused lumps and itching (including urticaria)

Reporting of side effects

If you experience 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side 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 is the last day of the month stated.

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

Store in a refrigerator (2°C - 8°C).

Do not freeze. If frozen, the vaccine should 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. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Avaxim

• The active substance is

• Hepatitis A virus strain GBM (inactivated) 1,2............160 EU

1 produced in human diploid cells (MRC-5)

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

• 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, vitamins, and other components.

Appearance and pack contents

The inactivated hepatitis A vaccine is a white, cloudy 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, 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 responsible for batch release

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

Date of last revision of this leaflet: September 2021

Other sources of information

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