AVAXIM suspension for injection in a pre-filled syringe

• 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Avaxim is and what it is used for
2. What you need to know before you use Avaxim
3. How to use Avaxim
4. Possible side effects
5. How to store Avaxim
6. Further information

• if you are allergic to:
  • the active ingredient or any ingredients of Avaxim (listed in section 6), or
  • neomycin, an antibiotic used during vaccine production, which may be present in the vaccine in small amounts, or
  • Avaxim,
• if you are ill with a high temperature, the vaccination will be delayed until you have recovered.

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

• liver disease.
• a poor or weakened immune system due to:
  • corticosteroids, cytotoxic drugs, radiotherapy or other treatments that can weaken your immune system. Your doctor or nurse may wait until the treatment has finished.
  • HIV (human immunodeficiency virus) infection or any disease that weakens your immune system. It is recommended that you are given the vaccine, although it may not protect as well as it protects people with a normal immune system.
• haemophilia or any other condition where you bruise or bleed more easily

Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with 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 viruses).

If you already have the hepatitis A virus when you are given Avaxim, the vaccination may not work properly.

The vaccine cannot cause the infection against which it protects.

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

This vaccine can be given at the same time as any of the following, providing they are given in different parts of the body (for example another arm or leg) and are not mixed in the same syringe:

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

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

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

If there is any chance you are pregnant, tell your doctor or nurse. They will decide whether to delay the vaccination.

The use of this vaccine is possible during breast-feeding.

This vaccine is unlikely to have any effect on your ability to drive or use machines.

However, no studies on this have been performed.

Avaxim contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.

Avaxim contains 10 microgram phenylalanine in each 0.5ml dose which is equivalent to 0.17 microgram/kg for a 60 kg person. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Avaxim contains less than 1mmol of potassium (39 mg) and sodium (23 mg) per dose, that is to say essentially 'potassium-free'and 'sodium-free'.

Avaxim is given as an injection of half a millilitre of the vaccine to people 16 years of age and older.

You will be protected against hepatitis A about 14 days after you receive the first, single dose of Avaxim. This protection will last for up to 36 months.

If you need longer term protection against hepatitis A, you will need a second dose (booster) of an inactivated hepatitis A vaccine. This is usually given between 6 and 12 months after the first dose but can be given up to 36 months later. This booster will protect you against hepatitis A beyond 10 years.

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

The doctor or nurse will shake the syringe immediately before use and check that the liquid is white and cloudy, and that there are no unexpected particles in it.

Avaxim should be injected into a muscle in the upper outer part of your arm.

If you suffer from a bleeding disorder, you may be given the injection under the skin. The doctor or nurse must not inject the vaccine into the skin or into a blood vessel.

Avaxim will not be given into your buttock.

Serious or even life-threatening allergic reactions (anaphylactic reactions, including shock) can always happen, even if they are very rare.

If you experience an allergic reaction, contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away. Allergic reactions can occur either immediately or within several days of vaccination and symptoms may include:

• difficulty in breathing, blue colour of the tongue or lips,
• dizziness (low blood pressure) and possibly fainting.
• fast heart rate and weak pulse, cold skin
• swelling of the face and neck
• itching and skin rash

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

• mild pain at the injection site
• generally feeling weak (asthenia)

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

• headache
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• diarrhoea and/or stomach ache (abdominal pain)
• pain in the muscles and joints (myalgia, arthralgia)
• mild fever

Uncommon reactions (reported by less than 1 in a 100 but more than 1 in a 1000 people):

• redness (erythema) at the injection site

Rare reactions (reported by less than 1 in a 1000 but more than 1 in 10,000 people):

• a lump formed at the injection site (injection site nodule)
• mild and temporary changes in blood tests that measure how the liver is working (transaminases increased)

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

• fainting in response to injection
• rashes that have sometimes been lumpy and itchy (including urticaria)

If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is:

• Hepatitis A virus GBM strain (inactivated)^1,2, 160 EU
  ¹ produced in human diploid (MRC-5) cells
  ² adsorbed on aluminium hydroxide hydrated (0.3 milligram Al³⁺)

The other ingredients are:

• 2-phenoxyethanol
• ethanol anhydrous
• formaldehyde
• Medium 199 Hanks*
• water for injections
• polysorbate 80
• hydrochloric acid and sodium hydroxide for pH adjustment

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

The inactivated hepatitis A vaccine is a cloudy, 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 an attached needle (pack size of 1, 5, 10 or 20) or with 1 or 2 needles provided separately (pack size of 1 or 10). Not all pack sizes are marketed.

The manufacturer responsible for batch release is Sanofi Pasteur at one of the following manufacturing sites:

or