Patient Information Leaflet

AVAXIM®

Suspension for injection in a prefilled syringe

Hepatitis A vaccine (inactivated, adsorbed)

The full name of this vaccine is AVAXIM®, Suspension for injection in a prefilled syringe (Hepatitis A vaccine [inactivated, adsorbed]).

Each 0.5 millilitre dose of AVAXIM® contains 160 antigen units (these are units used to measure the vaccine activity) of the active ingredient, inactivated hepatitis A virus, which is produced on MRC-5 human diploid cells. The inactivated hepatitis A virus is attached to aluminium hydroxide (0.3 milligram as aluminium), which helps to increase the vaccine's effectiveness.

There are also some inactive ingredients. These are 2-phenoxyethanol (preservative), Medium 199 Hanks (a mixture of amino acids including phenylalanine, mineral salts, vitamins, polysorbate 80 and other ingredients), formaldehyde, and water for injections.

Hydrochloric acid and sodium hydroxide may also be used for pH adjustment.

As this product contains phenylalanine, it may be harmful for people with phenylketonuria.

AVAXIM® may also contain very small amounts of neomycin, which is an antibiotic used during manufacture of the vaccine.

1. WHAT AVAXIM® IS AND WHAT IT IS USED FOR?

AVAXIM® comes in a single 0.5 millilitre prefilled syringe (enough for one dose). It is supplied in packs of 1 and 10 prefilled syringes (doses).

AVAXIM® is one of a general group of medicines called vaccines. Different vaccines are used to protect people against various infectious diseases. AVAXIM® helps to protect adolescents from 16 years of age and adults against hepatitis A infection.

Hepatitis A infection is caused by a virus that attacks the liver. It may be caught from food or drink that contain the virus. Symptoms include jaundice and feeling generally unwell.

When you are given an injection of AVAXIM®, your body's natural defences will start to produce protection against the virus which causes hepatitis A. However it usually takes about 14 days after receiving the injection before you will be protected.

AVAXIM® will not protect you against other viruses known to infect the liver (such as hepatitis B, hepatitis C or hepatitis E viruses). Also if you are already infected with hepatitis A virus (in the incubation period) when you are given AVAXIM®, the vaccination may not work properly.

AVAXIM cannot cause the infection against which it protects. Remember that, like all vaccines, AVAXIM® cannot completely prevent the infection that it is meant to protect against and protection may not be lifelong (see section 3 of this leaflet).

2. BEFORE AVAXIM® IS GIVEN

AVAXIM® is only for people 16 years of age or older. To make sure that AVAXIM® is suitable for you/your child aged 16 years or older, it is important to tell the doctor or nurse if any of the points below apply to the person receiving the vaccine. If there is anything you do not understand, ask the doctor or nurse to explain.

AVAXIM® should not be given if the person receiving the vaccine:

• has ever had an allergic reaction to a previous injection of AVAXIM®.
• has ever had an allergic reaction to any of the other ingredients contained in AVAXIM® (including neomycin).
• has an infection with a high temperature. Vaccination with AVAXIM® may need to be delayed until after recovery from the infection.

AVAXIM® may or may not be suitable for the person receiving the vaccine if the answer to any of the following questions is 'YES'. Tell the doctor or nurse if any of the following apply to the person receiving the vaccine or ask them to explain if you are not sure.

 

• Does the person receiving the vaccine have a poor immune response because they have had, or are having a course of treatment such as corticosteroids, cytotoxic drugs or radiotherapy? The vaccine can still be given if necessary although your doctor may want to measure the response to AVAXIM® by testing the blood. Alternatively, your doctor may advise you to wait until the course of treatment has finished before having AVAXIM®.
• Does the person receiving the vaccine have problems with their immune system due to AIDS or have had a positive test for human immunodeficiency virus (HIV)? They may be given AVAXIM®, but the response to the vaccine may not be as good. The doctor may want to measure the response to AVAXIM® by testing the blood.
• Does the person receiving the vaccine have any problems with their liver? The doctor will advise you if AVAXIM® should be given.

3. HAVING THE VACCINE

The vaccination should be given by doctors or nurses who are trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection.

AVAXIM® is given as an injection of half a millilitre into a muscle in the upper part of the arm. The doctor or nurse will avoid giving the injection either into the skin or into a blood vessel. AVAXIM® should not be given into the buttock.

If the person receiving the vaccine suffers from haemophilia (a condition where you bruise or bleed easily) or any other condition that means they should not receive an injection into the muscle, they may be given the injection under the skin to reduce the risk of bleeding.

AVAXIM® will start to protect against hepatitis A infection from about 14 days after having the injection. The person receiving the vaccine will usually be protected against hepatitis A infection after one dose of the vaccine.

In order to provide long term protection (for at least 10 years) against hepatitis A infection, it is necessary to give a second (booster) dose. This is usually given between 6 and 12 months after the first dose but can be given up to 36 months later.

AVAXIM® can be given as a booster dose at 6 to 36 months after the first dose of another vaccine against hepatitis A (including vaccines that protect against both hepatitis A and typhoid).

4. POSSIBLE SIDE EFFECTS OF AVAXIM®

Like all medicines and vaccines, AVAXIM® can have side effects.

Serious allergic reactions are always a rare possibility after receiving a vaccine. These reactions may include difficulty in breathing, blue discolouration of the tongue or lips, low blood pressure (causing dizziness) and collapse. When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic or doctor's surgery. If any of these symptoms occur after leaving the place where your injection was given, you must consult a doctor IMMEDIATELY.

During clinical trials, the most common reactions (occurring in one in ten to one in a hundred persons vaccinated) were:

• mild pain at the injection site
• generally feeling weak
• pain in the muscles and joints
• headache
• feeling or being sick
• loss of appetite
• diarrhoea
• stomach ache
• mild fever

Uncommonly, (in less than one in a hundred persons vaccinated) redness occurred around the injection site.

Rarely (in less than one in a thousand persons vaccinated) a lump formed at the site of injection.

Occasionally, mild and temporary changes in some blood tests that measure how the liver is working have been seen.

Side effects reported very rarely (in approximately less than one in ten thousand persons) since the product was placed on the market include rashes that have sometimes been lumpy and itchy.

If you notice any other side effects after the vaccination that are not mentioned here, tell your doctor, nurse or pharmacist (chemist).

5. STORING AVAXIM®

The vaccine will normally be stored by the clinic or doctor's surgery. However, if you have been asked to collect the vaccine from a pharmacist (chemist) and to store it until the doctor or nurse can give it to you, the vaccine must be stored in a refrigerator at between 2°C and 8°C (making sure that it does not freeze) so that it keeps its effectiveness. The doctor or nurse will make sure that the vaccine is not used after the expiry date on the box and that it is shaken before use.

The vaccine should always be kept out of the sight and reach of children.