• 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/your child 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 Rabipur is and what it is used for
2. What you need to know before you/your child receives Rabipur
3. How to use Rabipur
4. Possible side effects
5. How to store Rabipur
6. Contents of the pack and other information

Rabipur is a vaccine containing rabies virus that has been killed. After administration of the vaccine, the immune system (the body’s natural defence system) forms antibodies to rabies viruses. These antibodies protect from infections or diseases by the virus that causes rabies. None of the components of the vaccine can cause rabies.

Rabipur can be used in individuals of all ages.

Rabipur can be used to prevent rabies:

• before possible risk of exposure to rabies virus (pre-exposure prophylaxis).

or

• after suspected or proven exposure to rabies virus (post-exposure prophylaxis).
  Rabies is an infection that can be transmitted when a person is bitten, scratched or even just licked by an infected animal, particularly when the skin is already injured.
  Even contact with animal traps that were licked or bitten by infected animals can cause infections in humans.

• Have/has a history of having a severe allergic reaction to the active substance or any ingredient of the vaccine listed in section 6.
• Have/has an acute disease requiring treatment.

Because of the seriousness of rabies infection, Rabipur can be given to anyone if they have been exposed to rabies, even those who are pregnant.

If you or your child is known to be at risk of a severe allergic reaction to the vaccine or to any of the ingredients, you/ your child may be given a different vaccine against rabies that does not contain these ingredients. If there is no alternative vaccine available, your doctor or nurse will discuss the risks of vaccination and rabies virus infection with you before you or your child receives the vaccine.

In case of acute disease requiring treatment, vaccination is usually postponed until at least 2 weeks after recovery. The presence of a minor infection should not require postponement of the vaccination, but talk to your doctor or nurse first.

Tell your doctor or nurse before you or your child receives Rabipur for post exposure prophylaxis if you/your child:

• Have/has a severe allergy to egg or egg products (for symptoms see section 4 of this leaflet). Rabipur contains residues of chicken proteins left over from the manufacturing process.
• Have/has a severe allergy to the antibiotics neomycin, chlortetracycline, or amphotericin B. These antibiotics may be present in very small amounts in the vaccine.
• Have/has a severe allergy to polygeline. Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.

Cases of very rare but severe conditions affecting the nervous system have been reported following the receipt of Rabipur vaccine. See section 4. Anti-inflammatory medicines (steroids), often used to treat these conditions, may interfere with the effectiveness of the vaccine (see below, other medicines and Rabipur). Your doctor or nurse will decide how to proceed in this circumstance.

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

The vaccine should not be given into the buttocks, under the skin or into a blood vessel.

Tell your doctor or nurse if you are /your child is taking, have/has recently taken, or plan to take any other medicines, even those not prescribed. Unless your doctor tells you otherwise, you/your child should continue to take all prescribed medicines as usual.

If you or your child already has a poor immune system or is already taking medicines that reduce the body’s immunity to infections, Rabipur can still be given but you/your child may not be as well protected as other people. In this case, your/your child’s doctor may decide to carry out blood tests after the vaccine administration, to check if the body has produced enough antibodies to the virus. If necessary, you/your child will be given extra doses of the vaccine (see section 3 of this leaflet).

Rabipur can be given at the same time as other inactivated vaccines. A different injection site will be used for each type of vaccine.

You/Your child may also need to be given an injection of antibodies against rabies (called “rabies immunoglobulin”) if you or your child have not been fully vaccinated against rabies and it is very likely that you or your child has been infected with the virus. If so, the rabies immunoglobulin injection (given only once and usually with the first dose of the vaccine) and the vaccine will be given in different parts of the body.

If you are pregnant or breastfeeding, if you think you may be pregnant, or are planning to have a baby, you should still be given rabies vaccine if you have had, or are likely to have had, contact with the virus. You can also be vaccinated with Rabipur during pregnancy or while breastfeeding and before exposure to the virus, if the risk of contact with the virus is thought to be considerable. In this instance, your doctor will discuss the risks of vaccination and rabies infection with you and advise on the best timing of Rabipur vaccination.

Some of the adverse effects described in section 4 of this leaflet may affect the ability to drive and use machines.

Less than 23 mg of sodium per dose, and is therefore essentially ‘sodium- free’.

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

If you or your child get any side effects, talk to your doctor 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 substance in the vaccine is rabies virus (inactivated, strain Flury LEP) ≥ 2.5 IU. This has been produced on purified chick embryo cells (PCEC).

The other ingredients are: trometamol, sodium chloride, disodium edetate, potassium-L-glutamate, polygeline, sucrose and water for injections. Chicken proteins (e.g., ovalbumin), human serum albumin, neomycin, chlortetracycline, amphotericin B are present as residues.

Rabipur is a white freeze-dried powder to be reconstituted with the clear colourless solvent. The reconstituted vaccine is clear to slightly opalescent and colourless to slightly pink. Rabipur is supplied in packs containing 1 vial of the powder, 1 disposable pre-filled syringe of sterile diluent with 1 small orange needle for injection and one long green needle for reconstitution.

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0800 198 5000 (UK Only).

Please be ready to give the following information: Product name Rabipur

Reference number 40365/0004

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