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RABIPUR POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabipur

Powder and solvent for solution for injection
Rabies vaccine, inactivated

Read all of this leaflet carefully before you/your child receive Rabipur.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you/your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Rabipur is and what it is used for
2. Before you receive Rabipur
3. How to use Rabipur
4. Possible side effects
5. How to store Rabipur
6. Further information

1. WHAT RABIPUR IS AND WHAT IT IS USED FOR
What Rabipur is
Rabipur is one of a group of medicines called vaccines that interact with the immune system (the body s natural defence against infections) to protect
against diseases. Rabipur is used to prevent infection by the virus that causes rabies.
Rabies vaccine works by causing your body to produce its own protection (antibodies) against the virus. The vaccine contains rabies viruses that have been completely
inactivated by chemical processing so that the vaccine cannot cause rabies. However, it can still cause the immune system to make antibodies to the virus.

What Rabipur is used for
Rabipur can be used in 2 ways:
to prevent rabies in people who may be at risk of catching the virus in the future. For example, people who work with animals or are travelling to parts
of the world where rabies cases are known to occur.
or
to prevent rabies in people who are likely to have caught the virus already through contact with live or dead animals, as described below.
Rabies is an infection that can be caught by being bitten by an infected animal or by being scratched or even just licked by an animal, especially if the skin
is already broken. Contact with animal snares that have been licked or bitten by infected animals can also cause infections in humans.
Animals that are perfectly well themselves may carry the virus and pass it on to humans. These animals may or may not go on to develop rabies themselves.
Contact with the carcasses of dead infected animals is also sometimes a way of catching the disease.
There is no treatment for rabies once there are symptoms of the infection present and in these cases the infection is always fatal.
Prevention of the development of symptoms of infection and death depends on vaccination either before any possible contact with the
virus or as soon as possible after contact with the virus, even if only suspected.
2. BEFORE YOU/YOUR CHILD RECEIVE RABIPUR
You/Your child must not receive Rabipur to prevent rabies in future if you/your child:
Are/is allergic to any ingredient of the vaccine, including:
o traces of neomycin, chlortetracycline or amphotericin B.
o eggs and egg products (the vaccine may contain traces of chick proteins)
o polygeline (a gelatine).
Have/has an illness associated with fever.
Have/has an acute infection.
If you are/your child is known to be allergic to any of the ingredients, you/your child may be given a different vaccine against rabies that does not contain
these ingredients.

You/Your child may be given Rabipur if you/your child:
Have/has already been in contact with the virus and may be infected, even if you are/your child is allergic to any ingredient of the vaccine, have fever,
or an acute infection. This is because rabies is such a serious infection.
If there is no alternative vaccine for you/your child, your doctor or nurse will discuss the risks of vaccination and rabies infection with you before you have/
your child has the vaccine.
Take special care with Rabipur
If you already have/your child already has a poor immune system or if you are/your child is already taking medicines that reduce your/your child s immunity
to infections, you can still have/your child can still have Rabipur but you/your child may not be as well protected as other people. In this case, your doctor
may decide to carry out blood tests after you have/your child has received the vaccine, to check if your/your child s body has produced enough antibodies
to the virus. If necessary, you/your child will be given extra doses of the vaccine.

Taking other medicines
Please tell your doctor or nurse if you are/your child is taking or have/has recently taken 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. You can have/Your child can have Rabipur at the same time
as other vaccines if this is necessary.
You/Your child may also need to be given an injection of antibodies against rabies (called rabies immunoglobulin ) if you are/your child is
very likely to have already caught 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 your/your child s body. Usually, as much as possible of the rabies immunoglobulin is injected into the area
of the body that came into contact with the animal and any that is left is given to you as a separate injection.
Pregnancy:
If you are or think you may be pregnant, you should still be given rabies vaccine if you have had, or are likely to have had, contact with the virus.
You can have Rabipur during pregnancy if the risk of contact with the virus is thought to be considerable. In this instance, your doctor will advise you
whether to have rabies vaccine now or to wait.
Breast-feeding:
Rabipur should still be given if you have had, or are likely to have had, contact with the virus.
You can also have Rabipur while you are breastfeeding if the risk of contact with the virus is thought to be considerable. Your doctor will advise you.

Driving and using machines:
The vaccine is unlikely to have any effect on your ability to drive or use machines.
3. HOW RABIPUR IS GIVEN
Rabipur will be given to you/your child by a doctor or nurse who has been trained to give vaccines. They should also have been trained to deal with the very
rare but serious types of allergic reactions that can occur after you/your child receive the vaccine (see section 4 of this leaflet). The vaccine should be given
to you/your child in a clinic or surgery that has the necessary equipment to treat these reactions.
The powder will be dissolved in water to make the solution for injection. The recommended dose in all age groups for each injection is one millilitre (1 ml).
The vaccine will usually be given into the muscle of the upper arm or, in small children, into the muscle of the thigh. The vaccine should not be given into
the buttocks. Your doctor or nurse will take care that the vaccine is not given into the upper layer of the skin or into a blood vessel.
Your doctor will decide how many doses you/your child should receive, this will depend on whether you are being given/your child is being given Rabipur
before or after any possible contact with the virus.
BEFORE ANY POSSIBLE CONTACT WITH THE VIRUS
If you have/your child has never had any rabies vaccine before, you/your child need to have 3 doses in the first instance. The first dose is given at the
first visit, the second 7 days later and the third dose 2-3 weeks after that.
If you/your child miss an appointment for an injection, you should arrange to have it as soon as possible after the due date.
If you/your child continue to be at risk of catching rabies after your primary immunisation, you/your child will need booster doses at intervals to keep
up your antibody levels against rabies.
The need for boosters depends on the risk of contact with rabies virus. Your doctor will consult the official recommendations on rabies vaccination and will
tell you when you/your child need to have a booster.
If you are/your child is at high risk of infection, your doctor may also ask you to have regular blood tests to measure the amount of antibody against
rabies in your/your child s blood so that boosters can be given as soon as needed. Booster doses are generally required every 2-5 years. If you have/your child
has had all the injections due and have/has kept up with regular boosters, you/your child will still need to have extra injections if you/your child actually
come into contact with the virus and the risk of infection is thought to be high.
This is explained below.
AFTER ANY POSSIBLE CONTACT WITH THE VIRUS
After any possible contact with rabies virus, your doctor will consider the risk of infection according to the type of contact you have/your child has had.
For example, if you have been bitten by an animal that could have the virus, you are at much greater risk of rabies infection than someone who has been
licked but has no break in the skin.
When vaccination is necessary, the first dose will be given as soon as possible and any wound will also be treated with an antiseptic.
The number of doses of vaccine, with or without rabies immunoglobulin (see Section 2: Taking other medicines) depends on the risk of catching
rabies and whether you have/your child has had any rabies vaccine before.

If you have/your child has an increased risk of catching the virus because your immune system is not working properly or you have/your child has
wounds that are especially likely to lead to infection, you/your child will need special attention as explained below.
Remember that rabies can be a fatal infection.
In all cases, it is very important that you/your child attend on time for all the doses of vaccine that you need/your child needs (see
below) and for any blood tests that your doctor considers are necessary.
If you are/your child is late for any appointment you/your child must attend as soon as possible.
If you are/your child is unwell at any time while you are/your child is having the course of vaccinations you must let your doctor know
immediately and must not miss any injections.
Vaccinated people
If you have/your child has already been vaccinated against rabies and have/has kept up your boosters, you usually need/your child usually needs only 2
extra doses. One is given immediately and the second is given 3 days later. However, if the last dose of vaccine was more than two years ago, you/your child
may need 4 or 5 doses (as for unvaccinated people; see below).
Unvaccinated people
If you/your child
Have/has not been vaccinated before,
Have/has not been vaccinated for some time (2-5 years)
Have/has received certain types of rabies vaccine in the past that may give lower protection than those now used in most countries either 4 or 5 doses
can be given.
If 4 doses are used, the first 2 are given immediately and then single doses are given 1 and 3 weeks later.
If 5 doses are used, the first dose is given immediately and the others are given on days 3, 7, 14 and 28 after the first dose.
People needing special care
You/Your child will need special care if you/your child:
Have/has poor immunity to infections for any reason,
Have/has several wounds from animal contact,
Have/has wounds on the head and neck,
cannot get medical attention for some time after the possible contact with rabies virus.
You/Your child will probably receive at least 5 doses of vaccine, at the times described above. Sometimes an extra dose is given immediately so that 6
injections are given over 4 weeks. You are/Your child is also more likely to need rabies immunoglobulin as well as vaccinations.
It may also be necessary for you/your child to have blood tests to measure the amount of antibody to rabies virus in your/your child s blood so that extra
doses of vaccine can be given if needed. Your doctor will explain what needs to be done and will tell you when to attend for extra tests or doses. If you have
any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rabipur can cause side effects, although only a few people get them. The frequency of side effects is classified as follows:
Very common in more than 1 in 10 patients
Common
in more than 1 in 100 patients, but less than 1 in 10 patients
Uncommon in more than 1 in 1,000 patients, but less than 1 in 100 patients
Rare
in more than 1 in 10,000 patients, but less than 1 in 1,000 patients
Very rare
in less than 1 in 10,000 patients, including isolated reports
If any of the following side effects gets serious, or if you notice any other effects not listed above, please tell your doctor or nurse.
Serious allergic reactions are very rare after receiving a vaccine. These reactions may include:
difficulty in breathing,
blue discolouration of the tongue or lips,
swelling of the face and neck or elsewhere
low blood pressure causing collapse and shock.
When these signs or symptoms occur, they usually develop very quickly after the injection is given and while you are/your child is still in the clinic or doctor s
surgery. If any of these symptoms occurs after leaving the clinic or surgery, you must consult a doctor IMMEDIATELY.
Very common: pain, swelling and other reactions at the site of the injection may occur.
Common: reddening at the injection site, weakness, generally feeling unwell, fever, chills, tiredness, flu-like illness, swollen glands, headache, muscle
pain, joint pain and digestive upsets such as feeling sick and stomach pains, rash that may be red, lumpy and itchy.
Uncommon: Dizziness
Rare: disturbances in blood circulation (which may cause symptoms like palpitations or hot flushes), problems with vision, or pins and needles or tingling
sensations.
Very rare: unsteadiness with dizziness, nerve disturbances that can cause weakness, inability to move or loss of feeling in some parts of the body, serum
sickness-like symptoms (fever, general redness, joint pain, swelling of lymph nodes 6 to 14 days after injection).

5. HOW TO STORE RABIPUR
Keep out of the reach and sight of children. Do not use Rabipur after the expiry date which is stated on the label and carton. Store in a refrigerator (2 C 8 C). Do not freeze. The vaccine should be visually inspected before and after reconstitution for any foreign particulate matter and or change in physical
appearance. The vaccine must not be used if any change in the appearance has taken place. A clear colourless solution results after reconstitution of the
white freeze-dried powder with the clear and colourless solvent.
The powder for solution should be reconstituted using the solvent for solution supplied and carefully agitated prior to injection.
The reconstituted vaccine should be used immediately.
During manufacturing, the vial is sealed under vacuum. Therefore to prevent problems in withdrawing the reconstituted vaccine from the vial after
reconstitution of the vaccine, it is recommended to unscrew the syringe from the needle to eliminate the negative pressure. After that, the vaccine can be
easily withdrawn from the vial. It is not recommended to induce excess pressure, since over-pressurization will create the problems in withdrawing the
proper amount of the vaccine. In the absence of compatibility studies, Rabipur must not be mixed in the same syringe with other medicinal products.
No interactions with concomitant administration of other vaccines have been reported. Any unused vaccine or waste material should be disposed of in
accordance with local requirements.

6. FURTHER INFORMATION
What Rabipur contains
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.
The other ingredients are: trometamol, sodium chloride, disodium edetate, potassium-L-glutamate, polygeline, sucrose and Water for Injections.
What Rabipur looks like and contents of the pack
Rabipur is a white freeze-dried powder which, when reconstituted with the clear colourless solvent, becomes a clear colourless solution.
Rabipur is supplied in packs containing 1 vial of the powder, 1 ampoule of sterile water, with/without 1 injection syringe with separate needle.

Marketing Authorisation Holder and Manufacturer
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Str. 76, 35041 Marburg, Germany

This leaflet was last approved in 10/2011

RKGPF016(1210A)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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