Rabipur

Powder and solvent for solution for injection in pre-filled syringe

Rabies virus (Inactivated, strain Flury LEP)

Rabipur will be given to you/your child by a doctor or nurse who has been trained to give vaccines.

Treatment that may be needed to manage very serious types of allergic reactions that can occur after receipt of the vaccine should be available (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.

Instructions intended for doctors and medical personnel for reconstituting the vaccine can be found at the end of this leaflet.

The recommended dose for adults and children of any age is one millilitre (1.0 ml) per injection.

Your doctor will decide how many doses you/your child should receive; this will depend on whether you/your child are/is being given Rabipur before or after any possible contact with the virus.

The vaccine is given as an injection into a muscle (usually in the upper arm, or in small children, into the muscle of the thigh).

BEFORE ANY POSSIBLE CONTACT WITH THE VIRUS

If you have/your child has never had any rabies vaccine before:

• you need to have 3 doses in the first instance. The first dose is given at the first visit, the second dose is given 7 days later and the third dose 21 or 28 days after the first dose.
• if you are an adult between 18 and 65 years of age needing a rapid protection, Rabipur can also be given to you as a total of three doses over 7 days. The first dose is given at the first visit, the second dose is given 3 days later and the third dose 4 days after the second dose.
• alternatively, if you are an individual with a normal immune response, Rabipur can be given to you as two doses over 7 days. The first dose is given at the first visit and the second dose is given 7 days later.

If you/your child miss an appointment for an injection, you should arrange to have it as soon as possible after the due date.

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 a booster is needed.

If you are at continuous 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 blood so that boosters can be given as soon as needed. Experience shows that booster doses are generally required every 2-5 years.

AFTER SUSPECTED OR PROVEN CONTACT WITH THE VIRUS

Vaccinated people

If you have/your child has already been fully vaccinated against rabies and/or have received boosters, and have been in contact with a rabid or suspected rabid animal, you/ your child usually need 2 more doses of vaccine (1.0 ml each). The first dose is given as soon as possible after the contact, and the second is given 3 days later.

Unvaccinated people

If you/your child have/has not been vaccinated before or received inadequate basic immunisation, either 4 or 5 doses (1.0 ml each) will be given according to one of the following schedules:

• If an immunisation schedule of 4 doses is used, the first 2 vaccine doses are given as soon as possible after the contact on day 0 and then single doses are given 7 and 21 days after the first dose.
• An alternative 4 doses schedule can be adopted as well for healthy people who are known to have a good immune response; the first vaccine dose given as soon as possible after the contact on day 0 and the others given on days 3, 7 and 14 after the first dose.
• If an immunisation schedule of 5 doses is used, the first vaccine dose is given as soon as possible after the contact on day 0 and the others are given on days 3, 7, 14 and 28 after the first dose.

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 or scratched by an animal that could have the virus, or have been in contact with bats, you are at much greater risk of rabies infection than someone who has been licked but has no break in the skin.

People with a compromised immune system (poor immunity to infection)

If you have/your child has an increased risk of rabies infection because your immune system is not working properly, you/your child will need five or six doses (each of 1.0 ml) of rabies vaccine after contact with a rabid or suspected rabid animal. Vaccination is given in combination with local treatment of the wound and rabies immunoglobulin.

If six doses are used, the first two are given as soon as possible after the contact, and then single doses are given on days 3, 7, 14 and 28 after the first dose.

If five doses are used, the first dose is given as soon as possible after the contact, and the others are given on days 3, 7, 14 and 28 after the first dose.

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions involving the whole body, sometimes associated with shock (dangerously low blood pressure)* can occur following Rabipur vaccination. Appropriate medical treatment and supervision should always be readily available in case of a rare severe allergic reaction to the vaccine. Talk to a doctor straight away if they happen.

The most common side effects reported with the use of Rabipur were pain at the injection site, mainly pain due to the injection, or hardness of the skin at the site of injection. These reactions are very common (occurring in more than 1 in 10 persons). Most injection site reactions were not severe and resolved within 24 to 48 hours after injection.

Other side effects include:

Very common (these may affect more than 1 in 10 people)

Headache

Dizziness

Rash

General discomfort

Fatigue

Weakness

Fever

Common (these may affect up to 1 in 10 people)

Swollen glands

Decreased appetite

Nausea

Vomiting

Diarrhoea

Stomach pain/discomfort

Hives

Muscles pain

Joint pain

Rare (these may affect up to 1 in 1,000 people)

Allergic reactions

Pins and needles or tingling sensations

Sweating

Chills

Very rare (these may affect up to 1 in 10,000 people)

Inflammation of the brain, nerve disturbances that can cause weakness, inability to move or loss of feeling in some parts of the body*

Fainting, unsteadiness with dizziness*

Serious allergic reaction which causes swelling of the face or throat*

*Description of adverse reactions from spontaneous reporting

Keep this vaccine out of the sight and reach of children.

Store protected from light in a refrigerator (at 2°C to 8°C). Do not freeze.

Keep the vial and the syringe in the outer carton in order to protect from light.

Do not use this vaccine after the expiry date which is stated on the outer carton. The expiry date refers to the last day of the month. Do not throw away any vaccine via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Other formats:

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0800 198 5000 (UK Only)

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Product name Rabipur

Reference number 40365/0004

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