RABIPUR®

(Rab-ee-per)
Inactivated Rabies Virus Vaccine


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about RABIPUR (Inactivated Rabies Virus Vaccine).

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having RABIPUR against the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What RABIPUR is used for

RABIPUR is a vaccine used to help prevent rabies infection in people who either

Rabies is a very serious infection. The rabies virus attacks the nerves and the brain. Rabies infection can be fatal if not treated as early as possible.

How it works

RABIPUR works by causing your body to protect itself against rabies. The body makes substances that fight the rabies virus. They are called antibodies and circulate in the blood. If the rabies virus gets into someone who has been vaccinated against rabies, the antibodies kill the virus before it can cause damage.

After vaccination your body takes several weeks to develop enough antibodies to successfully fight rabies.

For vaccination against rabies you need a course of 3 to 5 injections.

After this course, most people produce enough antibodies against rabies. However, as with all vaccines, 100% protection cannot be guaranteed

Further booster injections of rabies vaccine may be needed every few years to ensure enough antibodies are present.

The vaccine will not give you or your child rabies.

The chance of a severe reaction from RABIPUR is very small, but the risks from not being vaccinated against rabies may be very serious.

Before you are given RABIPUR

When you or your child must not be given RABIPUR

Do NOT have RABIPUR if you have :

However, untreated rabies infection can be fatal. Therefore, even if you may be allergic to an ingredient of this vaccine and you have been bitten or scratched by an animal which has/is thought to have rabies, it is essential to have the rabies vaccine. Your doctor will be able to manage any allergic reaction you may have.

If you are not sure whether you or your child should have RABIPUR, talk to your doctor or pharmacist.

Before you or your child are given RABIPUR

Tell your doctor if you have, or have had, any medical conditions, especially the following:

Tell your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the possible risks and benefits of having RABIPUR during pregnancy.

Tell your doctor if you are breast-feeding.

Your doctor will discuss the possible risks and benefits of having RABIPUR during breastfeeding.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

RABIPUR and some medicines may interfere with each other. These include:

These medicines may be affected by RABIPUR or may affect how well it works. You may need different amounts of these medicines, or you may need to take different medicines. Your doctor or pharmacist will advise you.

How RABIPUR is given

A doctor or nurse gives RABIPUR as an injection (usually into muscle in your upper arm).

RABIPUR should not be injected directly into the skin or a vein.

How much is given

Each injection of rabies vaccine is 1.0mL.

Your doctor will decide how many injections of RABIPUR you will need.

When it is given

"Post exposure":
RABIPUR may be given to people after they have been exposed to rabies infection.

The usual course is 4 to 5 injections, given at intervals over 3 or 4 weeks.

"Pre-exposure":
RABIPUR may be given in advance to people at risk of being infected with rabies.
The usual course is 3 injections given at intervals over 3 - 4 weeks.

"Booster Injections":
After two to five years, depending on the circumstances, a booster injection may be needed. Further boosters may be needed every few years.

Your doctor will tell you how many injections you should have and when you should have them.

Follow carefully all your doctor's directions.

If you miss a dose

If you miss a dose, talk to your doctor and arrange another visit as soon as possible.

Overdose

Overdose is most unlikely because your doctor or nurse gives the injections.

If you have any concerns, ask your doctor.

After having RABIPUR

Things you or your child must do

It is important to have your follow-up doses of RABIPUR, and any blood tests, at the correct intervals. This gives the vaccine the best chance of providing protection against rabies and allows the antibody level to be measured.

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well after having RABIPUR.

Ask your doctor or pharmacist to answer any questions you may have.

RABIPUR may have unwanted side effects. All medicines, including vaccines can have side effects. Sometimes they are serious, most of the time they are not. You or your child may need medical treatment if you get some of the side effects.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

These are common side effects of RABIPUR. Mostly these are mild and short-lived.

Tell your doctor immediately if you notice any of the following:

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

These are very serious side effects. You or your child may need urgent medical attention or hospitalisation.

All of these side effects are very rare.

This is not a complete list of side effects. Tell your doctor or pharmacist if you notice anything related to RABIPUR that makes you or your child feel unwell.

Storing RABIPUR

RABIPUR is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store RABIPUR:

Product description

What RABIPUR looks like

Each pack of RABIPUR contains

Your doctor will inject the sterile water into the vial to make the liquid for your injection. This liquid is clear and colourless.

Ingredients

Vaccine
Active ingredients:

Other ingredients:

Diluent

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product.

Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.

Manufacturer

RABIPUR is made by:
Novartis Vaccines and Diagnostics GmbH
P.O. Box 16 30
D-35006 Marburg
Germany

Sponsor

RABIPUR is sponsored in Australia by:
CSL Limited
ABN 99 051 588 348
45 Poplar Road
Parkville Vic 3052
AUSTRALIA

Registration number

AUST R 100582

Date of preparation

November 2010

RABIPUR®is a registered trademark of Novartis Vaccines and Diagnostics GmbH

Published by MIMS/myDr February 2011