Rabipur
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
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
have been, or
are at risk of being bitten, licked or scratched by an animal infected with rabies virus.
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 :
an allergy to RABIPUR or any of the ingredients listed at the end of this leaflet
a severe allergy to chicken eggs.
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.
You or your child is suffering from any illness or has a fever
Do not have RABIPUR after the expiry date printed on the pack.
Do not have RABIPUR if the packaging is torn or shows signs of tampering.
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:
low immunity due to an illness OR treatment with medicines such as corticosteroids, cyclosporin or cancer treatment (including radiation therapy);
a severe allergy to chicken eggs
an allergy to antibiotics, particularly neomycin, chlortetracycline or amphotericin B.
fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection. Tell your doctor or nurse if you have experienced this kind of reaction previously.
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:
medicines that lower the body’s immunity, such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy)
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
Keep an updated record of your vaccinations.
Keep follow-up appointments with your doctor or clinic.
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:
any effects at the injection site such as redness, swelling or pain
headache
fever
tiredness
generally feeling unwell
flu-like symptoms
chills
increased sweating
swollen glands in the neck or armpit
muscle ache, weakness, joint pain
nausea or vomiting
stomach cramps or pain
rash
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:
fast or irregular heartbeat or hot flushes
problems with vision
tingling or numbness of the hands or feet
dizziness or light-headedness, feeling faint or fainting
weakness that restricts movement
inability to move or loss of feeling in some parts of the body
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
signs of allergy, such as itchy pink rash, itchy swellings on the skin (also called hives or nettle rash)
swelling of the face, lips, tongue or other parts of the body such as limbs
difficulty breathing
blue discolouration of the tongue or lips
headache and high-temperatures associated with hallucinations, confusion, paralysis of part or all of the body, disturbances of behaviour, speech and eye movements, stiff neck and sensitivity to light.
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:
Keep it where children cannot reach it.
Keep RABIPUR in the original pack until it is time for it to be given.
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze RABIPUR.
Freezing can lower the effectiveness of the vaccine.
Product description
What RABIPUR looks like
Each pack of RABIPUR contains
one vial of vaccine powder
one ampoule or pre-filled syringe of sterile water for injections
one disposable syringe (ampoule presentation)
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:
Not less than 2.5 International Units of inactivated Rabies virus (Flury LEP strain)
Other ingredients:
Trometamol
Sodium chloride
Disodium edetate
Monopotassium glutamate
Polygeline
Sucrose
Possible trace amounts: neomycin, chlortetracycline, amphotericin B (amphotericin)
Diluent
Water for Injections
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:
GSK Vaccines and Diagnostics GmbH
P.O. Box 16 30
D-35006 Marburg
Germany
Sponsor
RABIPUR is sponsored in Australia by:
GlaxoSmithKline Australia Pty Limited
Level 4, 436 Johnston Street
Abbotsford, Victoria
AUSTRALIA 3067
Registration number
AUST R 100582, AUST R 298194
Date of preparation
27 March 2018
Trade marks are owned by or licensed to the GSK group of companies.
© 2018 GSK group of companies or its licensor.
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