Powder and solvent for solution for injection in pre-filled syringe
Rabies virus (inactivated, Flury LEP strain)
What RABIPUR is and what it is used for
What Rabipur is
Rabipur is a vaccine that contains inactivated rabies virus. After vaccination, the immune system (the body’s natural defense system) produces antibodies against the rabies virus. These antibodies protect against infections or diseases caused by the virus that causes rabies. None of the vaccine’s components can cause rabies.
What Rabipur is used for
Rabipur can be used for people of all ages.
Rabipur can be used to prevent rabies:
- before any risk of exposure to rabies virus (pre-exposure prophylaxis).
- after suspected or proven exposure to rabies virus ( post-exposure prophylaxis ).
Rabies is an infection that can be transmitted if you are bitten, torn, or even licked by an infected animal, especially if the skin is already damaged. Contact with animal traps that infected animals have licked or bitten can also cause infection in humans.
What you need to know before you / your child is vaccinated with RABIPUR
You / your child must not be vaccinated with Rabipur before any risk of exposure to rabies virus if you / your child:
- have previously had a severe allergic reaction to the active substance or any of the other ingredients of the vaccine listed in section 6
- have an acute illness that requires treatment.
After suspected or proven exposure to rabies virus, you / your child may receive Rabipur
Because rabies is a very serious disease, Rabipur can be given to anyone who has been exposed to rabies, including pregnant women.
Severe allergic reactions (hypersensitivity)
If it is known that you / your child is at risk of a serious allergic reaction to the vaccine or any of the ingredients, you / your child may receive another rabies vaccine that does not contain these substances. If there is no alternative vaccine, your doctor or nurse will discuss the risks of vaccination and rabies infection with you before you or your child are vaccinated.
Warnings and cautions
In acute illness that requires treatment, the vaccination is generally postponed for at least 2 weeks after recovery. A minor infection usually does not require a delay in vaccination, but talk to a doctor or nurse first.
Talk to a doctor or nurse before you or your child are vaccinated with Rabipur after rabies exposure if you / your child:
- have a severe allergy to eggs or egg products (for symptoms, see section 4 of this leaflet). Rabipur contains residues of chicken protein from the manufacturing process
- have a severe allergy to the antibiotic products neomycin, chlortetracycline or amphotericin B. These antibiotics may be present in very small amounts in the vaccine
- have a severe allergy to polygeline.
Fainting can occur after or even before a needle injection. Therefore, tell your doctor or nurse if you have fainted from any previous injection.
Cases of very rare but serious conditions affecting the nervous system have been reported following vaccination with Rabipur. See section 4 . Anti-inflammatory drugs ( steroids such as cortisone preparations) that are often used to treat such conditions may impair the effectiveness of the vaccine (see below, Other drugs and Rabipur ). Your doctor or nurse will decide how to proceed in such circumstances.
As with all vaccines, Rabipur may not provide adequate protection for everyone who has been vaccinated.
The vaccine should not be given in the buttocks, under the skin, or in a blood vessel.
Other medicines and Rabipur
Tell your doctor or nurse if you / your child are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Unless your doctor tells you otherwise, you / your child should continue to take all prescribed medicines as usual.
If you or your child already have a weakened immune system or are already taking medicines that reduce the body’s resistance to infection, Rabipur can still be given, but you / your child may not have as good protection as others. In this case, the doctor may decide to take blood samples after the vaccine has been given to check if the body has produced enough antibodies against the virus. If necessary, you / your child will receive an extra dose of the vaccine (see section 3 of this leaflet).
Rabipur can be given at the same time as other inactivated vaccines. A separate injection site should be used for each type of vaccine.
You / your child may also need to receive an injection of antibodies against rabies (so-called rabies immunoglobulin ) if you or your child have not been completely vaccinated against rabies and if it is very likely that you / your child has already been infected with the virus. In this case, injection of one of the rabies immunoglobulins (given only once and usually at the same time as the first dose of vaccine) and the vaccine will be given in different parts of the body.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should still get the rabies vaccine if you have or have probably been in contact with the virus.
You can also be vaccinated with Rabipur during pregnancy or lactation and before exposure to the virus if the risk of contact with the virus is considered significant. Then the doctor will discuss the risks of vaccination and rabies infection with you and advise on the best time for a vaccination with Rabipur.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rabipur contains:
Less than 23 mg sodium per dose, and is therefore largely “sodium-free”.
How to use Rabipur
You / your child will be vaccinated with Rabipur by a doctor or nurse trained in vaccination. Treatment that may be required to deal with the very severe types of allergic reactions that may occur after injection of the vaccine should be available (see section 4 of this leaflet). The vaccine should be given at a clinic or doctor’s office that has the equipment required to treat such reactions.
Instructions for doctors and medical staff on the preparation of the vaccine can be found at the end of this leaflet.
The recommended dose for adults and children of all ages is one milliliter (1.0 ml) per injection.
The doctor will decide how many doses you / your child should receive, and this depends on whether you / your child receive Rabipur before or after any contact with the virus.
The vaccine is given as an injection into a muscle (usually in the upper arm, or on small children in the thigh muscle).
BEFORE ANY CONTACT WITH VIRUS ET
If you / your child have never received a rabies vaccine before:
- Do you / your child need 3 doses, to begin with? The first dose is given at the first visit, the second dose is given 7 days later and the third dose is given 21 or 28 days after the first dose.
- If you are an adult between the ages of 18 and 65 and need prompt protection, Rabipur can also be given with a total of 3 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 is given 4 days after the second dose.
If you / your child misses an appointment for an injection, be sure to get the vaccine as soon as possible after the missed time.
The need for repeated doses for continued effect (booster doses) depends on the risk of contact with the rabies virus. Your doctor will find out the official recommendations for rabies vaccination and will tell you when a booster dose is needed.
If you are constantly at high risk of infection, your doctor may also ask you to provide regular blood tests to measure the level of antibodies to rabies in your blood so that booster doses can be given as soon as needed. Experience shows that booster doses are generally required every two to five years.
AFTER SUSPICIOUS OR PROVEN CONTACT WITH VIRUS ET
Vaccinated people
If you / your child have already been vaccinated against rabies and/or followed up with booster doses, and have been in contact with a rabies-infected or suspected rabies-infected animal, you / your child usually need 2 additional doses of the vaccine (1.0 ml per dose ). The first dose is given as soon as possible after contact and the second 3 days later.
Non-vaccinated persons
If you / your child have not been vaccinated before or have received insufficient basic immunization, either 4 or 5 doses (1.0 ml per dose ) will be given according to one of the following schedules:
- If a 4 – dose immunization schedule is used, the first 2 vaccine doses are given as soon as possible after contact on day 0, and then a dose is given 7 and 21 days after the first dose.
- An alternative 4-dose schedule can also be used for healthy people without problems with the immune system. The first vaccination dose is given as soon as possible after contact on day 0 and the others are given on days 3, 7, and 14 after the first dose.
- If an immunization schedule of 5 doses is used, the first vaccine dose is given as soon as possible after contact on day 0, and the remaining doses are given 3, 7, 14, and 28 days after the first dose.
After possible contact with the rabies virus, the doctor assesses the risk of infection based on the type of contact you / your child has had. For example, if you have been bitten or torn by an animal that may have been infected with the virus or have been in contact with bats, you are at a much greater risk of infection with rabies than a person who has been licked without a hole in the skin.
People with the weakened immune system (poor immunity to infection )
If you / your child is at increased risk of rabies infection due to the immune system not working properly, you / your child will need five or six doses (1.0 ml each) of the rabies vaccine after contact with a rabies-infected or suspected rabies-infected animal. The vaccination is given in combination with local treatment of the wound and rabies immunoglobulin.
If 6 doses are used, the first 2 are given as soon as possible after contact, and then a dose is given on days 3, 7, 14, and 28 after the first dose.
If 5 doses are used, the first dose is given as soon as possible after contact, and then the remaining days 3, 7, 14, and 28 after the first dose are given.
You / your child may also need to submit blood samples to measure the number of antibodies against the rabies virus in the blood so that extra vaccine doses can be given if needed. The doctor explains what needs to be done and when you should come for extra tests or doses.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions affecting the whole body, sometimes associated with shock (dangerously low blood pressure ) * may occur after vaccination with Rabipur. Appropriate medical treatment and monitoring should always be readily available in the event of a rare severe allergic reaction to the vaccine. Talk to a doctor immediately if this happens.
The most common side effects reported after using Rabipur are injection site pain, mainly pain due to injection one, or hardening of the skin at the injection site. These reactions are very common (affect more than 1 in 10 people). Most injection site reactions were not severe and resolved within 24 to 48 hours after injection.
Other side effects include:
Very common (may affect more than 1 in 10 people):
headache
dizziness
rash
general malaise
fatigue
weakness
fever.
Common (may affect up to 1 in 10 people):
swollen glands
decreased appetite
nausea
vomiting
diarrhea
abdominal pain/discomfort
hives
muscle pain
joint pain.
Rare (may affect up to 1 in 1,000 people):
allergic reactions
tingling or a tingling sensation
sweating
overindulge.
Very rare (may affect up to 1 in 10,000 people):
encephalitis, nerve disorders that can cause weakness, inability to move, or loss of sensation in certain parts of the body *
fainting, instability with dizziness *
the severe allergic reaction that causes swelling of the face or neck *.
* Description of side effects from spontaneous reporting
Additional side effects are in children
The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.
How to store Rabipur
Keep this vaccine out of the reach and sight of children.
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
Keep the vial and syringe in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton (after EXP). The expiration date is the last day of the specified month. Vaccines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance in the vaccine is rabies virus (inactivated, strain Flury LEP) ≥ 2.5 IU. This has been produced in purified cells from chicken embryos (PCEC).
The other ingredients are Trometamol, sodium chloride, disodium edetate, potassium -L- glutamate, polygeline, sucrose, and water for injections.
Chicken protein (eg ovalbumin), human serum albumin, neomycin, chlortetracycline, and amphotericin B are included as residues.
What the medicine looks like and the contents of the pack
Rabipur is a white, lyophilized powder that is to be reconstituted with a clear, colorless liquid. The reconstituted vaccine is ready for something opalescent and colorless to a little pink.
Rabipur is supplied in packs containing 1 vial of powder, 1 pre-filled syringe of sterile liquid with a small orange needle for injection, and a long green needle for reconstitution.
Marketing Authorisation Holder
Bavarian Nordic A / S
Philip Heymans Allé 3
2900 Hellerup
Denmark
Manufacturer
Bavarian Nordic A / S
Hejreskovvej 10A
3490 Kvistgaard
Denmark
GSK Vaccines GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Rabipur |
| Belgium | Rabipur |
| Croatia | Rabipur |
| Denmark | Rabipur |
| France | Rabipur |
| Germany | Rabipur |
| Hungary | Rabipur |
| Italy | Rabipur |
| Luxembourg | Rabipur |
| Netherlands | Rabipur |
| Norway | Rabipur |
| Poland | Rabipur |
| Portugal | Rabipur |
| Spain | Rabipur |
| Sweden | Rabipur |