Rabipur powder and solvent for solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rabipur

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

rabies virus (inactivated, Flury LEP strain)

Read all of this leaflet carefully before you or your child is given Rabipur, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only, and must not be passed on to other people.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if the adverse reactions are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rabipur is and what it is used for
2. What you need to know before you or your child is given Rabipur
3. How to use Rabipur
4. Possible side effects
5. How to store Rabipur
6. Contents of the pack and other information

1. What Rabipur is and what it is used for

What Rabipur is

Rabipur is a vaccine containing inactivated rabies virus. After administration of the vaccine, the immune system (the body's natural defence system) produces antibodies against the rabies virus. These antibodies protect you from infections or diseases caused by the rabies virus. None of the components of the vaccine can cause rabies.

What Rabipur is used for

Rabipur can be used in people of all ages.

Rabipur can be used to prevent rabies:

• before possible exposure to the rabies virus (pre-exposure prophylaxis)

or

• after suspected or confirmed exposure to the rabies virus (post-exposure prophylaxis).

Rabies is an infection that can be transmitted when an infected animal bites, scratches, or even licks a person, especially when the skin is not intact. Even contact with animal traps that have been licked or bitten by infected animals may cause infections in humans.

2. What you need to know before you or your child receives Rabipur

You or your child must not receive Rabipur prior to potential exposure to the rabies virus if:

• You have a history of severe allergic reactions to the active substance or to any of the other components of the vaccine (listed in section 6).
• You are suffering from an acute illness requiring treatment.

Due to the severity of rabies virus infection, Rabipur may be administered to anyone who has been exposed to rabies, including pregnant women.

Severe allergic reactions (hypersensitivity)

If you or your child is known to be at risk of a severe allergic reaction to the vaccine or to any of its components, you or your child may be given a different rabies vaccine that does not contain such components. If no alternative vaccine is available, your doctor or nurse will discuss with you the risks of vaccination and of rabies virus infection before you or your child receives the vaccine.

Warnings and precautions

If you have an acute illness requiring treatment, vaccination is usually postponed until at least 2 weeks after recovery. However, a mild infection does not require postponing vaccination. Nevertheless, consult your doctor or nurse first.

Consult your doctor or nurse before receiving Rabipur for post-exposure prophylaxis if you or your child:

• Has a severe allergy to egg or egg-derived products (for symptoms, see section 4 of this leaflet). Rabipur contains residual chicken proteins from the manufacturing process.
• Has a severe allergy to the antibiotics neomycin, chlortetracycline, or amphotericin B. These antibiotics may be present in very small amounts in the vaccine.
• Has a severe allergy to polygeline.

Fainting may occur before or after any injection. Therefore, inform your doctor or nurse if you or your child has previously fainted after receiving an injection.

Very rare but serious disorders affecting the nervous system have been reported after administration of the Rabipur vaccine. See section 4. Anti-inflammatory medicines (steroids), which are often used to treat these disorders, may interfere with the effectiveness of the vaccine (see below, Other medicines and Rabipur). Your doctor or nurse will decide how to proceed in such cases.

Like all vaccines, Rabipur may not fully protect all individuals who are vaccinated.

The vaccine must not be administered into the buttocks, under the skin, or into a blood vessel.

Other medicines and Rabipur

Inform your doctor or nurse if you or your child is taking, has recently taken, or might need to take any other medicines, including over-the-counter medicines. Unless your doctor tells you otherwise, you or your child should continue taking all prescribed medicines as usual.

If you or your child has an immunodeficiency or is taking medicines that reduce the body’s immune response to infections, Rabipur may still be administered; however, you or your child may not be as well protected as others. In such cases, your doctor may request blood tests after vaccination to check whether the body has produced enough antibodies against the virus. If necessary, you or your child will receive additional doses of the vaccine (see section 3 of this leaflet).

Rabipur can be administered at the same time as other inactivated vaccines. A different injection site will be used for each type of vaccine.

You or your child may also need to receive an injection of rabies antibodies (called "rabies immunoglobulin") if you or your child has not been fully vaccinated against rabies and infection with the virus is highly likely. In this case, the rabies immunoglobulin injection (which is given only once, usually at the same time as the first vaccine dose) and the vaccine will be administered in different parts of the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, you should still receive the rabies vaccine if you have had or are likely to have had contact with the virus.

You may also be vaccinated with Rabipur during pregnancy or breastfeeding and before exposure to the virus if a significant risk of contact with the virus is expected. In such cases, your doctor will discuss with you the risks of vaccination and of rabies virus infection and will advise you on the best time to receive Rabipur.

Driving and use of machines

Some of the adverse effects described in section 4 of this leaflet may affect the ability to drive or operate machinery.

Rabipur contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to use Rabipur

A doctor or nurse trained in administering vaccines will give you or your child Rabipur. Treatment necessary to manage very severe allergic reactions that may occur after vaccination must be available (see section 4 of this leaflet). The vaccine should be administered to you or your child in a clinic or office equipped with the necessary equipment to treat these reactions.

Reconstitution instructions for the vaccine intended for doctors and medical personnel are located at the end of this leaflet.

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

Your doctor will decide the number of doses to be given to you or your child, depending on whether Rabipur has been administered before or after any possible exposure to the virus.

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

BEFORE ANY POSSIBLE EXPOSURE TO THE VIRUS

If you or your child has never been vaccinated against rabies:

• You need to receive 3 doses initially. The first dose is given on 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 who requires rapid protection, you may also be given three doses of Rabipur over 7 days. The first dose is given on 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 a person with a normal immune response, Rabipur may be given in two doses over 7 days. The first dose is given on the first visit and the second dose 7 days later.

If you or your child misses an appointment for a dose, you should schedule an appointment as soon as possible after the originally scheduled date.

The need for booster doses depends on the risk of exposure to the rabies virus. Your doctor will consult official anti-rabies vaccination recommendations and inform you whether a booster dose is required.

If you are at continuous high risk of infection, your doctor may also recommend periodic blood tests to measure the level of rabies antibodies in your blood, so that booster doses can be administered as soon as necessary. Experience indicates that booster doses are generally required every 2–5 years.

AFTER A SUSPECTED OR CONFIRMED EXPOSURE TO THE VIRUS

Vaccinated individuals

If you or your child has already been fully vaccinated against rabies and/or has received booster doses and has been exposed to an animal known or suspected to have rabies, you or your child will generally require 2 additional doses of the vaccine (each 1.0 ml). The first dose should be administered as soon as possible after exposure, and the second dose 3 days later.

Unvaccinated individuals

If you or your child has not been previously vaccinated or has received inadequate primary immunization, 4 or 5 doses (each 1.0 ml) will be administered according to one of the following schedules:

• If a 4-dose schedule is used, the first two doses are given on day 0 as soon as possible after exposure, followed by single doses on days 7 and 21 after the first dose.
• An alternative 4-dose schedule may also be used for healthy individuals known to have a good immune response; the first dose is given as soon as possible after exposure (day 0), and subsequent doses on days 3, 7, and 14 after the first dose.
• If a 5-dose schedule is used, the first dose is given on day 0 as soon as possible after exposure, and subsequent doses on days 3, 7, 14, and 28 after the first dose.

After any possible exposure to the rabies virus, your doctor will assess the risk of infection based on the type of exposure you or your child has had. For example, if you were bitten or scratched by an animal that might have the virus, or have had contact with bats, your risk of rabies infection is much higher than for someone with intact skin who has only been licked.

Individuals with weakened immune systems (impaired immunity to infections)

If you or your child is at higher risk of rabies infection because your immune system is not functioning properly, you or your child will need five or six doses (each 1.0 ml) of rabies vaccine after exposure to an animal known or suspected to have rabies. Vaccination will be administered in combination with local wound treatment and rabies immunoglobulin.

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

Blood tests may also be necessary to measure the level of rabies virus antibodies in your or your child's blood, so that additional vaccine doses can be administered if needed. Your doctor will explain the necessary steps and inform you when to return for blood tests or additional doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

After vaccination with Rabipur, serious allergic reactions affecting the whole body may occur, sometimes associated with shock (dangerously low blood pressure)*. Appropriate medical treatment and supervision must always be available in case a rare severe allergic reaction to the vaccine occurs. If this happens, contact a doctor immediately.

The most frequently reported adverse effects with the use of Rabipur were: pain at the injection site, mainly injection-related pain, or hardening of the skin at the injection site. These reactions are very common (occur in more than 1 in 10 people). Most injection site reactions were not serious and resolved within 24–48 hours after injection.

Other adverse 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)

Swelling of glands
Loss of appetite
Nausea
Vomiting
Diarrhea
Stomach pain/discomfort
Hives
Muscle pain
Joint pain

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

Allergic reactions
Tingling or pins and needles sensation
Sweating
Chills

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

Inflammation of the brain, nervous system disturbances that may cause weakness, inability to move, or loss of sensation in certain parts of the body*
Fainting, unsteadiness with dizziness*
Severe allergic reaction causing swelling of the face or throat*

*Description of adverse reactions reported spontaneously

Additional adverse effects in children

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of adverse effects

If you or your child experience any kind of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabipur

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

Store in the refrigerator, protected from light (between 2 °C and 8 °C). Do not freeze.

Keep the vial and the syringe in the outer packaging to protect them from light.

Do not use this vaccine after the expiry date stated on the outer packaging. The expiry date refers to the last day of the month indicated. Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabipur

The active substance in the vaccine is rabies virus (inactivated, Flury LEP strain) 27.9 IU. This has been produced on purified chicken embryo cells (PCEC).

The other components are: trometamol, sodium chloride, disodium edetate, potassium L-glutamate, polygeline, sucrose, and water for injections.

Contains residues of chicken proteins (e.g., ovalbumin), human serum albumin, neomycin, chlortetracycline, and amphotericin B.

Appearance of the product and contents of the container

Rabipur is a white lyophilized powder which must be reconstituted with the clear, colourless solvent. The reconstituted vaccine is transparent to slightly opalescent and colourless to slightly pink.

Rabipur is supplied in packs containing:

• 1 vial of powder,

• 1 pre-filled disposable syringe of sterile solvent

  • either with a white closure cap with a tamper-evident seal
  • or with a transparent screw closure cap

• and 2 identical needles (25 gauge, 25 mm), one for reconstitution and one for injection.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bavarian Nordic A/S

Philip Heymans Alle 3

2900 Hellerup

Denmark

Manufacturer

Bavarian Nordic A/S

Hejreskovvej 10A

3490 Kvistgaard

Denmark

or

GSK Vaccines GmbH

Emil-von-Behring-Str. 76

35041 Marburg

Germany

This medicinal product is authorised in the European Economic Area member states under the following name:

Germany, Austria, Belgium, Croatia, Denmark, Spain, France, Hungary, Italy, Luxembourg, Norway, the Netherlands, Poland, Portugal, Sweden: Rabipur

Date of the most recent review of this leaflet: 03/2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

Other sources of information

This information is intended for healthcare professionals only:

There are two types of pre-filled syringes, which differ by the type of closure cap.

Both types of syringes are equipped with a rear stopper that facilitates handling and administration of the injection. In addition, the rear stopper reduces the opening diameter of the syringe barrel and simultaneously enlarges the finger flange with ergonomically designed wings. This prevents the plunger stopper from being inadvertently removed from the syringe.

Before preparing Rabipur for administration, identify the pre-filled syringe supplied in the pack (either with a white closure cap with tamper-evident seal, or with a transparent screw closure cap) and follow the instructions for the specific pre-filled syringe included in the pack.

Instructions for use of the disposable pre-filled syringe of Rabipur

Pre-filled syringe with white closure cap with tamper-evident seal:

Needle application (these instructions apply to both needles provided):

Prefilled syringe with transparent screw-cap closure:

Needle application (these instructions apply to both needles supplied)

Instructions for reconstitution of Rabipur using the pre-filled syringe:

The vaccine should be inspected visually before and after reconstitution for the presence of any foreign particles and/or changes in physical appearance. The vaccine must not be used if any changes in its appearance are detected. The reconstituted vaccine is between transparent and slightly opalescent and ranges from colorless to slightly pink.

The powder for solution must be reconstituted with the solvent for solution supplied, and the mixture should be gently agitated before injection. The reconstituted vaccine must be used immediately.

During manufacturing, the vial is vacuum-sealed. Therefore, to avoid difficulties when withdrawing the reconstituted vaccine from the vial, after reconstitution it is recommended to unscrew the syringe from the needle to release the negative pressure. After this, the vaccine can be easily withdrawn from the vial. Inducing excessive pressure is not recommended, as over-pressurization will cause difficulties in withdrawing the correct amount of vaccine.

The needle length is not sufficient to reach the bottom of the vial; therefore, it is necessary to invert the vial and gently pull back on the plunger to bring the needle close to the stopper. This will allow complete withdrawal of the vaccine solution from the vial.

After completing the reconstitution of the vaccine, remove the closure cap from the second needle (as explained in step 1 for needles) and replace the needle used for reconstitution with the second needle, which will be used for administration. Do not use the same needle for reconstitution and administration.