Prospecto: information for the user

Rabipur

Powder and solvent for injectable solution in pre-filled syringe

rabies virus (inactivated, strain Flury LEP)

Read this prospect carefully before you or your child receives Rabipur, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child, and must not be given to other people.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What isRabipurand what it is used for

2.What you need to know before you or your child receiveRabipur

3.How to useRabipur

4.Possible adverse effects

5.Storage ofRabipur

6. Contents of the pack and additional information

What is Rabipur

Rabipur is a vaccine that contains inactivated rabies virus. After administration of the vaccine, the immune system (the body's natural defense system) forms antibodies against the rabies virus. These antibodies protect against infections or diseases caused by the rabies virus. None of the vaccine components can produce rabies.

What is Rabipur used for

Rabipur can be used in people of all ages.

Rabipur can be used to prevent rabies:

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

or

• after a 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 traps for animals that have been licked or bitten by infected animals can cause infections in humans.

You or your child should not receive Rabipur before the possible risk of exposure to the rabies virus if:

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

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

Severe allergic reactions (hypersensitivity)

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

Warnings and precautions

In the case of an acute illness that requires treatment, vaccination is usually postponed for at least 2 weeks after recovery. A mild infection does not require postponing vaccination, but 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 eggs or egg products (for symptoms, see section 4 of this leaflet). Rabipur contains residual chicken protein from the manufacturing process.
• Has a severe allergy to the antibiotics neomycin, chloramphenicol, or amphotericin B. These antibiotics may be present in very small quantities in the vaccine.
• Has a severe allergy to polygeline.

Before or after any injection, dizziness may occur, so inform your doctor or nurse if you or your child has fainted after previous injections.

There have been reports of rare but serious neurological disorders following administration of the Rabipur vaccine. See section 4. Medications used to treat these disorders, such as anti-inflammatory steroids, may interfere with the effectiveness of the vaccine (see below, Use of Rabipur with other medications). Your doctor or nurse will decide how to proceed in these circumstances.

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

Rabipur should not be administered in the buttocks, under the skin, or in a vein.

Other medications and Rabipur

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

If you or your child has a weakened immune system or is taking medications that reduce the body's ability to fight infections, it is still possible to administer Rabipur; however, you or your child may not be as well protected as others. In this case, your doctor or your child's doctor may request blood tests after vaccination to check if the body has produced sufficient 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 is likely to have been infected with the virus. In that case, you will be given the injection of rabies immunoglobulin (which is given only once and usually with the first dose of the vaccine) and the vaccine in different parts of the body.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

Rabipur contains sodium

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

A healthcare professional who has received training to administer vaccines will give you or your child Rabipur. They must be available to provide treatment that may be necessary to treat severe allergic reactions that can occur after the vaccine is administered (seesection 4of this prospectus). The vaccine must be administered to you or your child in a clinic or consultation that has the necessary equipment to treat these reactions.

The instructions for reconstituting the vaccine intended for healthcare professionals and medical staff are at the end of this prospectus.

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

Your doctor will decide how many doses you or your child should receive, depending on whether you or your child has received Rabipur before or after any possible contact with the virus.

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

BEFORE ANY POSSIBLE CONTACT WITH THE VIRUS

If you or your child has not been vaccinated against rabies:

If you or your child does not attend a scheduled appointment for a dose, you should schedule an appointment as soon as possible after the initially scheduled date.

The need for booster doses depends on the risk of contact with the rabies virus. Your doctor will consult official vaccination guidelines and inform you if a booster dose is necessary.

If you are at high risk of continuous infectionyour doctor may also ask you to have blood tests periodically to determine the amount of rabies antibodies present in your blood, so that booster doses can be administered as soon as possible. Experience indicates that, generally, booster doses are needed every 2-5 years.

AFTER A SUSPECTED OR CONFIRMED CONTACT WITH THE VIRUS

Vaccinated individuals

If you or your child has been fully vaccinated against rabies and/or has received booster doses and has been in contact with an animal that has or is suspected to have rabies, you or your child will usually need 2 additional doses of the vaccine (each 1.0 ml). The first dose will be administered as soon as possible after the contact and the second 3 days later.

Unvaccinated individuals

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

• If a 4-dose immunization schedule is used, the first 2 doses of the vaccine will be administered on day 0as soon as possible after the contactand, subsequently, single doses will be administered on days 7 and 21 after the first dose.
• An alternative 4-dose schedule may also be adopted for healthy individuals who are known to have a good immune response; the first dose will be administered as soon as possible after the contact, on day 0, and the others will be administered on days 3, 7, and 14 after the first dose.
• If a 5-dose immunization schedule is used, the first dose of the vaccine will be administered on day 0,as soon as possible after the contact,and the others will be administered on days 3, 7, 14, and 28 after the first dose.

After any possible contactwith the rabies virus, your doctor will consider the risk of infection based on the type of contact you or your child has had. For example, if you have been bitten or scratched by an animal that may have the virus or have been in contact with bats, you will have a much higher risk of infection with the rabies virus than someone with intact skin who has been licked.

Individuals with immunodeficiency (deficient immunity to infections)

If you or your child has a higher riskof infection with the rabies virus because your immune system does not function correctly, you or your child will needfive or six doses (each 1.0 ml) of rabies vaccine after contact with an animal that has or is suspected to have rabies. The vaccination will be administered in combination with local treatment of the wound and rabies immunoglobulin.

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

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

You may also need to have blood tests to measure the amount of rabies antibodies present in your blood, so that additional doses of the vaccine can be administered if necessary. Your doctor will explain the steps to follow and inform you when to attend for blood tests or additional doses.

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

After vaccination with Rabipur, severe allergic reactions that affect the whole body may occur, sometimes associated with shock (dangerously low blood pressure)*. It is always necessary to have appropriate medical treatment and supervision in case a rare severe allergic reaction to the vaccine occurs. If it happens, you should talk to a doctor immediately.

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

Other side effects included:

Very frequent(thesemay affect more than 1 in 10 people)

Headache

Dizziness

Rash

General feeling of being unwell

Fatigue

Weakness

Fever

Frequent(thesemay affect up to 1 in 10 people)

Swollen lymph nodes

Loss of appetite

Nausea

Vomiting

Diarrhea

Abdominal pain/discomfort

Flatulence

Muscle pain

Joint pain

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

Allergic reactions

Tickling or tingling sensation

Sweating

Chills

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

Brain inflammation, nervous system disturbances that may cause weakness, inability to move, or loss of sensation in certain parts of the body*

Loss of consciousness, instability with dizziness*

Severe allergic reaction that causes swelling of the face or throat*

*Spontaneously reported adverse reactions

Additional side effects in children

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

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

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

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

Do not use this vaccine after the expiration date shown on the original packaging. The expiration date is the last day of the month indicated. Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medicines. This will help protect the environment.

Composition of Rabipur

The active principleof the vaccine is the rabies virus (inactivated, strain Flury LEP)?2.5 UI. This has been produced in purified chicken embryo cell cultures (PCEC).

The other componentsare: trometamol, sodium chloride, disodium edetate, potassium L-glutamate, polygelin, saccharoseand water for injection.

It contains residues of chicken proteins (e.g., ovalbumin), human serum albumin, neomycin, chlorotetracycline and amphotericin B.

Appearance of the product and contents of the pack

Rabipur is a white lyophilized powder that must be reconstituted with the transparent and colourless solvent.The reconstituted vaccine is between transparent and slightly opalescent and between colourless and slightly pink.

Rabipur is supplied in packs containing 1vial of powder, 1 disposable sterile solvent syringe preloaded with 2 identical needles (calibre 25, 25 mm), one for reconstitution and the other for injection.

Holder of the marketing authorisation and manufacturer responsible

Holder of the marketing authorisation

Bavarian Nordic A/S

Philip Heymans Alle 3

2900 Hellerup

Denmark

Manufacturer responsible

GSK Vaccines GmbH

Emil-von-Behring-Str. 76

35041 Marburg

Germany

or

Bavarian Nordic A/S

Hejreskovvej 10A

3490 Kvistgaard

Denmark

This medicinal product is authorised in the member states of the European Economic Area with the following names:

GermanyRabipur

AustriaRabipur

BelgiumRabipur

CroatiaRabipur

DenmarkRabipur

SpainRabipur

FranceRabipur

HungaryRabipur

ItalyRabipur

LuxembourgRabipur

NorwayRabipur

NetherlandsRabipur

PolandRabipur

PortugalRabipur

SwedenRabipur

Date of the last revision of this leaflet: 11/2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

Other sources of information

This information is intended solely for healthcare professionals:

Instructions for use of the disposable preloaded syringe of Rabipur

Disposable preloaded syringe

Application of the needle (these instructions are valid for the two needles supplied):

Instructions for the reconstitution of Rabipur using the disposable preloaded syringe:

The vaccine must be visually inspected before and after reconstitution to detect any foreign particles and/or changes in its physical appearance. The vaccine should not be used if any change in its appearance has been detected.The reconstituted vaccine is between transparent and slightly opalescent and between colourless and slightly pink.

The powder for solution must be reconstituted with the solvent for solution supplied, shaking the mixture carefully before injection. The reconstituted vaccine must be used immediately.

During manufacture, the vial is sealed under vacuum. In order to avoid problems when extracting the reconstituted vaccine from the vial, after reconstitution of the vaccine, it is recommended to unscrew the syringe from the needle to eliminate the negative pressure. After this, the vaccine can be extracted easily from the vial. Do not induce excessive pressure, as excessive pressure will create problems in extracting the correct amount of vaccine.

The length of the needle is not sufficient to reach the bottom of the vial, so it is necessary to invert the vial and pull the needle back until it is close to the stopper. This will allow the total amount of vaccine solution to be extracted from the vial.

After completing the reconstitution of the vaccine, remove the closure cap from the second needle (as explained in step 1 for the 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.