Bimervax emulsion inyectable

Prospect: information for the user

BIMERVAX

Vaccine against COVID-19 (recombinant, with adjuvant)

selvacovateína

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may have. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before receiving this vaccine, 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.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects that do not appear in this prospect. See section 4.

BIMERVAX is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus.

BIMERVAX is administered to individuals 16 years of age and older who have previously received an mRNA vaccine against COVID-19.

The vaccine stimulates the immune system (the body's natural defenses) to produce specific antibodies that work against the virus and provide protection against COVID-19. None of the components of this vaccine can cause COVID-19.

Do not administer BIMERVAX

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to receive BIMERVAX if:

• you have ever had a severe or potentially fatal allergic reaction after receiving any other vaccine injection;
• you have ever fainted after any injection with a needle;
• you have a high temperature (above 38 °C) or a severe infection. However, you can be vaccinated if you have a mild fever or an upper respiratory tract infection, such as a cold;
• you have bleeding problems, have easy bruising or are taking a blood thinner (anticoagulant) medication;
• your immune system does not work correctly (immunodeficiency) or you are taking medications that weaken your immune system (such as high-dose corticosteroids, immunosuppressants or cancer medications).

If you find yourself in any of the above circumstances (or are unsure), consult with your doctor, pharmacist or nurse before receiving BIMERVAX.

Like any vaccine, BIMERVAX may not protect everyone who receives it completely, and it is unknown for how long you will be protected.

Children and adolescents

BIMERVAX is not recommended for children under 16 years of age. Currently, there is no available information on the use of BIMERVAX in children under 16 years of age.

Other medications and BIMERVAX

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medication or vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor, pharmacist or nurse before receiving this vaccine.

Driving and operating machinery

Some of the adverse effects of BIMERVAX listed in section 4 (Possible adverse effects) may temporarily reduce your ability to drive and operate machinery. Wait until the effects of the vaccine have disappeared before driving or operating machinery.

BIMERVAX contains sodium and potassium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

This vaccine contains less than 1 mmol of potassium (39 mg) per dose; this is essentially "potassium-free".

BIMERVAX will be administered as a 0.5 ml injection into a muscle in the upper arm.

It is recommended to receive BIMERVAX as a single dose at least 6 months after a previous vaccination course with an mRNA vaccine against COVID-19.

After the injection, the doctor, pharmacist, or nurse will observe you for about 15 minutes to detect signs of allergic reaction.

If you have any other questions about the use of BIMERVAX, ask your doctor, pharmacist, or nurse.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The majority of side effects appear within 3 days after receiving the vaccine and disappear a few days later. If symptoms persist, contact your doctor, pharmacist, or nurse.

Seek urgent medical attention if you experience severe allergic reaction symptoms shortly after vaccination. These symptoms may include:

• dizziness or fainting sensation
• changes in heart rhythm
• difficulty breathing
• whistling
• swelling of the lips, face, or throat
• pruritic swelling under the skin (hives) or rash
• nausea or vomiting
• abdominal pain

The following side effects may occur with BIMERVAX:

Very common(may affect more than 1 in 10 people)

• headache
• pain at the injection site
• feeling extremely tired (fatigue)
• muscle pain

Common(may affect up to 1 in 10 people)

• redness, swelling, or sensitivity at the injection site
• feeling unwell (nausea) or vomiting
• diarrhea
• fever
• enlarged lymph nodes
• axillary pain

Rare(may affect up to 1 in 100 people):

• chills or feeling of fever
• insomnia
• dizziness
• itching at the injection site
• hypersensitivity at the injection site
• joint pain
• feeling weak or lacking energy
• drowsiness
• abdominal pain
• itching on the skin
• difficulty swallowing
• general feeling of discomfort

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

• cold sweating
• unusual sensation on the skin, such as tingling or numbness (paresthesia)
• decreased sensitivity, especially in the skin (hypoesthesia)
• allergic reactions such as hives, skin rash, or itching
• back pain
• hematoma at the injection site

Unknown frequency(cannot be estimated from available data, based on a single case during clinical trials:

• Inflammation of the outer covering of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix Vand include the batch number if available. By reporting adverse effects, you can contribute to providing more information about the safety of this vaccine.

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

Your doctor, pharmacist, or nurse is responsible for conserving this vaccine and properly disposing of any unused product. The following information on conservation, expiration, use, and handling, as well as disposal, is intended for healthcare professionals.

Do not use this vaccine after the expiration date that appears on the label after CAD.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze. Store vials in the outer packaging to protect them from light.

After the first puncture, store between 2 °C and 8 °C and use within 6 hours.

Information on handling is described in the section intended for healthcare professionals at the end of the prospectus.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of BIMERVAX

• One dose (0.5 ml) contains 40 micrograms of selvacovatein with SQBA as an adjuvant.

• Selvacovatein is a fusion heterodimer with a receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) recombinant protein produced by recombinant DNA technology.

• SQBA is included in this vaccine as an adjuvant to accelerate and improve the protective effects of the vaccine. SQBA contains per dose of 0.5 ml: squalene (9.75 mg), polysorbate 80 (1.18 mg), trioleate of sorbitan (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injection.

• The other components (excipients) are: dodecahydrate disodium phosphate, dihydrogen potassium phosphate, sodium chloride, potassium chloride and water for injection. BIMERVAX contains potassium and sodium (see section 2).

Appearance of the product and contents of the pack

The vaccine is a white and homogeneous injectable emulsion.

5 ml of emulsion are supplied in a vial with a rubber stopper and a plastic removable closure.

Each vial contains 10 doses of 0.5 ml.

Size of the pack: 10 multidose vials.

Marketing authorisation holder

Hipra Human Health, S.L.U.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

Responsible for manufacturing

Laboratorios Hipra, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

Last revision date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

Scan the code with a mobile device to obtain the leaflet in different languages.

Código QR to include

Or visit the URL:www.hipracovidvaccine.com

The leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended solely for healthcare professionals:

Administer BIMERVAX by intramuscular injection, preferably in the deltoid muscle of the upper arm.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Instructions for handling and administration

Do not use this vaccine after the expiry date appearing on the label after CAD. The expiry date refers to the last day of that month.

This vaccine must be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose.

Preparation for use:

• The vaccine is ready for use.
• The unopened vaccine must be stored between 2°C and 8°C and protected from light within the outer packaging.
• Immediately before use, remove the vaccine vial from the outer packaging.
• After the first puncture of the vial, record the date and time when it was discarded (6 hours after the first puncture) in the designated area on the vial label.

Inspect the vial:

• Gently rotate the multidose vial before and between each dose withdrawal. Do not agitate.
• Each multidose vial contains a white and homogeneous emulsion.
• Visually inspect the vaccine content to check for particles or discoloration before administration. Do not administer the vaccine in the presence of either.

Administer the vaccine:

• A built-in overfill is provided per multidose vial to ensure that a maximum of ten (10) doses of 0.5 ml each can be withdrawn.
• Discard the remaining vaccine in the vial after 10 doses have been withdrawn.
• Each dose of 0.5 ml is withdrawn with a sterile needle and a sterile syringe to administer by intramuscular injection, preferably in the deltoid muscle of the upper arm.
• Once the vaccine is loaded into the syringe, it is stable for at least 6 hours, either under refrigeration or at room temperature (<25°C).
• Do not mix the vaccine in the same syringe with any other vaccine or medication.
• Do not mix the excess vaccine from multiple vials.

Dispose of:

• Discard this vaccine if it is not used within 6 hours after the first puncture of the vial.

Disposal:

• The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.