BIMERVAX EMULSION FOR INJECTION

Introduction

Package Leaflet: Information for the User

BIMERVAX Injectable Emulsion

COVID-19 Vaccine (Recombinant, Adjuvanted)

selvacovateine

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is BIMERVAX and what is it used for
2. What you need to know before you receive BIMERVAX
3. How BIMERVAX is administered
4. Possible side effects
5. Storage of BIMERVAX
6. Contents of the pack and other information

1. What is BIMERVAX and what is it used for

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

BIMERVAX is administered to people aged 16 years 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.

2. What you need to know before you receive BIMERVAX

BIMERVAX must not be administered

• if you are allergic to the active substance or to any of the other ingredients of this medicinal product (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 life-threatening allergic reaction after receiving any other injection of the vaccine;
• you have ever fainted after any injection with a needle;
• you have a high fever (over 38 °C) or a severe infection. However, you can be vaccinated if you have a mild fever or upper respiratory tract infection, such as a cold;
• you have bleeding problems, bruise easily, or use a medicine to prevent blood clots (anticoagulant);
• your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines).

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

As with any vaccine, BIMERVAX may not completely protect all who receive it, and it is unknown how long protection will last.

Children and adolescents

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

Other medicines and BIMERVAX

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine or vaccine.

Pregnancy and breastfeeding

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

Driving and using machines

Some of the side effects of BIMERVAX listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines. Wait until the effects of the vaccine have disappeared before driving or using machines.

BIMERVAX contains sodium, potassium, and polysorbate

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".

This vaccine contains 1.18 mg of polysorbate 80 in each dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How BIMERVAX is administered

People aged 16 years and older

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

It is recommended to receive BIMERVAX in a single dose at least 6 months after a previous vaccination schedule with an mRNA vaccine against COVID-19 or after a previous booster dose of BIMERVAX.

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

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

Immunocompromised individuals

If your immune system does not work properly, additional doses may be administered according to official recommendations.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Most 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 immediate medical attention if you experience symptoms of a severe allergic reaction shortly after vaccination. These symptoms may include:

• feeling of fainting or dizziness
• changes in heart rhythm
• difficulty breathing
• wheezing
• swelling of the lips, face, or throat
• itchy swelling under the skin (hives) or rash
• nausea or vomiting
• stomach 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 very tired (fatigue)
• muscle pain

Common(may affect up to 1 in 10 people)

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

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

• chills or feeling of fever
• dizziness
• itching at the injection site
• joint pain
• feeling weak or lacking energy
• feeling sleepy
• itching of the skin
• feeling unwell

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

• cold sweating
• unusual feeling in the skin, such as tingling or numbness (paresthesia)
• decreased sensitivity, especially in the skin (hypoesthesia)
• abdominal pain
• pain when swallowing
• allergic reactions such as hives, skin rash, or itching
• bruising at the injection site
• hypersensitivity at the injection site

Frequency not known(cannot be estimated from the available data, based on a single case during clinical trials

• inflammation of the outer lining of the heart (pericarditis), which can lead to shortness of breath, palpitations, or chest pain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V and include the batch number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. Storage of BIMERVAX

Keep this medicinal product out of the sight and reach of children.

Your doctor, pharmacist, or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The following information on storage, expiry date, use, and handling, as well as disposal, is intended for healthcare professionals.

Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

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

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

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

Disposal of the unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.

6. Contents of the pack and other information

Composition of BIMERVAX

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

• Selvacovateine is a fusion heterodimer with a receptor-binding domain (RBD) of the spike (S) protein of the SARS-CoV-2 virus (strains B.1.351 and B.1.1.7) produced by recombinant DNA technology.

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

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

Appearance and packaging

The vaccine is a homogeneous white injectable emulsion.

Multidose vial

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

Each multidose vial contains 10 doses of 0.5 ml.

Pack size: 10 multidose vials.

Single-dose vial

0.5 ml of emulsion are supplied in a vial with a rubber stopper and a removable plastic cap.

Each single-dose vial contains 1 dose of 0.5 ml.

Pack sizes: 5, 10, or 20 single-dose vials.

Not all pack sizes may be marketed.

Marketing authorisation holder

Hipra Human Health, S.L.U.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

Manufacturer

Laboratorios Hipra, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

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

QR code to be included

Or visit the URL: www.hipracovidvaccine.com

The leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

-------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

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

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Instructions for handling and administration

Do not use this vaccine after the expiry date which is stated on the label after EXP. 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 should be stored between 2 °C and 8 °C and kept in the outer packaging to protect it from light.
• Immediately before use, remove the vaccine vial from the outer packaging.
• After the first puncture of the multidose vial, record the date and time of discard (6 hours after the first puncture) in the designated area on the vial label.

Inspect the vial

• Gently turn the vial before each dose withdrawal, as well as between each dose withdrawal in the case of the multidose vial. Do not shake.
• Each vial contains a homogeneous white emulsion.
• Visually inspect the vaccine for particles or discoloration before administration. Do not administer the vaccine in the presence of either.

Administer the vaccine

• An overfill is included in each vial to ensure that a maximum of ten (10) doses (multidose vial) or one (1) dose (single-dose vial) of 0.5 ml each can be withdrawn.
• Discard the remaining vaccine in the single-dose vial or in the multidose vial after 10 doses have been withdrawn.
• Each 0.5 ml dose is withdrawn with a sterile needle and a sterile syringe for administration 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).< li>
• Do not mix the vaccine in the same syringe with any other vaccine or medicinal product.
• Do not mix excess vaccine from several vials.

Discard

• After the first puncture of the multidose vial, store the opened multidose vial between 2 °C and 8 °C for a maximum of 6 hours. Discard the vaccine if it is not used within 6 hours after the first puncture of the multidose vial.
• Discard the remaining vaccine in the single-dose vial or in the multidose vial after 10 doses have been withdrawn.

Disposal

• Disposal of the unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.