Bimervax LP.8.1 emulsion for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BIMERVAX LP.8.1 injectable emulsion

COVID-19 vaccine (recombinant, adjuvanted)

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any suspected adverse reactions you may experience. Section 4 at the end includes information on how to report these adverse reactions.

Read the entire leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What BIMERVAX LP.8.1 is and what it is used for
2. What you need to know before receiving BIMERVAX LP.8.1
3. How BIMERVAX LP.8.1 is administered
4. Possible adverse reactions
5. How to store BIMERVAX LP.8.1
6. Contents of the pack and other information

1. What BIMERVAX LP.8.1 is and what it is used for

BIMERVAX LP.8.1 is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus.

BIMERVAX LP.8.1 is given to individuals 12 years of age and older.

The vaccine stimulates the immune system (the body's natural defenses) to produce specific antibodies that act 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 receiving BIMERVAX LP.8.1

Do not administer BIMERVAX LP.8.1

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving BIMERVAX LP.8.1 if:

• you have ever had a severe or potentially life-threatening allergic reaction after receiving any other vaccine injection;
• you have ever fainted after an injection with a needle;
• you have a high fever (over 38 °C) or a serious infection. However, vaccination may still be given if you have a mild fever or a minor upper respiratory tract infection, such as a cold;
• you have bleeding disorders, bruise easily, or are taking a medication to prevent blood clots (anticoagulant);
• your immune system is not functioning properly (immunodeficiency), or you are taking medications that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer drugs).

If you are in any of the above situations (or are unsure), consult your doctor, pharmacist, or nurse before receiving BIMERVAX LP.8.1.

Like any vaccine, BIMERVAX LP.8.1 may not fully protect all individuals who receive it, and it is unknown how long protection will last.

Children

BIMERVAX LP.8.1 is not recommended for children under 12 years of age. Currently, there is no available information on the use of BIMERVAX LP.8.1 in children under 12 years of age.

Other medicines and BIMERVAX LP.8.1

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines or vaccines.

Pregnancy and breastfeeding

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

Driving and use of machines

Some of the adverse effects of BIMERVAX LP.8.1 listed in section 4 (Possible side effects) may temporarily reduce your ability to drive or operate machinery. Wait until the effects of the vaccine have subsided before driving or operating machinery.

BIMERVAX LP.8.1 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 allergies.

3. How BIMERVAX LP.8.1 is administered

Individuals 12 years of age and older

BIMERVAX LP.8.1 will be administered as a 0.5 ml injection into a muscle in the upper arm.

It is recommended that you receive BIMERVAX LP.8.1 as a single dose at least 6 months after a previous dose of a COVID-19 vaccine.

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

If you have any further questions about the use of BIMERVAX LP.8.1, ask your doctor, pharmacist, or nurse.

Immunocompromised individuals

If your immune system is not functioning properly, additional doses may be given in accordance with official recommendations.

4. Possible side effects

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

Most side effects occur within 3 days after receiving the vaccine and resolve a few days later. If symptoms persist, contact your doctor, pharmacist, or nurse.

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

• feeling faint or dizzy
• changes in heart rate
• 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 LP.8.1:

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 tenderness at the injection site
• feeling unwell (nausea) or being sick (vomiting)
• diarrhoea
• fever
• enlarged lymph nodes
• armpit pain

Uncommon (may affect up to 1 in 100 people)

• chills or feeling feverish
• dizziness
• itching at the injection site
• joint pain
• feeling weak or lacking energy
• feeling sleepy
• itching of the skin
• general feeling of discomfort

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

• cold sweats
• unusual skin sensations such as tingling or prickling (paraesthesia)
• reduced sensation, 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 available data, based on a single case during clinical trials)

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

Reporting of side effects

If you experience any kind of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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 LP.8.1

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

This vaccine must be stored, and any unused product properly disposed of, by your doctor, pharmacist, or nurse. The following information on storage, expiry, use, handling, and disposal is intended for healthcare professionals.

Do not use this vaccine after the expiry date stated on the label after EXP.

The expiry date refers to the last day of the month indicated.

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

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

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of BIMERVAX LP.8.1

• One dose (0.5 ml) contains 40 micrograms of recombinant spike (S) protein receptor-binding domain (RBD) homodimer* fusion from SARS-CoV-2 virus (Omicron LP.8.1 – LP.8.1 strain), adjuvanted with SQBA.

*Produced by recombinant DNA technology using a plasmid expression vector in a CHO cell line.

• 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 components (excipients) are: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, and water for injections. BIMERVAX LP.8.1 contains potassium, sodium and polysorbate (see section 2).

Nature and contents of the container

The vaccine is a white, homogeneous injectable emulsion.

0.5 ml of emulsion is supplied in a vial with a rubber stopper and an overcap made of removable plastic.

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

Pack sizes: 1, 10 or 20 single-dose vials.

Marketing Authorization 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 the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu

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

Or visit the URL: www.hipracovidvaccine.com

This information is intended for healthcare professionals only:

Administer BIMERVAX LP.8.1 by intramuscular injection, preferably into 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 should be clearly recorded.

Instructions for handling and administration

Do not use this vaccine after the expiry date 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 to use.
• Unopened vaccine must be stored between 2 °C and 8 °C and kept within the outer packaging to protect it from light.
• Immediately before use, remove the vaccine vial from the outer packaging.

Inspect the vial

• Gently rotate the vial before withdrawing the dose. Do not shake.
• Each vial contains a white, homogeneous emulsion.
• Visually inspect the vaccine for particles or discoloration before administration. Do not administer the vaccine if either is present.

Administer the vaccine

• Each vial includes an overfill to ensure that a 0.5 ml dose can be withdrawn. Discard any remaining vaccine in the vial.
• A dose of 0.5 ml is withdrawn using a sterile needle and syringe and administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.
• Do not mix the vaccine in the same syringe with any other vaccine or medicine.
• Do not pool excess vaccine from multiple vials.

Disposal

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