Bimervax LP.8.1

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. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you may experience while receiving this medicinal product. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 side effects
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, a disease caused by the SARS-CoV-2 virus.
BIMERVAX LP.8.1 is administered to individuals aged 16 years and older.
The vaccine stimulates the immune system (the body's natural defenses) to produce specific antibodies against the virus, thereby providing protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

2. What you should know before receiving BIMERVAX LP.8.1

BIMERVAX LP.8.1 must not be administered

• 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
Talk to your doctor, pharmacist, or nurse before receiving BIMERVAX LP.8.1 if:

• you have previously had a severe or potentially life-threatening allergic reaction after receiving any other vaccine injection;
• you have fainted after a previous needle injection;
• 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 problems, bruise easily, or are taking a medicine to prevent blood clots (anticoagulants);
• your immune system is not working properly (immunodeficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines).

If you fall into any of the above conditions (or if you have any doubts), 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 not known how long protection lasts.
Children and adolescents
BIMERVAX LP.8.1 is not recommended for children and adolescents under 16 years of age.
Currently, there is no available information on the use of BIMERVAX LP.8.1 in children and adolescents under 16 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 take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor, pharmacist, or nurse before receiving this vaccine.
Driving and using machines
Some of the side effects of BIMERVAX LP.8.1 listed in section 4 (Possible side effects) may temporarily reduce your ability to drive vehicles or operate machinery.
Wait until these side effects have passed before driving or using machinery.
BIMERVAX LP.8.1 contains sodium, potassium, and polysorbate
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.
This vaccine contains less than 1 mmol (39 milligrams) of potassium per 0.5 mL dose, i.e., 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 known allergies.

3. How BIMERVAX LP.8.1 is administered

Subjects aged 16 years and older
BIMERVAX LP.8.1 will be administered to you as a 0.5 mL injection into a muscle in the upper arm.
It is recommended to receive BIMERVAX LP.8.1 as a single dose at least 6 months after a previous dose of a COVID-19 vaccine.
After the vaccine injection, the doctor, pharmacist, or nurse will observe you for approximately 15 minutes to monitor for any signs of an allergic reaction.
If you have any doubts about the use of BIMERVAX LP.8.1, consult your doctor, pharmacist, or nurse.

Immunocompromised subjects
If the immune system is not functioning properly, additional doses may be administered in accordance with official recommendations.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone gets them.
Most side effects occur within 3 days of vaccination and resolve within a few days of onset. If symptoms persist, consult your doctor, pharmacist, or nurse.
Seek urgent medical attention if you experience symptoms of a severe allergic reaction shortly after vaccination. Symptoms may include:

• feeling faint or dizzy
• changes in heart rate
• shortness of breath
• wheezing
• swelling of the lips, face, or throat
• swelling with itching under the skin (hives) or skin rash
• nausea or vomiting
• stomach ache

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 extremely tired
• muscle pain

Common (may affect up to 1 in 10 people):

• redness, swelling, or tenderness at the injection site
• nausea or vomiting
• diarrhoea
• fever
• swollen 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
• drowsiness
• itchy skin
• general feeling of being unwell

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

• cold sweats
• unusual skin sensations such as tingling or a crawling sensation (paraesthesia)
• reduced sensitivity, especially of the skin (hypoesthesia)
• abdominal pain
• pain on swallowing
• allergic reactions such as hives, rash, or itching
• bruising at the injection site
• increased sensitivity at the injection site

Not known (frequency 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 may cause difficulty breathing, palpitations, or chest pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system mentioned in Annex V, including the batch number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store BIMERVAX LP.8.1

Keep this medicinal product out of the sight and reach of children.
The doctor, pharmacist or nurse is responsible for the storage of this vaccine and the proper disposal of unused medicine. 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 that month.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the vials in the outer packaging to protect the medicinal product from light.
Information on handling is described in the section for healthcare professionals at the end of the package leaflet.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

6. Package contents and other information

What BIMERVAX LP.8.1 contains

• 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 using recombinant DNA technology with 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. Each 0.5 mL dose contains: 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.

• 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).

Description of the appearance of BIMERVAX LP.8.1 and package contents
The vaccine is a homogeneous, white, injectable emulsion.
0.5 mL of emulsion is supplied in a vial with a rubber stopper and a removable plastic cap.
Each single-dose vial contains one 0.5 mL dose.
Packaging: 1, 10 or 20 single-dose vials.

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu
Scan the code with a mobile device to access the package leaflet in multiple languages.
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Alternatively, visit the website: www.hipracovidvaccine.com
The package leaflet is available in all European Union/European Economic Area languages on the European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

Administer BIMERVAXLP.8.1 by intramuscular injection only, preferably into the deltoid muscle of the arm.
Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly documented.
Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label following 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 sterility of each dose.
Preparation for use

• The vaccine is ready for use.
• Unopened vaccine must be stored at a temperature 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 refrigerator and its outer packaging.

Vial inspection

• Gently rotate the vial before withdrawing the dose. Do not shake.
• Each vial contains a white, homogeneous emulsion.
• Prior to administration, visually inspect the vaccine for presence of visible particulate matter and/or discoloration. Do not administer the vaccine if either of these conditions is observed.

Vaccine administration

• Each vial contains excess product to ensure that a 0.5 ml dose can be withdrawn. Discard any remaining vaccine in the vial after withdrawal.
• Each 0.5 ml dose should be drawn into 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 other vaccines or medicinal products.
• Do not pool residual vaccine from multiple vials.

Disposal

• Unused medicinal product and waste material arising from its use must be disposed of in accordance with local regulations.