InfoCons Consumer Protection informs you – Nuvaxovid – Package Leaflet

Before anything else

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.

ℹ️ 1. What Nuvaxovid XFG is and what it is used for

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

Nuvaxovid XFG is given to individuals 12 years of age and older.

The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, to give protection against COVID-19. None of the ingredients in this vaccine can cause COVID -19.

⚠️ 2. What you need to know before you receive Nuvaxovid XFG

Nuvaxovid XFG should not be given

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid XFG if:

• you have ever had a severe or life-threatening allergic reaction after receiving any other vaccine injection or after you were given Nuvaxovid or Nuvaxovid XFG in the past,
• you have ever fainted following any needle injection,
• you have a high fever (over 38°C) or severe infection. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold,
• you have bleeding problems, you bruise easily or you use a medicine to prevent blood clots,
• 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 cancer medicines).

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Nuvaxovid, see section 4.

These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days.

Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid XFG .

As with any vaccine, a single dose of Nuvaxovid XFG may not fully protect all those who receive it and it is not known how long you will be protected.

Children

Nuvaxovid XFG is not recommended for children aged below 12 years. Currently, there is no information available on the use of Nuvaxovid XFG in children younger than 12 years of age.

Other medicines and Nuvaxovid XFG

Tell 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before you receive this vaccine.

Driving and using machines

Some of the side effects of Nuvaxovid XFG listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines (for example, feeling faint or lightheaded or feeling very tired).

Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

Nuvaxovid XFG contains sodium, potassium and polysorbate 80

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium – free’.

This vaccine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say, essentially ‘potassium -free’.

This vaccine contains 0.05 mg of polysorbate 80 in each dosage unit. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How Nuvaxovid XFG is given

Individuals 12 years of age and older Nuvaxovid XFG will be given to you as a single dose 0.5 mL injection.

If you were previously vaccinated with a COVID -19 vaccine, Nuvaxovid XFG should be administered at least 3 months after the most recent dose of a COVID -19 vaccine.

Your doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in your upper arm.

During and after each injection of the vaccine, your doctor, pharmacist, or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.

Additional doses (0.5 mL) of Nuvaxovid XFG may be administered at the discretion of your physician, taking into consideration your clinical conditions in line with national recommendations .

Immunocompromised individuals If your immune system does not work properly additional doses may be administered in line with national recommendations.

❗ 4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away within a few days of appearing. If symptoms persist, contact your doctor, pharmacist or nurse.

As with other vaccines, you may feel pain or discomfort at the injection site, or you may see some redness and swelling at this site. However, these reactions usually clear up within a few days.

Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:

• feeling faint or light- headed
• changes in your heartbeat
• shortness of breath
• wheezing
• swelling of your lips, face, or throat
• hives or rash
• nausea or vomiting
• stomach pain Talk to your doctor or nurse if you develop any other side effects. These can include:

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

• headache
• feeling sick (nausea) or getting sick (vomiting)
• muscle ache
• joint pain
• tenderness or pain where the injection is given
• feeling very tired (fatigue)
• generally feeling unwell

Common (may affect up to 1 in 10 people)

• redness where the injection is given
• swelling where the injection is given
• fever (>38°C)
• pain or discomfort in the arm, hand, leg and/or foot (pain in the extremity)

Uncommon (may affect up to 1 in 100 people)

• enlarged lymph nodes
• high blood pressure
• itchy skin, rash or hives
• redness of the skin
• itchy skin where the injection is given
• chills

Rare (may affect up to 1 in 1000 people)

• warmth where the injection is given

Not known (cannot be

estimated from available data):

• severe allergic reaction
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V and include batch/Lot number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.

🌡️ 5. How to store Nuvaxovid XFG

Keep this medicine 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.

Information about storage, expiry, use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.

📦 6. Contents of the pack and other information

What Nuvaxovid XFG contains

• One dose (0.5 mL) Nuvaxovid XFG contains 5 micrograms of SARS -CoV -2 (Omicron XFG ) spike protein* and is adjuvanted with Matrix- M.

*produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.

• Matrix -M is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, and/or prolong the protective effects of the vaccine. Matrix -M adjuvant contains Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract per 0.5 mL dose.
• The other ingredients (excipients) included in Nuvaxovid XFG are:
• Disodium hydrogen phosphate heptahydrate
• Sodium dihydrogen phosphate monohydrate
• Disodium hydrogen phosphate dihydrate
• Sodium chloride
• Polysorbate 80
• Cholesterol
• Phosphatidylcholine (including all -rac-α-Tocopherol)
• Potassium dihydrogen phosphate
• Potassium chloride
• Sodium hydroxide (for the adjustment of pH)
• Hydrochloric acid (for the adjustment of pH)
• Water for injections

What Nuvaxovid XFG looks like and contents of the pack

• The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2).
• 0.5 mL of dispersion for injection in a pre-filled syringe with a plunger stopper and a tip cap, without a needle or co -packed with a separate needle.
• Pack size: o 10 pre- filled syringes. o 1 pre- filled syringe o 1 pre- filled syringe with a separate needle
• Each syringe contains 1 dose of 0.5 mL.

Marketing Authorisation Holder

Sanofi Winthrop Industrie 82 Avenue Raspail 94250 Gentilly France

Manufacturer

Novavax CZ a.s.

Líbalova 2348/1, Chodov 149 00 Praha 4 Czechia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique /Belgien Sanofi Belgium tel: +32 2 710.54.00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 9140 България Swixx Biopharma EOOD Teл.: +359 2 4942 480 Luxembourg/Luxemburg Sanofi Belgium tel.: +32 2 710.54.00 Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Magyarország SANOFI -AVENTIS Zrt Tel: +36 1 505 0055 Danmark Sanofi A/S Tel: +45 4516 7000 Malta Sanofi S.r.l. Tel: +39 02 39394 275 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 54 54 010 Tel. aus dem Ausland: +49 69 305 21 130 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge Sanofi -aventis Norge AS Tel: + 47 67 10 71 00 Ελλάδα ΒΙΑΝΕΞ Α.Ε.

Τηλ: +30.210.8009111 Österreich Sanofi -Aventis GmbH Tel: +43 (1) 80185- 0.

España sanofi -aventis, S.A.

Tel: +34 93 485 94 00 Polska Sanofi Sp. z o.o.

Tel: + 48 22 280 00 00 France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda.

Tel: + 351 21 35 89 400 Hrvatska Swixx Biopharma d.o.o Tel: +385 1 2078 500 Ireland sanofi -aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 600 România Sanofi Romania SRL Tel: +40 21 317 31 36 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 2355 100 Ísland Vistor Tel: +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 20833 600 Italia Sanofi S.r.l.

Tel: 800536389 Suomi/Finland Sanofi Oy Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ.: +357 22 741741 Sverige Sanofi AB Tel: +46 8- 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 6164 750 This leaflet was last revised in.

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

Or visit the URL: https://nuvaxovid.info.sanofi Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu This leaflet is available in all EU/EEA languages on the European Medicines Agency website. ————————————————————————————————————————

🩺 Information intended for healthcare professionals only

Administer Nuvaxovid XFG intramuscularly, preferably into the deltoid muscle of the upper arm, as a single dose.

For individuals who have previously been vaccinated with a COVID- 19 vaccine, Nuvaxovid XFG should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations.

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

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

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

Preparation for use

• The vaccine comes ready to use.
• The pre-filled syringe should be stored in a refrigerator (2°C – 8°C) and kept within the outer carton to protect from light.
• Immediately prior to use, remove the pre -filled syringe from the carton in the refrigerator.
• Each pre-filled syringe is for single use only.

Inspect the pre -filled syringe

• Do not shake the pre -filled syringe.
• Each pre- filled syringe contains a colourless to slightly yellow, clear to mildly opalescent dispersion.
• Visually inspect the contents of the pre- filled syringe for visible particulate matter and/or discolouration prior to administration. Do not administer the vaccine if either are present.
• Do not use the pre- filled syringe if the tip cap has been removed or is missing.
• Do not use the pre- filled syringe if it leaks or there are some visible cracks on it.

Administer the pre-filled syringe

• Pre-filled syringe without a needle o Needles are not included in the pre- filled syringe cartons. o Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles)
• Pre-filled syringe with a separate needle o Use a needle included in the pack.
• With tip cap of the pre -filled syringe upright, remove tip cap twisting counter -clockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
• Uncap the needle when ready for administration.
• Administer the entire dose intramuscularly, preferably in the deltoid muscle of the upper arm.

Discard

• Discard the pre- filled syringe after administration.

Disposal

• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Nuvaxovid (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1618).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.