Nuvaxovid xbb.1.5 dispersion inyectable

Prospect: information for the user

Nuvaxovid XBB.1.5 injectable dispersion

COVID-19 vaccine (recombinant, with adjuvant)

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

Read this prospectus carefully before receiving this vaccine, as it contains important information for you.

• Keep this prospectus, 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 not listed in this prospectus. See section 4.

Nuvaxovid XBB.1.5 is a vaccine to prevent COVID-19 caused by the SARS-CoV-2 virus.

Nuvaxovid XBB.1.5 is administered to individuals 12 years of age and older.

The vaccine causes the immune system (the body's natural defenses) to produce antibodies and specialized white blood cells that act against the virus to provide protection against COVID-19. None of the components of this vaccine can cause COVID-19.

Nuvaxovid XBB.1.5 should not be administered

• 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 receiving Nuvaxovid XBB.1.5 if:

• you have ever had a severe or potentially life-threatening allergic reaction after receiving any vaccine injection or after receiving Nuvaxovid or Nuvaxovid XBB.1.5 in the past,
• you have ever fainted after a needle injection,
• you have high fever (over 38°C) or a severe infection. However, you may receive the vaccine if you have a mild fever or an upper respiratory tract infection, such as a cold,
• you have bleeding problems, develop bruises easily, or are taking a blood thinner,
• your immune system does not function correctly (immunodeficiency) or you are taking medications that weaken your immune system (such as high doses of corticosteroids, immunosuppressants, or cancer medications).

There is a higher risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) after vaccination with Nuvaxovid (see section 4). These conditions may appear a few days after vaccination and have occurred mainly within 14 days.

After vaccination, be alert to signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and seek immediate medical attention if they occur.

If you are in any of the above circumstances (or are unsure), consult your doctor, pharmacist, or nurse before receiving Nuvaxovid XBB.1.5.

As with any vaccine, there is a possibility that a single dose of Nuvaxovid XBB.1.5 may not protect all those who receive it, and it is unknown for how long you will be protected.

Children

Nuvaxovid XBB.1.5 is not recommended for children under 12 years of age. Currently, there is no available information on the use of Nuvaxovid XBB.1.5 in children under 12 years of age.

Other medications and Nuvaxovid XBB.1.5

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

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 operating machinery

Some of the side effects of Nuvaxovid XBB.1.5 listed in section 4 (Possible adverse effects) may temporarily reduce your ability to drive and operate machinery (e.g., feeling faint or dizzy or feeling extremely tired).

Do not drive or operate machinery if you feel unwell after vaccination. Wait until all vaccine effects have disappeared before driving or operating machinery.

Nuvaxovid XBB.1.5 contains sodium and potassium

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

This vaccine contains less than 1 mmol of potassium (39 milligrams) per dose, essentially "potassium-free."

People 12 years of age and older

Nuvaxovid XBB.1.5 will be administered as a single dose of 0.5 ml injection.

If you have previously received a COVID-19 vaccine, Nuvaxovid XBB.1.5 must be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

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

During and after each vaccine injection, the doctor, pharmacist, or nurse will observe you for 15 minutes to detect signs of allergic reaction.

Additional doses (0.5 ml) of Nuvaxovid XBB.1.5 may be administered at the discretion of the healthcare professional, taking into account your clinical conditions in accordance with national recommendations.

People with immunodeficiency

If your immune system does not function correctly, you may receive additional doses in accordance with national recommendations.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them. Most side effects disappear a few days after they appear. If symptoms persist, contact your doctor, pharmacist, or nurse.

Like with other vaccines, you may feel pain or discomfort at the injection site or experience some redness and swelling in that area. However, these reactions usually disappear a few days later.

Seek urgent medical attentionif you have any of the following signs and symptoms of an allergic reaction:

• dizziness or lightheadedness
• changes in heart rate
• shortness of breath
• whistling
• swelling of the lips, face, or throat
• rashes or skin eruption
• nausea or vomiting
• stomach pain

Consult your doctor or nurse if you experience any other side effect. These may include:

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

• headache
• nausea and vomiting
• muscle pain
• joint pain
• sensitivity or pain at the injection site
• feeling extremely tired (fatigue)
• general feeling of discomfort

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

• redness at the injection site
• swelling at the injection site
• fever (>38 °C)
• pain or discomfort in the arm, hand, leg, and/or foot (pain in the extremities)

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

• enlarged lymph nodes
• high blood pressure
• itching, skin rash, or urticaria
• skin redness
• itching at the injection site
• chills

Rare(may affect up to 1 in 1000 people):

• heat at the injection site

Unknown frequency(cannot be estimated from available data):

• severe allergic reaction
• unusual sensation in the skin, such as tingling or prickling (paresthesia)
• decreased sensitivity, especially in the skin (hypoesthesia)
• inflammation of the heart muscle (myocarditis) or inflammation of the membrane surrounding the heart (pericarditis), which may cause difficulty breathing, palpitations, or chest pain

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is an adverse reaction that does not appear 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 reactions, you can contribute to providing more information on 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 unused product.

Information on conservation, expiration, use, and handling is described in the section for healthcare professionals at the end of the prospectus.

Composition of Nuvaxovid XBB.1.5

• Nuvaxovid XBB.1.5 contains 5 micrograms of SARS-CoV-2 spike protein (omicron XBB.1.5)* and the adjuvant Matrix-M in one dose (0.5 ml).

*produced using recombinant DNA technology utilizing the baculovirus expression system in a line of insect cells derived from Spodoptera Frugiperda Sf9 cells.

• Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, or prolong the protective effects of the vaccine. The adjuvant Matrix-M contains fraction-A (42.5 micrograms) and fraction-C (7.5 micrograms) of Quillaia Saponaria Molina extract per 0.5 ml dose.

• The remaining ingredients (excipients) included in Nuvaxovid XBB.1.5 are:

• Sodium hydrogen phosphate heptahydrate
• Sodium dihydrogen phosphate monohydrate
• Dihydrogen sodium phosphate dihydrate
• Sodium chloride
• Polysorbate 80
• Cholesterol
• Phosphatidylcholine (including all-rac-α-Tocoferol)
• Potassium dihydrogen phosphate
• Potassium chloride
• Sodium hydroxide (for pH adjustment)
• Hydrochloric acid (for pH adjustment)
• Water for injection

Appearance of Nuvaxovid XBB.1.5 and contents of the container

• The suspension is colorless to slightly yellow, transparent to slightly opalescent (pH 7.2).

5-dose vial

• 2.5 ml of injectable suspension in a vial with a rubber stopper and a removable blue closure.
• Container size: 2 multi-dose vials or 10 multi-dose vials. Each vial contains 5 doses of 0.5 ml.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Novavax CZ a.s.

Bohumil 138

Jevany, 28163

Czechia

Responsible Person for Manufacturing

Novavax CZ a.s.

Bohumil 138

Jevany, 28163

Czechia

Last review date of this leaflet:

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

Or visit the URL: https://www.NovavaxCovidVaccine.com

Other sources of information

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

This 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 Nuvaxovid XBB.1.5 by intramuscular injection, preferably in the deltoid muscle of the upper arm, as a single dose.

In individuals who have previously received a COVID-19 vaccine, Nuvaxovid XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Additional doses may be administered to individuals with severe immunodeficiency, in accordance with national recommendations.

Traceability

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

Instructions for handling and administration

Do not use this vaccine after the expiry date appearing on the label and the box after EXP. The expiry date is the last day of the month indicated.

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 supplied ready for use.
• The unopened vaccine must be stored in the refrigerator (2 °C - 8 °C) and protected from light in the outer packaging.
• Immediately before use, remove the vaccine vial from the carton box from the refrigerator.
• Record the date and time of disposal on the vial label. Use it within 12 hours at 2 °C - 8 °C or within 6 hours at room temperature (maximum 25 °C) after the first puncture.

Inspect the vial

• Gently move the multi-dose vial before and between each dose extraction. Do not shake.
• Each multi-dose vial contains a colorless to slightly yellow, transparent to slightly opalescent suspension.
• Visually inspect the vial contents for visible particles and/or discoloration before administration. Do not administer the vaccine if detected.

Administer the vaccine

• A built-in overfill is included in each vial to ensure that a maximum of 5 doses (2.5 ml vial) of 0.5 ml each can be extracted.
• Each 0.5 ml dose is extracted using a sterile needle and a sterile syringe for intramuscular injection, preferably in the deltoid muscle of the upper arm.

• Do not mix the vaccine in the same syringe with other vaccines or medicinal products.
• Do not mix the vaccine remaining from multiple vials.

Storage after the first puncture with the needle

• Store the opened vial at a temperature of 2 °C - 8 °C for a maximum of 12 hours or at room temperature (maximum 25 °C) for a maximum of 6 hours after the first puncture.

Dispose of

• Dispose of this vaccine if not used within 12 hours at 2 °C - 8 °C or within 6 hours at room temperature after the first puncture of the vial, see section 6.3.

Disposal

• The disposal of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.