NUVAXOVID 5 micrograms Injectable
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How to use NUVAXOVID XBB.1.5 INJECTABLE DISPERSION
Contents of the leaflet
- Introduction
- What is Nuvaxovid XBB.1.5 and what is it used for
- What you need to know before you receive Nuvaxovid XBB.1.5
- How to use Nuvaxovid XBB.1.5
- Possible side effects
- Storage of Nuvaxovid XBB.1.5
- Contents of the pack and other information
Introduction
Package Leaflet: Information for the User
Nuvaxovid XBB.1.5 Injectable Suspension
Vaccine against COVID-19 (recombinant, adjuvanted)
This medicine 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. The last section of section 4 will tell you 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 package leaflet
- What is Nuvaxovid XBB.1.5 and what is it used for
- What you need to know before you receive Nuvaxovid XBB.1.5
- How to use Nuvaxovid XBB.1.5
- Possible side effects
- Storage of Nuvaxovid XBB.1.5
- Contents of the pack and other information
1. What is Nuvaxovid XBB.1.5 and what is it used for
Nuvaxovid XBB.1.5 is a vaccine to prevent COVID-19 caused by the SARS-CoV-2 virus.
Nuvaxovid XBB.1.5 is given to people from 12 years of age.
The vaccine makes the immune system (the body's natural defenses) 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.
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2. What you need to know before you receive Nuvaxovid XBB.1.5
Nuvaxovid XBB.1.5 must 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 XBB.1.5 if:
- you have ever had a severe or potentially life-threatening allergic reaction after receiving any injection of a vaccine or after you were given Nuvaxovid or Nuvaxovid XBB.1.5 in the past,
- you have ever fainted after an injection with a needle,
- you have a high fever (over 38 °C) or a severe infection. However, you can receive the vaccine if you have a mild fever or an upper respiratory tract infection, such as a cold,
- you have bleeding problems, bruise easily, or take 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 doses of corticosteroids, immunosuppressants, or anticancer medicines).
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 disorders can occur a few days after vaccination and have mainly occurred within 14 days.
After vaccination, you should be alert to the signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and should seek immediate medical attention if they occur.
If you are in any of the above circumstances (or are unsure), talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid XBB.1.5.
As with any vaccine, it is possible that a single dose of Nuvaxovid XBB.1.5 may not protect all those who receive it, and it is not known for how long you will be protected.
Children
Nuvaxovid XBB.1.5 is not recommended for children under 12 years of age. There is currently no information available on the use of Nuvaxovid XBB.1.5 in children under 12 years of age.
Other medicines and Nuvaxovid XBB.1.5
Tell your doctor, nurse, or pharmacist 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 XBB.1.5 listed in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines (such as feeling faint or dizzy or feeling very tired).
Do not drive or use machines if you feel unwell after vaccination. Wait until the effects of the vaccine have worn off before driving or using machines.
Nuvaxovid XBB.1.5 contains sodium and potassium
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".
This vaccine contains less than 1 mmol of potassium (39 milligrams) per dose, which is essentially "potassium-free".
3. How to use Nuvaxovid XBB.1.5
People from 12 years of age
Nuvaxovid XBB.1.5 will be given as a single injection of 0.5 ml.
If you have previously received a COVID-19 vaccine, Nuvaxovid XBB.1.5 should be given 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 the upper arm.
During and after each injection of the vaccine, the doctor, pharmacist, or nurse will observe you for about 15 minutes to detect signs of an allergic reaction.
Additional doses (0.5 ml) of Nuvaxovid XBB.1.5 may be given at the discretion of the healthcare professional, taking into account your clinical conditions in accordance with national recommendations.
People with weakened immune systems
If your immune system does not work properly, you may receive additional doses in accordance with national recommendations.
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4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away a few days after they appear. If symptoms persist, talk to your doctor, pharmacist, or nurse.
As with other vaccines, you may feel pain or discomfort at the injection site or may experience some redness and swelling at that site. However, these reactions usually go away a few days after they appear.
Get urgent medical attention if you have any of the following signs and symptoms of an allergic reaction:
- feeling faint or dizzy
- changes in heartbeat
- shortness of breath
- wheezing
- swelling of the lips, face, or throat
- hives or rash on the skin
- nausea or vomiting
- stomach pain
Talk to 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
- feeling sick (nausea) and being sick (vomiting)
- muscle pain
- joint pain
- tenderness or pain at the injection site
- feeling very tired (fatigue)
- feeling unwell
Common(may affect up to 1 in 10 people):
- redness at the injection site
- swelling at the injection site
- fever (over 38 °C)
- pain or discomfort in the arm, hand, leg, and/or foot (pain in the limbs)
Uncommon(may affect up to 1 in 100 people):
- enlarged lymph nodes
- high blood pressure
- itching of the skin, skin rash, or hives
- redness of the skin
- itching at the injection site
- chills
Rare(may affect up to 1 in 1,000 people):
- heat at the injection site
Frequency not known(cannot be estimated from the available data):
- severe allergic reaction
- unusual sensation in the skin, such as tingling or prickling (paresthesia)
- reduced sensitivity, especially in the skin (hypoesthesia)
- inflammation of the heart muscle (myocarditis) or inflammation of the membrane surrounding the heart (pericarditis), which can lead to difficulty breathing, 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 not listed in this leaflet. You can also report side effects directly via the national reporting system listed 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 Nuvaxovid XBB.1.5
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 properly.
Information on storage, expiry date, use, and handling is described in the section for healthcare professionals at the end of the leaflet.
6. Contents of the pack and other information
Empty section
Composition of Nuvaxovid XBB.1.5
- One dose (0.5 ml) of Nuvaxovid XBB.1.5 contains 5 micrograms of SARS-CoV-2 spike protein (omicron XBB.1.5)* and the adjuvant Matrix-M.
*produced using recombinant DNA technology using a baculovirus expression system in an insect cell line 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 Quillaja saponaria Molina extract per 0.5 ml dose.
- The other ingredients (excipients) included in Nuvaxovid XBB.1.5 are:
- disodium hydrogen phosphate heptahydrate
- sodium dihydrogen phosphate monohydrate
- disodium phosphate dihydrate
- sodium chloride
- polysorbate 80
- cholesterol
- phosphatidylcholine (including all-rac-α-tocopherol)
- potassium dihydrogen phosphate
- potassium chloride
- sodium hydroxide (for pH adjustment)
- hydrochloric acid (for pH adjustment)
- water for injections
Appearance of Nuvaxovid XBB.1.5 and pack contents
- The suspension is colorless to slightly yellowish, transparent to slightly opalescent (pH 7.2).
Single-dose vial
- 0.5 ml of injectable suspension in a vial with a rubber stopper and a removable blue cap.
- Pack size: 1 single-dose vial or 10 single-dose vials. Each vial contains 1 dose of 0.5 ml.
Multi-dose vial of 5 doses
- 2.5 ml of injectable suspension in a vial with a rubber stopper and a removable blue cap.
- Pack size: 2 multi-dose vials or 10 multi-dose vials. Each vial contains 5 doses of 0.5 ml.
Not all pack sizes may be marketed.
Marketing authorization holder
Novavax CZ a.s.
Líbalova 2348/1, Chodov
149 00 Praha 4
Czechia
Manufacturer
Novavax CZ a.s.
Bohumil 138
Jevany, 28163
Czechia
You can request more information about this medicine from the local representative of the marketing authorization holder:
Spain
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
France
Sanofi Winthrop Industrie
Tel: +33 800 222 555
Call from abroad: +33 1 57 63 23 23
BE, BG, CZ, DK, DE, EE, GR, HR, IE, IS, IT, CY, LV, LT, LU, HU, MT, NL, NO, AT, PL, PT, RO, SI, SK, FI, SE:
Novavax CZ a.s.
Tel: +353 1 513 6137
Date of last revision of this leaflet:
Scan the code with a mobile device to get 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 European Medicines Agency website: http://www.ema.europa.eu
The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.
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This information is intended only 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 people who have previously received a COVID-19 vaccine, Nuvaxovid XBB.1.5 should be given at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be given to people with severe immunosuppression, in accordance with national recommendations.
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 and carton after EXP. The expiry date is the last day of the month shown.
This vaccine should 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 should be stored in a refrigerator (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 carton from the refrigerator.
- Single-dose vial
- Discard the vial and any excess volume after extraction and administration of one dose.
- Multi-dose vial
- Use within 12 hours at 2 °C to 8 °C or 6 hours at room temperature (up to 25 °C) after the first needle puncture. Record the date and time of disposal on the vial label.
Inspect the vial
- Gently move the vial before extracting the dose. Do not shake. Gently move the multi-dose vial before each new dose extraction.
- Each vial contains a colorless to slightly yellowish, transparent to slightly opalescent suspension.
- Visually inspect the contents of the vial for visible particles and/or discoloration before administration. Do not administer the vaccine if you detect any.
Administer the vaccine
- An overfill is included per vial to ensure that a single dose of 0.5 ml can be extracted from the single-dose vial or a maximum of 5 doses of 0.5 ml from the multi-dose vial (2.5 ml vial).
- Each 0.5 ml dose is extracted into 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 leftover vaccine from several vials.
Storage after first needle puncture of the multi-dose vial
- Store the opened multi-dose vial at a temperature of 2 °C to 8 °C for a maximum of 12 hours or at room temperature (up to 25 °C) for a maximum of 6 hours after the first needle puncture.
Disposal
- Single-dose vial
- Discard the vial and any excess volume after extraction and administration of one dose.
- Multi-dose vial
- Discard this vaccine if it is not used within 12 hours if stored at 2 °C to 8 °C or 6 hours if stored at room temperature after the first needle puncture.
Elimination
- The disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.
- Country of registration
- Dosage formINJECTABLE, 5 micrograms
- ATC codeJ07BN04
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionHIDROGENOFOSFATO DE SODIO HEPTAHIDRATO (2,46 mg mg), DIHIDROGENOFOSFATO DE SODIO MONOHIDRATO (0,44 mg mg), CLORURO DE SODIO (8,76 mg mg), POLISORBATO 80 (0,050 mg mg), HIDROXIDO DE SODIO (E 524) (c.s.p. 0,5 ml mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to NUVAXOVID XBB.1.5 INJECTABLE DISPERSIONDosage form: INJECTABLE, 0.5 mLActive substance: covid-19, protein subunitManufacturer: Hipra Human Health S.L.Prescription requiredDosage form: INJECTABLE, 0.5 mlActive substance: covid-19, protein subunitManufacturer: Novavax Cz A.S.Prescription requiredDosage form: INJECTABLE, 5 micrograms/doseActive substance: covid-19, protein subunitManufacturer: Novavax Cz A.S.Prescription required
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Frequently Asked Questions
NUVAXOVID XBB.1.5 INJECTABLE DISPERSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in NUVAXOVID XBB.1.5 INJECTABLE DISPERSION is covid-19, protein subunit. This information helps identify medicines with the same composition but different brand names.
NUVAXOVID XBB.1.5 INJECTABLE DISPERSION is manufactured by Novavax Cz A.S.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NUVAXOVID XBB.1.5 INJECTABLE DISPERSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy NUVAXOVID XBB.1.5 INJECTABLE DISPERSION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (covid-19, protein subunit) include BIMERVAX EMULSION FOR INJECTION, NUVAXOVID Injectable Dispersion, NUVAXOVID JN.1 INJECTABLE DISPERSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
