mNEXSPIKE – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine mNEXSPIKE, as authorised in the European Union and published in the Union Register of medicinal products.
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 mNEXSPIKE is and what it is used for
mNEXSPIKE is a vaccine that helps to protect adults and children aged 12 years and older against COVID -19 caused by the SARS -CoV -2 virus. The active substance in mNEXSPIKE is mRNA that has instructions to make parts of the SARS -CoV -2 spike protein. The mRNA is embedded in lipid nanoparticles , very small spheres made of fatty substances.
The vaccine uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make parts of the spike protein that is also on the virus. When the body then recognises the se parts, it causes the immune system (the body’s natural defences) to produce antibodies (substances in the blood that recognise and fight infections) and certain white blood cells that work against the virus . This then helps protect against COVID -19.
As mNEXSPIKE does not contain the virus, it cannot give you COVID -19.
⚠️ 2. What you need to know before you are given mNEXSPIKE
The vaccine must not be given if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given mNEXSPIKE if:
- you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given a COVID-19 mRNA vaccine in the past.
- you have a very weak or compromised immune system.
- you have a bleeding disorder.
- you have a high fever or severe infection. If this is the case, then vaccination will be postponed. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold. T alk to your doctor first.
24 – you have any serious illness.
- you have anxiety related to injections .
Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction following your vaccine :
- 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.
Cases of myocarditis and pericarditis (inflammation of the heart muscle or the membrane around the heart) have been reported for some other COVID- 19 vaccines.
These conditions can develop within a few days ; most cases occur within 14 days. They have been observed more often in younger males.
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.
Some people may experience anxiety or anxiety -related reactions in response to the vaccine injection.
Your healthcare providers will be sure that precautions are in place to avoid injury from fainting.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given mNEXSPIKE .
Duration of protection As with any vaccine, mNEXSPIKE may not fully protect all people who are vaccinated.
Children and adolescents
mNEXSPIKE is not indicated for use in children below the age of 12 years because t he effects of this vaccine in this population have not been studied.
Other medicines and mNEXSPIKE
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Immunocompromised individuals mNEXSPIKE may not work as well in people who are immunocompromised. I f you r immune system is weakened because of disease or medical treatment , you should continue to maintain physical precautions to help prevent COVID -19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Pregnancy , breast -feeding and fertility If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. No or limited data are available yet regarding the use of mNEXSPIKE during pregnancy or breast feeding.
Driving and using machines
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.
25 Some of the effects of vaccination mentioned in section 4 (Possible side effects) , like feeling tired , may temporarily affect your ability to drive or use machines. If you experience such side effect s, wait until these effects have worn off before you drive or use machines .
💊 3. How mNEXSPIKE is given
The recommended dose is one dose of 10 micrograms . If you have previously had a COVID -19 vaccine , mNEXSPIKE should be given at least 3 months after the last vaccin ation .
Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.
After injection of the vaccine, your doctor, pharmacist or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.
If you have any further questions on the use of this medicine , ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor or nurse if you develop any side effects. These can include:
Very common (may affect more than 1 in 10 people )
- swelling/tenderness in the underarm (lymphadenopathy )
- headache
- feeling sick ( nausea )/vomiting
- muscle ache (myalgia)
- joint aches (arthralgia)
- pain at the injection site
- feeling tired (fatigue )
- chills
Common (may affect up to 1 in 10 people )
- fever (pyrexia)
- swelling at the injection site
- redness (erythema) at the injection site
Uncommon (may affect up to 1 in 100 people)
- reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)
Rare (may affect up to 1 in 1 000 people)
- swelling/tenderness above the collarbone (lymphadenopathy)
- decreased sense of touch or sensation
- diarrhoea
- itchiness at the injection site
- bruising at the injection site
Very rare (may affect up to 1 in 10 000 people )
- rash Frequency not known
- severe allergic reactions with breathing difficulties (anaphylactic reaction) 26 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store mNEXSPIKE
Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The following information is intended for healthcare professionals.
Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.
The expiry date refers to the last day of that month.
Keep this vaccine out of the sight and reach of children.
Frozen vaccine Store in a freezer between -40 °C to -15 °C up to 1 year.
Keep the pre-filled syringes in the outer carton in order to protect from light.
Thawed vaccine Within the shelf life of 1 year, the vaccine is stable for 30 days when stored at 2 °C to 8 °C and protected from light. At the end of 30 days, the vaccine should be used immediately or discarded. Upon moving the vaccine to 2 °C to 8 °C storage, the outer carton should be marked with the new expiry date at 2 °C to 8 °C.
Once thawed, the vaccine should not be refrozen.
The pre- filled syringes may be stored at 8 °C to 25 °C for up to 24 hours after removal from the refrigerated conditions. Within this period of time, pre- filled syringes may be handled in ambient light conditions. Do not refrigerate after being stored at 8 °C to 25 °C. Discard the syringe if not used within this time .
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What mNEXSPIKE contains
The active substance is a single-stranded, 5’- capped messenger RNA (mRNA) produced using a cell- free in vitro transcription from the corresponding DNA template, encoding the N- terminal domain and receptor -binding domain of the viral spike (S) protein of SARS- CoV -2 (XBB.1.5).
Each pre-filled syringe contains one dose of 0.2 mL. One dose contains 10 micrograms of
SARS -CoV -2 mRNA.
The other ingredients are heptadecan -9-yl 8- {(2-hydroxyethyl)[6-oxo-6- (undecyloxy)hexyl]amino}octanoate ( SM-102), cholesterol, 1,2- distearoyl -sn-glycero-3- phosphocholine (DSPC), 1,2- Dimyristoyl- rac-glycero -3-methoxypolyethylene glycol -2000 (PEG2000-DMG), trometamol, trometamol hydrochloride, sucrose, water for injections.
27 What mNEXSPIKE looks like and contents of the pack mNEXSPIKE is a white to off white dispersion (pH: 7.1 – 7.8) supplied in a pre -filled syringe ( cyclic olefin copolymer) with plunger stopper and a tip cap (without needle).
The pre -filled syringe is available in packs containing 1, 2 or 10 pre -filled syringes .
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo nº 31 28037 Madrid Spain For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Tél/Tel: 0800 81 460 Lietuva Tel.: 88 003 1114 България Teл: 0800 115 4477 Luxembourg/Luxemburg Tél/Tel: 800 85 499 Česká republika Tel: 800 050 719 Magyarország Tel.: 06 809 87488 Danmark Tlf.: 80 81 06 53 Malta Tel: 8006 5066 Deutschland Tel.: 0800 100 9632 Nederland Tel: 0 800 409 0001 Eesti Tel: 800 0044 702 Norge Tlf: 800 31 401 Ελλάδα Τηλ: +30 800 000 0030 Österreich Tel: 0800 909636 España Tel: 900 031 015 Polska Tel.: 800 702 406 France Tél: 0805 54 30 16 Portugal Tel: 800 210 256 Hrvatska Tel: 0 8009614 România Tel: 0800 400 625 Ireland Tel: 1800 800 354 Slovenija Tel: 080 083082 Ísland Sími: 800 4382 Slovenská republika Tel: 0800 191 647 Italia Tel: 800 928 007 Suomi/Finland Puh/Tel: 0800 774198 Κύπρος Sverige 28 Τηλ: 80091080 Tel: 020 10 92 13 Latvija Tel: 80 005 898 This leaflet was last revised i n.
Other sources of information Detailed information on this vaccine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ————————————————————————————————————————
🩺 Information intended for healthcare professionals only
The vaccine should be administered by a trained healthcare professional using aseptic techniques to ensure sterility of the dispersion.
Handling instructions for mNEXSPIKE before use The vaccine is ready to use once thawed.
Do not dilute the product.
Do not shake the pre- filled syringe before use.
The pre -filled syringe is for single -use only.
Do not use if the pre -filled syringe has been dropped or damaged or the security seal on the carton has been broken .
One (1) dose of 0.2 mL can be administered from each pre- filled syringe. mNEXSPIKE is shipped and supplied as a frozen pre -filled syringe (see section 5). If the vaccine is frozen, it must be completely thawed before use. Thaw each pre- filled syringe before use, either in the refrigerator or at room temperature, following the instructions in Table 1.
Prior to immediate use, single syringes may be removed from a carton of 1, 2 or 10 pre -filled syringes and thawed either in the refrigerator or at room temperature. The remaining syringes must continue to be stored in their original carton in the freezer or refrigerator.
If the vaccine has been thawed at room temperature (15 °C to 25 °C), the pre -filled syringe is ready to administer. Syringes should not be returned to the refrigerator after being thawed at room temperature.
The pre -filled syringes may be stored at 8 °C to 25 °C for a total of 24 hours after removal from refrigerated conditions. Within this period of time, pre -filled syringes may be handled in ambient light conditions. Discard the syringe if not used within this time.
Thaw each pre- filled syringe before use following the instructions below. Pre -filled syringes may be thawed outside the carton or in the carton itself, either in the refrigerator or at room temperature (Table 1).
29 Table 1. Thawing instructions for mNEXSPIKE pre-filled syringes and cartons before use Configuration Thaw instructions and duration Thaw temperature (in a refrigerator) (°C) Thaw duration (minutes) Thaw temperature (at room temperature) (°C) Thaw duration (minutes) One syringe or a carton of 1 or 2 syringes 2 – 8 100 15 – 25 40 Carton of 10 syringes 2 – 8 160 15 – 25 80 Administration
- Pre-filled syringe should be inspected visually for particulate matter and discolouration prior to administration.
- Do not administer if vaccine is discoloured or contains other particulate matter.
- Needles are not included in the pre -filled syringe cartons.
- Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles) .
- With tip cap upright, remove tip cap by 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.
- The vaccine should be administered immediately after uncapping .
- Administer the entire dose intramuscularly.
- Discard after single use.
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 mNEXSPIKE (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/2010).
⚠️ 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.