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The European Medicines Agency has published a brochure for Comirnaty. The Delfi portal offers patients access to its content.
Package leaflet: information for the user
Comirnaty concentrate for suspension for injection.
COVID-19 mRNA vaccine (modified nucleosides)
This drug is still being monitored. This will allow new information to be identified more quickly for your security. You can help by reporting any side effects. How to do this, read the end of Chapter 4.
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
- Do not throw away this leaflet as you may have to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you experience side effects, consult your doctor, pharmacist or nurse. Side effects may not be listed in this leaflet. See Chapter 4.
Vaccine for coronavirus
What’s in the leaflet?
1. What is Comirnaty and what is it used for
2. What you need to know before taking Comirnaty
3. How to take Comirnaty
4. Possible side effects
5. How to store Comirnaty
6. Contents of the container and other information
1. What is Comirnaty and what is it used for
Comirnaty is a vaccine to protect against COVID-19, which is caused by the SARS-CoV-2 virus.
Comirnaty is intended for adults and adolescents 16 years of age and older.
This vaccine causes the immune system (the body’s natural defenses) to produce antibodies and blood cells to fight the virus, thereby protecting against COVID-19.
Because Comirnaty does not contain an immunity-boosting virus, it cannot infect your COVID-19.
2. What you need to know before you take Comirnaty
Comirnaty should not be used:
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or nurse before vaccination if:
- You have ever had a serious allergic reaction or breathing problems after taking other vaccines or taking Comirnaty before.
- Some time after the injections, the needle passed out.
- You are seriously ill or infected and have a high fever. However, you can get the vaccine if your fever is mild or you have upper respiratory infections, such as colds.
- You have bleeding problems, bruise easily, or are taking medicine for blood clots.
- You have a weakened immune system due to diseases such as HIV or medications such as corticosteroids that affect the immune system.
As with other vaccines, a 2-dose cycle of Comirnaty may not protect all vaccinated people. It is also unknown how long this protection will last.
Children and adolescents
Comirnaty is not recommended for children under 16 years of age.
Other medicines and Comirnaty
Please inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, or if you have recently received any other vaccines.
Pregnancy and breastfeeding
If you are pregnant, breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before receiving this vaccine.
Driving and using machines
Some of the side effects mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before driving or using machines.
Comirnaty contains sodium and potassium
This vaccine contains less than 1 mmol potassium (39 mg) per dose, ie essentially “sodium-free”.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, ie essentially “sodium free”.
Vaccine for coronavirus
3. How to use Comirnaty
After dilution, 0.3 ml of Comirnaty is injected into the muscle of the upper arm.
You must receive 2 injections at least 21 days apart.
21 days after the first dose of Comirnaty, you should receive a second dose of the same vaccine to complete the vaccination cycle.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, Comirnaty can cause side effects, although not everyone suffers from them.
Very common side effects (may affect more than 1 in 10 people):
• pain and swelling at the injection site;
• fatigue;
• headache;
• muscle pains;
• joint pain;
• tremors, fever.
Common side effects (may affect less than 1 in 10 people):
• redness at the injection site;
• nausea.
Uncommon side effects (may affect less than 1 in 100 people):
• enlarged lymph nodes;
• Feel bad.
• pain in the extremities;
• insomnia;
• itching at the injection site.
Rare side effects (may affect less than 1 in 1,000 people):
• temporary paralysis of one side of the face.
Unknown side effects (cannot be estimated from the available data):
• severe allergic reaction.
Notification of side effects
If you experience any side effects, consult your doctor, pharmacist or nurse, including possible side effects that are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. In this case, a batch / serial number should be included if possible. By reporting side effects, you can help us learn more about the safety of this drug.
5. How to store Comirnaty
Keep this vaccine out of the sight and reach of children.
Additional information on storage, shelf life, preparation and use is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP. The expiration date refers to the last day of that month.
Store in a freezer between -90 ° C and -60 ° C.
Store in the original package to protect from light.
The reconstituted vaccine must be diluted and used immediately. However, data from stability testing have shown that the reconstituted, undiluted vaccine can be stored for up to five days at 2 ° C to 8 ° C or up to two days at 30 ° C until use.
Store reconstituted vaccine between 2 ° C and 30 ° C and use within 6 hours.
Any unused vaccine should be discarded.
Once the vaccines have been removed from the freezer and diluted, a new release date and time should be written on the vial. Thawed vaccines should not be re-frozen.
Do not use this vaccine if you notice dangerous particles in the solution or if it has an unusual color.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. Contents of the container and other information
Comirnaty composition
• The active substance in Comirnaty is the COVID-19 mRNA vaccine. After reconstitution of the vaccine, each vial contains 5 doses of 0.3 ml with 30 micrograms of mRNA.
• Other ingredients:
– ((4-hydroxybutyl) azanediyl) bis (hexane-6,1-diyl) bis (2-hexyldecanoate) (ALC-0315)
– 2-[(polyethylene glycol)-2000]-N, N-ditetradecylacetamide (ALC-0159)
– 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
– cholesterolis
– potassium chloride
– potassium dihydrogen phosphate
– sodium chloride
– disodium phosphate dihydrate
– sucrose
– water for injections.
What Comirnaty looks like and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9 to 7.9) that is presented in transparent vials of 2 ml of 5 doses (type I glass) with a rubber stopper and a plastic cap with a aluminum seal.
It is strictly prohibited to use the information published by DELFI on other websites, in the media or elsewhere, or to distribute our material in any way without consent, and if consent has been obtained, it is necessary to indicate DELFI as the source.
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