concentrate for solution for injection, dispersion mRNA vaccine against covid ‑ 19 (nucleoside modified)
1. What Comirnaty is and what it is used for
Comirnaty is a vaccine used to prevent covid ‑ 19 caused by virus et SARS-CoV ‑ 2.
Comirnaty is given to adults and adolescents from 16 years of age.
The vaccine causes the immune system (the body’s own defenses) to start producing antibodies and blood cells that act against the virus so that you are protected against covid ‑ 19.
Because Comirnaty does not contain the immunity virus, you can not get covid-19 from it.
2. What you need to know before you get Comirnaty
Comirnaty 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 cautions
Talk to your doctor, pharmacist, or nurse before giving the vaccine if:
- you have ever had a severe allergic reaction or breathing problems after other vaccine injections or after you have received Comirnaty before
- you have ever fainted after a needle injection
- you have a serious illness or infection with a high fever. However, it is possible to get the vaccine if you have a mild fever or a mild upper respiratory tract infection such as a cold.
- you have a bleeding disorder, easily get bruises, or use medicines for blood clots
- you have a weakened immune system, due to a disease such as. HIV or using drugs such as corticosteroids that affect the immune system.
Like all vaccines, the 2- dose vaccination series Comirnaty may not provide full protection to all people who receive it and it is not known how long the protection will last.
Children and young people
Comirnaty is not recommended for children under 16 years of age.
Other medicines and Comirnaty
Tell your doctor or nurse if you are taking, have recently taken, or might take any other vaccines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Driving and using machines
Some of the side effects of the vaccination mentioned in section 4 (Possible side effects ) may temporarily affect the ability to drive and use machines. Wait until these effects have disappeared before driving or using machines.
Comirnaty contains potassium and sodium
This vaccine contains less than 1 mmol (39 mg) potassium per dose, ie essentially ‘potassium’. is almost “potassium-free”.
This vaccine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
3. How to get Comirnaty
Comirnaty is given after dilution as an injection of 0.3 ml into a muscle in the upper arm.
You will receive 2 injections.
It is recommended that you receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination series.
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 everybody gets them.
Very common side effects: may affect more than 1 in 10 people
- at the injection site: pain, swelling
- fatigue
- headache
- muscle aches
- joint pain
- chills, fever
Common side effects: may affect up to 1 in 10 people
- redness at the injection site
- nausea
Uncommon side effects: may affect up to 1 in 100 people
- enlarged lymph nodes
- feeling sick
- pain in arms or legs
- insomnia
- itching at the injection site
Rare side effects: may affect up to 1 in 1,000 people
- temporary unilateral facial paralysis
Has been reported (occurs in an unknown number of users)
- severe allergic reaction
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Comirnaty
Keep this medicine out of the sight and reach of children.
The following information about storage, expiration date, and use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
The store is frozen at -90 ° C to -60 ° C.
Store in the original package. Sensitive to light.
After thawing, the vaccine should be diluted and used immediately. However, post-opening stability data have shown that undiluted vaccine taken out of the freezer can be stored before use for up to 5 days at 2-8 ° C, and up to 2 hours at temperatures up to 30 ° C.
After dilution, store the vaccine at 2-30 ° C and use it within 6 hours. Discard any unused vaccine.
Vials taken out of the freezer and diluted should be marked with a new date/time of disposal. After thawing, the vaccine cannot be re-frozen.
Do not use if the vaccine contains particles or is discolored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is covid co 19 mRNA vaccine. After dilution, the vial contains 6 doses of 0.3 ml with 30 micrograms of mRNA each.
- Other ingredients are:
- ((4-hydroxybutyl) azandiyl) bis (hexane-6,1-diyl) bis (2-hexyl decanoate) (ALC ‑ 0315)
- 2 – [(polyethylene glycol) -2000] -N, N-di-tetradecyl acetamide (ALC ‑ 0159)
- 1,2-distearoyl-sn-glycerol-3-phosphocholine (DSPC)
- cholesterol
- potassium chloride
- potassium dihydrogen phosphate
- sodium chloride
- disodium phosphate dihydrate
- sucrose
- water for injections
What the medicine looks like and the contents of the pack
This vaccine is a white to off-white dispersion (pH: 6.9‑7.9) supplied in a 6- dosemultidose vial in a 2 ml clear vial (type I glass) with a rubber stopper and a snap-on cap with an aluminum seal.
Pack sizes: 195 vials
Marketing Authorisation Holder
BioNTech Manufacturing GmbH
At the gold mine 12
55131 Mainz
Germany
Tel: +49 6131 90840
Fax: +49 6131 9084390
info@biontech.de
Manufacturer
BioNTech Manufacturing GmbH
Kupferbergterrasse 17‑19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger
| Belgium / Belgique / BelgienLuxembourg / Luxemburg Pfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +370 52 51 4000 |
| BulgariaPfizer Luxembourg SAUR, CloneBulgariaTel: +359 2 970 4333 | HungaryPfizer KftTel: +36 1 488 3700 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| DenmarkPfizer ApSTel: +45 44 201 100 | NorwayPfizer ASTel: +47 67 526 100 |
| GermanyBioNTech Manufacturing GmbHTel: +49 6131 90840 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| GreecePfizer Aλλάς AE.:Ηλ .: +30 210 6785 800 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34914909900 | PortugalPfizer Laboratories, Biopharmaceuticals, Sociedade Unipessoal Lda. |
| FrancePfizerPhone +33 1 58 07 34 40 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: +385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel .: +386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL,organizing serviceTel: +421 2 3355 5500 |
| IcelandIcepharma hfPhone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| ΚύπροςPfizer Αλλάς Α.Ε. (Cyprus Branch)Tηλ: +357 22 817690 | United Kingdom ( Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: +371 670 35 775 |
This leaflet was last amended on 01/2021
Other sources of information
This medicine has received a “conditional marketing authorization”. This means that more information about the drug is expected. The European Medicines Agency reviews new information on this medicine at least every year and updates this leaflet as needed.
Scan the following code to get the package leaflet in other languages.
URL: www.comirnatyglobal.com
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.