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The package leaflet for the vaccine produced by Pfizer-BioNTech, which will begin to be administered today in all the countries of the European Union, has been published by the European Medicines Agency. The package leaflet contains both information on the commercial name of the vaccine and information on the content, administration or contraindications for use.
The trade name for the Pfizer-BioNTech vaccine is COMIRNATY, according to the labeling instructions in the package insert.
The document presents information on the substances contained, but also on the contraindications for use.
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 of the package leaflet).
Warnings and cautions
Before you are given the vaccine, ask your doctor, pharmacist or nurse if:
- Have you ever had a serious allergic reaction or breathing problems after any other injectable vaccine or after receiving Comirnaty in the past?
- Have you ever passed out after a needle injection?
- have a serious illness or infection with a high fever. However, you may be given the vaccine if you have a low-grade fever or a mild upper respiratory infection, such as a cold.
- have a bleeding problem, bruise easily, or use a medicine that prevents blood clots.
- have a weakened immune system due to a disease such as HIV infection or a medicine that affects your immune system such as a corticosteroid
The vaccine is given as a 0.3 ml injection into a muscle in the upper arm in two doses every 21 days.
Adverse reaction
The side effects that the vaccine can trigger are classified into categories, from very common to unknown frequency. The most common are fatigue, headache, muscle aches, and the rarest are severe allergic reactions.
The package leaflet indicates that if you experience any side effects, you should contact your doctor, pharmacist or nurse.
Storage conditions
the vaccine is stored in the freezer at temperatures between -90 ° C and -60 ° C, in the original container, to protect it from light.
After thawing, the vaccine should be diluted and used immediately. However, in-use stability data has shown that, after removal from the freezer, undiluted vaccine can be stored for up to 5 days prior to use at 2 ° C-8 ° C or up to 2 hours, at temperatures up to 30 ° C, shown on the package insert.
What substances does the vaccine contain?
Active substance it is a COVID-19 mRNA vaccine. After dilution, the vial contains 5 doses of 0.3 ml, each containing 30 micrograms of mRNA.
The other components are:
- ((4-hydroxybutyl) azanediyl) bis (hexane-6,1-diyl) bis (2-hexyldecanoate) (ALC-0315)
- 2-[(polietilenglicol)-2000]-N, N-ditetradecylacetamidă (ALC-0159)
- 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
- cholesterol
- potassium chloride
- potassium dihydrogen phosphate
- sodium chloride
- disodium phosphate dihydrate
- saccharose
- water for injections
The full prospectus can be read here:
Prospect_vaccin_COVID_150522_ro
Publisher: BP
