Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - comirnaty

Document Subject

Generated Narrative: MedicinalProductDefinition mp2bcf0e7ec94902b3190ce3b77086faa9

identifier: http://ema.europa.eu/identifier/EU/1/20/1528/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Comirnaty 30 micrograms/dose concentrate for dispersion for injection

type: Full name

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part: nan

type: Invented name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2bcf0e7ec94902b3190ce3b77086faa9

identifier: http://ema.europa.eu/identifier/EU/1/20/1528/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - comirnaty

Attesters

What is in this leaflet

1. What Comirnaty is and what it is used for
2. What you need to know before you receive Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information

Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2. Comirnaty 30 micrograms/dose concentrate for dispersion for injection is given to adults and adolescents from 12 years of age and older.

The vaccine causes the immune system (the body s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19. As Comirnaty does not contain the virus to produce immunity, it cannot give you COVID-19. The use of this vaccine should be in accordance with official recommendations.

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 precautions Talk to your doctor, pharmacist or nurse before you are given the vaccine if:

• you have ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given this vaccine in the past.
• you are feeling nervous about the vaccination process or have ever fainted following any needle injection.
• you have a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
• you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.
• you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your immune system.

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years compared with ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen. 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.

As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known how long you will be protected.

The efficacy of Comirnaty may be lower in people who are immunocompromised. If you are immunocompromised, you may receive additional doses of Comirnaty. In these cases, 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.

Children Comirnaty 30 micrograms/dose concentrate for dispersion for injection is not recommended for children aged under 12 years.

There are paediatric formulations available for infants aged 6 months and above and children below 12 years of age. For details, please refer to the Package Leaflet for other formulations.

The vaccine is not recommended for infants aged under 6 months.

Other medicines and Comirnaty Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.

Pregnancy and breast-feeding If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine.

Comirnaty can be used during pregnancy. A large amount of information from pregnant women vaccinated with Comirnaty during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.

Comirnaty can be given during breast-feeding.

Driving and using machines Some of the effects of vaccination 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 you drive or use machines.

Comirnaty contains potassium and sodium This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially potassium-free .

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Comirnaty is given after dilution as an injection of 0.3 mL into a muscle of your upper arm.

You will receive 1 injection, regardless whether you have received a COVID-19 vaccine before.

If you were previously vaccinated with a COVID-19 vaccine, you should not receive a dose of Comirnaty until at least 3 months after the most recent dose.

If you are immunocompromised, you may receive additional doses of Comirnaty.

If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.

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

• injection site: pain, swelling
• tiredness, headache
• muscle pain, joint pain
• chills, fever
• diarrhoea Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.

Common side effects: may affect up to 1 in 10 people

• injection site redness
• nausea, vomiting
• enlarged lymph nodes (more frequently observed after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• feeling unwell, feeling weak or lack of energy/sleepy
• arm pain
• insomnia
• injection site itching
• allergic reactions such as rash or itching
• decreased appetite
• dizziness
• excessive sweating, night sweats

Rare side effects: may affect up to 1 in 1 000 people

• temporary one sided facial drooping
• allergic reactions such as hives or swelling of the face

Very rare side effects: may affect up to 1 in 10 000 people

• inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain

Not known (cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated limb
• swelling of the face (swelling of the face may occur in patients who have had facial dermatological fillers)
• a skin reaction that causes red spots or patches on the skin, that may look like a target or bulls-eye with a dark red centre surrounded by paler red rings (erythema multiforme)
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)

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 and include batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

The following information about storage, expiry 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 expiry date refers to the last day of that month.

Store in freezer at -90 C to -60 C. Unopened vials may be stored and transported at -25 C to -15 C for a single period of up to 2 weeks and can be returned to -90 C to -60 C; not exceeding the printed expiry date (EXP).

Store in the original package in order to protect from light.

When stored frozen at -90 C to -60 C, 195-vial packs of the vaccine can be thawed at 2 C to 8 C for 3 hours or individual vials can be thawed at room temperature (up to 30 C) for 30 minutes.

Transfers of frozen vials stored at ultra-low temperature (< -60 C)

• Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage (< -60 C) may be at temperatures up to 25 C for up to 5 minutes.
• Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low temperature frozen storage (< -60 C) may be at temperatures up to 25 C for up to 3 minutes.
• After vial trays are returned to frozen storage following temperature exposure up to 25 C, they must remain in frozen storage for at least 2 hours before they can be removed again.

Transfers of frozen vials stored at -25 C to -15 C

• Closed-lid vial trays containing 195 vials removed from frozen storage (-25 C to -15 C) may be at temperatures up to 25 C for up to 3 minutes.
• Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 C to -15 C) may be at temperatures up to 25 C for up to 1 minute.

Once a vial is removed from the vial tray, it should be thawed for use.

After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to 1 month at 2 C to 8 C; not exceeding the printed expiry date (EXP). Within the 1-month shelf life at 2 C to 8 C, up to 48 hours may be used for transportation. Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 30 C.

Thawed vials can be handled in room light conditions.

After dilution, store and transport the vaccine at 2 C to 30 C and use within 6 hours. Discard any unused vaccine.

Once removed from the freezer and diluted, the vials should be marked with the new discard date and time. Once thawed, the vaccine cannot be re-frozen.

Do not use this vaccine if you notice particulates in the dilution or discolouration.

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.

What Comirnaty contains

• The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called tozinameran. After dilution, the vial contains 6 doses of 0.3 mL with 30 micrograms tozinameran each.
• The other ingredients are:
  ((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) cholesterol potassium chloride potassium dihydrogen phosphate sodium chloride disodium phosphate dihydrate sucrose water for injections sodium hydroxide (for pH adjustment) hydrochloric acid (for pH adjustment)

What Comirnaty looks like and contents of the pack The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a purple flip-off plastic cap with aluminium seal.

Pack size: 195 vials

Marketing Authorisation Holder BioNTech Manufacturing GmbH An der Goldgrube 55131 Mainz Germany Phone: +49 6131 9084-0 Fax: +49 6131 9084-2service@biontech.de

Manufacturers BioNTech Manufacturing GmbH Kupferbergterrasse 17 - 55116 Mainz Germany

Pfizer Manufacturing Belgium NV
Rijksweg Puurs-Sint-Amands, 2Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

• Belgi /Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., T l/Tel: +32 (0)2 554 62 * : , , , Te : +359 2 970 4* esk republika: Pfizer, spol. s r.o., Tel: +420 283 004 * Danmark: Pfizer ApS, Tlf: +45 44 201 * Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90* Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7* : Pfizer A.E., .: +30 210 6785 * Espa a: Pfizer, S.L., Tel: +34914909* France: Pfizer, T l +33 1 58 07 34 * Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 * Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616* sland: Icepharma hf, Simi: +354 540 8* Italia: Pfizer S.r.l., Tel: +39 06 33 18 * : Pfizer . . (Cyprus Branch), T : +357 22 817* Latvija: Pfizer Luxembourg SARL fili le Latvij ,Tel.: +371 670 35 * Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4* Magyarorsz g: Pfizer Kft, Tel: +36 1 488 3* Malta: Vivian Corporation Ltd., Tel: +35621 344* Norge: Pfizer AS, Tlf: +47 67 526 * Nederland: Pfizer BV, Tel: +31 (0)10 406 43 * sterreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 * Portugal: Laborat rios Pfizer, Lda., Tel: +351 21 423 5* Rom nia: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 * Slovenija: Pfizer Luxembourg SARL, Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 * Slovensk republika: Pfizer Luxembourg SARL, organiza n zlo ka, Tel: +421 2 3355 5* Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 * Sverige: Pfizer AB, Tel: +46 (0)8 550 520 * United Kingdom (Northern Ireland): Pfizer Limited, Tel: +44 (0) 1304 616This leaflet was last revised in

Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only: Administer Comirnaty intramuscularly after dilution as a single dose of 0.3 mL regardless of prior COVID-19 vaccination status.

For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be given to individuals who are severely immunocompromised.

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Handling instructions prior to use Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

• Verify that the vial has a purple plastic cap and the product name is Comirnaty 30 micrograms/dose concentrate for dispersion for injection (12 years and older).
• If the vial has another product name on the label, please make reference to the Summary of Product Characteristics for that formulation.
• The vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 C to 8 C to thaw; a 195-vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 C for immediate use.
• The unopened vial can be stored for up to 1 month at 2 C to 8 C; not exceeding the printed expiry date (EXP). Within the 1-month shelf life at 2 C to 8 C, up to 48 hours may be used for transportation.
• Allow the thawed vial to come to room temperature. Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 C. Thawed vials can be handled in room light conditions.

Dilution

• Gently invert the vial 10 times prior to dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
• The thawed vaccine must be diluted in its original vial with 1.8 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
• Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe.
• Gently invert the diluted dispersion 10 times. Do not shake.
• The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
• The diluted vials should be marked with the appropriate discard date and time.
• After dilution, store at 2 C to 30 C and use within 6 hours, including any transportation time.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.

Preparation of 0.3 mL doses

• After dilution, the vial contains 2.25 mL from which 6 doses of 0.3 mL can be extracted.
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
• Withdraw 0.3 mL of Comirnaty.
  Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Discard any unused vaccine within 6 hours after dilution.

Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Package leaflet: Information for the user

Comirnaty 30 micrograms/dose dispersion for injection Adults and adolescents from 12 years COVID-19 mRNA Vaccine
tozinameran

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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.