КОМИРНАТИ ОРИДЖИНАЛ/ОМИКРОН BA.1 15 mcg + 15 mcg Диспергируемый порошок для инъекционного приготовления

Содержание инструкции

1. Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for preparation
   1. What is Comirnaty Original/Omicron BA.1 and what it is used for
   2. What you need to know before you receive Comirnaty Original/Omicron BA.1
   3. How Comirnaty Original/Omicron BA.1 is administered
   4. Possible side effects
   5. How to store Comirnaty Original/Omicron BA.1
   6. Contents of the pack and other information

Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for preparation

injectable
Adults and adolescents from 12 years of age
mRNA anti-COVID-19 vaccine
tozinameran/riltozinameran
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before receiving this vaccine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If any adverse effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Comirnaty Original/Omicron BA.1 and what it is used for

Comirnaty Original/Omicron BA.1 is a vaccine used for the prevention of COVID-19, a disease
caused by SARS-CoV-2. It is administered to adults and adolescents aged 12 years and older.
Comirnaty Original/Omicron BA.1 is indicated only in subjects who have previously received at
least one primary vaccination cycle against COVID-19.
The vaccine induces the immune system (the body's natural defenses) to produce antibodies and
blood cells active against the virus, thus conferring protection against COVID-19.
Since Comirnaty Original/Omicron BA.1 does not contain the virus to induce immunity, it cannot
transmit COVID-19.
The use of this vaccine must be in accordance with official recommendations.

2. What you need to know before you receive Comirnaty Original/Omicron BA.1

Comirnaty Original/Omicron BA.1 should not be administered

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive the vaccine if:

• you have had a severe allergic reaction or breathing problems after an injection of another vaccine

or after having received this vaccine in the past;

• the vaccination procedure makes you feel faint or you have fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or an upper respiratory tract infection (such as a cold) you may still receive the vaccination;
• you have a bleeding problem, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system, due to an illness such as HIV infection, or medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty there is an increased risk of myocarditis (inflammation
of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see
section 4). These conditions can develop a few days after vaccination and have
occurred mainly within 14 days. They have been observed more often after the second dose of
vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in
children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been observed. After vaccination, pay close attention to signs of
myocarditis and pericarditis, such as shortness of breath, palpitations and chest pain, and
seek immediate medical attention if any of these symptoms occur.
Like all vaccines, Comirnaty Original/Omicron BA.1 may not fully protect
everyone who receives it, and the duration of protection is unknown.
It is possible that the effectiveness of Comirnaty Original/Omicron BA.1 may be lower in
people with a weakened immune system. If you are immunocompromised, you may be given
additional doses of Comirnaty Original/Omicron BA.1. In these cases, you should continue to
maintain physical precautions to help prevent COVID-19. If appropriate, your
close contacts should also be vaccinated. Talk to your doctor about the most appropriate recommendations for you.

Children
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injectable preparation
is not recommended in children under 12 years of age.
Paediatric formulations are available for young children aged 6 months and older
other formulations.
The vaccine is not recommended in early infancy, in children under 6 months of age.

Other medicines and Comirnaty Original/Omicron BA.1
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines, or if you have recently received any other vaccine.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, tell your doctor, nurse or
pharmacist before receiving this vaccine.
Data relating to the use of Comirnaty Original/Omicron BA.1 in pregnant women are not yet
available. However, a large number of data relating to pregnant women vaccinated during the
second and third trimesters of gestation with the initially authorised Comirnaty vaccine have not
shown any adverse effects on pregnancy or the newborn. Although data on the effects on
pregnancy or the newborn after vaccination during the first trimester of gestation are limited,
no change in the risk of miscarriage has been observed. Comirnaty
Original/Omicron BA.1 can be used during pregnancy.
Data relating to the use of Comirnaty Original/Omicron BA.1 during breastfeeding are not yet
available. However, it is not believed that the vaccine can cause effects on newborns/infants. Data relating
to breastfeeding women after administration of the initially authorised Comirnaty vaccine have not
shown any risk of adverse effects in newborns/infants. Comirnaty Original/Omicron BA.1
can be used during breastfeeding.

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 operate machinery. Wait for these
effects to subside before driving or operating machinery.

3. How Comirnaty Original/Omicron BA.1 is administered

Comirnaty Original/Omicron BA.1 is administered as an intramuscular injection of
0.3 mL in the upper arm.
Comirnaty Original/Omicron BA.1 is indicated only in subjects who have previously received at
least one primary vaccination cycle against COVID-19.
Comirnaty Original/Omicron BA.1 can be administered at least 3 months after the most recent
dose of a COVID-19 vaccine.
Check with your doctor whether you are eligible to receive the booster dose and the indicated times for
administration.
If you are an immunocompromised person, you may be given additional doses of
Comirnaty Original/Omicron BA.1.
For details on the primary vaccination cycle in subjects aged 12 years or older, refer to the
summary of product characteristics of the corresponding formulations.
If you have any doubts about the use of Comirnaty Original/Omicron BA.1, ask your doctor,
pharmacist or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.1 can cause side effects, although not everyone will experience them.

Very common side effects:may affect more than 1 in 10 people

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

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

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

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

• malaise, feeling weak or lacking energy/sleep
• arm pain
• insomnia
• itching at the injection site
• 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 paralysis of one side of the face
• 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 outer lining of the heart (pericarditis) which can cause shortness of breath, palpitations or chest pain

Not known(frequency cannot be estimated from available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in subjects who have previously undergone facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may look like a target or “bull's-eye” with a dark red core surrounded by light red rings (erythema multiforme)
• unusual sensation on the skin, such as tingling or prickling (paresthesia)
• decreased sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases appeared to be non-serious and transient)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V, including the batch number, if
available. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Comirnaty Original/Omicron BA.1

Keep this medicine out of the sight and reach of children.
The following information, relating to storage, expiry date, use and handling, is
intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the pack and label
after “Exp.”. The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Store in the original package to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the
frozen vaccine can be stored at a temperature between -90 °C and -60 °C or between
2 °C and 8 °C.
If stored frozen at a temperature between -90 °C and -60 °C, packs of
10 vials of vaccine can be thawed at a temperature between 2 °C and 8 °C for
6 hours, or individual vials can be thawed at room temperature (not exceeding
30 °C) for 30 minutes.
Once removed from the freezer, the closed vial can be stored and transported in
a refrigerator at a temperature between 2 °C and 8 °C for a maximum of 10 weeks, without ever
exceeding the expiry date printed (Exp.). Note the expiry date for
storage at a temperature between 2 °C and 8 °C on the outer pack. Once thawed, the vaccine cannot
be refrozen.
Before use, closed vials can be stored for up to 12 hours at a temperature between
8 °C and 30 °C.
After thawing, vials can be handled in normal light conditions.
After first puncture, store the vaccine at a temperature between 2 °C and 30 °C and
use within 12 hours, including any maximum transport time of 6 hours. Discard any
unused vaccine.
Do not use this vaccine if you notice the presence of particles in the dilution or a change in colour.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ComirnatyOriginal/Omicron BA.1contains

• The active ingredients of the mRNA anti-COVID-19 vaccine (nucleoside-modified) are called tozinameran and riltozinameran. The vial contains 6 doses of 0.3 mL, containing 15 micrograms of tozinameran (Original) and 15 micrograms of riltozinameran (Omicron BA.1) per dose.
• 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
• trometamol
• trometamol hydrochloride
• sucrose
• water for injections

Description of the appearance of ComirnatyOriginal/Omicron BA.1 and contents of the pack
The vaccine is presented as a dispersion (pH: 6.9-7.9) from white to off-white in colour, supplied in
a multi-dose vial of 6 doses in a transparent 2 mL vial (Type I glass) with a rubber stopper and a removable
grey plastic flip-off seal with an aluminium seal.
Packs of 10 or 195 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For further information on this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Teл: +359 2 970 4333
• Česká republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Tηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā,Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: 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 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România:Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00
• United Kingdom (Northern Ireland): Pfizer Limited, Tel: +44 (0) 1304 616161

URL: www.comirnatyglobal.com
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/.
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The following information is intended for healthcare professionals only:
The dose of Comirnaty Original/Omicron BA.1 is 0.3 mL administered intramuscularly.
Comirnaty Original/Omicron BA.1 is indicated only in subjects who have previously received at least one primary vaccination cycle against COVID-19.
At least 3 months must elapse between the administration of Comirnaty
Original/Omicron BA.1 and the last previous dose of a COVID-19 vaccine.
Additional doses may be administered to severely immunocompromised subjects.

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

Instructions for handling before use
Comirnaty Original/Omicron BA.1 must be prepared by a healthcare professional using aseptic techniques to ensure the sterility of the prepared dispersion.

• Checkthat the vial has a grey plastic flip-off sealand that the nameof the product is Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion forinjection(adults and children ≥ 12 years).
• If the vial bears a different name on the label, refer to the summary of product characteristics of that formulation.
• If the vial is stored in a freezer, it must be thawed before use. Frozen vials must be transferred to an environment at a temperature between 2 °C and 8 °C to thaw. It may take 6 hours to thaw a pack of 10 vials. Ensure that the vials are completely thawed before use.
• When transferring the product to the storage temperature between 2 °C and 8 °C, update the expiry date on the box.
• Closed vials can be stored at a temperature between 2 °C and 8 °Cfor a maximum of 10 weeks, without ever exceeding the expiry date printed (Exp.).
• Alternatively, individual frozen vials can be thawed for 30 minutes at a temperature no higher than 30 °C.
• Before use, the closed vial can be stored for up to 12 hours at a temperature no higher than 30 °C. After thawing, the vials can be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Before mixing, the thawed dispersion may contain opaque, off-white particles.
• After mixing, the vaccine should appear as a dispersion from white to off-white, free from visible particles. If particles are present or if the

colour changes, do not use the vaccine.

• Draw up 0.3 mL of Comirnaty Original/Omicron BA.1. To extract 6 doses from a single vial, precision syringes and/or needles(low dead volume) must be used. The syringe and precision needle assembly must have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, the residual volume may not be sufficient to extract a sixth dose from a single vial.
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining inside the vial is not sufficient to ensure a full 0.3 mL dose, discard the vial and any excess volume.
• Clearly record the date and expiry time on the vial. Discard any unused vaccine within 12 hours of first puncture.

Disposal
Unused medicinal product and waste material derived from such medicinal product must be disposed of in accordance with
local regulations.