SPIKEVAX BIVALENT ORIJINAL/OMIKRON BA.1 25 mcg + 25 mcg Диспергируемый порошок для инъекционного приготовления

Содержание инструкции

1. Spikevax bivalent Original/Omicron BA.1
2. Spikevax bivalent Original/Omicron BA.1
3. Spikevax bivalent Original/Omicron BA.1
   1. What is Spikevax bivalent Original/Omicron BA.1 and what it is used for
   2. What you need to know before you receive Spikevax bivalent Original/Omicron BA.1
   3. How Spikevax bivalent Original/Omicron BA.1 is administered
   4. Possible side effects
   5. How to store Spikevax bivalent Original/Omicron BA.1
   6. Contents of the pack and other information
4. Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for

Spikevax bivalent Original/Omicron BA.1

(50 micrograms/50 micrograms)/mL dispersion for injectable preparation

Spikevax bivalent Original/Omicron BA.1

25 micrograms/25 micrograms dispersion for injectable preparation

Spikevax bivalent Original/Omicron BA.1

25 micrograms/25 micrograms injectable dispersion in a pre-filled syringe
mRNA anti-COVID-19 vaccine
elasomeran/ imelasomeran
Medicinal product subject to additional monitoring. This will allow for 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Spikevax bivalent Original/Omicron BA.1 is a vaccine used to prevent COVID-19, a disease
caused by the SARS-CoV-2 coronavirus. It is administered to adults and children aged 6 years and older.
The active substance of Spikevax bivalent Original/Omicron BA.1 is mRNA that encodes for the
spike protein of SARS-CoV-2. The mRNA is inserted into SM-102 lipid nanoparticles.
Spikevax bivalent Original/Omicron BA.1 is intended only for subjects who have previously
received at least one primary vaccination cycle against COVID-19.
Since Spikevax bivalent Original/Omicron BA.1 does not contain the virus, it cannot cause COVID-

• 19.

How the vaccine works
Spikevax bivalent Original/Omicron BA.1 stimulates the body's natural defenses (the immune
system). The vaccine induces the body to produce protection (antibodies) against the virus that
causes COVID-19. Spikevax bivalent Original/Omicron BA.1 uses a substance called messenger
ribonucleic acid (mRNA) to deliver a set of instructions that body cells can use to create the spike
protein also present on the virus. Cells then produce antibodies against the spike protein to help
fight the virus. This helps to protect against COVID-19.

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

The vaccine should not be administeredif you are allergicto the active ingredient or to any of the
other ingredients of this vaccine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Spikevax bivalent
Original/Omicron BA.1 if:

• you have had a severe, potentially life-threatening allergicreaction in the past to any other injection of a vaccine or after the administration of Spikevax (original).
• you have a very weak or compromised immune system
• you have previously fainted following an injection with a needle
• you suffer from a blood clotting disorder
• you have a high fever or a serious infection; however, you can receive the vaccination if you have a slight fever or a mild respiratory infection such as a cold
• you have a serious illness
• you suffer from anxiety associated with injections

After vaccination with Spikevax there is an increased risk of myocarditis (inflammation of the
heart) 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 in young males, and more often after the
second dose compared to the first dose.
Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care and fatal cases have been observed.
After vaccination, pay particular 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.
If you fall into any of the above conditions (or if you have doubts), talk to your doctor, pharmacist or nurse before receiving Spikevax bivalent Original/Omicron BA.1.

Recurrences of capillary leak syndrome (CLS)
Some cases of capillary leak syndrome recurrences have been reported following
vaccination with Spikevax (original). This condition causes fluid to leak from small blood
vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden
weight gain and feeling faint, low blood pressure. If you have previously
experienced episodes of CLS, talk to your doctor before receiving Spikevax bivalent
Original/Omicron BA.1.

Duration of protection
As with any vaccine, the third dose of Spikevax bivalent Original/Omicron BA.1 may not
fully protect everyone who receives it, nor is the duration of the period of coverage known.

Children
Spikevax bivalent Original/Omicron BA.1 is not recommended in children under 6 years of age.

Other medicines and Spikevax bivalent Original/Omicron BA.1
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines. Spikevax bivalent Original/Omicron BA.1 can affect the way other
medicines work and other medicines can affect the way Spikevax
bivalent Original/Omicron BA.1 works.

Immunocompromised individuals
The effectiveness of Spikevax bivalent Original/Omicron BA.1 may be lower in people
who are immunocompromised. In this case, you should continue to take physical precautions to help
prevent COVID-19. If appropriate, your close contacts should also be vaccinated. Talk
to your doctor about the most suitable recommendations for you.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, tell your doctor, nurse or
pharmacist before receiving this vaccine. There are currently no data regarding the use of
Spikevax bivalent Original/Omicron BA.1 during pregnancy. However, a large number of data
relating to pregnant women vaccinated with Spikevax (original) during the second and third trimester
of gestation have not shown adverse effects on pregnancy or the newborn. Although data relating
to effects on pregnancy or the newborn after administration of the vaccine during the first
trimester of gestation are limited, no increase in the risk of miscarriages has been observed. Because the differences between the two products relate only to the spike protein in the vaccine, and not
there are no clinically significant differences, Spikevax bivalent Original/Omicron BA.1
can be
used during pregnancy.
There are currently no data regarding the use of Spikevax bivalent Original/Omicron BA.1
during breastfeeding.
However, no adverse effects on breastfed infants are expected. Data from
women who breastfed after vaccination with Spikevax (original) have not
shown a risk of adverse events in breastfed infants. Spikevax bivalent
Original/Omicron BA.1 can be administered during breastfeeding.

Driving and using machines
Avoid driving or using machines if you do not feel well after vaccination. Wait until
any effects of the vaccine have worn off before driving or using machines.

Spikevax bivalent Original/Omicron BA.1contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.

3. How Spikevax bivalent Original/Omicron BA.1 is administered

Subjects aged 12 years and older
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.5 mL administered at least 3 months after
the last previous dose of a COVID-19 vaccine.

Children aged 6 to 11 years
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.25 mL administered at least 3 months after
the last previous dose of a COVID-19 vaccine.
The doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection)
in the upper arm.

Aftereach injection of the vaccine, the doctor, pharmacist or nurse will keep you under observation for
at least 15 minutesto monitor for any signs of an allergic reaction.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist or nurse.
Spikevax bivalent Original/Omicron BA.1 is intended exclusively for subjects who have previously received at least
one primary vaccination cycle against COVID-19.
of Spikevax 0.2 mg/mL.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Seek urgentmedical attention if you experience any of the following signs and symptoms of an
allergic reaction:

• feeling of fainting or dizziness;
• changes in heart rate;
• shortness of breath;
• wheezing;
• swelling of the tongue, face or throat;
• hives or skin rash;
• nausea or vomiting;
• stomach pain.

Contact your doctor or nurse if you experience any other side effects. These
may include:

Very common(may affect more than 1 in 10 people)

• swelling/tenderness under the armpits
• decreased appetite (observed in children aged between 6 months and 5 years)
• irritability/crying (observed in children aged between 6 months and 5 years)
• headache
• drowsiness (observed in children aged between 6 months and 5 years)
• nausea
• vomiting
• muscle, joint pain and stiffness
• pain or swelling at the injection site
• redness at the injection site (this may occur approximately 9 to 11 days after the injection in some cases)
• feeling of extreme tiredness
• chills
• fever

Common(may affect up to 1 in 10 people)

• diarrhoea
• skin rash
• skin rash or hives at the injection site (this may occur approximately 9 to 11 days after the injection in some cases)

Uncommon(may affect up to 1 in 100 people)

• itching at the injection site
• dizziness
• stomach pain
• raised bumps on the skin with itching (urticaria) (which may appear immediately after the injection and up to approximately two weeks after the injection)

Rare(may affect up to 1 in 1,000 people)

• temporary paralysis of one side of the face (Bell's palsy)
• swelling of the face (facial swelling may occur in people who have previously had cosmetic facial injections)
• decreased sense of touch or sensitivity
• unusual skin sensation, such as tingling or prickling (paresthesia)

Very rare(may affect up to 1 in 10,000 people)

• inflammation of the heart (myocarditis) or inflammation of the outer lining of the heart (pericarditis) which can cause shortness of breath, palpitations or chest pain

Frequency not known

• severe allergic reactions with difficulty breathing (anaphylaxis)
• immune system reaction of increased sensitivity or intolerance (hypersensitivity)
• skin reaction causing red spots or patches on the skin, which may look like a target or “bulls-eye” with a dark red centre surrounded by rings of lighter red (erythema multiforme)
• extensive swelling of the vaccinated limb
• heavy menstrual bleeding (most cases appeared to be non-serious and transient)
• skin irritation induced by external stimuli such as rubbing, scratching or pressure on the skin (mechanical urticaria)
• itchy, raised skin irritation lasting longer than six weeks (chronic urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Annex V. By reporting side effects you can help provide more information on the safety of this vaccine.

5. How to store Spikevax bivalent Original/Omicron BA.1

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date that is stated on the label after Exp. The expiry
date refers to the last day of that month.
Information on storage, expiry, use and handling is described in the
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Spikevax bivalent Original/Omicron BA.1 contains
Table 1. Composition by container type

Elasomeran is a single-stranded messenger RNA (mRNA) with 5’ capping, produced by
in vitrotranscription without the aid of cells from the corresponding DNA template, which encodes for
the spike (S) viral protein of SARS-CoV-2 (original).
Imelasomeran is a single-stranded messenger RNA (mRNA) with 5’ capping, produced by
in vitrotranscription without the aid of cells from the corresponding DNA template, which encodes for
a full-length variant, codon-optimized, stabilized in a pre-fusion conformation
(K983P and V984P) of the spike (S) glycoprotein of SARS-CoV-2 (Omicron BA.1 variant).
The other components are SM-102 (eptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-
(undecyloxy)hexyl]amino}octanoate), cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-
dimyristoyl-rac-glycero-3-methoxy polyethylene glycol-2000 (PEG2000-DMG), trometamol, trometamol
hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.

Description of the appearance of Spikevax bivalent Original/Omicron BA.1 and contents of the
pack

Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for

preparation for injection
Spikevax bivalent Original/Omicron BA.1 is a dispersion of color from white to off-white, provided
in a multi-dose glass vial of 2.5 mL or 5 mL with a rubber stopper and a removable blue plastic
closure cap with an aluminum seal.
Package size:
10 multi-dose vials. Each vial contains 2.5 mL.
10 multi-dose vials. Each vial contains 5 mL.
It is possible that not all packages are marketed.
Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for
preparation for injection
Spikevax bivalent Original/Omicron BA.1 is a dispersion of color from white to off-white, provided
in a single-dose glass vial of 0.5 mL with a rubber stopper and a removable plastic closure cap in
blue with an aluminum seal.
Package size: 10 single-dose vials
Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion in
pre-filled syringe
Spikevax bivalent Original/Omicron BA.1 is a dispersion of color from white to off-white, provided
in a pre-filled syringe (cyclic olefinic polymer) with a plunger stopper and a closure cap
(without needle).
The pre-filled syringe is packaged in 5 transparent blisters, each containing 2 pre-filled syringes
preriempite.
Package size: 10 pre-filled syringes

Marketing Authorization Holder
MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo nº 31
28037 Madrid
Spain

Manufacturers
Rovi Pharma Industrial Services, S.A.
Paseo de Europa, 50
28703, San Sebastián de los Reyes
Madrid
Spain
Recipharm Monts
18 Rue de Montbazon
Monts, France 37260
Moderna Biotech Spain S.L.
C/ Julián Camarillo nº 31
28037 Madrid
Spain
Rovi Pharma Industrial Services, S.A.
Calle Julián Camarillo n°35
28037 Madrid
Spain
Patheon Italia S.p.a.
Viale G.B. Stucchi, 110
20900 Monza
Italy
Patheon Italia S.p.A.
2 Trav. SX Via Morolense 5
03013 Ferentino (FR)
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorization holder.

België/Belgique/Belgien
Tél/Tel: 0800 81 460

Lietuva
Tel: 88 003 1114

България
Teл: 0800 115 4477

Luxembourg/Luxemburg
Tél/Tel: 800 85 499

Česká republika
Tel: 800 050 719

Magyarország
Tel: 06 809 87488

Danmark
Tlf.: 80 81 06 53

Malta
Tel: 8006 5066

Deutschland
Tel: 0800 100 9632

Nederland
Tel: 0800 409 0001

Eesti
Tel: 800 0044 702

Norge
Tlf: 800 31 401

Ελλάδα
Τηλ: 008004 4149571

Österreich
Tel: 0800 909636

España
Tel: 900 031 015

Polska
Tel: 800 702 406

France
Tél: 0805 54 30 16

Portugal
Tel: 800 210 256

Hrvatska
Tel: 08009614

Ireland
Tel: 1800 800 354

România
Tel: 0800 400 625

Slovenija
Tel: 080 083082

Ísland
Sími: 800 4382

Slovenská republika
Tel: 0800 191 647

Italia
Tel: 800 928 007

Suomi/Finland
Puh/Tel: 0800 774198

Κύπρος
Τηλ: 80091080

Sverige
Tel: 020 10 92 13

Latvija
Tel: 80 005 898
Scan with a mobile device to obtain the package leaflet in other languages.

Or visit the site https://www.ModernaCovid19Global.com
More detailed information on this vaccine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu .
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.
------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
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.
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for
preparation for injection (multi-dose vials with removable blue closure cap)
Spikevax bivalent Original/Omicron BA.1 must be administered by a trained healthcare professional.
Once thawed, the vaccine is ready for use.
Do not shake or dilute.
The vaccine must be visually inspected for particles and discoloration before administration.
Spikevax bivalent Original/Omicron BA.1 is a dispersion of color from white to off-white. It may
contain white or translucent particles related to the product. Do not administer the vaccine if
it shows discoloration or contains other particulate matter.
The vials are stored in a freezer at a temperature between -50 ºC and -15 ºC.
Five (5) or ten (10) doses (0.5 mL each) can be drawn from each multi-dose vial, depending on the size
of the vial. Ten (10) or twenty (20) doses (0.25 mL each) can be drawn from each multi-dose vial,
depending on the size of the vial.
It is recommended to puncture the stopper each time in a different point.
Verify that the vial has the removable blue closure cap and that the product name is
Spikevax bivalent Original/Omicron BA.1. If the vial has the removable blue closure cap and
the product name is Spikevax 0.1 mg/mL or Spikevax bivalent Original/Omicron BA.4-5, please
consult the summary of product characteristics for that formulation.
Thaw each multi-dose vial before use following the instructions below
(Table 2).

Table 2. Instructions for thawing multi-dose vials before use

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for
preparation for injection (single-dose vials)
Once thawed, the vaccine is ready for use.
Do not shake or dilute. Gently rotate the vial after thawing and before withdrawal. Thaw each single-dose vial before use following the instructions below.
Each single-dose vial or the box containing 10 single-dose vials can be
thawed in the refrigerator or at room temperature (Table 3).

Table 3. Instructions for thawing single-dose vials and boxes before use
Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion in
pre-filled syringe
Do not shake or dilute the contents of the pre-filled syringe.
Each pre-filled syringe is for single use only. Once thawed, the vaccine is ready for use.
One (1) dose of 0.5 mL can be administered from each pre-filled syringe.
Spikevax bivalent Original/Omicron BA.1 is supplied in a single-dose pre-filled syringe (without
needle) containing 0.5 mL (25 micrograms of elasomeran and 25 micrograms of imelasomeran) of
mRNA and must be thawed before administration.
During storage, minimize exposure to ambient light and avoid exposure to
direct sunlight and ultraviolet light.
Thaw each pre-filled syringe before use following the instructions below. The
syringes can be thawed in the blisters (each blister contains 2 pre-filled syringes) or in the
box itself, in the refrigerator or at room temperature (Table 4).

Table 4. Instructions for thawing Spikevax bivalent pre-filled syringes
Original/Omicron BA.1 and boxes before use

Verify that the product name of the pre-filled syringe is Spikevax bivalent Original/Omicron
BA.1. If the product name is Spikevax 50 micrograms or Spikevax bivalent Original/Omicron
BA.4-5, please consult the summary of product characteristics for that formulation.

Instructions for handling pre-filled syringes

• Do not shake.
• The pre-filled syringe must be visually inspected for particles and discoloration before administration.
• Spikevax is a dispersion of color from white to off-white. It may contain white or translucent particles related to the product. Do not administer the vaccine if it shows discoloration or contains other particulate matter.
• Needles are not included in the boxes of pre-filled syringes.
• Use a sterile needle of the appropriate gauge for intramuscular injection (21 gauge or thinner needles).
• Remove the closure cap in a vertical position, rotating counterclockwise until it disengages. Remove the closure cap with a slow and steady movement. Do not pull the closure cap while rotating it.
• Insert the needle by rotating clockwise until it is securely attached to the syringe.
• Remove the needle cap when you are ready to administer.
• Administer the entire dose intramuscularly.
• Do not refreeze after thawing.

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

Subjects aged 12 years and over
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.5 mL, administered at least 3 months after
the last previous dose of a COVID-19 vaccine.

Children aged 6 to 11 years
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.25 mL, administered at least 3 months
after the last previous dose of a COVID-19 vaccine.
Medical supervision and appropriate medical treatment must always be readily available for all injectable vaccines in case of an anaphylactic reaction following the administration of
Spikevax bivalent Original/Omicron BA.1.
Vaccinated subjects must be kept under observation by a healthcare professional for at least
15 minutes after vaccination.
Spikevax (all different variants) can be administered concurrently with influenza vaccines (standard and high dose) and with the subunit vaccine against herpes zoster (shingles).
The different injectable vaccines must be administered at different injection sites.
Spikevax bivalent Original/Omicron BA.1 must not be mixed in the same syringe with other
vaccines or medicines.
Administration
The vaccine must be administered intramuscularly. The preferred site is the deltoid region of the
arm. Do not inject this vaccine intravascularly, subcutaneously or intradermally.

Multi-dose vials

Pre-filled syringes
Use a sterile needle of the appropriate gauge for intramuscular injection (21 gauge or thinner).
Remove the closure cap in a vertical position, rotating counterclockwise until
it disengages. Remove the closure cap with a slow and steady movement. Do not pull the
closure cap while rotating it. Insert the needle by rotating clockwise until it is securely
attached to the syringe. Remove the needle cap when you are ready to administer. Administer
the entire dose intramuscularly. Dispose of the syringe after use. For single use only.