The leaflet of the anti-covid vaccine developed by Moderna. Information on content, administration or contraindications for use

The leaflet of the anti-covid vaccine developed by Moderna. Information on content, administration or contraindications for use.

The leaflet of the covid vaccine developed by Moderna with information for the user is available for consultation HERE.

The document contains information about:

1. What COVID-19 Vaccine Moderna is and what it is used for

2. What you need to know before you are given COVID-19 Vaccine Moderna

3. How COVID-19 Modern Vaccine is given

4. Possible side effects

5. How to store COVID-19 Modern Vaccine

6. Package contents and other information

Package leaflet: Modern vaccine for injection. COVID-19 mRNA vaccine (with modified nucleosides)

This medicine is subject to additional monitoring. This will allow new safety information to be quickly identified. You can be helpful in reporting any side effects you may have. See the last part of section 4 for how to report side effects

Read all of this leaflet carefully before you are given the vaccine, as it contains important information for you.

• Keep this leaflet. You may need to reread it.
• 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. These include any possible side effects not listed in this leaflet. See point 4

The leaflet of the anti-covid vaccine developed by Moderna. What you find in this leaflet

1. What COVID-19 VaccineModerna is and what it is used for
2. What you need to know before you are given COVID-19 VaccineModerna
3. How COVID-19 VaccineModerna is given
4. Possible side effects 5.How to store COVID-19 VaccineModerna6.Contents of the pack and other information

1. What COVID-19 VaccineModerna is and what it is used for

COVID-19 VaccineModerna is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus. It is given to adults over the age of 18. The active substance in COVID-19Vaccine Moderna is mRNA encoding the surface protein of SARS-CoV-2. MRNA is integrated into the lipid nanoparticles SM-102. Because COVID-19 VaccineModerna does not contain the virus, it cannot transmit COVID-19 disease to you.

How COVID-19 vaccine works

Modern vaccine stimulates the body’s natural defense system (immune system). The vaccine works by causing the body to produce its own protection (antibodies) against the virus that causes COVID-19 disease. COVID-19 VaccineModerna uses a substance called messenger ribonucleic acid (mRNA) to transfer instructions, which the body’s cells can use to produce the surface protein found in the virus. The cells can then produce antibodies against the surface protein to help fight the virus. This will help protect against COVID-19. The active substance in COVID-19 VaccineModerna is mRNA encoding the surface protein of SARS-CoV-2, which is integrated into lipid nanoparticles.

2. What you need to know before you are given COVID-19 Vaccine Moderna

The vaccine should not be given if you are allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6).

Warnings and precautions

Before taking COVID-19 VaccineModerna, ask your doctor, pharmacist or nurse if:

• You have had any life-threatening allergic reactions after any other injectable vaccine or before you have been given COVID-19 VaccineModerna.
• You have a weakened or compromised immune system
• You have had a fainting episode following a previous injection
• You have a bleeding disorder-
• You have a high fever or severe infection; however, you may be given the vaccine if you have a mild fever or upper respiratory tract infection, such as a cold.
• You have any other serious illness- You have anxiety about taking the injections.

If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given COVID-19 VaccineModerna.

As with any vaccine, the two-dose vaccination schedule of COVID-19 VaccineModerna may not protect all those who receive it and the duration of protection is not known.

Children and adolescents

COVID-19 Modern Vaccine is not recommended for children and adolescents under 18 years of age.

COVID-19 VaccineModerna with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. COVID-19 VaccineModerna may affect the action of other medicines, and other medicines may change the action of COVID-19 VaccineModerna.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this vaccine.

Driving and using machines

Do not drive or use machines unless you feel well after vaccination. Wait until the effects of the vaccine have passed before driving or using machines.

COVID-19 Modern Vaccine contains sodium

COVID-19 VaccineModerna contains less than 1 mmol sodium (23 mg) per dose, ie it is ‘sodium-free’.

3. How COVID-19 VaccineModerna is administered

COVID-19 VaccineModerna will be given to you in two injections of 0.5 ml each. It is recommended that the second dose be given 28 days after the first dose to complete the vaccination schedule.

Your doctor, pharmacist or nurse will inject your vaccine into a muscle (intramuscular injection) in the upper arm.

After the first dose of COVID-19 VaccineModerna, you should be given a second dose of the same vaccine after 28 days to complete the vaccination schedule.

During and after each vaccine injection, your doctor, pharmacist or nurse will monitor you for about 15 minutes to see if you have an allergic reaction.

If you miss an appointment for the second dose of COVID-19 VaccineModerna

• If you miss an appointment, schedule another visit with your doctor, nurse, or pharmacist as soon as possible.
• If you miss a scheduled injection, you may not be completely protected against COVID-19 disease.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Seek emergency medical attention if you experience any of the following signs and symptoms of an allergic reaction:

• fainting or confusion;
• changes in the rhythm of the heartbeat;
• difficulty breathing;
• wheezing;
• swelling of the lips, face or neck;
• hives or rash on the skin;
• nausea and vomiting;
• stomachache.

If you get any side effects, talk to your doctor or nurse. These may include:

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

• swelling in the armpit area
• headache
• nausea
• vomiting
• muscle pain, joint pain and stiffness
• pain or swelling at the injection site
• excessive fatigue
• chills
• fever

Common (may affect up to 1 in 10 people):

• eruption
• rash, redness or hives at the injection site

Uncommon (may affect up to 1 in 100 people):

• itching at the injection site

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

• temporary peripheral facial paralysis (Bell’s palsy)
• swelling of the face (may occur in patients who have been given cosmetic injections)

Not known:

• severe allergic reactions (anaphylaxis)
• hypersensitivity

Reporting side effects

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

5. How to store COVID-19 Modern Vaccine

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

Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Information on storage, expiry and use and handling is described in the section for healthcare professionals at the end of the package leaflet.

Do not throw any medicine in the way of water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Package contents and other information

What COVID-19 VaccineModerna contains

• This multidose vial contains 10 doses of 0.5 ml each.
• One dose (0.5 ml) contains 100 micrograms of messenger RNA (mRNA) (integrated into the lipid nanoparticles SM-102).
• Single-stranded messenger RNA (mRNA), 5 ′ end, produced by using an in vitro, acellular transcript from appropriate DNA models encoding the SARS-CoV-2 surface viral protein (S).
• The other ingredients are lipid SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene-glycol-2000 (PEG2000DMG), trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.

What COVID-19 VaccineModerna looks like and contents of the pack

COVID-19 VaccineModerna is a white to off-white dispersion supplied in a glass vial with a rubber stopper and an aluminum seal.

Pack size: 10 multidose vials

The marketing authorization holder:

MODERNA BIOTECH SPAIN, S.L.

MonteEsquinza Street30

28010 Madrid

Spain

Manufacturer:

Rovi Pharma Industrial Services, S.A.

Paseode Europa, 50

28703. San Sebastián de los Reyes

Madrid, Spania

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Romania

Tel: +40800630047