Mresvia

Package leaflet: Information for the patient

mRESVIA injectable dispersion

mRNA vaccine against respiratory syncytial virus
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given 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 effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

What this leaflet contains

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

1. What mRESVIA is and what it is used for

mRESVIA is a vaccine that helps protect adults aged 60 years and older against a virus called respiratory syncytial virus (RSV).
mRESVIA also helps protect adults aged 18 to 59 years who are at increased risk of developing RSV disease.
RSV is a common virus that spreads very easily and causes respiratory illnesses in people of all ages. RSV infection may be mild and characterized by cold-like symptoms such as a stuffy nose, cough, and/or sore throat. However, the virus can also lead to more serious problems, such as lung infections and pneumonia. In older adults, complications can be more severe and may lead to hospitalization or even death.
mRESVIA activates the immune system (the body's natural defenses) to protect against lung diseases caused by RSV. The vaccine contains a substance called messenger ribonucleic acid (mRNA), which carries instructions that the body can use to produce the same protein found on RSV. When the immune system encounters this protein, it produces antibodies (substances in the blood that recognize and fight infections) directed against it. If a person is exposed to RSV, the immune system recognizes and attacks the virus, helping to protect against lung diseases caused by the virus.

2. What you should know before being given mRESVIA

Do not use mRESVIA

• if you are allergic to the active substance or to any of the other components of this vaccine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given mRESVIA if:

• you have previously had a severe allergic reaction after injection of any other vaccine.
• you have bleeding problems or bruise easily.
• you have a weakened immune system which might prevent you from getting full benefit from mRESVIA.
• you are afraid of receiving the vaccine or have fainted after a previous injection.
• you have an infection with high fever. In this case, vaccination will be postponed. If you have a mild infection, such as a cold, vaccination does not need to be postponed, but discuss this with your doctor first.

As with all vaccines, it is possible that mRESVIA may not fully protect all vaccinated individuals.
Children and adolescents
The use of mRESVIA is not indicated in children and adolescents under 18 years of age.
Other medicines and mRESVIA
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this vaccine.
This vaccine must not be used in pregnant women.
Driving and using machines
Some of the side effects listed below in section 4 “Possible side effects”, such as fatigue and dizziness, may temporarily affect your ability to drive or operate machinery. If you experience such side effects, wait until they have resolved before driving or using machines.
mRESVIA contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How and when mRESVIA is administered

mRESVIA is administered by a doctor, pharmacist, or nurse, usually as a single injection into the muscle of the arm (deltoid muscle).
The recommended dose is 0.5 mL.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody will experience them.
The side effects that may occur after administration of RESVIA include:
Very common (may affect more than 1 in 10 people)

• swelling/tenderness in the armpit (lymphadenopathy)
• headache
• feeling unwell (nausea)/vomiting
• muscle pain (myalgia)
• joint pain (arthralgia)
• pain at the injection site
• tiredness (fatigue)
• chills

Common (may affect up to 1 in 10 people)

• redness (erythema) at the injection site
• swelling/hardening (induration) at the injection site
• fever (pyrexia)

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity reaction (increased sensitivity or intolerance of the immune system)
• dizziness

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

• temporary facial paralysis (Bell's palsy)
• itchy rash (urticaria)
• itching (pruritus) at the injection site

Inform your doctor or pharmacist if you experience any of the side effects listed above. Most of these side effects are mild to moderate in severity and do not last for long.
If any side effect worsens or if you notice any side effect not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 mRESVIA

The doctor, pharmacist, or nurse is responsible for the storage of this vaccine and the proper disposal of unused waste. The following information is intended for healthcare professionals.
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.

Frozen vaccine
Store in a freezer at a temperature between -40 °C and -15 °C.
Keep the pre-filled syringes in their original carton to protect the medicinal product from light.
During the 1-year shelf life, stability data indicate that the vaccine is stable for 30 days when stored at 2 °C – 8 °C, protected from light. After the 30-day period, the vaccine must be used immediately or discarded.
Once thawed, the vaccine must not be refrozen.
When the vaccine is brought to 2 °C – 8 °C, the new expiry date at 2 °C – 8 °C must be indicated on the outer packaging.
If the vaccine is received at a temperature of 2 °C – 8 °C, store it at 2 °C – 8 °C. The expiry date on the outer packaging must have been updated to reflect the new expiry date at 2 °C – 8 °C.
Pre-filled syringes may be stored at a temperature between 8 °C and 25 °C for up to 24 hours after removal from the refrigerator. During this period, pre-filled syringes may be handled under ambient light conditions. Do not refrigerate again after storage at 8 °C – 25 °C. Discard the syringe if not used within this period.

Transport of thawed pre-filled syringes in liquid form, in the outer packaging, at a temperature between 2 °C and 8 °C
If transport at a temperature between -40 °C and -15 °C is not possible, based on available data, transport of one or more thawed pre-filled syringes in liquid form at a temperature between 2 °C and 8 °C is permitted (within the 30-day validity period).
Once thawed and transported in liquid form at a temperature between 2 °C and 8 °C, the pre-filled syringes must not be refrozen and must be stored at 2 °C – 8 °C until use.

6. Package contents and other information

What mRESVIA contains
A 0.5 mL pre-filled syringe contains 50 micrograms of mRNA (nucleoside-modified) vaccine against respiratory syncytial virus (RSV), encapsulated in lipid nanoparticles.
The active substance is a single-stranded mRNA with 5’ capping encoding the pre-fusion stabilized conformation of the respiratory syncytial virus F glycoprotein.
The other components are SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl)(6-oxo-6-(undecoxy)hexyl)amino)octanoate), cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-dimyristoyl-rac-glycero-3-methoxy polyethylene glycol-2000 (PEG2000-DMG), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, and water for injections.
See section 2 “mRESVIA contains sodium”.

Description of the appearance of mRESVIA and contents of the pack
mRESVIA is a white or almost white injectable dispersion (pH: 7.0 – 8.0).
mRESVIA is available in packs containing 1 or 10 pre-filled syringes.
Not all pack sizes may be marketed.
Needles are not included in the pack.

Marketing Authorisation Holder and Manufacturer
MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo nº 31
28037 Madrid
Spain
For further information about this vaccine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

The following information is intended for healthcare professionals only:

This vaccine must be administered by a specially trained healthcare professional
using aseptic techniques to ensure sterility.
Instructions for handling mRESVIA prior to use
Once thawed, the vaccine is ready for use.
Do not dilute the product.
Do not shake the prefilled syringe before use.
The prefilled syringe is for single use only.
Do not use the prefilled syringe if it has been dropped or damaged, or if the security seal on the box
is broken.
mRESVIA is transported and supplied as a frozen or thawed prefilled syringe (see
section 5). If the vaccine is frozen, it must be completely thawed before use.
Thaw each prefilled syringe before use in a refrigerator or at room temperature,
following the instructions in Table 1.
Immediately before use, individual blisters or prefilled syringes may be removed from a box of 1 or 10 prefilled syringes and thawed in a refrigerator or at room temperature. Remaining blisters or syringes must continue to be stored in the original box in a freezer or refrigerator.
Table 1: Thawing conditions and times according to packaging and temperature prior to use

• After thawing, the vaccine must not be refrozen.
• If the vaccine has been thawed at room temperature (15 °C - 25 °C), the prefilled syringe is ready for use.
• Do not place the syringes back into the refrigerator after thawing at room temperature.
• Prefilled syringes may be stored at a temperature between 8 °C and 25 °C for a total of 24 hours after removal from the refrigerator. During this period, the prefilled syringes may be handled under normal light conditions. Discard the syringe if not used within this time frame.

Administration

• Remove a prefilled syringe from the blister or tray.
• Before administration, visually inspect the vaccine for particulate matter and discoloration. mRESVIA is a white to off-white dispersion. It may contain white or translucent particles associated with the product. Do not administer the vaccine if discoloration is observed or if it contains any other particulate matter.
• Hold the closure cap facing upward and remove it by turning counterclockwise until it detaches. Remove the closure cap with a slow, continuous motion. Do not pull on the closure cap while rotating it.
• The vaccine should be administered immediately after removing the closure cap.
• Needles are not provided in the package.
• Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer needles).
• Attach the needle by rotating it clockwise until it is securely fixed to the prefilled syringe.
• Administer the entire dose intramuscularly.
• Dispose of the prefilled syringe after use.

Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with
local regulations.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.