mRESVIA Dispersion for injection Ref.[115162] Active ingredients: Respiratory syncytial virus vaccine

Posology

The recommended dose of mRESVIA is one single dose of 0.5 mL.

Paediatric population

The safety and efficacy of mRESVIA in children (from birth to less than 18 years of age) have not yet been established. No data are available.

Method of administration

For intramuscular injection only.

mRESVIA should be administered preferably in the deltoid muscle of the upper arm. The injection should be given using standard aseptic technique.

The vaccine must not be injected intravenously, subcutaneously or intradermally.

The vaccine should not be mixed with any other vaccines or medicinal products in the same syringe.

For instructions for preparation of the medicinal product before administration and special handling requirements, see section 6.6.

Overdose with mRESVIA is unlikely due to its single dose presentation (see section 4.2).

In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

1 year at -40°C to -15°C.

Within the shelf life of 1 year, stability data indicate that the vaccine is stable for 30 days when stored at 2°C to 8°C and protected from light. At the end of 30 days, the vaccine should be used immediately or discarded.

Once thawed, the vaccine should not be refrozen.

Upon moving the vaccine to 2°C to 8°C storage, the outer carton should be marked with the new expiry date at 2°C to 8°C.

If the vaccine is received at 2°C to 8°C, it should be stored at 2°C to 8°C. The expiry date on the outer carton should have been marked with the new expiry date at 2°C to 8°C.

The pre-filled syringes may be stored at 8°C to 25°C for up to 24 hours after removal from refrigerated conditions. Within this period of time, pre-filled syringes may be handled in ambient light conditions. Do not refrigerate after being stored at 8°C to 25°C. Discard the syringe if not used within this time.

Store in a freezer at -40°C to -15°C.

Keep the pre-filled syringes in the original carton in order to protect from light.

For storage conditions after thawing of the vaccine, see section 6.3.

Transportation of thawed pre-filled syringes in the outer carton in liquid state at 2°C to 8°C

If transport at -40°C to -15°C is not feasible, available data support transportation of one or more thawed pre-filled syringes in liquid state at 2°C to 8°C (within the 30 days shelf life). Once thawed and transported in liquid state at 2°C to 8°C, pre-filled syringes should not be refrozen and should be stored at 2°C to 8°C until use (see section 6.3).

0.5 mL dispersion in a pre-filled syringe (polymeric barrel) with plunger stopper and a rubber tip cap (without needle).

The pre-filled syringe is packaged within a carton in either a tray containing 1 or 10 pre-filled syringes, in 1 clear blister containing 1 pre-filled syringe or in 5 clear blisters containing 2 pre-filled syringes in each blister.

Pack sizes:

10 pre-filled syringes per carton
1 pre-filled syringe per carton

Each pre-filled syringe contains 0.5 mL.

Not all pack sizes may be marketed.

This vaccine should be administered by a trained healthcare professional using aseptic techniques to ensure sterility.

Handling instructions for mRESVIA before use:

The vaccine is ready to use once thawed.

Do not dilute the product.

Do not shake the pre-filled syringe before use.

The pre-filled syringe is for single-use only.

Do not use if the pre-filled syringe has been dropped or damaged or the security seal on the carton has been broken.

mRESVIA is shipped and supplied either as a frozen or thawed pre-filled syringe (see section 6.4). If the vaccine is frozen, it must be completely thawed before use. Thaw each pre-filled syringe before use, either in the refrigerator or at room temperature, following the instructions in Table 3.

Prior to immediate use, single blisters or pre-filled syringes may be removed from a carton of 1 or 10 pre-filled syringes and thawed either in the refrigerator or at room temperature. The remaining blisters or syringes must continue to be stored in their original carton in the freezer or refrigerator.

Table 3. Thawing conditions and times based on pack size and temperature before use:

• After thawing, the vaccine cannot be refrozen.
• If the vaccine has been thawed at room temperature (15°C to 25°C), the pre-filled syringe is ready to administer. Syringes should not be returned to the refrigerator after being thawed at room temperature.
• The pre-filled syringes may be stored at 8°C to 25°C for a total of 24 hours after removal from refrigerated conditions. Within this period of time, pre-filled syringes may be handled in ambient light conditions. Discard the syringe if not used within this time.

Administration:

• Remove a pre-filled syringe from the blister or tray.
• The vaccine should be inspected visually for particulate matter and discolouration prior to administration. mRESVIA is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.
• With tip cap upright, remove tip cap by twisting counter-clockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.
• The vaccine should be administered immediately after uncapping.
• Needles are not provided in the pack.
• Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles).
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the pre-filled syringe.
• Administer the entire dose intramuscularly.
• Discard the pre-filled syringe after use.

Disposal:

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