Spikevax JN.1 Caution For Usage

Special precautions for disposal and other handling: The vaccine should be prepared and administered by a trained healthcare professional using aseptic techniques to ensure sterility of the dispersion.
Do not shake or dilute the contents of the pre-filled syringe.
Each pre-filled syringe is for single use only. The vaccine comes ready to use once thawed.
One (1) dose of 0.5 mL can be administered from each pre-filled syringe.
Spikevax JN.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARS-CoV-2 JN.1 mRNA) and must be thawed prior to administration.
Thaw each pre-filled syringe before use following the instructions as follows. Syringes may be thawed in in the carton itself, either in the refrigerator or at room temperature (see Table 6).

Click on icon to see table/diagram/image

Verify that the product name of the pre-filled syringe is Spikevax JN.1 dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine 0.5 micrograms/dose 0.5 mL. If the product name is Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, make reference to the Summary of Product Characteristics for that formulation.
Handling instructions for the Spikevax JN.1 pre-filled syringes: Let each pre-filled syringe stand at room temperature (15°C to 25°C) for 15 minutes before administering.
Do not shake.
Pre-filled syringe should be inspected visually for particulate matter and discolouration prior to administration.
Spikevax JN.1 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.
Needles are not included in the pre-filled syringe cartons.
Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles).
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.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Uncap the needle when ready for administration.
Administer the entire dose intramuscularly.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products or diluted.