Spikevax LP.8.1 Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products or diluted.
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 LP.8.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARS-CoV-2 LP.8.1 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 the carton itself, either in the refrigerator or at room temperature (see Table 6).

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Verify that the product name of the pre-filled syringe is Spikevax LP.8.1 dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine 50 micrograms/dose 0.5 mL. If the product name is Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, make reference to the package insert for that formulation.
Handling instructions for the Spikevax LP.8.1 pre-filled syringes: Do not shake.
Pre-filled syringe should be inspected visually for particulate matter and discolouration prior to administration.
Spikevax LP.8.1 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.