BIMERVAX Emulsion for injection Ref.[50884] Active ingredients: SARS-CoV-2 spike glycoprotein (B.1 strains)

Posology

Individuals 16 years of age and older

A single intramuscular dose (0.5 mL) of BIMERVAX should be administered. There should be an interval of at least 6 months between prior receipt of a mRNA vaccine and administration of BIMERVAX (see section 5.1).

Elderly population

No dose adjustment is required in elderly individuals ≥65 years of age.

Paediatric population

The safety and efficacy of BIMERVAX in children and adolescents less than 16 years of age have not been established yet. No data are available.

Method of administration

BIMERVAX is for intramuscular administration only, preferably into the deltoid muscle of the upper arm.

Do not administer this vaccine intravascularly, subcutaneously or intradermally.

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

For precautions to be taken before administering the vaccine, see section 4.4.

For instructions regarding handling and disposal of the vaccine, see section 6.6.

In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

Unopened vial:

1 year at 2ºC–8ºC.

Punctured vial:

Chemical and physical in-use stability has been demonstrated for 6 hours at 2ºC–8ºC from the time of first needle puncture.

From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Keep the vials in the outer carton in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

5 mL of emulsion in a multidose vial (type I glass) closed with a type I elastomeric stopper and an aluminium seal fitted with a plastic flip-off cap.

Each vial contains: 10 doses of 0.5 mL.

Pack size: 10 multidose vials.

Handling instructions and administration

The vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.

Preparation for use:

• The vaccine comes ready to use.
• Unopened vaccine should be stored at 2ºC to 8ºC and kept within the outer carton to protect from light.
• Immediately prior to use, remove the vaccine vial from the outer carton.
• After first puncture of the vial, record the discard date and time (6 hours after first puncture) on the designated area of the vial label.

Inspect the vial:

• Gently swirl the multidose vial before and in between each dose withdrawal. Do not shake.
• Each multidose vial contains a white and homogeneous emulsion.
• Visually inspect the vaccine for particulate matter and/or discolouration prior to administration. Do not administer the vaccine if any of these are present.

Administer the vaccine:

• An overfill is included in each vial to ensure that a maximum of 10 doses of 0.5 mL each can be extracted. Discard any remaining vaccine in the vial after 10 doses have been extracted.
• Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm.
• Once the vaccine is loaded in the syringe, it is stable up to at least 6 hours either under refrigerated conditions or at room temperature (<25ºC).
• Do not mix the vaccine in the same syringe with any other vaccines or medicinal products.
• Do not pool excess vaccine from multiple vials.

Storage after first needle puncture:

• After first puncture, store the opened vial at 2°C to 8°C for up to 6 hours.

Discard:

Discard this vaccine if not used within 6 hours after first puncture of the vial, see section 6.3.

Disposal:

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