NUVAXOVID Dispersion for injection Ref.[28183] Active ingredients: SARS-CoV-2 protein subunit vaccine (NVX-CoV2373)

Posology

Individuals 18 years of age and older

Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 mL each. It is recommended to administer the second dose 3 weeks after the first dose (see section 5.1).

There are no data available on the interchangeability of Nuvaxovid with other COVID-19 vaccines to complete the primary vaccination course. Individuals who have received a first dose of Nuvaxovid should receive the second dose of Nuvaxovid to complete the vaccination course.

Paediatric population

The safety and efficacy of Nuvaxovid in children and adolescents aged less than 18 years have not yet been established. No data are available.

Elderly population

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

Method of administration

Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm.

Do not inject the 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 on handling and disposal of the vaccine, see section 6.6.

No case of overdose has been reported. In the event of an overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

Unopened vial

9 months at 2°C to 8°C, protected from light.

Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25°C. Storage at 25°C is not the recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions during the 9-month storage at 2°C to 8°C.

Punctured vial

Chemical and physical in-use stability has been demonstrated for 6 hours at 2°C to 25°C from the time of first needle puncture to administration.

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 to 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 dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap.

Each vial contains 10 doses of 0.5 mL.

Pack size: 10 multidose vials.

Handling instructions and administration

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

Preparation for use:

• The vaccine comes ready to use.
• Unopened vaccine should be stored at 2°C to 8°C and kept within the outer carton to protect from light.
• Immediately prior to use, remove the vaccine vial from the carton in the refrigerator.
• Record the date and time of discard on the vial label. Use within 6 hours after first puncture.

Inspect the vial:

• Gently swirl the multidose vial before and in between each dose withdrawal. Do not shake.
• Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles.
• Visually inspect the contents of the vial for visible particulate matter and/or discolouration prior to administration. Do not administer the vaccine if either are present.

Administer the vaccine:

• An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be 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.
• 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:

• Nuvaxovid does not contain a preservative. Store the opened vial between 2°C to 25°C for up to 6 hours after first puncture, see section 6.3.

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.