NUVAXOVID Dispersion for injection (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nuvaxovid dispersion for injection. COVID-19 Vaccine (recombinant, adjuvanted).

2. Qualitative and quantitative composition

This is a multidose vial which contains 10 doses of 0.5 mL. One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. Adjuvant Matrix-M containing per ...

3. Pharmaceutical form

Dispersion for injection (injection). The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2).

4.1. Therapeutic indications

Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations. ...

4.2. Posology and method of administration

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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity and anaphylaxis ...

4.5. Interaction with other medicinal products and other forms of interaction

Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The ...

4.6. Fertility, pregnancy and lactation

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, ...

4.7. Effects on ability to drive and use machines

Nuvaxovid has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. ...

4.8. Undesirable effects

Summary of safety profile The safety of Nuvaxovid was evaluated from an interim analysis of pooled data from 5 ongoing clinical trials conducted in Australia, South Africa, the United Kingdom, the United ...

4.9. Overdose

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

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Vaccine, other viral vaccines ATC code: J07BX03 Mechanism of action Nuvaxovid is composed of purified full-length SARS-CoV-2 recombinant spike (S) protein that ...

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeat-dose toxicity, local tolerance and reproductive and developmental toxicity. Genotoxicity and Carcinogenicity ...

6.1. List of excipients

Disodium hydrogen phosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride Polysorbate 80 Sodium hydroxide (for adjustment of pH) Hydrochloric acid (for adjustment of pH) Water for ...

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products or diluted.

6.3. Shelf life

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 ...

6.4. Special precautions for storage

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 ...

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

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 ...

7. Marketing authorization holder

Novavax CZ a.s., Bohumil 138, Jevany, 28163, Czechia

8. Marketing authorization number(s)

EU/1/21/1618/001

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