COVID-19 mRNA VACCINE BNT162b2 Concentrate for solution for injection (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection.

2. Qualitative and quantitative composition

This is a multidose vial and must be diluted before use. 1 vial (0.45 mL) contains 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles). COVID-19 mRNA Vaccine BNT162b2 is highly purified ...

3. Pharmaceutical form

Concentrate for solution for injection. The vaccine is a white to off-white frozen solution.

4.1. Therapeutic indications

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance. ...

4.2. Posology and method of administration

Posology Individuals 16 years of age and older COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) 21 days apart (see section 5.1). There ...

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. General recommendations As with ...

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

No interaction studies have been performed. Concomitant administration of COVID-19 mRNA Vaccine BNT162b2 with other vaccines has not been studied (see section 5.1). Do not mix COVID-19 mRNA Vaccine BNT162b2 ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended ...

4.7. Effects on ability to drive and use machines

COVID-19 mRNA Vaccine BNT162b2 has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability ...

4.8. Undesirable effects

Summary of safety profile The safety of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South ...

4.9. Overdose

Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events. In the event of overdose, monitoring of vital functions ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: {group} ATC code: not yet assigned Mechanism of action The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, ...

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on a conventional study of repeat dose toxicity. Animal studies into potential toxicity to reproduction and development have not been completed. ...

6.1. List of excipients

ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine Cholesterol ...

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

6 months at -80 °C to -60 °C.

6.4. Special precautions for storage

Store in a freezer at -80°C to -60°C. Store in the thermal container at -90°C to -60°C. Store in the original package in order to protect from light. After thawing, the vaccine should be diluted and used ...

6.5. Nature and contents of container

Concentrate for solution for injection for 5 doses in a 2 mL clear vial (type I glass) with a stopper (bromobutyl) and a flip-off plastic cap with aluminium seal. Pack size: 195 vials

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. For instructions on dose preparation of the medicinal product before administration, see section ...

7. Marketing authorization holder

Not applicable.

8. Marketing authorization number(s)

Not applicable.

9. Date of first authorization / renewal of the authorization

Not applicable.

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