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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

COMIRNATY Concentrate for dispersion for injection (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Comirnaty concentrate for dispersion for injection. COVID-19 mRNA Vaccine (nucleoside modified).

2. Qualitative and quantitative composition

This is a multidose vial and must be diluted before use. One vial (0.45 mL) contains 5 doses of 0.3 mL after dilution. 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid ...

3. Pharmaceutical form

Concentrate for dispersion for injection (sterile concentrate). The vaccine is a white to off-white frozen dispersion (pH: 6.9-7.9).

4.1. Therapeutic indications

Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 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 16 years of age and older Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each) at least 21 days apart (see sections 4.4 and 5.1). There are ...

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 Hypersensitivity ...

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

No interaction studies have been performed. Concomitant administration of Comirnaty with other vaccines has not been studied.

4.6. Pregnancy and lactation

Pregnancy There is limited experience with use of Comirnaty 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

Comirnaty 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 Comirnaty was evaluated in participants 16 years of age and older in 2 clinical studies that included 21,744 participants that have received at least one dose of ...

4.9. Overdose

Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> vaccines, other viral vaccines <b>ATC code:</b> J07BX03 Mechanism of action The nucleoside-modified messenger RNA in Comirnaty is formulated in lipid nanoparticles, which ...

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 and reproductive and developmental toxicity. General toxicity Rats intramuscularly administered ...

6.1. List of excipients

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

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3. Shelf life

Unopened vial Frozen vial 6 months at -90°C to -60°C. Within the 6 months shelf-life unopened vials may be stored and transported at -25°C to -15°C for a single period of up to 2 weeks and can be returned ...

6.4. Special precautions for storage

Store in a freezer at -90°C to -60°C. Store in the original package in order to protect from light. During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet ...

6.5. Nature and contents of container

2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6. <u>Pack size:</u> 195 ...

6.6. Special precautions for disposal and other handling

Handling instructions Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion. <b>Thawing prior to dilution:</b> • The multidose ...

7. Marketing authorization holder

BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany, Phone: +49 6131 90840, Fax: +49 6131 9084390, info@biontech.de

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 21 December 2020

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