COMIRNATY Concentrate for dispersion for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Comirnaty 30 micrograms/dose 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 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6. One dose (0.3 mL) contains 30 micrograms of tozinameran, ...
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 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older. The ...
4.2. Posology and method of administration
Posology Individuals 12 years of age and older Comirnaty is administered intramuscularly after dilution as a primary course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks ...
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 12 years of age and older in 2 clinical studies that included 23,205 participants (comprised of 22,074 participants 16 years ...
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 9 months when stored at -90°C to -60°C. Within the 9-month 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 ...
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
0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section ...
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>Dose verification of comirnaty 30 micrograms/dose ...
7. Marketing authorization holder
BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
8. Marketing authorization number(s)
EU/1/20/1528/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 21 December 2020 Date of latest renewal: 03 November 2021
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