Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain)
Sanofi Pasteur
J07BX03
COVID-19 Vaccine (recombinant, adjuvanted)
Vaccines
COVID-19 virus infection
VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1 in product information document).The use of this vaccine should be in accordance with official recommendations.
Revision: 1
Authorised
2022-11-10
29 B. PACKAGE LEAFLET Medicinal product no longer authorised 30 PACKAGE LEAFLET: INFORMATION FOR THE USER VIDPREVTYN BETA SOLUTION AND EMULSION FOR EMULSION FOR INJECTION COVID-19 vaccine (recombinant, adjuvanted) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What VidPrevtyn Beta is and what it is used for 2. What you need to know before you receive VidPrevtyn Beta 3. How VidPrevtyn Beta is given 4. Possible side effects 5. How to store VidPrevtyn Beta 6. Contents of the pack and other information 1. WHAT VIDPREVTYN BETA IS AND WHAT IT IS USED FOR VidPrevtyn Beta is a vaccine used for preventing COVID-19. VidPrevtyn Beta is given to adults who previously received either mRNA or adenoviral vector COVID-19 vaccine. The vaccine stimulates the immune system (the body’s natural defences) to produce specific antibodies that work against the virus, giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE VIDPREVTYN BETA _ _ DO NOT USE VIDPREVTYN BETA: If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); If you are allergic to octylphenol ethoxylate, a substance that is used in the manufacturing process. Small amounts of this substance may remain after manufacturing. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are given the vaccine if: • you Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT VidPrevtyn Beta solution and emulsion for emulsion for injection COVID-19 vaccine (recombinant, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION These are two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. After mixing, the vaccine vial contains 10 doses of 0.5 mL. One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein (B.1.351 strain) produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the fall armyworm, _Spodoptera frugiperda._ AS03 adjuvant is composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). VidPrevtyn Beta may contain traces of octylphenol ethoxylate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution and emulsion for emulsion for injection The antigen solution is a colourless, clear liquid. The adjuvant emulsion is a whitish to yellowish homogeneous milky liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1). 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 _ VidPrevtyn Beta is administered intramuscularly as a single dose of 0.5 mL at least 4 months after a previous COVID-19 vaccine. VidPrevtyn Beta may be given once as a booster to adults that have received prior vaccination series with either Izlasiet visu dokumentu