Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
Valneva Austria GmbH
J07BX03
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
Vaccines
COVID-19 virus infection
COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations.
Revision: 6
Withdrawn
2022-06-24
23 B. PACKAGE LEAFLET Medicinal product no longer authorised 24 PACKAGE LEAFLET: INFORMATION FOR THE USER COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA SUSPENSION FOR INJECTION COVID-19 vaccine (inactivated, adjuvanted, adsorbed) • 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 VACCINE 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 COVID-19 Vaccine (inactivated, adjuvanted) Valneva is and what it is used for 2. What you need to know before you are given COVID-19 Vaccine (inactivated, adjuvanted) Valneva 3. How COVID-19 Vaccine (inactivated, adjuvanted) Valneva is given 4. Possible side effects 5. How to store COVID-19 Vaccine (inactivated, adjuvanted) Valneva 6. Contents of the pack and other information 1. WHAT COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA IS AND WHAT IT IS USED FOR COVID-19 Vaccine (inactivated, adjuvanted) Valneva is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. COVID-19 Vaccine (inactivated, adjuvanted) Valneva is given to adults 18 to 50 years of age. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that works against the virus so giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA _ _ COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA MUST NOT BE GIVEN - if you are allergic to the active substance, to yeast or yeast-derive Lugege kogu dokumenti
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 COVID-19 Vaccine (inactivated, adjuvanted) Valneva suspension for injection COVID-19 vaccine (inactivated, adjuvanted, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multi-dose vial which contains 10 doses of 0.5 mL One dose (0.5 mL) contains 33 Antigen Units (AgU) of inactivated SARS-CoV-2 virus 1,2,3. 1 Wuhan strain hCoV-19/Italy/INMI1-isl/2020 2 Produced on Vero cells (African green monkey cells) 3 Adsorbed on aluminium hydroxide (0.5 mg Al 3 + in total) and adjuvanted by 1 mg CpG 1018 (cytosine phospho-guanine) in total. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection (injection) White to off-white suspension (pH 7.5 ± 0.5) 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Primary series _ _Individuals 18 to 50 years of age_ _ _ COVID-19 Vaccine (inactivated, adjuvanted) Valneva is administered intramuscularly as a course of 2 doses of 0.5 mL each. The second dose should be administered 28 days after the first dose (see sections 4.4 and 5.1). There are no data available on the interchangeability of COVID-19 Vaccine (inactivated, adjuvanted) Valneva with other COVID-19 vaccines to complete the vaccination course. Individuals who have received the first dose of COVID-19 Vaccine (inactivated, adjuvanted) Valneva should receive the Medicinal product no longer authorised 3 second dose o Lugege kogu dokumenti