Երկիր: Եվրոպական Միություն
Լեզու: անգլերեն
Աղբյուրը: EMA (European Medicines Agency)
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains
Hipra Human Health S.L.
J07BN
COVID-19 Vaccine (recombinant, adjuvanted)
Vaccines
COVID-19 virus infection
Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine
Revision: 2
Authorised
2023-03-30
24 If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V and include batch/Lot number if available. By reporting side effects, you can help provide more information on the safety of this vaccine. 5. HOW TO STORE BIMERVAX Keep this medicine out of the sight and reach of children. Your doctor, pharmacist, or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The following information about storage, expiry, use and handling as well as disposal is intended for healthcare professionals. Do not use this vaccine after the expiry date which is stated on the label after EXP. Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep vials in outer carton in order to protect from light. After first puncture, store at 2 °C – 8 °C, use within 6 hours. Information on handling are described in the section intended for healthcare professionals at the end of the package leaflet. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT BIMERVAX CONTAINS - One dose (0.5 mL) contains 40 micrograms of selvacovatein adjuvanted with SQBA. - Selvacovatein is SARS-CoV-2 virus recombinant spike (S) protein R B D fusion heterodimer B.1.351 and B.1.1.7 strains) produced by recombinant D N A technology. - SQBA is included in this vaccine as an adjuvant to accelerate and improve the protective effects of the vaccine. SQBA contains per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections. - The other ingredients (excipients) are: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, potassium chloride and water for injections. BIMERVAX contains potassium and sodium (see section Կարդացեք ամբողջական փաստաթուղթը
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multidose vial which contains 10 doses of 0.5 mL One dose (0.5 mL) contains 40 micrograms of selvacovatein adjuvanted with SQBA. Selvacovatein is a SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) produced by recombinant DNA technology using a plasmid expression vector in a CHO cell line. SQBA adjuvant containing per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection (injection) White homogeneous emulsion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BIMERVAX is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA 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 16 years of age and older _ A single intramuscular dose (0.5 mL) of BIMERVAX should be administered. There should be an interval of at least 6 months between prior receipt of a mRNA vaccine and administration of BIMERVAX (see section 5.1). _Elderly population _ No dose adjustment is required in elderly individuals ≥ 65 years of age. _Paediatric population _ 3 The safety and efficacy of BIMERVAX in children and adolescents less than 16 years of age have not been established yet. No d Կարդացեք ամբողջական փաստաթուղթը