Երկիր: Եվրոպական Միություն
Լեզու: անգլերեն
Աղբյուրը: EMA (European Medicines Agency)
ChAdOx1-SARS-COV-2
AstraZeneca AB
J07BN02
COVID-19 Vaccine (ChAdOx1-S [recombinant])
Vaccines
COVID-19 virus infection
Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 years of age and older.The use of this vaccine should be in accordance with official recommendations.
Revision: 30
Authorised
2021-01-29
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE USER VAXZEVRIA SUSPENSION FOR INJECTION COVID-19 Vaccine (ChAdOx1-S [recombinant]) 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 THE VACCINE IS GIVEN 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 Vaxzevria is and what it is used for 2. What you need to know before you are given Vaxzevria 3. How Vaxzevria is given 4. Possible side effects 5. How to store Vaxzevria 6. Contents of the pack and other information 1. WHAT VAXZEVRIA IS AND WHAT IT IS USED FOR Vaxzevria is used for preventing COVID-19 caused by the SARS-CoV-2 virus. Vaxzevria is given to adults aged 18 years and older. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work 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 VAXZEVRIA THE VACCINE MUST NOT BE GIVEN: - If you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6). - If you have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving Vaxzevria. - If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nur Կարդացեք ամբողջական փաստաթուղթը
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 Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant]) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This is a multidose vial which contains 10 doses of 0.5 ml (see section 6.5). One dose (0.5 ml) contains: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S) * , not less than 2.5 × 10 8 infectious units (Inf.U) * Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology. This product contains genetically modified organisms (GMOs). Excipient with known effect Each dose (0.5 ml) contains approximately 2 mg of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection (injection). The suspension is colourless to slightly brown, clear to slightly opaque with a pH of 6.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vaxzevria is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations. Medicinal product no longer authorised 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Individuals 18 years of age and older_ The Vaxzevria primary vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks (28 to 84 days) after the first dose (see section 5.1). A booster dose (third dose) of 0.5 ml may be given to individuals who completed the primary vaccination course with Vaxzevria or an mRNA COVID-19 vaccine (see sections 4.8 and 5.1). The third dose should be administered at least 3 months after completing Կարդացեք ամբողջական փաստաթուղթը