Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Sotrovimab
GlaxoSmithKline Trading Services Limited
J06BD05
sotrovimab
Immune sera and immunoglobulins,
COVID-19 virus infection
Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19.
Revision: 11
Authorised
2021-12-17
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XEVUDY 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION sotrovimab 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. - Keep this leaflet. You may need to read it again. - If you have any questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xevudy is and what it is used for 2. What you need to know before you are given Xevudy 3. How Xevudy is given 4. Possible side effects 5. How to store Xevudy 6. Contents of the pack and other information 1. WHAT XEVUDY IS AND WHAT IT IS USED FOR Xevudy contains the active substance sotrovimab. Sotrovimab is a _monoclonal antibody_ , a type of protein designed to recognise a specific target on the SARS-CoV-2 virus, the virus that causes COVID-19. Xevudy is used to treat COVID-19 in adults and adolescents (from 12 years and weighing at least 40 kg). It targets the spike protein that the virus uses to attach to cells, blocking the virus from entering the cell and making new viruses. By preventing the virus from multiplying in the body, Xevudy can help your body overcome the infection and prevent you from getting seriously ill. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN_ _XEVUDY _ _ YOU MUST NOT RECEIVE XEVUDY • if you are allergic to sotrovimab or any of the other ingredients of this medicine (listed in section 6). CHECK WITH YOUR DOCTOR if you think this applies to you. WARNINGS AND PRECAUTIONS ALLERGIC REACTIONS Xevudy can cause allergic reactions. See ‘Allergic reactions’ in Section 4 . INFUSION-RELATED REACTIONS Xevudy can cause infusion-related reactions. See ‘Infusion-related reactions’ in Læs hele dokumentet
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 Xevudy 500 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of sotrovimab in 8 mL (62.5 mg/mL). Sotrovimab is a monoclonal antibody (IgG1, kappa) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) A clear, colourless or yellow to brown solution, free from visible particles, with a pH of approximately 6 and an osmolality of approximately 290 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19 (see section 5.1). The use of Xevudy should take into account information on the activity of sotrovimab against viral variants of concern (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Xevudy should be administered under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible and patients can be monitored during and for at least one hour after administration (see section 4.4). It is recommended that Xevudy is administered within 5 days of onset of symptoms of COVID-19 (see section 5.1). Posology _Adults and adolescents (from 12 years and 40 kg body weight)_ The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). Special populations _Elderly _ 3 No dose adjustment is required in elderl Læs hele dokumentet