Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Lebrikizumab
Almirall, S.A.
D11AH
Lebrikizumab
Other dermatological preparations
Dermatitis, Atopic
Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.
Authorised
2023-11-16
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER EBGLYSS 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE lebrikizumab 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 START USING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Ebglyss is and what it is used for 2. What you need to know before you use Ebglyss 3. How to use Ebglyss 4. Possible side effects 5. How to store Ebglyss 6. Contents of the pack and other information Instructions for use 1. WHAT EBGLYSS IS AND WHAT IT IS USED FOR Ebglyss contains the active substance lebrikizumab. Ebglyss is used to treat adults and adolescents 12 years and older with a body weight of at least 40 kg with moderate-to-severe atopic dermatitis, also known as atopic eczema, who can be treated with systemic treatments (a medicine given by mouth or injection). Ebglyss may be used with eczema medicines that you apply to the skin or it may be used on its own. Lebrikizumab is a monoclonal antibody (a type of protein) that blocks the action of another protein called interleukin-13. Interleukin-13 plays a major role in causing the symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve your atopic dermatitis and reduce the related itching and skin pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EBGLYSS _ _ DO NOT USE EBGLYSS - if you are allergic t Belgenin tamamını okuyun
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 Ebglyss 250 mg solution for injection in pre-filled syringe Ebglyss 250 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ebglyss 250 mg solution for injection in pre-filled syringe Each single-use pre-filled syringe contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL). Ebglyss 250 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL). Lebrikizumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear to opalescent, colourless to slightly yellow to slightly brown solution, free of visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Posology The recommended dose of lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16. Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24. Once clinical response is achieved, the recommended maintenance dose of lebr Belgenin tamamını okuyun