Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
dupilumab
Sanofi Winthrop Industrie
D11AH05
dupilumab
Agents for dermatitis, excluding corticosteroids
Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Atopic dermatitisAdults and adolescentsDupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.Children 6 months to 11 years of ageDupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.AsthmaAdults and adolescentsDupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.Children 6 to 11 years of ageDupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.Chronic rhinosinusitis with nasal polyposis (CRSwNP)Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.Prurigo Nodularis (PN)Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.Eosinophilic esophagitis (EoE)Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
Revision: 30
Authorised
2017-09-26
136 B. PACKAGE LEAFLET 137 PACKAGE LEAFLET: INFORMATION FOR THE USER DUPIXENT 300 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE dupilumab 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 Dupixent is and what it is used for 2. What you need to know before you use Dupixent 3. How to use Dupixent 4. Possible side effects 5. How to store Dupixent 6. Contents of the pack and other information 1. WHAT DUPIXENT IS AND WHAT IT IS USED FOR WHAT DUPIXENT IS Dupixent contains the active substance dupilumab. Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a major role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis (PN) and eosinophilic esophagitis (EoE). WHAT DUPIXENT IS USED FOR Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children 6 months to 11 years old with severe atopic dermatitis. Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own. Dupixent is also used with other asthma medicines for the maintenance treatment of severe asthma in adults, adolescents, and children aged 6 years and older whose asthma is not controlled with their current asthma medicines (e.g. corticosteroids). Dupixent is also used with other medicines for the mai Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dupixent 300 mg solution for injection in pre-filled syringe Dupixent 300 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dupilumab 300 mg solution for injection in pre-filled syringe Each single-use pre-filled syringe contains 300 mg of dupilumab in 2 mL solution (150 mg/mL). Dupilumab 300 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 300 mg of dupilumab in 2 mL solution (150 mg/mL). Dupilumab is a fully human monoclonal antibody 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 slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atopic dermatitis _Adults and adolescents_ Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. _Children 6 months to 11 years of age _ Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma _Adults and adolescents _ Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. _Children 6 to 11 years of age _ Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (Fe Прочетете целия документ