Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
ixekizumab
Eli Lilly and Company (Ireland) Limited
L04AC
ixekizumab
Immunosuppressants
Psoriasis
Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.
Revision: 17
Authorised
2016-04-25
71 B. PACKAGE LEAFLET 72 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TALTZ 80 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE ixekizumab 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 Taltz is and what it is used for 2. What you need to know before you use Taltz 3. How to use Taltz 4. Possible side effects 5. How to store Taltz 6. Contents of the pack and other information 1. WHAT TALTZ IS AND WHAT IT IS USED FOR Taltz contains the active substance ixekizumab. Taltz is intended for the treatment of the inflammatory diseases described below: • Plaque psoriasis in adults • Plaque psoriasis in children from the age of 6 and with a body weight of at least 25 kg _ _ and in adolescents • Psoriatic arthritis in adults _ _ • Radiographic Axial Spondyloarthritis in adults _ _ • Non-radiographic Axial _S_ pondyloarthritis in adults _ _ Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL-17A, which promotes psoriasis and inflammatory disease of the joints and the spine. Plaque psoriasis Taltz is used to treat a skin condition called “plaque psoriasis” in adults and in children from the age of 6 years and with a body weight of at least 25 kg _ _ and in adolescents with moderate to severe disease. Taltz reduces the signs and symptoms of the disease. Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms such as scaling, itching and pain. Psoriatic arth Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Taltz 80 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 80 mg ixekizumab in 1 ml. Ixekizumab is produced in CHO cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). The solution is clear and colourless to slightly yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. Psoriatic arthritis Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1). Axial spondyloarthritis _ _ _Ankylosing spondylitis (radiographic axial spondyloarthritis) _ Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. _ _ _Non-radiographic axial spondyloarthritis _ Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated. Posology _Plaque p Đọc toàn bộ tài liệu