Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
vedolizumab
Takeda Pharma A/S
L04AA
vedolizumab
Selective immunosuppressants
Colitis, Ulcerative; Crohn Disease
Ulcerative colitisEntyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.Crohn’s diseaseEntyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.PouchitisEntyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
Revision: 25
Authorised
2014-05-22
66 B. PACKAGE LEAFLET 67 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENTYVIO 300 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION vedolizumab 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 or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Entyvio is and what it is used for 2. What you need to know before you are given Entyvio 3. How Entyvio will be given 4. Possible side effects 5. How to store Entyvio 6. Contents of the pack and other information 1. WHAT ENTYVIO IS AND WHAT IT IS USED FOR WHAT ENTYVIO IS Entyvio contains the active substance ‘vedolizumab’. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). HOW ENTYVIO WORKS Entyvio works by blocking a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis, Crohn’s disease and pouchitis. This reduces the amount of inflammation. WHAT ENTYVIO IS USED FOR Entyvio is used to treat the signs and symptoms in adults of: • moderately to severely active ulcerative colitis • moderately to severely active Crohn’s disease • moderately to severely active chronic pouchitis Ulcerative colitis Ulcerative colitis is a disease that causes inflammation of the large bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease. Crohn’s disease Crohn’s disease is a disease that causes inflammation of the digestive system. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to redu Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of vedolizumab. After reconstitution, each mL contains 60 mg of vedolizumab. Vedolizumab is a humanised IgG 1 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 Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis, Crohn’s disease or pouchitis (see section 4.4). Patients should be given the package leaflet. 3 Posology _Ulcerative colitis _ The recommended dose regimen of intravenous vedolizumab is 300 mg administered by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. Therapy for patients with ulcerative colitis s Прочетете целия документ