Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
Ustekinumab
Janssen-Cilag International NV
L04AC05
ustekinumab
Immunosuppressants
Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative
Crohn’s DiseaseStelara 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 TNFα antagonist or have medical contraindications to such therapies.Ulcerative colitisSTELARA 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 biologic or have medical contraindications to such therapies.Plaque psoriasisStelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen ultraviolet A.Paediatric plaque psoriasisStelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritisStelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
Revision: 44
Authorised
2009-01-15
101 B. PACKAGE LEAFLET 102 PACKAGE LEAFLET: INFORMATION FOR THE USER STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION ustekinumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS LEAFLET HAS BEEN WRITTEN FOR THE PERSON TAKING THE MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Stelara is and what it is used for 2. What you need to know before you use Stelara 3. How Stelara will be given 4. Possible side effects 5. How to store Stelara 6. Contents of the pack and other information 1. WHAT STELARA IS AND WHAT IT IS USED FOR WHAT STELARA IS Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system. WHAT STELARA IS USED FOR Stelara is used to treat the following inflammatory diseases: Moderate to severe Crohn’s disease - in adults Moderate to severe ulcerative colitis - in adults CROHN’S DISEASE Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease. ULCERATIVE COLITIS Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STELARA DO N Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT STELARA 130 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL). Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The solution is clear, colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Crohn’s Disease STELARA 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 TNFα antagonist or have medical contraindications to such therapies. Ulcerative colitis STELARA 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 biologic or have medical contraindications to such therapies (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis. STELARA concentrate for solution for infusion should only be used for the intravenous induction dose. Posology Crohn’s Disease and Ulcerative Colitis STELARA treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation). 3 _Table 1_ _Initial intravenous dosing of STELARA_ BODY WEIGHT OF PATIENT AT THE TIME OF DOSING RECOMMENDED DOSE a NUMBER OF 130 MG STELARA VIALS ≤ 55 kg 260 mg 2 > 55 kg to ≤ Olvassa el a teljes dokumentumot