Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Guselkumab
Janssen-Cilag International NV
L04AC
guselkumab
Immunosuppressants
Psoriasis
Plaque psoriasis Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).,
Revision: 8
Authorised
2017-11-10
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER TREMFYA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE guselkumab 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 Tremfya is and what it is used for 2. What you need to know before you use Tremfya 3. How to use Tremfya 4. Possible side effects 5. How to store Tremfya 6. Contents of the pack and other information 1. WHAT TREMFYA IS AND WHAT IT IS USED FOR Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis and psoriatic arthritis. PLAQUE PSORIASIS Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails. Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning. PSORIATIC ARTHRITIS Tremfya is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by plaque psoriasis. If you have psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be given Tremfya to reduce the signs and symptoms of the disease. Tremfya can be used alone or with another medicine named methotrexate. Using Tremfya in psoriatic arthritis w Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tremfya 100 mg solution for injection in pre-filled syringe Tremfya 100 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tremfya 100 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution. Tremfya 100 mg solution for injection in pre-filled pen Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution. Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) 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) The solution is clear and colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plaque psoriasis Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1). 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 psoriasis_ The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w). Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. 3 _Psoriatic arthritis_ The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. For patients at high risk for joint damage according to clinical judgement, a do Citiți documentul complet