Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
Tofacitinib
Pfizer Europe MA EEIG
L04AA29
tofacitinib
Immunosuppressants
Arthritis, Rheumatoid
Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) 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).Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
Revision: 28
Authorised
2017-03-22
142 B. PACKAGE LEAFLET 143 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XELJANZ 5 MG FILM-COATED TABLETS XELJANZ 10 MG FILM-COATED TABLETS tofacitinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In addition to this leaflet, your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ. Keep this Patient Alert Card with you. WHAT IS IN THIS LEAFLET 1. What XELJANZ is and what it is used for 2. What you need to know before you take XELJANZ 3. How to take XELJANZ 4. Possible side effects 5. How to store XELJANZ 6. Contents of the pack and other information 1. WHAT XELJANZ IS AND WHAT IT IS USED FOR XELJANZ is a medicine that contains the active substance tofacitinib. XELJANZ is used for the treatment of the following inflammatory diseases: rheumatoid arthritis psoriatic arthritis ulcerative colitis ankylosing spondylitis polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis RHEUMATOID ARTHRITIS XELJANZ is used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints. XELJANZ is used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated. XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised. XELJANZ has been shown to re Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XELJANZ 5 mg film-coated tablets Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib. _Excipient with known effect_ Each film-coated tablet contains 59.44 mg of lactose. XELJANZ 10 mg film-coated tablets Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib. _Excipient with known effect_ Each film-coated tablet contains 118.88 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) XELJANZ 5 mg film-coated tablets White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other. XELJANZ 10 mg film-coated tablets Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Rheumatoid arthritis Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritis Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) 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). 3 Ankylosing spondylitis Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. Ulcerative colitis Tofacitinib is indicated for the treatment of adult patients with moderate Baca dokumen lengkapnya