Država: Europska Unija
Jezik: malteški
Izvor: EMA (European Medicines Agency)
Tofacitinib
Pfizer Europe MA EEIG
L04AA29
tofacitinib
Immunosoppressanti
Artrite, Rewmatika
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. Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4. 4 u 4. 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. 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. 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
Awtorizzat
2017-03-22
1 ANNESS I SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT 2 1. ISEM IL-PRODOTT MEDIĊINALI XELJANZ 5 mg pilloli miksija b’rita XELJANZ 10 mg pilloli miksija b’rita 2. GĦAMLA KWALITATTIVA U KWANTITATTIVA XELJANZ 5 mg pilloli miksija b’rita Kull pillola miksija b’rita fiha tofacitinib citrate, ekwivalenti għal 5 mg tofacitinib. _Eċċipjent b’effett magħruf_ Kull pillola miksija b’rita fiha 59.44 mg ta’ lactose. XELJANZ 10 mg pilloli miksija b’rita Kull pillola miksija b’rita fiha tofacitinib citrate, ekwivalenti għal 10 mg tofacitinib. _Eċċipjent b’effett magħruf_ Kull pillola miksija b’rita fiha 118.88 mg lactose. Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1. 3. GĦAMLA FARMAĊEWTIKA Pillola miksija b’rita (pillola) XELJANZ 5 mg pilloli miksija b’rita Pillola bajda, tonda b’dijametru ta’ 7.9 mm, bi “Pfizer” ibbuzzat fuq naħa waħda u “JKI 5” fuq l-oħra. XELJANZ 10 mg pilloli miksija b’rita Pillola blu, tonda b’dijametru ta’ 9.5 mm, bi “Pfizer” ibbuzzata fuq naħa waħda u “JKI 10” fuq l-oħra. 4. TAGĦRIF KLINIKU 4.1 INDIKAZZJONIJIET TERAPEWTIĊI Artrite rewmatika Tofacitinib f’kombinament ma’ methotrexate (MTX) huwa indikat għat-trattament ta’ artrite rewmatika (RA) attiva moderata sa severa f’pazjenti adulti li rrispondew b’mod inadegwat għal, jew li huma intolleranti għal waħda jew aktar mill-mediċini antirewmatiċi li jimmodifikaw il-marda (disease-modifying antirheumatic drugs, DMARDs) (ara sezzjoni 5.1). Tofacitinib jista’ jingħata bħala monoterapija f’każ ta’ intolleranza għal MTX jew meta kura b’MTX mhijiex xierqa (ara sezzjonijiet 4.4 u 4.5). Artrite psorjatika Tofacitinib f’kombinament ma’ MTX huwa indikat għall-kura ta’ artrite psorjatika (PsA) attiva f’pazjenti adulti li rrispondew b’mod inadegwat għal, jew li kienu intolleranti għal terapija b’mediċina antirewmatika li timmodifika marda preċedenti (disease-modifying antirheumatic drug, DMARD) (ara sezzjoni 5.1). 3 Spondilite ankilozzanti Tof Pročitajte cijeli dokument
1 ANNESS I SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT 2 1. ISEM IL-PRODOTT MEDIĊINALI XELJANZ 5 mg pilloli miksija b’rita XELJANZ 10 mg pilloli miksija b’rita 2. GĦAMLA KWALITATTIVA U KWANTITATTIVA XELJANZ 5 mg pilloli miksija b’rita Kull pillola miksija b’rita fiha tofacitinib citrate, ekwivalenti għal 5 mg tofacitinib. _Eċċipjent b’effett magħruf_ Kull pillola miksija b’rita fiha 59.44 mg ta’ lactose. XELJANZ 10 mg pilloli miksija b’rita Kull pillola miksija b’rita fiha tofacitinib citrate, ekwivalenti għal 10 mg tofacitinib. _Eċċipjent b’effett magħruf_ Kull pillola miksija b’rita fiha 118.88 mg lactose. Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1. 3. GĦAMLA FARMAĊEWTIKA Pillola miksija b’rita (pillola) XELJANZ 5 mg pilloli miksija b’rita Pillola bajda, tonda b’dijametru ta’ 7.9 mm, bi “Pfizer” ibbuzzat fuq naħa waħda u “JKI 5” fuq l-oħra. XELJANZ 10 mg pilloli miksija b’rita Pillola blu, tonda b’dijametru ta’ 9.5 mm, bi “Pfizer” ibbuzzata fuq naħa waħda u “JKI 10” fuq l-oħra. 4. TAGĦRIF KLINIKU 4.1 INDIKAZZJONIJIET TERAPEWTIĊI Artrite rewmatika Tofacitinib f’kombinament ma’ methotrexate (MTX) huwa indikat għat-trattament ta’ artrite rewmatika (RA) attiva moderata sa severa f’pazjenti adulti li rrispondew b’mod inadegwat għal, jew li huma intolleranti għal waħda jew aktar mill-mediċini antirewmatiċi li jimmodifikaw il-marda (disease-modifying antirheumatic drugs, DMARDs) (ara sezzjoni 5.1). Tofacitinib jista’ jingħata bħala monoterapija f’każ ta’ intolleranza għal MTX jew meta kura b’MTX mhijiex xierqa (ara sezzjonijiet 4.4 u 4.5). Artrite psorjatika Tofacitinib f’kombinament ma’ MTX huwa indikat għall-kura ta’ artrite psorjatika (PsA) attiva f’pazjenti adulti li rrispondew b’mod inadegwat għal, jew li kienu intolleranti għal terapija b’mediċina antirewmatika li timmodifika marda preċedenti (disease-modifying antirheumatic drug, DMARD) (ara sezzjoni 5.1). 3 Spondilite ankilozzanti Tof Pročitajte cijeli dokument