Xeljanz
Maa: Euroopan unioni
Kieli: malta
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
07-12-2023
Valmisteyhteenveto
(SPC)
07-12-2023
Julkisesta arviointikertomuksesta
(PAR)
12-06-2023
Aktiivinen ainesosa:
Tofacitinib
Saatavilla:
Pfizer Europe MA EEIG
ATC-koodi:
L04AA29
INN (Kansainvälinen yleisnimi):
tofacitinib
Terapeuttinen ryhmä:
Immunosoppressanti
Terapeuttinen alue:
Artrite, Rewmatika
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 28
Valtuutuksen tilan:
Awtorizzat
Valtuutus päivämäärä:
2017-03-22
Pakkausseloste
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
Lue koko asiakirja
Valmisteyhteenveto
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
Lue koko asiakirja
