Yuflyma

Nchi: Umoja wa Ulaya

Lugha: Kimalta

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

adalimumab

Inapatikana kutoka:

Celltrion Healthcare Hungary Kft.

ATC kanuni:

L04AB04

INN (Jina la Kimataifa):

adalimumab

Kundi la matibabu:

Immunosoppressanti

Eneo la matibabu:

Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid

Matibabu dalili:

Rheumatoid arthritisYuflyma in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' X-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisYuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. Enthesitis-related arthritisYuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. Axial spondyloarthritisAnkylosing spondylitis (AS)Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of ASYuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritisYuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' X-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. PsoriasisYuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisYuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS)Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5. 1 u 5. Crohn’s diseaseYuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's diseaseYuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitisYuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitisYuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. UveitisYuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitisYuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Bidhaa muhtasari:

Revision: 12

Idhini hali ya:

Awtorizzat

Idhini ya tarehe:

2021-02-11

Taarifa za kipeperushi

170
B. FULJETT TA’ TAGĦRIF
171
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
YUFLYMA 40 MG SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA
GĦAL-LEST
adalimumab
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL MA TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK
•
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
•
It-tabib tiegħek se jagħtik ukoll
KARTUNA TA’ TFAKKIR GĦALL-PAZJENT
, li fiha informazzjoni
importanti dwar is-sigurtà li inti għandek tkun taf biha qabel ma
tibda tuża Yuflyma u waqt it-
trattament b’Yuflyma. Żomm din il-
KARTUNA TA’ TFAKKIR GĦALL-PAZJENT
fuqek matul it-
trattament tiegħek u għal 4 xhur wara l-aħħar injezzjoni tiegħek
ta’ Yuflyma.
•
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
•
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
•
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Yuflyma u gћalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Yuflyma
3.
Kif għandek tuża Yuflyma
4.
Effetti sekondarji possibbli
5.
Kif taħżen Yuflyma
6.
Kontenut tal-pakkett u informazzjoni oħra
7.
Istruzzjonijiet dwar l-użu
1.
X’INHU YUFLYMA U GЋALXIEX JINTUŻA
Yuflyma fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq
is-sistema immuni (difiża) tal-
ġisem tiegħek.
Yuflyma huwa intenzjonat għat-trattament tal-mard infjammatorju li
ġej:
•
Artrite rew

Tabia za bidhaa

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti tal-kura tas-saħħa
huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata. Ara
sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Yuflyma 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Yuflyma 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Yuflyma 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Kull siringa mimlija għal-lest b’doża waħda ta’ 0.4 ml fiha 40
mg adalimumab.
Yuflyma 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Kull pinna mimlija għal-lest b’doża waħda ta’ 0.4 ml fiha 40 mg
adalimumab.
Adalimumab huwa anti-korp uman monoklonali rikombinanti prodott
fiċ-ċelluli ta’ l-ovarji tal- ħ
amster ċ iniż.
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni (injezzjoni)
Soluzzjoni ċara għal kemxejn opalexxenti, bla kulur għal kannella
ċar ħafna.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Artrite rewmatika
Yuflyma flimkien ma’ methotrexate, huwa indikat għall-:
•
kura ta’ artrite rewmatika attiva minn moderata sa severa
f’pazjenti adulti, meta r-rispons
tagħhom għal mediċini anti-rewmatiċi li jaffetwaw il-proċess
tal-mard, inkluż methotrexate, ma
kienx adegwat.
•
kura ta’ artrite rewmatika attiva u progressiva severa f’adulti li
ma jkunux ingħataw kura
b’methotrexate qabel.
Yuflyma jista’ jingħata waħdu f’każ ta’ intolleranza għal
methotrexate, jew f’każ li t-tkomplija tal-
kura b’methotrexate ma tkunx tajba.
Ġie ppruvat li, meta jingħata flimkien ma’ methotrexate,
adalimumab inaqqas ir-rata li biha
tipprogressa l-ħsara fil-ġogi kif imkejjel permezz ta’