Libmyris

Ülke: Avrupa Birliği

Dil: Maltaca

Kaynak: EMA (European Medicines Agency)

Aktif bileşen:

adalimumab

Mevcut itibaren:

Stada Arzneimittel AG

ATC kodu:

L04AB04

INN (International Adı):

adalimumab

Terapötik grubu:

Immunosoppressanti

Terapötik alanı:

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

Terapötik endikasyonlar:

Rheumatoid arthritisLibmyris 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 (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Libmyris 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 arthritisLibmyris 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 DMARD. Libmyris 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 arthritisLibmyris 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. Axial spondyloarthritisAnkylosing spondylitis (AS)Libmyris is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of ASLibmyris 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 nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritisLibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD 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, u li jtejjeb il-funzjoni fiżika. PsoriasisLibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisLibmyris 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)Libmyris is indicated for the treatment of active moderate to severe HS (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 diseaseLibmyris 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 diseaseLibmyris 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 colitisLibmyris 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 colitisLibmyris 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. UveitisLibmyris 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 uveitisLibmyris 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.

Ürün özeti:

Revision: 1

Yetkilendirme durumu:

Awtorizzat

Yetkilendirme tarihi:

2021-11-12

Bilgilendirme broşürü

120
B. FULJETT TA’ TAGĦRIF
121
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
LIBMYRIS 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 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 Libmyris u waqt it-
trattament b’Libmyris. Żomm din il-KARTUNA TA’ TFAKKIR
GĦALL-PAZJENT FUQEK WAQT IT-
TRATTAMENT TIEGĦEK U GĦAL 4 XHUR WARA L-AĦĦAR INJEZZJONI TA’
LIBMYRIS TIEGĦEK.
-
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 Libmyris u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Libmyris
3.
Kif għandek tuża Libmyris
4.
Effetti sekondarji possibbli
5.
Kif taħżen Libmyris
6.
Kontenut tal-pakkett u informazzjoni oħra
7.
Istruzzjonijiet għall-użu
1.
X’INHU LIBMYRIS U GЋALXIEX JINTUŻA
Libmyris fih is-sustanza attiva adalimumab.
Libmyris jintuża biex jittratta:

Artrite rewmatika

Artrite idjopatika poliartikulari taż-żgħażagħ

Artrite relatata mal-entesite

Ankylosing Spondyli

Ürün özellikleri

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
Libmyris 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Libmyris 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Libmyris 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Syringa waħda mimlija għal-lest ta’ doża waħda ta’ 0.4 ml fiha
40 mg adalimumab.
Libmyris 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Pinna waħda mimlija għal-lest ta’ doża waħda ta’ 0.4 ml fiha
40 mg adalimumab.
Adalimumab huwa antikorp monoklonali uman rikombinanti, prodott
fiċ-ċelluli tal-Ovarji tal-Ħamster
Ċiniż.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni.
Soluzzjoni għall-injezzjoni ċara u bla kulur.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Artrite rewmatika
Libmyris, flimkien ma’ methotrexate, huwa indikat:

għat-trattament ta’ artrite rewmatika attiva minn moderata sa
severa f’pazjenti adulti, meta r-
rispons tagħhom għal mediċini antirewmatiċi li jimmodifikaw
il-marda (DMARDs) inkluż
methotrexate, ma kienx adegwat.

għat-trattament ta’ artrite rewmatika attiva u progressiva severa
f’adulti li ma jkunux ingħataw
trattament b’methotrexate qabel.
Libmyris jista’ jingħata bħala monoterapija f’każ ta’
intolleranza għal methotrexate jew meta t-
tkomplija tat-trattament b’methotrexate ma tkunx
adattata
.
Intwera li meta jingħata flimkien ma’ methotrexate, adalimumab
inaqqas ir-rata li biha tipprogressa l-
ħsara fil-ġogi kif imkejjel permezz ta’ _X-ray_, u l