Land: Europese Unie
Taal: Maltees
Bron: EMA (European Medicines Agency)
adalimumab
Stada Arzneimittel AG
L04AB04
adalimumab
Immunosoppressanti
Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Rheumatoid arthritisHukyndra 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. Hukyndra 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 arthritisHukyndra 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. Hukyndra 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 arthritisHukyndra 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)Hukyndra 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 ASHukyndra 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 arthritisHukyndra 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 (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. PsoriasisHukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisHukyndra 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)Hukyndra 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 diseaseHukyndra 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 diseaseHukyndra 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 colitisHukyndra 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 colitisHukyndra 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. UveitisHukyndra 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 uveitisHukyndra 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.
Revision: 4
Awtorizzat
2021-11-15
120 B. FULJETT TA’ TAGĦRIF 121 FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT HUKYNDRA 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 Hukyndra u waqt it- trattament b’Hukyndra. Żomm din il-KARTUNA TA’ TFAKKIR GĦALL-PAZJENT FUQEK WAQT IT- TRATTAMENT TIEGĦEK U GĦAL 4 XHUR WARA L-AĦĦAR INJEZZJONI TA’ HUKYNDRA 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 Hukyndra u għalxiex jintuża 2. X’għandek tkun taf qabel ma tuża Hukyndra 3. Kif għandek tuża Hukyndra 4. Effetti sekondarji possibbli 5. Kif taħżen Hukyndra 6. Kontenut tal-pakkett u informazzjoni oħra 7. Istruzzjonijiet għall-użu 1. X’INHU HUKYNDRA U GЋALXIEX JINTUŻA Hukyndra fih is-sustanza attiva adalimumab. Hukyndra jintuża biex jittratta: Artrite rewmatika Artrite idjopatika poliartikulari taż-żgħażagħ Artrite relatata mal-entesite Ankylosing Spondyli Lees het volledige document
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 Hukyndra 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest Hukyndra 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija għal-lest 2. GĦAMLA KWALITATTIVA U KWANTITATTIVA Hukyndra 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. Hukyndra 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 Hukyndra, 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. Hukyndra 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 Lees het volledige document