Amgevita

Riik: Euroopa Liit

keel: malta

Allikas: EMA (European Medicines Agency)

Toimeaine:

adalimumab

Saadav alates:

Amgen Europe B.V.

ATC kood:

L04AB04

INN (Rahvusvaheline Nimetus):

adalimumab

Terapeutiline rühm:

Immunosoppressanti

Terapeutiline ala:

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

Näidustused:

Rheumatoid arthritis  Amgevita 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. , il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. ,  Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita inaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita 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). Amgevita jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta titkompla l-kura b'methotrexate ma tkunx tajba (għall-effikaċja fil-monoterapija ara sezzjoni 5. Adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. Enthesitis-related arthritis Amgevita 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 spondyloarthritis Ankylosing spondylitis (AS) Amgevita 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 AS Amgevita 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. Psoriatic arthritis Amgevita 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. Amgevita inaqqas 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 jtejjeb il-funzjoni fiżika. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita 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) Amgevita 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 disease Amgevita 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 disease Amgevita 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 colitis Amgevita 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. Uveitis Amgevita 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 uveitis Amgevita 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.

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Awtorizzat

Loa andmise kuupäev:

2017-03-21

Infovoldik

83
B. FULJETT TA’ TAGĦRIF
84
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
AMGEVITA 20
MG SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA GĦAL-LEST
AMGEVITA 40
MG SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA GĦAL-LEST
adalimumab
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
it-tifel jew it-tifla tiegħek
jingħataw AMGEVITA u waqt it-trattament b’AMGEVITA. Żomm
IL-KARTUNA TA’ TFAKKIR
GĦALL-PAZJENT
fuqhek.
-
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 għandhoml-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).
X’FIH DAN IL-FULJETT
1.
X’inhu AMGEVITA u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża AMGEVITA
3.
Kif għandek tuża AMGEVITA
4.
Effetti sekondarji possibbli
5.
Kif taħżen AMGEVITA
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU AMGEVITA U GЋALXIEX JINTUŻA
AMGEVITA fih is-sustanza attiva adalimumab, mediċina li taħdem fuq
is-sistema immuni (ta’
difiża) ta’ ġismek.
AMGEVITA huwa intenzjonat għat-trattament tal-mard infjammatorju
deskritt hawn taħt:
•
Artrite rewmatika
•
Artrite idjopatika poliartikulari taż-żagħżagħ
•
Artrite relatata mal-entesite
•
Infjammazzjoni tal-vertebri li twassal għal twaħħil tal-vertebri
flimkien (
_ankylosing _
_spondylitis_
)
•
_Axial spondyloarthritis _
mingħajr evidenza radjografika ta’
_ankylosing spondylitis_
•
Artrite psorjatika
•
Psorjasi tal-plakka
•
Hidra

Toote omadused

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
AMGEVITA 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
AMGEVITA 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
AMGEVITA 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
AMGEVITA 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Kull siringa mimlija għal-lest b’doża waħda fiha 20 mg ta’
adalimumab f’0.4 mL ta’ soluzzjoni
(50 mg/mL).
AMGEVITA 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Kull siringa mimlija għal-lest b’doża waħda fiha 40 mg ta’
adalimumab f’0.8 mL ta’ soluzzjoni
(50 mg/mL).
AMGEVITA 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Kull pinna mimlija għal-lest b’doża waħda fiha 40 mg ta’
adalimumab f’0.8 mL ta’ soluzzjoni
(50 mg/mL).
Adalimumab huwa anti-korp monoklonali rikombinanti uman magħmul
fiċ-ċelluli tal-Ovarju
tal-Ħamster Ċiniż.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni (injezzjoni)
Soluzzjoni għall-injezzjoni (injezzjoni) f’pinna mimlija għal-lest
(SureClick)
Soluzzjoni ċara u bla kulur sa kemmxejn safranija.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Artrite rewmatika
AMGEVITA, flimkien ma’ methotrexate, huwa indikat għal:
•
trattament 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 (DMARDs,
_disease-modifying anti-rheumatic drugs_
), inkluż methotrexate, ma kienx adegwat.
•
trattament ta’ artrite rewmatika attiva u progressiva severa
f’adulti li ma jkunux
ingħataw trattament b’methotrexate qabel.
AMGEVITA jista’ jingħata waħdu f’każ ta’ intolleranza għal
methotrexate, jew f’każ li t-
tkomplija tat-trattament b’methotrexate ma tkunx xierqa.
3
Meta jingħata flimkien ma’ methotrexate, AMGEVIT