Hyrimoz

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Active ingredient:

adalimumab

Available from:

Sandoz GmbH

ATC code:

L04AB04

INN (International Name):

adalimumab

Therapeutic group:

Immunosoppressanti

Therapeutic area:

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous

Therapeutic indications:

Rheumatoid arthritisHyrimoz 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. Hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. 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 arthritis- Polyarticular juvenile idiopathic arthritisHyrimoz 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). Hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. Adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. - Enthesitis-related arthritisHyrimoz 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 spondyloarthritis- Ankylosing spondylitis (AS)Hyrimoz 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 ASHyrimoz 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. Psoriatic arthritisHyrimoz 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, u li jtejjeb il-funzjoni fiżika. PsoriasisHyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisHyrimoz 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)Hyrimoz 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. Crohn’s diseaseHyrimoz 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 diseaseHyrimoz 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.  Paediatric ulcerative colitisHyrimoz 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. Ulcerative colitisHyrimoz 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. UveitisHyrimoz 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 uveitisHyrimoz 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.

Product summary:

Revision: 13

Authorization status:

Awtorizzat

Authorization date:

2018-07-26

Patient Information leaflet

177
B. FULJETT TA’ TAGĦRIF
178
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
HYRIMOZ 20 MG SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA
GĦAL-LEST
adalimumab
20 MG/0.4 ML
AQRA SEW DAN IL-FULJETT KOLLU QABEL MAT-TIFEL JEW IT-TIFLA TIEGĦEK
JIBDEW JUŻAŻW DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI IMPORTANTI.
-
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
Hyrimoz u waqt il-kura b’Hyrimoz. Żomm il-
KARTUNA TA’ TFAKKIR GĦALL-PAZJENT
miegħek jew
mat-tifel jew tifla tiegħek waqt il-kura tiegħek u għal 4 xhur wara
l-aħħar injezzjoni ta’ Hyrimoz
tat-tifel jew tifla tiegħek.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lit-tifel jew it-tifla tiegħek biss.
M’għandekx tgħaddiha lil persuni
oħra. Tista’ tagħmlilhom il-ħsara anke jekk għandhom l-istess
sinjali ta’ mard bħal tat-tifel jew
tat-tifla tiegħek.
-
Jekk it-tifel jew it-tifla tiegħek ikollhom 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 Hyrimoz u għalxiex jintuża
2.
X’għandek tkun taf qabel mat-tifel jew it-tifla tiegħek jużaw
Hyrimoz
3.
Kif għandek tuża Hyrimoz
4.
Effetti sekondarji possibbli
5.
Kif taħżen Hyrimoz
6.
Kontenut tal-pakkett u informazzjoni oħra
7.
Istruzzjonijiet għall-użu
1.
X’INHU HYRIMOZ U GЋALXIEX JINTUŻA
Hyrimoz fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq
is-sistema immuni (tad-difiża) tal-
ġisem.
Hyrimoz huwa intenzjonat għall-kura tal-mard infjammatorju li ġej:
•
artrite attiva idjopatika poliartikulari taż-żgħażagħ,
•
artrite relatata mal-entesite,
•
psorjasi tal-plakka fit-tfal,
•
il-marda
_Crohn _
(
_Cro

Summary of Product characteristics

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Hyrimoz 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Hyrimoz 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Hyrimoz 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Hyrimoz 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Kull siringa mimlija għal-lest b’doża waħda ta’ 0.4 mL fiha 20
mg ta’ adalimumab.
Hyrimoz 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Kull siringa mimlija għal-lest b’doża waħda ta’ 0.8 mL fiha 40
mg adalimumab.
Hyrimoz 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest
Kull pinna mimlija għal-lest b’doża waħda ta’ 0.8 mL fiha 40 mg
adalimumab.
Adalimumab huwa anti-korp uman monoklonali rikombinanti, prodott
fiċ-ċelluli tal-ovarji
tal-ħamster ċiniż.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni (injezzjoni) f’siringa mimlija
għal-lest
Soluzzjoni għall-injezzjoni (injezzjoni) f’pinna mimlija għal-lest
(SensoReady)
Soluzzjoni ċara għal ftit opalexxenti, bla kulur jew tagħti ftit
fl-isfar.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Artrite rewmatika
Hyrimoz, flimkien ma’ methotrexate, huwa indikat għall-:
•
kura ta’ artrite rewmatika attiva minn moderata sa severa
f’pazjenti adulti, meta r-rispons
tagħhom għal mediċini antirewmatiċi li jaffetwaw il-proċess
tal-mard, inkluż methotrexate, ma
kinitx adegwata.
•
kura ta’ artrite rewmatika attiva u progressiva severa f’adulti li
ma jkunux ingħataw kura
b’methotrexate qabel.
Hyrimoz 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’
_X-ray_
, u li