Solymbic

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
10-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
10-07-2018
Public Assessment Report Public Assessment Report (PAR)
07-04-2017

Active ingredient:

adalimumab

Available from:

Amgen Europe B.V.

ATC code:

L04AB04

INN (International Name):

adalimumab

Therapeutic group:

Immunosoppressanti

Therapeutic area:

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

Therapeutic indications:

Jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-Sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2017-03-22

Patient Information leaflet

                                64
B. FULJETT TA’ TAGĦRIF
65
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
SOLYMBIC 20
MG SOLUZZJONI GĦALL-INJEZZJONI F’SIRINGA MIMLIJA GĦAL-LEST
SOLYMBIC 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’ Twissija
tal-Pazjent, li fiha informazzjoni importanti
dwar is-sigurtà, li inti għandek tkun taf biha qabel it-tifel jew
it-tifla tiegħek jingħataw
SOLYMBIC u waqt it-trattament b’SOLYMBIC. Żomm il-Kartuna ta’
Twissija tal-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 SOLYMBIC u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża SOLYMBIC
3.
Kif għandek tuża SOLYMBIC
4.
Effetti sekondarji possibbli
5.
Kif taħżen SOLYMBIC
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU SOLYMBIC U GЋALXIEX JINTUŻA
SOLYMBIC fih is-sustanza attiva adalimumab li huwa aġent silettiv
immuno suppressiv.
SOLYMBIC huwa intenzjonat għat-trattament tal-artrite rewmatika,
artrite relatata mal-entesite fi tfal
ta’ 6 snin sa 17-il sena, infjammazzjoni tal-verteb
                                
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Summary of Product characteristics

                                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
SOLYMBIC 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest.
SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest.
SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
SOLYMBIC 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 (50 mg/mL) ta’
soluzzjoni.
SOLYMBIC 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 (50 mg/mL) ta’
soluzzjoni.
SOLYMBIC 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 (50 mg/mL) ta’
soluzzjoni.
Adalimumab huwa anti-korp monoklonali rikombinanti uman espress
fiċ-ċelluli tal-Ovarju tal-
Ħamster Ċiniż.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
SOLYMBIC 20 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f’siringa mimlija
għal-lest
Soluzzjoni għall-injezzjoni.
SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f’pinna mimlija
għal-lest (SureClick)
Soluzzjoni għall-injezzjoni.
Soluzzjoni ċara u bla kulur sa kemmxejn safranija.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Artrite rewmatika
SOLYMBIC, flimkien ma’ methotrexate, huwa indikat għal:
•
trattament ta’ artrite rewmatika attiva minn moderata sa severa
f’pazjenti adulti, meta r-ris
                                
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Similar products

Active ingredient adalimumab

adalimumab

ATC code L04AB04

L04AB04

Marketed by Amgen Europe B.V.

Amgen Europe B.V.

INN (International Name) adalimumab

adalimumab

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Patient Information leaflet Patient Information leaflet Bulgarian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-07-2018
Public Assessment Report Public Assessment Report Bulgarian 07-04-2017
Patient Information leaflet Patient Information leaflet Spanish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 10-07-2018
Public Assessment Report Public Assessment Report Spanish 07-04-2017
Patient Information leaflet Patient Information leaflet Czech 10-07-2018
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Public Assessment Report Public Assessment Report Czech 07-04-2017
Patient Information leaflet Patient Information leaflet Danish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Danish 10-07-2018
Public Assessment Report Public Assessment Report Danish 07-04-2017
Patient Information leaflet Patient Information leaflet German 10-07-2018
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Public Assessment Report Public Assessment Report German 07-04-2017
Patient Information leaflet Patient Information leaflet Estonian 10-07-2018
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Public Assessment Report Public Assessment Report Estonian 07-04-2017
Patient Information leaflet Patient Information leaflet Greek 10-07-2018
Summary of Product characteristics Summary of Product characteristics Greek 10-07-2018
Public Assessment Report Public Assessment Report Greek 07-04-2017
Patient Information leaflet Patient Information leaflet English 10-07-2018
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Public Assessment Report Public Assessment Report English 07-04-2017
Patient Information leaflet Patient Information leaflet French 10-07-2018
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