Yuflyma

Kraj: Unia Europejska

Język: duński

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

adalimumab

Dostępny od:

Celltrion Healthcare Hungary Kft.

Kod ATC:

L04AB04

INN (International Nazwa):

adalimumab

Grupa terapeutyczna:

immunosuppressiva

Dziedzina terapeutyczna:

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

Wskazania:

Rheumatoid arthritisYuflyma 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. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af X-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisYuflyma 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). Yuflyma 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 er ikke blevet undersøgt hos patienter i alderen mindre end 2 år. Enthesitis-related arthritisYuflyma 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)Yuflyma 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 ASYuflyma 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 (NSAIDs). Psoriatic arthritisYuflyma 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 har vist sig at reducere hastigheden af progressionen af perifere ledskader, som målt ved hjælp af X-ray i patienter med polyartikulær symmetrisk undertyper af sygdommen (se afsnit 5. 1) og at forbedre den fysiske funktion. PsoriasisYuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisYuflyma 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)Yuflyma 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 og 5. Crohn’s diseaseYuflyma 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 diseaseYuflyma 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 colitisYuflyma 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 colitisYuflyma 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. UveitisYuflyma 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 uveitisYuflyma 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.

Podsumowanie produktu:

Revision: 12

Status autoryzacji:

autoriseret

Data autoryzacji:

2021-02-11

Ulotka dla pacjenta

166
B. INDLÆ GSSEDDEL
167
INDLÆ GSSEDDEL: INFORMATION TIL PATIENTEN
YUFLYMA 40 MG INJEKTIONSVÆ SKE, OPLØSNING I FYLDT INJEKTIONSSPRØJTE
adalimumab
Dette læ gemiddel er underlagt supplerende overvågning. Dermed kan
der hurtigt tilvejebringes nye
oplysninger om sikkerheden. Du kan hjæ lpe ved at indberette alle de
bivirkninger, du får. Se i punkt.
4, hvordan du indberetter bivirkninger.
LÆ S DENNE INDLÆ GSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT BRUGE DETTE
LÆ GEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
•
Gem indlæ gssedlen. Du kan få brug for at læ se den igen.
•
Din læ ge giver dig også et
PATIENTKORT,
som indeholder vigtige sikkerhedsoplysninger, som du
skal væ re opmæ rksom på, inden du begynder at bruge Yuflyma og
under behandling med
Yuflyma. Opbevar dette
PATIENTKORT
på dig under din behandling og i 4 måneder efter din sidste
indsprøjtning med Yuflyma.
•
Spørg læ gen eller apotekspersonalet, hvis der er mere, du vil vide.
•
Læ gen har ordineret dette læ gemiddel til dig personligt. Lad
derfor væ re med at give medicinen
til andre. Det kan væ re skadeligt for andre, selvom de har samme
symptomer, som du har
•
Kontakt læ gen eller apotekspersonalet, hvis du får bivirkninger,
herunder bivirkninger, som ikke
er næ vnt i denne indlæ gsseddel. Se punkt 4.
OVERSIGT OVER INDLÆ GSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at bruge Yuflyma
3.
Sådan skal du bruge Yuflyma
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
7.
Brugervejledning
1.
VIRKNING OG ANVENDELSE
Yuflyma indeholder det aktive stof adalimumab, et læ gemiddel, der
virker på din krops immunforsvar.
Yuflyma er beregnet til behandling af følgende inflammatoriske
sygdomme:
•
Rheumatoid artrit
•
Polyartikulæ r juvenil idiopatisk artrit
•
Entesopatirelateret artrit
•
Ankyloserende spondylitis
•
Axial spondyloartritis uden radiografisk evidens for ankyloserende
spondylitis
•
Psoriasisartrit
•
Plaque-psoriasis
•
Hidradenitis suppurativa
�

Charakterystyka produktu

1
BILAG I
PRODUKTRESUME
2
Dette læ gemiddel er underlagt supplerende overvågning. Dermed kan
nye sikkerhedsoplysninger
hurtigt tilvejebringes. Sundhedspersoner anmodes om at indberette alle
formodede bivirkninger. Se i
pkt. 4.8, hvordan bivirkninger indberettes.
1.
LÆ GEMIDLETS NAVN
Yuflyma 40 mg injektionsvæ ske, opløsning i fyldt injektionssprøjte
Yuflyma 40 mg injektionsvæ ske, opløsning i fyldt pen
2.
KVALITATIV OG KVANTITATIV SAMMENSÆ TNING
Yuflyma 40 mg injektionsvæ ske, opløsning i fyldt injektionssprøjte
Hver fyldte 0,4 ml enkeltdosis injektionssprøjte indeholder 40 mg
adalimumab.
Yuflyma 40 mg injektionsvæ ske, opløsning i fyldt pen
Hver fyldte 0,4 ml enkeltdosis pen indeholder 40 mg adalimumab.
Adalimumab er et rekombinant humant monoklonalt antistof fremstillet i
ovarieceller fra kinesiske
hamstere.
Alle hjæ lpestoffer er anført under pkt. 6.1.
3.
LÆ GEMIDDELFORM
Injektionsvæ ske, opløsning (injektion)
Klar til let opaliserende, farveløs til lysebrun opløsning.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Reumatoid artrit
Yuflyma er i kombination med methotrexat indiceret til:
•
behandling af moderat til svæ r, aktiv reumatoid artrit hos voksne
patienter, når responset på
sygdomsmodificerende antireumatiske læ gemidler, inklusive
methotrexat, har væ ret
utilstræ kkeligt.
•
behandling af alvorlig, aktiv og progressiv reumatoid artrit hos
voksne patienter, som ikke
tidligere er blevet behandlet med methotrexat.
Yuflyma kan gives som monoterapi i tilfæ lde af intolerans over for
methotrexat eller hvis fortsat
behandling med methotrexat er uhensigtsmæ ssig.
Adalimumab har vist sig at reducere progressionen af ledskader målt
ved røntgen og forbedre den
fysiske funktion, når det gives i kombination med methotrexat.
3
Juvenil idiopatisk artrit
_Polyartikulæ r Juvenil idiopatisk artrit _
Yuflyma er i kombination med methotrexat indiceret til behandling af
aktiv polyartikulæ r Juvenil
idiopatisk artrit hos patienter fra 2 år, som har haft et utilstræ
kkeligt res