Hukyndra

Țară: Uniunea Europeană

Limbă: daneză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

adalimumab

Disponibil de la:

Stada Arzneimittel AG

Codul ATC:

L04AB04

INN (nume internaţional):

adalimumab

Grupul Terapeutică:

immunosuppressiva

Zonă Terapeutică:

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

Indicații terapeutice:

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 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 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 er ikke blevet undersøgt hos patienter i alderen mindre end 2 år. 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 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. 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 og 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.

Rezumat produs:

Revision: 4

Statutul autorizaţiei:

autoriseret

Data de autorizare:

2021-11-15

Prospect

116
B. INDLÆGSSEDDEL
117
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
HUKYNDRA 40 MG INJEKTIONSVÆSKE, OPLØSNING I FYLDT INJEKTIONSSPRØJTE
adalimumab
Dette lægemiddel er underlagt supplerende overvågning. Dermed kan
nye sikkerhedsoplysninger
hurtigt tilvejebringes. Du kan hjælpe ved at indberette alle de
bivirkninger, du får. Se sidst i punkt 4,
hvordan du indberetter bivirkninger.
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT BRUGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Din læge vil også udlevere et PATIENTKORT, der indeholder vigtige
sikkerhedsinformationer, som
du skal være opmærksom på, før du begynder at tage Hukyndra og
under din behandling med
Hukyndra. Opbevar PATIENTKORTET på dig UNDER DIN BEHANDLING OG I 4
MÅNEDER EFTER DIN
SIDSTE INJEKTION MED HUKYNDRA.
-
Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give den til
andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger,
herunder bivirkninger, som
ikke er nævnt i denne indlægsseddel. Se punkt 4.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Hukyndra
3.
Sådan skal du bruge Hukyndra
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
7.
Brugsanvisning
1.
VIRKNING OG ANVENDELSE
Hukyndra indeholder det aktive stof adalimumab.
Hukyndra bruges til behandling af:

Reumatoid artritis

Polyartikulær juvenil idiopatisk artritis

Entesopati-relateret artritis

Ankyloserende spondylitis

Aksial spondyloartritis uden radiografiske tegn på ankyloserende
spondylitis

Psoriasisartritisis

Plaque-psoriasis

Hidrosadenitis suppurativa

Crohns sygdom

Colitis ulcerosa

Ikke-infektiøs uveitis
Det aktive stof i Hukyndra, adalimumab, er et humant mo

Caracteristicilor produsului

1
BILAG I
PRODUKTRESUMÉ
2
▼Dette lægemiddel 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.
LÆGEMIDLETS NAVN
Hukyndra 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Hukyndra 40 mg injektionsvæske, opløsning i fyldt pen
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hukyndra 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte
En fyldt 0,4 ml injektionssprøjte indeholder 40 mg adalimumab.
Hukyndra 40 mg injektionsvæske, opløsning i fyldt pen
En fyldt 0,4 ml pen indeholder 40 mg adalimumab.
Adalimumab er et rekombinant humant monoklonalt antistof fremstillet i
ovarieceller fra kinesiske
hamstre.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Injektionsvæske, opløsning.
Klar og farveløs injektionsvæske, opløsning.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Reumatoid artritis
Hukyndra i kombination med methotrexat er indiceret til:

behandling af moderat til alvorlig aktiv reumatoid artritis hos voksne
patienter, hvor responsen
på sygdomsmodificerende antireumatiske lægemidler (DMARD’er),
herunder methotrexat, har
været utilstrækkeligt.

behandling af alvorlig, aktiv og progressiv reumatoid artritis hos
voksne, som ikke tidligere er
blevet behandlet med methotrexat.
Hukyndra kan gives som monoterapi i tilfælde af intolerans over for
methotrexat, eller hvis fortsat
behandling med methotrexat er uhensigtsmæssig.
Adalimumab har vist sig at hæmme udviklingen af leddestruktion
bedømt ved måling med røntgen og
at forbedre den fysiske funktion, når det gives i kombination med
methotrexat.
Juvenil idiopatisk artritis
_Polyartikulær juvenil idiopatisk artritis_
Hukyndra er i kombination med methotrexat er indiceret til behandling
af aktiv polyartikulær juvenil
idiopatisk artritis hos patienter fra 2 år, som har haft
utilstrækkelig respons på en eller flere
3
DMARD�