Amgevita

Țară: Uniunea Europeană

Limbă: finlandeză

Sursă: EMA (European Medicines Agency)

Cumpara asta acum

Prospect Prospect (PIL)
18-01-2023

Ingredient activ:

adalimumabi

Disponibil de la:

Amgen Europe B.V.

Codul ATC:

L04AB04

INN (nume internaţional):

adalimumab

Grupul Terapeutică:

immunosuppressantit

Zonă Terapeutică:

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

Indicații terapeutice:

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. hoitoon vaikean, aktiivisen ja progressiivisen nivelreuman hoitoon aikuisilla, joita ei aiemmin ole hoidettu metotreksaatilla. ,  Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita vähentää määrä etenemistä nivelvaurioita mitattuna x-ray ja parantaa fyysistä toimintakykyä, kun sitä annetaan yhdessä metotreksaatin kanssa. 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 voidaan antaa monoterapiana, jos potilas ei siedä metotreksaattia tai metotreksaattihoidon jatkaminen ei ole tarkoituksenmukaista (tehoa monoterapiana ks. kohta 5. Humiraa ei ole tutkittu potilailla, joiden ikä on alle 2 vuotta. 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 vähentää määrä etenemistä perifeeristen nivelvaurioiden mitattuna x-ray potilailla, joilla idiopaattisen symmetrinen alatyypit sairauden (ks. kohta 5. 1) ja parantaa fyysistä toimintakykyä. 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 ja 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.

Rezumat produs:

Revision: 11

Statutul autorizaţiei:

valtuutettu

Data de autorizare:

2017-03-21

Prospect

                                80
B. PAKKAUSSELOSTE
81
PAKKAUSSELOSTE: TIETOA KÄYTTÄJÄLLE
AMGEVITA 20 MG INJEKTIONESTE, LIUOS, ESITÄYTETTY RUISKU
AMGEVITA 40 MG INJEKTIONESTE, LIUOS, ESITÄYTETTY RUISKU
adalimumabi
LUE TÄMÄ PAKKAUSSELOSTE HUOLELLISESTI, ENNEN KUIN ALOITAT LÄÄKKEEN
KÄYTTÄMISEN, SILLÄ SE SISÄLTÄÄ
SINULLE TÄRKEITÄ TIETOJA.
-
Säilytä tämä pakkausseloste. Voit tarvita sitä myöhemmin.
-
Lääkäri antaa sinulle
POTILASKORTIN
, jossa kerrotaan ennen hoidon aloittamista ja Amgevita-
hoidon aikana huomioitavat turvallisuusohjeet. Pidä tämä
POTILASKORTTI
mukanasi.
-
Jos sinulla on kysyttävää, käänny lääkärin tai
apteekkihenkilökunnan puoleen.
-
Tämä lääke on määrätty vain sinulle eikä sitä tule antaa
muiden käyttöön. Se voi aiheuttaa
haittaa muille, vaikka heillä olisikin samanlaiset oireet kuin
sinulla.
-
Jos havaitset haittavaikutuksia, kerro niistä lääkärille tai
apteekkihenkilökunnalle. Tämä koskee
myös sellaisia mahdollisia haittavaikutuksia, joita ei ole mainittu
tässä pakkausselosteessa (ks.
kohta 4).
TÄSSÄ PAKKAUSSELOSTEESSA KERROTAAN
1.
Mitä Amgevita on ja mihin sitä käytetään
2.
Mitä sinun on tiedettävä, ennen kuin käytät Amgevitaa
3.
Miten Amgevitaa käytetään
4.
Mahdolliset haittavaikutukset
5.
Amgevitan säilyttäminen
6.
Pakkauksen sisältö ja muuta tietoa
1.
MITÄ AMGEVITA ON JA MIHIN SITÄ KÄYTETÄÄN
Amgevitan vaikuttava aine on adalimumabi. Adalimumabi on lääkeaine,
joka vaikuttaa kehon
immuunipuolustusjärjestelmään eli vastustuskykyyn.
Amgevitaa käytetään seuraavien tulehduksellisten sairauksien
hoitoon:
•
nivelreuma
•
moninivelinen lastenreuma
•
entesiitteihin liittyvä niveltulehdus
•
selkärankareuma
•
aksiaalinen spondylartriitti (ilman radiografista näyttöä
selkärankareumasta)
•
nivelpsoriaasi
•
läiskäpsoriaasi
•
hidradenitis suppurativa (HS-tauti)
•
Crohnin tauti
•
haavainen paksusuolitulehdus
•
ei-infektioperäinen uveiitti
Amgevitan vaikuttava aine, adalimumabi, on humaani monoklonaalinen
vasta-aine. Mo
                                
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Caracteristicilor produsului

                                1
LIITE I
VALMISTEYHTEENVETO
2
1.
LÄÄKEVALMISTEEN NIMI
AMGEVITA 20 mg injektioneste, liuos, esitäytetty ruisku
AMGEVITA 40 mg injektioneste, liuos, esitäytetty ruisku
AMGEVITA 40 mg injektioneste, liuos, esitäytetty kynä
2.
VAIKUTTAVAT AINEET JA NIIDEN MÄÄRÄT
AMGEVITA 20 mg injektioneste, liuos, esitäytetty ruisku
Yksi esitäytetty kerta-annosruisku sisältää 20 mg adalimumabia 0,4
millilitrassa liuosta (50 mg/ml).
AMGEVITA 40 mg injektioneste, liuos, esitäytetty ruisku
Yksi esitäytetty kerta-annosruisku sisältää 40 mg adalimumabia 0,8
millilitrassa liuosta (50 mg/ml).
AMGEVITA 40 mg injektioneste, liuos, esitäytetty kynä
Yksi esitäytetty kerta-annoskynä sisältää 40 mg adalimumabia 0,8
millilitrassa liuosta (50 mg/ml).
Adalimumabi on rekombinantti ihmisen monoklonaalinen vasta-aine, joka
on tuotettu kiinanhamsterin
munasarjasoluissa (CHO).
Täydellinen apuaineluettelo, ks. kohta 6.1.
3.
LÄÄKEMUOTO
Injektioneste, liuos (injektioneste)
Injektioneste, liuos (injektioneste), esitäytetty kynä (SureClick)
Kirkas ja väritön tai kellertävä liuos.
4.
KLIINISET TIEDOT
4.1
KÄYTTÖAIHEET
Nivelreuma
Amgevitan ja metotreksaatin yhdistelmä on tarkoitettu:
•
keskivaikeaa tai vaikeaa, aktiivista nivelreumaa sairastavien
aikuispotilaiden hoitoon silloin, kun
varsinaisilla taudin kulkuun vaikuttavilla reumalääkkeillä (DMARD =
disease-modifying anti-
rheumatic drugs), kuten metotreksaatilla, ei ole saatu riittävää
vastetta.
•
vaikean, aktiivisen ja progressiivisen nivelreuman hoitoon aikuisilla,
jotka eivät ole aiemmin
saaneet metotreksaattihoitoa.
Amgevitaa voidaan antaa myös yksinään, jos potilas ei siedä
metotreksaattia tai metotreksaattihoidon
jatkaminen ei ole tarkoituksenmukaista.
Metotreksaattiin yhdistettynä Amgevita vähentää nivelvaurion
etenemistä röntgenkuvista mitattuna ja
parantaa fyysistä toimintakykyä.
3
Idiopaattinen juveniili artriitti
_Idiopaattinen juveniili polyartriitti _
Amgevita yhdessä metotreksaatin kanssa on tarkoitettu
käytettäväksi aktiivisen id
                                
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