Amgevita

מדינה: האיחוד האירופי

שפה: קרואטית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

adalimumab

זמין מ:

Amgen Europe B.V.

קוד ATC:

L04AB04

INN (שם בינלאומי):

adalimumab

קבוצה תרפויטית:

imunosupresivi

איזור תרפויטי:

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

סממני תרפויטית:

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. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. ,  Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita smanjuje brzinu progresije oštećenja zglobova kao što se mjeri x-ray i poboljšava fizičke funkcije, imenovanje u kombinaciji s metotreksatom. 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 može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično (na učinkovitost u monoterapija vidi odjeljak 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. 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 smanjuje brzinu progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti (vidi odjeljak 5. 1) i poboljšava fizičke značajke. 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 i 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.

leaflet_short:

Revision: 11

מצב אישור:

odobren

תאריך אישור:

2017-03-21

עלון מידע

80
B. UPUTA O LIJEKU
81
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
AMGEVITA 20 MG OTOPINA ZA INJEKCIJU U NAPUNJENOJ ŠTRCALJKI
AMGEVITA 40 MG OTOPINA ZA INJEKCIJU U NAPUNJENOJ ŠTRCALJKI
adalimumab
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Liječnik će Vam također dati
KARTICU S PODSJETNIKOM ZA BOLESNIKA
koja sadrži važne podatke o
sigurnosti s kojima morate biti upoznati prije i za vrijeme liječenja
lijekom AMGEVITA.
KARTICU S PODSJETNIKOM ZA BOLESNIKA
držite kod sebe.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi (pogledajte
dio 4).
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je AMGEVITA i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati lijek AMGEVITA
3.
Kako primjenjivati lijek AMGEVITA
4.
Moguće nuspojave
5.
Kako čuvati lijek AMGEVITA
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE AMGEVITA I ZA ŠTO SE KORISTI
AMGEVITA sadrži djelatnu tvar adalimumab, lijek koji djeluje na
imunološki (obrambeni) sustav
Vašeg tijela.
AMGEVITA je namijenjena liječenju upalnih bolesti opisanih u
nastavku:
•
reumatoidnog artritisa
•
poliartikularnog juvenilnog idiopatskog artritisa
•
artritisa povezanim s entezitisom
•
ankilozantnog spondilitisa
•
aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog
spondilitisa
•
psorijatičnog artritisa
•
plak psorijaze
•
gnojnog hidradenitisa (
_Hidradenitis suppurativa_
)
•
Crohnove bolesti
•
ulceroznog kolitisa
•
nezaraznog uveitisa
Djelatna tvar u lijeku AMGEVITA, adalimumab, ljudsko je monoklonsko
protutijelo. Monoklonska
protutijela su proteini koji se vežu za

מאפייני מוצר

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki
AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki
AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki
Jedna jednodozna napunjena štrcaljka sadrži 20 mg adalimumaba u 0,4
ml otopine (50 mg/ml).
AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki
Jedna jednodozna napunjena štrcaljka sadrži 40 mg adalimumaba u 0,8
ml otopine (50 mg/ml).
AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici
Jedna jednodozna napunjena brizgalica sadrži 40 mg adalimumaba u 0,8
ml otopine (50 mg/ml).
Adalimumab je rekombinantno humano monoklonsko protutijelo, koje se
proizvodi u stanicama jajnika
kineskog hrčka.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za injekciju (injekcija)
Otopina za injekciju (injekcija) u napunjenoj brizgalici (SureClick)
Bistra i bezbojna do blago žuta otopina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Reumatoidni artritis
U kombinaciji s metotreksatom, AMGEVITA je indicirana za:
•
liječenje umjereno teškog do teškog oblika reumatoidnog artritisa u
aktivnoj fazi u odraslih
bolesnika u kojih prethodnim liječenjem antireumaticima koji
modificiraju tijek bolesti (engl.
_disease-modifying anti-rheumatic drug_
, DMARD), uključujući metotreksat, nije postignut
zadovoljavajući odgovor.
•
liječenje teškog oblika aktivnog i progresivnog reumatoidnog
artritisa u odraslih bolesnika koji
nisu bili prethodno liječeni metotreksatom.
AMGEVITA se može davati i kao monoterapija ako bolesnik ne podnosi
metotreksat ili kada
kontinuirana primjena metotreksata nije prikladna.
AMGEVITA smanjuje brzinu progresije oštećenja zglobova mjerene
radiološki i poboljšava fizičku
funkciju kada se uzima u kombinaciji s metotreksatom.
3
Juvenilni idiopatski artritis
_Poliartikularni juvenilni idiopatski artritis _
AMGEVITA je,