Libmyris

Negara: Uni Eropa

Bahasa: Kroasia

Sumber: EMA (European Medicines Agency)

Bahan aktif:

adalimumab

Tersedia dari:

Stada Arzneimittel AG

Kode ATC:

L04AB04

INN (Nama Internasional):

adalimumab

Kelompok Terapi:

imunosupresivi

Area terapi:

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

Indikasi Terapi:

Rheumatoid arthritisLibmyris 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. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisLibmyris 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. Libmyris 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. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. Enthesitis-related arthritisLibmyris 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. Axial spondyloarthritisAnkylosing spondylitis (AS)Libmyris 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 ASLibmyris 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 arthritisLibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti i poboljšati tjelesne funkcije. PsoriasisLibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisLibmyris 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)Libmyris 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 i 5. Crohn’s diseaseLibmyris 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 diseaseLibmyris 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 colitisLibmyris 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 colitisLibmyris 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. UveitisLibmyris 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 uveitisLibmyris 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.

Ringkasan produk:

Revision: 1

Status otorisasi:

odobren

Tanggal Otorisasi:

2021-11-12

Selebaran informasi

119
B. UPUTA O LIJEKU
120
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
LIBMYRIS 40 MG OTOPINA ZA INJEKCIJU U NAPUNJENOJ ŠTRCALJKI
adalimumab
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava pogledajte dio 4.
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI 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 Libmyris. KARTICU
S PODSJETNIKOM ZA BOLESNIKA DRŽITE KOD SEBE ZA VRIJEME LIJEČENJA I
JOŠ 4 MJESECA NAKON
POSLJEDNJE INJEKCIJE LIJEKA LIBMYRIS.
-
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 Libmyris i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati lijek Libmyris
3.
Kako primjenjivati lijek Libmyris
4.
Moguće nuspojave
5.
Kako čuvati lijek Libmyris
6.
Sadržaj pakiranja i druge informacije
7.
Upute za uporabu
1.
ŠTO JE LIBMYRIS I ZA ŠTO SE KORISTI
Libmyris sadrži djelatnu tvar adalimumab.
Libmyris se koristi za liječenje:

reumatoidnog artritisa

poliartikularnog juvenilnog idiopatskog artritisa

artritisa povezanog s entezitisom

ankilozantnog spondilitisa

aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog
spondilitisa

psorijatičnog artritisa

plak psorijaze

gnojnog hidradenitisa (Hidradenitis suppurativa)

Crohnove bolesti

ulceroznog kolitisa

nezaraznog

Karakteristik produk

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
▼Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih radnika se traži da prijave svaku sumnju
na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Libmyris 40 mg otopina za injekciju u napunjenoj štrcaljki
Libmyris 40 mg otopina za injekciju u napunjenoj brizgalici
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Libmyris 40 mg otopina za injekciju u napunjenoj štrcaljki
Jedna napunjena štrcaljka s jednokratnom dozom od 0,4 ml sadrži 40
mg adalimumaba.
Libmyris 40 mg otopina za injekciju u napunjenoj brizgalici
Jedna napunjena brizgalica s jednokratnom dozom od 0,4 ml sadrži 40
mg adalimumaba.
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.
Bistra i bezbojna otopina za injekciju.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Reumatoidni artritis
U kombinaciji s metotreksatom, Libmyris 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 drugs_ DMARD), uključujući
metotreksat, nije postignut
zadovoljavajući odgovor.

liječenje teškog oblika aktivnog i progresivnog reumatoidnog
artritisa u odraslih bolesnika koji
nisu bili prethodno liječeni metotreksatom.
Libmyris se može davati i kao monoterapija ako bolesnik ne podnosi
metotreksat ili kada nastavak
terapije metotreksatom nije prikladan.
Radiološke su pretrage pokazale da adalimumab usporava brzinu
progresije oštećenja zglobova i
poboljšava fizičku funkciju kada se daje u kombinaciji s
metotreksatom.
Juvenilni idiopatski artritis
_Poliartikularni juvenilni idiopatski artritis_
Libmyris je, u kombinaciji s metotreksatom, indicirana za liječenj