국가: 유럽 연합
언어: 크로아티아어
출처: EMA (European Medicines Agency)
adalimumab
Stada Arzneimittel AG
L04AB04
adalimumab
imunosupresivi
Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
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. 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 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. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. 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. 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 (vidi odjeljak 5. 1) i poboljšati tjelesne funkcije. 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 i 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.
Revision: 4
odobren
2021-11-15
121 B. UPUTA O LIJEKU 122 UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA HUKYNDRA 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 Hukyndra. KARTICU S PODSJETNIKOM ZA BOLESNIKA DRŽITE KOD SEBE ZA VRIJEME LIJEČENJA I JOŠ 4 MJESECA NAKON POSLJEDNJE INJEKCIJE LIJEKA HUKYNDRA. - 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 Hukyndra i za što se koristi 2. Što morate znati prije nego počnete primjenjivati lijek Hukyndra 3. Kako primjenjivati lijek Hukyndra 4. Moguće nuspojave 5. Kako čuvati lijek Hukyndra 6. Sadržaj pakiranja i druge informacije 7. Upute za uporabu 1. ŠTO JE HUKYNDRA I ZA ŠTO SE KORISTI Hukyndra sadrži djelatnu tvar adalimumab. Hukyndra 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 전체 문서 읽기
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 Hukyndra 40 mg otopina za injekciju u napunjenoj štrcaljki Hukyndra 40 mg otopina za injekciju u napunjenoj brizgalici 2. KVALITATIVNI I KVANTITATIVNI SASTAV Hukyndra 40 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka s jednokratnom dozom od 0,4 ml sadrži 40 mg adalimumaba. Hukyndra 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, Hukyndra 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. Hukyndra 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_ Hukyndra je, u kombinaciji s metotreksatom, indicirana za liječenj 전체 문서 읽기