Country: Unjoni Ewropea
Lingwa: Sloven
Sors: EMA (European Medicines Agency)
adalimumab
Sandoz GmbH
L04AB04
adalimumab
Imunosupresivi
Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Rheumatoid arthritisHyrimoz 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. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz lahko podana kot monotherapy v primeru nestrpnost do metotreksatom ali ko nadaljnje zdravljenje z metotreksatom ni primerno. Adalimumab je dokazano, da zmanjša stopnjo napredovanja skupno škodo, merjeno z X-ray in izboljšati telesno funkcijo, če bi imeli v kombinaciji z metotreksatom. Juvenile idiopathic arthritis- Polyarticular juvenile idiopathic arthritisHyrimoz 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). Hyrimoz lahko podana kot monotherapy v primeru nestrpnost do metotreksatom ali ko nadaljnje zdravljenje z metotreksatom ni primerno. Adalimumab ni raziskano pri bolnikih, starih manj kot 2 leti. - Enthesitis-related arthritisHyrimoz 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 spondyloarthritis- Ankylosing spondylitis (AS)Hyrimoz 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 ASHyrimoz 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. Psoriatic arthritisHyrimoz 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. Adalimumab je dokazano, da zmanjša stopnjo napredovanja perifernih skupno škodo, merjeno z X-ray pri bolnikih z polyarticular simetrični podtipov bolezni in izboljšanje telesne funkcije. PsoriasisHyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisHyrimoz 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)Hyrimoz 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. Crohn’s diseaseHyrimoz 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 diseaseHyrimoz 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. Paediatric ulcerative colitisHyrimoz 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. Ulcerative colitisHyrimoz 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. UveitisHyrimoz 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 uveitisHyrimoz 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: 13
Pooblaščeni
2018-07-26
123 9. POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku. Ne zamrzujte. Napolnjeni injekcijski brizgi shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo. 10. POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI 11. IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Avstrija 12. ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/18/1286/007 2 napolnjeni injekcijski brizgi 13. ŠTEVILKA SERIJE Lot 14. NAČIN IZDAJANJA ZDRAVILA 15. NAVODILA ZA UPORABO 16. PODATKI V BRAILLOVI PISAVI Hyrimoz 20 mg/0,4 ml 17. EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako. 18. EDINSTVENA OZNAKA – V BERLJIVI OBLIKI PC SN NN 124 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU BESEDILO NA OMOTU 1. IME ZDRAVILA Hyrimoz 20 mg injekcija adalimumab 2. IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM SANDOZ a Novartis Division 3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 4. ŠTEVILKA SERIJE Lot 5. DRUGI PODATKI s.c. 20 mg/0,4 ml 125 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAČITEV NA BRIZGI 1. IME ZDRAVILA IN POT(I) UPORABE Hyrimoz 20 mg injekcija adalimumab s.c. 2. POSTOPEK UPORABE 3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 4. ŠTEVILKA SERIJE Lot 5. VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 6. DRUGI PODATKI 0,4 ml 126 PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA VEČKRATNO PAKIRANJE (VKLJUČUJE MODRO OKENCE) 1. IME ZDRAVILA Hyrimoz 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab 2. NAVEDBA ENE ALI VEČ UČINKOVIN Ena 0,2 ml napolnjena injekcijska brizga vsebuje 20 mg adalimumaba. 3. SEZNAM POMOŽNIH SNOVI Pomožne snovi: adipinska kislina, manitol, polisorbat 80, klorovodikova kislina, natrijev hidroksid, voda za injekcije. 4. FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje 20 mg/0,2 ml Večkratno pakiranje: 2 napolnjeni injekci Aqra d-dokument sħiħ
1 PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 2 1. IME ZDRAVILA Hyrimoz 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hyrimoz 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hyrimoz 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 2. KAKOVOSTNA IN KOLIČINSKA SESTAVA Hyrimoz 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,4 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 20 mg adalimumaba. Hyrimoz 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba. Hyrimoz 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En 0,8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba. Adalimumab je rekombinantno humano monoklonsko protitelo, proizvedeno v celicah jajčnika kitajskega hrčka. Za celoten seznam pomožnih snovi glejte poglavje 6.1. 3. FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku (SensoReady) bistra do rahlo opalescentna, brezbarvna ali rahlo rumenkasta raztopina 4. KLINIČNI PODATKI 4.1 TERAPEVTSKE INDIKACIJE Revmatoidni artritis Zdravilo Hyrimoz je v kombinaciji z metotreksatom indicirano za: • Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten. • Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata. Zdravilo Hyrimoz je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno. Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom. 3 Juvenilni idiopatski artritis _Poliartikularni juvenilni Aqra d-dokument sħiħ