Country: European Union
Language: Slovenian
Source: 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. 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 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. Adalimumab ni raziskano pri bolnikih, starih manj kot 2 leti. 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. Adalimumab je dokazano, da zmanjša stopnjo napredovanja perifernih skupno škodo, merjeno z X-ray pri bolnikih z polyarticular simetrični podtipov bolezni (glej poglavje 5. 1), ter za izboljšanje telesne 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 in 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
Pooblaščeni
2021-11-15
110 8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 9. POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku. Ne zamrzujte. Za podrobnosti alternativnega shranjevanja glejte navodilo za uporabo. Napolnjeno brizgo 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 STADA Arzneimittel AG Stadastrasse 2–18 61118 Bad Vilbel Nemčija 12. ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/21/1589/001 EU/1/21/1589/002 EU/1/21/1589/003 13. ŠTEVILKA SERIJE Lot 14. NAČIN IZDAJANJA ZDRAVILA 15. NAVODILA ZA UPORABO 16. PODATKI V BRAILLOVI PISAVI Hukyndra 40 mg 17. EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako. 111 18. EDINSTVENA OZNAKA – V BERLJIVI OBLIKI PC SN NN 112 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU BESEDILO NA HRBTU OMOTA 1. IME ZDRAVILA Hukyndra 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab 2. IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM STADA Arzneimittel AG 3. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 4. ŠTEVILKA SERIJE Lot 5. DRUGI PODATKI Za informacije o shranjevanju glejte navodilo za uporabo. 40 mg/0,4 ml 113 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA BRIZGI 1. IME ZDRAVILA IN POT(I) UPORABE Hukyndra 40 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 40 mg/0,4 ml 6. DRUGI PODATKI 114 PODATKI NA ZUNANJI OVOJNINI ŠKATLA NAPOLNJENEGA PERESNIKA 1. IME ZDRAVILA Hukyndra 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab 2. NAVEDBA ENE ALI VEČ UČINKOVIN En 0,4-ml napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba. 3. SEZNAM POMOŽNIH SNOVI natrijev klorid, saharoza, polisorbat 80, voda za inje Read the complete document
1 PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 2 Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo hitreje na voljo nove informacije o njegovi varnosti. Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnem neželenem učinku zdravila. Glejte poglavje 4.8, kako poročati o neželenih učinkih. 1. IME ZDRAVILA Hukyndra 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hukyndra 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 2. KAKOVOSTNA IN KOLIČINSKA SESTAVA Hukyndra 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,4-ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba. Hukyndra 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En 0,4-ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba. Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka. Za celoten seznam pomožnih snovi glejte poglavje 6.1. 3. FARMACEVTSKA OBLIKA raztopina za injiciranje bistra in brezbarvna raztopina za injiciranje 4. KLINIČNI PODATKI 4.1 TERAPEVTSKE INDIKACIJE Revmatoidni artritis Zdravilo Hukyndra je v kombinaciji z metotreksatom indicirano za: zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, kadar odziv na imunomodulirajoča zdravila (DMARD-_ disease-modifying anti-rheumatic drugs_), vključno z metotreksatom, ni zadosten; zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata. Zdravilo Hukyndra 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 idiopatski artritis_ Zdravilo Hukyndra je v kombinaciji z Read the complete document