Valsts: Eiropas Savienība
Valoda: slovēņu
Klimata pārmaiņas: EMA (European Medicines Agency)
adalimumab
Amgen Europe B.V.
L04AB04
adalimumab
Imunosupresivi
Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
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. , zdravljenje hude, aktivne in postopno revmatoidni artritis pri odraslih, ki še niso bila obdelana z metotreksatom. , Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita zmanjšuje stopnja napredovanje skupno škodo, merjeno z x-ray in izboljšuje telesno funkcijo, če bi imeli v kombinaciji z 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 lahko podana kot monotherapy v primeru nestrpnost do metotreksatom ali ko nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost v monotherapy glej oddelek 5. Adalimumab ni raziskano pri bolnikih, starih manj kot 2 leti. 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 zmanjšuje stopnja napredovanje perifernih skupno škodo, merjeno z x-ray pri bolnikih z polyarticular simetrični podtipov bolezni (glej poglavje 5. 1), in izboljša telesno funkcijo. 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 in 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.
Revision: 11
Pooblaščeni
2017-03-21
63 9. POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku. Ne zamrzujte. Shranjujte v originalni 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 Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nizozemska 12. ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/001 13. ŠTEVILKA SERIJE Lot 14. NAČIN IZDAJANJA ZDRAVILA 15. NAVODILA ZA UPORABO 16. PODATKI V BRAILLOVI PISAVI AMGEVITA 20 mg brizga 17. EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _ Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako. 18. EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _ PC SN NN 64 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA ZA BRIZGO 1. IME ZDRAVILA IN POT(I) UPORABE AMGEVITA 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 0,4 ml 6. DRUGI PODATKI 65 PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 1. IME ZDRAVILA AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab 2. NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 40 mg adalimumaba v 0,8 ml raztopine. 3. SEZNAM POMOŽNIH SNOVI Ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije. 4. FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje 1 napolnjena injekcijska brizga. 2 napolnjeni injekcijski brizgi. 4 napolnjene injekcijske brizge. 5. POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana uporaba. Pred uporabo preberite priloženo navodilo! Za enkratno uporabo. 6. POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom! 7. DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 66 9. POSEBNA NAVODILA ZA SHRANJEVANJE Sh Izlasiet visu dokumentu
1 PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 2 1. IME ZDRAVILA AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi AMGEVITA 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 2. KAKOVOSTNA IN KOLIČINSKA SESTAVA AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z enim odmerkom vsebuje 20 mg adalimumaba v 0,4 ml raztopine (50 mg/ml). AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba v 0,8 ml raztopine (50 mg/ml). AMGEVITA 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba v 0,8 ml raztopine (50 mg/ml). Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah ovarija kitajskega hrčka. Za celoten seznam pomožnih snovi glejte poglavje 6.1. 3. FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku (SureClick) Bistra in brezbarvna do rahlo rumena raztopina. 4. KLINIČNI PODATKI 4.1 TERAPEVTSKE INDIKACIJE Revmatoidni artritis Zdravilo AMGEVITA je v kombinaciji z metotreksatom indicirano za: • Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča antirevmatična zdravila (DMARDs – _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 AMGEVITA 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 zdravilo AMGEVITA upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se Izlasiet visu dokumentu