Yuflyma

Država: Evropska unija

Jezik: slovenščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

adalimumab

Dostopno od:

Celltrion Healthcare Hungary Kft.

Koda artikla:

L04AB04

INN (mednarodno ime):

adalimumab

Terapevtska skupina:

Imunosupresivi

Terapevtsko območje:

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

Terapevtske indikacije:

Rheumatoid arthritisYuflyma 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. Yuflyma 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 arthritisYuflyma 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). Yuflyma 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 arthritisYuflyma 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)Yuflyma 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 ASYuflyma 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 (NSAIDs). Psoriatic arthritisYuflyma 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 (glej poglavje 5. 1), ter za izboljšanje telesne funkcije. PsoriasisYuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisYuflyma 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)Yuflyma 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 diseaseYuflyma 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 diseaseYuflyma 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 colitisYuflyma 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 colitisYuflyma 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. UveitisYuflyma 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 uveitisYuflyma 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.

Povzetek izdelek:

Revision: 12

Status dovoljenje:

Pooblaščeni

Datum dovoljenje:

2021-02-11

Navodilo za uporabo

148
EU/1/20/1513/002 2 napolnjeni injekcijski brizgi
EU/1/20/1513/003 4 napolnjene injekcijske brizge
EU/1/20/1513/004 6 napolnjenih injekcijskih brizg
EU/1/20/1513/005 1 napolnjena injekcijska brizga s ščitnikom za iglo
EU/1/20/1513/006 2 napolnjeni injekcijski brizgi s ščitnikom za iglo
EU/1/20/1513/007 4 napolnjene injekcijske brizge s ščitnikom za iglo
EU/1/20/1513/008 6 napolnjenih injekcijskih brizg s ščitnikom za
iglo
Lot
Yuflyma 40 mg
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
PC
SN
NN
13.
ŠTEVILKA SERIJE
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
149
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
OZNAKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
Yuflyma 40 mg injekcija
adalimumab
s.c.
EXP
Lot
40 mg/0,4 ml
1.
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
4.
ŠTEVILKA SERIJE
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
6.
DRUGI PODATKI
150
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA ZA NAPOLNJEN INJEKCIJSKI PERESNIK
Yuflyma 40 mg raztopina za injiciranje v napolnjenem injekcijskem
peresniku
adalimumab
En 0,4-mililitrski napolnjen injekcijski peresnik vsebuje 40 mg
adalimumaba.
Pomožne snovi: ocetna kislina, natrijev acetat trihidrat, glicin,
polisorbat 80, voda za injekcije.
Za dodatne informacije glejte navodilo za uporabo.
raztopina za injiciranje
1 napolnjen injekcijski peresnik
2 alkoholna zloženca
2 napolnjena injekcijska peresnika
2 alkoholna zloženca
4 napolnjeni injekcijski peresniki
4 alkoholni zloženci
6 napolnjenih injekcijskih peresnikov
6 alkoholnih zložencev
subkutana uporaba
Pred uporabo preberite priloženo navodilo!
Samo za enkratno uporabo.
1.
IME ZDRAVILA
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA

Lastnosti izdelka

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
Yuflyma 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Yuflyma 40 mg raztopina za injiciranje v napolnjenem injekcijskem
peresniku
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Yuflyma 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Ena 0,4-mililitrska napolnjena injekcijska brizga z enkratnim odmerkom
vsebuje 40 mg adalimumaba.
Yuflyma 40 mg raztopina za injiciranje v napolnjenem injekcijskem
peresniku
En 0,4-ml napolnjen injekcijski peresnik z enkratnim 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 (injekcija)
Bistra do rahlo motna, brezbarvna do bledo rjavkasta raztopina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Revmatoidni artritis
Zdravilo Yuflyma v kombinaciji z metotreksatom je indicirano za:
•
zdravljenje zmernega do hudega, aktivnega revmatoidnega artritisa pri
odraslih bolnikih, če je bil
odziv na imunomodulirajoča protirevmatična zdravila, vključno z
metotreksatom, neustrezen.
•
zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa
pri odraslih, ki predhodno
niso bili zdravljeni z metotreksatom.
Zdravilo Yuflyma se lahko daje kot monoterapija v primeru intolerance
za metotreksat ali kadar je nadaljnje
zdravljenje z metotreksatom neprimerno.
Dokazano je bilo, da adalimumab upočasni hitrost napredovanja
prizadetosti sklepov, kot je bilo izmerjeno z
rentgenskim posnetkom, in izboljša telesno funkcijo, kadar se daje v
kombinaciji z metotreksatom.
Juvenilni idiopatski artritis
3
_Poliartikularni juvenilni idiopatsk