Libmyris

Maa: Euroopan unioni

Kieli: sloveeni

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

adalimumab

Saatavilla:

Stada Arzneimittel AG

ATC-koodi:

L04AB04

INN (Kansainvälinen yleisnimi):

adalimumab

Terapeuttinen ryhmä:

Imunosupresivi

Terapeuttinen alue:

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

Käyttöaiheet:

Rheumatoid arthritisLibmyris 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. Libmyris 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 arthritisLibmyris 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. Libmyris 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 arthritisLibmyris 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 spondyloarthritisAnkylosing spondylitis (AS)Libmyris 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 ASLibmyris 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 arthritisLibmyris 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 in izboljšanje telesne funkcije. PsoriasisLibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasisLibmyris 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)Libmyris 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 diseaseLibmyris 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 diseaseLibmyris 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 colitisLibmyris 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 colitisLibmyris 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. UveitisLibmyris 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 uveitisLibmyris 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.

Tuoteyhteenveto:

Revision: 1

Valtuutuksen tilan:

Pooblaščeni

Valtuutus päivämäärä:

2021-11-12

Pakkausseloste

110
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/1/21/1590/001
EU/1/21/1590/002
EU/1/21/1590/003
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Libmyris 40 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
111
NN
112
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
BESEDILO NA HRBTU OMOTA
1.
IME ZDRAVILA
Libmyris 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
Libmyris 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
Libmyris 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 injekcije,
klorovodikova kislina in natrijev h

Valmisteyhteenveto

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
Libmyris 40 mg raztopina za injiciranje v napolnjeni injekcijski
brizgi
Libmyris 40 mg raztopina za injiciranje v napolnjenem injekcijskem
peresniku
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Libmyris 40 mg raztopina za injiciranje v napolnjeni injekcijski
brizgi
Ena 0,4-ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg
adalimumaba.
Libmyris 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 Libmyris 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 Libmyris 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 Libmyris je v kombinaciji z