Hyrimoz

Maa: Euroopan unioni

Kieli: sloveeni

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

adalimumab

Saatavilla:

Sandoz GmbH

ATC-koodi:

L04AB04

INN (Kansainvälinen yleisnimi):

adalimumab

Terapeuttinen ryhmä:

Imunosupresivi

Terapeuttinen alue:

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Pooblaščeni

Valtuutus päivämäärä:

2018-07-26

Pakkausseloste

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

Valmisteyhteenveto

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