Amgevita

Riik: Euroopa Liit

keel: sloveeni

Allikas: EMA (European Medicines Agency)

Toimeaine:

adalimumab

Saadav alates:

Amgen Europe B.V.

ATC kood:

L04AB04

INN (Rahvusvaheline Nimetus):

adalimumab

Terapeutiline rühm:

Imunosupresivi

Terapeutiline ala:

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

Näidustused:

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.

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Pooblaščeni

Loa andmise kuupäev:

2017-03-21

Infovoldik

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

Toote omadused

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