Jayempi

Country: Եվրոպական Միություն

language: մալթերեն

source: EMA (European Medicines Agency)

active_ingredient:

azathioprine

MAH:

Nova Laboratories Ireland Limited

ATC_code:

L04AX01

INN:

azathioprine

therapeutic_group:

Immunosoppressanti

therapeutic_area:

Rifjut ta 'Graft

therapeutic_indication:

Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidBehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm IgG antibodieschronic refractory idiopathic thrombocytopenic purpuraJayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

leaflet_short:

Revision: 1

authorization_status:

Awtorizzat

authorization_date:

2021-06-21

PIL

29
B. FULJETT TA’ TAGĦRIF
30
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
JAYEMPI 10 MG/ML SOSPENSJONI ORALI
azathioprine
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar, jew
lill-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar
jew lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Jayempi u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Jayempi
3.
Kif għandek tieħu Jayempi
4.
Effetti sekondarji possibbli
5.
Kif taħżen Jayempi
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU JAYEMPI U GĦALXIEX JINTUŻA
Jayempi 10 mg/ml sospensjoni orali fih is-sustanza attiva
azathioprine. Dan jagħmel parti minn grupp
ta’ mediċini msejħa immunosuppressanti.
Dawn il-mediċini jnaqqsu l-attività tas-sistema immuni tiegħek
(id-difiżi tal-ġisem).
Jayempi jintuża biex:
•
Jipprevjeni lill-ġisem tiegħek milli jirrifjuta trapjant ta’
organu. Jayempi normalment jintuża
flimkien ma’ immunosoppressivi oħra għal dan il-għan
•
Jittratta xi mard fuq perjodu ta’ żmien twil fejn is-sistema immuni
tkun qed tirreaġixxi kontra l-
ġisem tiegħek. Jayempi normalment jintuża flimkien ma’ sterojdi
jew mediċini
antiinfjammatorji oħra. Dan il-mard jinkludi:
-
Artrite rewmatika severa jew poliartrite kronika (infjammazzjoni
kronika fit-tul tal-ġogi
multipli) li ma jistgħux jiġu kkontrollati b’mediċini oħra
-
Mard infjammatorju kroniku tal-musrana (mard tal-imsaren bħall-marda
ta’ Crohn u kolite
ulċerattiva)
-
Epatite kronika (epatite awtoimmuni), marda

SPC

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Jayempi 10 mg/ml sospensjoni orali
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull ml ta’ sospensjoni fih 10 mg azathioprine.
Eċċipjenti b’effett magħruf
Is-sospensjoni fiha 1.5 mg sodium benzoate (E211) f’kull ml.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Sospensjoni orali
Sospensjoni viskuża safra
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Jayempi huwa indikat flimkien ma’ sustanzi immunosoppressivi oħra
għall-profilassi ta’ rifjut ta’
trapjant f’pazjenti li jkunu qed jirċievu trapjanti alloġeniċi
tal-kliewi, tal-fwied, tal-qalb, tal-pulmun
jew tal-frixa. Azathioprine huwa indikat f’korsijiet
immunosoppressivi bħala żieda ma’ sustanzi
immunosuppressivi li jiffurmaw il-bażi tat-trattament
(immunosoppressjoni ta’ bażi).
Jayempi jintuża bħala antimetabolit immunosuppressanti jew waħdu
jew, b’mod aktar komuni,
flimkien ma’ sustanzi oħra (normalment kortikosterojdi) u/jew
proċeduri li jinfluwenzaw ir-rispons
immuni.
Jayempi huwa indikat f’pazjenti li ma jittollerawx
il-glukokortikosterojdi jew jekk ir-rispons
terapewtiku ma jkunx adegwat minkejja t-trattament b’dożi għoljin
ta’ glukokortikosterojdi, fil-mard li
ġej:
-
artrite rewmatika attiva severa (poliartrite kronika) li ma tistax
tinżamm taħt kontroll b’sustanzi
anqas tossiċi (prodotti mediċinali antirewmatiċi li jimmodifikaw
il-marda – DMARDs)
-
epatite awtoimmuni
-
lupus eritematuż sistemiku
-
dermatomijożite
-
poliarterite nodosa
-
pemfigus vulgaris u pemfigojd bulluż
-
il-marda ta’ Behçet
-
anemija emolitika awtoimmuni refrattarja, ikkawżata minn antikorpi
sħan tal-IgG
-
purpura tromboċitopenika idjopatika refrattarja kronika
Jayempi jintuża għat-trattament ta’ forom moderatament severi sa
severi ta’ marda infjammatorja tal-
imsaren (IBD) kronika (il-marda ta’ Crohn jew kolite ulċerattiva)
f’pazjenti li fihom hija meħtieġa
terapija bil-glukokorti