Imatinib Accord

Country: Եվրոպական Միություն

language: մալթերեն

source: EMA (European Medicines Agency)

active_ingredient:

imatinib

MAH:

Accord Healthcare S.L.U.

ATC_code:

L01EA01

INN:

imatinib

therapeutic_group:

imatinib

therapeutic_area:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome

therapeutic_indication:

Imatinib Accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. - adult patients with relapsed or refractory Ph+ ALL as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. - the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatmentThe effect of imatinib on the outcome of bone marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati CML ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard. .

leaflet_short:

Revision: 20

authorization_status:

Awtorizzat

authorization_date:

2013-06-30

PIL

49
B. FULJETT TA’ TAGĦRIF
50
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
IMATINIB ACCORD 100 MG PILLOLI MIKSIJA B’RITA
IMATINIB ACCORD 400 MG PILLOLI MIKSIJA B’RITA
Imatinib
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 Imatinib Accord u għalxiex jintuża
2.
X'għandek tkun taf qabel ma tieħu Imatinib Accord
3.
Kif għandek tieħu Imatinib Accord
4.
Effetti sekondarji possibbli
5.
Kif taħżen Imatinib Accord
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU IMATINIB ACCORD U GЋALXIEX JINTUŻA
Imatinib Accord huwa mediċina li fih is-sustanza attiva imatinib. Din
il-mediċina taħdem billi
tinibixxi t-tkattir ta’ ċelloli abnormali fil-mard imniżżel hawn
taħt. Dawn jinkludi xi tipi ta’ kanċer.
IMATINIB ACCORD HUWA KURA GĦALL-ADULTI U T-TFAL U L-ADOLEXXENTI
GĦAL-:
LEWKIMJA MAJELOJD KRONIKA (CML).
Il-lewkemja hija kanċer taċ-ċelloli bojod tad-demm.
Dawn iċ-ċelloli bojod issoltu jgħinu lill-ġisem biex jiġġieled
l-infezzjonijiet. Lewkimja majelojd
kronika hija forma ta’ lewkimja fejn iċ-ċelloli bojod (li
jissejħu majelojd), jibdew jitkattru
mingħajr kontroll.
−
LEWKIMJA LIMFOBLASTIKA AKUTA POŻITTIVA GĦALL-KROMOSOMA TA’
FILADELFJA (PH-POŻITTIVA
ALL).
Il-lewkimja hija kanċer taċ-ċelluli bojod tad-demm. Dawn
iċ-ċelloli bojod issoltu jgħinu
lill-ġisem biex jiġġieled l-infezzjonijiet. Lewkimja limfoblastika
akuta hija for

SPC

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Imatinib Accord 100 mg pilloli miksija b’rita
Imatinib Accord 400 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola miksija b’rita fiha 100 mg ta’ imatinib (bħala
mesilate).
Kull pillola miksija b’rita fiha 400 mg ta’ imatinib (bħala
mesilate).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Imatinib Accord 100 mg pilloli miksija b’rita
Pilloli oranġjo fil-kannella, tondi, bikonvessi, miksija b'rita,
imnaqqxa b’‘IM’ fuq naħa waħda u
b’‘T1’ fuq kull naħa tas-sinjal minn fejn il-pillola tinqasam u
lixxa fuq in-naħa l-oħra.
Imatinib Accord 400 mg pilloli miksija b’rita
Pilloli kannella fl-oranġjo, tondi, bikonvessi, miksija b'rita,
imnaqqxa b’‘IM’ fuq naħa waħda u ‘T2’
fuq kull naħa tas-sinjal min fejn il-pillola tinqasam u lixxa fuq
in-naħa l-oħra.
Is-sinjal imnaqqax mhuwiex intiż biex tinqasam il-pillola.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Imatinib Accord huwa indikat għall-kura ta’
•
pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew
dijanjostikati b’lewkimja majelojd kronika
(CML) li huma posittivi (Ph+) għall-kromosoma ta’ Filadelfja
(bcr-abl) u li ma jkunux jistgħu
jirċievu trapjant tal-mudullun bħala l-kura preferita.
•
pazjenti adulti u pedjatriċi b’Ph+ CML fil-fażi kronika wara li
tkun falliet it-terapija ta’ alfa-
interferon jew inkella meta l-marda tkun daħlet f’Fażi
aċċelerata ħafna jew jekk ikun hemm
_blast crisis_
.
•
pazjenti adulti li jkunu għadhom kif ġew dijanjostikati posittivi
għall-lewkimja limfoblastika
akuta b’kromosoma ta’ Filadelfja (Ph+ ALL) integrata
b’kimoterapija.
•
pazjenti adulti li rkadew jew li jkollhom Ph+ ALL rifrattorja bħala
monoterapija.
•
pazjenti adulti u pedjatriċi b’mard
majelopisplatiku/majeloproliferattiv (MDS/MPD) assoċjat
ma’ tibdil fil-ġene tar-riċettur tal-fattur ta’