Imatinib Actavis

Nchi: Umoja wa Ulaya

Lugha: Kimalta

Chanzo: EMA (European Medicines Agency)

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
05-07-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
05-07-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
05-07-2022

Viambatanisho vya kazi:

imatinib

Inapatikana kutoka:

Actavis Group PTC ehf

ATC kanuni:

L01EA01

INN (Jina la Kimataifa):

imatinib

Kundi la matibabu:

Protein kinase inhibitors, Antineoplastic agents

Eneo la matibabu:

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

Matibabu dalili:

Imatinib Actavis is indicated for the treatment of: , 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;, paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with Ph+ CML in blast crisis;, adult 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-PDGFR rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. , L-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. Imatinib Actavis is indicated for: , 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. L-esperjenza b'imatinib f'pazjenti b'MDS/MPD assoċjati ma ' tibdil fil-ġene PDGFR hija limitata ħafna. M'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Bidhaa muhtasari:

Revision: 13

Idhini hali ya:

Irtirat

Idhini ya tarehe:

2013-04-17

Taarifa za kipeperushi

                                79
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
80
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
IMATINIB ACTAVIS 50 MG KAPSULI IEBSIN
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
l-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar jew
l-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 Actavis u għalxiex jintuża
2.
X'għandek tkun taf qabel ma tieħu Imatinib Actavis
3.
Kif għandek tieħu Imatinib Actavis
4.
Effetti sekondarji possibbli
5.
Kif taħżen Imatinib Actavis
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU IMATINIB ACTAVIS U GЋALXIEX JINTUŻA
Imatinib Actavis huwa mediċina li fih is-sustanza attiva imatinib.
Din il-mediċina taħdem billi
tinibixxi t-tkattir ta’ ċelloli anormali fil-mard elenkati hawn
taħt. Dawn jinkludu ċertu tipi ta’ kanċer.
IMATINIB ACTAVIS HUWA KURA GĦALL-:
-
LEWKIMJA MAJELOJD KRONIKA (_CHRONIC MYELOID LEUKAEMIA_ (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.
F'pazjenti adulti, Imatinib Actavis huwa maħsub għall-użu fil-fażi
l-aktar avvanzata tal-marda (
_blast_
_crisis_
). Fit-tfal u adolexxenti, Imatinib Actavis jista’ jintuża
fil-fażijiet differenti tal-marda (kronika,
fażi aċċelerata u
_blast crisis_
).
-
LEWKIMJA LIMFOBLASTIKA AKUTA 
                                
                                Soma hati kamili

Tabia za bidhaa

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Imatinib Actavis 50 mg kapsuli iebsin
Imatinib Actavis 100 mg kapsuli iebsin
Imatinib Actavis 400 mg kapsuli iebsin
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Imatinib Actavis 50 mg kapsuli iebsin
Kull kapsula iebsa fiha 50 mg ta’ imatinib (bħala mesilate).
Imatinib Actavis 100 mg kapsuli iebsin
Kull kapsula iebsa fiha 100 mg ta’ imatinib (bħala mesilate).
Imatinib Actavis 400 mg kapsuli iebsin
Kull kapsula iebsa fiha 400 mg ta’ imatinib (bħala mesilate).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Kapsula iebsa (kapsula).
Imatinib Actavis 50 mg kapsuli iebsin
Kapsula iebsa ta’ daqs 3 b’ għatu isfar ċar u korp isfar ċar
mmarkata b' "50 mg" bl-inka sewda.
Imatinib Actavis 100 mg kapsuli iebsin
Kapsula iebsa ta’ daqs 1 b’ għatu oranġjo ċar u korp oranġjo
ċar mmarkata b' "100 mg" bl-inka sewda.
Imatinib Actavis 400 mg kapsuli iebsin
Kapsula iebsa ta’ daqs 00 b’ għatu u korp oranġjo opak mmarkata
b' "400 mg" bl-inka sewda.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Imatinib Actavis huwa indikat għall-kura ta’
-
pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati
b’lewkimja majelojd kronika
(
_chronic myeloid leukaemia (CML_
)) li huma pożittivi (Ph+) għall-kromosoma ta’ Filadelfja
(bcr-abl) u li ma jkunux jistgħu jirċievu trapjant tal-mudullun
bħala l-kura preferita.
-
pazjenti 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 b’Ph+ CML li jkunu fi
_blast crisis._
-
pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew
dijanjostikati pożittivi għal-lewkimja
limfoblastika akuta b’kromosoma ta’ Filadelfja (Ph+ ALL),
integrata mal-kemoterapija.
-
monoterapija għal Ph+ ALL f’pazjenti adulti li rkadew jew f’faż
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi imatinib

imatinib

ATC kanuni L01EA01

L01EA01

Mzalishaji au wazalishaji wadogowadogo Actavis Group PTC ehf

Actavis Group PTC ehf

INN (Jina la Kimataifa) imatinib

imatinib

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