Imatinib Actavis

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
05-07-2022
Public Assessment Report Public Assessment Report (PAR)
05-07-2022

Active ingredient:

imatinib

Available from:

Actavis Group PTC ehf

ATC code:

L01EA01

INN (International Name):

imatinib

Therapeutic group:

Protein kinase inhibitors, Antineoplastic agents

Therapeutic area:

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

Therapeutic indications:

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. Učinak иматиниба na ishod transplantacije koštane srži nije određena. 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. Iskustvo s иматинибом u bolesnika s MDS/RAFINERIJA u svezi s PDGFR генных permutacija-vrlo ograničen. Nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Product summary:

Revision: 13

Authorization status:

povučen

Authorization date:

2013-04-17

Patient Information leaflet

                                76
B. UPUTA O LIJEKU
Lijek koji više nije odobren
77
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
IMATINIB ACTAVIS 50 MG TVRDE KAPSULE
imatinib
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili
medicinskoj sestri.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte dio
4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Imatinib Actavis i za što se koristi
2.
Što morate znati prije nego počnete uzimati Imatinib Actavis
3.
Kako uzimati Imatinib Actavis
4.
Moguće nuspojave
5.
Kako čuvati Imatinib Actavis
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE IMATINIB ACTAVIS I ZA ŠTO SE KORISTI
Imatinib Actavis je lijek koji sadrži djelatnu tvar zvanu imatinib.
Ovaj lijek djeluje tako da inhibira
rast abnormalnih stanica kod niže navedenih bolesti. One obuhvaćaju
i neke vrste raka.
IMATINIB ACTAVIS SE KORISTI ZA LIJEČENJE:
-
KRONIČNE MIJELOIČNE LEUKEMIJE (KML).
Leukemija je rak bijelih krvnih stanica. Te bijele
krvne stanice obično pomažu tijelu u borbi protiv infekcije.
Kronična mijeloična leukemija je
oblik leukemije u kojem određene abnormalne bijele krvne stanice
(zvane mijeloidne stanice)
počinju nekontrolirano rasti.
U odraslih bolesnika Imatinib Actavis namijenjen je za primjenu u fazi
najvećeg uznapredovanja
bolesti (blastičnoj krizi). U djece i adolescenata Imatinib Actavis
se može koristiti u različitim fazama
bolesti (kroničnoj fazi, ubrzanoj fazi i blastičnoj krizi).
-
AKUTNE LIMFOBLASTIČNE LEUKEMIJE S POZITIVNIM PHILADELPHIA KROMOSOMOM
(PH-POZITIVNI
ALL).
Leukemija je rak bijelih krvnih stanica. Te bijele krvne stanice
obično
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Imatinib Actavis 50 mg tvrde kapsule
Imatinib Actavis 100 mg tvrde kapsule
Imatinib Actavis 400 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Imatinib Actavis 50 mg tvrde kapsule
Svaka tvrda kapsula sadrži 50 mg imatiniba (u obliku
imatinibmesilata).
Imatinib Actavis 100 mg tvrde kapsule
Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku
imatinibmesilata).
Imatinib Actavis 400 mg tvrde kapsule
Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku
imatinibmesilata).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula (kapsula).
Imatinib Actavis 50 mg tvrde kapsule
Tvrda kapsula veličine 3 sa svijetložutom kapicom i svijetložutim
tijelom s oznakom "50 mg"
otisnutom crnom tintom.
Imatinib Actavis 100 mg tvrde kapsule
Tvrda kapsula veličine 1 sa svijetlonarančastom kapicom i
svijetlonarančastim tijelom s oznakom
"100 mg" otisnutom crnom tintom.
Imatinib Actavis 400 mg tvrde kapsule
Tvrda kapsula veličine 00 s narančastom i neprozirnom kapicom i
tijelom s oznakom „400 mg“
otisnutom crnom tintom.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Imatinib Actavis indiciran je za liječenje
-
pedijatrijskih bolesnika s novodijagnosticiranom kroničnom
mijeloičnom leukemijom (KML) s
pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se
transplantacija koštane srži ne
smatra prvom linijom liječenja.
-
pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon
neuspjeha terapije interferonom-
alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
-
odraslih bolesnika s Ph+ KML-om u blastičnoj krizi.
-
odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom
limfoblastičnom
leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz
kemoterapiju.
-
odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u
obliku monoterapije.
-
odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim
bolestima (MDS/MPD)
povezanim s preraspodjelom gena
                                
                                Read the complete document

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Active ingredient imatinib

imatinib

ATC code L01EA01

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Marketed by Actavis Group PTC ehf

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INN (International Name) imatinib

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