Imatinib Actavis

Country: European Union

Language: Norwegian

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

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. Effekten av imatinib på utfallet av bein marg transplantasjon har ikke fastsatt. 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. Erfaring med imatinib hos pasienter med MDS/MPD forbundet med PDGFR gene re-ordninger er svært begrenset. Det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer.

Product summary:

Revision: 13

Authorization status:

Tilbaketrukket

Authorization date:

2013-04-17

Patient Information leaflet

                                86
B. PAKNINGSVEDLEGG
Utgått markedsføringstillatelse
87
PAKNINGSVEDLEGG: INFORMASJON TIL BRUKEREN
IMATINIB ACTAVIS 50 MG HARDE KAPSLER
imatinib
LES NØYE GJENNOM DETTE PAKNINGSVEDLEGGET FØR DU BEGYNNER Å BRUKE
DETTE LEGEMIDLET.
DET INNEHOLDER
INFORMASJON SOM ER VIKTIG FOR DEG.
-
Ta vare på dette pakningsvedlegget. Du kan få behov for å lese det
igjen.
-
Spør lege, apotek eller sykepleier hvis du har flere spørsmål eller
trenger mer informasjon.
-
Dette legemidlet er skrevet ut kun til deg. Ikke gi det videre til
andre. Det kan skade dem, selv om
de har symptomer på sykdom som ligner dine.
-
Kontakt lege, apotek eller sykepleier dersom du opplever bivirkninger,
inkludert mulige
bivirkninger som ikke er nevnt i dette pakningsvedlegget. Se avsnitt
4.
I DETTE PAKNINGSVEDLEGGET FINNER DU INFORMASJON OM
1.
Hva Imatinib Actavis er, og hva det brukes mot
2.
Hva du må vite før du bruker Imatinib Actavis
3.
Hvordan du bruker Imatinib Actavis
4.
Mulige bivirkninger
5.
Hvordan du oppbevarer Imatinib Actavis
6.
Innholdet i pakningen samt ytterligere informasjon
1.
HVA IMATINIB ACTAVIS ER, OG HVA DET BRUKES MOT
Imatinib Actavis er et legemiddel som inneholder virkestoffet
imatinib. Dette legemidlet virker ved å
hemme vekst av unormale celler ved sykdommene listet nedenfor. Dette
inkluderer visse krefttyper.
IMATINIB ACTAVIS ER EN BEHANDLING FOR:
-
KRONISK MYELOGEN LEUKEMI (KML).
Leukemi er kreft som rammer de hvite blodcellene. Hvite blodceller
hjelper vanligvis kroppen med
å bekjempe infeksjoner. Kronisk myelogen leukemi er en form for
leukemi hvor visse unormale
hvite blodceller (som kalles myeloide celler) begynner å vokse
ukontrollert.
Hos voksne pasienter skal Imatinib Actavis brukes i den mest
fremskredne fasen av sykdommen
(blastkrise). Hos barn og ungdom kan Imatinib Actavis brukes i ulike
faser av sykdommen (kronisk,
akselerert fase og blastkrise).
.
-
PHILADELPHIAKROMOSOM POSITIV AKUTT LYMFOBLASTISK LEUKEMI (PH-POSITIV
ALL).
Leukemi er en
kreft som rammer hvite blodceller. Disse hvite blodcellene hje
                                
                                Read the complete document

Summary of Product characteristics

                                1
VEDLEGG I
PREPARATOMTALE
Utgått markedsføringstillatelse
2
1.
LEGEMIDLETS NAVN
Imatinib Actavis 50 mg harde kapsler
Imatinib Actavis 100 mg harde kapsler
Imatinib Actavis 400 mg harde kapsler
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Imatinib Actavis 50 mg harde kapsler
Hver hard kapsel inneholder 50 mg imatinib (som mesilat).
Imatinib Actavis 100 mg harde kapsler
Hver hard kapsel inneholder 100 mg imatinib (som mesilat).
Imatinib Actavis 400 mg harde kapsler
Hver hard kapsel inneholder 400 mg imatinib (som mesilat).
For fullstendig liste over hjelpestoffer, se pkt. 6.1.
3.
LEGEMIDDELFORM
Hard kapsel (kapsel)
Imatinib Actavis 50 mg harde kapsler
Hard kapsel i størrelse 3 med lys gul hette og lys gul kropp, merket
"50 mg" i sort blekk.
Imatinib Actavis 100 mg harde kapsler
Hard kapsel i størrelse 1 med lys oransje hette og lys oransje kropp,
merket "100 mg" i sort blekk.
Imatinib Actavis 400 mg harde kapsler
Hard kapsel i størrelse 00 med oransje ugjennomsiktig hette og kropp,
merket med "400 mg" i sort blekk.
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJON(ER)
Imatinib Actavis er indisert ved behandling av
-
barn med nylig diagnostisert Philadelphiakromosom (bcr-abl) positiv
(Ph+) kronisk myelogen
leukemi (KML) i de tilfeller beinmargstransplantasjon ikke vurderes
som førstelinjebehandling.
-
barn med Ph+ KML i kronisk fase etter mislykket behandling med
interferon alfa, eller i akselerert
fase eller blastkrise.
-
voksne med Ph+ CML i blastkrise.
-
voksne og barn med nylig diagnostisert Philadelphiakromosom positiv
akutt lymfoblastisk leukemi
(Ph+ ALL) samtidig med kjemoterapi.
-
voksne pasienter som monoterapi ved tilbakevendende eller refraktær
Ph+ ALL.
-
voksne pasienter med myelodysplastiske/myeloproliferative sykdommer
(MDS/MPD) assosiert
med blodplatederivert vekstfaktor-reseptor (PDGFR) gen-rearrangering.
Utgått markedsføringstillatelse
3
-
voksne pasienter med avansert hypereosinofilt syndrom (HES) og/eller
kronisk eosinofil leukemi
(KEL) med FIP1L1-PDGFRα rearrangering
Effekten av imatinib på utfal
                                
                                Read the complete document

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