Imatinib Accord

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
14-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
14-12-2022
Public Assessment Report Public Assessment Report (PAR)
19-07-2017

Active ingredient:

imatinib

Available from:

Accord Healthcare S.L.U.

ATC code:

L01EA01

INN (International Name):

imatinib

Therapeutic group:

imatinib

Therapeutic area:

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

Therapeutic indications:

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. Undtagen i nyligt diagnosticeret kronisk CML-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme. .

Product summary:

Revision: 20

Authorization status:

autoriseret

Authorization date:

2013-06-30

Patient Information leaflet

                                45
B. INDLÆGSSEDDEL
46
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
IMATINIB ACCORD 100 MG FILMOVERTRUKNE TABLETTER
IMATINIB ACCORD 400 MG FILMOVERTRUKNE TABLETTER
imatinib
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er
mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give medicinen
til andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen, apotekspersonalet eller sygeplejersken, hvis du får
bivirkninger, herunder
bivirkninger, som ikke er nævnt i denne indlægsseddel. Se afsnit 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Imatinib Accord
3.
Sådan skal du tage Imatinib Accord
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Imatinib Accord er et lægemiddel, der indeholder et aktivt stof
kaldet imatinib. Dette lægemiddel
virker ved at hæmme væksten af unormale celler ved de sygdomme, der
er nævnt nedenfor. Disse
omfatter nogle former for kræft.
IMATINIB ACCORD ER EN BEHANDLING TIL VOKSNE OG BØRN OG UNGE MOD:
-
KRONISK MYELOID LEUKÆMI (CML).
Leukæmi er kræft i de hvide blodlegemer. Hvide
blodlegemer hjælper som regel kroppen med at bekæmpe infektioner.
Kronisk myeloid leukæmi
er en type leukæmi, hvor nogle bestemte unormale hvide blodlegemer
(der kaldes myeloide
celler) vokser ukontrolleret.
-
PHILADELPHIA KROMOSOM POSITIV AKUT LYMFOBLAST LEUKÆMI (PH-POSITIV
ALL).
Leukæmi er
kræft i de hvide blodlegemer. Hvide blodlegemer hjælper som regel
kroppen med at bekæmpe
infektioner. Akut lymfoblast leukæmi er en form af leukæmi, hvor
visse abnorme hvide
blodlegemer (kaldet lymfoblaster) vokser ukontrolleret. Imatinib
Accord hæmmer
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Imatinib Accord 100 mg filmovertrukne tabletter
Imatinib Accord 400 mg filmovertrukne tabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat).
Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat).
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Filmovertrukket tablet
Imatinib Accord 100 mg filmovertrukne tabletter
Brun-orange, runde, bikonvekse filmovertrukne tabletter, præget med
‘IM’ og ‘T1’ på hver sin side af
delekærven på den ene side, jævne på den anden side.
Imatinib Accord 400 mg filmovertrukne tabletter
Brun-orange, ovale, bikonvekse filmovertrukne tabletter, præget med
‘IM’ og ‘T2’ på hver sin side af
delekærven på den ene side, jævne på den anden.
Formålet med delekærven er ikke at kunne brække tabletten over.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Imatinib Accord er indiceret til behandling af
•
voksne og børn med nydiagnosticeret Philadelphiakromosom (bcr-abl)
positiv (Ph+) kronisk
myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke
anses for
førstevalgsbehandling.
•
voksne og børn med Ph+ CML i kronisk fase efter manglende effekt af
alfa-
interferonbehandling, eller i accelereret fase eller blastkrise.
•
voksne og børn patienter med nydiagnosticeret Philadelphiakromosom
positiv akut
lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi.
•
voksne patienter med Ph+ ALL med tilbagefald eller refraktær sygdom
som monoterapi.
•
voksne patienter med myelodysplastisk syndrom/myeloproliferative
sygdomme (MDS/MPD)
som er forbundet med platelet-derived growth factor receptor-omlejring
(PDGFR-omlejring).
•
voksne patienter med refraktært hypereosiniphil syndrom (HES)
og/eller kronisk eosinofil
leukæmi (CEL) med FIP1L1-PDGFR
α
-omlejring.
Effekten af imatinib på resultatet af knoglemarvstransplantation er
ikke blevet bestemt.
Imatinib Accord er indiceret til
•
behandling af vok
                                
                                Read the complete document

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Active ingredient imatinib

imatinib

ATC code L01EA01

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Marketed by Accord Healthcare S.L.U.

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INN (International Name) imatinib

imatinib

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Patient Information leaflet Patient Information leaflet Bulgarian 14-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 14-12-2022
Public Assessment Report Public Assessment Report Bulgarian 19-07-2017
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Public Assessment Report Public Assessment Report Spanish 19-07-2017
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