Imatinib Actavis

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

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. , Áhrif imatinib á niðurstöðu beinmerg ígræðslu hefur ekki verið ákveðið. 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. Reynslu með imatinib í sjúklinga með stýrð útgjöld/MPD tengslum við PDGFR gene aftur fyrirkomulag er mjög takmarkað. Það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.

Product summary:

Revision: 13

Authorization status:

Aftakað

Authorization date:

2013-04-17

Patient Information leaflet

                                78
B. FYLGISEÐILL
Lyfið er ekki lengur með markaðsleyfi
79
FYLGISEÐILL: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
IMATINIB ACTAVIS 50 MG HÖRÐ HYLKI
imatinib
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins
ef þörf er á frekari upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn, lyfjafræðing eða hjúkrunarfræðinginn vita um
allar aukaverkanir. Þetta gildir
einnig um aukaverkanir sem ekki er minnst á í þessum fylgiseðli.
Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR
1.
Upplýsingar um Imatinib Actavis og við hverju það er notað
2.
Áður en byrjað er að nota Imatinib Actavis
3.
Hvernig nota á Imatinib Actavis
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Imatinib Actavis
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM IMATINIB ACTAVIS OG VIÐ HVERJU ÞAÐ ER NOTAÐ
Imatinib Actavis er lyf sem inniheldur virkt efni sem kallast
imatinib. Við neðangreinda sjúkdóma
hemur þetta lyf vöxt óeðlilegra frumna. Þar á meðal eru nokkrar
gerðir af krabbameini.
IMATINIB ACTAVIS ER TIL MEÐFERÐAR VIÐ:
-
LANGVINNU KYRNINGAHVÍTBLÆÐI (CML).
Hvítblæði er krabbamein hvítra blóðkorna. Þessar
hvítfrumur hjálpa yfirleitt líkamanum að berjast gegn sýkingu.
Langvinnt kyrningahvítblæði er
tegund hvítblæðis þar sem ákveðnar óeðlilegar hvítfrumur (sem
nefnast kyrningar) byrja að
fjölga sér stjórnlaust.
Hjá fullorðnum sjúklingum er Imatinib Actavis ætlað til notkunar
þegar sjúkdómurinn er kominn á
hæsta stig (bráðafasa). Hjá börnum og unglingum má nota Imatinib
Actavis við mismunandi fösum
sjúkdómsins (jafnvægis-, hröðunar- og bráðafasa).
-
FÍLADELFÍULITNINGS-JÁKVÆ
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
Lyfið er ekki lengur með markaðsleyfi
2
1.
HEITI LYFS
Imatinib Actavis 50 mg hörð hylki
Imatinib Actavis 100 mg hörð hylki
Imatinib Actavis 400 mg hörð hylki
2.
INNIHALDSLÝSING
Imatinib Actavis 50 mg hörð hylk
Hvert hart hylki inniheldur 50 mg af imatinibi (sem mesilat).
Imatinib Actavis 100 mg hörð hylk
Hvert hart hylki inniheldur 100 mg af imatinibi (sem mesilat).
Imatinib Actavis 400 mg hörð hylk
Hvert hart hylki inniheldur 400 mg af imatinibi (sem mesilat).
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Hart hylki (hylki).
Imatinib Actavis 50 mg hörð hylk
Hart hylki af stærð 3 með ljósgulan efri hluta og gulan neðri
hluta merktan „50 mg“ með svörtu bleki.
Imatinib Actavis 100 mg hörð hylk
Hart hylki af stærð 1 með ljósappelsínugulan efri hluta og
ljósappelsínugulan neðri hluta merktan „100
mg“ með svörtu bleki.
Imatinib Actavis 400 mg hörð hylk
Hart hylki af stærð 00 með ógagnsæjan appelsínugulan efri hluta
og neðri hluta merktan „400 mg“
með svörtu bleki.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Imatinib Actavis er ætlað til meðferðar hjá
-
börnum með nýlega greint Fíladelfíulitnings (bcr-abl) jákvætt
(Ph+) langvarandi
kyrningahvítblæði (chronic myeloid leukaemia [CML]), þar sem
beinmergsskipti eru ekki talin
eiga við sem fyrsta meðferð.
-
börnum með Ph+ CML í stöðugum (chronic) fasa eftir að meðferð
með interferon-alfa hefur
ekki borið árangur, eða í hröðunarfasa (accelerated phase) eða
bráðafasa (blast crisis).
-
fullorðnum sjúklingum með Ph+ CNL í bráðafasa (blast crisis).
-
fullorðnum sjúklingum og börnum með nýlega greint
Fíladelfíulitnings jákvætt brátt
eitilfrumuhvítblæði (acute lymphoblastic leukaemia) (Ph+ ALL) í
tengslum við
krabbameinslyfjameðferð.
-
fullorðnum sjúklingum með endurkomið eða þrálátt Ph+ ALL, sem
einlyfjameðferð.
-
fullorðnum sjúklingum með
mergrangvaxtarsjúkdóma/mergfrumnafjölgunarsjúkdó
                                
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Active ingredient imatinib

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ATC code L01EA01

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