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müelodüsplastiliste sündroomide ravi;
treatment of myelodysplastic syndromes;
Ultimo aggiornamento 2017-04-26
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lenalidomiidi kasutamise kohta müelodüsplastiliste
myelodysplastic syndromes (mds) treated with lenalidomide to gather
Ultimo aggiornamento 2017-04-26
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müelodüsplastiliste sündroomide ii faasi uuring
myelodysplastic syndromes phase ii study
Ultimo aggiornamento 2017-04-26
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olemasolevate müelodüsplastiliste sündroomide (mds) progresseerumine
progression of existing myelodysplastic syndrome (mds)
Ultimo aggiornamento 2017-04-26
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müelodüsplastiliste sündroomide puhul kasutatud algoritm:
algorithm applied for myelodysplastic syndromes:
Ultimo aggiornamento 2017-04-26
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müelodüsplastiliste/müeloproliferatiivsete haiguste (mds/mpd) ravis.
myelodysplastic/myeloproliferative diseases (mds/mpd).
Ultimo aggiornamento 2017-04-26
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◊müelodüsplastiliste sündroomide kliinilistes uuringutes teatatud tõsiste kõrvalnähtudena.
◊adverse events reported as serious in myelodysplastic syndromes clinical trials
Ultimo aggiornamento 2017-04-26
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olemasolevate hematopoeetiliste kasvajate või müelodüsplastiliste sündroomide (mds) progresseerumine
16 progression of existing haematopoietic malignancies or myelodysplastic syndromes (mds)
Ultimo aggiornamento 2012-04-11
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müelodüsplastiliste sündroomide soovitatav raviannus on 10 mg revlimidi üks kord ööpäevas.
in the treatment of myelodysplastic syndromes, the recommended dose of revlimid is 10 mg a day.
Ultimo aggiornamento 2017-04-26
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veel kahes põhiuuringus osales kokku 353 müelodüsplastiliste sündroomide väikese riskiga patsienti.
two main studies have also been carried out involving a total of 353 patients with lower risk myelodysplastic syndromes.
Ultimo aggiornamento 2017-04-26
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kerge neerukahjustusega ja hulgimüeloomi, müelodüsplastiliste sündroomidega või mantelrakulise lümfoomiga patsientidel ei ole annuse korrigeerimine vajalik.
no dose adjustments are required for patients with mild renal impairment and multiple myeloma, myelodysplastic syndromes, or mantle cell lymphoma.
Ultimo aggiornamento 2017-04-26
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5q deletsioonist tingitud müelodüsplastiliste sündroomide puhul pärssis lenalidomiid selektiivselt ebanormaalset klooni, suurendades 5q deletsiooniga rakkude apoptoosi.
in mds del (5q), lenalidomide was shown to selectively inhibit the abnormal clone by increasing the apoptosis of del (5q) cells.
Ultimo aggiornamento 2017-04-26
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järgnev tabel on koostatud andmete põhjal, mis on kogutud müelodüsplastiliste sündroomide ja mantelrakulise lümfoomi monoravi peamistest kliinilistest uuringutest.
the following tables are derived from data gathered during the main studies in monotherapy for myelodysplastic syndromes and mantle cell lymphoma.
Ultimo aggiornamento 2017-04-26
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peamistes müügiloa taotlemiseks tehtud uuringutes lenalidomiidi efektiivsuse ja ohutuse kindlakstegemiseks hulgimüeloomi ja müelodüsplastiliste sündroomide ravis manustati ravimit siiski toidukordadest sõltumatult.
however, in the main multiple myeloma and myelodysplastic syndromes registration trials where the efficacy and safety were established for lenalidomide, the medicinal product was administered without regard to food intake.
Ultimo aggiornamento 2017-04-26
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müelodüsplastiliste sündroomidega patsientide ravil lenalidomiidiga ei täheldatud üldisi erinevusi ohutuses ja efektiivsuses üle 65-aastaste ja nooremate patsientide vahel.
for myelodysplastic syndromes patients treated with lenalidomide, no overall difference in safety and efficacy was observed between patients aged over 65 and younger patients.
Ultimo aggiornamento 2017-04-26
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annuste puhul 5 kuni 25 mg päevas on tervetel vabatahtlikel poolväärtusaeg plasmas ligikaudu 3 tundi ja hulgimüeloomiga, müelodüsplastiliste sündroomidega või mantelrakulise lümfoomiga patsientidel vahemikus 3 kuni 5 tundi.
at doses of 5 to 25 mg/day, half-life in plasma is approximately 3 hours in healthy volunteers and ranges from 3 to 5 hours in patients with multiple myeloma, myelodysplastic syndromes or mantle cell lymphoma..
Ultimo aggiornamento 2017-04-26
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glivecit kasutatakse müelodüsplastiliste või müeloproliferatiivsete haigustega täiskasvanute ravimiseks, kellel on trombotsüütide kasvuteguri retseptori (pdgfr) geen asendit muutnud.
glivec is used to treat adults with md/ mpd who have re-arrangements of the gene for platelet-derived growth factor receptor (pdgfr).
Ultimo aggiornamento 2012-04-11
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samuti ei saa seda kasutada müelodüsplastiliste sündroomidega (haigus, mille korral valgeliblesid tekib liiga palju, mis võib areneda leukeemiaks) patsientidel.
it also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).
Ultimo aggiornamento 2017-04-26
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lenalidomiidiga ravitud müelodüsplastiliste sündroomidega patsientidel on 3. ja 4. astme neutropeenia ja trombotsütopeenia tekkesagedus kõrgem kui platseebot saavatel patsientidel (vt lõik 4.8).
lenalidomide treatment in myelodysplastic syndromes patients is associated with a higher incidence of grade 3 and 4 neutropenia and thrombocytopenia compared to patients on placebo (see section 4.8).
Ultimo aggiornamento 2017-04-26
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uuringus mds-003, milles 148 patsiendile manustati lenalidomiidi annuses 10 mg, seisnes esmane efektiivsuse analüüs lenalidomiidi efektiivsuse hindamises hematopoeetilise paranemise saavutamisel madala või 1. keskastme riskiga müelodüsplastiliste sündroomidega patsientidel.
in, study mds-003, in which 148 patients received lenalidomide at a dose of 10 mg, the primary efficacy analysis consisted of an evaluation of the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk myelodysplastic syndromes.
Ultimo aggiornamento 2017-04-26
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