FrancophonIA/ELRC3.0 huggingface dataset:
English: Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Slovenian: Mielodisplastične/mieloproliferativne bolezni s preureditvijo gena za PDGFR so lahko povezane z visokimi koncentracijami eozinofilcev.
English: Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia.
Slovenian: Zdravljenje bolnikov s KML z imatinibom je povezano z nevtropenijo ali s trombocitopenijo.
English: If this applies to you, tell your doctor without taking Imatinib medac.
Slovenian: Če to velja za vas, povejte zdravniku in ne jemljite zdravila Imatinib medac.
English: Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Slovenian: Odmerke po 400 mg ali 600 mg je treba jemati enkrat na dan, medtem ko je treba dnevni odmerek 800 mg vzeti kot 400 mg dvakrat na dan, zjutraj in zvečer.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54 % and 74 %, of the respective values without rifampicin treatment.
Slovenian: Predzdravljenje z večkratnimi odmerki rifampicina 600 mg, ki jim je sledil en 400-miligramski odmerek imatiniba, je povzročilo zmanjšanje Cmax oziroma AUC(0-∞) za vsaj 54 % oziroma 74 % zadevnih vrednosti brez zdravljenja z rifampicinom.
English: Do not stop taking Imatinib medac unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Imatinib medac, razen če vam tako naroči zdravnik.
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Slovenian: In vitro so pokazali, da je imatinib kompetitiven inhibitor markerskih substratov za CYP2C9, CYP2D6 in CYP3A4/5.
English: GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Slovenian: Tumorska mesta v prebavilih so bili lahko viri krvavitev (glejte poglavje 4.4).
English: Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Slovenian: Glede na opazovalno naravo registra so bile ocene hematoloških podatkov na voljo za 22, ocene citogenetskih podatkov za 9 in ocene molekularnih podatkov za 17 od 23 vključenih bolnikov.
English: The estimated 4-year OS in cohort 5-patients was 83.6 % compared to 44.8 % in the historical controls.
Slovenian: Ocenjen delež bolnikov s 4-letnim celokupnim preživetjem (OS - overall survival) v 5. kohorti je bil 83,6 % v primerjavi s 44,8 % pri zgodovinskih kontrolah.
English: The effect of prior gastrointestinal surgery on imatinib absorption has not been investigated.
Slovenian: Učinka predhodne operacije prebavil na absorpcijo imatiniba niso raziskali.
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Slovenian: Izkušenj z uporabo imatiniba pri bolnikih MDS/MPD v povezavi s preureditvijo genov za PDGFR je malo (glejte poglavje 5.1).
English: • adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Slovenian: • odraslih bolnikov z neresektabilnim protuberantnim dermatofibrosarkomom (DFSPdermatofibrosarcoma protuberans) in tistih odraslih bolnikov z rekurentnim in/ali metastatskim DFSP, ki niso primerni za operacijo.
English: Stop imatinib until ANC ≥ 1.5 x 10
Slovenian: Prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1,5 x 10
English: The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Slovenian: Stanje je opisano kot reverzibilno ob uporabi steroidov s sistemskim delovanjem, podpori krvnemu obtoku in začasni odtegnitvi imatiniba.
English: Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Slovenian: Po povečanju odmerka je treba bolnike natančno spremljati, ker pri večjih odmerkih obstaja možnost povečane pogostnosti neželenih reakcij.
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10 % of a therapeutic dose).
Slovenian: Pri seštevku koncentracij imatiniba in njegovega presnovka je pri največji zaužiti količini materinega mleka na dan mogoče pričakoviti nizko skupno izpostavljenost dojenčka zdravilu in presnovku (~10 % terapevtskega odmerka).
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11 % decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4 %) compared to fasting conditions.
Slovenian: Če so imatinib dajali z zelo mastnim obrokom, se je obseg njegove absorpcije minimalno zmanjšal (Cmax se je zmanjšala za 11 %, tmax pa se je podaljšala za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
English: In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3).
Slovenian: Predklinične študje niso pokazale vpliva na plodnost pri podganjih samcih in samicah (glejte poglavje 5.3).
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Slovenian: Vseh 65 bolnikov z dokazano FIP1L1-PDGFRα fuzijsko kinazo je doseglo popolni hematološki odziv in ga ohranilo mesece (od več kot 1 mesec do več kot 44 mesecev, ocenjeno v času poročanja).
English: DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
Slovenian: DFSP je rak podkožnega tkiva, pri katerem se začnejo nenadzorovano razraščati nekatere celice.
English: (3 h, q 12 h), day 5
Slovenian: (3 ure, na 12 ur), 5. dan
English: 6+7) Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Slovenian: 6+7) Bolečine v trebuhu in krvavitev iz prebavil so najpogosteje opazovali pri bolnikih z GIST.
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23 % (90 %CI [1.16 - 1.30]).
Slovenian: Imatinib je v odmerku 400 mg dvakrat dnevno zaviral presnovo metoprolola s CYP2D6, tako da sta se Cmax in AUC metoprolola povečala za približno 23 % (90 % IZ [1,16 - 1,30]).
English: The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.
Slovenian: Predpisani odmerek mora bolnik vzeti peroralno z obrokom in velikim kozarcem vode, da se čim bolj zmanjša tveganje draženja prebavil.
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Slovenian: Rezultati analize potrjujejo, da je pri pediatričnih bolnikih, ki prejemajo 260 mg/m enkrat na dan (pri čemer odmerek ne presega 400 mg dnevno) ali 340 mg/m enkrat na dan (pri čemer odmerek ne presega 600 mg dnevno) izpostavljenost imatinibu podobna kot pri odraslih bolnikih, ki prejemajo imatinib v odmerkih 400 mg oziroma 600 mg enkrat na dan.
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg, or from 800 mg to 600 mg, and in paediatric patients from 340 mg to 260 mg/m2/day.
Slovenian: Pri odraslih je treba zmanjšati odmerek s 400 mg na 300 mg ali s 600 mg na 400 mg ali z 800 mg na 600 mg, pri pediatričnih bolnikih pa s 340 mg na 260 mg/m²/dan.
English: Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
Slovenian: Imatinib zavira signaliziranje in proliferacijo celic, ki ju povzroča napačno uravnavano delovanje PDGFR in Abl kinaze.
English: : intravenous
Slovenian: : intravensko
English: Resume treatment with imatinib at 600 mg.
Slovenian: Spet začnite zdravljenje z imatinibom z odmerkom 600 mg.
English: In the study in patients with unresectable and/or metastatic GIST, 7 (5 %) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
Slovenian: V raziskavi bolnikov z neoperabilnim in/ali metastatskim GIST je pri 7 bolnikih (5 %) prišlo do CTC krvavitve stopnje 3/4 (3 bolniki), krvavitve v tumor (3 bolniki) ali obojega (1 bolnik).
English: In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Slovenian: Pri pediatričnih bolnikih s KML so izmed toksičnih učinkov najpogosteje opažali citopenije 3. ali 4. stopnje, ki vključuje nevtropenijo, trombocitopenijo in anemijo.
English: Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Slovenian: Baza podatkov do zdaj sporočenih neželenih dogodkov pri otrocih je majhna, vendar se podatki v njej ujemajo z varnostnimi lastnostmi zdravila pri odraslih bolnikih s Ph+ ALL.
English: 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.
Slovenian: Pri odraslih in pediatričnih bolnikih temelji učinkovitost imatiniba na celotni hematološki in citogenetični odzivnosti in preživetju brez napredovanja bolezni pri KML, na hematološki in citogenetični odzivnosti pri Ph+ ALL in MDS/MPD, na hematološki odzivnosti pri HES/CEL ter na objektivni odzivnosti odraslih bolnikov z neresektabilnimi in/ali metastatskimi DFSP.
English: For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day can be given until disease progression occurs.
Slovenian: Odrasli bolniki z relapsom ali neodzivno Ph+ ALL lahko imatinib kot monoterapijo v odmerku 600 mg/dan prejemajo, dokler ne pride do napredovanja bolezni.
English: Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Slovenian: Imatinib je zaviralec proteinskih kinaz, ki močno zavira Bcr-Abl tirozin-kinazo na in vitro, celični in in vivo ravni.
English: Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Slovenian: Zato je pri sočasni uporabi visokih odmerkov imatiniba in paracetamola potrebna previdnost.
English: In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
Slovenian: V opazovalni študiji pri pediatrični populaciji s kronično mieloično levkemijo so po 12 in 24 mesecih zdravljenja poročali o statistično značilnem zmanjšanju (klinična pomembnost tega zmanjšanja ni znana) v vrednostih standardnega odklona mediane telesne višine pri dveh manjših podskupinah, ne glede na spolno dozorelost in spol.
English: 1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Slovenian: Odmerki od 1800 mg do 3200 mg (tudi do 3200 mg na dan 6 dni): oslabelost, mialgija, zvišana kreatin-kinaza, zvišan bilirubin, bolečine v prebavilih.
English: Liver dysfunction classification:
Slovenian: Razvrstitev disfunkcije jeter:
English: In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
Slovenian: In vivo spojina kaže protitumorsko aktivnost, če se uporablja kot edino sredstvo, v živalskih modelih z Bcr-Abl pozitivnimi tumorskimi celicami.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Slovenian: Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) imatiniba dnevno.
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Slovenian: Študija AIT07 je bila multicentrična, odprta, randomizirana študija faze II/III, v katero so vključili 128 bolnikov (starih od 1 do manj kot 18 let) in jih zdravili z imatinibom v kombinaciji s kemoterapijo.
English: • Pain in your hips or difficulty walking.
Slovenian: • bolečine v kolkih ali težave pri hoji,
English: Therefore, caution should be exercised in patients with cardiac dysfunction.
Slovenian: Zato je pri bolnikih z motnjami delovanja srca potrebna previdnost.
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Slovenian: In vitro imatinib zavira paracetamol O-glukuronidacijo z vrednostjo Ki 58,5 mikromolov/l.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Slovenian: V tej študiji je 14 bolnikov s HES/CEL prejemalo od 100 mg do 1.000 mg imatiniba na dan.
English: Imatinib medac 400 mg hard capsules EU/1/13/876/002
Slovenian: Imatinib medac 400 mg trde kapsule EU/1/13/876/002
English: These are a group of blood diseases in which some blood cells start growing out of control.
Slovenian: Te bolezni sodijo v skupino krvnih bolezni, pri katerih se začnejo nenadzorovano razraščati nekatere krvne celice.
English: There were no special safety findings in paediatric clinical trials.
Slovenian: V pediatričnih kliničnih preskušanjih ni bilo posebnih ugotovitev o varnosti.
English: • Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line of treatment;
Slovenian: • z novo odkrito KML, za katero presaditev kostnega mozga kot zdravilo prve izbire ne pride v poštev;
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Slovenian: Ni kontroliranih kliničnih preskušanj, ki bi dokazovala klinično koristnost, na primer izboljšanje bolezenskih simptomov ali povečano preživetje.
English: In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Slovenian: Kaže, da je pri bolnikih z okvarjenim delovanjem ledvic izpostavljenost imatinibu v plazmi višja kot pri bolnikih z normalnim delovanjem ledvic, verjetno zato, ker je pri teh bolnikih zvišana vrednost alfa kislega glikoproteina (AGP-alpha-acid glycoprotein), proteina, ki veže imatinib, v plazmi.
English: Imatinib medac 100 mg hard capsules EU/1/13/876/001
Slovenian: Imatinib medac 100 mg trde kapsule EU/1/13/876/001
English: If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Slovenian: V primeru nenormalnega izvida katere od teh preiskav je potrebno razmisliti o kontrolnem pregledu pri kardiologu in sočasni profilaktični uporabi steroidov s sistemskim delovanjem (1-2 mg/kg) ob uvedbi zdravljenja z imatinibom, v obdobju enega do dveh tednov.
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and ALL patients.
Slovenian: Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr-Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s KML, s prisotnim kromosomom Philadelphia, in z ALL.
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Slovenian: Bolniki so bili zdravljeni z odmerki imatiniba 340 mg/m²/dan brez prekinitev; toksičnih učinkov, zaradi katerih bi zmanjševali odmerjanje, ni bilo.
English: • adult and paediatric patients with Ph+ CML in blast crisis.
Slovenian: • odraslih in pediatričnih bolnikov s Ph+ KML v blastni krizi,
English: There is no effect of gender on the kinetics of imatinib.
Slovenian: Spol na kinetiko imatiniba ne vpliva.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. Do not store above 30 °C.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Slovenian: Če pride do zvišanja bilirubina na > 3-kratno zgornjo mejo normalnih vrednosti, specifično za ustanovo (IULN-institutional upper limit of normal) ali zvišanja jetrnih aminotransferaz na > 5-kratno IULN, je treba zdravljenje z imatinibom prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5-kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Slovenian: Imatinib je bil teratogen pri podganah, če so ga dobivale med organogenezo v odmerkih ≥ 100 mg/kg, kar je približno enako največjemu kliničnemu odmerku 800 mg/dan, izračunanemu na podlagi telesne površine.
English: • Severely decreased urine output, feeling thirsty (signs of kidney problems).
Slovenian: • zelo zmanjšano odvajanje urina, občutek žeje (znaki težav z ledvicami),
English: Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Slovenian: Po rezultatih populacijske farmakokinetične analize združenih podatkov pediatričnih bolnikov s hematološkimi boleznimi (s KML, s Ph+ ALL ali s katero od drugih hematoloških bolezni, pri katerih se pri zdravljenju uporablja imatinib), se očistek imatiniba zvišuje z večanjem telesne površine.
English: In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
Slovenian: V 2-letni študiji karcinogenosti pri podganah je odmerjanje imanitiba 15, 30 in 60 mg/kg/dan povzročilo statistično značilno skrajšanje življenjske dobe samcev pri 60 mg/kg/dan in samic pri ≥ 30 mg/kg/dan.
English: These changes are not considered sufficient to warrant dose adjustment based on kg bodyweight.
Slovenian: Te spremembe pa niso dovolj velike, da bi bilo potrebno prilagajanje odmerjanja telesni masi.
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance (see section 4.5).
Slovenian: Od skupine možnih zdravil za sočasno uporabo (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksisečnina, norfloksacin, penicilin V) sta samo eritromicin (IC50 50 μM) in flukonazol (IC50 118 μM) pokazala inhibicijo presnove imatiniba, ki bi bila lahko klinično pomembna (glejte poglavje 4.5).
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Slovenian: Plodnost F1 ni bila prizadeta, pač pa se je pri odmerku 45 mg/kg/dan povečalo število resorpcij in zmanjšalo število za življenje sposobnih plodov.
English: The age of these patients ranged from 2 to 79 years.
Slovenian: Starost teh bolnikov je bila od 2 do 79 let.
English: A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Slovenian: Opravili so veliko mednarodno odprto nekontrolirano študijo faze II pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v fazi blastne krize bolezni.
English: • Hot flushes, chills or night sweats.
Slovenian: • navali vročine, mrazenje ali nočno znojenje.
English: • paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Slovenian: • pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa,
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Slovenian: Poleg tega so v 13 publikacijah poročali o nadaljnjih 24 bolnikih z MDS/MPD.
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Slovenian: Imatinib je v kombinaciji z indukcijo s kemoterapijo (glejte preglednico 3) povzročil popolni hematološki odziv pri 93 % (147 od 158 za oceno primernih bolnikov) in pomembni citogenetični odziv pri 90 % (19 od 21 za oceno primernih bolnikov).
English: The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Slovenian: Učinkovitost imatiniba temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Slovenian: In vitro imatinib zavira aktivnost izoencima CYP2D6 citokroma P450 pri koncentracijah, ki so podobne tistim, ki vplivajo na aktivnost CYP3A4.
English: At a dose of 60 mg/kg, female rats had significant postimplantation foetal loss and a reduced number of live foetuses.
Slovenian: Pri odmerku 60 mg/kg je prišlo pri samicah do znatne izgube plodov po vgnezditvi in do zmanjšanja števila živih plodov.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19 - 60) and 47 months (range 16-59), respectively.
Slovenian: Hematološki odzivi so ostali enaki mediano 49 mesecev (razpon 19 - 60), citogenetični odzivi pa 47 mesecev (razpon 16 - 59).
English: The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
Slovenian: Otrok lahko zdravilo vzame v enem samem dnevnem odmerku ali pa lahko dnevni odmerek razdelimo na dva dela (polovico damo otroku zjutraj, polovico pa zvečer).
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12 % increase in patients > 65 years old).
Slovenian: Na podlagi analize populacijske farmakokinetike pri bolnikih s KML so ugotovili majhen učinek starosti na volumen porazdelitve (12-odstotno povečanje pri bolnikih, starejših od 65 let), vendar ta sprememba ni klinično pomembna.
English: All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Slovenian: Pri vseh bolnikih je prišlo do popolnega hematološkega odziva, do popolnega citogenetičnega odziva in/ali do popolnega molekularnega odziva.