FrancophonIA/ELRC3.0 huggingface dataset:
English: The no observed effect level (NOEL) was 15 mg/kg/day.
Slovenian: Odmerek brez opaženega učinka (NOEL) je bil 15 mg/kg/dan.
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Slovenian: Navajali so izboljšanje na področju srca, živčevja, kože/podkožnega tkiva, dihalnega/torakalnega/mediastinalnega organskega sistema, mišičnoskeletnega/vezivnotkivnega/žilnega organskega sistema in prebavil.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Slovenian: Kadar so imatinib uporabljali v kombinaciji z visokoodmerno kemoterapevtsko shemo pri bolnikih s Ph+ ALL, je prišlo do prehodne toksičnosti za jetra v obliki zvišanja aminotransferaz in hiperbilirubinemije.
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Slovenian: Zaradi možnosti, da pride do sindroma tumorske lize, je pred začetkom zdravljenja z imatinibom priporočeno odpraviti klinično pomembno dehidriranost in visoko koncentracijo sečne kisline (glejte poglavje 4.8).
English: (24 h), days 1, 15;
Slovenian: (24 ur), 1., 15. dan;
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6 % vs. 31.6 %, respectively).
Slovenian: Pri bolnikih v 5. kohorti (n=50) je neprekinjena vsakodnevna izpostavljenost imatinibu zgodaj v poteku zdravljenja v kombinaciji s kemoterapijo povečala delež bolnikov s 4-letnim preživetjem brez dogodkov (EFSevent-free survival) v primerjavi z zgodovinskimi kontrolami (n=120), ki so prejemale standardno kemoterapijo brez imatiniba (69,6 % v primerjavi z 31,6 %).
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Slovenian: Kaže, da pri sočasni uporabi imatiniba s substrati CYP2D6 prilagajanje odmerkov ni potrebno, vendar pa je potrebna previdnost pri substratih CYP2D6 z ozkim terapevtskim oknom, kot je metoprolol.
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea.
Slovenian: Pri enem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 400 mg, je prišlo do bruhanja, driske in anoreksije, pri drugem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 980 mg, pa je prišlo do znižane koncentracije levkocitov in driske.
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Slovenian: Največje koncentracije imatiniba v plazmi bolnikov so 2-4 μmol/l, zato je možna inhibicija sočasno uporabljanih zdravil s presnovo, ki poteka preko CYP2D6 in/ali CYP3A4/5.
English: There is very limited experience in children with MDS/MPD and DFSP.
Slovenian: Izkušenj pri otrocih z MDS/MPD in DFSP je zelo malo.
English: • The active substance is imatinib (as mesilate).
Slovenian: • Učinkovina je imatinib (v obliki mesilata).
English: Very common: Headache Common:
Slovenian: glavobol pogosti:
English: Table 3 Chemotherapy regimen used in combination with imatinib
Slovenian: Preglednica 3 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Slovenian: Občasni (lahko prizadenejo do 1 bolnika od 100 bolnikov) ali redki (lahko prizadenejo do 1 bolnika od 1.000 bolnikov):
English: • Chronic myeloid leukaemia (CML) in blast crisis.
Slovenian: • s kronično mieloično levkemijo (KML) v blastni krizi.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Slovenian: V obdobju trženja zdravila so poročali o spontanih splavih in prirojenih nepravilnostih pri dojenčkih mater, ki so med nosečnostjo prejemale zdravilo Imatinib medac.
English: Imatinib is a small molecule protein kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Slovenian: Imatinib je majhna molekula in je zaviralec proteinskih kinaz, ki močno zavira aktivnost Bcr-Abl tirozin-kinaze, pa tudi nekaj receptorskih tirozin-kinaz: pri receptorju Kit, ki je receptor za dejavnik matičnih celic (stem cell factor, SCF), ki ga kodira protoonkogen c-Kit, pri receptorjih za diskoidinsko domeno (DDR1 in DDR2), pri receptorju za kolonije stimulirajoči faktor (CSF-1R) in pri receptorjih za rastni faktor iz trombocitov alfa in beta (platelet-derived growth factor PDGFR-alfa in PDGFR-beta).
English: In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses > 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Slovenian: Pri podganah so v 13-tedenski študiji pri odmerkih > 6 mg/kg našli hiperplazijo prehodnega epitela v ledvični papili in v sečnem mehurju, brez sprememb serumskih ali urinskih parametrov.
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”.
Slovenian: Različne neželene reakcije, na primer plevralni izliv, ascites, pljučni edem in hitro naraščanje telesne mase, bodisi s površinskimi edemi bodisi brez njih, imenujemo s skupnim izrazom “retenca tekočine”.
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95 % on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Slovenian: Pri klinično pomembnih koncentracijah imatiniba je bila vezava na plazemske beljakovine na podlagi poskusov in vitro približno 95-odstotna, večina imatiniba se je vezala na albumine in kisli glikoprotein alfa, malo pa na lipoproteine.
English: What you need to know before you take Imatinib medac
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Imatinib medac
English: The no observed effect level (NOEL) was 30 mg/kg/day.
Slovenian: Odmerek brez opaženega učinka (NOEL) je bil 30 mg/kg/dan.
English: Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Slovenian: Imatinib se ni izkazal za genotoksičnega pri in vitro testiranju na bakterijskih celicah (Amesov test), in vitro testiranju na sesalskih celicah (mišji limfom) in in vivo podganjem mikronukleusnem testu.
English: Imatinib medac inhibits the growth of these cells.
Slovenian: Zdravilo Imatinib medac zavira rast teh celic.
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Slovenian: Imatinib lahko zviša plazemske koncentracije drugih zdravil, ki jih presnavlja CYP3A4 (na primer triazolo-benzodiazepinov, dihidropiridinskih blokatorjev kalcijevih kanalčkov, nekaterih zaviralcev reduktaze HMG-CoA, tj. statinov, itn.).
English: When imatinib is co-administered with other medicinal products, there is a potential for drug interactions.
Slovenian: Ob sočasni uporabi imatiniba z drugimi zdravili obstaja možnost njihovega medsebojnega delovanja.
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Slovenian: Ker so občasno poročali o s srcem povezanih neželenih dogodkih z imatinibom, je treba pri populaciji bolnikov s HES/CEL pred uvedbo zdravljenja pretehtati razmerje med koristjo in tveganjem.
English: • Cough, having difficulty breathing or painful breathing (signs of lung problems).
Slovenian: • kašelj, težave z dihanjem ali bolečine pri dihanju (znaki težav s pljuči),
English: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM medac GmbH
English: • Chronic renal failure.
Slovenian: • kronična ledvična bolezen.
English: If your daily dose is 800 mg, you should take 1 capsule of 400 mg in the morning and 1 capsule of 400 mg in the evening.
Slovenian: Če je vaš dnevni odmerek 800 mg, morate vzeti 1 kapsulo po 400 mg zjutraj in 1 kapsulo po 400 mg zvečer.
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Slovenian: Vse faze zdravljenja morajo nadzorovati hematološki strokovnjaki za zdravljenje te bolezni.
English: Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Slovenian: Bolniki z blago, zmerno ali težko disfunkcijo jeter naj prejmejo najmanjši priporočeni odmerek 400 mg na dan.
English: The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Slovenian: Očistek nevezane učinkovine je pri imatinibu verjetno podoben pri bolnikih z okvaro ledvic in pri tistih z normalnim delovanjem ledvic, saj predstavlja izločanje skozi ledvice manj pomemben način izločanja za imatinib (glejte poglavji 4.2 in 4.4).
English: The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Slovenian: Učinek imatiniba na izid presaditve kostnega mozga ni raziskan.
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Slovenian: Farmakokinetiko imatiniba so ovrednotili v območju odmerjanja od 25 do 1.000 mg. Plazemski farmakokinetični profili so bili analizirani 1. dne, nato pa bodisi 7. bodisi 28. dne, ko so plazemske koncentracije že dosegle stanje dinamičnega ravnovesja.
English: Table 2 Response in adult CML study
Slovenian: Preglednica 2 Odziv pri odraslih bolnikih s KML v klinični študiji
English: In patients with hypereosinophilic syndrome (HES) with occult infiltration of HES cells within the myocardium, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with HES cell degranulation upon the initiation of imatinib therapy.
Slovenian: Pri bolnikih s hipereozinofilnim sindromom (HES) z okultno infiltracijo celic HES znotraj miokarda je v posameznih primerih ob uvedbi zdravljenja z imatinibom prišlo, v povezavi z degranulacijo celic HES, do kardiogenega šoka/disfunkcije levega prekata.
English: Eleven patients achieved rapid CHR; ten had complete resolution of cytogenetic abnormalities and a decrease or disappearance of fusion transcripts as measured by RT-PCR.
Slovenian: 11 bolnikov je doseglo hiter popolni hematološki odziv, pri desetih je prišlo do popolne normalizacije citogenetičnih nepravilnosti in zmanjšanja oziroma izginotja fuzijskih transkriptov, kot so izmerili z verižno reakcijo s polimerazo v realnem času (RT-PCR).
English: Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for patients with newly diagnosed Ph+ ALL.
Slovenian: Razpored zdravljenja: Na osnovi obstoječih podatkov se je imatinib izkazal kot učinkovito in varno zdravilo, če je bilo pri odraslih bolnikih z novo diagnosticirano Ph+ ALL uporabljeno v odmerku 600 mg/dan v kombinaciji s kemoterapijo v začetni fazi, konsolidacijski in vzdrževalni fazi kemoterapije (glejte poglavje 5.1).
English: This was not seen at doses ≤ 20 mg/kg.
Slovenian: Tega pri odmerkih ≤ 20 mg/kg niso opazili.
English: Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Slovenian: Bolnikom je treba razložiti, da lahko med zdravljenjem z imatinibom doživijo neželene učinke, na primer vrtoglavost, meglen vid ali zaspanost.
English: Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Slovenian: Kaže, da je pri bolnikih z blago in zmerno okvarjenim delovanjem ledvic izpostavljenost imatinibu v plazmi višja kot pri bolnikih z normalnim delovanjem ledvic.
English: Therefore, caution should be recommended when driving a car or operating machinery.
Slovenian: Zato je treba bolnikom, ki vozijo avto ali uporabljajo stroje, priporočiti previdnost.
English: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Slovenian: Zdravilo deluje tako, da zavira rast nenormalnih celic pri spodaj navedenih boleznih, med katerimi so tudi nekatere vrste raka.
English: There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Slovenian: Pri bolnikih s KML je bila mielosupresija izrazitejša kot pri bolnikih z GIST, kar je verjetno posledica osnovne bolezni.
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in paediatric patients (based on AUC) at 340 mg/m2/day.
Slovenian: Papilome/karcinome prepucijske/klitorisne žleze so opazili pri odmerkih od 30 mg/kg/dan naprej, kar predstavlja približno 0,5-kratnik oziroma 0,3-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan, in 0,4-kratnik dnevne izpostavljenosti pediatričnih bolnikov (na podlagi AUC) pri 340 mg/m²/dan.
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Slovenian: • odraslih bolnikov z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD) v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR - platelet derived growth factor receptor),
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p < 0.001; OS p < 0.0001) in two studies (AJP01 and AUS01).
Slovenian: V dveh študijah (AJP01 in AUS01) sta preživetje brez bolezni (DSF - disease-free survival) in celokupno preživetje (OS - overall survival) pogosto presegala 1 leto in sta bila daljša kot pri zgodovinskih kontrolah (DFS p < 0,001; OS p < 0,0001).
English: All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Slovenian: Pri vseh bolnikih je prišlo do popolnega hematološkega odziva, do citogenetičnega odziva in/ali do kliničnega odziva.
English: Imatinib medac may cause your body to retain water (severe fluid retention).
Slovenian: Zaradi zdravila Imatinib medac lahko telo zadržuje vodo (lahko pride do močnega zastajanja tekočine).
English: These effects were not seen at doses ≤ 30 mg/kg.
Slovenian: Teh učinkov pri odmerkih ≤ 30 mg/kg niso opazili.
English: imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Slovenian: Bolnikom v kohortah 1-5 so imatinib odmerjali intermitentno, pri čemer je bilo v vsaki nadaljnji kohorti trajanje zdravljenja daljše, začetek zdravljenja z imatinibom pa zgodnejši, tako da je bila v 1. kohorti intenzivnost zdravljenja z imatinibom najnižja, v 5. kohorti pa najvišja (najdaljše trajanje zdravljenja glede na število dni neprekinjenega enkrat dnevnega odmerjanja imatiniba pri prvem poteku kemoterapije).
English: The dose of 340 mg/m daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Slovenian: Za otroke s Ph+ ALL je priporočeni odmerek 340 mg/m na dan (ne sme preseči celotnega odmerka 600 mg).
English: Maintenance (8-week cycles) Cycles 6-12
Slovenian: 50. dan vzdrževalno zdravljenje (8 tedenski ciklusi) 6.-12. ciklus
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Dosing for children should be on the basis of body surface area (mg/m2).
Slovenian: Odmerjanje pri Ph+ ALL pri otrocih Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
English: The age of these patients ranged from 20 to 72 years.
Slovenian: Starost teh bolnikov je bila od 20 do 72 let.
English: Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n = 11) or CML in blast crisis or Ph+ acute leukaemias (n = 15) were enrolled in a dose-escalation phase I trial.
Slovenian: Pediatrični bolniki: V preskušanje stopnjevanja odmerka prve faze so vključili skupaj 26 pediatričnih bolnikov, starih < 18 let, bodisi s kronično fazo KML (n = 11) bodisi s KML v blastni krizi ali Ph+ akutnimi levkemijami (n = 15).
English: • Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Slovenian: • z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
English: 1) Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
Slovenian: 1) O pljučnici so najpogosteje poročali pri bolnikih s transformacijo KML in pri bolnikih z GIST.
English: The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Slovenian: Običajni začetni odmerek pri zdravljenju KML v blastni krizi je 600 mg, odmerek jemljite v obliki 6 kapsul po 100 mg (ali 1 kapsule po 400 mg in 2 kapsuli po 100 mg) enkrat na dan.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Slovenian: Pred začetkom zdravljenja bo zdravnik skrbno pregledal bolnike glede znakov te
English: No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Slovenian: Glede na znane tarčne organe pri odraslih podganah niso v toksikološki študiji razvoja mladih podgan (10.-70. dan po skotitvi) ugotovili novih tarčnih organov.
English: UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: RTC: < 15 % blasts BM and PB, < 30 % blasts+promyelocytes in BM and PB, < 20 % basophils in PB, no extramedullary disease other than spleen and liver.
Slovenian: 9/l RTC: < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v
English: Patients with renal impairment should be given the minimum starting dose.
Slovenian: Bolniki z okvarjenim delovanjem ledvic naj prejmejo najmanjši priporočeni začetni odmerek.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in paediatric patients (based on AUC) at 340 mg/m2/day.
Slovenian: Adenome/karcinome ledvic, papilome sečnega mehurja in sečnice, adenokarcinome tankega črevesa, adenome obščitničnih žlez, benigne in maligne medularne tumorje nadlevičnih žlez in papilome/karcinome ne-žleznega dela želodca so opazili pri odmerku 60 mg/kg/dan, kar predstavlja približno 1,7 do 1-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan in 1,2-kratnik dnevne izpostavljenosti pediatričnih bolnikov (na podlagi AUC) pri 340 mg/m²/dan.
English: If cytopenia persists for 2 weeks, reduce further to 300 mg.
Slovenian: Če citopenija vztraja 2 tedna, odmerek zmanjšajte na 300 mg.
English: Studies on patients receiving imatinib and its effect on fertility and gametogenesis have not been performed.
Slovenian: Pri ljudeh niso opravili študij z bolniki, ki prejemajo imatinib, da bi preučili vpliv zdravila na plodnost in na gametogenezo.
English: It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Slovenian: Bolniki z GIST imajo lahko jetrne metastaze, zaradi česar lahko pride do okvare jeter.
English: What Imatinib medac is and what it is used for
Slovenian: Kaj je zdravilo Imatinib medac in za kaj ga uporabljamo
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Slovenian: metotreksat (20 mg/m2/teden, peroralno): 8., 15., 22., 29., 36., 43. in
English: How long to take Imatinib medac Keep taking Imatinib medac every day for as long as your doctor tells you.
Slovenian: Koliko časa jemati zdravilo Imatinib medac Zdravilo Imatinib medac jemljite vsak dan, dokler vam zdravnik ne naroči, da ga prenehajte jemati.
English: 2) Headache was the most common in GIST patients.
Slovenian: 2) Pri bolnikih z GIST je bil najpogostejši glavobol.
English: If you forget to take Imatinib medac • If you forget a dose, take it as soon as you remember.
Slovenian: • Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Slovenian: Kljub temu, da klinične izkušnje s sočasno uporabo imatiniba in kemoterapije pri bolnikih s Ph+ ALL obstajajo (glejte poglavje 5.1), pa interakcije med imatinibom in posameznimi kemoterapevtskimi shemami niso dobro opredeljene.
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Slovenian: V enem odprtem multicentričnem kliničnem preskušanju faze II (študija B2225) so preskušali imatinib pri različnih populacijah bolnikov z življenjsko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
English: • Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of
Slovenian: • oslabelost mišic in mišični spazmi z nepravilnim ritmom bitja srca (znaki spremenjenih