FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59),
Slovenian: Hematološki odzivi so ostali enaki mediano 49 mesecev (od 19 do 60), citogenetični odzivi pa 47 mesecev (od 16 do 59).
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Actavis, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Slovenian: Če se pri bolniku, ki prejema zdravilo Imatinib Actavis, pojavijo laboratorijski ali klinični znaki trombotične mikroangiopatije, je treba zdravljenje prekiniti in izvesti temeljito oceno pojava trombotične mikroangiopatije, vključno z aktivnostjo ADAMTS13 in določanjem protiteles proti ADAMTS13.
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Slovenian: Če citopenija vztraja 2 tedna, odmerek zmanjšajte na 200 mg/m2.
English: This will help protect you from stomach problems when taking Imatinib Actavis.
Slovenian: Tako boste laže preprečili težave z želodcem, do katerih lahko pride pri jemanju zdravila Imatinib Actavis.
English: Imatinib Actavis inhibits the growth of these cells.
Slovenian: Zdravilo Imatinib Actavis zavira rast teh celic.
English: - adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Slovenian: - odraslih bolnikov z napredovalim hipereozinofilnim sindromom (HES) ali s kronično eozinofilno levkemijo (CEL) s premestitvijo FIP1L1-PDGFRα ali z obojim.
English: Pack containing either 30 or 90 capsules.
Slovenian: Škatle, ki vsebujejo 30 ali 90 kapsul.
English: Dosing in children at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Slovenian: Odmerek 260 mg/m2 oziroma 340 mg/m2 pri otrocih je dosegel enako izpostavljenost kot odmerek 400 mg oziroma 600 mg pri odraslih bolnikih.
English: Imatinib Actavis is a treatment for:
Slovenian: Zdravilo Imatinib Actavis je zdravilo za:
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: Gastrointestinal haemorrhage
Slovenian: Gastrointestinalne krvavitve
English: - If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
Slovenian: - Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne vode ali jabolčnega soka.
English: - adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Slovenian: - odraslih bolnikov z relapsom ali neodzivno Ph+ ALL v monoterapiji.
English: For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Slovenian: Za odmerke, ki niso 400 mg in 800 mg (glejte zgoraj navedeno priporočeno odmerjanje) so na voljo tablete po 100 mg.
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Slovenian: Povečanje odmerka s 600 mg na največ 800 mg (odmerjanih po 400 mg dvakrat na dan) pri bolnikih v blastni krizi lahko pride v poštev, če bolnik nima hude neželene reakcije na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja; odsotnost citogenetičnega odziva po 12 mesecih zdravljenja; ali izguba že prej doseženega hematološkega in/ali citogenetičnega odziva.
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 vrtoglavico, meglen vid ali somnolenco.
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: Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Slovenian: Insuficienca ledvic: Bolniki s poslabšanim delovanjem ledvic ali bolniki na dializi naj za začetni odmerek prejmejo najmanjši priporočeni odmerek 400 mg na dan.
English: 24 hard capsules 48 hard capsules 60 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Slovenian: 24 trdih kapsul 48 trdih kapsul 60 trdih kapsul 96 trdih kapsul 120 trdih kapsul 180 trdih kapsul
English: Pack containing either 10, 30, 60, or 90 capsules.
Slovenian: Škatle, ki vsebujejo 10, 30, 60 ali 90 kapsul.
English: The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Slovenian: Učinkovitost zdravila Imatinib Actavis temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
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: If you take more Imatinib Actavis than you should
Slovenian: Če ste vzeli večji odmerek zdravila Imatinib Actavis, kot bi smeli
English: This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon coadministration of either 5-fluorouracil or paclitaxel and imatinib.
Slovenian: Ta vrednost Ki je mnogo večja kot pričakovane plazemske koncentracije imatiniba pri bolnikih, zato po sočasnem dajanju bodisi 5-fluorouracila ali paklitaksela in imatiniba ni pričakovati medsebojnega delovanja.
English: How to store Imatinib Actavis Contents of the pack and other information
Slovenian: Shranjevanje zdravila Imatinib Actavis Vsebina pakiranja in dodatne informacije
English: Dose adjustment for adverse reactions
Slovenian: Prilagoditev odmerjanja zaradi neželenih učinkov
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.
Slovenian: Od skupine možnih zdravil za sočasno uporabo (paracetamol, 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.
English: The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Slovenian: Celotni dnevni odmerek pri otrocih ne sme preseči 800 mg pri zdravljenju KML in 600 mg pri zdravljenju Ph-pozitivne ALL.
English: Consolidation (de novo Ph+ ALL)
Slovenian: Dan konsolidacija (novo odkrita Ph+ ALL)
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Slovenian: Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska, izpuščaj, eritemi, edemi, otekanje, utrujenost, mišični spazmi, trombocitopenija, pancitopenija, bolečine v trebuhu, glavobol, zmanjšan tek.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Slovenian: Pri ponavljajočem se odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega ravnovesja 1,5-2,5-kratno.
English: - Chronic myeloid leukaemia (CML).
Slovenian: - kronično mieloično levkemijo (KML).
English: These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Slovenian: Ti bolniki so prejemali zdravilo Imatinib Actavis mediano 47 mesecev (od 24 dni do 60 mesecev).
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 na dan zaviral presnovo metoprolola s CYP2D6, tako da sta se Cmax in AUC metoprolola povečala za približno 23 % (90 % IZ [1,16-1,30]).
English: Contents of the pack and other information What Imatinib Actavis contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Imatinib Actavis
English: In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Slovenian: V študiji toksičnih učinkov na razvoj mladičev so opažali vpliv na rast ter zakasnjeno odpiranje nožnice in ločevanje prepucija pri izpostavljenosti, ki ustreza približno 0,3 do 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo največjii priporočeni odmerek 340 mg/m2.
English: In adult patients, Imatinib Actavis is intended for use in the most advanced phase of the disease (blast crisis).
Slovenian: Pri odraslih bolnikih se zdravilo Imatinib Actavis uporablja za zdravljenje pozne napredovale faze bolezni, imenovane tudi blastna kriza.
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
Slovenian: (0,5 ure), 7., 8., 14., 15. dan; CP 500 mg/m2 i.v.
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 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 otrocih pa s 340 mg/m2/dan na 260 mg/m2/dan.
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: 3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Slovenian: 3 Dogodke v zvezi s srcem, vključno s kongestivnim popuščanjem srca, so na podlagi enote bolnik-leto pogosteje opažali pri bolnikih s transformacijo KML kot pri bolnikih s kroničnim potekom KML.
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 mg 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: (1 h), days 1-5
Slovenian: (1 ura), 1.-5.
English: What Imatinib Actavis is and what it is used for
Slovenian: Kaj je zdravilo Imatinib Actavis in za kaj ga uporabljamo
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: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Slovenian: Pediatrični bolniki: V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Slovenian: Poleg tega so zabeležili tudi delen citogenetični odziv (PCyRpartial cytogenetic response) pri 16 % bolnikov ob 81 % s pomembnim citogentičnim odzivom.
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 children (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 otrok (na podlagi AUC) pri 340 mg/m2/dan.
English: Induction therapy (de novo Ph+ ALL)
Slovenian: indukcijsko zdravljenje (novo odkrita Ph+ ALL)
English: Some medicines can interfere with the effect of Imatinib Actavis when taken together.
Slovenian: Nekatera zdravila lahko ob sočasnem jemanju vplivajo na delovanje zdravila Imatinib Actavis.
English: Ara-C 1,000 mg/m2 /12 h i.v.
Slovenian: Ara-C 1.000 mg/m2/12 ur i.v.
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Slovenian: DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m2 i.v.
English: CHR: In study 0102 [ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, no blood blasts, BM blasts < 5% and no extramedullary disease]
Slovenian: CHR V študiji 0102 [ANC ≥ 1,5 x 109/L, trombociti ≥ 100 x 109/L, brez blastov v krvi, BM blasti
English: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Slovenian: - odraslih in pediatričnih bolnikov z na novo diagnosticirano akutno limfoblastno levkemijo, s prisotnim kromosomom Philadelphia (Ph+ ALL) skupaj s kemoterapijo.
English: Other medicines and Imatinib Actavis
Slovenian: Druga zdravila in zdravilo Imatinib Actavis
English: Excipients(s)
Slovenian: Pomožna(e) snov(i)
English: Maintenance (8-week cycles) Cycles 1-4
Slovenian: ): 44. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 1.-4. ciklus
English: - If you are being treated for HES/CEL:
Slovenian: - Če se zdravite zaradi HES/CEL:
English: - Do not breast-feed during the treatment with Imatinib Actavis.
Slovenian: - Med zdravljenjem z zdravilom Imatinib Actavis ne dojite.
English: Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
Slovenian: Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
English: This is because Imatinib Actavis could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: - če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib Actavis namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
English: Not known (frequency cannot be estimated from the available data): - Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - kombinacija hudo razširjene hude oblike izpuščaja, siljenja na bruhanje, povišane telesne temperature, visoke ravni določenih belih krvnih celic ali porumenelost kože ali oči (znaki zlatenice) z zasoplostjo, bolečinami v prsnem košu / neugodje, zelo zmanjšanim izločanjem urina in občutekom žeje itd (znaki alergijske reakcije povezane z zdravljenjem).
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Actavis, contact your doctor.
Slovenian: - Če se v obdobju, ko jemljete zdravilo Imatinib Actavis, pri vas pojavijo modrice, krvavitev, povišana telesna temperatura, utrujenost in zmedenost, se posvetujte z zdravnikom.
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 druge faze pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v blastni krizi.
English: Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Slovenian: Zato je pri sočasni uporabi velikih odmerkov imatiniba in paracetamola potrebna previdnost.
English: days 2 and 3
Slovenian: Dne in 1.
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 veliko koncentracijo sečne kisline (glejte poglavje 4.8).
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 adult patients with newly diagnosed Ph+ ALL.
Slovenian: Razpored zdravljenja: Na osnovi obstoječih podatkov se je zdravilo Imatinib Actavis izkazalo 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: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Slovenian: Imatinib je tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF-platelet derived growth factor), PDGF-R in zavira celične dogodke, ki jih posreduje PDGF.
English: No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older.
Slovenian: Pri odraslih bolnikih v kliničnih preskušanjih, v katerih je bilo več kot 20 % bolnikov starih 65 let ali več, ni bilo pomembnih farmakokinetičnih razlik, povezanih s starostjo.
English: Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Slovenian: Velikosti pakiranja: Kapsule so na voljo v aluminiastih pretisnih omotih, pakiranih po 24, 48, 60, 96, 120 ali 180 kapsul
English: There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Slovenian: Izkušenj pri otrocih z MDS/MPD, DFSP in s HES/CEL je zelo malo.
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 acute lymphoblastic leukaemia (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
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Slovenian: - s hipereozinofilnim sindromom (HES) ali kronično eozinofilno levkemijo (CEL) ali z obojim.
English: If you forget to take Imatinib Actavis
Slovenian: Če ste pozabili vzeti zdravilo Imatinib Actavis
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Slovenian: Relaps/neodzivna Ph+ ALL: Zdravljenje z imatinibom kot edinim zdravilom pri bolnikih z relapsom/neodzivno Ph+ ALL je povzročilo pri 53 od 411 za oceno odziva primernih bolnikov stopnjo hematološkega odziva 30 % (v 9 % popolni hematološki odziv) in stopnjo pomembnega citogenetičnega odziva 23 %.
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: - The other ingredients are cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev hidroksid (hidrofoben koloidni in brezvodni koloidni), polivinil alkohol delno hidroliziran, smukec, rumeni železov oksid (E172), titanov dioksid (E171), rdeči železov oksid (E172), sojin lecitin (E322), ksantan gumi (E415).
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 300 mg.
Slovenian: Če citopenija vztraja 4 tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1 x 109/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 300 mg.
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Slovenian: IULN = zgornja meja normalnih vrednosti, specifična za ustanovo AST = aspartat-aminotransferaza
English: 30 hard capsules 90 hard capsules
Slovenian: 30 trdih kapsul 90 trdih kapsul