FrancophonIA/ELRC3.0 huggingface dataset:
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Slovenian: Ara-C: citozin arabinozid; CP: ciklofosfamid; DEX: deksametazon; MTX: metotreksat; 6-MP: 6merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Accord should not be resumed.
Slovenian: V primeru, da je koncentracija protiteles proti ADAMTS13 zvišana, aktivnost ADAMTS13 pa nizka, se zdravljenja z zdravilom Imatinib Accord ne sme nadaljevati.
English: The safety and efficacy of imatinib in children and adolescents with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Slovenian: Varnost in učinkovitost uporabe imatiniba pri otrocih in mladostnikih, ki imajo MDS/MPD, DFSP ali HES/CEL in so stari manj kot 18 let, nista bili dokazani v kliničnih preskušanjih.
English: Imatinib Accord can help you to fight this condition.
Slovenian: Zdravilo Imatinib Accord vam lahko pomaga pri premagovanju te bolezni.
English: Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Slovenian: Konstitutivna aktivacija receptorja za rastni faktor iz trombocitov ali Abl protein-tirozin-kinaze kot posledica združitve različnih sodelujočih proteinov, ali konstitutivna tvorba PDGF sta vpleteni v patogenezo MDS/MPD, HES/CEL in DFSP.
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Slovenian: Pri mnogih od teh živali sta se zvišala dušik sečnine v krvi (BUN) in kreatinin.
English: In clinical trials, there was an increased incidence of these events in elderly and those with a prior history of cardiac disease.
Slovenian: V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših in pri bolnikih z anamnezo bolezni srca.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Slovenian: Gre za približno 1,5 do 2-kratno zvišanje, ki ustreza 1,5-kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Imatinib Accord - če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Slovenian: FIP1L1PDGFRα pozitivni so bili še štirje bolniki s HES, ki so jih opisovali v drugih 3 objavljenih poročilih.
English: Packs containing 10, 30, or 90 film-coated tablets.
Slovenian: Škatle, ki vsebujejo po 10, 30 ali 90 filmsko obloženih tablet.
English: For adult patients with relapsed or refractory Ph+ALL Imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Slovenian: Za odrasle bolnike z relapsom ali neodzivno Ph+ ALL je zdravilo Imatinib kot monoterapija v odmerku 600 mg/dan varno in učinkovito ter ga lahko prejemajo dokler ne pride do napredovanja bolezni.
English: This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Slovenian: Ta klinični učinek je bil povezan z večjim zmanjšanjem količine transkriptov bcrabl pri bolnikih, zdravljenih z imatinibom, kot pri skupini, zdravljeni s kemoterapijo po 2 tednih zdravljenja (p=0,02).
English: What you need to know before you take Imatinib Accord
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Accord
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Slovenian: Za razliko od tega je bilo v kraku z IFN+Ara-C 165 (29,8 %) dogodkov, od tega se jih je 130 zgodilo v času zdravljenja z IFN+Ara-C kot zdravilom prvega izbora.
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Slovenian: 23 bolnikov, ki so bili vključeni v register, je prejemalo zdravilo imatiniba z mediano dnevnega odmerka 264 mg (v razponu od 100 do 400 mg) in z mediano trajanja zdravljenja 7,2 leti (v razponu od 0,1 do 12,7 leta).
English: • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
Slovenian: • odraslih in pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa, ali v pospešeni fazi ali blastni krizi;
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 imatinibom pri bolnikih MDS/MPD v povezavi s preureditvijo genov za PDGFR je malo (glejte poglavje 5.1).
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 and adolescents from 340 to 260 mg/m2/day.
Slovenian: Pri odraslih je treba zmanjšati odmerek s 400 na 300 mg ali s 600 na 400 mg ali z 800 na 600 mg, pri otrocih in mladostnikih pa s 340 na 260 mg/m2/dan.
English: Packs containing 20, 60, 120 or 180 film-coated tablets.
Slovenian: Škatle, ki vsebujejo po 20, 60, 120 ali 180 filmsko obloženih tablet.
English: Do not stop taking Imatinib Accord unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Imatinib Accord, razen če vam tako naroči zdravnik.
English: What Imatinib Accord is and what it is used for
Slovenian: Kaj je zdravilo Imatinib Accord in za kaj ga uporabljamo
English: The high rate of CHR is accompanied by the development of a completecytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Slovenian: Ob veliki stopnji popolnega hematološkega odziva je prišlo tudi do popolnega citogenetičnega odziva (CCyR) v 65 %, kar je primerljivo z zabeleženimi rezultati pri odraslih.
English: The effect of Imatinib treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Imatinib data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Slovenian: Vpliv zdravljenja z zdravilom Imatinib Accord na preživetje v kronični fazi pri novo diagnosticirani KML so nadalje preiskovali z retrospektivno analizo zgoraj opisanih podatkov o zdravilu Imatinib Accord skupaj s prvotnimi podatki druge študije faze III, v kateri so uporabljali IFN+Ara-C s povsem enakim režimom zdravljenja (n=325).
English: Imatinib Accord may cause your body to retain water (severe fluid retention).
Slovenian: Zaradi zdravila Imatinib Accord lahko telo zadržuje vodo (lahko pride do močnega zastajanja tekočine).
English: of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Slovenian: 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Slovenian: Ugotovili so, da je plazemska AUC tega presnovka samo 16 % AUC imatiniba.
English: Chronic phase CML, MDS/MPD (starting dose 400 mg) HES/CEL (at dose 400 mg)
Slovenian: kronična faza KML, MDS/MPD (začetni odmerek 400 mg) HES/CEL (pri odmerku 400 mg)
English: Imatinib Accord may do the same to some other medicines.
Slovenian: Zdravilo Imatinib Accord lahko enako vpliva na druga zdravila.
English: The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on Imatinib.
Slovenian: Stopnja citogenetičnega in molekularnega odziva ima nedvomen učinek na dolgoročni izid pri bolnikih, zdravljenih z zdravilom Imatinib Accord.
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Slovenian: Študija 0102 podatki pri 38 mesecih mieloidna blastna kriza (n=260)
English: Study AJP01 Induction therapy
Slovenian: Študija AJP01 indukcijsko zdravljenje
English: Dosing for children and adolescents should be on the basis of body surface area (mg/m2).
Slovenian: Odmerjanje pri KML pri otrocih in mladostnikih Odmerjanje za otroke in mladostnike mora temeljiti na telesni površini (mg/m2).
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Slovenian: Po 84 mesecih je ocenjeno celotno preživetje v skupini randomizirani na zdravilo Imatinib Accord 86,4 % (83, 90) v primerjavi z 83,3 % (80, 87) v skupini randomizirani na IFN+Ara-C (p=0,073, test log-rank).
English: Imatinib Accord is also a treatment for children and adolescents with CML.
Slovenian: Zdravilo Imatinib Accord je namenjeno tudi zdravljenju otrok in mladostnikov s KML.
English: In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Slovenian: V tej retrospektivni analizi se je z vidika celotnega preživetja zdravilo Imatinib Accord izkazalo za boljše od IFN+Ara-C (p<0,001): v 42 mesecih je umrlo 47 (8,5 %) bolnikov z zdravilom Imatinib Accord in 63 (19,4 %) bolnikov z IFN+Ara-C.
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 imanitib 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: 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: - Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
Slovenian: - Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Imatinib Accord, naj se posvetujejo s svojim zdravnikom.
English: The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
Slovenian: Predpisano število tablet je treba dati v primerno količino napitka (približno 50 ml za tableto po 100 mg in 200 ml za tableto po 400 mg) in premešati z žlico.
English: Imatinib is a small molecule protein-tyrosine 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 protein-tirozin-kinaze, 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 PDGFRbeta).
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: Imatinib Accord is a treatment for adults and children and adolescents for:
Slovenian: Zdravilo Imatinib Accord je zdravilo za odrasle in otroke ter mladostnike:
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia, or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Slovenian: Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije ali kot vrnitev v kronično fazo KML, pri čemer so uporabljali enaka merila kot pri študiji v pospešeni fazi.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
Slovenian: V študiji pri bolnikih z neresektabilnimi in/ali metastatskimi GIST so poročali tako o gastrointestinalnih kot o intratumorskih krvavitvah (glejte poglavje 4.8).
English: In paediatric CML patients the most frequent toxicities observed were grade3 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: 3) [95% CI]
Slovenian: 3) [95 %-ni interval zaupanja] delen
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia
Slovenian: Hematološki odziv popolni hematološki odziv (CHR) nobenih znakov levkemije (NEL)
English: Considering the limited safety database, the adverse events thus far reported in children and adolescents are consistent with the known safety profile in adult patients with Ph+ ALL.
Slovenian: Baza podatkov do zdaj sporočenih neželenih dogodkov pri otrocih in mladostnikih je majhna, vendar se podatki v njej ujemajo z varnostnimi lastnostmi zdravila pri odraslih bolnikih s Ph+ ALL.
English: 1800 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 do 3200 mg (tudi do 3200 mg na dan 6 dni): oslabelost, mialgija, zvišana kreatinkinaza, zvišan bilirubin, bolečine v prebavilih.
English: Close monitoring of growth in children and adolescents under imatinib treatment is recommended (see section 4.8).
Slovenian: Pri otrocih in mladostnikih, ki prejemajo imatinib, je priporočeno natančno spremljanje njihove rasti (glejte poglavje 4.8).
English: Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
Slovenian: AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin > IULN)
English: • For Alu/Alu blisters This medicine does not require any special storage conditions.
Slovenian: • Za pretisne omote iz aluminija/aluminija • Za shranjevanje tega zdravila niso potrebna posebna navodila.
English: A total of 71 (12.8%) and 85 (15.4%) patients died in the Imatinib and IFN+Ara-C groups, respectively.
Slovenian: Skupno je umrlo 71 (12,8 %) bolnikov iz skupine z zdravilom Imatinib Accord in 85 (15,4 %) iz skupine z IFN+Ara-C.
English: Other medicines and Imatinib Accord
Slovenian: Druga zdravila in zdravilo Imatinib Accord
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 Philadelphia, in z akutno limfoblastno levkemijo (ALL).
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z imatinibom za vse skupine pediatrične populacije s kronično mieloično levkemijo s prisotnim kromosomom Philadelphia (s translokacijo bcr-abl) (za podatke o uporabi pri pediatrični populaciji glejte poglavje
English: The median duration of second-line treatment with Imatinib was 64 months.
Slovenian: Mediano trajanje zdravljenja z zdravilom Imatinib Accord kot zdravilom drugega izbora je bilo 64 mesecev.
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 imatiniba.
English: At a dose of 60 mg/kg, female rats had significant post-implantation 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: Table 4 Chemotherapy regimen used in combination with imatinib
Slovenian: Preglednica 4 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Accord (see section 4.8).
Slovenian: Zaviralce tirozin kinaze BCR-ABL povezujejo z razvojem trombotične mikroangiopatije, o posameznih primerih so poročali tudi pri uporabi zdravila Imatinib Accord (glejte poglavje 4.8).
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Slovenian: Po 7 letih spremljanja je bilo v kraku z zdravilom Imatinib Accord 93 (16,8 %) dogodkov, ki pomenijo napredovanje bolezni: 37 (6,7 %) jih je vključevalo napredovanje v pospešeno fazo/blastno krizo, 31 (5,6 %) izgubo pomembnega citogenetičnega odziva, 15 (2,7 %) izgubo popolnega hematološkega odziva ali zvišanje WBC, 10 (1,8 %) pa je bilo smrti brez povezave s KML.
English: Dosing in children and adolescents 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 oziroma 340 mg/m2 pri otrocih in mladostnikih je dosegel enako izpostavljenost kot odmerek 400 mg oziroma 600 mg pri odraslih bolnikih.
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 drugs is possible.
Slovenian: Največje koncentracije imatiniba v plazmi bolnikov so 2-4 μmol/l, zato je možna inhibicija sočasno uporabljanih zdravil,katerih presnova poteka preko CYP2D6 in/ali CYP3A4/5.
English: VCR 1 mg i.v., days 7, 14;
Slovenian: VCR 1 mg i.v., 7. in 14. dan;
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 90 filmsko obloženih tablet 30 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Accord, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13antibody determination, should be completed.
Slovenian: Če se pri bolniku, ki prejema zdravilo Imatinib Accord, 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: 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 omotico, meglen vid ali zaspanost.
English: If you are being treated for DFSP
Slovenian: - Če se zdravite zaradi DFSP
English: - If you forget a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Imatinib Accord - Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Slovenian: 10 Mišično-skeletne bolečine in z njimi povezane dogodke so pogosteje opažali pri bolnikih s KML kot pri bolnikih z GIST.
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 60 filmsko obloženih tablet 120 filmsko obloženih tablet 180 filmsko obloženih tablet 30 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 120 x 1 filmsko obložena tableta 180 x 1 filmsko obložena tableta
English: The estimated rate of progression-free survival at 84 months was 81.2% in the Imatinib arm and 60.6% in the control arm (p<0.001).
Slovenian: Ocenjeni delež preživelih brez napredovanja bolezni pri 84 mesecih je bil 81,2 % na kraku z zdravilo Imatinib Accord in 60,6 % na kontrolnem kraku (p<0,001).
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (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 zdravilu imatinib zgodaj v poteku zdravljenja v kombinaciji s kemoterapijo povečala delež bolnikov s 4-letnim preživetjem brez dogodkov (EFS - event-free survival) v primerjavi z zgodovinskimi kontrolami (n=120), kjer so bolniki prejeli standardno kemoterapijo brez zdravila imatinib (69,6 % v primerjavi z 31,6 %).
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Slovenian: Če citopenija ni povezana z levkemijo, zmanjšajte odmerek zdravila Imatinib Accord na 260 mg/m2.
English: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Slovenian: V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96,3 % v primerjavi s 50 %; p=0,0001).
English: This will help protect you from stomach problems when taking Imatinib Accord.
Slovenian: Tako boste laže preprečili težave z želodcem, do katerih lahko pride pri jemanju zdravila Imatinib Accord.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets of 100 mg or one tablet of 400 mg once a day, depending on how you respond to treatment.
Slovenian: Vaš zdravnik se lahko odloči za zvišanje odmerka na 400 mg, kar vzamete kot 4 tablete po 100 mg ali eno tableto po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.