FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0x109/1) and thrombocytopenias (platelet count < 50x109/1) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Slovenian: Nevtropenija 3. ali 4. stopnje (ANC  1,0 x 109/l) in trombocitopenija (koncentracija trombocitov  50 x 109/l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Slovenian: Previdnost je potrebna pri uporabi imatiniba z zaviralci proteaze, azolnimi antimikotiki, določenimi makrolidi (glejte poglavje 4.5), s substrati CYP3A4 z ozkim terapevtskim oknom (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminom, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom, kinidinom) ali z varfarinom in drugimi derivati kumarina (glejte poglavje 4.5).
English: Talk to your doctor before taking Imatinib Accord: - if you have or have ever had a liver, kidney or heart problem.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Imatinib Accord se posvetujte z zdravnikom: - če imate ali ste kdaj imeli težave z jetri, ledvicami ali srcem; - če jemljete zdravilo levotiroksin, ker so vam odstranili ščitnico.
English: 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, nonrandomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Slovenian: 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 zdravilom imatinib (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
English: INFORMATION IN BRAILLE Imatinib Accord 400 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Imatinib Accord 400 mg
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycinand telithromycin) could decrease metabolism and increase imatinib concentrations.
Slovenian: Snovi, ki zavirajo aktivnost izoencima CYP3A4 citokroma P450 (na primer zaviralci proteaze, kot so indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotiki vključno s ketokonazolom, itrokonazolom, posakonazolom, vorikonazolom; določenimi makrolidi kot so eritromicin, klaritromicin in telitromicin), bi lahko zmanjševale presnovo in zviševale koncentracije imatiniba.
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) ali pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Slovenian: - s hipereozinofilnim sindromom (HES) ali kronično eozinofilno levkemijo (CEL) ali z obojim.
English: INFORMATION IN BRAILLE Imatinib Accord 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Imatinib Accord 100 mg
English: There is limited experience in children and adolescents with Ph-positive ALL and very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
Slovenian: Izkušenj pri otrocih in mladostnikih s Ph pozitivno ALL je malo, pri otrocih in mladostnikih z MDS/MPD, DFSP ali s HES/CEL pa zelo malo.
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
Slovenian: • odraslih in pediatričnih bolnikov z na novo diagnosticirano kronično mieloično levkemijo (KML), s prisotnim kromosomom Philadelphia (bcr-abl) (Ph+), pri katerih presaditev kostnega mozga kot zdravljenje prve izbire ne pride v poštev;
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Slovenian: Podobne rezultate so opažali pri bolnikih z malignim gliomom, ki so jih zdravili z imatinibom, sočasno pa so jemali tudi antiepileptična zdravila, ki inducirajo encime.
English: Ara-C 1,000 mg/m2/12h i.v.
Slovenian: Ara-C 1.000 mg/m2/12 ur i.v.
English: The dose of 340 mg/m2 daily is recommended for children and adolescents with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Slovenian: Za otroke in mladostnike s kronično fazo KML oziroma z napredovalimi fazami KML je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 800 mg).
English: Active substances that may decrease imatinib plasma concentrations
Slovenian: Učinkovine, ki lahko znižajo plazemske koncentracije imatiniba:
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
Slovenian: Če citopenija vztraja 4 tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z zdravilom Imatinib Accord, dokler ni ANC  1 x 109/l in koncentracija trombocitov  20 x 109/l, nato spet začnite zdravljenje z odmerkom 300 mg.
English: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
Slovenian: • mišični spazmi z vročino, rdeče-rjavo obarvan urin, boleče ali oslabele mišice (znaki težav z mišicami),
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Slovenian: V isti publikaciji poročajo o podatkih z dolgoročnih kontrolnih pregledov za 12 bolnikov z MDS/MPD s preureditvijo gena za PDGFR (5 bolnikov iz študije B2225).
English: There is very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
Slovenian: Izkušenj pri otrocih in mladostnikih z MDS/MPD, DFSP ali s HES/CEL pa zelo malo.
English: Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Slovenian: Tega zaviranja po uporabi imatiniba 400 mg in paracetamola 1000 mg in vivo niso opažali.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
Slovenian: Če citopenija vztraja 4 tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z zdravilom Imatinib Accord, dokler ni ANC  1 x 109/l in koncentracija trombocitov  20 x 109/l, nato spet začnite zdravljenje z odmerkom 200 mg/m2.
English: Resume treatment with Imatinib Accord at previous dose (i.e. before severe adverse reaction).
Slovenian: Spet začnite zdravljenje z zdravilom Imatinib Accord s prejšnjim odmerkom (t.j.
English: IFN+Ara-C n=553
Slovenian: IFN+Ara-C
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose ofimatinibresulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Slovenian: 400-miligramski odmerek imatiniba, je povzročilo zmanjšanje Cmax oziroma AUC(0-∞) za vsaj 54 % oziroma 74 % zadevnih vrednosti brez zdravljenja z rifampicinom.
English: How to take Imatinib Accord
Slovenian: Kako jemati zdravilo Imatinib Accord
English: Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Slovenian: mesecev, bolniki pa so bili vsi v pozni kronični fazi s povprečnim časom 32 mesecev od postavitve diagnoze.
English: Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Slovenian: Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Imatinib Accord, naj se posvetujejo s svojim zdravnikom.
English: Not applicable.
Slovenian: se smiselno ne uporablja
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Imatinib Accord testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje epatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Imatinib Accord, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glejte poglavje
English: A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Slovenian: Randomiziranih je bilo skupno 1.106 bolnikov, 553 na vsak krak.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/845/009-011
English: VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Slovenian: VCR 1,3 g/m2 i.v., 1. dan; prednizolon 60 mg/m2 peroralno, 1.-5. dan
English: Keep taking Imatinib Accord every day for as long as your doctor tells you.
Slovenian: Koliko časa jemati zdravilo Imatinib Accord Zdravilo Imatinib Accord jemljite vsak dan, dokler vam zdravnik ne naroči, da ga prenehate jemati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/845/001-004
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Slovenian: Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan oziroma v odmerkih od 200 do 400 mg na dan.
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Slovenian: Ti bolniki so bili stari od 3 mesece do 4 leta, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 92,5 do 340 mg/m2 na dan.
English: Study ADE10 Prephase
Slovenian: Študija ADE10
English: If any of these apply to you, tell your doctor before taking Imatinib Accord.
Slovenian: Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib Accord posvetujte s svojim zdravnikom.
English: Confusional state Nervous system disorders Very common Headache2
Slovenian: Bolezni živčevja zelo pogosti glavobol2
English: Ara-C 60 mg/ m2 i.v., days 22-25, 29-32
Slovenian: Ara-C 60 mg/m2 i.v., 22.-25., 29.-32. dan konsolidacijska terapija I, III, V
English: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Slovenian: Zato je pri uporabi imatiniba skupaj s substrati CYP3A4 z ozko terapevtsko širino (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminov, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom in kinidinom) priporočljiva previdnost.
English: Depending on your condition the usual starting dose is either 400 mg or 600 mg: - 400 mg to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once a day - 600 mg to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot 4 tablete po 100 mg ali 1 tableto po 400 mg enkrat na dan, 600 mg vzamete kot 6 tablet po 100 mg ali 1 tableto po 400 mg plus 2 tableti po 100 mg enkrat na dan.
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1
Slovenian: metotreksat (5 g/m2 v času 24 ur, i.v.
English: If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 6 tablets of 100 mg or one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: - Če se zdravite zaradi Ph pozitivne ALL Začetni odmerek je 600 mg, kar vzamete kot 6 tablet po 100 mg ali eno tableto po 400 mg plus 2 tableti po 100 mg enkrat na dan.
English: In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
Slovenian: Na kraku z zdravilom Imatinib Accord so bili bolniki zdravljeni s 400 mg na dan. Na kraku z IFN so bili bolniki zdravljeni 10 dni na mesec s tarčnim odmerkom IFN 5 MIU/m2/dan subkutano v kombinaciji s subkutanim Ara-C 20 mg/m2/dan.
English: Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Slovenian: Snovi, ki inducirajo aktivnost CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka), lahko znatno zmanjša izpostavljenost imatinibu in s tem potencialno poveča tveganje za neuspešnost zdravljenja.
English: (24 h), day 1, Ara-C 1 g/ m2 i.v.
Slovenian: (24 ur), 1. dan, Ara-C 1 g/m2 i.v.
English: (NEL) Return to chronic phase
Slovenian: se smiselno ne uporablja vrnitev v kronično fazo (RTC)
English: SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Za pretisne omote iz PVC/PVdC/aluminija Shranjujte pri temperaturi do 30 C.
English: The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Slovenian: Odmerek je 800 mg na dan (kar vzamete kot 4 tablete po 100 mg ali 1 tableto po 400 mg zjutraj in 4 tablete po 100 mg ali 1 tableto po 400 mg zvečer).
English: * p< 0.001, Fischer's exact test ** molecular response percentages are based on available samples
Slovenian: mesecih (%) * p<0,001, Fischerjev eksaktni test ** odstotek bolnikov z molekularnim odzivom na osnovi dostopnih razpoložljivih vzorcev Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po  4 tednih): WBC < 10 x 10
English: • Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
Slovenian: • Za vsako tableto po 100 mg potrebujete približno 50 ml vode, za vsako tableto po 400 mg pa približno 200 ml vode.
English: Additionally Imatinib Accord 100 mg tablets are also available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Slovenian: Imatinib Accord 100 mg tablete so na voljo tudi v perforiranem pretisnem omotu za enkratni odmerek (PVC/ PVdC/aluminij) v pakiranjih po 30 x 1, 60 x 1, 90 x 1, 120 x 1 ali 180 x 1 filmsko obložena tableta.
English: • For PVC/PVdC/Alu blisters Do not store above 30C.
Slovenian: • Za pretisne omote iz PVC/PVdC/aluminija • Shranjujte pri temperaturi do 30 C.
English: Hyper-CVAD regimen: CP 300 mg/ m2 i.v.
Slovenian: Študija AUS01 indukcijskokonsolidacijsko zdravljenje hyper-CVAD shema: CP 300 mg/m2 i.v.
English: Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure or renal failure should be evaluated and treated.
Slovenian: Srčni bolniki Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
English: The dose of 340 mg/m2 daily is recommended for children and adolescents with Ph+ ALL (not to exceed the total dose of 600 mg).
Slovenian: Za otroke in mladostnike s Ph+ ALL je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Slovenian: Za razliko od bolnikov s popolnim oziroma delnim citogenetičnim odzivom pri 12 mesecih, od katerih pri 96 % (za popolni odziv) oziroma 93 % (za delni odziv) ni prišlo do napredovanja bolezni v pospešeno fazo/blastno krizo po 84 mesecih, pa od bolnikov, ki so bili pri 12 mesecih brez pomembnega citogentičnega odziva, le pri 81 % ni prišlo do napredovanja bolezni v napredovalo fazo KML po 84 mesecih (p<0,001 skupno, p=0,25 med popolnim in delnim citogenetičnim odzivom).
English: The recommended dose of Imatinib is 600 mg/day for adults patients with Ph+ ALL.
Slovenian: Priporočeni odmerek zdravila Imatinib pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
English: Major response at 24 months (%)
Slovenian: Molekularni odziv** pomemben odziv pri 12 mesecih (%) pomemben odziv pri 24 mesecih (%) pomemben odziv pri 84
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Slovenian: Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 do 520 mg/m2 na dan.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
Slovenian: DEX 10 mg/m2 peroralno, 1.-5. dan; CP 200 mg/m2 i.v., 3., 4., 5. dan;
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Slovenian: Srčne bolezni občasni palpitacije, tahikardija, kongestivno popuščanje srca3, pljučni edem redki aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris,
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
Slovenian: utrujenost in/ali bolečine v sklepih skupaj z nenormalnimi izvidi laboratorijskih preiskav (na primer z visokimi vrednostmi kalija, sečne kisline in fosforja ter nizko vrednostjo kalcija v krvi).
English: One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.In addition, children and adolescents have been treated in two phase I studies and one phase II study.
Slovenian: Eno veliko odprto, multicentrično, mednarodno randomizirano študijo tretje faze so opravili pri bolnikih z na novo diagnosticirano Ph+ KML.
English: • Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
Slovenian: • izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje ali zamegljen vid,
English: - The other ingredients are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica.The tablet coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172).
Slovenian: Oblogo tablete sestavljajo hipromeloza 6 cps (E464), smukec (E553b), polietilenglikol, rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Slovenian: Učinkovine, katerih plazemske koncentracije lahko imatinib spremeni Imatinib povečuje povprečno Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
English: (24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
Slovenian: (24 ur), 1., 15. dan; 6-MP 25 mg/m2 peroralno, 1.-20. dan konsolidacijska terapija II, IV
English: (3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Slovenian: (3 ure), 1.-4. dan; mitoksantron 10 mg/m2 i.v.
English: DEX 10 mg/ m2 oral, days 1-5;
Slovenian: DEX 10 mg/m2 peroralno, 1.-5. dan;
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and
Slovenian: Če bolnik odmerek dobro prenaša, ga je mogoče v primeru nezadostnega učinka povečati (glejte poglavji 4.4 in 5.2).
English: Organ function impairment
Slovenian: Motnje v delovanju organov
English: 6 doses)iii: days 2, 3, 16, and 17
Slovenian: ali peroralno vsakih 6 ur x 6 odmerkov) iii: 2., 3., 16. in 17. dan trojno i.t.
English: ANC < 1.0x109/l and/or platelets < 50 x 109/l
Slovenian: ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l
English: The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Slovenian: Priporočeno odmerjanje zdravila Imatinib Accord za odrasle bolnike v pospešeni fazi je 600 mg/dan.
English: Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets.
Slovenian: Imatinib Accord 400 mg tablete so na voljo tudi v perforiranem pretisnem omotu za enkratni odmerek (PVC/ PVdC/aluminij) v pakiranjih po 30 x 1, 60 x 1, 90 x 1 filmsko obložena tableta.
English: (3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
Slovenian: (3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
English: In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
Slovenian: Če se pojav/a ANC  1,0 x 109/l in/ali koncentracija trombocitov  50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Accord z zmanjšanim odmerkom 260 mg/m2.
English: In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Slovenian: Poleg tega so v okviru izkušenj v obdobju trženja zdravila pri bolnikih s KML, ALL in drugimi boleznimi poročali o žilnih ektazijah antruma želodca (GAVE - gastric antral vascular ectasia), redkem vzroku gastrointestinalne krvavitve (glejte poglavje 4.8).