FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Slovenian: Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije (tj. izginotje blastov iz kostnega mozga in krvi, a brez popolnega okrevanja periferne krvi kot pri popolnem odzivu) ali kot vrnitev v kronično fazo KML, pri čemer so uporabljali enaka merila kot pri študiji v pospešeni fazi.
English: EU/1/17/1243/025 30 film-coated tablets EU/1/17/1243/026 30x1 film-coated tablets EU/1/17/1243/027 90 film-coated tablets EU/1/17/1243/028 90x1 film-coated tablets EU/1/17/1243/029 30 film-coated tablets EU/1/17/1243/030 30x1 film-coated tablets EU/1/17/1243/031 90 film-coated tablets EU/1/17/1243/032 90x1 film-coated tablets imatinib teva b.v. 400 mg film-coated tablets
Slovenian: EU/1/17/1243/025 30 filmsko obloženih tablet EU/1/17/1243/026 30x1 filmsko obložena tableta EU/1/17/1243/027 90 filmsko obloženih tablet EU/1/17/1243/028 90x1 filmsko obložena tableta EU/1/17/1243/029 30 filmsko obloženih tablet EU/1/17/1243/030 30x1 filmsko obložena tableta EU/1/17/1243/031 90 filmsko obloženih tablet EU/1/17/1243/032 90x1 filmsko obložena tableta
English: Clinical studies in unresectable and/or metastatic GIST One phase II, open-label, randomised, uncontrolled multinational study was conducted in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST).
Slovenian: Klinične študije pri neresektabilnih in/ali metastatskih GIST Eno odprto, randomizirano, nekontrolirano, večnacionalno študijo druge faze so opravili pri bolnikih z neresektabilnimi ali metastatičnimi malignimi gastrointestinalnimi stromalnimi tumorji (GIST).
English: The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
Slovenian: Kapsula je dolga od 23,0 mm do 23,6 mm in široka 8,53 mm.
English: Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).
Slovenian: O učinku povečanja odmerka s 400 mg na 600 mg ali na 800 mg pri bolnikih, pri katerih bolezen pri manjšem odmerku napreduje, obstaja malo podatkov (glejte poglavje 5.1).
English: For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Slovenian: Pri zdravljenju KML ali GIST vam lahko zdravnik predpiše večji ali manjši odmerek, odvisno od tega, kako se odzivate na zdravljenje.
English: All treatment regimens include administration of steroids for CNS prophylaxis.
Slovenian: Vse terapevtske sheme vključujejo aplikacijo steroidov za zaščito centralnega živčnega sistema.
English: Do not stop taking Imatinib Teva B.V. unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Imatinib Teva B.V., razen če vam tako naroči zdravnik.
English: 12 h), days 2-3, for 4 cycles
Slovenian: (na 12 ur), 2.-3. dan, v 4 ciklusih
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Slovenian: tej študiji je 31 % bolnikov doseglo hematološki odziv (36 % pri predhodno nezdravljenih bolnikih in
English: Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Slovenian: Imunohistokemijo so rutinsko opravljali s protitelesi Kit (A-4502, kunčji poliklonalni antiserum, 1:100; DAKO Corporation, Carpinteria, CA) v skladu z analizo z metodo avidin-biotin-peroksidaznega kompleksa po ponovni pridobitvi antigena.
English: All patients achieved partial and/or complete response.
Slovenian: Pri vseh bolnikih je prišlo do delnega in/ali
English: Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial)
Slovenian: Preglednica 7 12-mesečno in 36-mesečno zdravljenje z imatinibom (študija SSGXVIII/AIO)
English: Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Slovenian: Po povečanju odmerka je treba bolnike natančno spremljati, ker pri večjih odmerkih obstaja možnost povečane pogostnosti neželenih učinkov.
English: - Women who might become pregnant are advised to use effective contraception during treatment.
Slovenian: Ženskam, ki bi lahko zanosile, med zdravljenjem priporočamo uporabo učinkovite
English: Median time to treatment failure in responders was 122 weeks (95% C.I 106-147), while in the overall study population it was 84 weeks (95% C.I 71-109).
Slovenian: 122 tednov (95-odstotni interval zaupanja 106-147), medtem ko je bil pri celotni populaciji študije 84 tednov (95-odstotni interval zaupanja 71-109).
English: No specific dose recommendation is necessary in older people.
Slovenian: Pri starejših niso potrebna posebna priporočila glede odmerjanja.
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Slovenian: Pri odraslih in pediatričnih bolnikih temelji učinkovitost imatiniba na celotni hematološki in citogenetični odzivnosti in preživetju brez napredovanja bolezni pri KML, na hematološki in citogenetični odzivnosti pri Ph+ ALL, MDS/MPD, na hematološki odzivnosti pri HES/CEL ter na objektivni odzivnosti odraslih bolnikov z neresektabilnimi in/ali metastatskimi GIST in DFSP ter na preživetju brez ponovitve bolezni pri adjuvantnem zdravljenju GIST.
English: The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
Slovenian: Kapsula je dolga od 19,1 mm do 19,7 mm in široka 6,91 mm.
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Slovenian: Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Slovenian: Izkušnje z uporabo imatiniba pri bolnikih z MDS/MPD v povezavi s preureditvijo genov za PDGFR je zelo malo (glejte poglavje 5.1).
English: • Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Slovenian: • pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa, ali v pospešeni fazi ali blastni krizi;
English: NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l 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: NEL enaki kriteriji kot za CHR, a ANC ≥ 1 x 109/l in trombociti ≥ 20 x 109/l RTC < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih.
English: , Ελλάδα Τηλ: +30 210 72 79 099
Slovenian: Τηλ: +30 210 72 79 099
English: Prednisolone 200 mg oral, 5 days per month for 13
Slovenian: prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
English: The expiry date refers to the last day of the month.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: - Chronic myeloid leukaemia (CML).
Slovenian: - kronične mieloične levkemije (KML).
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Slovenian: Vključili so 260 bolnikov z mieloidno blastno krizo.
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 vrednosti
English: Longer duration of the treatment (> 36 months) may delay the onset of further recurrences; however the impact of this finding on the overall survival remains unknown.
Slovenian: Daljše trajanje zdravljenja (> 36 mesecev) bi lahko podaljšalo čas do nadaljnjih ponovitev bolezni,
English: The effect of stopping treatment after the achievement of a complete cytogenetic response has not been
Slovenian: Učinek prekinitve zdravljenja po doseženem popolnem citogenetičnem
English: At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Slovenian: Po enem letu je bilo preživetje brez ponovitve bolezni statistično značilno boljše v skupini z imatinibom (97,7%) v primerjavi s skupino s placebom (82,3%), (p<0,0001).
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
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 zmanjšane koncentracije levkocitov in driske.
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.
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 (EFS - event-free survival) v primerjavi z zgodovinskimi kontrolami (n=120), kjer so bolniki prejeli standardno kemoterapijo brez imatiniba (69,6 % v primerjavi z 31,6 %).
English: - Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Slovenian: v nosečnosti ni priporočena, če to ni nujno potrebno, saj lahko škoduje vašemu otroku.
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
Slovenian: Za odmerke, drugačne od 400 mg in 800 mg (glejte spodaj navedeno priporočeno odmerjanje), so na voljo 100 mg filmsko obložene tablete.
English: In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months.
Slovenian: V to študijo so vključili 147 bolnikov, ki so bili razporejeni po metodi naključne izbire, da so dobivali bodisi po 400 mg bodisi po 600 mg zdravila na dan peroralno v obdobju do 36 mesecev.
English: There are no controlled trials in paediatric patients with c-Kit positive GIST.
Slovenian: Pri pediatričnih bolnikih s c-Kit-pozitivnim GIST niso opravili nobenega kontroliranega preskušanja.
English: However if it is nearly time for the next dose, - Then continue with your normal schedule.
Slovenian: Če je že skoraj čas za naslednjiodmerek, izpustite pozabljeni odmerek.
English: Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
Slovenian: V 7 publikacijah so objavljeni podatki sedemnajstih (17) bolnikov z GIST (z mutacijo genov Kit oziroma PDGFR ali brez njiju).
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Slovenian: Delovanje jeter (aminotransferaze, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo
English: - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Slovenian: Presnova imatiniba poteka predvsem v jetrih in le 13 % se ga imatiniba izloča skozi ledvice.
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: 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/vezivno tkivnega
English: It is important that you do this as long as your doctor or pharmacist tells you to.
Slovenian: Pomembno je, da zdravilo jemljete tako dolgo, kot vam naroči zdravnik, farmacevt ali medicinska sestra.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Slovenian: Predzdravljenje z večkratnimi odmerki rifampicina 600 mg, ki jim je sledil en 400-miligramski odmerek imatiniba, je povzročilo zmanjšanje Cmax oziroma AUC(0-∞) za vsaj 54 %
English: 5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
Slovenian: 5 O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in bolnikih s transformacijo
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Slovenian: Bolnikom, ki ne morejo pogoltniti filmsko obloženih tablet, lahko njihovo vsebino razredčimo v kozarcu navadne vode ali jabolčnega soka.
English: In addition, thirty-six (36) months of imatinib treatment significantly prolonged overall survival (OS) compared to 12 months of imatinib treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 7, Figure 2).
Slovenian: Poleg tega je šestintrideset (36) mesecev zdravljenja z imatinibom statistično značilno bolj podaljšalo celotno preživetje v primerjavi z 12-mesečnim zdravljenjem z imatinibom (razmerje tveganj = 0,45 [0,22, 0,89], p=0,0187) (preglednica 8, slika 2).
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
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
English: One of these intermediates was also positive in the mouse lymphoma assay.
Slovenian: Eden od teh vmesnih produktov je bil pozitiven tudi v testu mišjega
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Slovenian: Omejeno število bolnikov so vključili v študije prve faze (n=10).
English: Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Slovenian: Imatinib lahko zavira tudi celične dogodke, ki jih omogoča aktivacija
English: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Slovenian: - z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
English: Do not use any pack that is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali so vidni znaki odprtja ovojnine.
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
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 < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) 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: What you need to know before you take Imatinib Teva B.V.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Teva B.V.
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: 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: Your doctor will discuss with you the possible risks of taking Imatinib Teva B.V. during pregnancy.
Slovenian: Zdravnik se bo pogovoril z vami o možnih nevarnostih jemanja zdravila Imatinib Teva B.V.
English: Anorexia
Slovenian: Hematologija
English: - If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
Slovenian: Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne vode
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e.
Slovenian: Imatinib lahko zveča plazemske koncentracije drugih zdravil, ki jih presnavlja CYP3A4 (na primer triazolo-benzodiazepinov, dihidropiridinskih zaviralcev kalcijevih kanalčkov, nekaterih zaviralcev reduktaze HMG-CoA, tj. statinov, itd.).
English: 2-3 (total of 8 courses)
Slovenian: 2.-3. dan (skupno 8 kur)
English: There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
Slovenian: (199 bolnikov v skupino z 12-mesečnim zdravljenjem, 198 bolnikov pa v skupino s 36 mesečnim zdravljenjem), pri čemer je bila srednja vrednost starosti bolnikov 61 let (v okviru od 22 do 84 let).
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
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Slovenian: Če pride do zvišanja bilirubina na > 3-kratno zgornjo mejo normalnih vrednosti, specifično za ustanovo, (IULN-institutional upper limit of normal) ali zvišanja jetrnih aminotransferaz na > 5-kratno IULN, je treba zdravljenje z imatinibom prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
English: The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
Slovenian: V skupini z 12-mesečnim zdravljenjem je skupno umrlo 25 bolnikov, v skupini s 36-mesečnim zdravljenjem pa 12.
English: Consolidation therapy I, III, V MTX 500 mg/m i.v.
Slovenian: Konsolidacijsko zdravljenje I, III, V MTX 500 mg/m2 i.v.
English: Median time to response was 13 weeks (95% C.I.
Slovenian: Mediani čas do odziva je bil 13 tednov (95odstotni interval zaupanja 12-23).
English: Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Slovenian: Indukcijsko-konsolidacijsko zdravljenje hiper-CVAD shema: CP 300 mg/m2 i.v.
English: There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Slovenian: Kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh boleznih,
English: Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l.
Slovenian: Prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1,5 x 109/l in koncentracija trombocitov ≥ 75 x 109/l.
English: - Gastrointestinal stromal tumours (GIST).
Slovenian: - z gastrointestinalnimi stromalnimi tumorji (GIST).
English: Thereafter, treatment can be resumed as appropriate depending on the initial severity
Slovenian: Nato se lahko zdravljenje spet začne po ustrezni shemi, odvisni
English: Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression.
Slovenian: Trajanje zdravljenja: V kliničnih preskušanjih pri bolnikih z GIST so zdravljenje z imatinibom nadaljevali, dokler ni začela bolezen napredovati.
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 fazi bolezni v blastni krizi.
English: Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
Slovenian: Šestintrideset (36) mesecev zdravljenja z imatinibom je statistično značilno bolj podaljšalo preživetje brez ponovitve bolezni v primerjavi z 12 meseci zdravljenja z imatinibom (z razmerjem tveganj 0,46 [0,32, 0,65], p<0,0001) (preglednica 7, slika 1).
English: Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Slovenian: Imatinib je statistično značilno podaljšal preživetje brez ponovitve bolezni, saj je bilo v skupini z imatinibom 75% bolnikov brez ponovitve bolezni 38 mesecev v primerjavi z 20 meseci v skupini s placebom (95% IZ: [30 - neocenljivo] oziroma [14 - neocenljivo]); (razmerje tveganj = 0,398 [0,259
English: Musculoskeletal and connective tissue disorders Muscle spasm and cramps, musculoskeletal pain including myalgia9,
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo9, artralgijo in bolečinami v kosteh10
English: Immune system disorders Not known:
Slovenian: Bolezni imunskega sistema pogostnost neznana:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKERBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I : Povzetek glavnih značilnosti zdravila, poglavje 4.2).