FrancophonIA/ELRC3.0 huggingface dataset:
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: V sodelovanje v študiji je privolilo skupaj 397 bolnikov, ki so jih randomizirali (199 bolnikov v skupino z 12-mesečnim zdravljenjem, 198 bolnikov pa v skupino s 36mesečnim zdravljenjem), pri čemer je bila srednja vrednost starosti bolnikov 61 let (v okviru od 22 do 84 let).
English: The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Slovenian: Učinek zdravila Glivec na izid presaditve kostnega mozga ni raziskan.
English: In vitro, Glivec inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Slovenian: In vitro zdravilo Glivec zavira paracetamol O-glukuronidacijo z vrednostjo Ki 58,5 mikromolov/l.
English: Glivec is a treatment for adults and children for:
Slovenian: Zdravilo Glivec je zdravilo za odrasle in otroke:
English: Mean absolute bioavailability for the capsule formulation is 98%.
Slovenian: Povprečna absolutna biološka uporabnost za zdravilo v obliki kapsul je 98 %.
English: The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Slovenian: Izkušenj z uporabo zdravila Glivec pri bolnikih MDS/MPD v povezavi s preureditvijo genov za PDGFR je malo (glejte poglavje 5.1).
English: When Glivec is co-administered with other medicinal products, there is a potential for drug interactions.
Slovenian: Ob sočasni uporabi zdravila Glivec z drugimi zdravili obstaja možnost njihovega medsebojnega delovanja.
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: Mediani čas do neuspeha zdravljenja pri odzivnih bolnikih je bil 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: A total of 71 (12.8%) and 85 (15.4%) patients died in the Glivec and IFN+Ara-C groups, respectively.
Slovenian: Skupno je umrlo 71 (12,8 %) bolnikov iz skupine z zdravilom Glivec in 85 (15,4 %) iz skupine z IFN+Ara-C.
English: From the safety data available, escalating the dose to 800 mg daily in patients progressing at lower doses of 400 mg or 600 mg daily does not seem to affect the safety profile of Glivec.
Slovenian: Razpoložljivi varnostni podatki ne kažejo, da bi zvečanje odmerka na 800 mg na dan pri bolnikih, pri katerih je pri manjših odmerkih 400 mg ali 600 mg na dan bolezen napredovala, vplivalo na varnostni profil zdravila Glivec.
English: EU/1/01/198/009 10 tablets EU/1/01/198/010 30 tablets EU/1/01/198/013 90 tablets
Slovenian: EU/1/01/198/009 10 tablet EU/1/01/198/010 30 tablet EU/1/01/198/013 90 tablet
English: • the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Slovenian: • zdravljenje odraslih bolnikov z neresektabilnim protuberantnim dermatofibrosarkomom (DFSP - dermatofibrosarcoma protuberans) in tistih odraslih bolnikov z rekurentnim in/ali metastatskim DFSP, ki niso primerni za operacijo.
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Glivec 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 Glivec 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: In vitro, imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation.
Slovenian: In vitro imatinib zavira proliferacijo in inducira apoptozo v gastrointestinalnih stromalnih tumorskih (GIST) celicah, ki izražajo aktivirajočo mutacijo kit.
English: Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.
Slovenian: Zato je pri sočasni uporabi velikih odmerkov zdravila Glivec in paracetamola potrebna previdnost.
English: The effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival.
Slovenian: Učinkovitost zdravila Glivec temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
English: 9/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: 9/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: Glivec is indicated for
Slovenian: Zdravilo Glivec je indicirano za
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Glivec 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 Glivec 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: After resection of primary GIST, patients were randomised to one of the two arms: Glivec at 400 mg/day or matching placebo for one year.
Slovenian: Po resekciji primarnega GIST so bolnike randomizirali v enega od dveh krakov: z zdravilom Glivec v odmerku 400 mg/dan ali s skladnim placebom za eno leto.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Glivec.
Slovenian: V obdobju trženja zdravila so poročali o spontanih splavih in prirojenih nepravilnostih pri dojenčkih mater, ki so med nosečnostjo prejemale zdravilo Glivec.
English: 24 hard capsules 48 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Slovenian: 24 trdih kapsul 48 trdih kapsul 96 trdih kapsul 120 trdih kapsul 180 trdih kapsul
English: Table 7 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Slovenian: Preglednica 7 Povzetek študije Z9001: analiza preživetja brez ponovitve bolezni po klasifikacijah tveganj NIH in AFIP
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Slovenian: To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom preizkušanja 46 % imelo presaditev kostnega mozga (BMT - bone marrow transplantation), 73 % pa kemoterapijo z več zdravili.
English: Glivec is indicated for the treatment of
Slovenian: Zdravilo Glivec je indicirano za zdravljenje
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec 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 zdravilom Glivec prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5-kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
English: Imatinib in combination with chemotherapy induction (see Table 4) 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 4) 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: - Patients who are concerned about their fertility while taking Glivec are advised to consult with their doctor.
Slovenian: - Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Glivec, naj se posvetujejo s svojim zdravnikom.
English: In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses  6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Slovenian: Pri podganah so v 13-tedenski študiji pri odmerkih ≥ 6 mg/kg našli hiperplazijo prehodnega epitela v ledvični papili in v sečnem mehurju, brez sprememb serumskih ali urinskih parametrov.
English: Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side.
Slovenian: Zelo temno rumena do rjavkastooranžna filmsko obložena tableta, okrogla in z oznako “NVR” na eni ter “SA” in zarezo na drugi strani.
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed.
Slovenian: Če se pri bolniku, ki prejema zdravilo Glivec, 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: 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 Glivec (see section 4.8).
Slovenian: Zaradi možnosti, da pride do sindroma tumorske lize, je pred začetkom zdravljenja z zdravilom Glivec priporočeno odpraviti klinično pomembno dehidriranost in veliko koncentracijo sečne kisline (glejte poglavje 4.8).
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Slovenian: 9/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez ekstramedularne prizadetosti Kriteriji citogenetičnega odziva: popolni (0 % Ph+ metafaz), delni (1-35 %), manjši (36-65 %) ali minimalni (66-95 %).
English: In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Slovenian: In vitro zdravilo Glivec zavira aktivnost izoencima CYP2D6 citokroma P450 pri koncentracijah, ki so podobne tistim, ki vplivajo na aktivnost CYP3A4.
English: EU/1/01/198/002 24 capsules EU/1/01/198/003 48 capsules EU/1/01/198/004 96 capsules EU/1/01/198/005 120 capsules EU/1/01/198/006 180 capsules
Slovenian: EU/1/01/198/002 24 kapsul EU/1/01/198/003 48 kapsul EU/1/01/198/004 96 kapsul EU/1/01/198/005 120 kapsul EU/1/01/198/006 180 kapsul
English: Survival time in months
Slovenian: : │││ cenzurirani podatki trajanje preživetja v mesecih
English: In the adjuvant setting, Glivec was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
Slovenian: Klinične študije z adjuvantnim zdravljenjem GIST V okviru adjuvantnega zdravljenja so zdravilo Glivec raziskovali v multicentrični, dvojno slepi, dolgoročni, s placebom kontrolirani študiji faze III (Z9001), ki je vključevala 773 bolnikov.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of Glivec daily.
Slovenian: V tej študiji je 14 bolnikov s HES/CEL prejemalo od 100 mg do 1.000 mg zdravila Glivec na dan.
English: Patients concerned about their fertility on Glivec treatment should consult with their physician.
Slovenian: Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Glivec, naj se posvetujejo s svojim zdravnikom.
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 (SCF - stem cell factor), 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 (PDGFR-alfa in PDGFR-beta - plateletderived growth factor receptors).
English: In adult and paediatric patients, the effectiveness of Glivec 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 zdravila Glivec na celotni hematološki in citogenetični odzivnosti in preživetju brez napredovanja bolezni pri KML, na hematološki in citogenetični odzivnosti pri Ph+ ALL in 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: Maximal plasma concentrations of imatinib in patients are 2-4 mol/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 s presnovo, ki poteka preko CYP2D6 in/ali CYP3A4/5.
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8).
Slovenian: Zaviralce tirozin kinaze BCR-ABL povezujejo z razvojem trombotične mikroangiopatije, o posameznih primerih so poročali tudi pri uporabi zdravila Glivec (glejte poglavje 4.8).
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Slovenian: Odmerek brez opaženega učinka (NOEL- no observed effect level) tako na samice-matere kot na generacijo F1 je bil 15 mg/kg/dan (ena četrtina največjega odmerka za človeka, ki je 800 mg).
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/m oziroma 340 mg/m pri otrocih je dosegel enako izpostavljenost kot odmerek 400 mg oziroma 600 mg pri odraslih bolnikih.
English: At-risk : Events
Slovenian: število tveganju izpostavljenih bolnikov : število dogodkov
English: Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10
Slovenian: Kronična faza KML je opredeljena z naslednjimi kriteriji: blasti < 15 % v krvi in kostnem mozgu, bazofilci v periferni krvi < 20 %, trombociti > 100 x 10
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 60 filmsko obloženih tablet 120 filmsko obloženih tablet 180 filmsko obloženih tablet
English: IDA 9 mg/m oral, days 1-28;
Slovenian: IDA 9 mg/m peroralno, 1.-28. dan;
English: Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
Slovenian: kronična faza KML, MDS/MPD in GIST (začetni odmerek 400 mg)
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Glivec and IFN arms, respectively.
Slovenian: Sedem let po vključitvi zadnjega bolnika je bilo mediano trajanje zdravljenja z zdravili prvega izbora v kraku z zdravilom Glivec 82 mesecev, v kraku z IFN pa 8 mesecev.
English: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m i.v.
Slovenian: vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m i.v.
English: Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Slovenian: Zdravilo Glivec 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, itn.).
English: Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Slovenian: Trajanje zdravljenja: V edinem do zdaj izvedenem kliničnem preskušanju so zdravljenje z zdravilom Glivec nadaljevali do napredovanja bolezni (glejte poglavje 5.1).
English: EU/1/01/198/007 20 tablets (PVC/alu blisters) EU/1/01/198/008 60 tablets (PVC/alu blisters) EU/1/01/198/011 120 tablets (PVC/alu blisters) EU/1/01/198/012 180 tablets (PVC/alu blisters) EU/1/01/198/014 60 tablets (PVDC/alu blisters) EU/1/01/198/015 120 tablets (PVDC/alu blisters) EU/1/01/198/016 180 tablets (PVDC/alu blisters)
Slovenian: EU/1/01/198/007 20 tablet (Pretisni omoti iz PVC/aluminija) EU/1/01/198/008 60 tablet (Pretisni omoti iz PVC/aluminija) EU/1/01/198/011 120 tablet (Pretisni omoti iz PVC/aluminija) EU/1/01/198/012 180 tablet (Pretisni omoti iz PVC/aluminija) EU/1/01/198/014 60 tablet (Pretisni omoti iz PVDC/aluminija) EU/1/01/198/015 120 tablet (Pretisni omoti iz PVDC/aluminija) EU/1/01/198/016 180 tablet (Pretisni omoti iz PVDC/aluminija)
English: Continuous daily exposure to Glivec early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without Glivec (69.6% vs. 31.6%, respectively).
Slovenian: Pri bolnikih v 5. kohorti (n=50) je neprekinjena vsakodnevna izpostavljenost zdravilu Glivec 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 Glivec (69,6 % v primerjavi z 31,6 %).
English: The risk of recurrence was thus reduced by approximately 89% as compared with placebo (hazard ratio = 0.113
Slovenian: Tveganje za ponovitev bolezni je bilo torej zmanjšano za približno 89% v primerjavi s placebom (razmerje tveganj = 0,113 [0,049-0,264]).
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Slovenian: Papilome/karcinome prepucijske/klitorisne žleze so opazili pri odmerkih od 30 mg/kg/dan naprej, kar predstavlja približno 0,5-kratnik oziroma 0,3-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan, in 0,4-kratnik dnevne izpostavljenosti otrok (na podlagi AUC) pri 340 mg/m2/dan.
English: Treatment schedule: On the basis of the existing data, Glivec 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 Glivec 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: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.
Slovenian: • odraslih bolnikov z napredovalim hipereozinofilnim sindromom (HES) ali s kronično eozinofilno levkemijo (CEL) s premestitvijo FIP1L1-PDGFR ali z obojim.
English: The doctor will tell you how many tablets of Glivec to give to your child.
Slovenian: Zdravnik vam bo povedal, koliko tablet zdravila Glivec dajte svojemu otroku.
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
Slovenian: Za odmerke, drugačne od 400 mg in 800 mg (glejte priporočila za odmerjanje v nadaljevanju), so na voljo deljive tablete po 100 mg.
English: This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.
Slovenian: Tega zaviranja po uporabi zdravila Glivec 400 mg in paracetamola 1000 mg in vivo niso opažali.
English: A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day Glivec 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Slovenian: V drugi multicentrični, odprti študiji faze III (SSG XVIII/AIO) so primerjali 12-mesečno zdravljenje z odmerkom 400 mg zdravila Glivec na dan s 36-mesečnim zdravljenjem pri bolnikih po kirurški resekciji GIST z eno od naslednjih možnosti: premer tumorja > 5 cm in število mitoz > 5/50 v vidnem polju mikroskopa pri veliki povečavi (HPF - high power fields) ali premer tumorja > 10 cm in kakršnokoli število mitoz ali kakršnakoli velikost tumorja in število mitoz > 10/50 HPF ali pa razpok tumorja v peritonealno votlino.
English: (1 h), days 26, 46; Ara-C 75 mg/m i.v.
Slovenian: (1 ura), 26., 46. dan; Ara-C 75 mg/m i.v.
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m
Slovenian: Pri mladih živalih (okrog obdobja odstavljanja) so opažali tudi povečano smrtnost pri približno 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo največji priporočeni odmerek 340 mg/m
English: Some medicines can interfere with the effect of Glivec when taken together.
Slovenian: Nekatera zdravila lahko ob sočasnem jemanju vplivajo na delovanje zdravila Glivec.
English: The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Glivec arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Slovenian: Ocenjeni odstotek bolnikov, ki niso napredovali v pospešeno fazo ali blastno krizo pri 84 mesecih, je bil bistveno večji na kraku z zdravilom Glivec v primerjavi s krakom z IFN (92,5 % proti 85,1 %, p < 0,001).