FrancophonIA/ELRC3.0 huggingface dataset:
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p<0.001; OS p<0.0001) in two studies (AJP01 and AUS01).
Slovenian: V dveh študijah (AJP01 in AUS01) sta preživetje brez bolezni (DSFdisease-free survival) in celokupno preživetje (OS - overall survival) konstantno presegala 1 leto in sta bila daljša kot pri zgodovinskih kontrolah (DFS p<0,001; OS p<0,0001).
English: 2 Headache was the most common in GIST patients.
Slovenian: Glavobol je bil najpogostejši pri bolnikih z GIST.
English: Patients showing lack of response (lack of complete haematological response (CHR) at 6 months, increasing WBC, no major cytogenetic response (MCyR) at 24 months), loss of response (loss of CHR or MCyR) or severe intolerance to treatment were allowed to cross over to the alternative treatment arm.
Slovenian: Bolnikom, pri katerih se je pokazala odsotnost odziva (odsotnost popolnega hematološkega odziva (CHR - complete haematological response) pri 6 mesecih, povečanje WBC, odsotnost pomembnega citogenetičnega odziva (MCyR - major cytogenetic response) pri 24 mesecih), izguba odziva (izguba CHR ali MCyR) ali težko neprenašanje zdravljenja, je bilo dovoljeno preiti na krak alternativnega zdravljenja.
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 imatinib 86,4 % (83, 90) v primerjavi s 83,3 % (80, 87) v skupini randomizirani na IFN+Ara-C (p= 0,073, test log-rank).
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Slovenian: Zdravljenje z imatinibom povzroči hiter odziv pri na novo diagnosticiranih pediatričnih bolnikih s popolnim hematološkim odzivom 78 % po 8 tednih zdravljenja.
English: What you need to know before you take Imatinib Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Teva
English: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Slovenian: mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo9, artralgijo in bolečinami v kosteh10
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Slovenian: - s hipereozinofilnim sindromom (HES) in/ali kronično eozinofilno levkemijo (CEL).
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Slovenian: ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne ektazije antruma želodca (GAVE)*
English: The tablet is debossed with “IT” and “1” at each side of the score line.
Slovenian: Tableta ima oznako “IT” na eni in “1” na drugi strani zareze.
English: This will help protect you from stomach problems when taking Imatinib Teva.
Slovenian: Tako boste laže preprečili težave z želodcem, do katerih pride pri jemanju zdravila Imatinib Teva.
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Teva (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 Teva (glejte poglavje 4.8).
English: The tablet is debossed with “IT” and “4” at each side of the score line.
Slovenian: Tableta ima oznako “IT” na eni in “4” na drugi strani zareze.
English: 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Slovenian: 18 Gy v 10 frakcijah za bolnike, ki imajo ob postavitvi diagnoze CNS3 VCR (1,5 mg/m2/dan, i.v.
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: The rate of haematological response was 70% with a duration of 2-3 months.
Slovenian: 70 %, njegovo trajanje pa 2-3 mesece.
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 tablete dispergiramo v kozarcu navadne vode ali jabolčnega soka.
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the imatinib and IFN arms, respectively.
Slovenian: Sedem let po vključitvi zadnjega bolnika je bilo mediano trajanje zdravljenja z zdravili prvega izbora v kraku z imatinibom 82 mesecev, v kraku z IFN pa 8 mesecev.
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 vrtoglavost, meglen vid ali somnolenca.
English: - If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Slovenian: Če ste noseči ali bi lahko zanosili, ravnajte pri odpiranju kapsule z vsebino pazljivo in se izogibajte stiku zdravila z očmi preko rok ali vdihavanju zdravila.
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 imatinibom in 60,6 % na kontrolnem kraku (p < 0,001).
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 ALL patients.
Slovenian: Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr-Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s KML, s prisotnim kromosomom
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Slovenian: • odraslih bolnikov z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD) v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR - platelet derived growth factor receptor);
English: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Slovenian: vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
English: Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Slovenian: Opravili so tri velike mednarodne odprte nekontrolirane študije druge faze pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v napredovali, blastni ali pospešeni fazi bolezni, z drugimi Ph+ levkemijami ali s KML v kronični fazi, a po predhodnem neuspešnem zdravljenju z interferonom alfa (IFN).
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
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 109/l.
Slovenian: Kronična faza KML je opredeljena z naslednjimi kriteriji: blasti < 15 % v krvi in kostnem mozgu, bazofilci v periferni krvi < 20 %, trombociti > 100 x 109/l.
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Teva , treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Slovenian: Če se pri bolniku, ki prejema zdravilo Imatinib Teva, 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: Pregnancy, breast-feeding and fertility - 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: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Slovenian: Farmakoterapevtska skupina: Druga zdravila z delovanjem na novotvorbe , zaviralec protein-kinaze, oznaka ATC: L01XE01
English: Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Slovenian: Odmerke po 400 mg ali 600 mg je treba jemati enkrat na dan, medtem ko je treba odmerek 800 mg na dan vzeti kot 400 mg dvakrat na dan, zjutraj in zvečer.
English: - The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.
Slovenian: - Druge sestavine zdravila so kalcijev hidrogenfosfat, krospovidon in magnezijev stearat.
English: The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
Slovenian: Odstotni delež nekaterih neželenih reakcij je bil večji pri tistih 40 bolnikih, pri katerih je bil odmerek zvečan na 800 mg na dan, kot pri populaciji bolnikov pred zvečanjem odmerka
English: Pancytopenia, febrile neutropenia
Slovenian: pancitopenija, febrilna nevtropenija občasni:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/808/001-020
Slovenian: EU/1/12/808/001-020
English: Myeloid blast crisis
Slovenian: Mieloidna blastna kriza
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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 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: If you take more Imatinib Teva than you should If you have accidentally taken too many tablets, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Imatinib Teva kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte z zdravnikom.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu uporabnosti, ki je naveden na stični ovojnini in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Rates of complete haematological response, major cytogenetic response and complete cytogenetic response on first-line treatment were estimated using the Kaplan-Meier approach, for which non-responses were censored at the date of last examination.
Slovenian: Stopnje popolnega hematološkega odziva, pomembnega citogenetičnega odziva in popolnega citogenetičnega odziva pri zdravljenju z zdravilom prvega izbora so ocenili po Kaplan-Meierjevi metodi, za katero so izide ne-odzivnosti določili na datum zadnjega pregleda.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Slovenian: Če citopenija ni povezana z levkemijo, zmanjšajte odmerek imatiniba na 400 mg.
English: Imatinib 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: 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: 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 kot popolni hematološki odziv, kot odsotnost vseh znakov 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.
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Slovenian: • občutek slabosti s siljenjem na bruhanje (navzea) z izgubo apetita, temno obarvan urin, rumena koža ali oči (znaki težav z jetri),
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 >
English: (1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Slovenian: (1 ura), 1.-3. dan; vinkristin 1,3 mg/m2 i.v., 1., 8., 15., 21. dan;
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Slovenian: V tej študiji je 65 % bolnikov doseglo pomemben citogenetični odziv, ki je bil popoln pri 53 %
English: Depending on your condition the usual starting dose is either 400 mg or 600 mg:
Slovenian: Če se zdravite zaradi KML: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg:
English: Progression was defined as any of the following events: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management.
Slovenian: Napredovanje je bilo definirano kot katerikoli od sledečih dogodkov: napredovanje v pospešeno fazo ali blastno krizo, smrt, izguba popolnega hematološkega odziva ali pomembnega citogenetičnega odziva, oziroma pri bolnikih, ki niso dosegli popolnega hematološkega odziva, rast WBC kljub ustreznemu zdravljenju.
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Slovenian: (1 ura), 28.-31., 35.-38., 42.-45. dan; 6-MP 60 mg/m2 peroralno, 26.-46. dan
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
Slovenian: DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m2 i.v.
English: This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Slovenian: Ta vrednost Ki je mnogo večja kot pričakovane plazemske koncentracije imatiniba pri bolnikih, zato po sočasnem dajanju bodisi 5-fluorouracila ali paklitaksela in imatiniba ni pričakovati medsebojnega delovanja.
English: 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 < 1,5 kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
English: The primary efficacy endpoint of the study is progression-free survival.
Slovenian: V študiji je bil primarni cilj opazovanja glede učinkovitosti preživetje brez napredovanja bolezni.
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Slovenian: prilagajanje odmerkov ni potrebno, vendar pa je potrebna previdnost pri substratih CYP2D6 z ozkim terapevtskim oknom, kot je metoprolol.
English: BM = bone marrow, PB = peripheral blood 2 Cytogenetic response criteria:
Slovenian: BM = kostni mozeg, PB = periferna kri
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF- mediated cellular events.
Slovenian: Imatinib je tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF - platelet derived growth factor), PDGF-R in zavira celične dogodke, ki jih posreduje PDGF.
English: They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective.
Slovenian: Lahko povečajo ali zmanjšajo učinek zdravila Imatinib Teva in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib Teva.
English: - Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.
Slovenian: Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z imatinibom, naj se posvetujejo s svojim zdravnikom.
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 živorojenih plodov.
English: What Imatinib Teva is and what it is used for
Slovenian: Kaj je zdravilo Imatinib Teva in za kaj ga uporabljamo
English: Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control.
Slovenian: Akutna limfoblastna levkemija je oblika levkemije, pri kateri se začnejo nenadzorovano razraščati določene nenormalne bele krvničke (imenovane limfoblasti).
English: Imatinib is mainly metabolised through the liver.
Slovenian: Imatinib se presnavlja predvsem v jetrih.
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Slovenian: Pri odraslih je treba zmanjšati odmerek s 400 mg na 300 mg ali s 600 mg na 400 mg ali z 800 mg na 600 mg, pri otrocih pa s 340 mg/m2/dan na 260 mg/m2/dan.
English: Total bilirubin: > 1.5-3.0 ULN AST: any
Slovenian: zmerna celotni bilirubin: > 1,5-3,0 IULN AST: kakršnakoli težka celotni bilirubin: > 3-10 IULN AST: kakršnakoli
English: Hyperkalaemia, hypomagnesaemia
Slovenian: hiperkaliemija, hipomagneziemija
English: There is very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Slovenian: Izkušnje pri otrocih z MDS/MPD, DFSP in HES/CEL so zelo omejene.
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)
English: (24 h), day 1,
Slovenian: (24 ur), 1. dan,
English: Study AJP01 Induction therapy
Slovenian: Študija AJP01
English: In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day.
Slovenian: V 2-letni študiji karcinogenosti pri podganah je odmerjanje imanitiba 15 mg/kg/dan, 30 mg/kg/dan in 60 mg/kg/dan povzročilo statistično značilno skrajšanje življenjske dobe samcev pri 60 mg/kg/dan in samic pri ≥ 30 mg/kg/dan.
English: The diameter of the film-coated tablet is approximately 9 mm.
Slovenian: Premer filmsko obložene tablete je približno 9 mm.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Slovenian: Adenome/karcinome ledvic, papilome sečnega mehurja in sečnice, adenokarcinome tankega črevesa, adenome obščitničnih žlez, benigne in maligne medularne tumorje nadlevičnih žlez in papilome/karcinome ne-žleznega dela želodca so opazili pri odmerku 60 mg/kg/dan, kar predstavlja približno 1,7 do 1-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan in 1,2-kratnik dnevne izpostavljenosti otrok (na podlagi AUC) pri 340
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/808/021-040
Slovenian: EU/1/12/808/021-040
English: In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily.
Slovenian: V tej študiji so bila dovoljena zvečanja odmerka s 400 mg na dan na 600 mg na dan, nato s 600 mg na dan na 800 mg na dan.
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: 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: 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: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Slovenian: V enem odprtem multicentričnem kliničnem preskušanju faze II (študija B2225) so preskušali imatinib pri različnih populacijah bolnikov z življensko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Slovenian: • kombinacija hudo razširjenega hudega izpuščaja, slabosti s siljenjem na bruhanje, povišane telesne temperature, visoke vrednosti nekaterih vrst belih krvnih celic ali rumene obarvanosti kože ali oči (znaka zlatenice) z zasoplostjo, bolečino/neugodjem v prsnem košu, izrazito zmanjšanim izločanjem urina in žejo itd. (znaki alergijske reakcije na zdravljenje).
English: Active substances that may increase imatinib plasma concentrations
Slovenian: Učinkovine, ki lahko zvišajo plazemske koncentracije imatiniba: