FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Slovenian: Povečanje odmerka s 340 mg/m² dnevno na 570 mg/m² (ne sme preseči celotnega odmerka 800 mg) pride v poštev, kadar ni hudih neželenih učinkov na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, in sicer v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja; odsotnost citogenetičnega odziva po 12 mesecih zdravljenja; ali izguba že prej doseženega hematološkega ali citogenetičnega odziva ali obojega.
English: Your doctor will discuss with you the possible risks of taking Imatinib medac during
Slovenian: Zdravnik se bo pogovoril z vami o možnih nevarnostih jemanja
English: This is because Imatinib medac could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: • če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib medac namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
English: The age of the DFSP patients ranged from 23 to 75 years; DFSP was metastatic, locally recurrent following initial resective surgery and not considered amenable to further resective surgery at the time of study entry.
Slovenian: DFSP je bil metastatičen, z lokalno ponovitvijo po začetni kirurški odstranitvi in v času vključitve v študijo ocenjen kot neprimeren za nadaljnje kirurško odstranjevanje.
English: • Swelling such as round your ankles or puffy eyes.
Slovenian: • otekanje, na primer otekline okrog gležnjev ali oči,
English: Non-haematological adverse reactions
Slovenian: Nehematološke neželene reakcije
English: Haematological adverse reactions
Slovenian: Hematološke neželene reakcije
English: There are no controlled trials in paediatric patients with MDS/MPD.
Slovenian: Pri pediatričnih bolnikih z MDS/MPD niso opravili nobenega kontroliranega preskušanja.
English: Study ADE04 Prephase
Slovenian: Študija ADE04 predhodna faza indukcijsko zdravljenje I
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Slovenian: Pri bolnikih, ki so po tiroidektomiji prejemali levotiroksin, je lahko ob sočasni uporabi imatiniba izpostavljenost levotiroksinu v plazmi zmanjšana (glejte poglavje 4.4).
English: (1 h), days 1-5
Slovenian: (1 ura), 1.-5. dan
English: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of
Slovenian: • mišični spazmi z vročino, rdeče-rjavo obarvan urin, boleče ali oslabele mišice (znaki težav z
English: There was high between-patient variability in plasma imatinib AUC levels after an oral dose.
Slovenian: Po peroralnem odmerku so med posameznimi bolniki opazili veliko variabilnost plazemske AUC imatiniba.
English: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity
Slovenian: pruritus, edem obraza, suha koža, eritem, alopecija, nočno potenje, fotosenzitivna reakcija občasni:
English: Imatinib medac may do the same to some other medicines.
Slovenian: Zdravilo Imatinib medac lahko enako vpliva na druga zdravila.
English: Induction therapy (de novo Ph+ ALL)
Slovenian: Študija AAU02 indukcijsko zdravljenje (novo odkrita Ph+ ALL)
English: An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Slovenian: Pri kroničnem dajanju imatiniba se je povečala pogostnost oportunističnih okužb.
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Slovenian: Imatinib ni oviral biotransformacije 5-fluorouracila, je pa zaviral presnovo paklitaksela zaradi kompetitivne inhibicije
English: Caution is recommended in thyroidectomy patients receiving levothyroxine and imatinib.
Slovenian: Pri bolnikih po tiroidektomiji, ki prejemajo levotiroksin in imatinib, je potrebna previdnost.
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Slovenian: Pri obeh živalskih vrstah so opazili blago do zmerno zvišanje aminotransferaz in rahlo znižanje koncentracij holesterola, trigliceridov, celotnih beljakovin in albuminov.
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Slovenian: Vezava N-demetiliranega presnovka na plazemske beljakovine je podobna kot pri izhodni spojini.
English: The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Slovenian: Odmerek je mogoče znižati, če ga bolnik ne prenaša dobro (glejte poglavji 4.2 in 5.2).
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (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: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Slovenian: • z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph-pozitivna ALL).
English: Posology for DFSP in adult patients The recommended dose of imatinib is 800 mg/day for patients with DFSP.
Slovenian: Odmerjanje pri DFSP pri odraslih bolnikih Priporočeni odmerek imatiniba pri bolnikih z DFSP je 800 mg/dan.
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
Slovenian: • hude bolečine v trebuhu, kri v izbruhku, blatu ali urinu, črno blato (znaki bolezni prebavil),
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Slovenian: Nadaljnjih 162 bolnikov s HES/CEL, o katerih so poročali v 35 objavljenih opisih primerov in skupinah primerov, je prejemalo imatinib v odmerkih od 75 mg do 800 mg na dan. Citogenetske nepravilnosti so pregledali pri 117 bolnikih od celotne populacije 176 bolnikov.
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Slovenian: Zelo pogosti (lahko prizadenejo več kot 1 bolnika od 10 bolnikov) ali pogosti (lahko prizadenejo do 1 bolnika od 10 bolnikov):
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Slovenian: 12 Gy v 8 frakcijah za vse bolnike, ki imajo ob postavitvi diagnoze CNS1 in CNS2
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Slovenian: PEG-ASP (2500 i.e./m
English: • Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red
Slovenian: • bledica, občutek utrujenosti in zasoplost in temen urin (znaki pomanjkanja rdečih krvničk),
English: • Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Slovenian: • stemnitev pred očmi, omotičnost ali izguba zavesti (znaki nizkega krvnega tlaka),
English: Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate.
Slovenian: Imatinib medac 400 mg trde kapsule Ena trda kapsula vsebuje 50,072 mg laktoze monohidrata.
English: Imatinib medac 400 mg capsules are supplied in packs containing 30 capsules in blisters.
Slovenian: Imatinib medac 400 mg kapsule so na voljo v kartonskih škatlah, ki vsebujejo po 30 kapsul v pretisnem omotu.
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Slovenian: aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris,
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Slovenian: hipokaliemija, povečan apetit, hipofosfatemija, zmanjšan apetit, dehidracija, protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija redki:
English: Active substances that may increase imatinib plasma concentrations 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, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Slovenian: Snovi, ki zavirajo aktivnost izoencima CYP3A4 citokroma P450 (na primer proteazni inhibitorji, kot so indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotiki, med drugim ketokonazol, itrakonazol, pozakonazol, vorikonazol; nekateri makrolidi, n.pr.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Slovenian: • bolečine v prsih, neredno bitje srca (znaki težav s srcem),
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (lahko prizadenejo več kot 1 bolnika od 10 bolnikov):
English: • Stomach pain with feeling sick (nausea).
Slovenian: • bolečine v želodcu z občutkom slabosti s siljenjem na bruhanje (navzea),
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
Slovenian: Imatinib medac 100 mg trde kapsule Ena trda kapsula vsebuje 12,518 mg laktoze monohidrata.
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Slovenian: migrena, somnolenca, sinkopa, periferna nevropatija, motnje spomina, išias, sindrom nemirnih nog, tremor, možganska krvavitev redki:
English: Imatinib medac is a treatment for adults and children and adolescents for:
Slovenian: Zdravilo Imatinib medac je zdravilo za odrasle in otroke ter mladostnike:
English: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Slovenian: Pri hudi nevtropeniji in trombocitopeniji je priporočljivo zmanjšanje odmerka ali prekinitev zdravljenja, kot kaže spodnja preglednica.
English: The milk/plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Slovenian: Pri proučevanju prehajanja pri eni doječi materi so za imatinib določili razmerje med koncentracijama v mleku in plazmi 0,5, za njegov presnovek pa 0,9, kar kaže, da se presnovek v večji meri izloča v materinem mleku kot imatinib.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Slovenian: redki: pogostnost neznana: ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne
English: Hyperbilirubinaemia, hepatitis, jaundice
Slovenian: hiperbilirubinemija, hepatitis, ikterus redki:
English: Paediatric chronic phase CML (at dose 340 mg/m
Slovenian: kronična faza KML pri pediatričnih bolnikih (ob odmerku 340 mg/m²)
English: The most commonly reported (≥ 10 %) treatment-related adverse reactions were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Slovenian: Z zdravljenjem povezane neželene reakcije, o katerih so najpogosteje poročali (≥ 10 %), so bile blaga navzea, bruhanje, driska, bolečine v trebuhu, utrujenost, mialgija, mišični krči in izpuščaj.
English: • Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
Slovenian: • izpuščaj, rdeča koža z mehurčki na ustnicah, očeh, koži ali v ustih, luščenje kože, povišana telesna temperatura, rdeče ali vijolične lise nad nivojem kože, srbenje, pekoč občutek, gnojni
English: Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Slovenian: Pozitivne genotoksične učinke so dobili za imatinib pri in vitro testiranju na sesalskih celicah (jajčnik kitajskega hrčka) za klastogenost (kromosomska aberacija) v prisotnosti presnovne aktivacije pri koncentraciji 125 μg/ml.
English: 30 hard capsules.
Slovenian: 30 trdih kapsul
English: Complete blood counts must be performed regularly during therapy with imatinib.
Slovenian: Med zdravljenjem z imatinibom je treba redno opravljati kompletne hemograme.
English: Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Slovenian: Kronična mieloična levkemija je oblika levkemije, pri kateri se začnejo nenadzorovano razraščati določene nenormalne bele krvničke, ki se imenujejo mieloidne celice.
English: If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).
Slovenian: Če bolnik odmerek dobro prenaša, ga je mogoče v primeru nezadostnega učinka povečati (glejte poglavji 4.4 in 5.2).
English: Posology for CML in adult patients
Slovenian: Odmerjanje pri KML pri odraslih bolnikih
English: Study AJP01 Induction therapy i.v.
Slovenian: Študija AJP01 indukcijsko zdravljenje
English: • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Slovenian: • bolečine v medenici, včasih z občutkom slabosti s siljenjem na bruhanje in bruhanjem, z nepričakovano krvavitvijo iz nožnice, omotičnost ali izguba zavesti zaradi nizkega krvnega tlaka (znaki težav z jajčniki ali maternico),
English: Laboratory test abnormalities
Slovenian: Nenormalnosti pri laboratorijskih preiskavah
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m 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/m 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/m 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/m na dan.
English: Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Slovenian: Pri psih, ki so zdravilo dobivali po 2 tedna, so opazili hudo toksičnost za jetra z zvišanimi jetrnimi encimi, hepatocelularno nekrozo, nekrozo žolčevodov in hiperplazijo žolčevodov.
English: Imatinib medac 100 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Slovenian: Imatinib medac 100 mg trde kapsule Pretisni omot iz PA-aluminija/PVC/aluminija.
English: As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Slovenian: Tako kot pri odraslih bolnikih, se je pri pediatričnih bolnikih v študijah tako prve kot druge faze imatinib po peroralni uporabi hitro absorbiral.
English: Blast crisis is the most
Slovenian: Blastna kriza je najbolj napredovali stadij te bolezni.
English: In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Slovenian: V študiji plodnosti na podganjih samcih, ki so dobivali zdravilo 70 dni pred parjenjem, se je pri odmerku 60 mg/kg, ki je približno enakovreden največjemu kliničnemu odmerku 800 mg/dan, izračunanemu na podlagi telesne površine, zmanjšala masa mod in obmodkov in odstotek gibljivih semenčic.
English: Days 2 and 3
Slovenian: ): 1. in 2. dan
English: Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Slovenian: Spet začnite zdravljenje z imatinibom s prejšnjim odmerkom (t.j.
English: When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Slovenian: Pri uporabi imatiniba v kombinaciji z visokoodmernimi kemoterapevtskimi shemami so ugotavljali zvečanje obsega resnih neželenih učinkov na jetrih.
English: 9) Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing
Slovenian: 9) V obdobju trženja zdravila so opažali mišično-skeletne bolečine med zdravljenjem z imatinibom ali po prekinitvi zdravljenja.
English: (1 h), days 1-3; i.v., days 1, 8, 15, 21; 2/day oral Consolidation therapy Alternating chemotherapy course: high dose chemotherapy with MTX 1 i.v.
Slovenian: (1 ura), 1.-3. dan; vinkristin 1,3 mg/m² i.v., 1., 8., 15., 21. dan; prednizolon 60 mg/m²/dan peroralno konsolidacijsko zdravljenje izmenična kemoterapija: visokoodmerna kemoterapija z MTX 1 g/m² i.v.
English: In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
Slovenian: V 39-tedenski študiji na opicah pri najmanjšem odmerku 15 mg/kg, kar je približno ena tretjina največjega odmerka za človeka (ki je 800 mg, izračunan na podlagi telesne površine), niso našli NOAEL (odmerek brez opaženih neželenih učinkov).
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Slovenian: Klinične študije pri protuberantnem dermatofibrosarkomu (DFSP) Eno odprto, multicentrično klinično preskušanje faze II (študija B2225) je vključevalo 12 bolnikov z DFSP, zdravljenih z imatinibom 800 mg na dan. Starost bolnikov z DFSP se je gibala med 23 in 75 leti.
English: Adverse reactions and their frequencies are reported in Table 1.
Slovenian: V preglednici 1 so navedeni neželeni učinki in njihove pogostnosti.
English: In eleven patients PDGFR gene rearrangements were detected, 9 of them achieved a CHR and 1 PHR.
Slovenian: Pri enajstih bolnikih so odkrili preureditev gena za PDGFR, 9 izmed njih je doseglo popolni hematološki odziv, 1 pa delni hematološki odziv.
English: Biochemistry
Slovenian: Biokemija
English: The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Slovenian: Priporočeni odmerek imatiniba pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
English: (n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Slovenian: Bolniki so bili zdravljeni z odmerki imatiniba 260 mg/m²/dan (n = 5), 340 mg/m²/dan (n = 9), 440 mg/m²/dan (n = 7) in 570 mg/m²/dan (n = 5).
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of
Slovenian: • občutek slabosti s siljenjem na bruhanje (navzea) z izgubo apetita, temno obarvan urin, rumena
English: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Slovenian: ginekomastija, erektilna disfunkcija, menoragija, neredne menstrualne krvavitve, motnje spolnih funkcij, boleče bradavice, povečanje dojk, edem redki:
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Slovenian: zvišana vrednost kreatinina v krvi, zvišana vrednost kreatin-kinaze v krvi, zvišana vrednost laktat-dehidrogenaze v krvi, zvišana vrednost alkalne redki:
English: Patients with cardiac disease
Slovenian: Srčni bolniki
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Slovenian: DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m² i.v.
English: Imatinib medac 400 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Slovenian: Imatinib medac 400 mg trde kapsule Pretisni omot iz PA-aluminija/PVC/aluminija.
English: There are no controlled trials in paediatric patients with HES/CEL.
Slovenian: Pri pediatričnih bolnikih s HES/CEL niso opravili nobenega kontroliranega preskušanja.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Slovenian: pospešena faza KML in blastna kriza pri pediatričnih bolnikih (začetni odmerek 340 mg/m²)
English: Dose adjustments for neutropenia and thrombocytopenia:
Slovenian: Prilagajanje odmerkov zaradi nevtropenije in trombocitopenije:
English: i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Slovenian: daunorubicin 30 mg/m² i.v., 1.-3., 15.-16. dan; VCR skupni odmerek 2 mg i.v., 1., 8., 15., 22. dan;
English: For patients unable to swallow the capsules (e.g. paediatric patients), their content may be dispersed in a glass of still mineral water or apple juice.
Slovenian: pediatričnim bolnikom), lahko njihovo vsebino raztopimo v kozarcu navadne mineralne vode ali jabolčnega soka.
English: Fluid retention
Slovenian: Retenca tekočine
English: Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
Slovenian: V literaturi in spontano so poročali o posameznih primerih prevelikega odmerjanja imatiniba.
English: Imatinib medac contains lactose.
Slovenian: Zdravilo Imatinib medac vsebuje laktozo.
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).
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).
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Slovenian: Pri bolnikih, ki so med zdravljenjem z imatinibom prejemali nadomestno zdravljenje z levotiroksinom po tiroidektomiji, so poročali o kliničnih primerih hipotiroidizma (glejte poglavje 4.5).
English: There is limited information on imatinib distribution on human milk.
Slovenian: Podatkov o prehajanju imatiniba v materino mleko pri človeku ni veliko.
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 or renal failure should be evaluated and treated.
Slovenian: Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
English: DEX 10 mg/m oral, days 1-5;
Slovenian: DEX 10 mg/m² peroralno, 1.-5. dan;
English: Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
Slovenian: Kadar se imatinib uporablja v kombinaciji s kemoterapevtskimi shemami, pri katerih je znana povezava z motnjami delovanja jeter, je treba skrbno spremljati delovanje jeter (glejte poglavji 4.5 in 4.8).