FrancophonIA/ELRC3.0 huggingface dataset:
English: Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred začetkom zdravljenja s sunitinibom je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot so hipertenzija ali anamneza anevrizme.
English: Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.
Slovenian: Zdravnik mora narediti krvne teste, da preveri delovanje vaših jeter pred in med zdravljenjem z zdravilom Sutent in kot je klinično indicirano.
English: Available data indicate that females could have about 30% lower apparent clearance (CL/F) of sunitinib than males: this difference, however, does not necessitate starting dose adjustments.
Slovenian: Razpoložljivi podatki kažejo, da imajo ženske lahko za približno 30 % manjši navidezni očistek (CL/F) kot moški; ta razlika pa ne zahteva prilagajanja odmerka.
English: The overall PFS and OS, observed in the ITT population, as determined by the core radiology laboratory assessment, are summarised in Table 3.
Slovenian: Skupni podatki o PFS in OS pri populaciji ITT, ugotovljeni pri centralnem ocenjevanju radioloških izvidov, so povzeti v Preglednici 3:
English: The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Slovenian: Navidezni volumen porazdelitve (Vd) za sunitinib je bil velik - 2.230 l - kar kaže, da se sunitinib porazdeli v tkiva.
English: Lung or breathing problems.
Slovenian: Težave s pljuči ali dihanjem.
English: If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Slovenian: Če jemljete varfarin ali acenokumarol, zdravila za redčenje krvi za preprečevanje nastajanja krvnih strdkov, lahko obstaja večje tveganje za krvavitev.
English: • Fluid retention including around the lungs.
Slovenian: • zastajanje tekočine, vključno okrog pljuč
English: These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Slovenian: Zmanjšanja LVEF niso napredovala in so se med nadaljevanjem zdravljenja pogosto izboljšala.
English: Minor metabolites were identified in urine and faeces, but generally were not found in plasma.
Slovenian: V urinu in blatu so odkrili nekaj manj pomembnih presnovkov, ki pa jih na splošno ni bilo mogoče najti v plazmi.
English: If you have accidentally taken too many capsules, talk to your doctor straight away.
Slovenian: Če ste pomotoma vzeli preveč kapsul, se nemudoma posvetujte z zdravnikom.
English: Patients with pre-existing hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Slovenian: Bolnike z obstoječim hipotiroidizmom ali hipertiroidizmom je treba zdraviti v skladu z običajno medicinsko prakso še pred začetkom zdravljenja s sunitinibom.
English: Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
Slovenian: V celoti je imelo 7 % populacije z MRCC bodisi klinične bodisi laboratorijske znake hipotiroidizma zaradi zdravljenja.
English: Sutent has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Sutent ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures.
Slovenian: Specifičnega antidota za preveliko odmerjanje zdravila Sutent ni. Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe.
English: The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Slovenian: FK sunitiniba so ocenili pri 135 zdravih prostovoljcih in 266 bolnikih s čvrstimi tumorji.
English: Prior to treatment with Sutent, a dental examination and appropriate preventive dentistry should be considered.
Slovenian: Pred začetkom zdravljenja z zdravilom Sutent je treba razmisliti o pregledu zobovja in ustreznih preventivnih zobozdravstvenih posegih.
English: The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Slovenian: Največji odmerek, ki so ga uporabili v študiji 3. faze pri pNET, je znašal 50 mg na dan.
English: QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Slovenian: Podaljšanje intervala QT lahko zveča tveganje za ventrikularne aritmije, vključno s Torsade de pointes.
English: The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Slovenian: Uporaba zaviralcev poti žilnega endotelijskega rastnega faktorja (VEGF) pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
English: There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Slovenian: Na voljo so le omejene klinične izkušnje glede časa ponovnega začetka zdravljenja po večjem kirurškem posegu.
English: Sutent is not approved for use in patients with lung cancer.
Slovenian: Zdravilo Sutent ni odobreno za uporabo pri bolnikih s pljučnim rakom.
English: These symptoms may diminish as treatment continues.
Slovenian: Ti simptomi se lahko izboljšajo ob nadaljevanju zdravljenja.
English: None of the subjects achieved complete response or partial response.
Slovenian: Noben preskušanec ni dosegel popolnega ali delnega odziva na zdravljenje.
English: 28 x 1 hard capsules
Slovenian: 28 x 1 trda kapsula
English: Routine assessment of bleeding events should include complete blood counts and physical examination.
Slovenian: Rutinsko ocenjevanje pojavov krvavitev mora obsegati celotno krvno sliko in klinični pregled.
English: The above reactions were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Slovenian: Opisani učinki niso bili kumulativni, so bili praviloma reverzibilni in na splošno niso povzročili prekinitve zdravljenja.
English: Stable disease was observed in 6 patients (17%).
Slovenian: Nespremenjeno stanje bolezni so opazili pri 6 bolnikih (17 %).
English: • Depression.
Slovenian: • depresija
English: The primary objective was to compare PFS in patients receiving sunitinib versus patients receiving placebo.
Slovenian: Primarni cilj je bil primerjati PFS pri bolnikih, ki so prejemali sunitinib v primerjavi z bolniki, ki so prejemali placebo.
English: It is not known whether sunitinib or its primary active metabolite is excreted in human milk.
Slovenian: Ni znano, ali se sunitinib ali njegov primarni aktivni presnovek izloča v materino mleko.
English: Sutent should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravila Sutent se ne sme uporabljati med nosečnostjo in pri ženskah, ki ne uporabljajo učinkovite kontracepcije, razen če možna korist odtehta možno tveganje za plod.
English: Heart problems.
Slovenian: Težave s srcem.
English: - Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
Slovenian: - Metastatski karcinom ledvičnih celic (MRCC), vrsta raka ledvic, ki se je razširil na druge dele telesa.
English: Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Slovenian: Nadaljnje prilagajanje odmerka mora temeljiti na varnosti in prenašanju pri posameznem bolniku (glejte poglavje 5.2).
English: These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
Slovenian: To so lahko znaki stanja, imenovanega pljučna embolija, ki se pojavi, ko krvni strdki potujejo v pljuča.
English: • Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
Slovenian: • vnetje (otekanje in pordelost) žolčnika z ali brez povezanih žolčnih kamnov
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Slovenian: Farmakoterapevtska skupina: antineoplastiki, zaviralci protein-kinaze, oznaka ATC: L01XE04
English: If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate vprašanja o tem, kako zdravilo Sutent deluje ali zakaj ste ga dobili, se posvetujte z zdravnikom.
English: One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
Slovenian: En bolnik z GIST je bil v študijo vključen pri odmerku 15 mg/m2 brez znakov koristi.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and even those not prescribed.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: - If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sutent in particular when you are also receiving or have received intravenous bisphosphonates.
Slovenian: - Če ste naročeni na invazivno zobozdravstveno zdravljenje ali zobozdravstveni poseg, obvestite zobozdravnika, da se zdravite z zdravilom Sutent, še posebej v primeru, če sočasno prejemate ali ste prejeli intravenske bisfosfonate.
English: • Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
Slovenian: • zmanjšanje števila trombocitov, rdečih krvnih celic in/ali belih krvnih celic (npr. nevtrofilcev)
English: The pivotal study in pancreatic NET was terminated prematurely at the recommendation of an independent drug monitoring committee and the primary endpoint was based upon investigator assessment, both of which may have affected the estimates of the treatment effect.
Slovenian: Ključna študija pri nevroendokrinih tumorjih trebušne slinavke je bila predčasno zaključena na priporočilo neodvisnega Odbora za nadzor zdravil (drug monitoring committee), primarni opazovani dogodek pa je temeljil na oceni raziskovalca, obe pa sta lahko vplivali na ocene učinkovitosti zdravljenja.
English: Based on the modelling analyses, the younger age and lower body size did not appear to affect negatively the safety and efficacy responses to sunitinib plasma exposures.
Slovenian: Analize modelov so pokazale, da nižja starost in manjša velikost telesa nimata negativnega vpliva na odzive glede varnosti in učinkovitosti na izpostavljenosti sunitinibu v plazmi.
English: A sensitivity analysis of PFS was conducted where progression was based upon investigator-reported tumour measurements and where all subjects censored for reasons other than study termination were treated as PFS events.
Slovenian: Opravili so občutljivostno analizo PFS, pri čemer je napredovanje temeljilo na merjenjih tumorja, o katerih so poročali raziskovalci, in kjer so bile vse osebe, pri katerih je bilo zdravljenje prekinjeno iz vzrokov, ki niso predstavljali zaključka študije, obravnavane kot da je pri njih šlo za PFS dogodke.
English: (not to exceed the total dose of 50 mg/day) based on individual patient safety/tolerability.
Slovenian: (odmerki niso presegli celokupnega odmerka 50 mg/dan) glede na varnost in prenašanje pri posameznem bolniku.
English: After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Slovenian: Po peroralni uporabi sunitinib na splošno doseže Cmax od 6 do 12 ur do največje koncentracije (tmax) po aplikaciji.
English: If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
Slovenian: Če vaša ščitnica ne proizvaja dovolj ščitničnega hormona, vas bodo morda zdravili z nadomestkom ščitničnega hormona.
English: The relevance to humans of the neoplastic findings observed in the mouse (rasH2 transgenic) and rat carcinogenicity studies with sunitinib treatment is unclear.
Slovenian: Pomen ugotovitev, ki se nanašajo na neoplastične spremembe opažene pri miših (rasH2 transgenih) in študije kancerogenosti na podganah, zdravljenih s sunitinibom, za človeka ni jasen.
English: Monitor liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) before initiation of treatment, during each cycle of treatment, and as clinically indicated.
Slovenian: Nadzirati je treba rezultate testov jetrne funkcije (alanin transaminazo [ALT], aspartat transaminazo [AST], ravni bilirubina) pred začetkom zdravljenja, med vsakim ciklom zdravljenja, in kadar je klinično indicirano.
English: • Decreased in the amount of blood pumped by the heart.
Slovenian: • zmanjšana količina krvi, ki jo prečrpa srce
English: In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
Slovenian: Pri bolnikih, ki so predhodno prejemali ali trenutno prejemajo intravenske bisfosfonate, se je treba, če je le mogoče, izogibati invazivnim zobozdravstvenim posegom (glejte poglavje 4.8).
English: • Problems with wound healing after surgery.
Slovenian: • težave s celjenjem rane po kirurškem posegu
English: The dose of sunitinib was reduced or its administration temporarily suspended in approximately 2.7% of the patients who experienced hypertension.
Slovenian: Odmerek sunitiniba so zmanjšali ali začasno odložili odmerjanje pri približno 2,7 % bolnikov s hipertenzijo.
English: In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.
Slovenian: Pri bolnikih brez kardialnih dejavnikov tveganja je treba razmisliti o izhodiščni oceni iztisnega deleža.
English: It is unknown whether patients with these concomitant conditions may be at a higher risk of developing sunitinib-related left ventricular dysfunction.
Slovenian: Ni znano, ali je pri bolnikih s temi sočasno prisotnimi boleznimi tveganje za razvoj s sunitinibom povezanega nepravilnega delovanja levega ventrikla lahko povečano.
English: Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Slovenian: Poročali so o primerih prevelikega odmerjanja; nekateri primeri so bili povezani z neželenimi učinki, ki so se ujemali z znanim varnostnim profilom sunitiniba.
English: If you take more Sutent than you should
Slovenian: Če ste vzeli večji odmerek zdravila Sutent, kot bi smeli
English: Tell your doctor if you have any bleeding while on treatment with Sutent.
Slovenian: Obvestite zdravnika, če imate krvavitev med zdravljenjem z zdravilom Sutent.
English: - If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Slovenian: Če imate ali ste imeli poškodbe najmanjših krvnih žil, znane kot trombotična mikroangiopatija (TMA).
English: The observed adverse drug reactions were similar overall to those seen in adults (see section 4.8).
Slovenian: Opaženi neželeni učinki zdravila so bili na splošno podobni tistim pri odraslih (glejte poglavje 4.8).
English: Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Slovenian: Populacijske FK analize demografskih podatkov kažejo, da začetnega odmerka ni treba prilagajati glede na telesno maso ali stanje zmogljivosti, ocenjeni po lestvici ECOG (Eastern Cooperative Oncology Group).
English: From a 2-sided log-rank test.
Slovenian: a iz dvostranskega log-rang testa
English: No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Slovenian: Pri nobenem preskušancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE, različica 3.0) (glejte poglavje 4.4).
English: - Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki in pretisnem omotu poleg oznake “Uporabno do”.
English: NA 0.0066
Slovenian: N/A 0,0066
English: Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Slovenian: Zato mora odločitev o ponovnem začetku zdravljenja s sunitinibom temeljiti na klinični presoji okrevanja po kirurškem posegu.
English: Similarly, body surface area was a significant covariate on the apparent clearance of the active metabolite (the lower the body surface area, the lower the apparent clearance).
Slovenian: Podobno je bila telesna površina pomembna sospremenljivka navideznega očistka aktivnega presnovka (manjša kot je bila telesna površina, manjši je bil navidezni očistek).
English: Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group.
Slovenian: Mediano celokupno OS je bilo 5,1 meseca v skupini s HGG in 12,3 meseca v skupini z ependimomom.
English: Sutent can be taken with or without food.
Slovenian: Zdravilo Sutent lahko vzamete s hrano ali brez nje.
English: Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre-and postnatal development study in pregnant rats.
Slovenian: Sunitinib (0,3; 1,0; 3,0 mg/kg/dan) so ocenili v študiji pre- in postnatalnega razvoja pri brejih podganah.
English: Results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall global health-related quality of life and the 5 functioning domains (physical, role, cognitive, emotional, and social) were maintained for patients on sunitinib treatment as compared to placebo with limited adverse symptomatic effects.
Slovenian: Rezultati iz vprašalnika Evropske organizacije za raziskave in zdravljenje rakavih bolezni, ki se je nanašal na kakovost življenja /European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)/ so pokazali, da so se ohranili celokupna, s splošnim zdravstvenim stanjem povezana kakovost življenja in 5 življenjskih področij (fizično, funkcijsko, kognitivno, čustveno in socialno) pri bolnikih, ki so se zdravili s sunitinibom, v primerjavi s placebom, z omejenimi neželenimi simptomatskimi učinki.
English: If you experience dizziness or you feel unusually tired, take special care when driving or using machines.
Slovenian: Če vas obide omotica ali nenavadna utrujenost, bodite pri upravljanju vozil in strojev posebno previdni.
English: Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking Sutent.
Slovenian: Obvestite zdravnika, če ste hitreje utrujeni, če vas ponavadi bolj zebe kot druge ljudi ali se je vaš glas poglobil med jemanjem zdravila Sutent.
English: Some of the epistaxis events were severe, but very rarely fatal.
Slovenian: Nekatere epistakse so bile hude, vendar so se zelo redko končale s smrtnim izidom.
English: Sutent can cause abnormality of your heart rhythm.
Slovenian: Zdravilo Sutent lahko povzroči nepravilnosti vašega srčnega ritma.
English: Caution should therefore be exercised when Sutent and intravenous bisphosphonates are used either simultaneously or sequentially.
Slovenian: Zato je pri sočasnem ali zaporednem dajanju zdravila Sutent in intravenskih bisfosfonatov potrebna previdnost.
English: Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
Slovenian: Obvestite zdravnika, kakor hitro je mogoče, če se pri vas pojavi visok krvni tlak, glavobol ali izguba vida.
English: Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with solid tumours.
Slovenian: Huda hipertenzija (sistolični tlak > 200 mmHg ali diastolični tlak > 110 mmHg) se je pojavila pri 4,7 % bolnikov s čvrstimi tumorji.
English: • Heart attack caused by an interrupted or decreased blood supply to the heart.
Slovenian: • srčni infarkt zaradi prekinjenega ali zmanjšanega dotoka krvi v srce
English: Nevertheless, most of these adverse events observed in clinical studies were not considered related to study treatment (see section 4.4).
Slovenian: Kljub temu so ocenili, da večina teh neželenih učinkov, opaženih v kliničnih študijah, ni bila povezana z zdravilom v študiji (glejte poglavje 4.4).
English: Furthermore, according to the published literatures in paediatric patients with GIST, the calculated starting dose ranged from 16.6 mg/m to 36 mg/m increased to doses as high as 40.4 mg/m
Slovenian: Nadalje je skladno z objavljeno literaturo pri pediatričnih bolnikih z GIST izračunani začetni odmerek znašal od 16,6 mg/m 2 do 36 mg/m 2, ki so ga povečali celo do odmerka 40,4 mg/m
English: All thyroid-related events reported were Grade 1-2 (see section 4.4).
Slovenian: Vsi s ščitnico povezani dogodki, o katerih so poročali, so bili 1.-2. stopnje (glejte poglavje 4.4).
English: b Efficacy results for the 99 subjects who crossed over from placebo to Sutent after unblinding.
Slovenian: b Rezultati učinkovitosti za 99 bolnikov, ki so po razkritju zamenjali placebo z zdravilom Sutent.
English: Demographics were comparable between the sunitinib and placebo groups.
Slovenian: Demografski podatki so bili med skupinama, ki sta prejemali sunitinib oziroma placebo, primerljivi.
English: Changes in sunitinib PK parameters were of no clinical significance and did not indicate any drug-drug interactions; however, considering the relatively low number of subjects (i.e. N=7+4) and the moderate-large interpatient variability in the pharmacokinetic parameters, caution needs to be taken when interpreting the PK drug-drug interaction findings from this study.
Slovenian: Spremembe FK parametrov sunitiniba niso bile klinično pomembne in niso kazale na medsebojno delovanje zdravil, vendar je, glede na sorazmerno majhno število preskušancev (tj. n = 7 + 4) in zmerno do veliko variabilnost FK parametrov med bolniki, pri interpretaciji izsledkov o FK medsebojnem delovanju zdravil iz te študije potrebna previdnost.
English: These may be caused by inflammation of the pancreas or gallbladder.
Slovenian: Ti so lahko posledica vnetja trebušne slinavke ali žolčnika.
English: This analysis was based on data collected from adults with GIST or solid tumours and from paediatric patients with solid tumours.
Slovenian: Ta analiza je temeljila na podatkih, pridobljenih pri odraslih z GIST ali čvrstimi tumorji ter pri pediatričnih bolnikih s čvrstimi tumorji.
English: Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
Slovenian: Obvestite zdravnika, če imate spremenjeno frekvenco ali odsotnost uriniranja, kar so lahko simptomi odpovedi ledvic.
English: Other endpoints included ORR, OS, and safety.
Slovenian: Drugi opazovani dogodki so bili ORR, OS in varnost.
English: Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Slovenian: Sunitiniba niso preskušali pri bolnikih z resno jetrno okvaro razreda C po Child-Pughu in zato njegova uporaba pri bolnikih z resno jetrno okvaro ni priporočljiva (glejte poglavje 5.2).
English: No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies.
Slovenian: V registracijskih študijah GIST, MRCC in pNET niso poročali o smrtnih izidih.
English: Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Slovenian: Priporočljiva je izhodiščna analiza urina, bolnike pa je treba spremljati, da bi odkrili pojav ali poslabšanje proteinurije.
English: The rash may progress to widespread blistering or peeling of the skin and may be life-threatening.
Slovenian: Izpuščaj lahko napreduje do obširnih mehurjev na koži in luščenja kože in je lahko življenjsko ogrožajoč.