FrancophonIA/ELRC3.0 huggingface dataset:
English: The area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of larotrectinib after a single dose in healthy adult subjects were dose proportional up to 400 mg and slightly greater than proportional at doses of 600 to 900 mg.
Slovenian: Linearnost/nelinearnost Pri odmerkih do 400 mg sta bili vrednost območja pod krivuljo (AUC) in vrednost največje koncentracije v plazmi (Cmax) larotrektiniba po enkratnem odmerku pri zdravih odraslih osebah sorazmerni z odmerkom, pri odmerkih od 600 do 900 mg pa rahlo večji od sorazmerne vrednosti.
English: Effect of larotrectinib on CYP2B6 substrates
Slovenian: Učinek larotrektiniba na substrate CYP2B6
English: 5.3 Preclinical safety data
Slovenian: 5.3 Predklinični podatki o varnosti Sistemska toksičnost
English: All primary CNS tumour patients had received prior cancer treatment (surgery, radiotherapy and/or previous systemic therapy).
Slovenian: Vsi bolniki s primarnim tumorjem osrednjega živčevja so se predhodno zdravili zaradi raka (operacija, radioterapija in/ali predhodno sistemsko zdravljenje).
English: Dosing in paediatric patients is based on body surface area (BSA).
Slovenian: Odmerjanje pri pediatričnih bolnikih je odvisno od telesne površine.
English: Contains: sucrose, E 420, E 1520, E 218.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje: saharozo, E 420, E 1520, E 218.
English: Put the bottle cap on and tightly close the bottle - leave the adapter in the bottle.
Slovenian: Zaporko steklenice dajte na steklenico in jo dobro zaprite - nastavek pustite v steklenici.
English: No relevant effects on fertility were observed in repeat-dose toxicity studies (see section 5.3).
Slovenian: V študijah o toksičnosti ponavljajočih odmerkov niso opazili pomembnih učinkov na plodnost (glejte poglavje 5.3).
English: Titanium dioxide (E 171)
Slovenian: - želatina - titanov dioksid (E 171)
English: Larotrectinib was not teratogenic and embryotoxic when dosed daily during the period of organogenesis to pregnant rats and rabbits at maternotoxic doses, i.e. corresponding to 32-times (rats) and 16-times (rabbits) the human AUC at the recommended clinical dose.
Slovenian: Larotrektinib ni bil teratogen in embriotoksičen pri dnevnem odmerjanju v obdobju organogeneze pri brejih podganah in kuncih, po odmerkih, ki so toksični za brejo samico, tj. odmerkih, ki ustrezajo 32-kratniku (za podgane) in 16-kratniku (za kunce) AUC pri ljudeh po priporočenem kliničnem odmerku.
English: Larotrectinib had no effect on respiratory function in rats; at exposures (Cmax) at least 8-times the human therapeutic exposure.
Slovenian: Larotrektinib ni vplival na dihalno funkcijo pri podganah pri izpostavljenostih (Cmax) najmanj 8-kratnika terapevtskih izpostavljenosti pri ljudeh.
English: Baseline characteristics for the 9 patients with primary CNS tumours with an NTRK gene fusion assessed by investigator were as follows: median age 12 years (range 2-79 years); 6 patients
Slovenian: Izhodišče značilnosti za 9 bolnikov s primarnimi tumorji osrednjega živčevja s fuzijo gena NTRK, ki so jih ocenili raziskovalci, so bili kot sledi: mediana starost 12 let (razpon 2 - 79 let); 6 bolnikov, starih
English: In vitro studies show that in liquid volumes relevant to the gastrointestinal (GI) tract larotrectinib is fully soluble over entire pH range of the GI tract.
Slovenian: Študije in vitro kažejo, da je larotrektinib v volumnu tekočine ki je pomembna za gastrointestinalni (GI) trakt, povsem topen pri vseh vrednostih pH v prebavilih.
English: Each carton contains 1 child-resistant plastic bottle containing 56 hard gelatine capsules.
Slovenian: Vsaka škatla vsebuje 1 za otroke varno plastenko s 56 trdimi želatinastimi kapsulami.
English: Grade 3 ALT and AST increases in 3 (2%) and 2 (2%) patients, respectively.
Slovenian: Zvišanja vrednosti ALT in AST 3. stopnje so opazili pri 3 (2 %) oziroma 2 (2 %) bolnikih.
English: An oral solution of VITRAKVI is available for patients who cannot swallow the capsules.
Slovenian: Za bolnike, ki kapsul ne morejo zaužiti, je na voljo peroralna raztopina.
English: EU/1/19/1385/003 - VITRAKVI 20 mg/mL oral solution
Slovenian: EU/1/19/1385/003 - VITRAKVI 20 mg/ml peroralna raztopina
English: If concomitant use of these CYP3A substrates with narrow therapeutic range is required in patients taking VITRAKVI, dose reductions of the CYP3A substrates may be required due to adverse reactions.
Slovenian: Če je pri bolnikih, ki jemljejo zdravilo VITRAKVI, potrebna sočasna uporaba teh substratov CYP3A z ozkim terapevtskim oknom, bo zaradi neželenih učinkov morda potrebno zmanjšanje odmerka substratov CYP3A.
English: ≥ 12 months Range (months)
Slovenian: % 95-% IZ ≥ 12 mesecev razpon (meseci)
English: Congenital mesoblastic nephromaa
Slovenian: kongenitalni mezoblastni nefroma
English: ALT and AST increase were reported in patients receiving larotrectinib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali larotrektinib, so poročali o zvišanih vrednostih ALT in AST (glejte poglavje 4.8).
English: The adverse reactions gait disturbance (17% versus 3% in under 65 years), and blood alkaline phosphatase increased (4% versus 2% in under 65 years) were more frequent in patients of 65 years or older.
Slovenian: (17 % v primerjavi s 3 % bolnikov, mlajših od 65 let), in zvišane vrednosti alkalne fosfataze v krvi (4 % v primerjavi s 2 % bolnikov, mlajših od 65 let) so bili pogostejši pri bolnikih, starih 65 let ali več.
English: Table 3: Adverse drug reactions reported in TRK fusion-positive paediatric cancer patients treated with VITRAKVI at recommended dose (n=37); all Grades System organ class
Slovenian: Preglednica 3: Neželeni učinki zdravila, o katerih so poročali pri pediatričnih bolnikih z rakom z dokazano fuzijo TRK zdravljenimi z zdravilom VITRAKVI v priporočenih odmerkih (n = 37); vse stopnje
English: Push the plunger fully into the syringe and then put the syringe in the adapter opening.
Slovenian: Bat potisnite do konca v brizgo in nato brizgo vstavite v odprtino nastavka.
English: For the majority of neurologic reactions, onset occurred within the first three months of treatment.
Slovenian: Večina nevroloških učinkov se je pojavila v prvih treh mesecih zdravljenja.
English: - Fill the oral syringe with small amount of solution by pulling the plunger down, then push the plunger upwards to remove any bubbles.
Slovenian: - Peroralno brizgo napolnite z majhno količino raztopine tako, da bat povlečete navzdol, nato pa bat potisnite navzgor, da odstranite morebitne mehurčke.
English: The oral solution should be administered by mouth using an oral syringe of 1 mL or 5 mL volume or enterally by using a nasogastric feeding tube.
Slovenian: Peroralno raztopino je treba dajati peroralno s peroralno brizgo z volumnom 1 ml ali 5 ml ali enteralno z uporabo nazogastrične sonde za hranjenje.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse.
Slovenian: Če kar koli od navedenega velja za vas (ali niste prepričani), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Baseline characteristics for the 9 patients with primary CNS tumours with an NTRK gene fusion assessed by investigator were as follows: median age 12 years (range 2-79 years); 6 patients < 18 years of age, and 3 patients ≥ 18 years, and 8 patients white and 5 patients male; and ECOG PS 0-1 (8 patients), or 2 (1 patient).
Slovenian: Izhodišče značilnosti za 9 bolnikov s primarnimi tumorji osrednjega živčevja s fuzijo gena NTRK, ki so jih ocenili raziskovalci, so bili kot sledi: mediana starost 12 let (razpon 2 - 79 let); 6 bolnikov, starih < 18 let, in 3 bolniki ≥ 18 let; 8 belcev in 5 moških; ECOG PS 0-1 (8 bolnikov) ali 2 (1 bolnik).
English: Put the bottle adapter into the bottle neck and make sure it is well fixed.
Slovenian: Nastavek za steklenico vstavite v vrat steklenice in preverite, da je dobro pritrjen.
English: Withholding, reducing, or discontinuing VITRAKVI dosing should be considered, depending on the severity and persistence of these symptoms (see section 4.2).
Slovenian: Glede na resnost in trajanje teh simptomov je treba razmisliti o prenehanju zdravljenja, zmanjšanju odmerka ali prekinitvi odmerjanja zdravila VITRAKVI (glejte poglavje 4.2).
English: Parahydroxybenzoate: may cause allergic reactions (possibly delayed).
Slovenian: Parahidroksibenzoat: lahko povzroči alergijske reakcije (lahko z zapoznelim učinkom).
English: The most common tumour types represented were soft tissue sarcoma (23%), salivary gland tumour (18%), infantile fibrosarcoma (14%), thyroid cancer (11%), lung and melanoma cancer (8% for each), and colon cancer (6%).
Slovenian: Najpogostejše vrste tumorjev so bili sarkom mehkega tkiva (23 %), tumor žleze slinavke (18 %), infantilni fibrosarkom (14 %), rak ščitnice (11 %), pljučni rak in melanom (8 % za vsakega) in rak debelega črevesa (6 %).
English: All patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Slovenian: Vsi bolniki so se predhodno zdravili zaradi raka, in sicer s kirurškim posegom, radioterapijo ali sistemskim zdravljenjem.
English: Baseline characteristics for the pooled 93 patients with solid tumours with an NTRK gene fusion were as follows: median age 41 years (range 0.1-78 years); 30% < 18 years of age, and 70% ≥ 18 years;
Slovenian: Izhodiščne značilnosti združenih izsledkov 93 bolnikov s solidnimi tumorji s fuzijo genov NTRK so bile naslednje: mediana starosti 41 let (razpon 0,1 - 78 let); 30 % < 18 let starosti in 70 % ≥ 18 let;
English: Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger upwards to remove any large bubbles that are in the syringe.
Slovenian: Brizgo napolnite z majhno količino raztopine tako, da bat povlečete navzdol, nato pa bat potisnite navzgor, da odstranite morebitne mehurčke iz brizge.
English: Cmax was observed to increase slightly by 1.1, 1.1 and 1.5-fold respectively.
Slovenian: Opazili so rahlo zvečane vrednosti Cmax, in sicer za 1,1-, 1,1- oziroma
English: Larotrectinib was metabolised predominantly by CYP3A4/5 in vitro.
Slovenian: Biotransformacija Larotrektinib se je pretežno presnovil in vitro z encimom CYP3A4/5.
English: What VITRAKVI is and what it is used for What VITRAKVI is used for
Slovenian: Kaj je zdravilo VITRAKVI in za kaj ga uporabljamo
English: - Do not eat grapefruit or drink grapefruit juice while taking this medicine.
Slovenian: - Med jemanjem tega zdravila ne jejte grenivk niti ne pijte soka grenivk.
English: At the time of data cut-off, 8 of 9 enrolled patients with primary CNS tumours were evaluable for response by investigator assessment.
Slovenian: Ob zaključku zbiranja podatkov je raziskovalec ocenil odziv pri 8 od 9 vključenih bolnikov s primarnimi tumorji osrednjega živčevja.
English: Table 7: Recommended tube dimensions per age group Patient
Slovenian: Preglednica 7: Priporočeni premeri sonde glede na starostno skupino Bolnik
English: Overall response rate (ORR) % (n)
Slovenian: (n=102)a, b celokupni delež odziva (ORR) % (n)
English: Ninety-seven percent of patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Slovenian: Sedemindevetdeset odstotkov bolnikov je bilo predhodno zdravljenih zaradi raka, in sicer s kirurškim posegom, radioterapijo ali sistemskim zdravljenjem.
English: The active substance is larotrectinib.
Slovenian: Učinkovina je larotrektinib.
English: - The maximum recommended dose is 100 mg (5 mL), two times a day.
Slovenian: - Največji priporočeni odmerek je 100 mg (5 ml), dvakrat na dan.
English: Bayer Oy Puh/Tel: +358- 20 785 21
Slovenian: Puh/Tel: +358- 20 785 21
English: - 22 mg sorbitol in 1 mL.
Slovenian: - 22 mg sorbitola v 1 ml. Sorbitol je vir fruktoze.
English: What you need to know before you take VITRAKVI Do not take VITRAKVI if
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo VITRAKVI
English: Weight increased (Abnormal weight gain)
Slovenian: povečana telesna masa (nenormalno povečanje telesne mase)
English: How to take VITRAKVI
Slovenian: Kako jemati zdravilo VITRAKVI
English: No relevant systemic toxicity was observed in monkeys at doses which correspond to > 10-times the human AUC at the recommended clinical dose.
Slovenian: Pri opicah niso opazili pomembne sistemske toksičnosti pri odmerkih, ki ustrezajo > 10-kratniku AUC pri ljudeh po priporočenem kliničnem odmerku.
English: Additional information on special populations
Slovenian: Dodatne informacije o posebnih populacijah Pediatrična populacijai
English: - feeling dizzy, tingling, feeling numb, or a burning feeling in your hands and feet (very common side effect, may affect more than 1 in 10 people), difficulty walking normally (common side effect, may affect up to 1 in 10 people).
Slovenian: Če se pojavi kateri od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikom: - občutek vrtoglavice, mravljinčenje, občutek otrplosti ali pekoč občutek v rokah in nogah (zelo pogost neželeni učinek, ki se lahko pojavi pri več kot 1 od 10 ljudi), težave pri hoji (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10 ljudi).
English: Package leaflet: Information for the patient VITRAKVI 20 mg/mL oral solution larotrectinib This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo VITRAKVI 20 mg/ml peroralna raztopina larotrektinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Typical tube diameter, tube lengths and derived prime volumes are presented in Table 7.
Slovenian: Običajni premer sonde, dolžine sonde in ustrezne količine polnjenja so navedeni v preglednici 7.
English: The adverse drug reactions reported in patients treated with VITRAKVI are shown in Table 2 and Table 3.
Slovenian: Tabelarični pregled neželenih učinkov Neželeni učinki zdravila, o katerih so poročali pri bolnikih, zdravljenih z zdravilom VITRAKVI, so prikazani v preglednicah 2 in 3.
English: Co-administration with strong CYP3A4 inhibitors If co-administration with a strong CYP3A4 inhibitor is necessary, the VITRAKVI dose should be reduced by 50%.
Slovenian: Če je potrebna sočasna uporaba z močnimi zaviralci CYP3A4, je treba odmerek zdravila VITRAKVI zmanjšati za 50 %.
English: Bayer Limited Tel: +353 1 2999313
Slovenian: Tel: +353 1 2999313
English: A pharmacokinetic study was conducted in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, and in healthy adult control subjects with normal hepatic function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Slovenian: Bolniki z okvaro jeter Farmakokinetično študijo so izvedli pri osebah z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter ter pri zdravih odraslih kontrolnih osebah z normalnim delovanjem jeter, ki so se ujemale glede na starost, indeks telesne mase in spol.
English: One reported Grade 3 case each of Neutrophil count decreased (Neutropenia), Paraesthesia, Myalgia, Weight increased (Abnormal weight gain).
Slovenian: Poročali so o po enem primeru 3. stopnje kot so zmanjšanje števila nevtrofilcev (neutropenija), parestezija, mialgija, povečanje telesne mase (nenormalno povečanje telesne mase).
English: - The recommended dose of VITRAKVI is 100 mg (5 mL), two times a day.
Slovenian: - Priporočeni odmerek zdravila VITRAKVI je 100 mg (5 ml), dvakrat na dan.
English: - Insert the bottle adapter into the bottle neck and ensure it is well fixed.
Slovenian: - Nastavek za steklenico vstavite v vrat steklenice in preverite, da je dobro pritrjen.
English: What VITRAKVI looks like and the contents of the bottle
Slovenian: Izgled zdravila VITRAKVI in vsebina pakiranja
English: - For doses below 1 mL a 1 mL oral syringe should be used.
Slovenian: - Za odmerke, manjše od 1 ml, je treba uporabiti 1-ml peroralno brizgo.
English: The majority of ALT and AST increases occurred in the first 3 months of treatment.
Slovenian: Vrednosti ALT in AST so se zvišale predvsem v prvih 3 mesecih zdravljenja.
English: two times a day.
Slovenian: dvakrat na dan, je bila približno 3 ure.
English: Following oral administration of a single 100 mg dose of radiolabeled larotrectinib to healthy adult subjects, unchanged larotrectinib (19%) and an O-glucuronide that is formed following loss of the hydroxypyrrolidine-urea moiety (26%) were the major circulating radioactive drug components.
Slovenian: Po enkratnem peroralnem odmerku 100 mg radioaktivno označenega larotrektiniba zdravim odraslim osebam sta bili glavni radioaktivni komponenti zdravila v obtoku nespremenjeni larotrektinib (19 %) in O-glukuronid, ki nastane po izgubi dela hidroksipirolidin-sečnine (26 %).
English: Study 3 “SCOUT” NCT02637687
Slovenian: NCT02637687
English: Elderly No dose adjustment is recommended in elderly patients (see section 5.2).
Slovenian: Pri starejših bolnikih odmerka ni priporočljivo prilagajati (glejte poglavje 5.2).
English: This is because it is not known if VITRAKVI passes into breast milk.
Slovenian: Ni znano, ali se zdravilo VITRAKVI izloča v materino mleko.
English: The highest reported grade was Grade 3 for adverse reactions anaemia, weight increased, fatigue, increased AST, dizziness, paraesthesia, nausea, myalgia, and leukocyte count decreased.
Slovenian: Najvišja stopnja anemije, povečanja telesne mase, utrujenosti, zvišanja vrednosti AST, vrtoglavice, parestezije, občutek siljenja na bruhanje, mialgije in zmanjšanja števila levkocitov, o katerih so poročali, je bila 3. stopnja.
English: Turn the bottle the right way up and take the syringe out of the adapter.
Slovenian: Steklenico obrnite v pravilni položaj in iz nastavka za steklenico odstranite brizgo.
English: (neutropenia, leukopenia) - feeling or being sick (nausea or vomiting) - constipation - muscle pain (myalgia) - muscle weakness - feeling tired (fatigue) - increased amount of liver enzymes in blood tests - weight increase.
Slovenian: - bolečine v mišicah (mialgija) - mišična šibkost - občutek utrujenosti (šibkosti) - povečano število jetrnih encimov v izvidih krvnih preiskav - povečanje telesne mase
English: Doses up to 200 mg once or twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Slovenian: odmerki do 200 mg enkrat ali dvakrat na dan (25 mg, 100 mg kapsule ali 20 mg/ml peroralna raztopina)
English: Grade 2 ALT and AST increases were observed in 9 (7%) and 6 (5%) of patients, respectively, and Grade 1 ALT and AST increases were observed in 26 (21%) and 28 (22%) of patients, respectively.
Slovenian: Zvišanja vrednosti ALT in AST 1. stopnje so opazili pri 26 (21 %) oziroma 28 (22 %) bolnikih.
English: An increase in larotrectinib AUC0-inf was observed in subjects with mild, moderate and severe hepatic impairment of 1.3, 2 and 3.2-fold respectively versus those with normal hepatic function.
Slovenian: Pri osebah z blago, zmerno in hudo okvaro jeter so opazili zvečane vrednosti AUC0-inf larotrektiniba, in sicer za 1,3-, 2- oziroma 3,2-krat v primerjavi z osebami z normalnim delovanjem jeter.
English: The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI.
Slovenian: Pred uvedbo zdravljenja z zdravilom VITRAKVI je treba v vzorcu tumorja z validiranim testom potrditi prisotnost fuzije genov NTRK.
English: tacrolimus - a medicine used to treat an abnormal heart rhythm called quinidine - medicines used to treat migraines called dihydroergotamine, ergotamine - a medicine used to treat long-term pain called fentanyl - a medicine used to control involuntary movements or sounds called pimozide - a medicine to help you stop smoking called bupropion - medicines to reduce blood sugar levels called repaglinide, tolbutamide - a medicine that prevents blood clots called warfarin - a medicine used to reduce the amount of acid produced in the stomach called omeprazole - a medicine used to help control high blood pressure called valsartan - a group of medicines used to help lower cholesterol called statins - hormonal medicines used for contraception, see section “contraception - for men and women”
Slovenian: - zdravilo, ki pomaga pri odvajanju od kajenja, ki se imenuje bupropion - zdravila za zmanjševanje ravni sladkorja v krvi, ki se imenujejo repaglinid, tolbutamid - zdravilo, ki preprečuje nastajanje krvnih strdkov, ki se imenuje varfarin - zdravilom za zmanjševanje nastajanja kisline v želodcu, ki se imenuje omeprazol - zdravilo, ki se uporablja pri nadzoru visokega krvnega tlaka, ki se imenuje valsartan - skupina zdravila za zniževanje holesterola, ki se imenujejo statini
English: Women of reproductive potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo.
English: VITRAKVI is available as a capsule and oral solution formulation.
Slovenian: Zdravilo VITRAKVI je na voljo v obliki kapsule in peroralne raztopine.
English: VITRAKVI is only used when - these cancers are advanced or have spread to other parts of the body or if a surgery to remove the cancer is likely to cause severe complications and - there are no satisfactory treatment options.
Slovenian: - kadar so tumorji napredovali ali so se razširili na druge dele telesa ali bi kirurški poseg za odstranitev tumorja verjetno povzročil hude zaplete in
English: Grade 4 was the highest reported grade for adverse reactions neutrophil count decreased (1.6%) and ALT increased (< 1%).
Slovenian: Najvišja stopnja zmanjšanja števila nevtrofilcev (1,6 %) in zvišanja vrednosti ALT (< 1 %), o katerih so poročali, je bila 4. stopnja.
English: In 36 healthy adult subjects receiving single doses ranging from 100 mg to 900 mg, VITRAKVI did not prolong the QT interval to any clinically relevant extent.
Slovenian: Pri 36 zdravih odraslih osebah, ki so prejemale enkratne odmerke od 100 mg do 900 mg, zdravilo
English: Clear yellow to orange solution.
Slovenian: peroralna raztopina bistra rumena do oranžna raztopina
English: • Phase 1, open-label, dose escalation and expansion study; expansion phase required tumours with an NTRK gene fusion
Slovenian: • odprta študija faze 1, s stopnjevanjem odmerka in podaljšanjem študije; za vključitev v podaljšano fazo študije je bila potrebna dokazana fuzija genov NTRK
English: For details how to do so, please ask your doctor, pharmacist or nurse.
Slovenian: Za podrobnosti o tem, kako to lahko naredite, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: In 3-months toxicity studies, larotrectinib had no histological effect on the male reproductive organs in rats and monkeys at the highest tested doses corresponding to approximately 7-times (male rats) and 10-times (male monkeys) the human AUC at the recommended clinical dose.
Slovenian: V 3-mesečnih študijah toksičnosti larotrektinib ni imel histoloških učinkov na reproduktivne organe samcev pri podganah in opicah pri največjih preskušanih odmerkih, ki ustrezajo približno 7-kratniku (pri podganjih samcih) in 10-kratniku (pri opičjih samcih) AUC pri ljudeh po priporočenem kliničnem odmerku.
English: Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni potrebno prilagajati (glejte poglavje 5.2).
English: A pharmacokinetic study was conducted in subjects with end stage renal disease requiring dialysis, and in healthy adult control subjects with normal renal function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Slovenian: Farmakokinetično študijo so izvedli pri osebah z ledvično boleznijo v končnem stadiju, ki so bili na dializi, ter pri zdravih odraslih kontrolnih osebah z normalnim delovanjem ledvic, ki so se ujemale glede na starost, indeks telesne mase in spol.
English: Each carton contains one bottle of 100 mL oral solution.
Slovenian: Vsaka škatla vsebuje eno steklenico s 100 ml peroralne raztopine.