FrancophonIA/ELRC3.0 huggingface dataset:
English: The pooled primary analysis set of efficacy includes 93 patients with TRK fusion-positive cancer enrolled across the three studies that had measurable disease assessed by RECIST v1.1, a non-CNS primary tumour and received at least one dose of larotrectinib.
Croatian: Objedinjeni skup podataka za primarnu analizu djelotvornosti uključuje 93 bolesnika s tumorom pozitivnim na fuzijski gen TRK uključenih u sva tri ispitivanja koji su imali mjerljivu bolest prema kriterijima RECIST v1.1, primarni tumor izvan SŽS-a i primili su najmanje jednu dozu larotrektiniba.
English: - Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing.
Croatian: - Polako potiskujte klip, usmjeravajući mlaz tekućine prema unutarnjoj strani obraza kako biste omogućili prirodno gutanje.
English: Sorbitol: patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Croatian: Sorbitol: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi smjeli uzimati ovaj lijek.
English: Put the bottle cap on and tightly close the bottle - leave the adapter in the bottle.
Croatian: Vratite zatvarač na bocu i čvrsto je zatvorite - ostavite adapter u boci.
English: In in vitro and in vivo tumour models, larotrectinib demonstrated anti-tumour activity in cells with constitutive activation of TRK proteins resulting from gene fusions, deletion of a protein regulatory domain, or in cells with TRK protein overexpression.
Croatian: U in vitro i in vivo modelima tumora larotrektinib je pokazao antitumorsko djelovanje u stanicama s konstitutivnom aktivacijom TRK proteina nastalom zbog fuzije gena, delecije regulatorne proteinske domene ili u stanicama s pretjeranom ekspresijom TRK proteina.
English: Patients (n=102)
Croatian: (n = 102)
English: In order to further investigate the long-term toxicity and developmental effects of larotrectinib in paediatric patients, with particular focus on neurodevelopment including cognitive function, the MAH should submit the final report of study LOXO-TRK-15003 (SCOUT) including 5 year follow up data.
Croatian: Kako bi se dodatno ispitala dugotrajna toksičnost i utjecaj larotrektiniba na razvoj u pedijatrijskih bolesnika, s posebnim naglaskom na neurološki razvoj uključujući kognitivnu funkciju, nositelj odobrenja dužan je dostaviti završno izvješće ispitivanja LOXO-TRK-15003 (SCOUT) uključujući 5-godišnje podatke praćenja.
English: The safety pharmacology of larotrectinib was evaluated in several in vitro and in vivo studies that assessed effects on the CV, CNS, respiratory, and GI systems in various species.
Croatian: Sigurnosna farmakologija larotrektiniba bila je procijenjena u nekoliko in vitro i in vivo ispitivanja u kojima su se procijenili učinci na kardiovaskularni, središnji živčani, dišni i probavni sustav kod različitih vrsta.
English: • Phase 1/2 multinational, open-label, dose escalation and expansion study; Phase 2 expansion cohort required advanced solid tumours with an NTRK gene fusion, including locally advanced infantile fibrosarcoma
Croatian: • multinacionalno, otvoreno ispitivanje faze 1/2 povišenja doze i proširenja; faza 2 proširenja zahtijevala je kohortu s uznapredovalim solidnim tumorima s fuzijskim genom NTRK, uključujući lokalno uznapredovali infantilni fibrosarkom
English: The adverse drug reactions reported in patients treated with VITRAKVI are shown in Table 2 and Table 3.
Croatian: Nuspojave prijavljene u bolesnika liječenih lijekom VITRAKVI prikazane su u tablici 2 i tablici
English: Slowly press the plunger in.
Croatian: Polako potiskujte klip u štrcaljku.
English: Gastrointestinal stromal tumoura Bone sarcomaa Cholangiocarcinomaa
Croatian: Gastrointestinalni stromalni tumora Sarkom kostia Kolangiokarcinoma
English: Of 125 patients treated with VITRAKVI, 37 (30%) patients were from 28 days to 18 years of age.
Croatian: Od 125 bolesnika liječenih lijekom VITRAKVI, 37 (30 %) bolesnika bilo je u dobi od 28 dana do 18 godina.
English: The benefit of VITRAKVI has been established in single arm trials encompassing a relatively small sample of patients whose tumours exhibit NTRK gene fusions.
Croatian: Korist lijeka VITRAKVI utvrđena je u ispitivanjima s jednom skupinom ispitanika koja obuhvaćaju relativno mali uzorak bolesnika čiji tumori pokazuju fuziju gena NTRK.
English: What you need to know before you take VITRAKVI Do not take VITRAKVI if
Croatian: Što morate znati prije nego počnete uzimati VITRAKVI
English: EU/1/19/1385/001 - VITRAKVI 25 mg EU/1/19/1385/002 - VITRAKVI 100 mg
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1385/001 - VITRAKVI 25 mg EU/1/19/1385/002 - VITRAKVI 100 mg
English: Overall response rate (ORR) % (n)
Croatian: Ukupna stopa odgovora (ORR) % (n) [95 % CI]
English: There are no clinical data on the effect of larotrectinib on fertility.
Croatian: Ne postoje klinički podaci o učinku larotrektiniba na plodnost.
English: In the overall safety database (n=125), the maximum grade neurologic reaction observed was Grade 3 which was observed in three (2%) patients and included dizziness (one patient, <1%) and paraesthesia (two patients, 1.6%).
Croatian: U bazi podataka o cjelokupnoj populaciji u ispitivanju sigurnosti primjene (n=125), najviši stupanj opaženih neuroloških reakcija bio je 3. stupanj, zabilježen u tri (2 %) bolesnika, a uključivao je omaglicu (jedan bolesnik, <1%) i paresteziju (dva bolesnika, 1,6 %).
English: The efficacy and safety of VITRAKVI were studied in three multicentre, open-label, single-arm clinical studies in adult and paediatric cancer patients (Table 4).
Croatian: Djelotvornost i sigurnost lijeka VITRAKVI ispitane su u tri multicentrična, otvorena klinička ispitivanja s jednom skupinom provedena u odraslih i pedijatrijskih onkoloških bolesnika (tablica 4).
English: For the majority of neurologic reactions, onset occurred within the first three months of treatment.
Croatian: Većina neuroloških reakcija pojavila se unutar prva tri mjeseca liječenja.
English: In rats, larotrectinib accelerated intestinal transit and increased gastric secretion and acidity.
Croatian: Kod štakora je larotrektinib ubrzao prolazak crijevnog sadržaja i povećao lučenje želučanog soka i kiselost.
English: Based on population pharmacokinetic analyses exposure (Cmax and AUC) in paediatric patients (1 month to <3 months of age) at the recommended dose of 100 mg/m2 with a maximum of 100 mg BID was 3-fold higher than in adults (≥18 years of age) given the dose of 100 mg BID.
Croatian: Na temelju populacijske farmakokinetičke analize, izloženost (Cmax i AUC) u pedijatrijskih bolesnika (u dobi od 1 mjeseca do <3 mjeseca starosti) kod preporučene doze od 100 mg/m2 uz najviše 100 mg dvaput na dan bila je 3 puta viša nego u odraslih (≥18 godina starosti) koji su dobivali dozu od 100 mg dvaput na dan.
English: In a 1-month repeat-dose study in rats, fewer corpora lutea, increased incidence of anestrus and decreased uterine weight with uterine atrophy were observed and these effects were reversible.
Croatian: U 1-mjesečnom ispitivanju ponovljenih doza na štakorima opaženo je manje žutih tijela, povećana incidencija anestrusa i smanjena težina maternice s atrofijom maternice i ti su učinci bili reverzibilni.
English: The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs.
Croatian: Preporučena doza u odraslih je 100 mg larotrektiniba dvaput na dan do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: At the time of analysis, the median duration of response had not been reached, 75% patients had responses which were ongoing with an estimated 88% of responses lasting 6 months or longer and 75% of responses lasting 12 months or longer.
Croatian: U vrijeme analize, medijan trajanja odgovora nije bio postignut; 75 % bolesnika imalo je terapijske odgovore koji su u 88 % slučajeva prema procjeni trajali 6 mjeseci ili dulje, a u 75 % trajali su 12 mjeseci ili dulje.
English: Women of childbearing potential must use highly effective contraception while taking VITRAKVI and for at least one month after stopping treatment (see sections 4.5 and 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju za vrijeme uzimanja lijeka VITRAKVI i najmanje mjesec dana nakon prekida liječenja (vidjeti dijelove 4.5 i 4.6).
English: What VITRAKVI is and what it is used for What VITRAKVI is used for
Croatian: Što je VITRAKVI i za što se koristi
English: Co-administration with CYP3A4/P-gp inducers
Croatian: Istodobna primjena s induktorima CYP3A4/P-gp-a
English: In-frame gene fusion events resulting from chromosomal rearrangements of the human genes NTRK1, NTRK2, and NTRK3 lead to the formation of oncogenic TRK fusion proteins.
Croatian: Fuzija gena unutar otvorenog okvira čitanja (engl. in-frame) koja je posljedica kromosomske preraspodjele ljudskih gena NTRK1, NTRK2 i NTRK3 dovodi do stvaranja onkogenih fuzijskih TRK proteina.
English: Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies.
Croatian: Liječenje lijekom VITRAKVI moraju započeti liječnici s iskustvom u primjeni antitumorskih terapija.
English: In order to further confirm the appropriate dose recommended in paediatric patients, the MAH should submit an updated pop PK model based on additional PK sampling in patients aged 1 month to 6 years from study LOXO-TRK-15003 (SCOUT).
Croatian: Kako bi se dodatno potvrdila odgovarajuća doza preporučena za pedijatrijske bolesnike, nositelj odobrenja dužan je dostaviti ažurirani model populacijske farmakokinetike (PK), koji se temelji na dodatnom PK uzorkovanju u bolesnika u dobi od 1 mjeseca do 6 godina iz ispitivanja LOXO-TRK-15003 (SCOUT).
English: There are no data from the use of larotrectinib in pregnant women.
Croatian: Nema podataka o primjeni larotrektiniba u trudnica.
English: Paediatric patients with body surface area less than 1.0 m2
Croatian: Pedijatrijski bolesnici čija je površina tijela manja od 1,0 m2
English: The fraction excreted as unchanged drug in urine was 29% following IV microtracer dose, indicating that direct renal excretion accounted for 29% of total clearance.
Croatian: Dio izlučen kao neizmijenjeni lijek u mokraći iznosio je 29 % nakon i.v. doze mikroobilježivača, pokazujući da je izravno izlučivanje putem bubrega činilo 29 % ukupnog klirensa.
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.
Croatian: Nakon oralne primjene jednokratne doze od 100 mg radioaktivno obilježenog larotrektiniba zdravim odraslim ispitanicima, nepromijenjeni larotrektinib (19 %) i O-glukuronid koji nastaje nakon gubitka hidroksipirolidinskog dijela (26 %) bili su glavne sastavnice radioaktivnog lijeka u cirkulaciji.
English: Based on the mechanism of action, foetal harm cannot be excluded when administering larotrectinib to a pregnant woman.
Croatian: S obzirom na njegov mehanizam djelovanja, ne može se isključiti štetno djelovanje na fetus kod primjene larotrektiniba u trudnica.
English: The adverse reactions of vomiting (35% versus 14% in adults), leucocyte count decrease (22% versus 9% in adults), neutrophil count decrease (30% versus 7% in adults), blood alkaline phosphatase increased (14% versus 2% in adults) and transaminase elevations (ALT 41% versus 27% in adults and AST 35% versus 26% in adults) were more frequent in paediatric patients compared to adults.
Croatian: Nuspojave u vidu povraćanja (35 % naspram 14 % u odraslih), sniženja broja leukocita (22 % naspram 9 % u odraslih), sniženja broja neutrofila (30 % naspram 7 % u odraslih), povišenja alkalne fosfataze u krvi (14 % naspram 2 % u odraslih) i povišenja transaminaza (ALT 41 % naspram 27 % u odraslih i AST 35 % naspram 26 % u odraslih) bile su češće u pedijatrijskih bolesnika nego u odraslih.
English: The half-life of larotrectinib in plasma of cancer patients given 100 mg twice daily of VITRAKVI was approximately 3 hours.
Croatian: Poluvijek larotrektiniba u plazmi bolesnika s tumorima koji su primali 100 mg lijeka VITRAKVI dvaput na dan iznosio je približno 3 sata.
English: 70% white and 53% male; and ECOG PS 0-1 (89%), or 2 (11%).
Croatian: ≥ 18 godina; 70 % bijelci i 53 % muškarci; te ECOG PS 0-1 (89 %) ili 2 (11 %).
English: In cancer patients given VITRAKVI capsules, peak plasma levels (Cmax) of larotrectinib were achieved at approximately 1 hour after dosing.
Croatian: U bolesnika s karcinomom koji su uzimali VITRAKVI u kapsulama, larotrektinib je postigao vršne koncentracije u plazmi (Cmax) približno 1 sat nakon doziranja.
English: Growth and nervous system effects were seen at 0.5- to 4-times the AUC at the recommended dose.
Croatian: Utjecaj na rast i živčani sustav uočeni su pri razinama AUC-a koje su iznosile 0,5 do 4 puta AUC pri preporučenoj dozi.
English: At the recommended dose of 100 mg taken twice daily, steady-state arithmetic mean (± standard deviation) Cmax and daily AUC in adults were 914 ± 445 ng/mL and 5410 ± 3813 ng*h/mL, respectively.
Croatian: Pri preporučenoj dozi od 100 mg uzimanoj dvaput na dan, aritmetička srednja vrijednost (± standardna devijacija) Cmax u stanju dinamičke ravnoteže i svakodnevni AUC u odraslih iznosili su 914 ± 445 ng/ml odnosno 5410 ± 3813 ng*h/ml.
English: The outer diameter of the nasogastric feeding tube should be selected based on the patient characteristics.
Croatian: Vanjski promjer nazogastrične sonde treba izabrati u skladu sa značajkama bolesnika.
English: These resultant novel chimeric oncogenic proteins are aberrantly expressed, driving constitutive kinase activity subsequently activating downstream cell signalling pathways involved in cell proliferation and survival leading to TRK fusion-positive cancer.
Croatian: Tako nastali novi kimerički onkogeni proteini izražavaju se na aberantan način, potičući konstitutivnu aktivnost kinaze i posljedično aktivirajući nizvodne stanične signalne puteve uključene u staničnu proliferaciju i preživljenje, što dovodi do nastanka tumora pozitivnog na fuzijski gen TRK.
English: Ninety-seven percent of patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Croatian: Devedeset sedam posto bolesnika prethodno je primalo terapiju za liječenje karcinoma, definiranu kao kirurški zahvat, radioterapija ili sistemska terapija.
English: In addition, 9 patients with primary CNS tumours and measurable disease at baseline were treated in Study 2 (“NAVIGATE”) and in Study 3 (“SCOUT”).
Croatian: Nadalje, 9 bolesnika s primarnim tumorima SŽS-a i mjerljivom bolešću na početku ispitivanja liječeno je u ispitivanju 2 („NAVIGATE“) i ispitivanju 3 („SCOUT“).
English: Grade 4 was the highest reported grade for adverse reactions neutrophil count decreased (1.6%) and ALT increased (< 1%).
Croatian: Najviši prijavljeni stupanj nuspojava bio je 4. stupanj sniženja broja neutrofila (1,6 %) i povišenja ALT-a (< 1 %).
English: Tumour responses were assessed by the investigator using RANO or RECIST v1.1 criteria.
Croatian: Odgovor tumora procijenio je ispitivač prema kriterijima RANO ili RECIST v1.1.
English: There is limited experience of overdose with VITRAKVI.
Croatian: Iskustva s predoziranjem lijekom VITRAKVI su ograničena.
English: In order to further confirm the histology-independent efficacy of larotrectinib and to investigate the primary and secondary resistance mechanisms, the MAH should submit a pooled analysis for the increased sample size including the final report of study LOXO-TRK-15002 (NAVIGATE).
Croatian: Kako bi se dodatno potvrdila djelotvornost neovisna o histologiji te kako bi se ispitali primarni i sekundarni mehanizmi rezistencije, nositelj odobrenja dužan je dostaviti analizu objedinjenog skupa podataka za povećani uzorak uključujući završno izvješće ispitivanja LOXO-TRK-15002 (NAVIGATE).
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Bayer SA-NV
English: - VITRAKVI can be taken with or without food.
Croatian: Kako uzimati ovaj lijek - VITRAKVI se može uzimati s hranom ili bez nje.
English: Identification of NTRK gene fusions relied upon the molecular test methods: next generation sequencing (NGS) used in 98 patients, reverse transcription-polymerase chain reaction (RT-PCR) used in 1 patient and fluorescence in situ hybridization (FISH) used in 6 patients as routinely performed at certified laboratories.
Croatian: Identifikacija fuzijskih gena NTRK oslanjala se na molekularne metode sekvenciranja sljedeće generacije (engl. next generation sequencing, NGS) primijenjene u 98 bolesnika, reverzno transkripcijsku-lančanu reakciju polimerazom (engl. reverse transcription-polymerase chain reaction, RT-PCR) primijenjenu u 1 bolesnika i fluorescentnu in situ hibridizaciju (FISH) primijenjenu u 6 bolesnika, a koje se rutinski provode u certificiranim laboratorijima.
English: Common Blood alkaline phosphatase increased a Infant/toddlers (28 days to 23 months): one Grade 4 Neutrophil count decreased (Neutropenia) reaction reported.
Croatian: povišena alkalna fosfataza u krvi često povišena alkalna fosfataza u krvi a Dojenčad/mala djeca (28 dana do 23 mjeseca): prijavljena je jedna reakcija 4. stupnja: smanjen broj neutrofila
English: Push the plunger fully into the syringe and then put the syringe in the adapter opening.
Croatian: Potisnite klip u štrcaljku do kraja i zatim stavite štrcaljku u otvor adaptera.
English: Pre-weaning mortality (before PND 21) was observed at the high dose level corresponding to 2.5- to 4-times the AUC at the recommended dose.
Croatian: Smrtnost prije odbića (prije 21. dana od okota) uočena je pri visokim dozama koje odgovaraju AUC-u 2,5 do 4 puta većem od onoga pri preporučenoj dozi.
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with VITRAKVI.
Croatian: Žene reproduktivne dobi moraju se testirati na trudnoću prije početka liječenja lijekom VITRAKVI.
English: The majority of adverse reactions leading to dose reduction occurred in the first three months of treatment.
Croatian: Većina nuspojava koje su dovele do sniženja doze nastala je u prva tri mjeseca liječenja.
English: In the overall safety database (n=125), the maximum grade transaminase elevation observed was Grade 4 ALT increase in 1 patient (<1%).
Croatian: U bazi podataka o cjelokupnoj populaciji u ispitivanju sigurnosti primjene (n=125), najviši stupanj opaženog povišenja transaminaza bio je 4. stupanj povišenja ALT-a u jednog bolesnika (< 1 %).
English: Efficacy across tumour types
Croatian: Djelotvornost u tumorskim vrstama
English: Effect of larotrectinib on other transporter substrates In vitro studies indicate that larotrectinib is an inhibitor of OATP1B1.
Croatian: Učinak larotrektiniba na supstrate drugih prijenosnika Ispitivanja in vitro pokazuju da je larotrektinib inhibitor OATP1B1.
English: All primary CNS tumour patients had received prior cancer treatment (surgery, radiotherapy and/or previous systemic therapy).
Croatian: Svi bolesnici s primarnim tumorom SŽS-a prethodno su liječeni od karcinoma (kirurškim zahvatom, radioterapijom i/ili prethodnom sistemskom terapijom).
English: The other ingredients are: - Purified water - Sucrose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Sodium citrate (E 331) - Sodium dihydrogen phosphate dihydrate (E 339) - Citric acid (E 330) - Propylene glycol (E 1520) - Potassium sorbate (E 202) - Methyl parahydroxybenzoate (E 218) - Citrus fruit flavour - Natural flavour
Croatian: Drugi sastojci su: - pročišćena voda - saharoza - hidroksipropilbetadeks - glicerol (E 422) - sorbitol (E 420) - natrijev citrat (E 331) - natrijev dihidrogenfosfat dihidrat (E 339) - citratna kiselina (E 330) - propilenglikol (E 1520) - kalijev sorbat (E 202) - metilparahidroksibenzoat (E 218) - aroma citrusa - prirodni okus
English: Sodium: this medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially ‘sodium-free'.
Croatian: Natrij: ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 5 ml, tj. zanemarive količine natrija.
English: In vitro studies indicate that larotrectinib induces CYP2B6.
Croatian: In vitro ispitivanja pokazuju da larotrektinib inducira CYP2B6.
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.
Croatian: In vitro ispitivanja pokazuju da je u tekućem volumenu relevantnom za gastrointestinalni trakt larotrektinib potpuno topljiv u cijelom rasponu pH u gastrointestinalnom traktu.
English: An increase in larotrectinib Cmax and AUC0-inf, of 1.25 and 1.46-fold respectively was observed in renally impaired subjects versus those with normal renal function.
Croatian: Povećanje Cmax larotrektiniba od 1,25 puta i AUC0-inf od 1,46 puta bilo je opaženo u ispitanika s oštećenjem funkcije bubrega naspram onih s normalnom funkcijom bubrega.
English: The safety population characteristics were comprised of patients with a median age of 45 years (range: 0.1, 80) with 30% of patients being paediatric patients.
Croatian: Populacija u ispitivanju sigurnosti primjene sastojala se od bolesnika čiji je medijan dobi iznosio 45 godina (raspon: od 0,1 do 80), s time da su pedijatrijski bolesnici činili 30 % populacije.
English: Elderly No dose adjustment is recommended in elderly patients (see section 5.2).
Croatian: Ne preporučuje se prilagodba doze u starijih bolesnika (vidjeti dio 5.2).
English: Avoid co-administration of strong or moderate CYP3A4/P-gp inducers with VITRAKVI due to a risk of decreased exposure (see section 4.5).
Croatian: Izbjegavajte istodobnu primjenu jakih ili umjerenih induktora CYP3A4/P-gp-a s lijekom VITRAKVI zbog rizika od smanjene izloženosti (vidjeti dio 4.5).
English: Dizziness and fatigue have been reported in patients receiving larotrectinib, mostly Grade 1 and 2 during the first 3 months of treatment.
Croatian: U bolesnika koji primaju larotrektinib prijavljeni su omaglica i umor, uglavnom 1. i 2. stupnja, tijekom prva 3 mjeseca liječenja.
English: Each carton contains one bottle of 100 mL oral solution.
Croatian: Svaka kutija sadrži jednu bocu sa 100 ml oralne otopine.
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%).
Croatian: Najčešće zastupljene vrste tumora bile su sarkom mekog tkiva (23 %), tumor slinovnice (18 %), infantilni fibrosarkom (14 %), karcinom štitne žlijezde (11 %), karcinom pluća i melanom (8 % za svaki) te karcinom debelog crijeva (6 %).
English: The measured impact of any concomitant genomic alterations on larotrectinib efficacy is provided below (see clinical efficacy).
Croatian: U nastavku je naveden izmjereni utjecaj bilo kojih popratnih genomskih promjena na djelotvornost larotrektiniba (vidjeti kliničku djelotvornost).
English: In vitro studies indicate that larotrectinib is not a substrate for either OATP1B1 or OATP1B3.
Croatian: In-vitro ispitivanja pokazala su da larotrektinib nije supstrat za OATP1B1 ili OATP1B3.
English: Congenital mesoblastic nephromaa
Croatian: Kongenitalni mezoblastični nefroma
English: A shortening of QTcF was observed with VITRAKVI dosing, with a maximum mean effect observed between 3 and 24 hours after Cmax, with a geometric mean decrease in QTcF from baseline of -13.2 msec (range -10 to -15.6 msec).
Croatian: Uz primjenu lijeka VITRAKVI uočeno je skraćenje QTcF s najjačim prosječnim utjecajem uočenim između 3 i 24 sata nakon postizanja Cmax s geometrijskom srednjom vrijednošću skraćenja QTcF od -13,2 ms (raspon -10 do -15,6 ms) od početne vrijednosti.
English: How to take VITRAKVI
Croatian: Kako uzimati VITRAKVI
English: No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) (see section 5.2).
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh A) (vidjeti dio 5.2).