FrancophonIA/ELRC3.0 huggingface dataset:
English: < 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).
Croatian: ≥ 18 godina, 8 bolesnika bili su bijelci, 5 bolesnika bili su muškog spola, a ECOG status bio je 0-1 (8 bolesnika) ili 2 (1 bolesnik).
English: • Phase 1, open-label, dose escalation and expansion study; expansion phase required tumours with an NTRK gene fusion
Croatian: • otvoreno ispitivanje faze 1 povišenja doze s proširenjem; faza proširenja zahtijevala je tumore s fuzijskim genom NTRK
English: Co-administration of VITRAKVI with strong CYP3A inhibitors, P-gp and BCRP inhibitors (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole or grapefruit) may increase larotrectinib plasma concentrations (see section 4.2).
Croatian: Istodobna primjena lijeka VITRAKVI s jakim inhibitorima CYP3A, P-gp-a i BCRP-a (npr. atazanavirom, klaritromicinom, indinavirom, itrakonazolom, ketokonazolom, nefazodonom, nelfinavirom, ritonavirom, sakvinavirom, telitromicinom, troleandomicinom, vorikonazolom ili grejpom) može povećati koncentracije larotrektiniba u plazmi (vidjeti dio 4.2).
English: First
Croatian: Prva
English: - VITRAKVI 25 mg is supplied as white opaque hard gelatine capsule, (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on the body of the capsule - VITRAKVI 100 mg is supplied as white opaque hard gelatine capsule, (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on the body of the capsule
Croatian: Kako VITRAKVI izgleda i sadržaj pakiranja - VITRAKVI 25 mg isporučuje se kao bijela neprozirna tvrda želatinozna kapsula (18 mm dugačka x 6 mm široka), s plavo otisnutim križem „BAYER“ i „LARO 25 mg“ na tijelu kapsule - VITRAKVI 100 mg isporučuje se kao bijela neprozirna tvrda želatinozna kapsula (22 mm dugačka x 7 mm široka), s plavo otisnutim križem „BAYER“ i „LARO 100 mg“ na tijelu kapsule
English: For Grade 3 or 4 adverse reactions: - VITRAKVI should be withheld until the adverse reaction resolves or improves to baseline or
Croatian: Kod nuspojava 3. ili 4. stupnja: - Primjenu lijeka VITRAKVI potrebno je prekinuti do povlačenja nuspojave ili njezina poboljšanja do početnog stanja ili 1. stupnja.
English: Larotrectinib had no neurobehavioural findings in adult animals (rats, mice, cynomolgus monkeys) at exposure (Cmax) at least 7-fold higher than the human exposure.
Croatian: Larotrektinib nije imao neurobihevioralne učinke u odraslih životinja (npr. štakora, miševa, makaki majmuna) pri izloženosti (Cmax) koja je najmanje 7 puta veća od one u ljudi.
English: At the time of data cut-off, 8 of 9 enrolled patients with primary CNS tumours were evaluable for response by investigator assessment.
Croatian: U vrijeme prestanka prikupljanja podataka, ispitivač je mogao procijeniti terapijski odgovor u 8 od 9 uključenih bolesnika s primarnim tumorom SŽS-a.
English: • Adult and paediatric patients ≥ 12 years with advanced solid tumours with an NTRK gene fusion
Croatian: • odrasli i pedijatrijski bolesnici u dobi od ≥ 12 godina s uznapredovalim solidnim tumorima s fuzijskim genom
English: The recommended dose modifications for VITRAKVI for adverse reactions are provided in Table 1.
Croatian: Preporučene prilagodbe doze lijeka VITRAKVI zbog nuspojava prikazane su u tablici 1.
English: Patients with primary CNS tumours
Croatian: Bolesnici s primarnim tumorom SŽS-a
English: Larotrectinib had no adverse effect on haemodynamic parameters and ECG intervals in telemetered monkeys at exposures (Cmax) which are approximately 6-fold the human therapeutic exposures.
Croatian: Larotrektinib nije imao štetan učinak na hemodinamičke parametre i EKG intervale na telemetrijski praćenim majmunima pri izloženosti (Cmax) koja je bila približno 6 puta veća od terapijske izloženosti u ljudi.
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%.
Croatian: Ako je potrebna istodobna primjena s jakim inhibitorom CYP3A4, dozu lijeka VITRAKVI treba sniziti za 50 %.
English: High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer.
Croatian: Boce od polietilena visoke gustoće (HDPE) s polipropilenskim (PP) zatvaračem sigurnim za djecu i termički zapečaćene polietilenskom (PE) folijom.
English: Co-administration of larotrectinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may decrease their exposure.
Croatian: Istodobna primjena larotrektiniba sa supstratima CYP2B6 (npr. bupropionom, efavirenzom) može smanjiti izloženost tim supstratima.
English: No relevant systemic toxicity was observed in monkeys at doses which correspond to > 10-times the human AUC at the recommended clinical dose.
Croatian: Nije opažena značajna sistemska toksičnost na majmunima pri dozama koje odgovaraju onima > 10 puta većima od AUC-a kod ljudi pri preporučenoj kliničkoj dozi.
English: If withheld, the VITRAKVI dose should be modified when resumed (see section 4.2).
Croatian: Ako je prekid bio privremen, kod nastavka primjene potrebno je prilagoditi dozu lijeka VITRAKVI (vidjeti dio 4.2).
English: Neurologic reactions including dizziness, gait disturbance and paraesthesia were reported in patients receiving larotrectinib (see section 4.8).
Croatian: U bolesnika koji primaju larotrektinib bile su prijavljene neurološke reakcije uključujući omaglicu, poremećen hod i paresteziju (vidjeti dio 4.8).
English: 100 mL oral solution
Croatian: 100 ml oralne otopine
English: Bayer AS Tlf: +47 23 13 05 00
Croatian: Tlf: +47 23 13 05 00
English: Frequency Infants and toddlers (n=14)a
Croatian: Učestalost Dojenčad i mala djeca (n=14)a
English: Effect of CYP3A and P-gp inducers on larotrectinib Co-administration of VITRAKVI with strong or moderate CYP3A and P-gp inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's Wort) may decrease larotrectinib plasma concentrations and should be avoided (see section 4.4).
Croatian: Istodobna primjena lijeka VITRAKVI s jakim ili umjerenim induktorima CYP3A i P-gp-a (npr. karbamazepinom, fenobarbitalom, fenitoinom, rifabutinom, rifampicinom ili gospinom travom) može smanjiti koncentracije larotrektiniba u plazmi i treba je izbjegavati (vidjeti dio 4.4).
English: ALT and AST increase were reported in patients receiving larotrectinib (see section 4.8).
Croatian: U bolesnika koji primaju larotrektinib bilo je prijavljeno povišenje ALT-a i AST-a (vidjeti dio 4.8).
English: Press the bottle cap and turn it anti-clockwise to open the bottle.
Croatian: Pritisnite zatvarač boce i zakrenite ga u smjeru suprotnom od kazaljke na satu kako biste otvorili bocu.
English: Turn the bottle the right way up and take the syringe out of the adapter.
Croatian: Okrenite bocu dnom prema dolje i izvadite štrcaljku iz adaptera boce.
English: Titanium dioxide (E 171)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E 171)
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.
Croatian: Ženama reproduktivne dobi potrebno je savjetovati korištenje visoko učinkovite kontracepcije tijekom liječenja lijekom VITRAKVI i još najmanje mjesec dana nakon posljednje doze.
English: b Investigator assessment using either RANO or RECIST v1.1 criteria for primary CNS tumours (9 patients).
Croatian: (93 bolesnika) b Procjena ispitivača prema kriterijima RANO ili RECIST v1.1 za primarne tumore SŽS-a (9 bolesnika)
English: Effects of other agents on larotrectinib
Croatian: Učinci drugih lijekova na larotrektinib
English: For details how to do so, please ask your doctor, pharmacist or nurse.
Croatian: Za podrobnije informacije o tome kako to učiniti, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
Croatian: Za volumene manje od 1 ml koristite štrcaljku za usta od 1 ml graduiranu na 0,1 ml.
English: Third
Croatian: Treća
English: In the paediatric sub-population (n=28), the ORR was 82%.
Croatian: U pedijatrijskoj subpopulaciji (n=28) ORR je bio
English: NSCLC (n=1)c Soft tissue sarcoma (n=1) Thyroid (n=1)
Croatian: NSCLC (n=1)c sarkom mekog tkiva (n=1) štitna žlijezda (n=1)
English: For volumes of 1 mL and higher use a 5 mL oral syringe with 0.2 mL graduation.
Croatian: Za volumene od 1 ml i veće koristite štrcaljku za usta od 5 ml graduiranu na 0,2 ml.
English: Amber glass (type III) bottle with a child-resistant polypropylene (PP) cap with a polyethylene (PE) seal liner.
Croatian: Boca od smeđeg stakla (tipa III) sa polipropilenskim (PP) zatvaračem sigurnim za djecu i termički zapečaćena polietilenskom (PE) folijom.
English: VITRAKVI 20 mg/mL
Croatian: 20 mg/ml)
English: The 200 mg dose corresponds to a peak exposure (Cmax) similar to that observed with larotrectinib 100 mg BID at steady state.
Croatian: Doza od 200 mg odgovara maksimalnoj izloženosti (Cmax) sličnoj onoj uočenoj uz dozu larotrektiniba od 100 mg dva puta dnevno u stanju dinamičke ravnoteže.
English: The majority of ALT and AST increases occurred in the first 3 months of treatment.
Croatian: Povišenje ALT-a i AST-a većinom je nastalo u prva 3 mjeseca liječenja.
English: Clinical data in healthy adult subjects indicate that co-administration of VITRAKVI (100 mg twice daily for 10 days) increased the Cmax and AUC of oral midazolam 1.7-fold compared to midazolam alone, suggesting that larotrectinib is a weak inhibitor of CYP3A.
Croatian: Klinički podaci prikupljeni u zdravih odraslih ispitanika pokazuju da je istodobna primjena lijeka VITRAKVI (100 mg dvaput na dan tijekom 10 dana) povećala Cmax i AUC oralno primijenjenog midazolama 1,7 puta u usporedbi s primjenom samo midazolama, što ukazuje na to da je larotrektinib slabi inhibitor CYP3A.
English: Salivary gland (n=14) Thyroid (n=9)b Soft tissue sarcoma (n=9) Colorectal (n=6) Melanoma (n=6) NSCLC (n=5)b, c Primary CNS (n=4) GIST (n=2)a
Croatian: slinovnica (n=14) štitna žlijezda (n=9)b sarkom mekog tkiva (n=9) kolorektalni (n=6) melanom (n=6) NSCLC (n=5)b,c primarni SŽS-a (n=4) GIST (n=2)a žučni (n=2)
English: White opaque hard gelatine capsule, size 0 (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on body of capsule.
Croatian: Bijele, neprozirne, tvrde želatinozne kapsule, veličine 0 (22 mm dugačke x 7 mm široke), s plavo otisnutim križem „BAYER“ i „LARO 100 mg“ na tijelu kapsule.
English: glioblastoma and astrocytoma) with investigator tumour response assessment a GIST: gastrointestinal stromal tumour b brain metastases observed in one thyroid, one NSCLC, and one SCLC patient c NSCLC: non-small cell lung cancer d SCLC: small cell lung cancer
Croatian: *sastoji se od 93 bolesnika s procijenjenim odgovorom tumora od strane IRC-a i 9 bolesnika s primarnim tumorima SŽS-a (uključujući gliom, glioblastom i astrocitom) s procijenjenim odgovorom tumora od strane ispitivača a GIST: gastrointestinalni stromalni tumor b metastaze u mozgu opažene u jednog bolesnika s tumorom štitne žlijezde, jednog bolesnika s NSCLC-om i jednog bolesnika sa SCLC-om c NSCLC: karcinom ne-malih stanica pluća (engl. non-small cell lung cancer)
English: Transaminase elevations
Croatian: Povišenje transaminaza
English: - For doses of 1 mL and higher a 5 mL oral syringe should be used.
Croatian: - Za doze od 1 ml i veće treba primijeniti štrcaljku za usta od 5 ml.
English: clarithromycin, telithromycin, troleandomycin - a medicine used to treat Cushing's syndrome called ketoconazole - medicines used to treat HIV infection called atazanavir, indinavir, nelfinavir, ritonavir,
Croatian: - lijek koji se primjenjuje za liječenje Cushingovog sindroma, pod nazivom ketokonazol - lijekovi koji se primjenjuju za liječenje HIV-infekcije kao što su atazanavir, indinavir,
English: Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Croatian: Jedna VITRAKVI 100 mg kapsula sadrži 100 mg larotrektiniba (u obliku sulfata).
English: Each VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).
Croatian: Jedna VITRAKVI 25 mg kapsula sadrži 25 mg larotrektiniba (u obliku sulfata).
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.
Croatian: Opaženo je da se AUC0-inf larotrektiniba povećao 1,3 puta u ispitanika s blagim oštećenjem funkcije jetre, 2 puta u bolesnika s umjerenim i 3,2 puta u bolesnika s teškim oštećenjem jetre naspram onih s normalnom funkcijom jetre.
English: Tηλ: +357 22 48 38 58
Croatian: NOVAGEM Limited Tηλ: +357 22 48 38 58
English: Doses up to 200 mg once or twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Croatian: doze do 200 mg jedanput ili dvaput na dan (kapsule od 25 mg, 100 mg ili oralna otopina od 20 mg/ml)
English: White opaque hard gelatine capsule, size 2 (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on body of capsule.
Croatian: Bijele, neprozirne, tvrde želatinozne kapsule, veličine 2 (18 mm dugačke x 6 mm široke), s plavo otisnutim križem „BAYER“ i „LARO 25 mg“ na tijelu kapsule.
English: VITRAKVI is a clear yellow to orange oral solution.
Croatian: Kako VITRAKVI izgleda i sadržaj pakiranja VITRAKVI je bistra žuta do narančasta oralna otopina.
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.
Croatian: Farmakokinetičko ispitivanje bilo je provedeno u ispitanika sa završnim stadijem bubrežne bolesti koji su zahtijevali dijalizu, te u zdravih odraslih kontrolnih ispitanika s normalnom funkcijom bubrega koji su po dobi, indeksu tjelesne mase i spolu odgovarali bolesnicima.
English: Males of reproductive potential with a non-pregnant woman partner of child-bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Croatian: Muškarcima reproduktivne dobi s partnericom reproduktivne dobi koja nije trudna potrebno je savjetovati korištenje visoko učinkovite kontracepcije tijekom liječenja lijekom VITRAKVI i najmanje mjesec dana nakon primjene posljednje doze.
English: Soft tissue sarcoma (n=11) Primary CNS (n=5) Bone sarcoma (n=1) Congenital mesoblastic nephroma (n=1) Melanoma (n=1)
Croatian: sarkom mekog tkiva (n=11) primarni SŽS-a (n=5) sarkom kosti (n=1) kongenitalni mezoblastični nefrom (n=1) melanom (n=1)
English: Withhold or permanently discontinue VITRAKVI based on the severity.
Croatian: Ovisno o tome koliko su vrijednosti povišene, privremeno ili trajno prekinite primjenu lijeka VITRAKVI.
English: 56 capsules
Croatian: OBLIK I SADRŽAJ 56 kapsula
English: Table 2: Adverse drug reactions reported in TRK fusion-positive cancer patients treated with VITRAKVI at recommended dose (n=125)
Croatian: Tablica 2: Nuspojave prijavljene uz lijek VITRAKVI u preporučenoj dozi u bolesnika s tumorom pozitivnim na fuzijski gen TRK (n = 125) Klasifikacija organskih sustava
English: Effects of larotrectinib on other agents
Croatian: Učinci larotrektiniba na druge tvari
English: 100 mg twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Croatian: 100 mg dvaput na dan (kapsule od 25 mg, 100 mg ili oralna otopina od 20 mg/ml)
English: EU/1/19/1385/003 - VITRAKVI 20 mg/mL oral solution
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1385/003 - VITRAKVI 20 mg/ml oralna otopina
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Kapsule progutati cijele.
English: VITRAKVI contains the active substance larotrectinib.
Croatian: VITRAKVI sadrži djelatnu tvar larotrektinib.
English: Each carton contains 1 child-resistant glass bottle containing 100 mL oral solution.
Croatian: Jedna kutija sadrži jednu staklenu bocu sa zatvaračem sigurnim za djecu sa 100 ml oralne otopine.
English: Males of reproductive potential with a non-pregnant woman partner of child bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose (see section 4.6).
Croatian: Muškarcima reproduktivne dobi s partnericom reproduktivne dobi koja nije trudna potrebno je savjetovati korištenje visoko učinkovite kontracepcije tijekom liječenja lijekom VITRAKVI i najmanje mjesec dana nakon primjene posljednje doze (vidjeti dio 4.6).
English: Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI.
Croatian: Uzimanje lijeka VITRAKVI s hranom i pićem Nemojte jesti grejp ili piti sok od grejpa dok uzimate VITRAKVI, zato što Vam to može povećati količinu lijeka VITRAKVI u tijelu.
English: - Take the oral syringe and ensure that the plunger is fully depressed.
Croatian: - Uzmite štrcaljku za usta i provjerite je li klip potisnut do kraja.
English: Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: - Fill the oral syringe with small amount of solution by pulling the plunger down, then push the plunger upwards to remove any bubbles.
Croatian: - Povucite klip prema dolje kako biste napunili štrcaljku za usta malom količinom otopine, a zatim potisnite klip prema gore da uklonite eventualne mjehuriće.
English: VITRAKVI 25 mg hard capsules
Croatian: VITRAKVI 25 mg tvrde kapsule
English: An oral solution of VITRAKVI is available for patients who cannot swallow the capsules.
Croatian: Za bolesnike koji ne mogu progutati kapsule dostupna je oralna otopina lijeka VITRAKVI.
English: - For doses below 1 mL a 1 mL oral syringe should be used.
Croatian: - Za doze manje od 1 ml treba primijeniti štrcaljku za usta od 1 ml.
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).
Croatian: Početne značajke sva 93 bolesnika sa solidnim tumorima s fuzijskim genom NTRK bile su sljedeće: medijan dobi 41 godina (raspon 0,1-78 godina); 30 % u dobi < 18 godina, a 70 % u dobi od ≥ 18 godina; 70 % bijelci i 53 % muškarci; te ECOG PS 0-1 (89 %) ili 2 (11 %).
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).
Croatian: Odmah obavijestite liječnika ako primijetite bilo koju od sljedećih ozbiljnih nuspojava: - omaglica, trnci, utrnulost ili žarenje u šakama i stopalima (vrlo česta nuspojava, može se javiti u više od 1 na 10 osoba), otežan normalan hod (česta nuspojava, može se javiti u najviše 1 na
English: VITRAKVI 100 mg hard capsules
Croatian: VITRAKVI 100 mg tvrde kapsule
English: Median time on treatment was 12.1 months (range: 0.66 to 40.7 months) based on July 2018 cut-off. Fifty-two percent of patients had received VITRAKVI for 12 months or more and 30% had received VITRAKVI 18 months or more, with follow-up ongoing at the time of the analysis.
Croatian: Medijan trajanja liječenja iznosio je 12,1 mjeseci (raspon: od 0,66 do 40,7 mjeseci) na temelju prestanka prikupljanja podataka u srpnju 2018. godine.
English: NR: not reached + denotes ongoing a Independent review committee analysis by RECIST v1.1 for solid tumours except primary CNS tumours (93 patients).
Croatian: + označava da još traje a Analiza neovisnog stručnog povjerenstva prema kriterijima RECIST v1.1 za solidne tumore osim primarnih tumora SŽS-a
English: Therefore, larotrectinib is unlikely to be affected by pH-modifying agents.
Croatian: Stoga nije vjerojatno da će lijekovi koji mijenjaju pH utjecati na larotrektinib.
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with rifampin (a strong CYP3A and P-gp inducer) 600 mg twice daily for 11 days decreased larotrectinib Cmax and AUC by 71% and 81%, respectively.
Croatian: Klinički podaci prikupljeni u zdravih odraslih ispitanika pokazuju da je istodobna primjena jednokratne doze od 100 mg lijeka VITRAKVI s rifampicinom (jakim induktorom CYP3A i P-gp-a) u dozi od 600 mg dvaput na dan tijekom 11 dana smanjila Cmax larotrektiniba za 71 %, a AUC za 81 %.
English: Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).
Croatian: Jedan ml oralne otopine sadrži 20 mg larotrektiniba (u obliku sulfata).
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with a single dose of 600 mg rifampin (a P-gp and BCRP inhibitor) increased larotrectinib Cmax and AUC by 1.8-fold and 1.7-fold, respectively.
Croatian: Klinički podaci prikupljeni u zdravih odraslih ispitanika pokazuju da je istodobna primjena jednokratne doze od 100 mg lijeka VITRAKVI s jednokratnom dozom od 600 mg rifampicina (inhibitora P-gp-a i BCRP-a) povećala Cmax larotrektiniba 1,8 puta, a AUC 1,7 puta.
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with itraconazole (a strong CYP3A inhibitor and P-gp and BCRP inhibitor) 200 mg once daily for 7 days increased larotrectinib Cmax and AUC by 2.8-fold and 4.3-fold, respectively.
Croatian: Klinički podaci prikupljeni u zdravih odraslih ispitanika pokazuju da je istodobna primjena jednokratne doze od 100 mg lijeka VITRAKVI s itrakonazolom (jakim inhibitorom CYP3A i inhibitorom P-gp-a i BCRP-a) u dozi od 200 mg jedanput na dan tijekom 7 dana povećala Cmax larotrektiniba 2,8 puta, a AUC 4,3 puta.
English: 56 hard capsules
Croatian: OBLIK I SADRŽAJ 56 tvrdih kapsula
English: VITRAKVI contains:
Croatian: Što VITRAKVI sadrži
English: • Phase 2 multinational, open label, tumour “basket” study
Croatian: • multinacionalno, otvoreno ispitivanje faze 2 na raznim vrstama tumora
English: Very common Nausea Constipation Vomiting
Croatian: Poremećaji probavnog sustava vrlo često mučnina konstipacija povraćanje često disgeuzija mučnina
English: The starting dose of VITRAKVI should be reduced by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment.
Croatian: U bolesnika s umjerenim (Child-Pugh B) do teškim (Child-Pugh C) oštećenjem funkcije jetre početnu dozu lijeka VITRAKVI potrebno je sniziti za 50 %.
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.
Croatian: Prije početka liječenja lijekom VITRAKVI mora se validiranim testom potvrditi prisutnost fuzijskog gena NTRK u uzorku tumora.
English: Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone
Croatian: titanijev dioksid (E 171) propilenglikol (E 1520)
English: Each capsule contains larotrectinib sulfate, equivalent to 25 mg of larotrectinib.
Croatian: Jedna tvrda kapsula sadrži larotrektinibsulfat, što odgovara 25 mg larotrektiniba.
English: Each capsule contains larotrectinib sulfate, equivalent to 100 mg of larotrectinib.
Croatian: Jedna tvrda kapsula sadrži larotrektinibsulfat, što odgovara 100 mg larotrektiniba.