FrancophonIA/ELRC3.0 huggingface dataset:
English: Of 125 patients in the overall safety population who received VITRAKVI, 28 (22%) patients were 65 years or older and 8 (6%) patients were 75 years or older.
Slovenian: Od 125 bolnikov v celotni varnostni populaciji, ki so prejemali zdravilo VITRAKVI, je bilo 28 (22 %) bolnikov starih 65 let ali več in 8 (6 %) bolnikov starih 75 let ali več.
English: Oral syringe - Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable.
Slovenian: - Uporabite primerno peroralno brizgo z oznako CE in nastavek za steklenico (premera 28 mm), če je potrebno.
English: b Investigator assessment using either RANO or RECIST v1.1 criteria for primary CNS tumours (9 patients).
Slovenian: b Ocena raziskovalca z uporabo kriterijev RANO ali RECIST v1.1 za primarne tumorje osrednjega živčevja (9 bolnikov).
English: Contraception in female and male
Slovenian: Kontracepcija pri ženskah in moških
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”).
Slovenian: Poleg tega je bilo 9 bolnikov s primarnimi tumorji osrednjega živčevja in merljivo boleznijo na izhodišču, zdravljenih v študiji 2 (»NAVIGATE«) in študiji 3 (»SCOUT«).
English: If you take more VITRAKVI than you should
Slovenian: Če ste vzeli večji odmerek zdravila VITRAKVI, kot bi smeli
English: Table 6: Overall response rate and duration of response by tumour type Tumour type
Slovenian: Preglednica 6: Celokupni delež in trajanje odziva glede na vrsto tumorja Vrsta tumorja
English: First
Slovenian: prva
English: If you stop taking VITRAKVI
Slovenian: Če ste prenehali jemati zdravilo VITRAKVI
English: In all cases, patients with evidence of anti-tumour activity who required a dose reduction were able to continue dosing at a reduced dose and/or schedule (see section 4.4).
Slovenian: Bolniki z dokazanim protitumorskim delovanjem, pri katerih je bilo potrebno znižanje odmerka, so v vseh primerih lahko nadaljevali zdravljenje z jemanjem zmanjšanega odmerka in/ali po prilagojenem režimu zdravljenja (glejte poglavje 4.4).
English: In vitro studies indicate that larotrectinib is not a substrate for either OATP1B1 or OATP1B3.
Slovenian: Študije in vitro kažejo, da larotrektinib ni substrat za OATP1B1 niti za OATP1B3.
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.
Slovenian: Pri 75 % bolnikih je odziv še trajal; po ocenah je 88 % odzivov trajalo 6 mesecev ali dlje in 75 % odzivov 12 mesecev ali dlje.
English: In rats, larotrectinib accelerated intestinal transit and increased gastric secretion and acidity.
Slovenian: Pri podganah je larotrektinib pospešil pasažo skozi črevesje in povečal sekrecijo in kislost v želodcu.
English: • Phase 2 multinational, open label, tumour “basket” study
Slovenian: • mednarodna, odprta študija faze 2, tipa »košarica« pri tumorjih
English: Put the oral syringe in the adapter opening.
Slovenian: Peroralno brizgo vstavite v odprtino nastavka.
English: It is unknown whether larotrectinib/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se larotrektinib/presnovki izločajo v materino mleko.
English: If you have any questions on how VITRAKVI works or why it has been prescribed for you, ask your doctor, pharmacist or nurse.
Slovenian: Če imate vprašanja glede delovanja zdravila VITRAKVI ali zakaj vam je bilo predpisano, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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%).
Slovenian: V celotni podatkovni zbirki o varnosti (n = 125) je bila najvišja stopnja nevroloških učinkov, ki so jih opazili, 3. stopnja; opazili so jo pri treh (2 %) bolnikih, in je vključevala vrtoglavico (en bolnik; < 1 %) in parestezijo (2 bolnika, 1,6 %).
English: - less than 1 mmol (or 23 mg) of sodium per 5 mL, that is to say essentially ‘sodium free'.
Slovenian: - manj kot 1 mmol (ali 23 mg) natrija na 5 ml, kar v bistvu pomeni »brez natrija«.
English: Effect of larotrectinib on CYP3A substrates
Slovenian: Učinek larotrektiniba na substrate CYP3A
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.
Slovenian: Ob jemanju priporočenega odmerka 100 mg dvakrat na dan sta bili aritmetična srednja vrednost stanja dinamičnega ravnovesja (± standardni odklon) Cmax in dnevna vrednost AUC pri odraslih 914 ± 445 ng/ml oziroma 5410 ± 3813 ng*h/ml.
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.
Slovenian: Neželeni učinki bruhanje (35 % v primerjavi s 14 % pri odraslih), zmanjšano število levkocitov (22 % v primerjavi z 9 % pri odraslih), zmanjšano število nevtrofilcev (35 % v primerjavi s 7 % pri odraslih), zvišane vrednosti alkalne fosfataze v krvi (14 % v primerjavi z 2 % pri odraslih) in zvišane vrednosti transaminaz (41 % v primerjavi z 27 % pri odraslih za ALT in 35 % v primerjavi z 26 % pri odraslih za AST) so bili pogostejši pri pediatričnih bolnikih kot pri odraslih.
English: NOVAGEM Limited
Slovenian: Bayer Limited
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.
Slovenian: mikrooznačevalca v urinu izločilo 29 % zdravila , kar kaže, da je neposredno izločanje skozi ledvice predstavljalo 29 % skupnega očistka.
English: Effect of larotrectinib on substrates of PXR regulated enzymes In vitro studies indicate that larotrectinib may induce PXR regulated enzymes (e.g. CYP2C family and UGT).
Slovenian: Učinek larotrektiniba na substrate encimov reguliranih s PXR Študije in vitro kažejo, da larotrektinib lahko inducira encime regulirane s PXR (npr. družino CYP2C
English: • Adult patients (≥ 18 years) with advanced solid tumours with an NTRK gene fusion
Slovenian: • odrasli bolniki (≥ 18 let) z napredovalimi solidnimi tumorji s fuzijo genov NTRK
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.
Slovenian: Na podlagi farmakokinetičnih analiz populacije, izpostavljenost (Cmax in AUC) pri pediatričnih bolnikih (starih od 1 meseca do < 3 mesecev) pri priporočenem odmerku 100 mg/m2 z največ 100 mg dvakrat na dan je bila 3-krat večja kot pri odraslih (starih 18 let ali več), ki so jim dajali odmerek 100 mg dvakrat na dan.
English: Permanent discontinuation of VITRAKVI for treatment emergent adverse reactions, regardless of attribution occurred in 3% of patients (one case each of ALT increase, AST increase, intestinal perforation, jaundice, small intestinal obstruction).
Slovenian: Do trajne ukinitve zdravljenja z zdravilom VITRAKVI zaradi neželenih učinkov, ki so se pojavili med zdravljenjem in so jih pripisali preskušanemu zdravilu, je prišlo pri 3 % bolnikov (po en primer zaradi zvišanja vrednosti ALT, zvišanja vrednosti AST, perforacije v črevesju, zlatenice, majhne obstrukcije v črevesju).
English: As a precautionary measure, it is preferable to avoid the use of VITRAKVI during pregnancy.
Slovenian: Iz previdnosti se je med nosečnostjo uporabi zdravila VITRAKVI bolje izogibati.
English: Adolescents (n=8)c
Slovenian: (n = 8)c
English: Of these, 77% had received prior systemic therapy with a median of 1 prior systemic treatment regimen.
Slovenian: Predhodno sistemsko zdravljenje je prejelo 77 % od teh bolnikov, z mediano 1 predhodnega režima sistemskega zdravljenja.
English: The recommended dose modifications for VITRAKVI for adverse reactions are provided in Table 1.
Slovenian: Priporočene spremembe odmerka zdravila VITRAKVI pri pojavu neželenih učinkov so navedene v Preglednici 1.
English: Gastrointestinal stromal tumoura Bone sarcomaa Cholangiocarcinomaa
Slovenian: gastrointestinalni stromalni tumora kostni sarkoma holangiokarcinoma
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: - saharozo: če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs.
Slovenian: Priporočeni odmerek zdravila pri pediatričnih bolnikih je 100 mg/m2 larotrektiniba dvakrat na dan, z največ 100 mg na odmerek, dokler ne pride do napredovanja bolezni ali dokler se ne pojavi nesprejemljiva toksičnost.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antineoplastic agents, protein kinase inhibitors, ATC code: L01XE53.
Slovenian: Farmakoterapevtska skupina: antineoplastična sredstva in imunomodulatorji, antineoplastična sredstva, zaviralci proteinskih kinaz; oznaka ATC: L01XE53
English: Adult and paediatric patients with body surface area of at least 1.0 m2
Slovenian: Sprememba odmerka Odrasli in pediatrični bolniki s telesno površino najmanj 1,0 m2
English: The safety of VITRAKVI was evaluated in 125 patients with TRK fusion-positive cancer in one of three clinical trials, Studies 1, 2 (“NAVIGATE”), and 3 (“SCOUT”).
Slovenian: Povzetek varnostnega profila Varnost zdravila VITRAKVI je bila ocenjena pri 125 bolnikih z rakom z dokazano fuzijo TRK v enem od treh kliničnih preskušanj, tj. v študiji 1, 2 (»NAVIGATE«) in 3 (»SCOUT«).
English: The safety profile in the paediatric population (< 18 years) was consistent in types of reported adverse reactions to those observed in the adult population.
Slovenian: Varnostni profil pri pediatrični populaciji (< 18 let) glede neželenih učinkov, o katerih so poročali, je bil skladen s tistimi, ki so jih opazili pri odrasli populaciji.
English: The ORR in the total population may not reflect the expected response in a specific tumour type.
Slovenian: Rezultati za celotno populacijo se lahko razlikujejo od opaženega odziva pri posameznih vrstah tumorjev.
English: Do not breast-feed while taking this medicine and for 3 days after the last dose.
Slovenian: Med jemanjem tega zdravila in še 3 dni po zadnjem odmerku ne dojite.
English: The majority of adverse reactions leading to dose reduction occurred in the first three months of treatment.
Slovenian: Večina neželenih učinkov, zaradi katerih je bilo potrebno zmanjšanje odmerka, se je pojavila v prvih treh mesecih zdravljenja.
English: Co-administration of larotrectinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may decrease their exposure.
Slovenian: Sočasna uporaba larotrektiniba s substrati CYP2B6 (npr. bupropion, efavirenz) lahko zmanjša njihovo izpostavljenost.
English: - Take the oral syringe and ensure that the plunger is fully depressed.
Slovenian: - Vzemite peroralno brizgo in zagotovite, da je bat do konca stisnjen.
English: Gender did not appear to influence larotrectinib pharmacokinetics to a clinically significant extent.
Slovenian: Ne kaže, da bi spol klinično pomembno vplival na farmakokinetiko larotrektiniba.
English: Withhold or permanently discontinue VITRAKVI based on the severity.
Slovenian: Prenehanje ali trajna ukinitev zdravljenja z zdravilom VITRAKVI je odvisna od resnosti stanja.
English: In rats, severe toxicity (STD10) was observed at doses corresponding to 1- to 2-times the human AUC at the recommended clinical dose.
Slovenian: Pri podganah so opazili hudo toksičnost (STD10) pri odmerkih, ki ustrezajo 1- do 2-kratniku AUC pri ljudeh po priporočenem kliničnem odmerku.
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.
Slovenian: Novo nastali himerni onkogeni proteini se aberantno izražajo, kar povzroči spodbujanje konstitutivne aktivnosti kinaze in posledično aktivacijo vzdolž celičnih signalnih poti, ki sodelujejo pri celični proliferaciji in preživetju, in s tem privedejo do raka z dokazano fuzijo TRK.
English: Mixing with the feeding formulas could lead to tube blockages.
Slovenian: Mešanice s formulami za hranjenje lahko zamašijo sondo.
English: There is limited experience of overdose with VITRAKVI.
Slovenian: Izkušnje s prevelikim odmerjanjem zdravila VITRAKVI so omejene.
English: In vitro studies indicate that larotrectinib induces CYP2B6.
Slovenian: Študije in vitro kažejo, da larotrektinib inducira CYP2B6.
English: If necessary, VITRAKVI may be administered via a nasogastric feeding tube.
Slovenian: Če je potrebno, se zdravilo VITRAKVI lahko daje skozi nazogastrično ali gastrično sondo za hranjenje.
English: In vitro studies indicate that larotrectinib does not inhibit the transporters BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 and MATE2-K at clinically relevant concentrations and is unlikely to affect clearance of substrates of these transporters.
Slovenian: Študije in vitro kažejo, da larotrektinib ne zavira prenašalcev BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 in MATE2-K v klinično pomembnih koncentracijah in ni verjetno, da bi vplival na očistek substratov teh prenašalcev.
English: Each carton contains one bottle of 56 hard capsules.
Slovenian: Vsaka škatla vsebuje eno plastenko s 56 trdimi kapsulami.
English: At the recommended dose, the Cmax in paediatric patients (≥3 months to <12 years of age) was higher than in adults, but the AUC was similar to that in adults.
Slovenian: Vrednost Cmax pri pediatričnih bolnikih (starih > 3 mesece do < 12 let) pri priporočenem odmerku je bila višja kot pri odraslih, medtem ko je bila vrednost AUC podobna kot pri odraslih.
English: Table 1: Recommended dose modifications for VITRAKVI for adverse reactions Dose modification
Slovenian: Preglednica 1: Priporočene spremembe odmerka zdravila VITRAKVI pri pojavu neželenih učinkov
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).
Slovenian: so opazili skrajšanje intervala QTcF, pri čemer so največji povprečni učinek opazili od 3 do 24 ur po Cmax, z geometričnim povprečnim zmanjšanjem QTcF od izhodišča za -13,2 msec (razpon od -10 do15,6 msec).
English: This being a conditional marketing authorisation and pursuant to Article 14a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
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.
Slovenian: V 1-mesečni študiji ponavljajočih odmerkov pri podganah so opazili manj rumenih telesc, večjo incidenco anestrusa in zmanjšano težo maternice z atrofijo maternice; vsi učinki so bili reverzibilni.
English: If the patient vomits after taking a dose, the patient should not take an additional dose to make up for vomiting.
Slovenian: Če bolnik po zaužitem odmerku bruha, naj ne vzame dodatnega odmerka, da bi nadomestil izbruhani odmerek.
English: DOR: duration of response
Slovenian: Trajanje odziva
English: Neurologic reactions
Slovenian: Nevrološki učinki
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).
Slovenian: Ženske v rodni dobi morajo med jemanjem zdravila VITRAKVI in najmanj en mesec po zaključenem zdravljenju uporabljati visoko učinkovito kontracepcijsko metodo (glejte poglavji 4.5 in 4.6).
English: In healthy adult subjects, the AUC of larotrectinib in the oral solution formulation was similar to the capsule, with Cmax 36% higher with the oral solution formulation.
Slovenian: Pri zdravih odraslih osebah je bila AUC larotrektiniba v peroralni raztopini podobna kot pri kapsuli, vendar z vrednostjo Cmax , ki je bila 36 % višja pri zdravilu v obliki peroralne raztopine.
English: - Close the bottle with the original bottle cap (leaving the adapter in place).
Slovenian: - Steklenico zaprite z originalno zaporko steklenico (nastavek naj ostane v njej).
English: Slowly press the plunger in.
Slovenian: Počasi pritisnite na bat.
English: There are no clinical data on the effect of larotrectinib on fertility.
Slovenian: Kliničnih podatkov o učinku larotrektiniba na plodnost ni.
English: There was a median of 1 prior systemic treatment regimen received.
Slovenian: Mediana predhodnega režima sistemskega zdravljenja je bila 1.
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.
Slovenian: Larotrektinib ni imel neželenih učinkov na hemodinamske parametre in intervale EKG pri telemetriranih opicah pri izpostavljenostih koncentracijam zdravila (Cmax), ki so približno 6-kratnik terapevtske izpostavljenosti pri ljudeh.
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.
Slovenian: Korist zdravljenja z zdravilom VITRAKVI je bila ugotovljena pri preskušanjih z enim krakom, v katerih je bil vključen sorazmerno majhen vzorec bolnikov s tumorji s prisotno fuzijo gena NTRK.
English: In vitro studies indicate that larotrectinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations and is unlikely to affect clearance of substrates of these CYPs.
Slovenian: Študije in vitro kažejo, da larotrektinib ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6 v klinično pomembnih koncentracijah in ni verjetno, da bi vplival na očistek substratov teh CYP.
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
Slovenian: • mednarodna, odprta študija faze 1/2, s stopnjevanjem odmerka in podaljšanjem študije; v kohorti, vključeni v podaljšanje študije faze 2, so bili bolniki z napredovalimi solidnimi tumorji z dokazano fuzijo genov NTRK, vključno z lokalno napredovalim infantilnim fibrosarkomom
English: Women of childbearing potential / Contraception in males and females
Slovenian: Ženske v rodni dobi / kontracepcija pri moških in ženskah
English: Table 2: Adverse drug reactions reported in TRK fusion-positive cancer patients treated with VITRAKVI at recommended dose (n=125)
Slovenian: Preglednica 2: Neželeni učinki zdravila, o katerih so poročali pri bolnikih z rakom z dokazano fuzijo TRK zdravljenimi z zdravilom VITRAKVI v priporočenih odmerkih (n = 125)
English: a Grade 4 reactions were reported
Slovenian: a poročali so o učinkih 4. stopnje
English: Bayer AG 51368 Leverkusen Germany
Slovenian: 51368 Leverkusen Nemčija
English: Grade 1.
Slovenian: - 4. stopnje.
English: - VITRAKVI should be permanently discontinued if an adverse reaction does not resolve within
Slovenian: - Uporabo zdravila VITRAKVI je treba trajno ukiniti, če neželeni učinek ne izzveni v 4 tednih.
English: The most common adverse drug reactions (≥ 20%) of VITRAKVI in order of decreasing frequency were fatigue (32%), increased ALT (31%), dizziness (30%), increased AST (29%), constipation (29%), nausea (26%), anaemia (24%), and vomiting (20%).
Slovenian: Najpogostejši neželeni učinki zdravila VITRAKVI (≥ 20 %) po padajoči pogostnosti so bili: utrujenost (32 %), zvišana vrednost ALT (31 %), vrtoglavica (30 %), zvišana vrednost AST (29 %), obstipacija (29 %), občutek siljenja na bruhanje (26 %), anemija (24 %) in bruhanje (20 %).
English: Table 4: Clinical studies contributing to the efficacy analyses in solid and primary CNS tumours Study name, design and patient population
Slovenian: Preglednica 4: Klinične študije, vključene v analizo učinkovitosti pri solidnih in primarnih tumorjih osrednjega živčevja
English: Effects of larotrectinib on other agents
Slovenian: Učinki larotrektiniba na druga sredstva
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).
Slovenian: Sočasno dajanje zdravila VITRAKVI z močnimi zaviralci CYP3A, P-gp in zaviralci BCRP (npr. atazanavir, klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol ali grenivka) lahko poveča koncentracije larotrektiniba v plazmi (glejte poglavje 4.2).
English: If withheld, the VITRAKVI dose should be modified when resumed (see section 4.2).
Slovenian: Če se z zdravljenjem preneha, je treba odmerek zdravila VITRAKVI pri nadaljevanju zdravljenja prilagoditi (glejte poglavje 4.2).
English: Common Blood alkaline phosphatase increased a Infant/toddlers (28 days to 23 months): one Grade 4 Neutrophil count decreased (Neutropenia) reaction reported.
Slovenian: zvišane vrednosti alkalne fosfataze v krvi pogosti zvišane vrednosti alkalne fosfataze v krvi a Dojenčki/majhni otroci (stari od 28 dni do 23 mesecev): poročali so o enem primeru zmanjšanja števila nevtrofilcev (neutropenija) 4. stopnje.
English: NR: not reached + denotes ongoing a Independent review committee analysis by RECIST v1.1 for solid tumours except primary CNS tumours (93 patients).
Slovenian: NR: ni doseženo (not reached) + v času analize opazovanje še ni zaključeno a Analiza neodvisnega odbora za pregled z uporabo kriterijev RECIST v1.1 za solidne tumorje, z izjemo primarnih tumorjev osrednjega živčevja (93 bolnikov).
English: In 85 patients with wide molecular characterisation before larotrectinib treatment, the ORR in 48 patients who had other genomic alterations in addition to NTRK gene fusion was 58%, and in 37 patients without other genomic alterations ORR was 84%.
Slovenian: Pri 85 bolnikih s široko molekularno karakterizacijo pred zdravljenjem z larotrektinibom, je bil celokupni delež odziva pri 48 bolnikih, ki so imeli poleg fuzije gena NTRK tudi genomske spremembe 58 %.
English: Bayer HealthCare Tél (N° vert): +33-(0)800 87 54 54
Slovenian: Tél (N° vert): +33-(0)800 87 54 54
English: • Adult and paediatric patients ≥ 12 years with advanced solid tumours with an NTRK gene fusion
Slovenian: • odrasli in pediatrični bolniki, stari ≥ 12 let, z napredovalimi solidnimi tumorji s fuzijo genov NTRK
English: Effect of larotrectinib on other transporter substrates In vitro studies indicate that larotrectinib is an inhibitor of OATP1B1.
Slovenian: Učinek larotrektiniba na substrate drugih prenašalcev Študije in vitro kažejo, da je larotrektinib zaviralec OATP1B1.