FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data is available on the effect of a moderate inducer, but a decrease in larotrectinib exposure is expected.
Slovenian: Na voljo ni kliničnih podatkov o vplivu na zmerne induktorje, vendar pa se pričakuje zmanjšanja izpostavljenosti larotrektinibu.
English: Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Slovenian: Zato ni mogoče izključiti, ali sočasna uporaba larotrektiniba s substrati OATP1B1 (npr. valsartan, statini) lahko poveča njihovo izpostavljenost.
English: Propylene glycol: co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Slovenian: Propilenglikol: Sočasno jemanje katerega koli substrata alkohol-dehidrogenaze, kot je etanol, lahko povzroči hude neželene učinke pri novorojenčkih.
English: Do not take a double dose to make up for a forgotten dose or if you vomit after taking this medicine.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek ali če po jemanju tega zdravila bruhate.
English: The patient should be advised to swallow the capsule whole with a glass of water.
Slovenian: Bolniku je treba svetovati, da pogoltne celo kapsulo in hkrati popije kozarec vode.
English: Contraception - for men and women
Slovenian: Kontracepcija - pri moških in ženskah
English: - Your doctor will review your dose and change it as needed.
Slovenian: - Zdravnik bo preveril odmerek in ga po potrebi spremenil.
English: VITRAKVI has a moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo VITRAKVI ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: [range]
Slovenian: [razpon]
English: Of these 37 patients, 38% were 28 days to < 2 years (n=14), 41% were 2 years to < 12 years (n=15), and 22% were 12 years to < 18 years (n=8).
Slovenian: Med temi 37 bolniki jih je bilo 38 % starih od 28 dni do < 2 leti (n = 14), 41 % jih je bilo starih od 2 leti do < 12 let (n = 15) in 22 % jih je bilo starih od 12 let do < 18 let (n = 8).
English: ANNEX IV CONCLUSION ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Patients with Grade 2 ALT and/or AST increases, should be followed with serial laboratory evaluations every one to two weeks after the observation of Grade 2 toxicity until resolved to establish whether a dose interruption or reduction is required.
Slovenian: Bolnike s povečanjem vrednosti ALT in/ali povečanjem vrednosti AST 2. stopnje je treba po ugotovljeni toksičnosti 2. stopnje spremljati z rednimi laboratorijskimi preiskavami vsak teden oziroma vsaka dva tedna, da se ugotovi, ali je potrebna prekinitev zdravljenja ali zmanjšanje odmerka.
English: It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
Slovenian: Ni znano ali larotrektinib lahko zmanjša učinkovitost sistemskih hormonskih kontraceptivov.
English: None of these adverse reactions led to treatment discontinuation.
Slovenian: Pri nobenem od teh neželenih učinkov ni bila potrebna prekinitev zdravljenja.
English: For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised.
Slovenian: Pri vseh neželenih učinkih 2. stopnje se lahko nadaljuje z odmerjanjem, vendar je priporočljivo skrbno spremljanje bolnika, da se prepreči povečanje toksičnosti.
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.
Slovenian: Začetni odmerek zdravila VITRAKVI je treba zmanjšati za 50 % pri bolnikih z zmerno (Child-Pugh B) do hudo (Child-Pugh C) okvaro jeter.
English: Point mutations in the TRKC kinase domain with clinically identified acquired resistance to larotrectinib include G623R, G696A, and F617L.
Slovenian: Točkovne mutacije v domeni kinaze TRKC s klinično ugotovljeno pridobljeno odpornostjo na larotrektinib vključujejo G623R, G696A in F617L.
English: NA: not applicable due to small numbers or lack of response NE: not evaluable
Slovenian: DOR: trajanje odziva NA: ni primerno zaradi majhnega števila ali pomanjkanja odziva
English: The capsules can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Slovenian: Kapsule se smejo vzeti s hrano ali brez nje, vendar se jih ne sme jemati skupaj z grenivko ali sokom grenivke.
English: The adverse drug reactions are classified according to the System Organ Class.
Slovenian: Neželeni učinki zdravila so razvrščeni glede na organski sistem.
English: c Adolescents (12 to <18 years): no Grades 3 and 4 reactions were reported.
Slovenian: c Mladostniki (stari od 12 do manj kot 18 let): niso poročali o učinkih 3. in 4. stopnje.
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.
Slovenian: Okvirno genske fuzije, ki izvirajo iz kromosomske prerazporeditve človeških genov NTRK1, NTRK2 in NTRK3, povzročajo nastanek onkogenih fuzijskih proteinov TRK.
English: The outer diameter of the nasogastric feeding tube should be selected based on the patient characteristics.
Slovenian: Zunanji premer nazogastrične sonde za hranjenje je treba izbrati glede na značilnosti bolnika.
English: Median progression free survival had not been reached at the time of analysis.
Slovenian: V času analize ni bila dosežena mediana preživetja brez napredovanja bolezni.
English: - Your child's doctor will review the dose and change it as needed.
Slovenian: - Pediater vašega otroka bo preveril odmerek in ga po potrebi spremenil.
English: Pooled primary analysis set
Slovenian: Združeni rezultati primarnih analiz
English: Larotrectinib is an adenosine triphosphate (ATP)-competitive and selective tropomyosin receptor kinase (TRK) inhibitor that was rationally designed to avoid activity with off-target kinases.
Slovenian: Larotrektinib je kompetitivni zaviralec adenozin trifosfata (ATP) ter selektivni zaviralec tropomiozin receptorske kinaze (TRK), ki je bil racionalno zasnovan za izogibanje aktivnosti z ne-tarčnimi kinazami.
English: Binding of larotrectinib to human plasma proteins in vitro was approximately 70% and was independent of drug concentration.
Slovenian: Vezava larotrektiniba na beljakovine v humani plazmi in vitro je bila približno 70 % in ni bila odvisna od koncentracije zdravila.
English: Patients (n=102)
Slovenian: (n = 102)
English: Dose limiting skin lesions were only seen in rats and were primarily responsible for mortality and morbidity.
Slovenian: Kožne lezije, zaradi katerih je bila velikost odmerka omejena in so bile primarno odgovorne za umrljivost in obolevnost, so opazili samo pri podganah.
English: Talk to your doctor, pharmacist or nurse or go to a hospital straight away.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro ali takoj pojdite v bolnišnico.
English: Turn the bottle upside down.
Slovenian: Steklenico obrnite na glavo.
English: Therefore, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Slovenian: Ženskam, ki uporabljajo sistemske hormonske kontraceptive, je treba svetovati, naj dodatno uporabljajo še pregradno kontracepcijsko metodo.
English: - VITRAKVI can be taken with or without food.
Slovenian: - Zdravilo VITRAKVI lahko jemljete s hrano ali brez nje.
English: Overview of studies
Slovenian: Pregled študij
English: In the adult sub-population (n=65), the ORR was 68%.
Slovenian: V odrasli podpopulaciji (n = 65) je bil celokupni delež odziva 68 %.
English: - Store in a refrigerator (2 °C - 8 °C).
Slovenian: - Shranjujte v hladilniku (2 °C - 8 °C).
English: Of 125 patients treated with VITRAKVI, 37 (30%) patients were from 28 days to 18 years of age.
Slovenian: Od 125 bolnikov, zdravljenih z zdravilom VITRAKVI, je bilo 37 (30 %) bolnikov starih od 28 dni do 18 let.
English: Neurologic reactions leading to dose modification included dizziness (2%).
Slovenian: Med nevrološkimi učinki, pri katerih je bila potrebna sprememba odmerka, je bila tudi vrtoglavica (2 %).
English: There are no data from the use of larotrectinib in pregnant women.
Slovenian: Podatkov o uporabi larotrektiniba pri nosečnicah ni.
English: Due to the rarity of TRK fusion-positive cancer, patients were studied across multiple tumour types with a limited number of patients in some tumour types, causing uncertainty in the ORR estimate per tumour type.
Slovenian: Zaradi redkosti raka z dokazano fuzijo TRK so preučevali bolnike z različnimi vrstami tumorjev, pri čemer je bilo pri nekaterih vrstah tumorjev število bolnikov omejeno, kar ima za posledico negotovost pri oceni ORR glede na vrsto tumorja.
English: The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC).
Slovenian: Glavni merili učinkovitosti izida sta bila celokupni delež odziva (ORR - overall response rate) in trajanje odziva (DOR - duration of response), ki ju je opredelil neodvisni odbor za pregled, katerega člani niso imeli vpogleda v druge podatke bolnikov vključenih v raziskavo (BIRC - blinded independent review committee).
English: - parahydroxybenzoate: it may cause allergic reactions (possibly delayed).
Slovenian: - parahidroksibenzoat: lahko povzroči alergijske reakcije (lahko zapoznele).
English: After the inhibitor has been discontinued for 3 to 5 elimination half-lives, VITRAKVI should be resumed at the dose taken prior to initiating the CYP3A4 inhibitor (see section 4.5).
Slovenian: Potem ko je bil uporaba zaviralca prekinjena za 3 do 5 razpolovnih časov izločanja, je treba nadaljevati z odmerkom zdravila VITRAKVI, ki ga je bolnik jemal pred uvedbo zaviralca CYP3A4 (glejte poglavje 4.5).
English: Tumour types included in efficacy analysis n
Slovenian: Vrste tumorjev, vključene v analizo učinkovitosti n študija 1
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).
Slovenian: Za dodatno potrditev učinkovitosti larotrektiniba neodvisno od histologije in zato, da bi raziskali mehanizme primarne in sekundarne odpornosti, mora imetnik dovoljenja za promet predložiti združene analize za povečano velikost vzorca, vključno s končnim poročilom študije LOXO-TRK-15002 (NAVIGATE)
English: Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate.
Slovenian: 1 ml peroralne raztopine vsebuje 295 mg saharoze, 22 mg sorbitola, 1,6 mg propilenglikola in 0,2 mg metil parahidroksibenzoata.
English: In patients whose cancer is due to an altered NTRK gene, the change in the gene causes the body to make an abnormal protein called TRK fusion protein, which can lead to uncontrolled cell growth and cancer.
Slovenian: Pri bolnikih z rakom zaradi spremenjenega gena NTRK, spremembe gena povzročijo, da telo proizvaja protein, ki se imenuje fuzijski protein TRK, kar lahko privede do nenadzorovane rasti celic in raka.
English: If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose.
Slovenian: Če bolnik pozabi vzeti odmerek, ne sme hkrati vzeti dveh odmerkov, da bi nadomestil pozabljeni odmerek.
English: The majority of adverse reactions were Grade 1 or 2 in severity (see Table 3) and were resolved without VITRAKVI dose modification or discontinuation.
Slovenian: Večina neželenih učinkov je bilo 1. ali 2. stopnje (glejte preglednico 3) in so izzveneli ne da bi bil spremenjen odmerek ali bi bilo prekinjeno zdravljenje z zdravilom VITRAKVI.
English: The median change in tumour size in the pooled primary analysis set was a decrease of 66%.
Slovenian: V združeni primarni analizi je bila mediana spremembe velikosti tumorja 66 % zmanjšanje.
English: In the overall safety database (n=125), the maximum grade transaminase elevation observed was Grade 4 ALT increase in 1 patient (<1%).
Slovenian: V celotni podatkovni zbirki o varnosti (n = 125) je bila najvišja stopnja zvišane vrednosti ALT, ki so jo opazili, 4. stopnje pri 1 bolniku (< 1 %).
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).
Slovenian: Učinkovitost in varnost zdravila VITRAKVI so preučevali v treh multicentričnih, odprtih kliničnih študijah z enim krakom pri odraslih in pediatričnih bolnikih z rakom (preglednica 4).
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - medicines used to treat fungal or bacterial infections called itraconazole, voriconazole,
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete katero od naslednjih zdravil: - zdravila za zdravljenje glivičnih ali bakterijskih okužb, ki se imenujejo itrakonazol,
English: VITRAKVI is for oral use.
Slovenian: Zdravilo VITRAKVI je za peroralno uporabo.
English: In the paediatric sub-population (n=28), the ORR was 82%.
Slovenian: V pediatrični podpopulaciji (n = 28) je bil celokupni delež odziva 82 %.
English: These patients were required to have received prior standard therapy appropriate for their tumour type and stage of disease or who, in the opinion of the investigator, would have had to undergo radical surgery (such as limb amputation, facial resection, or paralysis causing procedure), or were unlikely to tolerate, or derive clinically meaningful benefit from available standard of care therapies in the advanced disease setting.
Slovenian: Pri teh bolnikih je bilo potrebno predhodno standardno zdravljenje glede na vrsto tumorja in stadij bolezni ali pa bi jim bilo treba po mnenju raziskovalca opraviti radikalen kirurški poseg (na primer amputacijo uda, resekcijo obraza ali poseg, ki povzroča paralizo) ali pa pri napredovali bolezni verjetno ne bi prenašali standardnih vrst zdravljenja, ki so na voljo, oziroma od njih verjetno ne bi imeli klinično pomembne koristi.
English: 100 mg once daily
Slovenian: 100 mg enkrat na dan
English: There was not enough data to investigate the potential influence of race on the systemic exposure of larotrectinib.
Slovenian: Za oceno možnega vpliva rase na sistemsko izpostavljenost larotrektinibu ni dovolj podatkov.
English: VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1).
Slovenian: Zdravilo VITRAKVI kot monoterapija je indicirano za zdravljenje odraslih in pediatričnih bolnikov s solidnimi tumorji s prisotno fuzijo gena nevrotropne receptorske tirozin kinaze (NTRK - Neurotrophic Tyrosine Receptor Kinase), - ki imajo bolezen, ki je lokalno napredovala, bolezen z metastazami ali kjer bi kirurška resekcija verjetno povzročila hudo obolevnost, in - pri katerih ni zadovoljivih možnosti zdravljenja (glejte poglavji 4.4 in 5.1).
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).
Slovenian: < 18 let, in 3 bolniki ≥ 18 let; 8 belcev in 5 moških; ECOG PS 0-1 (8 bolnikov) ali 2 (1 bolnik).
English: Co-administration with CYP3A4/P-gp inducers
Slovenian: Sočasna uporaba z induktorji CYP3A4/P-gp
English: The measured impact of any concomitant genomic alterations on larotrectinib efficacy is provided below (see clinical efficacy).
Slovenian: Izmerjeni vpliv katere koli sočasne spremembe genoma na učinkovitost larotrektiniba je navedena v nadaljevanju (glejte klinična učinkovitost).
English: No clinical studies have been performed to investigate interactions with OATP1B1 substrates.
Slovenian: Kliničnih študij za ugotavljanje interakcij s substrati OATP1B1 niso izvedli.
English: reactions included two cases Neutrophil count decreased (Neutropenia) and one case of anaemia.
Slovenian: Učinki 3. stopnje so vključevali dva primera zmanjšanja števila nevtrofilcev (neutropenija) in en primer anemije.
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with VITRAKVI.
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom VITRAKVI opraviti test nosečnosti.
English: The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs.
Slovenian: Priporočeni odmerek zdravila pri odraslih je 100 mg larotrektiniba dvakrat na dan, dokler ne pride do napredovanja bolezni ali dokler se ne pojavi nesprejemljiva toksičnost.
English: Sucrose: may be harmful to the teeth.
Slovenian: Saharoza: lahko škoduje zobem.
English: Tumour responses were assessed by the investigator using RANO or RECIST v1.1 criteria.
Slovenian: Odzive tumorja so raziskovalci ocenili z uporabo kriterijev RANO ali RECIST v1.1.
English: The target for larotrectinib is the TRK family of proteins inclusive of TRKA, TRKB, and TRKC that are encoded by NTRK1, NTRK2 and NTRK3 genes, respectively.
Slovenian: Tarča za larotrektinib je družina proteinov TRK, vključno s TRKA, TRKB in TRKC, ki jih kodirajo geni NTRK1, NTRK2 oziroma NTRK3.
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.
Slovenian: V in vitro ter in vivo tumorskih modelih je larotrektinib pokazal protitumorsko delovanje v celicah s konstitutivno aktivacijo proteinov TRK, ki je posledica genskih fuzij, izbrisa regulatorne domene proteina, ali v celicah s prekomerno izraženim proteinom TRK.
English: Effect of CYP3A, P-gp and BCRP inhibitors on larotrectinib Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Slovenian: Učinki zaviralcev CYP3A, P-gp BCRP na larotrektinib Larotrektinib je substrat citokroma P450 (CYP) 3A, P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein).
English: Safety pharmacology
Slovenian: Farmakologija glede varnosti
English: Larotrectinib was negative in the in vivo mouse micronucleus test at the maximum tolerated dose of 500 mg/kg.
Slovenian: Larotrektinib je bil negativen v in vivo mikronukleus testu z največjim toleriranim odmerkom 500 mg/kg pri miših.
English: The oral solution can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Slovenian: Peroralno raztopino se lahko uporablja s hrano ali brez nje, vendar se je ne sme jemati skupaj z grenivko ali sokom grenivke.
English: - Do not take the medicine if the bottle or bottle cap looks damaged or like it has leaked.
Slovenian: - Ne uporabljajte tega zdravila, če opazite, da je steklenica ali zaporka steklenice poškodovana ali pušča.
English: Based on the mechanism of action, foetal harm cannot be excluded when administering larotrectinib to a pregnant woman.
Slovenian: Glede na mehanizem delovanja, pri dajanju larotrektiniba nosečnicam ni mogoče izključiti poškodbe ploda.
English: If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment.
Slovenian: Če ste v rodni dobi, bo zdravnik pred začetkom zdravljenja pri vas opravil test nosečnosti.
English: The pooled primary analysis set consisted of 93 patients and did not include primary CNS tumours.
Slovenian: Združeni rezultati primarnih analiz so bili pridobljeni pri 93 bolnikih in niso vključevali primarnih tumorjev osrednjega živčevja.
English: The half-life of larotrectinib in plasma of cancer patients given 100 mg twice daily of VITRAKVI was approximately 3 hours.
Slovenian: Razpolovni čas larotrektiniba v plazmi bolnikov z rakom, ki so prejemali 100 mg zdravila VITRAKVI dvakrat na dan, je bila približno 3 ure.
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.
Slovenian: Farmakologija glede varnosti larotrektiniba je bila ocenjena v več in vitro ter in vivo študijah, v katerih so ocenjevalei učinke na kardiovaskularni sistem, osrednje živčevje, dihala in prebavila pri različnih vrstah.
English: The pooled efficacy results for overall response rate, duration of response and time to first response, in the primary analysis population (n=93) and with post-hoc addition of primary CNS tumours (n=9) resulting in the pooled population (n=102), are presented in Table 5 and Table 6.
Slovenian: Združeni rezultati učinkovitosti za celokupni delež odziva, trajanje odziva in čas do prvega odziva, v populaciji primarne analize (n = 93) in z ad-hoc dodajanimi primarnimi tumorji osrednjega živčevja (n = 9), kar se kaže kot združena populacija (n = 102), so predstavljeni v preglednici 5 in preglednici 6.
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).
Slovenian: Izogibajte se sočasni uporabi močnih ali zmernih induktorjev CYP3A4/P-gp z zdravilom VITRAKVI, ker obstaja tveganje za zmanjšano izpostavljenost (glejte poglavje 4.5).
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.
Slovenian: V varnostni populaciji je bila mediana starost bolnikov 45 let (razpon: 0,1, 80), 30 % bolnikov je bilo pediatričnih bolnikov.
English: 56 capsules
Slovenian: 56 trdih kapsul
English: VITRAKVI is available as a capsule or oral solution with equivalent oral bioavailability and may be used interchangeably.
Slovenian: Zdravilo VITRAKVI je na voljo v obliki kapsule ali peroralne raztopine z enakovredno biološko uporabnostjo pri peroralni uporabi in se ju sme uporabljati izmenično.
English: Children (n=15)b
Slovenian: (n = 15)b
English: Larotrectinib was not mutagenic in bacterial reverse mutation (Ames) assays and in in vitro mammalian mutagenesis assays.
Slovenian: Larotrektinib ni bil mutagen v preskusih bakterijske reverzne mutacije (Ames) in in vitro preskusih mutageneze pri sesalcih.
English: Larotrectinib had minimal activity in cell lines with point mutations in the TRKA kinase domain, including the clinically identified acquired resistance mutation, G595R.
Slovenian: Larotrektinib je imel minimalno aktivnost v celičnih linijah, s točkovnimi mutacijami v domeni kinaze TRKA, vključno s klinično ugotovljeno mutacijo G595R, ki povzroča pridobljeno odpornost.
English: - Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing.
Slovenian: - Bat počasi pritiskajte in tekočino usmerite proti notranjosti lica, da omogočite naravno požiranje.
English: Sodium: this medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially ‘sodium-free'.
Slovenian: Natrij: to zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 5 ml, kar v bistvu pomeni ‘brez natrija'.
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.
Slovenian: V združeno analizo izsledkov učinkovitosti je bilo vključenih 93 bolnikov z rakom z dokazano fuzijo TRK, ki so sodelovali v treh študijah in so imeli bolezen opredeljeno po kriterijih RECIST v1.1, primarni tumor izven osrednjega živčevja in so prejeli najmanj en odmerek larotrektiniba.