FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding should be discontinued during treatment with VITRAKVI and for 3 days following the final dose.
Slovenian: Med zdravljenjem z zdravilom VITRAKVI in še 3 dni po zadnjem odmerku se ne sme dojiti.
English: Systemic toxicity was assessed in studies with daily oral administration up to 3 months in rats and monkeys.
Slovenian: Sistemsko toksičnost so ocenili v študijah na podganah in opicah; zdravilo so jim dajali peroralno, vsak dan do 3 mesece.
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
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prečiščena voda saharoza hidroksipropilbetadeks glicerol (E 422) sorbitol (E 420) natrijev citrat (E 331) natrijev dihidrogenfosfat dihidrat (E 339) citronska kislina (E 330) propilenglikol (E 1520) kalijev sorbat (E 202) metil parahidroksibenzoat (E 218)
English: You should avoid getting pregnant while taking this medicine.
Slovenian: Med jemanjem tega zdravila ne smete zanositi.
English: How VITRAKVI works
Slovenian: Kako deluje zdravilo VITRAKVI
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
Slovenian: ščitnica (n = 9)b sarkom mehkih tkiv (n = 9) kolorektalni (n = 6) melanom (n = 6) NDPR (n = 5)b, c primarni tumor osrednjega živčevja
English: Salivary gland (n=3) GIST (n=2)a
Slovenian: GIST (n = 2)a
English: 100 mg twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Slovenian: 100 mg dvakrat na dan (25 mg, 100 mg kapsule ali 20 mg/ml peroralna raztopina)
English: Each VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).
Slovenian: Vsaka VITRAKVI 25 mg kapsula vsebuje 25 mg larotrektiniba (v obliki sulfata).
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.
Slovenian: Za identifikacijo fuzij genov NTRK so bile uporabljene molekularne testne metode: sekvenciranje druge generacije (NGS) pri 98 bolnikih, polimerazna verižna reakcija z reverzno transkriptazo
English: Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje z zdravilom VITRAKVI lahko uvedejo le zdravniki, ki imajo izkušnje z dajanjem zdravil za zdravljenje raka.
English: You must use effective methods of contraception while taking VITRAKVI and for at least 1 month after the last dose, if - you are able to become pregnant.
Slovenian: Med jemanjem zdravila VITRAKVI in najmanj 1 mesec po zadnjem odmerku morate uporabljati učinkovito kontracepcijsko metodo, če
English: - A suitable syringe should be used to administer VITRAKVI to the nasogastric feeding tube.
Slovenian: - Za vnašanje zdravila VITRAKVI v nazogastrično sondo za hranjenje je treba uporabiti ustrezno brizgo.
English: SD: stable disease + denotes ongoing response a independent review committee analysis by RECIST v1.1 b patients with a primary CNS tumour were evaluated per investigator assessment using either RANO or RECIST v1.1
Slovenian: + v času analize opazovanje še ni zaključeno a Analiza neodvisnega odbora za pregled z uporabo kriterijev RECIST v1.1 b Ocena raziskovalca z uporabo kriterijev RANO ali RECIST v1.1 za bolnike s primarnim tumorjem osrednjega živčevja c nesekretorni
English: For paediatric patients older than 12 years of age, the recommended dose is likely to give similar Cmax and AUC as observed in adults.
Slovenian: Pričakuje se, da bodo vrednosti Cmax in AUC pri pediatričnih bolnikih starejših od 12 let pri priporočenem odmerku podobne kot pri odraslih.
English: Neonates and children with fluid restrictions may require minimal flushing volume of 0.5 to 1 mL or flushing with air to deliver VITRAKVI.
Slovenian: morda potrebna minimalna količina za spiranje, tj. 0,5 do 1 ml, ali spiranje z zrakom.
English: Tηλ: +357 22 48 38 58
Slovenian: NOVAGEM Limited Tηλ: +357 22 48 38 58
English: Table 5: Pooled efficacy results in solid tumours including and excluding primary CNS tumours Efficacy parameter
Slovenian: Preglednica 5: Združeni rezultati učinkovitosti pri solidnih tumorjih z ali brez primarnih tumorjev osrednjega živčevja
English: ALT and AST increases leading to dose modifications occurred in 7 (6%) patients and 6 (5%) patients, respectively (see section 4.4).
Slovenian: 7 (6 %) oziroma 6 (5 %) bolnikih (glejte poglavje 4.4).
English: Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Slovenian: Vsaka VITRAKVI 100 mg kapsula vsebuje 100 mg larotrektiniba (v obliki sulfata).
English: Effect of gastric pH-elevating agents on larotrectinib Larotrectinib has pH-dependent solubility.
Slovenian: Učinki snovi, ki višajo vrednost pH v želodcu, na larotrektinib Topnost larotrektiniba je odvisna od pH.
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.
Slovenian: PND) so opazili pri velikem odmerku, ki je ustrezal 2,5- do 4-kratniku AUC pri priporočenem odmerku.
English: System organ class Frequency All grades
Slovenian: Organski sistem Pogostnost Dojenčki in majhni otroci
English: VITRAKVI should be permanently discontinued in patients who are unable to tolerate VITRAKVI after three dose modifications.
Slovenian: Pri bolnikih, ki zdravila VITRAKVI po treh spremembah odmerka še vedno ne prenašajo, je treba uporabo zdravila VITRAKVI trajno ukiniti.
English: Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone
Slovenian: tiskarsko črnilo šelak barvilo indigotin (E 132) titanov dioksid (E 171) propilenglikol (E 1520) dimetikon
English: The 200 mg dose corresponds to a peak exposure (Cmax) similar to that observed with larotrectinib 100 mg BID at steady state.
Slovenian: Odmerek 200 mg ustreza najvišji izpostavljenosti (Cmax), podobno, kot je opažena v stanju dinamičnega ravnovesja za larotrektinib 100 mg dvakrat na dan.
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.
Slovenian: Pri bolnikih z okvaro ledvic so opazili zvečane vrednosti Cmax in AUC0-inf larotrektiniba, in sicer za 1,25- oziroma 1,46-krat v primerjavi z osebami z normalnim delovanjem ledvic.
English: Each carton contains 1 child-resistant glass bottle containing 100 mL oral solution.
Slovenian: Vsaka škatla vsebuje 1 za otroke varno steklenico s 100 ml peroralne raztopine.
English: Press the bottle cap and turn it anti-clockwise to open the bottle.
Slovenian: Pritisnite na zaporko steklenice in jo obrnite v nasprotni smeri urinega kazalca, tako da jo odprete.
English: No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) (see section 5.2).
Slovenian: Pri bolnikih z blago okvaro jeter (Child-Pugh A) se ne priporoča prilagoditve odmerka (glejte poglavje 5.2).
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).
Slovenian: Moškim v reproduktivni dobi, ki imajo partnerko v rodni dobi, ki ni noseča, je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo (glejte poglavje 4.6).
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.
Slovenian: Moškim v rodni dobi, ki imajo partnerko v rodni dobi, ki ni noseča, je treba svetovati, naj med zdravljenjem z zdravilom VITRAKVI in vsaj en mesec po zadnjem odmerku uporabljajo visoko učinkovito kontracepcijsko metodo.
English: Study 2 “NAVIGATE” NCT02576431
Slovenian: NCT02576431
English: Biliary (n=2) SCLC (n=1)b, d Appendix (n=1) Breast (n=1)
Slovenian: DPR (n = 1)b, d slepič (n = 1)
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,
Slovenian: - zdravilo, ki se uporablja za zdravljenje Cushingovega sindroma, ki se imenuje ketokonazol - zdravila za zdravljenje okužb z virusom HIV, ki se imenujejo atazanavir, indinavir, nelfinavir,
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).
Slovenian: model, ki temelji na dodatnih PK vzorcih pri bolnikih starih od 1 meseca do 6 let iz študije LOXO-TRK-15003 (SCOUT)
English: Larotrectinib crosses the placenta in both species.
Slovenian: Pri obeh živalskih vrstah larotrektinib prehaja skozi placento.
English: Following oral administration of 100 mg radiolabeled larotrectinib to healthy adult subjects, 58% of the administered radioactivity was recovered in faeces and 39% was recovered in urine and when an IV microtracer dose was given in conjunction with a 100 mg oral dose of larotrectinib, 35% of the administered radioactivity was recovered in faeces and 53% was recovered in urine.
Slovenian: Po peroralnem dajanju 100 mg radioaktivno označenega larotrektiniba zdravim odraslim osebam je bilo v blatu 58 % dane radioaktivnosti, v urinu pa 39 %, po dajanju i.v.
English: Amber glass (type III) bottle with a child-resistant polypropylene (PP) cap with a polyethylene (PE) seal liner.
Slovenian: Steklenica iz stekla jantarjeve barve (tip III) z za otroke varno polipropilensko (PP) zaporko in polietilenskim (PE) tesnilom.
English: VITRAKVI 100 mg hard capsules Each hard capsule contains larotrectinib sulfate equivalent to 100 mg of larotrectinib.
Slovenian: VITRAKVI 100 mg trde kapsule Ena trda kapsula vsebuje larotrektinibijev sulfat, kar ustreza 100 mg larotrektiniba.
English: Carcinogenicity studies have not been performed with larotrectinib.
Slovenian: Študij karcenogenosti z larotrektinibom niso izvedli.
English: VITRAKVI 20 mg/mL oral solution larotrectinib
Slovenian: VITRAKVI 20 mg/ml peroralna raztopina larotrektinib
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Učinkovitost pri različnih vrstah tumorjev
English: saquinavir, rifabutin, efavirenz - a medicine used to treat depression called nefazodone - medicines used to treat epilepsy called phenytoin, carbamazepine, phenobarbital - a herbal medicine used to treat depression called St. John's wort - a medicine used to treat tuberculosis called rifampicin - a medicine used for strong pain relief called alfentanil - medicines used to prevent organ rejection after an organ transplant called ciclosporin, sirolimus,
Slovenian: - zeliščno zdravilo za zdravljenje depresije, ki se imenuje šentjanževka - zdravilo za zdravljenje tuberkuloze, ki se imenuje rifampicin - zdravilo za lajšanje močnih bolečin, ki se imenuje alfentanil - zdravila za preprečevanje zavrnitve organa po presaditvi organa, ki se imenujejo ciklosporin,
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.
Slovenian: Klinični podatki pri zdravih odraslih kažejo, da sta se ob sočasni uporabi zdravila VITRAKVI (100 mg dvakrat na dan 10 dni) vrednosti Cmax in AUC peroralno zaužitega midazolama povečali za 1,7-krat v primerjavi z jemanjem samo midazolama, kar kaže na to, da je larotrektinib šibak zaviralec
English: Clinical signs of gastrointestinal toxicity were dose limiting in monkeys.
Slovenian: Pri opicah je bil odmerek omejen s kliničnimi znaki gastrointestinalne toksičnosti.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people): - you may look pale and feel your heart pumping, which could be symptoms of low red blood cells (anaemia) - flu like symptoms including fever, which could be symptoms of low white blood cells
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 ljudi) - lahko ste videti bolj bledi in čutite bitje svojega srca, kar so simptomi nizkega števila rdečih krvnih celic (anemija)
English: Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Slovenian: Pri bolnikih, ki jemljejo zdravilo VITRAKVI, je potrebna previdnost pri sočasni uporabi substratov CYP3A z ozkim terapevtskim oknom (npr. alfentanil, ciklosporin, dihidroergotamin, ergotamin,
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.
Slovenian: Pri odraslih živalih (podganah, miših, opicah cinomolgus), izpostavljenih koncentracijam larotrektiniba (Cmax), ki je bila vsaj 7-krat večja kot izpostavljenost pri ljudeh, ni bilo nevrovedenjskih motenj.
English: If you miss a dose of VITRAKVI
Slovenian: Če ste pozabili vzeti zdravilo VITRAKVI
English: VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules
Slovenian: IME ZDRAVILA VITRAKVI 25 mg trde kapsule VITRAKVI 100 mg trde kapsule
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.
Slovenian: Klinični podatki pri zdravih odraslih kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI s 600 mg rifampina (močan induktor CYP3A in P-gp) dvakrat na dan 11 dni, vrednosti Cmax in AUC larotrektiniba znižali za 71 % oziroma 81 %.
English: What VITRAKVI is and what it is used for What you need to know before you take VITRAKVI How to take VITRAKVI
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo VITRAKVI Kako jemati zdravilo VITRAKVI
English: Fertility studies with larotrectinib have not been conducted.
Slovenian: Študij karcenogenosti z larotrektinibom niso izvedli..
English: 100 mL oral solution
Slovenian: 100 ml peroralna raztopina
English: Aspartate aminotransferase (AST) increased
Slovenian: (ALT)a zvišane vrednosti aspartat aminotransferaze (AST)
English: VITRAKVI 100 mg hard capsules larotrectinib
Slovenian: VITRAKVI 100 mg trde kapsule larotrektinib
English: Therefore, larotrectinib is unlikely to be affected by pH-modifying agents.
Slovenian: Zato ni verjetno, da bi snovi, ki spreminjajo vrednost pH, vplivale na larotrektinib.
English: See “VITRAKVI contains” in section 2 for more information.
Slovenian: Za več informacij glejte poglavje 2, »Zdravilo VITRAKVI vsebuje«.
English: High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer.
Slovenian: 6.5 Vrsta ovojnine in vsebina Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko (PP) zaporko s polietilensko (PE) toplotno zavarjeno plastjo.
English: Dysgeusia
Slovenian: fenobarbital
English: Marketing Authorisation Holder
Slovenian: Pogojno dovoljenje za promet
English: VITRAKVI 25 mg hard capsules larotrectinib
Slovenian: VITRAKVI 25 mg trde kapsule larotrektinib
English: For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
Slovenian: Za količine, manjše od 1 ml, je treba uporabiti 1-ml peroralno brizgo z oznakami za odmerjanje po 0,1 ml.
English: Patients should take the next dose at the next scheduled time.
Slovenian: Bolnik naj vzame naslednji odmerek kot običajno.
English: No effects on female reproductive organs were seen in the 3-months toxicity studies in rats and monkeys at doses corresponding to approximately 3-times (female rats) and 17-times (female monkeys) the human AUC at the recommended clinical dose.
Slovenian: V 3-mesečni študiji toksičnosti pri podganah in opicah niso opazili učinkov na reproduktivne organe samic pri odmerkih, ki ustrezajo približno 3-kratniku (pri podganjih samicah) in 17-kratniku (pri opičjih samich) AUC pri ljudeh po priporočenem kliničnem odmerku.
English: Ask your doctor about the best method of contraception for you.
Slovenian: Glede kontracepcijske metode, ki je za vas najbolj primerna, se posvetujte z zdravnikom.
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.
Slovenian: Klinični podatki pri zdravih odraslih osebah kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI z 200 mg itrakonazola (močan zaviralec CYP3A in zaviralec P-gp ter BCRP) enkrat na dan, 7 dni, vrednosti Cmax in AUC larotrektiniba zvišali za 2,8-krat oziroma 4,3-krat.
English: NSCLC (n=1)c Soft tissue sarcoma (n=1) Thyroid (n=1)
Slovenian: NDPR (n = 1)c sarkom mehkih tkiv (n = 1)
English: Patients with primary CNS tumours
Slovenian: Bolniki s primarnimi tumorji osrednjega živčevja
English: In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM.
Slovenian: V širšem naboru specifičnih encimskih testov je larotrektinib zaviral TRKA, TRKB in TRKC z vrednostmi IC50 med 5-11 nM. Edina druga aktivnost kinaze se je pojavila pri 100-krat večjih koncentracijah.
English: Lunga Melanomaa Colona
Slovenian: pljučaa melanoma debelo črevoa
English: Capsule shell: - Gelatin - Titanium dioxide (E 171) Printing ink: - Shellac - Indigo carmine aluminium lake (E 132) - Titanium dioxide (E 171) - Propylene glycol (E 1520) - Dimeticone
Slovenian: - šelak - barvilo indigotin (E 132) - titanov dioksid (E 171) - propilenglikol (E 1520) - dimetikon
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
Slovenian: * 93 bolnikov z oceno odziva tumorja s strani neodvisnega odbora za pregled in 9 bolnikov s primarnimi tumorji osrednjega živčevja (vključno z gliomom, glioblastomom in astrocitomom) z raziskovalčevo oceno odziva tumorja a GIST: gastrointestinalni stromalni tumor b metastaze v možganih so opazili pri enem bolniku s tumorjem ščitnice, enem bolniku z NDPR in enem bolniku z DPR c NDPR: nedrobnocelični pljučni rak d DPR: drobnocelični pljučni rak
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.
Slovenian: Dvainpetdeset odstotkov bolnikov je prejemalo zdravilo VITRAKVI 12 mesecev ali več, 30 % pa jih je prejemalo zdravilo VITRAKVI 18 mesecev ali več; v času analize je nadaljnje spremljanje bolnikov še trajalo.
English: The calculated dose volume should be rounded to the nearest 0.1 mL.
Slovenian: Količino izračunanega odmerka je treba zaokrožiti na odmerek, ki je najbližje 0,1 ml. - Za odmerke po 1 ml ali več je treba uporabiti 5-ml peroralno brizgo.
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.
Slovenian: vključno s kognitivnimi funkcijami, mora imetnik dovoljenja za promet predložiti končno poročilo študije LOXO-TRK-15003 (SCOUT) vključno s podatki 5-letnega spremljanja.
English: Dizziness and fatigue have been reported in patients receiving larotrectinib, mostly Grade 1 and 2 during the first 3 months of treatment.
Slovenian: Pri bolnikih, ki so prejemali larotrektinib, so v prvih treh mesecih zdravljenja poročali o vrtoglavici in utrujenosti,
English: Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI.
Slovenian: Med jemanjem zdravila VITRAKVI ne jejte grenivk niti ne pijte soka grenivk, ker lahko zviša koncentracijo zdravila VITRAKVI v vašem telesu.
English: Propylene glycol (E 1520) Potassium sorbate (E 202) Methyl parahydroxybenzoate (E 218) Citrus fruit flavour
Slovenian: - kalijev sorbat (E 202) - metil parahidroksibenzoat (E 218)
English: Nasogastric feeding tube - Use a suitable nasogastric feeding tube.
Slovenian: Nazogastrična sonda za hranjenje - Uporabite primerno nazogastrično sondo za hranjenje.
English: Very common Alanine aminotransferase (ALT) increased
Slovenian: Preiskave zelo pogosti zvišane vrednosti alanin aminotransferaze
English: Transaminase elevations
Slovenian: Zvišanja vrednosti ALT
English: Each capsule contains larotrectinib sulfate, equivalent to 25 mg of larotrectinib.
Slovenian: Ena trda kapsula vsebuje larotrektinibijev sulfat, kar ustreza 25 mg larotrektiniba.
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.
Slovenian: Klinični podatki pri zdravih odraslih osebah kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI z enkratnim 600-mg odmerkom rifampina (zaviralec P-gp in BCRP) vrednosti Cmax in AUC larotrektiniba zvišali za 1,8-krat oziroma in 1,7-krat.
English: Soft tissue sarcoma (n=11) Primary CNS (n=5) Bone sarcoma (n=1) Congenital mesoblastic nephroma (n=1) Melanoma (n=1)
Slovenian: (n = 5) kostni sarkom (n = 1) kongenitalni mezoblastni nefrom (n = 1) melanom (n = 1)
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.
Slovenian: VITRAKVI 100 mg trde kapsule bela, neprozorna, trda želatinasta kapsula, velikosti 0 (22 mm dolga x 7 mm široka), z modrim odtisnjenim znakom »BAYER« v obliki križa in napisom »LARO 100 mg« na telesu kapsule
English: The mean volume of distribution of larotrectinib in healthy adult subjects was 48 L following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose, indicating moderate distribution into tissues from the plasma.
Slovenian: mikrooznačevalca v povezavi s 100-mg peroralnim odmerkom, kar kaže zmerno porazdelitev iz plazme v tkiva.
English: Tube diameter for standard feeds
Slovenian: Premer sonde za standardno hrano
English: VITRAKVI is a clear yellow to orange oral solution.
Slovenian: Izgled zdravila VITRAKVI in vsebina pakiranja Zdravilo VITRAKVI je bistra, rumena do oranžna peroralna raztopina.
English: Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).
Slovenian: 1 ml peroralne raztopine vsebuje 20 mg larotrektiniba (v obliki sulfata).
English: Acquired resistance mutations after progression on TRK inhibitors have been observed.
Slovenian: Po prehodu na zaviralce TRK so opazili mutacije, ki povzročajo pridobljeno odpornost.