FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised not to drive and use machines, until they are reasonably certain VITRAKVI therapy does not affect them adversely (see section 4.4).
Croatian: Bolesnicima treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima sve dok ne budu u razumnoj mjeri sigurni da terapija lijekom VITRAKVI na njih nema štetan učinak (vidjeti dio 4.4).
English: As a precautionary measure, it is preferable to avoid the use of VITRAKVI during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka VITRAKVI tijekom trudnoće.
English: Systemic toxicity was assessed in studies with daily oral administration up to 3 months in rats and monkeys.
Croatian: Sistemska toksičnost bila je procijenjena u ispitivanjima svakodnevne oralne primjene u trajanju do 3 mjeseca na štakorima i majmunima.
English: The mean absolute bioavailability of larotrectinib was 34% (range: 32% to 37%) following a single 100 mg oral dose.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti larotrektiniba bila je 34 % (raspon: od 32 % do 37 %) nakon jednokratne oralne doze od 100 mg.
English: The capsules can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Croatian: Kapsule se mogu uzimati s hranom ili bez nje, ali se ne smiju uzimati s grejpom ili sokom od grejpa.
English: - Your child's doctor will review the dose and change it as needed.
Croatian: - Liječnik Vašeg djeteta provjerit će dozu i po potrebi je promijeniti.
English: Point mutations in the TRKC kinase domain with clinically identified acquired resistance to larotrectinib include G623R, G696A, and F617L.
Croatian: Točkaste mutacije u domeni kinaze TRKC s klinički identificiranom stečenom rezistencijom na larotrektinib uključuju G623R, G696A i F617L.
English: For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised.
Croatian: Kod svih nuspojava 2. stupnja može se nastaviti s doziranjem, iako se savjetuje pozorno praćenje bolesnika da se toksičnost ne bi pogoršala.
English: If you use hormonal contraceptives, you should also use a barrier method, such as a condom.
Croatian: Ako primjenjujete hormonske kontraceptive, trebate dodatno koristiti mehaničku metodu kontracepcije, npr. kondom.
English: Withholding, reducing, or discontinuing VITRAKVI dosing should be considered, depending on the severity and persistence of these symptoms (see section 4.2).
Croatian: Potrebno je razmotriti privremeni prekid, sniženje doze ili potpuni prestanak primjene lijeka VITRAKVI ovisno o težini i upornosti trajanja tih simptoma (vidjeti dio 4.2).
English: Table 4: Clinical studies contributing to the efficacy analyses in solid and primary CNS tumours Study name, design and patient population
Croatian: Tablica 4: Klinička ispitivanja koja su doprinijela analizama djelotvornosti kod solidnih i primarnih tumora SŽS-a Naziv i dizajn ispitivanja i populacija bolesnika
English: You should not use VITRAKVI during pregnancy since the effect of VITRAKVI on the unborn is not known.
Croatian: Lijek VITRAKVI se ne smije uzimati tijekom trudnoće jer učinak lijeka VITRAKVI na nerođeno dijete nije poznat.
English: Common (may affect up to 1 in 10 people): - change in how things taste (dysgeusia) - increased amount of “alkaline phosphatase” in blood tests (very common in children).
Croatian: Često (mogu se javiti u najviše 1 na 10 osoba): - promjena osjeta okusa (disgeuzija) - povišena razina alkalne fosfataze u krvnim pretragama (vrlo često u djece).
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.
Croatian: Morate primjenjivati učinkovite mjere kontracepcije dok uzimate lijek VITRAKVI te najmanje 1 mjesec nakon posljednje doze, ako - možete zatrudnjeti.
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).
Croatian: Nakon što je od prekida primjene inhibitora proteklo vrijeme od 3 do 5 poluvijekova eliminacije, primjenu lijeka VITRAKVI treba nastaviti u dozi u kojoj se uzimao prije početka primjene inhibitora CYP3A4 (vidjeti dio 4.5).
English: Clear yellow to orange solution.
Croatian: Bistra, žuta do narančasta otopina.
English: Children (n=15)b
Croatian: Djeca (n=15)b
English: If you miss a dose of VITRAKVI
Croatian: Ako ste propustili dozu lijeka VITRAKVI
English: Gender did not appear to influence larotrectinib pharmacokinetics to a clinically significant extent.
Croatian: Čini se da spol nije utjecao na farmakokinetiku larotrektiniba u klinički značajnoj mjeri.
English: c Paediatric patient (6 months old at enrolment) with locally advanced unresectable infantile fibrosarcoma with complete surgical response.
Croatian: Pedijatrijski bolesnik (u dobi od 6 mjeseci u trenutku uključenja u ispitivanje) s lokalno uznapredovalim neresektabilnim infantilnim fibrosarkomom s potpunim kirurškim odgovorom.
English: In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM.
Croatian: U širokom panelu testova s pročišćenim enzimima, larotrektinib je inhibirao TRKA, TRKB i TRKC, uz vrijednosti IC50 između 5 i 11 nM.
English: The calculated dose volume should be rounded to the nearest 0.1 mL.
Croatian: Izračunat volumen doze treba zaokružiti na najbliži 0,1 ml.
English: Nervous system effects (i.e. altered hindlimb functionality and, likely, increases in eyelid closure) demonstrated partial recovery.
Croatian: Učinci na neurološki sustav (npr. promijenjena funkcionalnost stražnjih nogu i, vjerojatno, pojačano zatvaranje očiju) djelomično su se povukli.
English: It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
Croatian: Trenutno nije poznato može li larotrektinib smanjiti učinkovitost sustavnih hormonskih kontraceptiva.
English: Table 6: Overall response rate and duration of response by tumour type Tumour type
Croatian: Tablica 6: Ukupna stopa i trajanje odgovora prema vrsti tumora Vrsta tumora
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.
Croatian: Ti su bolesnici morali prethodno primiti odgovarajuću standardnu terapiju za njihovu vrstu tumora i stadij bolesti ili koji su, prema mišljenju ispitivača, trebali biti podvrgnuti radikalnom kirurškom zahvatu (poput amputacije uda, resekcije lica ili postupka koji bi uzrokovao paralizu) ili vjerojatno ne bi podnijeli dostupnu standardnu terapiju ili izvukli klinički značajnu korist iz nje s obzirom na uznapredovalost bolesti.
English: Study 2 “NAVIGATE” NCT02576431
Croatian: Ispitivanje 2 „NAVIGATE“ NCT02576431
English: It is therefore not known if the presence of a concomitant oncogenic driver in addition to an NTRK gene fusion affects the efficacy of TRK inhibition.
Croatian: Stoga nije poznato utječe li prisutnost popratnog onkogenog pokretača uz fuzijski gen NTRK na djelotvornost inhibicije TRK.
English: Paediatric patients (n=37)
Croatian: Pedijatrijski bolesnici (n=37)
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antineoplastic agents, protein kinase inhibitors, ATC code: L01XE53.
Croatian: Farmakoterapijska skupina: antineoplastici i imunomodulirajući lijekovi, antineoplastici, inhibitori protein-kinaze; ATK oznaka: L01XE53.
English: VITRAKVI has a moderate influence on the ability to drive and use machines.
Croatian: VITRAKVI ima umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: A decrease in pregnancy rate was also reported despite normal mating at the high-dose level.
Croatian: Pri visokim dozama zabilježena je i manja stopa trudnoće unatoč normalnom parenju.
English: It is used in adults, adolescents and children to treat solid tumours (cancer) in various parts of the body that are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).
Croatian: Primjenjuje se u odraslih, adolescenata i djece za liječenje solidnih tumora (raka) na različitim mjestima u tijelu uzrokovanih promjenama gena NTRK (gena za neurotropnu receptorsku tirozin kinazu (engl.
English: Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Croatian: Stoga se ne može isključiti može li istodobna primjena larotrektiniba sa supstratima OATP1B1 (npr. valsartan, statini) povećati njihovu izloženost.
English: Binding of larotrectinib to human plasma proteins in vitro was approximately 70% and was independent of drug concentration.
Croatian: Vezanje larotrektiniba za proteine ljudske plazme in vitro iznosilo je približno 70 % i nije ovisilo o koncentraciji lijeka.
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%.
Croatian: U 85 bolesnika sa širokom molekularnom karakterizacijom prije liječenja larotrektinibom, u 48 bolesnika koji su dodatno uz fuzijski gen NTRK imali druge genomske promjene ORR je bio 58%, a u bolesnika bez drugih genomskih promjena ORR je bio 84%.
English: In 36 healthy adult subjects receiving single doses ranging from 100 mg to 900 mg, VITRAKVI did not prolong the QT interval to any clinically relevant extent.
Croatian: U 36 zdravih odraslih ispitanika koji su primili jednokratnu dozu u rasponu od 100 mg do 900 mg, VITRAKVI nije produljio QT-interval u klinički značajnoj mjeri.
English: ≥ 12 months Range (months)
Croatian: ≥ 12 mjeseci raspon (mjeseci)
English: Mixing with the feeding formulas could lead to tube blockages.
Croatian: Miješanje s enteralnim formulama može dovesti do blokade sonde.
English: - 1.6 mg propylene glycol in 1 mL.
Croatian: - 1,6 mg propilenglikola u 1 ml.
English: No clinical studies have been performed to investigate interactions with OATP1B1 substrates.
Croatian: Nisu provedena klinička ispitivanja za istraživanje interakcija sa supstratima OATP1B1.
English: Of these, 77% had received prior systemic therapy with a median of 1 prior systemic treatment regimen.
Croatian: Od njih je 77 % prethodno primilo sistemsku terapiju s medijanom od 1 prethodno primljenog terapijskog protokola.
English: Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate.
Croatian: Jedan ml oralne otopine sadrži 295 mg saharoze, 22 mg sorbitola, 1,6 mg propilenglikola i 0,2 mg metilparahidroksibenzoata.
English: There was not enough data to investigate the potential influence of race on the systemic exposure of larotrectinib.
Croatian: Nije bilo dovoljno podataka za ispitivanje mogućeg utjecaja etničke pripadnosti na sistemsku izloženost larotrektinibu.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukraza-izomaltaza ne bi smjeli uzimati ovaj lijek.
English: Majority of Grade 3 elevations were transient appearing in first or second month of treatment and resolving to Grade 1 by months 3-4.
Croatian: Većina povišenja 3. stupnja bila je prolazna, a pojavila se u prvom ili drugom mjesecu liječenja i smanjila se na 1. stupanj do 3.-4. mjeseca.
English: reactions included two cases Neutrophil count decreased (Neutropenia) and one case of anaemia.
Croatian: Reakcije 3. stupnja su uključivale 2 slučaja smanjenog broja neutrofila (neutropenija) i jedan slučaj anemije.
English: Oral syringe - Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable.
Croatian: - Upotrijebite pogodnu štrcaljku za usta s CE oznakom i adapter za bočicu (promjera 28 mm) ako je primjenjivo.
English: Larotrectinib Cmax was reduced by approximately 35% and there was no effect on AUC in healthy subjects administered VITRAKVI after a high-fat and high-calorie meal compared to the Cmax and AUC after overnight fasting.
Croatian: Cmax larotrektiniba bio je snižen za približno 35 % i nije bilo utjecaja na AUC u zdravih ispitanika kojima je VITRAKVI bio primijenjen nakon visokokaloričnog obroka bogatog mastima u usporedbi s Cmax i AUC nakon što su tijekom noći bili natašte.
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.
Croatian: U zdravih odraslih ispitanika, AUC larotrektiniba iz formulacije oralne otopine bila je slična onoj iz kapsule, s time da je Cmax bio 36 % viši kod oralne otopine.
English: Cmax was observed to increase slightly by 1.1, 1.1 and 1.5-fold respectively.
Croatian: Opaženo je blago povećanje Cmax za 1,1, 1,1 odnosno 1,5 puta.
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.
Croatian: Većina nuspojava bila je 1. ili 2. stupnja težine (vidjeti tablicu 3) i povukle su se bez prilagodbe doze lijeka VITRAKVI ili prekida liječenja.
English: - Close the bottle with the original bottle cap (leaving the adapter in place).
Croatian: - Zatvorite bocu originalnim zatvaračem (ostavite adapter na mjestu).
English: - For instructions for use of oral syringes and feeding tubes see section 6.6.
Croatian: - Za upute za uporabu štrcaljki za usta i nazogastričnih sondi vidjeti dio 6.6.
English: NCT02122913
Croatian: Ispitivanje 1 NCT02122913
English: VITRAKVI is only used when - these cancers are advanced or have spread to other parts of the body or if a surgery to remove the cancer is likely to cause severe complications and - there are no satisfactory treatment options.
Croatian: VITRAKVI se primjenjuje samo kada - su ti tumori uznapredovali ili se proširili na druge dijelove tijela ili bi njihovo kirurško uklanjanje vjerojatno prouzročilo teške komplikacije i - nema zadovoljavajućih mogućnosti liječenja.
English: No clinical data is available on the effect of a moderate inducer, but a decrease in larotrectinib exposure is expected.
Croatian: Nema kliničkih podataka o učinku umjerenih induktora, ali očekuje se smanjenje izloženosti larotrektiniba.
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”).
Croatian: Sigurnost lijeka VITRAKVI bila je procijenjena u 125 bolesnika s tumorom pozitivnim na fuzijski gen TRK, u jednom od tri klinička ispitivanja, ispitivanju 1, 2 („NAVIGATE“) i 3 („SCOUT“).
English: Favourable effects of VITRAKVI have been shown on the basis of overall response rate and response duration in a limited number of tumour types.
Croatian: Povoljni učinci lijeka VITRAKVI prikazani su na temelju ukupne stope i trajanja odgovora u ograničenom broju vrsta tumora.
English: Patients should take the next dose at the next scheduled time.
Croatian: Potrebno je da bolesnici uzmu sljedeću dozu prema uobičajenom rasporedu.
English: The area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of larotrectinib after a single dose in healthy adult subjects were dose proportional up to 400 mg and slightly greater than proportional at doses of 600 to 900 mg.
Croatian: Površina ispod krivulje koncentracija u plazmi-vrijeme (AUC) i maksimalna koncentracija u plazmi (Cmax) larotrektiniba nakon jedne doze u zdravih odraslih ispitanika bile su proporcionalne dozi do 400 mg i nešto veće od proporcionalnih kod doza od 600 do 900 mg.
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.
Croatian: Objedinjeni rezultati djelotvornosti za ukupnu stopu odgovora, trajanje odgovora i vrijeme do prvog odgovora u primarnoj analizi populacije (n=93) te nakon nastanka naknadnih primarnih tumora SŽS-a (n=9), rezultirajući objedinjenim skupom podataka (n=102), prikazani su u tablici 5 i tablici
English: As it is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Croatian: S obzirom da trenutno nije poznato može li larotrektinib smanjiti učinkovitost sustavnih hormonskih kontraceptiva, ženama koje koriste sustavne hormonske kontraceptive potrebno je savjetovati da dodatno koriste i mehaničku metodu kontracepcije.
English: Larotrectinib was negative in the in vivo mouse micronucleus test at the maximum tolerated dose of 500 mg/kg.
Croatian: Larotrektinib je bio negativan na in vivo mikronukleusnom testu na miševima kod maksimalne tolerirane doze od 500 mg/kg.
English: - you are allergic to larotrectinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati VITRAKVI - ako ste alergični na larotrektinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Breast-feeding should be discontinued during treatment with VITRAKVI and for 3 days following the final dose.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom VITRAKVI i tijekom 3 dana nakon zadnje doze.
English: It is unknown whether larotrectinib/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se larotrektinib/metaboliti u majčino mlijeko.
English: Pull the plunger down to the mark equal to the dose in mL prescribed by your doctor.
Croatian: Povucite klip prema dolje do oznake koja pokazuje količinu u ml koju je propisao liječnik.
English: Larotrectinib had minimal activity in cell lines with point mutations in the TRKA kinase domain, including the clinically identified acquired resistance mutation, G595R.
Croatian: Larotrektinib je imao minimalnu aktivnost u staničnim linijama s točkastim mutacijama u domeni kinaze TRKA, uključujući klinički identificiranu stečenu mutaciju G595R.
English: ANNEX IV CONCLUSION ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: PRILOG IV. ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O DAVANJU UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: 100 mg once daily
Croatian: 100 mg jedanput na dan
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.
Croatian: Larotrektinib je adenozin-trifosfat (ATP)-kompetitivni i selektivni inhibitor tropomiozin-receptor-kinaze (engl. tropomyosin receptor kinase, TRK) koji je namjerno oblikovan tako da se izbjegne djelovanje na neciljne kinaze.
English: The adverse reactions gait disturbance (17% versus 3% in under 65 years), and blood alkaline phosphatase increased (4% versus 2% in under 65 years) were more frequent in patients of 65 years or older.
Croatian: Nuspojave u vidu poremećenog hoda (17 % naspram 3 % u mlađih od 65 godina) i povišenja alkalne fosfataze u krvi (4 % naspram 2 % u mlađih od 65 godina) bile su češće u bolesnika u dobi od 65 godina ili starijih.
English: The tube should be flushed again with at least 10 mL water to ensure VITRAKVI is delivered and to clear the tube.
Croatian: Sondu treba ponovo isprati s najmanje 10 ml vode kako bi se osigurala isporuka lijeka VITRAKVI te očistila sonda.
English: Contraception in female and male
Croatian: Kontracepcija u žena i muškaraca
English: Adult and paediatric patients with body surface area of at least 1.0 m2
Croatian: Odrasli i pedijatrijski bolesnici čija je površina tijela najmanje 1,0 m2
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.
Croatian: U bolesnika čiji je rak nastao zbog promjene u genu NTRK, ta promjena gena uzrokuje da tijelo proizvodi nenormalan protein pod nazivom fuzijski TRK protein koji može dovesti do nekontroliranog rasta stanica i raka.
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).
Croatian: Glavne mjere ishoda za djelotvornost bile su ukupna stopa odgovora (engl. overall response rate, ORR) i trajanje odgovora (engl. duration of response, DOR), koje je utvrđivalo neovisno ocjenjivačko povjerenstvo na maskirani način (engl.
English: If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Croatian: Ako je Vaše dijete mlađe od 4 tjedna, obratite se liječniku ili ljekarniku prije nego mu date ovaj lijek, osobito ako dijete prima i druge lijekove koji sadrže propilenglikol ili alkohol. - parahidroksibenzoat: može uzrokovati alergijske reakcije (mogu biti odgođene).
English: Larotrectinib was administered to juvenile rats from postnatal day (PND) 7 to 70.
Croatian: Larotrektinib je primjenjivan na mladim štakorima od 7. do 70. dana nakon okota.
English: Bayer Hungária KFT Tel:+36 14 87-41 00
Croatian: Magyarország Bayer Hungária KFT Tel:+36 14 87-41 00
English: The oral solution can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Croatian: Oralna otopina može se uzimati s hranom ili bez nje, ali se ne smije uzimati s grejpom ili sokom od grejpa.
English: Salivary gland (n=3) GIST (n=2)a
Croatian: slinovnica (n=3) GIST (n=2)a
English: If your doctor has told you that you or your child have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you or your child take or receive this medicine.
Croatian: Ako Vam je liječnik rekao da Vi ili Vaše dijete ne podnosite neke šećere ili ako Vam je dijagnosticirano nasljedno nepodnošenje fruktoze, rijetki nasljedni poremećaj kod kojeg bolesnik ne može razgraditi fruktozu, obratite se liječniku prije nego
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.
Croatian: Sigurnosni profil u pedijatrijskoj populaciji (< 18 godina) s obzirom na vrstu prijavljenih nuspojava bio je sličan onome opaženome u odrasloj populaciji.
English: Therefore, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Croatian: Stoga je ženama koje koriste sustavne hormonske kontraceptive potrebno savjetovati da dodatno koriste i mehaničku metodu kontracepcije.
English: Tumour types included in efficacy analysis n
Croatian: Doza i formulacija Vrste tumora uključene u analizu djelotvornosti n
English: VITRAKVI is available as a capsule or oral solution with equivalent oral bioavailability and may be used interchangeably.
Croatian: VITRAKVI je dostupan kao kapsula ili oralna otopina, koje imaju jednaku oralnu bioraspoloživost i smiju se primjenjivati jedna umjesto druge.
English: VITRAKVI is available as a capsule and oral solution formulation.
Croatian: VITRAKVI je dostupan u obliku kapsula i oralne otopine.
English: The pooled primary analysis set consisted of 93 patients and did not include primary CNS tumours.
Croatian: Objedinjeni skup podataka za primarnu analizu sastojao se od 93 bolesnika te nije uključivao primarne tumore SŽS-a.