FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Kisqali
Croatian: Drugi lijekovi i Kisqali
English: These findings included reduced/small lung lobes and additional vessel on the aortic arch and diaphragmatic hernia, absent accessory lobe or (partly) fused lung lobes and reduced/small accessory lung lobe (30 and 60 mg/kg), extra/rudimentary thirteenth ribs and misshapen hyoid bone and reduced number of phalanges in the pollex.
Croatian: Ti su nalazi uključivali smanjene/male plućne režnjeve i dodatnu žilu na aortalnom luku i dijafragmalnu herniju, izostanak prekobrojnog režnja ili (djelomično) spojene plućne režnjeve i smanjeni/mali prekobrojni plućni režanj (30 i 60 mg/kg), dodatna/rudimentarna trinaesta rebra i deformiranu podjezičnu kost te smanjeni broj članaka u palcu.
English: Hazard ratio (95% CI) CI=confidence interval; N=number of patients; NE = Not estimable.
Croatian: Omjer hazarda (95% CI) CI=interval pouzdanosti; N=broj bolesnica; NP = ne može se procijeniti.
English: The dose of a sensitive CYP3A4 substrate with a narrow therapeutic index, including but not limited to alfentanil, ciclosporin, everolimus, fentanyl, sirolimus and tacrolimus, may need to be reduced as ribociclib can increase their exposure.
Croatian: Doza osjetljivog CYP3A4 supstrata s uskim terapijskim indeksom, uključujući, između ostalih, alfentanil, ciklosporin, everolimus, fentanil, sirolimus i takrolimus, možda će trebati biti smanjena budući da ribociklib može povećati njihovu izloženost.
English: • Antiarrhythmics such as amiodarone or quinidine.
Croatian: • Antiaritmike, kao što su amiodaron ili kinidin.
English: Progression free survival a
Croatian: Preživljenje bez progresije a
English: CBR: Clinical benefit rate = proportion of patients with complete response + partial response (+ stable disease or non-complete response/Non-progressive disease ≥24 weeks)
Croatian: CBR (engl. clinical benefit rate): Stopa kliničke koristi = udio bolesnica s potpunim odgovorom + djelomičnim odgovorom (+ stabilna bolest ili nepotpuni odgovor/neprogresivna bolest ≥24 tjedna)
English: 40.7 (37.4, NE)
Croatian: 40,7 (37,4; NP)
English: In study E2301 (MONALEESA-7), the observed mean QTcF increase from baseline was approximately 10 msec higher in the tamoxifen plus placebo subgroup compared with the NSAI plus placebo subgroup, suggesting that tamoxifen alone had a QTcF prolongation effect which can contribute to the QTcF values observed in the Kisqali plus tamoxifen group.
Croatian: U ispitivanju E2301 (MONALEESA-7), opažena srednja vrijednost produljenja QTcF intervala u odnosu na početnu vrijednost bila je otprilike 10 msek više u podskupini koja je primala tamoksifen plus placebo u usporedbi s podskupinom koja je primala NSAI plus placebo, što upućuje na to da je sami tamoksifen imao učinak na produljenje QTcF intervala koji može doprinijeti vrijednostima QTcF-a opaženima u skupini koja je primala Kisqali plus tamoksifen.
English: Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side.
Croatian: Svijetlo sivkasto ljubičasta, bez ureza, okrugla, sa zaobljenim rubovima (promjera otprilike 11,1 mm), s utisnutom oznakom „RIC“ s jedne strane i „NVR“ s druge strane.
English: There are no data on the effects of ribociclib on the breast-fed infant or the effects of ribociclib on milk production.
Croatian: Nema podataka o učincima ribocikliba na dojenčad ili o učincima ribocikliba na laktaciju.
English: • Medicines like intravenous ondansetron, used to prevent nausea and vomiting caused by chemotherapy (treatment with cancer medicines).
Croatian: • Lijekove kao što je ondanzetron koji se primjenjuje u venu, koji se koristi za sprječavanje mučnine i povraćanja uzrokovanih kemoterapijom (terapijom lijekovima protiv raka).
English: Cmax and AUClast for LEQ803 (a prominent metabolite of ribociclib accounting for less than 10% of parent exposure) decreased by 96% and 98%, respectively.
Croatian: Cmax za LEQ803 (istaknuti metabolit ribocikliba koji je odgovoran za manje od 10% izloženosti ishodišnom spoju) smanjen je za 96%, a AUClast za 98%.
English: At the time of the primary PFS analysis, overall survival data were not mature with 120 (16.5%) deaths (HR 0.670; [95%CI: 0.465, 0.964)].
Croatian: U vrijeme primarne analize PFS-a, podaci o ukupnom preživljenju nisu bili zreli uz 120 (16,5%) smrtnih slučajeva (HR 0,670; [95% CI: 0,465; 0,964]).
English: Ribociclib 600 mg N=248
Croatian: Ribociklib 600 mg N=248
English: Based on a population pharmacokinetic analysis that included 160 breast cancer patients with normal hepatic function and 47 patients with mild hepatic impairment, mild hepatic impairment had no effect on the exposure of ribociclib, further supporting the findings from the dedicated hepatic impairment study.
Croatian: Na temelju populacijske farmakokinetičke analize koja je uključivala 160 bolesnica s rakom dojke s normalnom funkcijom jetre i 47 bolesnica s blagim oštećenjem jetre, blago oštećenje jetre nije imalo učinka na izloženost ribociklibu, što dodatno podupire rezultate iz specifičnih ispitivanja oštećenja jetre.
English: • Medicines used to treat sleep disorders such as triazolam.
Croatian: • Lijekove koji se koriste za liječenje poremećaja spavanja kao što je triazolam.
English: Grade 4**
Croatian: Stupanj 4**
English: • Serious infection with increased heart rate, shortness of breath or rapid breathing, fever and chills (these may be signs of sepsis which is an infection in the blood system which may be life threatening).
Croatian: • Ozbiljna infekcija uz ubrzani puls, nedostatak zraka ili ubrzano disanje, vrućica i zimica (to mogu biti znakovi sepse, infekcije krvožilnog sustava koja može biti opasna po život).
English: ORR: Overall response rate = proportion of patients with complete response + partial response b
Croatian: ORR (engl. overall response rate): Stopa ukupnog odgovora = udio bolesnica s potpunim odgovorom + djelomičnim odgovorom b
English: • Skin reddening (erythema)
Croatian: • Crvenilo kože (eritem)
English: • Medicines used to treat symptoms of benign prostatic hyperplasia such as alfuzosin.
Croatian: • Lijekove koji se koriste za liječenje simptoma benigne hiperplazije prostate, kao što je alfuzosin.
English: The global health status/QoL data showed no relevant difference between the Kisqali plus letrozole arm and the placebo plus letrozole arm.
Croatian: Podaci o općem zdravstvenom stanju/kvaliteti života pokazali su da nema relevantne razlike između skupine koja je primala Kisqali plus letrozol i one koja je primala placebo plus letrozol.
English: Blood and lymphatic system disorders Neutropenia, leukopenia, anaemia
Croatian: Poremećaji krvi i limfnog sustava Neutropenija, leukopenija, anemija vrlo često
English: Based on findings in animals, ribociclib can cause foetal harm when administered to a pregnant woman (see section 5.3).
Croatian: Na temelju podataka dobivenih na životinjama, ribociklib može naškoditi fetusu kad se daje trudnici (vidjeti dio 5.3).
English: In study F2301 21.2% had bone-only disease and 60.5% had visceral disease.
Croatian: U ispitivanju F2301, 21,2% imalo je bolest koja je zahvaćala samo kosti, a 60,5% imalo je visceralnu bolest.
English: • Abnormal kidney blood test result (high level of creatinine in the blood)
Croatian: • Odstupanja u rezultatima krvnih pretraga funkcije bubrege (visoka razina kreatinina u krvi)
English: Kisqali contains soya lecithin.
Croatian: Kisqali sadrži sojin lecitin.
English: Dose interruptions and/or adjustments due to hepatobiliary toxicity events were reported in 10.4% of Kisqali plus any combination treated patients, primarily due to ALT increased (6.9%) and/or AST increased (6.1%).
Croatian: Prekidi i/ili prilagodbe doze zbog hepatobilijarne toksičnosti bili su prijavljeni u 10,4% bolesnica koje su primale Kisqali u bilo kojoj kombinaciji, u prvom redu zbog povišene vrijednosti ALT-a (6,9%) i/ili AST-a (6,1%).
English: • Medicines used to treat pulmonary arterial hypertension and erectile dysfunction such as sildenafil.
Croatian: • Lijekove koji se koriste za liječenje plućne arterijske hipertenzije i erektilne disfunkcije, kao što je sildenafil.
English: Ribociclib 600 mg N=335
Croatian: Ribociklib 600 mg N=335
English: You should take Kisqali once daily every day at the same time, preferably in the morning.
Croatian: Trebate uzimati Kisqali jedanput na dan svakoga dana u isto vrijeme, po mogućnosti ujutro.
English: Drug-drug interaction studies between ribociclib and oral contraceptives have not been conducted (see section 4.6)
Croatian: Interakcije između ribocikliba i oralnih kontraceptiva Nisu provedena ispitivanja interakcija između ribocikliba i oralnih kontraceptiva (vidjeti dio 4.6).
English: Repeated-dose toxicity studies (treatment schedule of 3 weeks on/1 week off) of up to 27 weeks' duration in rats and up to 39 weeks' duration in dogs, revealed the hepatobiliary system (proliferative changes, cholestasis, sand-like gallbladder calculi, and inspissated bile) as the primary target organ of toxicity of ribociclib.
Croatian: Ispitivanjima toksičnosti ponovljenih doza (raspored liječenja s 3 tjedna uzimanja lijeka/1 tjednom bez lijeka) u trajanju do 27 tjedana u štakora te u trajanju do 39 tjedana u pasa, otkriveno je da je primarni ciljani organ toksičnosti ribocikliba hepatobilijarni sustav (proliferativne promjene, kolestaza, žučni kamenci nalik na pijesak i zgusnuta žuč).
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Croatian: U predmenopauzalnih ili perimenopauzalnih žena, endokrinu terapiju treba primjenjivati u kombinaciji s agonistom hormona koji potiče otpuštanje luteinizirajućeg hormona (engl. luteinizing hormone releasing hormone, LHRH).
English: Medicinal products that elevate gastric pH
Croatian: Lijekovi koji podižu pH u želucu
English: Ribociclib did not inhibit OAT1, OAT3 or MRP2 at clinically relevant concentrations in vitro.
Croatian: Ribociklib nije inhibirao OAT1, OAT3 ili MRP2 u klinički relevantnim koncentracijama in vitro.
English: No dose adjustments of ribociclib are required at initiation of treatment with mild or moderate CYP3A4 inhibitors.
Croatian: Nisu potrebne prilagodbe doze ribocikliba na početku liječenja blagim ili umjerenim CYP3A4 inhibitorima.
English: Patients enrolled in this study had a median age of 62 years (range 23 to 91).
Croatian: Medijan dobi bolesnica uključenih u ovo ispitivanje bio je 62 godine (raspon 23 do 91).
English: The patients included were Caucasian (82.2%), Asian (7.6%), and Black (2.5%).
Croatian: Uključene bolesnice bile su bjelkinje (82,2%), Azijatkinje (7,6%) i crnkinje (2,5%).
English: Women of childbearing potential who are receiving Kisqali should use effective contraception (e.g. double-barrier contraception) during therapy and for at least 21 days after stopping treatment with Kisqali.
Croatian: Žene reproduktivne dobi koje primaju Kisqali moraju koristiti učinkovitu kontracepciju (npr. dvostruke barijerne metode) tijekom terapije i najmanje 21 dan nakon prestanka liječenja Kisqalijem.
English: CI=confidence interval; N=number of patients; p-value is obtained from the one-sided stratified log-rank test.
Croatian: CI=interval pouzdanosti; N=broj bolesnica; p-vrijednost dobivena je iz jednostranog stratificiranog log-rang testa.
English: Log-rank test and Cox model are stratified by lung and/or liver metastasis, prior chemotherapy for advanced disease, and endocrine combination partner per IRT
Croatian: Log-rang test i Cox model stratificirani su prema metastazama u jetri i/ili plućima, prethodnoj kemoterapiji za uznapredovalu bolest, te kombinacijskom endokrinom partneru po IRT-u.
English: The effect of renal impairment on the pharmacokinetics of ribociclib was also assessed in a renal impairment study that included 7 healthy subjects with normal renal function (absolute GFR [aGFR] ≥90 ml/min), 7 non-cancer subjects with severe renal impairment (aGFR 15 to <30 ml/min) and 3 noncancer subjects with end-stage renal disease (ESRD) (aGFR <15 ml/min) at a single ribociclib dose of 400 mg.
Croatian: Učinak oštećenja bubrega na farmakokinetiku ribocikliba je također ocjenjivan u ispitivanju oštećenja bubrega koje je uključivalo 7 zdravih ispitanika s normalnom bubrežnom funkcijom (apsolutni GFR [aGFR] ≥90 ml/min), 7 ispitanika bez raka s teškim oštećenjem bubrega (aGFR 15 do <30 ml/min) i 3 ispitanika bez raka sa završnom fazom bubrežne bolesti (ESRD, engl. end-stage renal disease) (aGFR <15 ml/min) uz jednokratnu dozu ribocikliba od 400 mg.
English: Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting in 50% inhibition (IC50) values of 0.01 (4.3 ng/ml) and 0.039 μM (16.9 ng/ml) in biochemical assays, respectively.
Croatian: Ribociklib je selektivni inhibitor ciklin-ovisnih kinaza (CDK) 4 i 6, što rezultira vrijednostima 50-postotne inhibicije (IC50) od 0,01 (4,3 ng/ml), odnosno 0,039 μM (16,9 ng/ml), u biokemijskim testovima.
English: Your doctor may also decide to stop treatment with Kisqali permanently.
Croatian: Vaš liječnik također može odlučiti trajno obustaviti Vaše liječenje Kisqalijem.
English: Tables 2, 3, 4 and 5 summarise recommendations for dose interruption, reduction or discontinuation of Kisqali in the management of specific ADRs.
Croatian: U Tablicama 2, 3, 4 i 5 naveden je sažetak preporuka za privremeni prekid doziranja, smanjenje doze ili trajni prekid liječenja Kisqalijem radi zbrinjavanja specifičnih nuspojava.
English: Based on a pharmacokinetic study in non-cancer subjects with hepatic impairment, mild hepatic impairment had no effect on the exposure of ribociclib (see section 4.2).
Croatian: Na temelju farmakokinetičkog ispitivanja u ispitanika bez raka s oštećenjem jetre, blago oštećenje jetre nije imalo učinka na izloženost ribociklibu (vidjeti dio 4.2).
English: Clinical benefit rate b a
Croatian: Stopa kliničke koristi b a
English: Take Kisqali once daily at the same time each day, preferably in the morning.
Croatian: Uzimajte Kisqali jedanput na dan u isto vrijeme svakoga dana, po mogućnosti ujutro.
English: In vitro and in vivo studies indicated ribociclib is eliminated primarily via hepatic metabolism mainly via CYP3A4 in humans.
Croatian: In vitro i in vivo ispitivanja ukazala su na to da se ribociklib u ljudi eliminira prvenstveno putem hepatičkog metabolizma uglavnom putem CYP3A4.
English: • Some medicines used to treat seizures or fits (anti-epileptics) such as carbamazepine and phenytoin.
Croatian: • Neke lijekove koji se koriste za liječenje epileptičkih i drugih napadaja (antiepileptici), kao što su karbamazepin i fenitoin.
English: Review of ECG data showed 14 patients (1.3%) had >500 msec post-baseline QTcF value, and 59 patients (5.6%) had a >60 msec increase from baseline in QTcF intervals.
Croatian: Pregled podataka s EKG-a pokazao je da je 14 bolesnica (1,3%) imalo vrijednost QTcF intervala >500 msek nakon početnog, a 59 bolesnica (5,6%) imalo je povećanje >60 msek u odnosu na početnu vrijednost QTcF intervala.
English: Due to inter-patient variability, the recommended dose adjustments may not be optimal in all patients, therefore close monitoring for ribociclib-related AEs is recommended.
Croatian: Zbog varijabilnosti između bolesnica, preporučene prilagodbe doze neće nužno biti optimalne kod svih bolesnica, pa se stoga preporučuje pažljivo praćenje zbog mogućih štetnih događaja povezanih s ribociklibom.
English: Pregnancy and women of childbearing potential
Croatian: Trudnoća i žene reproduktivne dobi
English: • Medicines used to treat low blood pressure or migraine such as ergotamine or dihydroergotamine.
Croatian: • Lijekove koji se koriste za liječenje niskog krvnog tlaka ili migrene kao što su ergotamin ili dihidroergotamin.
English: If treatment with a strong CYP3A4 inhibitor cannot be avoided, the dose should be reduced to 400 mg once daily (see sections 4.2 and 4.5).
Croatian: Ako se liječenje snažnim CYP3A4 inhibitorom ne može izbjeći, dozu treba smanjiti na 400 mg jedanput na dan (vidjeti dijelove 4.2 i 4.5).
English: Coating material: iron oxide black (E172); iron oxide red (E172); soya lecithin (E322); polyvinyl alcohol (partially hydrolysed); talc; titanium dioxide (E171); xanthan gum.
Croatian: Ovojnica tablete: željezov oksid, crni (E172); željezov oksid, crveni (E172); sojin lecitin (E322); poli(vinilni alkohol) (djelomično hidroliziran); talk; titanijev dioksid (E171); ksantanska guma.
English: If you stop taking Kisqali
Croatian: Ako prestanete uzimati Kisqali
English: Neutropenia was the most frequently reported adverse drug reaction (73.7%) and a grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was reported in 58.6% of patients receiving Kisqali plus any combination in the phase III studies.
Croatian: Neutropenija je bila najčešće prijavljena nuspojava (73,7%), a smanjenje broja neutrofila stupnja 3 ili 4 (na temelju laboratorijskih nalaza) bilo je prijavljeno u 58,6% bolesnica koje su primale Kisqali u bilo kojoj kombinaciji u ispitivanjima faze III.
English: CI=confidence interval, NE=not estimable, N=number of patients; p-value is obtained from the one-sided log-rank test stratified by lung and/or liver metastases, prior chemotherapy for advanced disease, and endocrine partner per IRT (interactive response technology).
Croatian: CI= interval pouzdanosti, NP= ne može se procijeniti, N= broj bolesnica; p-vrijednost dobivena je iz jednostranog log-rang testa stratificiranog prema metastazama u jetri i/ili plućima, prethodnoj kemoterapiji za uznapredovalu bolest, te endokrinom partneru po IRT-u (tehnologija interaktivnog odgovora, engl. interactive response technology)
English: There were no such cases reported in Study E2301 (MONALEESA-7).
Croatian: Nisu prijavljeni slični slučajevi u ispitivanju E2301 (MONALEESA-7).
English: Table 12 MONALEESA-3 - Efficacy results (PFS) based on investigator radiological assessment
Croatian: Tablica 12 MONALEESA-3 - Rezultati djelotvornosti (PFS) na temelju ispitivačeve radiološke procjene
English: Skin and subcutaneous tissue disorders Alopecia, rash
Croatian: Poremećaji kože i potkožnog tkiva Alopecija, osip
English: Dose reduction due to adverse events, regardless of causality, occurred in 37.3% of patients receiving Kisqali in the phase III clinical studies regardless of the combination and permanent discontinuation was reported in 7.0% of patients receiving Kisqali and any combination in the phase III clinical studies.
Croatian: Do smanjenja doze zbog štetnih događaja, bez obzira na uzrok, došlo je u 37,3% bolesnica koje su primale Kisqali u kliničkim ispitivanjima faze III, neovisno o kombinaciji, a trajni prekid liječenja bio je zabilježen u 7,0% bolesnica koje su primale Kisqali u bilo kojoj kombinaciji u kliničkim ispitivanjima faze III.
English: In vivo studies using patient-derived oestrogen receptor-positive breast cancer xenograft model combinations of ribociclib and antioestrogens (i.e. letrozole) resulted in superior tumour growth inhibition with sustained tumour regression and delayed tumour regrowth after stopping dosing compared to each substance alone.
Croatian: U in vivo ispitivanjima u kojima se koristio model ksenografta bolesnica s rakom dojke pozitivnim na estrogenski receptor, kombinacije ribocikliba i antiestrogena (odnosno letrozola) rezultirale su superiornom inhibicijom rasta tumora s održanom tumorskom regresijom i odgođenim ponovnim rastom tumora nakon prekida primjene u usporedbi sa svakim od lijekova kao monoterapijom.
English: Thus, ribociclib may interact with medicinal products which are metabolised via CYP3A4, which may lead to increased serum concentrations of CYP3A4 substrates (see section 4.5).
Croatian: Stoga ribociklib može ostvariti interakciju s lijekovima koji se metaboliziraju putem CYP3A4, što može dovesti do povećanih koncentracija CYP3A4 supstrata u serumu (vidjeti dio 4.5).
English: Patients receiving Kisqali should not breast-feed for at least 21 days after the last dose.
Croatian: Bolesnice koje uzimaju Kisqali ne smiju dojiti najmanje 21 dan nakon uzimanja posljednje doze.
English: In study E2301 40.2% of patients had de novo metastatic disease, 23.7% had bone-only disease, and 56.7% had visceral disease.
Croatian: U ispitivanju E2301, 40,2% bolesnica imalo je de novo metastatsku bolest, 23,7% imalo je metastatsku bolest koja je zahvaćala samo kosti, a 56,7% imalo je visceralnu bolest.
English: Lymphopenia, thrombocytopenia, febrile neutropenia
Croatian: Limfopenija, trombocitopenija, febrilna neutropenija često
English: Contains soya lecithin.
Croatian: Sadrži sojin lecitin.
English: Grade 3**
Croatian: Stupanj 3**
English: Ribociclib and its metabolites are eliminated mainly via faeces, with a small contribution of the renal route.
Croatian: Ribociklib i njegovi metaboliti se eliminiraju uglavnom putem fecesa, a mali dio putem bubrega.
English: The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days.
Croatian: Preporučena doza je 600 mg (tri filmom obložene tablete od po 200 mg) ribocikliba jedanput na dan tijekom 21 uzastopnog dana, nakon čega slijedi 7 dana bez liječenja, čime će se dobiti potpuni ciklus od 28 dana.
English: Drug-food interactions
Croatian: Interakcije lijeka i hrane
English: • Tiredness, itchy yellow skin or yellowing of the whites of your eyes, nausea or vomiting, loss of appetite, pain in the upper right side of the belly (abdomen), dark or brown urine, bleeding or bruising more easily than normal (these may be signs of a liver problem).
Croatian: • Umor, svrbež i žutilo kože ili žutilo bjeloočnica, mučnina ili povraćanje, gubitak apetita, bol u gornjem desnom dijelu trbuha (abdomen), tamna ili smeđa mokraća, krvarenje ili stvaranje modrica lakše no što je to uobičajeno (to bi mogli biti znakovi problema s jetrom).
English: Ribociclib was extensively metabolised, with unchanged drug accounting for 17.3% and 12.1% of the dose in faeces and urine, respectively.
Croatian: Ribociklib se ekstenzivno metabolizirao, pri čemu je nepromijenjeni lijek predstavljao 17,3% doze u fecesu, odnosno 12,1% doze u urinu.
English: The pharmacokinetics of ribociclib were investigated in patients with advanced cancer following oral daily doses of 50 mg to 1200 mg.
Croatian: Farmakokinetika ribocikliba istraživana je u bolesnica s uznapredovalim rakom nakon peroralnih svakodnevnih doza od 50 mg do 1200 mg.
English: Data from a clinical study in patients with breast cancer indicated that tamoxifen exposure was increased approximately 2-fold following co-administration of ribociclib and tamoxifen.
Croatian: Podaci iz kliničkog ispitivanja u bolesnica s rakom dojke ukazali su da je izloženost tamoksifenu otprilike dvostruko veća nakon istodobne primjene ribocikliba i tamoksifena.
English: The effect at the 200 mg once-daily dose was predicted to be a 1.7- and 2.8-fold increase, respectively.
Croatian: Predviđeno je da će učinak doze od 200 mg jedanput na dan rezultirati povećanjem od 1,7, odnosno od 2,8 puta.
English: Hazard Ratio = 0.568; 95% CI [0.457, 0.704] Kaplan-Meier median - Ribociclib: 25.3 months; Placebo: 16.0 months Log rank p-value = 9.63*10^(-8)
Croatian: Omjer hazarda = 0,568; 95% CI [0,457; 0,704] Kaplan-Meierov medijan - ribociklib: 25,3 mjeseca; placebo: 16,0 mjeseci Log rang p-vrijednost = 9,63*10^(-8)
English: At the clinically relevant dose of 600 mg, simulations using PBPK models predicted only weak inhibitory effects of ribociclib on CYP1A2 substrates (<2-fold increase in AUC).
Croatian: U klinički relevantnoj dozi od 600 mg, simulacije korištenjem fiziološki temeljenog farmakokinetičkog modela predvidjele su samo slabe inhibitorne učinke ribocikliba na CYP1A2 supstrate (povećanje AUC-a <2 puta).