FrancophonIA/ELRC3.0 huggingface dataset:
English: • Everolimus, used for several types of cancer and tuberous sclerosis (also used to prevent the rejection of an organ transplant).
Croatian: • Everolimus, koji se koristi za nekoliko vrsta raka i tuberoznu sklerozu (a koristi se i za sprječavanje odbacivanja presađenog organa).
English: Each film-coated tablet contains 0.344 mg soya lecithin.
Croatian: Jedna filmom obložena tableta sadrži 0,344 mg sojinog lecitina.
English: If necessary, your doctor may reduce your dose of Kisqali or temporarily stop it to allow your liver, blood cells, electrolyte levels or heart activity to recover.
Croatian: Ako je potrebno, Vaš liječnik može smanjiti Vašu dozu Kisqalija ili je privremeno obustaviti kako bi omogućio Vašoj jetri, krvnim stanicama, razinama elektrolita i srčanoj aktivnosti da se oporave.
English: The exposure to ribociclib was higher in milk than in plasma.
Croatian: Izloženost ribociklibu bila je viša u mlijeku nego u plazmi.
English: Switching the endocrine combination partners was also not permitted.
Croatian: Također, nije bilo dozvoljeno mijenjati kombinaciju u endokrinoj terapiji.
English: Appropriate monitoring of serum electrolytes (including potassium, calcium, phosphorus and magnesium) should be performed before initiating treatment, at the beginning of the first 6 cycles and then as clinically indicated.
Croatian: Odgovarajuće praćenje elektrolita u serumu (uključujući kalij, kalcij, fosfor i magnezij) potrebno je provesti prije početka liječenja, na početku prvih 6 ciklusa, a zatim prema kliničkoj indikaciji.
English: - ≤LLN)
Croatian: - ≤DGN)
English: The safety and efficacy of Kisqali in children and adolescents aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Kisqalija u djece i adolescenata u dobi manjoj od 18 godina nisu još ustanovljene.
English: Some side effects could be serious Tell your doctor immediately if you get any of the following symptoms during treatment with Kisqali:
Croatian: Neke nuspojave mogu biti ozbiljne Odmah obavijestite svog liječnika ako dobijete bilo koji od sljedećih simptoma tijekom liječenja Kisqalijem:
English: Table 11 MONALEESA-7 - Efficacy results (OS)
Croatian: Tablica 11 MONALEESA-7 - Rezultati djelotvornosti (OS)
English: It is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies.
Croatian: Koristi se u kombinaciji s inhibitorom aromataze ili fulvestrantom, koji se koriste kao hormonske terapije protiv raka.
English: Substances that are substrates of transporters
Croatian: Tvari koje su supstrati transportera
English: Numerous other metabolites were detected in both faeces and urine in minor amounts (≤2.78% of the administered dose).
Croatian: Brojni drugi metaboliti bili su detektirani i u fecesu i u urinu u manjim količinama (≤2,78% primijenjene doze).
English: Kisqali is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Kisqali se ne preporučuje za primjenu tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The dose should be interrupted.
Croatian: Doziranje treba prekinuti.
English: Binding of ribociclib to human plasma proteins in vitro was approximately 70% and was independent of concentration (10 to 10000 ng/ml).
Croatian: Vezanje ribocikliba za proteine ljudske plazme in vitro iznosilo je otprilike 70% i bilo je neovisno o koncentraciji (10 do 10 000 ng/ml).
English: Kisqali should be used together with 2.5 mg letrozole or another aromatase inhibitor or with 500 mg fulvestrant.
Croatian: Kisqali se mora uzimati zajedno s 2,5 mg letrozola ili drugog inhibitora aromataze ili s 500 mg fulvestranta.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE42
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE42
English: Kisqali Dose
Croatian: Kisqali Doza
English: 27.5 (19.1, NE)
Croatian: 27,5 (19,1; NP)
English: Baseline grade = 2: No dose interruption.
Croatian: Početni stupanj = 2: doziranje se ne prekida.
English: Do not take a tablet that is broken, cracked or otherwise damaged.
Croatian: Nemojte uzeti tabletu koja je razlomljena, napuknuta ili na drugi način oštećena.
English: There is only limited experience with reported cases of overdosage with Kisqali.
Croatian: Postoji samo ograničeno iskustvo s prijavljenim slučajevima predoziranja Kisqalijem.
English: If any of the following apply to you, tell your doctor or pharmacist before taking Kisqali:
Croatian: Ako se bilo što od sljedećeg odnosi na Vas, obavijestite svog liječnika ili ljekarnika prije nego što uzmete Kisqali:
English: ), with an estimated 41% reduction in relative risk of progression or death in favour of the Kisqali plus fulvestrant arm.
Croatian: ), uz procijenjeno smanjenje relativnog rizika od progresije bolesti ili smrti od 41% u korist skupine koja je primala Kisqali plus fulvestrant.
English: The primary efficacy results were supported by PFS results based on blinded independent central radiological assessment.
Croatian: Rezultati primarne djelotvornosti potvrđeni su rezultatima za PFS na temelju maskirane neovisne središnje radiološke procjene.
English: Data in subjects with ESRD are limited (n=3) but indicate a similar or somewhat larger increase in ribociclib exposure compared to subjects with severe renal impairment.
Croatian: Podaci u ispitanika s ESRD-om su ograničeni (n=3), ali ukazuju na sličan ili nešto veći porast izloženosti ribociklibu u usporedbi s ispitanicima s teškim oštećenjem bubrega.
English: Initiate appropriate medical therapy and monitor as clinically indicated.
Croatian: Započeti odgovarajuću medikamentoznu terapiju i pratiti prema kliničkoj indikaciji.
English: If you are a woman of childbearing potential you should have a negative pregnancy test before starting treatment with Kisqali.
Croatian: Ako ste žena reproduktivne dobi, morate imati negativan test na trudnoću prije početka liječenja Kisqalijem.
English: Updated analysis (02 January 2017 cut-off) Kisqali plus letrozole
Croatian: Ažurirana analiza (isključni datum 2. siječnja 2017.) Kisqali plus letrozol
English: Patients who are hypersensitive to peanut or soya should not take Kisqali (see section 4.3).
Croatian: Bolesnici koji su preosjetljivi na kikiriki ili soju ne smiju uzimati Kisqali (vidjeti dio 4.3).
English: Elderly No dose adjustment is required in patients over 65 years of age (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnica starijih od 65 godina (vidjeti dio 5.2).
English: A more mature update of overall survival data (30 November 2018 cut-off) is provided in Table 11 and Figures 4 and 5.
Croatian: Noviji podaci o ukupnom preživljenju (isključni datum 30. studenog 2018.) navedeni su u Tablici 11 i Slikama 4 i 5.
English: Updated analysis (30 November 2018 cut-off)
Croatian: Ažurirana analiza (isključni datum 30. studenog 2018.)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Kisqali.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Kisqali.
English: Patients with measurable disease N=379
Croatian: Bolesnice s mjerljivom bolešću N=379
English: You should not take Kisqali on days 22 to 28 of the cycle.
Croatian: Ne smijete uzimati Kisqali od 22. do 28. dana ciklusa.
English: • Analgesics such as alfentanil and fentanyl.
Croatian: • Analgetike kao što su alfentanil i fentanil.
English: The efficacy and safety of ribociclib have not been studied in patients with critical visceral disease.
Croatian: Djelotvornost i sigurnost ribocikliba nije ispitivana u bolesnica s kritičnom visceralnom bolešću.
English: Healthy subjects received single oral doses ranging from 400 mg to 600 mg or repeated daily doses (8 days) at 400 mg.
Croatian: Zdravi ispitanici primali su jednokratne peroralne doze u rasponu od 400 mg do 600 mg ili ponovljene dnevne doze (8 dana) od 400 mg.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kisqali in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Kisqali u svim podskupinama pedijatrijske populacije u raku dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: In the second OS analysis the study met its key secondary endpoint demonstrating a statistically significant improvement in OS.
Croatian: U drugoj analizi OS-a mjera ključnog sekundarnog ishoda za ispitivanje ostvarena je demonstrirajući statistički značajno poboljšanje OS-a.
English: 0.593 (0.480 to 0.732)
Croatian: 0,593 (0,480 do 0,732)
English: Do not change the Kisqali dose or schedule without talking to your doctor.
Croatian: Nemojte mijenjati dozu Kisqalija ili raspored uzimanja, a da se prethodno niste posavjetovali sa svojim liječnikom.
English: Kisqali contains the active substance ribociclib, which belongs to a group of medicines called cyclin-dependent kinase (CDK) inhibitors.
Croatian: Kisqali sadrži djelatnu tvar ribociklib, koja pripada skupini lijekovi koji se nazivaju inhibitori ciklinovisnih kinaza (CDK).
English: This analysis is limited by the small sample sizes for most of the dose cohorts with a majority of the data coming from the 600 mg dose cohort.
Croatian: Ta je analiza ograničena malom veličinom uzorka za većinu kohorti prema dozama, pri čemu većina podataka dolazi iz kohorte koja je primala dozu od 600 mg.
English: Updated results for overall response and clinical benefit rates are displayed in Table 8.
Croatian: Ažurirani rezultati za stope ukupnog odgovora i kliničke koristi prikazani su u Tablici 8.
English: Patients enrolled in this study had a median age of 44 years (range 25 to 58) and 27.7% of patients were younger than 40 years old.
Croatian: Medijan dobi bolesnica uključenih u ovo ispitivanje bio je 44 godine (raspon od 25 do 58), a 27,7% bolesnica bilo je mlađe od 40 godina.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a genotoxic potential of ribociclib.
Croatian: Ispitivanja genotoksičnosti u bakterijskim in vitro sustavima te u in vitro i in vivo sustavima u sisavaca sa i bez metaboličke aktivacije nisu otkrila nikakve dokaze genotoksičnog potencijala ribocikliba.
English: The time to reach Cmax (Tmax) following ribociclib oral administration was between 1 and 4 hours.
Croatian: Vrijeme do postizanja Cmax (Tmax) nakon peroralne primjene ribocikliba bilo je između 1 i 4 sata.
English: Ribociclib was equally distributed between red blood cells and plasma with a mean in vivo blood-to-plasma ratio of 1.04.
Croatian: Ribociklib je bio jednako distribuiran između crvenih krvnih stanica i plazme uz srednji in vivo omjer krv-plazma od 1,04.
English: If you vomit after taking the dose or forget a dose, skip the missed dose that day.
Croatian: Ako povraćate nakon što ste uzeli dozu ili ako zaboravite dozu, preskočite propuštenu dozu za taj dan.
English: What Kisqali is and what it is used for
Croatian: Što je Kisqali i za što se koristi
English: Patients with prior (neo)adjuvant therapy with anastrozole or letrozole must have completed this therapy at least 12 months before study randomisation.
Croatian: Bolesnice s prethodnom (neo)adjuvantnom terapijom anastrozolom ili letrozolom morale su dovršiti tu terapiju najmanje 12 mjeseci prije randomizacije u ispitivanju.
English: Clinical benefit rate (CBR)
Croatian: Stopa kliničke koristi (CBR)
English: Do not take Kisqali: - if you are allergic to ribociclib, peanut, soya or any of the other ingredients of this medicine
Croatian: Nemojte uzimati Kisqali: - ako ste alergični na ribociklib, kikiriki, soju ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: In the phase III clinical studies, 83.2% (89/107) of grade 3 or 4 ALT or AST elevation events occurred within the first 6 months of treatment.
Croatian: U kliničkim ispitivanjima faze III, 83,2% (89/107) događaja povišenja vrijednosti ALT-a ili AST-a stupnja 3 ili 4 nastalo je unutar prvih 6 mjeseci liječenja.
English: Metabolism and nutrition disorders Decreased appetite
Croatian: Poremećaji metabolizma i prehrane Smanjeni apetit vrlo često
English: Overall response rate a
Croatian: Stopa ukupnog odgovora a
English: ANC = absolute neutrophil count; LLN = lower limit of normal
Croatian: ABN = apsolutni broj neutrofila; DGN = donja granica normale
English: congestive heart failure, unstable angina and bradyarrhythmias;
Croatian: kongestivno zatajenje srca, nestabilnu anginu i bradiaritmije;
English: Table 6 Adverse drug reactions observed in the three phase III clinical studies
Croatian: Tablica 6 Nuspojave opažene u tri klinička ispitivanja faze III
English: What Kisqali looks like and contents of the pack Kisqali is supplied as film-coated tablets in aluminum blisters.
Croatian: Kako Kisqali izgleda i sadržaj pakiranja Kisqali je dostupan u obliku filmom obloženih tableta u aluminijskim blisterima.
English: When Kisqali is used in combination with an aromatase inhibitor, the aromatase inhibitor should be taken orally once daily continuously throughout the 28-day cycle.
Croatian: Kad se Kisqali koristi u kombinaciji s inhibitorom aromataze, inhibitor aromataze mora se uzimati peroralno jedanput na dan neprekidno tijekom ciklusa od 28 dana.
English: Of all patients who received Kisqali in studies MONALEESA-2 and MONALEESA-3, representative proportions of patients were ≥65 years and ≥75 years of age (see section 5.1).
Croatian: Od svih bolesnica koje su primale Kisqali u ispitivanjima MONALEESA-2 i MONALEESA-3, udio bolesnica ≥ 65 godina i ≥ 75 godina bio je reprezentativan (vidjeti dio 5.1).
English: • Tamoxifen, another medicine for the treatment of breast cancer.
Croatian: • Tamoksifen, drugi lijek za liječenje raka dojke.
English: Soya lecithin
Croatian: Sojin lecitin
English: These kinases are activated upon binding to D-cyclins and play a crucial role in signalling pathways which lead to cell cycle progression and cellular proliferation.
Croatian: Te se kinaze aktiviraju nakon vezanja za D-cikline i igraju ključnu ulogu u signalnim putevima koji dovode do progresije staničnog ciklusa i stanične proliferacije.
English: Log rank p-value = 9.83*10^(-8)
Croatian: Log rang p-vrijednost = 9,83*10^(-8)
English: a p-value is obtained from the one-sided stratified log-rank test.
Croatian: a p-vrijednost dobivena je iz jednostranog stratificiranog log-rang testa.
English: You will have regular blood tests before and during treatment with Kisqali to check your liver function and the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (blood salts including potassium, calcium, magnesium and phosphate) in your body.
Croatian: Obavljat ćete redovite krvne pretrage prije i tijekom liječenja Kisqalijem kako bi se provjerila Vaša jetrena funkcija te količina krvnih stanica (bijelih krvnih stanica, crvenih krvnih stanica i trombocita) i elektrolita (soli u krvi, uključujući kalij, kalcij, magnezij i fosfat) u Vašem tijelu.
English: 4, pruritus
Croatian: 4, pruritus vrlo često
English: • Hair loss or hair thinning (alopecia)
Croatian: • Gubitak kose ili prorijeđena kosa (alopecija)
English: No overall differences in safety or effectiveness of Kisqali were observed between these patients and younger patients (see section 4.2).
Croatian: Nisu opažene općenite razlike u pogledu sigurnosti ili djelotvornosti Kisqalija između ovih bolesnica i mlađih bolesnica (vidjeti dio 4.2).
English: Continue Kisqali treatment for as long as your doctor tells you to.
Croatian: Nastavite liječenje Kisqalijem onoliko dugo koliko Vam to kaže Vaš liječnik.
English: If the patient vomits after taking the dose or misses a dose, an additional dose should not be taken that day.
Croatian: Ako bolesnica povrati nakon uzimanja doze ili propusti dozu, toga se dana ne smije uzimati dodatna doza.
English: Following oral administration of a single 600 mg dose of [
Croatian: Nakon peroralne primjene jednokratne doze od 600 mg [
English: Febrile neutropenia was reported in about 1.4% of patients exposed to Kisqali in the phase III studies.
Croatian: Febrilna neutropenija bila je prijavljena u oko 1,4% bolesnica izloženih Kisqaliju u ispitivanjima faze III.
English: First and second line patients were enrolled in this study (of whom 19.1% had de novo metastatic disease).
Croatian: U ovom su ispitivanju sudjelovale bolesnice liječene terapijom u prvoj i drugoj liniji (od kojih je 19,1% imalo de novo metastatsku bolest).
English: C] ribociclib to humans, the primary metabolic pathways for ribociclib involved oxidation (dealkylation, C and/or N-oxygenation, oxidation (-2H)) and combinations thereof.
Croatian: C] ribocikliba u ljudi, primarni metabolički putevi za ribociklib uključivali su oksidaciju (dealkilaciju, C i/ili N-oksigenaciju, oksidaciju (-2H)) i njihove kombinacije.
English: Patients in MONALEESA-7 had not received prior endocrine treatment in the advanced breast cancer setting.
Croatian: Bolesnice u ispitivanju MONALEESA-7 nisu prethodno primale endokrinu terapiju za uznapredovali rak dojke.
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Grade 3 neutropenia with a single fever >38.3°C (or above 38°C for more than one hour and/or concurrent infection)
Croatian: Common Terminology Criteria for Adverse Events - Zajednički terminološki kriteriji za nuspojave) ** Neutropenija stupnja 3 s jednom vrućicom >38,3°C (ili iznad 38°C tijekom više od jednog sata i/ili istodobna infekcija)
English: Caution should be used in patients with severe renal impairment with close monitoring for signs of toxicity.
Croatian: Potreban je oprez kod bolesnica s teškim oštećenjem bubrega uz pažljivo praćenje radi znakova toksičnosti.
English: Hepatobiliary toxicity
Croatian: Hepatobilijarna toksičnost
English: • Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
Croatian: • Antibiotike kao što su klaritromicin, telitromicin, moksifloksacin, rifampicin, ciprofloksacin,
English: A pharmacokinetic-pharmacodynamic analysis included a total of 997 patients treated with ribociclib at doses ranging from 50 to 1200 mg.
Croatian: Farmakokinetičko-farmakodinamička analiza uključivala je ukupno 997 bolesnica liječenih ribociklibom u dozama od 50 do 1200 mg.
English: 44.2% patients were older than 65 years, including 69 patients older than 75 years.
Croatian: 44,2% bolesnica bilo je starije od 65 godina, što uključuje i 69 bolesnica koje su bile starije od 75 godina.
English: No of events
Croatian: Broj događaja
English: Amongst the patients who had QTcF prolongation >480 msec, the median time to onset was 15 days regardless of the combination and these changes were reversible with dose interruption and/or dose reduction (see sections 4.2, 4.4 and 5.2).
Croatian: Među bolesnicama koje su imale produljenje QTcF intervala >480 msek, medijan vremena do nastupa bio je 15 dana neovisno o kombinaciji i te su promjene bile reverzibilne uz privremeni prekid doziranja i/ili smanjenje doze (vidjeti dijelove 4.2, 4.4 i 5.2).
English: The concomitant use of strong CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for lack of efficacy.
Croatian: Istodobna primjena snažnih CYP3A4 induktora mogla bi stoga dovesti do smanjene izloženosti i posljedično do rizika od nedostatka djelotvornosti.
English: * Excluding neutropenia, hepatotoxicity and QT interval prolongation.
Croatian: * Isključuje neutropeniju, hepatotoksičnost i produljenje QT intervala.
English: Among the patients who had grade 2, 3 or 4 neutropenia, the median time to onset was 16 days, for those patients who had an event.
Croatian: Među bolesnicama koje su imale neutropeniju stupnja 2, 3 ili 4, medijan vremena do nastupa bio je 16 dana, za one bolesnice u kojih se pojavila neutropenija.
English: The outer carton of the Kisqali pack includes a “calendar tool” which allows you to track your daily Kisqali dose by marking off a circle for every tablet you take over the 28-day cycle.
Croatian: Vanjska kutija pakiranja Kisqalija uključuje „pomoćni kalendar“ koji Vam omogućuje da pratite svoju dnevnu dozu Kisqalija označavanjem kruga za svaku tabletu koju uzmete tijekom 28-dnevnog ciklusa.
English: C] ribociclib, 91.7% of the total administered radioactive dose was recovered within 22 days; faeces was the major route of excretion (69.1%), with 22.6% of the dose recovered in urine.
Croatian: C] ribocikliba, 91,7% ukupne primijenjene radioaktivne doze izlučilo se unutar 22 dana; feces je bio glavni put izlučivanja (69,1%), a 22,6% doze izlučilo se u urinu.
English: In vitro, ribociclib decreased pRb phosphorylation, leading to arrest in the G1 phase of the cell cycle, and reduced cell proliferation in breast cancer cell lines.
Croatian: In vitro je ribociklib smanjio fosforilaciju pRb, što je dovelo do zastoja u G1 fazi staničnog ciklusa i smanjilo staničnu proliferaciju u linijama stanica raka dojke.
English: Your doctor will tell you exactly how many tablets of Kisqali to take; in certain situations your doctor may instruct you to take a lower dose of Kisqali, e.g. 400 mg (2 tablets of 200 mg) once daily or 200 mg (1 tablet of 200 mg) once daily.
Croatian: Vaš će Vam liječnik reći koliko točno tableta Kisqalija trebate uzeti; u određenim situacijama liječnik Vas može uputiti da uzmete nižu dozu Kisqalija, npr. 400 mg (2 tablete od 200 mg) jedanput na dan ili 200 mg (1 tabletu od 200 mg) jedanput na dan.
English: • with long QT syndrome;
Croatian: • sa sindromom dugog QT intervala;
English: • Antimalarials such as chloroquine.
Croatian: • Antimalarike kao što je klorokin.
English: A series of pre-specified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Croatian: Serija analiza PFS-a za unaprijed utvrđene podskupine provedena je na temelju prognostičkih čimbenika i početnih karakteristika da bi se istražila interna dosljednost terapijskog učinka.
English: After initiating treatment, liver function should be monitored (see sections 4.2 and 4.8).
Croatian: Nakon početka liječenja treba pratiti jetrenu funkciju (vidjeti dijelove 4.2 i 4.8).
English: Clinical activity (pharmacological and safety) of ribociclib was due primarily to parent drug, with negligible contribution from circulating metabolites.
Croatian: Klinička aktivnost (farmakološka i sigurnosna) ribocikliba bila je u prvom redu uzrokovana ishodišnim lijekom, uz zanemariv doprinos cirkulirajućih metabolita.
English: Table 5 Dose modification and management - Other toxicities*
Croatian: Tablica 5 Prilagodba doze i zbrinjavanje - ostale toksičnosti*
English: The absolute bioavailability of ribociclib is not known.
Croatian: Apsolutna bioraspoloživost ribocikliba nije poznata.
English: Grade 4* (ANC <500/mm
Croatian: Stupanj 4* (ABN <500/mm
English: These effects can be linked to a direct anti-proliferative effects on the testicular germ cells resulting in atrophy of the seminiferous tubules.
Croatian: Ti se učinci mogu povezati s izravnim antiproliferativnim učincima na zametne stanice testisa koji rezultiraju atrofijom sjemenskih kanalića.
English: • Some medicines used as antipsychotics such as haloperidol.
Croatian: • Neke lijekove koji se koriste kao antipsihotici, kao što je haloperidol.
English: Blood creatinine increased, electrocardiogram QT prolonged
Croatian: Povišeni kreatinin u krvi, produljeni QT na elektrokardiogramu često
English: Ribociclib is a substrate for P-gp in vitro, but based on mass balance data inhibition of P-gp or BCRP is unlikely to affect ribociclib exposure at therapeutic doses.
Croatian: Ribociklib je supstrat za P-gp in vitro, no na temelju podataka o ravnoteži mase mala je vjerojatnost da će inhibicija P-gp ili BCRP utjecati na izloženost ribociklibu u terapijskim dozama.
English: Patients with measurable disease
Croatian: Bolesnice s mjerljivom bolešću