FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of pre- and perimenopausal women with the approved Kisqali combinations should also include an LHRH agonist in accordance with local clinical practice.
Croatian: U liječenje predmenopauzalnih i perimenopauzalnih žena odobrenim kombinacijama s Kisqalijem potrebno je uključiti i agonist LHRH-a u skladu s lokalnom kliničkom praksom.
English: The analysis suggested that ribociclib causes concentration-dependent increases in the QTc interval.
Croatian: Analiza je ukazala na to da ribociklib uzrokuje povećanja QTc intervala ovisna o koncentraciji.
English: Ribociclib showed foetotoxicity and teratogenicity at doses which did not show maternal toxicity in the rats or rabbits.
Croatian: Ribociklib je pokazao fetotoksičnost i teratogenost pri dozama koje nisu pokazale toksičnost za majku u štakora i kunića.
English: Hypocalcaemia, hypokalaemia, hypophosphataemia
Croatian: Hipokalcemija, hipokalijemija, hipofosfatemija često
English: Ribociclib was the major circulating drug-derived entity in plasma.
Croatian: Ribociklib je bio glavni cirkulirajući entitet u plazmi izveden iz lijeka.
English: • Tiredness, pale skin (potential sign of a low level of red blood cells, anaemia)
Croatian: • Umor, blijeda koža (potencijalni znakovi niske razine crvenih krvnih stanica, anemije)
English: 20.7% of patients had bone-only disease and 59.0% of patients had visceral disease.
Croatian: 20,7% bolesnica imalo je bolest koja je zahvaćala samo kosti, a 59,0% bolesnica imalo je visceralnu bolest.
English: Following repeated once-daily dosing, steady state was generally achieved after 8 days and ribociclib accumulated with a geometric mean accumulation ratio of 2.51 (range: 0.97 to 6.40).
Croatian: Nakon ponovljenog doziranja jedanput na dan, stanje dinamičke ravnoteže općenito je bilo postignuto nakon 8 dana, a ribociklib se akumulirao uz geometrijsku srednju vrijednost omjera akumulacije od 2,51 (raspon: 0,97 do 6,40).
English: When tested in a panel of breast cancer cell lines with known ER status, ribociclib demonstrated to be more efficacious in ER+ breast cancer cell lines than in the ER- ones.
Croatian: Kada je bio testiran u panelu linija stanica raka dojke s poznatim ER statusom, ribociklib se pokazao djelotvornijim u ER+ linijama stanica raka dojke nego u onima koje su bile ER-.
English: Patients should be advised to be cautious when driving or using machines in case they experience fatigue, dizziness or vertigo during treatment with Kisqali (see section 4.8).
Croatian: Bolesnice treba upozoriti da budu oprezne kada upravljaju vozilima ili rade sa strojevima u slučaju da osjete umor, omaglicu ili vrtoglavicu tijekom liječenja Kisqalijem (vidjeti dio 4.8).
English: It may change how Kisqali is processed in your body and may increase the amount of Kisqali in your bloodstream.
Croatian: Oni bi mogli promijeniti način na koji se Kisqali obrađuje u Vašem tijelu i povećati količinu Kisqalija u Vašem krvotoku.
English: • St. John's Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
Croatian: • Gospinu travu (poznatu i kao Hypericum perforatum) - biljni lijek koji se koristi za liječenje depresije i drugih bolesti.
English: A more mature update of efficacy data (02 January 2017 cut-off) is provided in Tables 7 and 8.
Croatian: Kasniji ažurirani podaci o djelotvornosti (isključni datum 2. siječnja 2017.) navedeni su u Tablicama 7 i 8.
English: Hepatotoxicity: hepatocellular injury, drug-induced liver injury (<1%), hepatotoxicity, hepatic failure, autoimmune hepatitis (single case).
Croatian: Hepatotoksičnost: hepatocelularno oštećenje, oštećenje jetre uzrokovano lijekom (<1%), hepatotoksičnost, zatajenje jetre, autoimuni hepatitis (jedan slučaj).
English: Due to inter-patient variability, the recommended dose adjustments may not be optimal in all patients, therefore close monitoring of signs of toxicity is recommended.
Croatian: Zbog varijabilnosti između bolesnica, preporučene prilagodbe doze nisu nužno optimalne kod svih bolesnica, pa se stoga preporučuje pažljivo praćenje znakova toksičnosti.
English: Table 1 Recommended dose modification guidelines
Croatian: Tablica 1 Smjernice za prilagodbu preporučene doze
English: 21 film-coated tablets 42 film-coated tablets 63 film-coated tablets
Croatian: Filmom obložena tableta 21 filmom obložena tableta 42 filmom obložene tablete 63 filmom obložene tablete
English: Based on its severity, neutropenia was managed by laboratory monitoring, dose interruption and/or dose modification.
Croatian: Ovisno o težini, neutropenija se zbrinjavala laboratorijskim praćenjem, privremenim prekidom doziranja i/ili prilagodbom doze.
English: Effect of ribociclib on cytochrome P450 enzymes
Croatian: Učinak ribocikliba na enzime citokroma P450
English: Population pharmacokinetic analysis showed that there are no clinically relevant effects of age, body weight or gender on the systemic exposure of ribociclib that would require a dose adjustment.
Croatian: Populacijska farmakokinetička analiza pokazala je da nema klinički relevantnih učinaka dobi, tjelesne težine ili spola na sistemsku izloženost ribociklibu zbog kojih bi bila potrebna prilagodba doze.
English: In rats, reduced foetal weights accompanied by skeletal changes considered to be transitory and/or related to the lower foetal weights were noted.
Croatian: U štakora je opažena smanjena fetalna težina popraćena promjenama u skeletu za koje se smatralo da su prolazne i/ili povezane s nižim fetalnim težinama.
English: The median follow-up time at the time of primary PFS analysis was 20.4 months.
Croatian: Medijan vremena praćenja u vrijeme primarne analize PFS-a iznosio je 20,4 mjeseca.
English: In the event of ribociclib-related toxicity, the dose should be modified or treatment should be interrupted until toxicity is resolved (see sections 4.2 and 5.2).
Croatian: U slučaju toksičnosti povezane s ribociklibom, potrebno je prilagoditi dozu ili prekinuti liječenje dok se toksičnost ne povuče (vidjeti dijelove 4.2 i 5.2).
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of ribociclib.
Croatian: Stoga lijekovi koji mogu utjecati na aktivnost CYP3A4 enzima mogu promijeniti farmakokinetiku ribocikliba.
English: Time (months) Ribociclib+ Fulvestrant Placebo+Fulvestrant
Croatian: Vrijeme (mjeseci) Ribociklib+ Fulvestrant Placebo+Fulvestrant
English: The median duration of exposure to Kisqali treatment across the pooled phase III studies dataset was 16.5 months, with 61.7% patients exposed ≥12 months.
Croatian: Medijan trajanja izloženosti Kisqaliju u objedinjenom skupu podataka iz ispitivanja faze III iznosio je 16,5 mjeseci, a 61,7% bolesnica bilo je izloženo 12 mjeseci.
English: Infections: urinary tract infections, respiratory tract infections, gastroenteritis, sepsis (<1%).
Croatian: Infekcije: infekcije mokraćnog sustava, infekcije dišnog sustava, gastroenteritis, sepsa (<1%).
English: LEQ803 Cmax increased 1.7-fold and AUCinf decreased by 27%, respectively.
Croatian: Cmax za LEQ803 povećao se 1,7 puta, a AUCinf se smanjio za 27%.
English: Women who have not reached menopause will also be treated with a medicine called a luteinising hormone releasing hormone (LHRH) agonist.
Croatian: Žene koje nisu još u menopauzi također će se liječiti lijekom koji se naziva agonist hormona koji potiče otpuštanje luteinizirajućeg hormona (engl. luteinising hormone releasing hormone, LHRH).
English: In rabbits, there were adverse effects on embryo-foetal development as evidenced by increased incidences of foetal abnormalities (malformations and external, visceral and skeletal variants) and foetal growth (lower foetal weights).
Croatian: Kod kunića je bilo štetnih učinaka na embriofetalni razvoj, što je bilo vidljivo iz povećanih incidencija fetalnih abnormalnosti (anomalija i vanjskih, visceralnih i skeletnih varijacija) i fetalnog rasta (nižih fetalnih težina).
English: Refer to the SmPC for the co-administered aromatase inhibitor, fulvestrant or LHRH agonist for dose modification guidelines and other relevant safety information in the event of toxicity.
Croatian: Provjerite sažetak opisa svojstava lijeka za istodobno primijenjeni inhibitor aromataze, fulvestrant ili agonist LHRH-a za smjernice o prilagodbi doze i ostale relevantne sigurnosne informacije u slučaju toksičnosti.
English: The median follow-up time at the time of primary PFS analysis was 19.2 months.
Croatian: Medijan vremena praćenja u vrijeme primarne analize PFS-a iznosio je 19,2 mjeseci.
English: • Loss of skin colour in patches (vitiligo)
Croatian: • Gubitak boje na nekim dijelovima kože (vitiligo)
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment (see section 4.4).
Croatian: Plan zbrinjavanja za svaku pojedinu bolesnicu mora se voditi kliničkom prosudbom liječnika koji provodi liječenje temeljenom na procjeni individualnog omjera koristi i rizika (vidjeti dio 4.4).
English: Table 3 Dose modification and management - Hepatobiliary toxicity
Croatian: Tablica 3 Prilagodba doze i zbrinjavanje - hepatobilijarna toksičnost
English: In vivo cardiac safety studies in dogs demonstrated dose and concentration related QTc interval prolongation at an exposure that would be expected to be achieved in patients following the recommended dose of 600 mg.
Croatian: In vivo ispitivanja sigurnosti primjene za srce provedena u pasa pokazala su produljenje QTc intervala povezano s dozom i koncentracijom pri izloženosti za koju bi se očekivalo da se postigne u bolesnica nakon preporučene doze od 600 mg.
English: Serial, triplicate ECGs were collected following a single dose and at steady state to evaluate the effect of ribociclib on the QTc interval in patients with advanced cancer.
Croatian: Serijski, trostruki EKG-ovi bili su prikupljeni nakon jednokratne doze i u stanju dinamičke ravnoteže da bi se ocijenio učinak ribocikliba na QTc interval u bolesnica s uznapredovalim rakom.
English: Simulations using physiologically-based pharmacokinetic models suggested that Kisqali given at the clinically relevant dose of 600 mg is expected to increase the midazolam AUC by 5.2-fold.
Croatian: Simulacije korištenjem fiziološki temeljenih farmakokinetičkih modela ukazuju na to da se očekuje da će Kisqali primijenjen u klinički relevantnoj dozi od 600 mg povećati AUC midazolama za 5,2 puta.
English: Please refer to the Summary of Product Characteristics (SmPC) of the aromatase inhibitor for additional details.
Croatian: Vidjeti sažetak opisa svojstava lijeka (SmPC) za inhibitor aromataze za dodatne pojedinosti.
English: Infections and infestations Infections
Croatian: Infekcije i infestacije Infekcije vrlo često
English: The tablets should be swallowed whole and should not be chewed, crushed or split prior to swallowing.
Croatian: Tablete se trebaju progutati cijele i ne smiju se žvakati, drobiti ili lomiti prije gutanja.
English: You should therefore be cautious when driving or using machines during your treatment with Kisqali.
Croatian: Stoga trebate biti oprezni prilikom upravljanja vozilom ili korištenja strojeva za vrijeme liječenja Kisqalijem.
English: Kisqali tablets should be swallowed whole (tablets should not be chewed, crushed or split before swallowing).
Croatian: Tablete Kisqalija trebate progutati cijele (tabletu ne smijete žvakati, drobiti ili lomiti prije gutanja).
English: In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.
Croatian: U slučaju produljenja QTcF intervala tijekom liječenja, preporučuje se učestalije praćenje EKG-om.
English: Grade 1 or 2**
Croatian: Stupanj 1 ili 2**
English: You should use effective contraception (e.g. double-barrier contraception such as condom and diaphragm) while taking Kisqali and for at least 21 days after the last dose.
Croatian: Morate koristiti učinkovitu kontracepciju (npr. dvostruka barijerna metoda, kao što je prezervativ i dijafragma) dok uzimate Kisqali i najmanje 21 dan nakon posljednje doze.
English: The film-coated tablets are light greyish violet in colour, unscored, round, debossed with “RIC” on one side and “NVR” on the other side.
Croatian: Filmom obložene tablete su svijetlo sivkasto ljubičaste boje, bez razdjelne crte, okrugle, s utisnutom oznakom „RIC“ s jedne strane i „NVR“ s druge strane.
English: The effect of a moderate CYP3A4 inducer on ribociclib exposure has not been studied.
Croatian: Učinak umjerenog CYP3A4 induktora na izloženost ribociklibu nije bila ispitivana.
English: The concomitant use of moderate CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for impaired efficacy, in particular in patients treated with ribociclib at 400 mg or 200 mg once daily.
Croatian: Istodobna primjena umjerenih CYP3A4 induktora stoga može dovesti do smanjene izloženosti te posljedično do rizika od smanjene djelotvornosti, osobito u bolesnica liječenih ribociklibom u dozi od 400 mg ili 200 mg jedanput na dan.
English: • Medicines used to treat high blood sugar levels (e.g. diabetes) such as metformin.
Croatian: • Lijekove koji se koriste za liječenje visokih razina šećera u krvi (npr. šećerne bolesti) kao što je metformin.
English: • The recommended starting dose of Kisqali is 600 mg (3 tablets of 200 mg) once daily.
Croatian: • Preporučena početna doza Kisqalija je 600 mg (3 tablete od 200 mg) jedanput na dan.
English: What Kisqali contains - The active substance is ribociclib.
Croatian: Što Kisqali sadrži - Djelatna tvar je ribociklib.
English: The major circulating metabolites included metabolite M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), and M1 (secondary glucuronide).
Croatian: M13 (CCI284, N-hidroksilacija), M4 (LEQ803, N-demetilacija) i M1 (sekundarni glukuronid).
English: Demographics and baseline disease characteristics were balanced and comparable between study arms.
Croatian: Demografske karakteristike i početne karakteristike bolesti bile su uravnotežene i usporedive između ispitivanih skupina.
English: Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje Kisqalijem mora započeti liječnik s iskustvom u primjeni terapija protiv raka.
English: Adverse drug reactions from the phase III clinical studies (Table 6) are listed by MedDRA system organ class.
Croatian: Nuspojave iz kliničkih ispitivanja faze III (Tablica 6) navedene su prema klasifikaciji organskih sustava iz MedDRA-e.
English: Compared to the fasted state, oral administration of a single 600 mg dose of ribociclib film-coated tablets with a high-fat, high-calorie meal had no effect on the rate and extent of absorption of ribociclib.
Croatian: U usporedbi sa stanjem natašte, peroralna primjena jednokratne doze filmom obloženih tableta od 600 mg ribocikliba uz obrok visokog udjela masti i kalorijske vrijednosti nije utjecala na brzinu i opseg apsorpcije ribocikliba.
English: • Methadone, used to treat pain or addiction to opioids.
Croatian: • Metadon, koji se koristi za liječenje boli ili ovisnosti o opioidima.
English: Stopping your treatment with Kisqali may cause your condition to get worse.
Croatian: Prestanak Vašeg liječenja Kisqalijem može uzrokovati pogoršanje bolesti.
English: Kisqali can be taken with or without food (see section 4.5).
Croatian: Kisqali se može uzimati s hranom ili bez nje (vidjeti dio 4.5).
English: The use of Kisqali should be avoided in patients who already have or who are at significant risk of developing QTc prolongation.
Croatian: Primjenu Kisqalija treba izbjegavati u bolesnica koje već imaju produljenje QTc intervala ili su pod značajnim rizikom od njegova razvoja.
English: Ribociclib exhibits high solubility at or below pH 4.5 and in bio-relevant media (at pH 5.0 and 6.5).
Croatian: Ribociklib ima visoku topljivost pri pH 4,5 ili nižem te u biorelevantnim medijima (pri pH 5,0 i 6,5).
English: ECGs with QTcF >500 msec
Croatian: EKG-ovi s QTcF intervalom >500 msek
English: ECGs with QTcF >480 msec
Croatian: EKG-ovi s QTcF intervalom >480 msek
English: The median time to resolution (to normalisation or grade ≤2) was 22 days in the Kisqali plus any combination arms.
Croatian: Medijan vremena do povlačenja (do normalizacije ili stupnja ≤2) bio je 22 dana u skupinama koje su primale Kisqali u bilo kojoj kombinaciji.
English: Make sure you tell your doctor of all medicines and supplements, including herbal medicines, that you are taking before you start treatment with Kisqali and if you are prescribed a new medicine after you have started treatment with Kisqali.
Croatian: Svakako recite svom liječniku o svim lijekovima i dodacima prehrani, uključujući biljne lijekove, koje trenutačno uzimate prije nego što započnete liječenje Kisqalijem te ako Vam je propisan bilo koji novi lijek nakon što ste započeli liječenje Kisqalijem.
English: Additionally, in vivo antitumour activity of ribociclib in combination with fulvestrant was assessed in immune-deficient mice bearing the ZR751 ER+ human breast cancer xenografts and the combination with fulvestrant resulted in complete tumour growth inhibition.
Croatian: Nadalje, in vivo antitumorska aktivnost ribocikliba u kombinaciji s fulvestrantom ocijenjena je u imunodeficijentnih miševa sa ZR751 ER+ ksenograftima humanog raka dojke te je kombinacija s fulvestrantom rezultirala potpunom inhibicijom rasta tumora.
English: However, monitoring of ribociclib-related AEs is recommended.
Croatian: Međutim, preporučuje se praćenje štetnih događaja povezanih s ribociklibom.
English: Combined elevations in AST and/or ALT together with total bilirubin increase, in the absence of cholestasis
Croatian: Kombinirani porast vrijednosti AST-a i/ili ALT-a zajedno s porastom ukupnog bilirubina, kad nema kolestaze
English: Effect of ribociclib on transporters
Croatian: Učinak ribocikliba na transportere
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A).
Croatian: Nije potrebna prilagodba doze u bolesnica s blagim oštećenjem jetre (Child-Pugh stadij A).
English: Recommendations for patients who have elevated AST/ALT grade ≥ 3 at baseline have not been established.
Croatian: Preporuke za bolesnice koje imaju povišene vrijednosti AST-a/ALT-a stupnja ≥3 na početku nisu utvrđene.
English: The median time to resolution of grade ≥3 (to normalisation or grade <3) was 12 days in the Kisqali plus any combination arms following treatment interruption and/or reduction and/or discontinuation.
Croatian: Medijan vremena do povlačenja stupnja ≥3 (do normalizacije ili stupnja <3) bio je 12 dana u skupinama koje su primale Kisqali u bilo kojoj kombinaciji nakon privremenog prekida liječenja i/ili smanjenja doze i/ili trajnog prekida liječenja.
English: Treatment discontinuation due to neutropenia was low (0.8%) (see sections 4.2 and
Croatian: Stopa trajnih prekida liječenja zbog neutropenije bila je niska (0,8%) (vidjeti dijelove 4.2 i 4.4).
English: Ribociclib is primarily metabolised by CYP3A4.
Croatian: Ribociklib se metabolizira prvenstveno putem CYP3A4.
English: If QTcF interval prolongation to greater than 500 msec or greater than 60 msec change from baseline occurs in combination with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue Kisqali.
Croatian: Ako je produljenje QTcF intervala veće od 500 msek ili ako se promjena za više od 60 msek u odnosu na početnu vrijednost pojavi zajedno uz torsade de pointes ili polimorfnu ventrikularnu tahikardiju ili znakove/simptome ozbiljne aritmije, potrebno je trajno prekinuti primjenu Kisqalija.
English: When Kisqali is used in combination with fulvestrant, fulvestrant is administered intramuscularly on days 1, 15 and 29, and once monthly thereafter.
Croatian: Kad se Kisqali koristi u kombinaciji s fulvestrantom, fulvestrant se primjenjuje intramuskularno 1., 15. i 29. dana te jedanput mjesečno nakon toga.
English: Patients enrolled in this study had a median age of 63 years (range 31 to 89).
Croatian: Medijan dobi bolesnica uključenih u ovo ispitivanje bio je 63 godine (raspon od 31 do 89).
English: 46.7% of patients were of age 65 years and older, including 13.8% patients of age 75 years and older.
Croatian: 46,7% bolesnica bilo je starije od 65 godina, što uključuje 13,8% bolesnica koje su bile starije od 75 godina.
English: Caution and monitoring for toxicity are advised during concomitant treatment with sensitive substrates of these transporters which exhibit a narrow therapeutic index, including but not limited to digoxin, pitavastatin, pravastatin, rosuvastatin and metformin.
Croatian: Savjetuju se oprez i praćenje toksičnosti tijekom istodobnog liječenja osjetljivim supstratima tih transportera koji imaju uski terapijski indeks, uključujući između ostalih digoksin, pitavastatin, pravastatin, rosuvastatin i metformin.
English: Time (months) Ribociclib Placebo
Croatian: Vrijeme (mjeseci) Ribociklib Placebo
English: There are no clinical data available regarding effects of ribociclib on fertility.
Croatian: Nisu dostupni klinički podaci o učincima ribocikliba na plodnost.
English: Based on a population pharmacokinetic analysis that included 77 patients with normal renal function (eGFR ≥90 ml/min/1.73 m2), 76 patients with mild renal impairment (eGFR 60 to
Croatian: Na temelju populacijske farmakokinetičke analize koja je uključivala 77 bolesnica s normalnom bubrežnom funkcijom (eGFR ≥90 ml/min/1,73 m2), 76 bolesnica s blagim oštećenjem bubrega (eGFR
English: It is not known if ribociclib is present in human milk.
Croatian: Nije poznato je li ribociklib prisutan u majčinu mlijeku.
English: 54.7% of patients receiving ribociclib plus letrozole were estimated to be progression-free at 24 months compared with 35.9% in the placebo plus letrozole arm.
Croatian: U 54,7% bolesnica koje su primale ribociklib plus letrozol bilo je procijenjeno da nije bilo progresije nakon 24 mjeseca u usporedbi s 35,9% u skupini koja je primala placebo plus letrozol.
English: Patients were not allowed to cross over from placebo to Kisqali during the study or after disease progression.
Croatian: Bolesnici nisu smjeli prijeći s placeba na Kisqali tijekom ispitivanja ili nakon progresije bolesti.
English: • Antipsychotics such as pimozide or quetiapine.
Croatian: • Antipsihotike, kao što su pimozid ili kvetiapin.
English: In addition, haematological (e.g. neutropenia, thrombocytopenia) toxicity and possible QTc prolongation may occur.
Croatian: Uz to, može doći do hematološke (npr. neutropenija, trombocitopenija) toksičnosti i mogućeg produljenja QTc intervala.
English: In the preclinical models tested so far, intact pRb was required for ribociclib activity.
Croatian: U dosad testiranim nekliničkim modelima, za aktivnost ribocikliba bio je potreban intaktni pRb.
English: If grade ≥2 abnormalities are noted, more frequent monitoring is recommended.
Croatian: Ako se opaze odstupanja u nalazima stupnja ≥2, preporučuje se učestalije praćenje.
English: Metabolite LEQ803 was a significant metabolite in excreta and represented approximately 13.9% and 3.74% of the administered dose in faeces and urine, respectively.
Croatian: Metabolit LEQ803 bio je značajan metabolit u izlučinama i predstavljao je otprilike 13,9% primijenjene doze u fecesu, odnosno 3,74% primijenjene doze u urinu.
English: Ribociclib+Fulvestrant: 210, Placebo+Fulvestrant: 151 Hazard Ratio = 0.593
Croatian: Ribociklib+Fulvestrant: 210, Placebo+Fulvestrant: 151 Omjer hazarda = 0,593
English: In non-cancer subjects with severe renal impairment AUCinf increased 1.96-fold, and Cmax increased 1.51-fold compared to healthy subjects with normal renal function (see section 4.2).
Croatian: U ispitanika bez raka s teškim oštećenjem bubrega AUCinf se povećao 1,96 puta, a Cmax se povećao 1,51 put, u usporedbi sa zdravim ispitanicima s normalnom bubrežnom funkcijom (vidjeti dio 4.2).
English: Exposure to ribociclib in animals in the toxicity studies was generally less than or equal to that observed in patients receiving multiple doses of 600 mg/day (based on AUC).
Croatian: Izloženost ribociklibu u životinja u ispitivanjima toksičnosti bila je općenito manja od ili jednaka onoj opaženoj u bolesnica koje su primile višestruke doze od 600 mg/dan (na temelju AUC-a).