FrancophonIA/ELRC3.0 huggingface dataset:
English: Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack).
Croatian: Svaka kutija sadrži 21 tvrdu kapsulu (3 blistera po pakiranju) ili 63 tvrde kapsule (9 blistera po pakiranju).
English: IBRANCE may affect the way some other medicines work.
Croatian: IBRANCE može utjecati na način djelovanja nekih lijekova.
English: IBRANCE capsules should be swallowed whole (should not be chewed, crushed, or opened prior to swallowing).
Croatian: Kapsule lijeka IBRANCE treba progutati cijele (ne smiju se žvakati, lomiti ili otvarati prije gutanja).
English: Appropriate monitoring should be performed (see sections 4.2 and 4.8).
Croatian: Mora se provoditi odgovarajući režim praćenja (vidjeti dijelove 4.2 i 4.8).
English: Palbociclib absorption and exposure were very low in approximately 13% of the population under the fasted condition.
Croatian: Apsorpcija palbocikliba i izloženosti bili su vrlo niski kod približno 13% populacije u uvjetima natašte.
English: No capsule should be ingested if it is broken, cracked, or otherwise not intact.
Croatian: Nijedna kapsula se ne smije progutati ako je slomljena, napuknuta ili oštećena na neki drugi način.
English: These systemic toxicities were generally observed at clinically relevant exposures based on AUC.
Croatian: Te sustavne toksičnosti općenito se uočavaju pri kliničkim značajnim izloženostima na temelju AUC.
English: Resume at next lower dose.
Croatian: Nastaviti pri sljedećoj nižoj dozi.
English: It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
Croatian: Daje se skupa s inhibitorima aromataze ili fulvestrantom, koji se koriste kao hormonska terapija protiv raka.
English: Women of childbearing potential or their partners
Croatian: Žene u reproduktivnoj dobi ili njihovi partneri
English: Steady state was achieved within 8 days following repeated once daily dosing.
Croatian: Stanje dinamičke ravnoteže postignuto je unutar 8 dana nakon ponovljenog doziranja jednom dnevno.
English: However, this finding was not reproduced consistently in subsequent studies in Japanese or Asian breast cancer patients after multiple dosing.
Croatian: Međutim, ovaj nalaz se nije ponovio na dosljedan način u naknadnim ispitivanjima provedenim na japanskim ili azijskim bolesnicama s rakom dojke nakon višekratnog doziranja.
English: What you need to know before you take IBRANCE
Croatian: Što morate znati prije nego počnete uzimati IBRANCE
English: Therefore, you may be at greater risk of getting an infection while you are taking IBRANCE.
Croatian: Stoga, možete biti pod većim rizikom od dobivanja infekcije dok uzimate IBRANCE.
English: Palbociclib is not a substrate of OATP1B1 or OATP1B3.
Croatian: Palbociklib nije supstrat OATP1B1 ili OATP1B3.
English: Based on an analysis of the cumulative pharmacokinetic, safety, and efficacy data across Asian and non-Asian populations, no dose adjustment based on Asian race is considered necessary.
Croatian: Na temelju analize ukupnih podataka o farmakokinetici, sigurnosti primjenete djelotvornosti za sve azijske i neazijske populacije, smatra se da nije potrebna prilagodba doze za bolesnice azijske rase.
English: Binding of palbociclib to human plasma proteins in vitro was ~85%, with no concentration dependence.
Croatian: Vezanje palbocikliba na proteine ljudske plazme in vitro iznosilo je ~85%, bez ovisnosti o koncentraciji.
English: The median age of patients enrolled in this study was 57 years (range 29, 88).
Croatian: Medijan dobi bolesnica uključenih u ovo ispitivanje bio je 57 godina (raspon 29 - 88).
English: More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Croatian: Više od polovice (62%) imalo je ECOG PS od 0, 60 % njih je imalo visceralne metastaze, a 60% je primilo više od jednog prethodnog hormonalnog režima za svoju primarnu dijagnozu.
English: A more mature update of efficacy data is reported in Table 8.
Croatian: Novije ažuriranje podataka o djelotvornosti zabilježeno je u Tablici 8.
English: You should not use IBRANCE if you are pregnant.
Croatian: Ne smijete uzimati lijek IBRANCE ako ste trudni.
English: In the cell lines tested, the loss of retinoblastoma (Rb) was associated with loss of palbociclib activity.
Croatian: Kod testiranja stanične linije, gubitak retinoblastoma (Rb) se povezivao sa gubljenjem aktivnosti palbocikliba.
English: Actual foetal exposure and cross-placenta transfer have not been examined.
Croatian: Aktualno izlaganje fetusa i prijenos kroz placentu nisu proučavani.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili da pokazuje znakove neovlaštenog otvaranja.
English: If you miss a dose or vomit, take your next dose as scheduled.
Croatian: Ako propustite dozu ili povraćate, uzmite sljedeću dozu prema rasporedu.
English: Treatment with IBRANCE should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje lijekom IBRANCE treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv raka.
English: Strong inhibitors of CYP3A4 may lead to increased toxicity (see section 4.5).
Croatian: Snažni inhibitori CYP3A4 mogu uzrokovati povećanu toksičnost (vidjeti dio 4.5).
English: • Rifampin used to treat tuberculosis (TB).
Croatian: • rifampicin, koji se koristi za liječenje tuberkuloze (TBC).
English: Since IBRANCE has myelosuppressive properties, it may predispose patients to infections.
Croatian: S obzirom da IBRANCE ima mijelosupresivna svojstva, može bolesnice učiniti sklonima infekcijama.
English: In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Croatian: U svakoj skupini liječenja većina bolesnica bile su bjelkinje, imale su dokazanu osjetljivost na prethodnu hormonsku terapiju i bile su u postmenopauzi.
English: Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways which lead to cellular proliferation.
Croatian: Ciklin D1 i CDK4/6 silazni su tok višestrukog signalnog puta koji uzrokuje staničnu proliferaciju.
English: Food intake increased the palbociclib exposure in this small subset of the population, but did not alter palbociclib exposure in the rest of the population to a clinically relevant extent.
Croatian: Unos hrane povećao je izloženost palbocikliba u ovoj maloj podskupini populacije, ali nije promijenio izloženost palbocikliba u ostatku populacije do klinički značajne mjere.
English: However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Croatian: Međutim, u daljnjem ispitivanju sa svježim tumorskim uzorcima, nije primijećena povezanost između ekspresije RB1 i tumorskog odgovora.
English: Pre/perimenopausal women
Croatian: Žene u pre/perimenopauzi
English: However, IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.
Croatian: Međutim, lijek IBRANCE može uzrokovati umor i bolesnice moraju biti oprezne kada upravljaju vozilima ili rade na strojevima.
English: There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Croatian: Nije bilo učinaka na ciklus estrusa (ženke štakora) ili parenje i plodnost u štakora (ženki ili mužjaka) u nekliničkim ispitivanjima reprodukcije.
English: Grade 3 ANCb (<1000 to 500/mm3) + Fever ≥38.5 ºC and/or infection
Croatian: Stupanj 3 ABN (< 1000 do 500/mm + vrućica ≥ 38,5 ºC i/ili infekcija
English: A series of prespecified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Croatian: Serija prethodno određene podskupine PFS analiza provedena je na temelju prognostičkih čimbenika i početnih karakteristika kako bi se ispitalo internu konzistenciju terapijskog učinka.
English: IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death.
Croatian: IBRANCE može uzrokovati tešku ili po život opasnu upalu pluća tijekom liječenja, koja može dovesti do smrti.
English: Do not use this medicine after the expiry date which is stated on the bottle or blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici ili blisteru i kutiji iza oznake „EXP“.
English: Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Croatian: Prekid doziranja, smanjenje doze ili odgoda početka ciklusa liječenja preporučuje se u bolesnica koje razviju neutropeniju stupnja 3 ili 4.
English: The following medicines may reduce the effectiveness of IBRANCE:
Croatian: Sljedeći lijekovi mogu smanjiti učinkovitost lijeka IBRANCE:
English: Grade ≥3 non-haematological toxicity (if persisting despite medical treatment)
Croatian: Nehematološka toksičnost stupnja ≥ 3 (ako potraje unatoč liječenju)
English: Coadministration of CYP3A inducers may lead to decreased palbociclib exposure and consequently a risk for lack of efficacy.
Croatian: Istodobna primjena induktora CYP3A može uzrokovati smanjenu izloženost palbociklibu te posljedično i rizik za nedostatak djelotvornosti.
English: IBRANCE has minor influence on the ability to drive and use machines.
Croatian: IBRANCE ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE33.
Croatian: Farmakoterapijska skupina: Antineoplatici, inhibitori protein kinaze, ATK oznaka: L01XE33.
English: OR* [% (95% CI)] OR* measurable disease [% (95% CI)] CBR* [% (95% CI)] N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; PFS=progression-free survival.
Croatian: OR* [% (95% CI)] OR* mjerljiva bolest [% (95% CI)] CBR* [% (95% CI)] N=broj bolesnika; CI=interval pouzdanosti; NP=nije procjenjivo; OR=objektivni odgovor; CBR=odgovor kliničke koristi; PFS=preživljenje bez progresije bolesti
English: Tell your healthcare provider right away if you have any new or worsening symptoms including:
Croatian: Odmah obavijestite svog liječnika ako imate bilo kakve nove simptome ili ako su se simptomi pogoršali, uključujući:
English: 30.5 (27.4, NE)
Croatian: 30,5 (27,4; NP)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
English: • Cyclosporine, everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection.
Croatian: • ciklosporin, everolimus, takrolimus, sirolimus, koji se koriste kod transplantacije organa kako bi se spriječilo njihovo odbacivanje.
English: It should be taken with food, preferably a meal to ensure consistent palbociclib exposure (see section 5.2).
Croatian: Treba ga uzimati s hranom, po mogućnosti uz obrok kako bi se osigurala konzistentna izloženost palbociklibu (vidjeti dio 5.2).
English: • Alfentanil used for anaesthesia in surgery; fentanyl used in pre-procedures as a pain reliever as well as an anaesthetic.
Croatian: • alfentanil, koji se koristi za anesteziju u kirurgiji; fentanil, koji se koristi prije samih postupaka kao sredstvo za olakšanje boli i kao anestetik.
English: Complete blood count should be monitored prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
Croatian: Kompletnu krvnu sliku treba nadzirati prije početka terapije lijekom IBRANCE i na početku svakog ciklusa, kao i 15. dana prva dva ciklusa, te prema kliničkoj potrebi.
English: An updated analysis of the primary and secondary endpoints was performed after an additional 15 months of follow up (data cutoff date: 31-May-2017).
Croatian: Ažurirana analiza primarnih i sekundarnih mjera ishoda provedena je nakon dodatnih 15 mjeseci praćenja (zaključni datum prikupljanja podataka bio je 31. svibnja 2017.).
English: Based on these results, palbociclib should be taken with food (see section 4.2).
Croatian: Na temelju tih rezultata palbociklib se mora uzeti s hranom (vidjeti dio 4.2).
English: Day 1 of cycle:
Croatian: 1. dan ciklusa:
English: • fever, chills, weakness, shortness of breath, bleeding, or easy bruising which could be a sign of a serious blood disorder.
Croatian: • vrućicu, zimicu, slabost, nedostatak zraka, krvarenje ili lako nastajanje modrica što bi moglo biti znak ozbiljnih poremećaja krvi.
English: The median duration of palbociclib treatment across the pooled dataset at the time of the final overall survival (OS) analysis was 14.8 months.
Croatian: Medijan trajanja liječenja palbociklibom za objedinjene podatke u vrijeme konačne analize ukupnog preživljenja iznosio je 14,8 mjeseci.
English: The efficacy and safety of palbociclib have not been studied in patients with critical visceral disease (see section 5.1).
Croatian: Djelotvornost i sigurnost palbocikliba nisu ispitane u bolesnica s teškom visceralnom bolesti (vidjeti dio 5.1).
English: HDPE bottle with a PP closure containing 21 hard capsules.
Croatian: HDPE bočice sa zatvaračem od polipropilena koje sadrže 21 tvrdu kapsulu.
English: Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
Croatian: Razmotriti smanjenje doze u slučajevima produljenog (> 1 tjedan) oporavka od neutropenije stupnja 3 ili ponovne neutropenije stupnja 3 1. dana narednih ciklusa.
English: If you stop taking IBRANCE
Croatian: Ako prestanete uzimati IBRANCE
English: In the placebo plus fulvestrant arm, 15.5% of randomised patients received palbociclib and other CDK inhibitors as post progression subsequent treatments.
Croatian: U skupini liječenoj placebom i fulvestrantom 15,5 % randomiziranih bolesnica primilo je palbociklib i druge inhibitore CDK-a kao naknadno liječenje nakon progresije.
English: 75 mg/day*
Croatian: 75 mg/dan*
English: Grading according to CTCAE 4.0.
Croatian: Stupnjevanje prema CTCAE 4.0.
English: All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis.
Croatian: Sve bolesnice koje su prethodno primile sistemsku terapiju i većina bolesnica u svakoj skupini liječenja primile su prethodni režim kemoterapije za svoje primarne dijagnoze.
English: Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Croatian: Bolesnice su nastavile primati dodijeljeno liječenje do objektivne progresije bolesti, simptomatskog pogoršavanja, neprihvatljive toksičnosti, smrti ili povlačenja pristanka, štogod se dogodilo prvo.
English: For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily on Schedule 3/1 (see sections 4.4 and 5.2).
Croatian: Za bolesnice s teškim oštećenjem jetre (Child-Pugh stadij C) preporučena doza lijeka IBRANCE je 75 mg jednom dnevno prema rasporedu 3/1 (vidjeti dijelove 4.4 i 5.2).
English: When the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor (see section 4.5).
Croatian: Kad se prekine primjena snažnog inhibitora, povećajte dozu lijeka IBRANCE (nakon perioda koji iznosi 3 - 5 poluvijekova inhibitora) na dozu koja je korištena prije početka liječenja snažnim inhibitora CYP3A (vidjeti dio 4.5).
English: Avoid grapefruit and grapefruit juice while you are taking IBRANCE as it may increase the side effects of IBRANCE.
Croatian: Izbjegavajte grejp i sok grejp dok uzimate lijek IBRANCE, jer može pojačati nuspojave lijeka IBRANCE.
English: In vitro, palbociclib is not an inhibitor of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, and 2D6, and is not an inducer of CYP1A2, 2B6, 2C8, and 3A4 at clinically relevant concentrations.
Croatian: In vitro, palbociklib nije inhibitor CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19 i 2D6 i nije induktor CYP1A2, 2B6, 2C8 te 3A4 pri klinički značajnim koncentracijama.
English: Palbociclib is considered to have the potential to impair reproductive function and fertility in male humans based on nonclinical findings in rats and dogs.
Croatian: Smatra se da palbociklib ima potencijal oštetiti reproduktivnu funkciju i plodnost u muškaraca na temelju nekliničkih nalaza u štakora i pasa.
English: • Clarithromycin and telithromycin antibiotics used to treat bacterial infections.
Croatian: • antibiotici klaritromicin i telitromicin, koji se koriste za liječenje bakterijskih infekcija.
English: The majority of patients (97.4%) had metastatic disease at baseline, 23.6% of patients had bone-only disease, and 49.2% of patients had visceral disease.
Croatian: Većina bolesnica (97,4%) je imala metastatsku bolest pri početnim vrijednostima, 23,6% bolesnica je imalo samo metastaze na kostima, a 49,2% bolesnica je imalo visceralne metastaze.
English: The mean Cmax of palbociclib is generally observed between 6 to 12 hours following oral administration.
Croatian: Prosječni Cmax palbocikliba općenito je opažen između 6 i 12 sati nakon peroralne primjene.
English: 24.8 (22.1, NE)
Croatian: 24,8 (22,1; NP)
English: Pre/perimenopausal women received the LHRH agonist goserelin.
Croatian: Pre/perimenopauzalne žene primale su LHRH agonist goserelin.
English: • Nefazodone used to treat depression.
Croatian: • nefazodon, koji se koristi za liječenje depresije.
English: The primary target organ findings of potential relevance to humans included haematolymphopoietic and male reproductive organ effects in rats and dogs in studies up to 39 weeks duration.
Croatian: Nalazi primarnog ciljnog organa potencijalne važnosti za ljude uključivali su učinke na hematolimfopoetičke i muške reproduktivne organe u štakora i pasa u ispitivanjima koja su trajala do 39 tjedana.
English: a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Croatian: Preffered Terms) navedeni su u skladu s MedDRA 17.1. b. Infekcije uključuju sve preporučene pojmove koji su dio Infekcija i infestacija u sklopu klasifikacije organskih sustava.
English: CBR=clinical benefit response; CI=confidence interval; N=number of patients; OR=objective response.
Croatian: CBR=odgovor kliničke koristi; CI=interval pouzdanosti; N=broj bolesnika; OR=objektivni odgovor.
English: The median time to first episode of any grade neutropenia was 15 days (12-700 days) and the median duration of Grade ≥3 neutropenia was 7 days across 3 randomised clinical studies.
Croatian: Medijan vremena do prve epizode bilo kojeg stupnja neutropenije iznosio je 15 dana (12 - 700 dana) i medijan trajanja stupnja ≥ 3 neutropenije iznosio je 7 dana u 3 randomizirana klinička ispitivanja.
English: Similarly, no relation was observed when studying the response to palbociclib in in vivo models with patient-derived xenografts (PDX models).
Croatian: Slično tome, nije primijećena nikakva veza pri proučavanju odgovora na palbociklib u in vivo modelima s ksenograftovima dobivenim od bolesnica (engl. patient-derived xenografts, PDX modeli).
English: If Grade 3 on Day 15, continue IBRANCE at the current dose to complete cycle and repeat complete blood count on Day 22.
Croatian: Ako se 15. dana ustanovi stupanj 3, nastaviti liječenje lijekom IBRANCE pri trenutnoj dozi kako biste dovršili ciklus i ponoviti kompletnu krvnu sliku 22. dana.
English: IBRANCE contains lactose
Croatian: IBRANCE sadrži laktozu
English: Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE across the overall clinical programme.
Croatian: Febrilna neutropenija je prijavljena u otprilike 2% bolesnica izloženih lijeku IBRANCE u sklopu ukupnog kliničkog programa.
English: The exposure of animals at the no observed effect level for aneugenicity was approximately 7 times human clinical exposure based on AUC.
Croatian: Izloženost životinja pri razini pri kojoj nije uočen učinak za aneugeničnost bila je približno 7 puta veća od izloženosti ljudi u kliničkim uvjetima na temelju AUC.
English: Table 6 shows the efficacy results based on the primary and the updated analyses from the PALOMA-2 study, as assessed by the investigator and by the independent review.
Croatian: Tablica 6 prikazuje rezultate djelotvornosti temeljene na primarnoj i ažuriranoj analizi iz ispitivanja PALOMA-2 te procjeni ispitivača i neovisnoj procjeni podataka.
English: In faeces, the sulfamic acid conjugate of palbociclib was the major drug-related component, accounting for 25.8% of the administered dose.
Croatian: U fecesu, konjugat sulfamične kiseline palbocikliba bila je glavna komponenta povezana s lijekom i čini 25,8% primijenjene doze.
English: Interstitial lung disease/pneumonitis
Croatian: Intersticijska bolest pluća/pneumonitis
English: Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 9.
Croatian: Dodatne mjere djelotvornosti (OR i TTR) primijećene u podskupinama bolesnica sa ili bez visceralne bolesti prikazane su u Tablici 9.
English: The recommended dose is 125 mg of IBRANCE taken once a day for 3 weeks followed by 1 week without taking IBRANCE.
Croatian: Preporučena doza lijeka IBRANCE je 125 mg koja se uzima jednom dnevno tijekom 3 tjedna, nakon čega slijedi tjedan dana bez uzimanja lijeka IBRANCE.
English: • Sulfasalazine used to treat rheumatoid arthritis.
Croatian: • sulfasalazin, koji se koristi za liječenje reumatoidnog artritisa.
English: In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient.
Croatian: U bolesnika s novim ili pogoršanim respiratornim simptomima, u kojih se sumnja na pojavu IBP-a/pneumonitisa, odmah prekinite primjenu lijeka IBRANCE i procijenite bolesnika.
English: Women of childbearing potential or their male partners must use a highly effective method of contraception while taking IBRANCE (see section 4.6).
Croatian: Žene u reproduktivnoj dobi ili partneri žena u reproduktivnoj dobi moraju koristiti visoko učinkovitu metodu kontracepcije dok uzimaju IBRANCE (vidjeti dio 4.6).
English: Pregnancy and breast-feeding and fertility
Croatian: Trudnoća, dojenje i plodnost
English: PALOMA-2 (intent-to-treat population) - Efficacy results based on primary and updated cutoff dates
Croatian: Tablica 6. PALOMA-2 (populacija predviđena za liječenje) - rezultati djelotvornosti temeljeni na primarnim i ažuriranim zaključnim datumima prikupljanja podataka
English: Palbociclib may decrease fertility in men.
Croatian: Palbociklib može smanjiti plodnost u muškaraca.
English: The European Medicines Agency has waived the obligation to submit the results of studies with IBRANCE in all subsets of the paediatric population in the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka IBRANCE u svim podskupinama pedijatrijske populacije liječene zbog raka dojka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Updated analysis (23 October 2015 cutoff) IBRANCE plus fulvestrant (N=347)
Croatian: Ažurirana analiza (Presjek podataka 23. listopada 2015.) IBRANCE i fulvestrant (N=347)
English: Concomitant treatment with inhibitors or inducers of CYP3A4
Croatian: Istodobno liječenje inhibitorima ili induktorima CYP3A4
English: With repeated once daily administration, palbociclib accumulates with a median accumulation ratio of 2.4 (range 1.5-4.2).
Croatian: S ponovljenom primjenom jednom dnevno, palbociklib se nakuplja s medijanom omjera akumulacije od 2,4 (raspon 1,5-4,2).