natgillin/translations-raw huggingface dataset:
• Grade ≤2 (if not considered a safety risk for the patient) Resume at the next lower dose.
• stupanj ≤ 2 (ako se ne smatra sigurnosnim rizikom za bolesnicu)
Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1).
Palbociklib nije produljio QTc interval ni do kakve klinički značajne mjere pri preporučenoj dozi od 125 mg na dan (raspored 3/1).
Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported (see section 4.8).
Dodatni slučajevi IBP-a/pneumonitisa opaženi su nakon stavljanja lijeka u promet te su prijavljeni i smrtni ishodi (vidjeti dio 4.8).
Palbociclib induced micronuclei via an aneugenic mechanism in Chinese Hamster Ovary cells in vitro and in the bone marrow of male rats at doses ≥100 mg/kg/day.
Palbociklib je inducirao mikrojezgre putem aneugeničnog mehanizma u stanicama jajnika kineskog hrčka in vitro i u koštanoj srži mužjaka štakora pri dozama od ≥ 100 mg/kg/dan.
Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.
Stoga, primjena palbocikliba s lijekovima koji su supstrati P-gp-a (primjerice, digoksin, dabigatran, kolhicin) ili BCRP-a (primjerice, pravastatin, rosuvastatin, sulfasalazin) može povećati njihov terapijski učinak i nuspojave.
Palbociclib was foetotoxic in pregnant animals.
Palbociklib se pokazao fetotoksičnim kod gravidnih životinja.
The mean absolute bioavailability of palbociclib after an oral 125 mg dose is 46%.
Srednja vrijednost apsolutne bioraspoloživosti palbocikliba nakon peroralne doze od 125 mg je 46%.
Compared to palbociclib given under overnight fasted conditions, the AUCinf and Cmax of palbociclib increased by 21% and 38% when given with high-fat food, by 12% and 27% when given with low-fat food, and by 13% and 24% when moderate-fat food was given 1 hour before and 2 hours after palbociclib dosing.
U usporedbi s palbociklibom u uvjetima natašte preko noći, AUCinf i Cmax palbocikliba porastao je za 21% odnosno za 38% kada se daje s masnom hranom, za 12% odnosno za 27% kada se daje s hranom s niskim udjelom masti i za 13% odnosno 24% kada se daje hrana s umjerenim sadržajem masti sat vremena prije i 2 sata nakon doziranja palbocikliba.
You should avoid becoming pregnant while taking IBRANCE.
Morate izbjegavati trudnoću dok uzimate lijek IBRANCE.
In vitro and in vivo studies indicate that palbociclib undergoes extensive hepatic metabolism in humans.
In vitro i in vivo ispitivanja ukazuju da palbociklib podliježe opsežnom jetrenom metabolizmu u ljudi.
The capsule length is 21.7 ± 0.3 mm.
Duljina kapsule je 21,7 ± 0,3 mm.
Tiredness is a very common side effect.
Umor je vrlo česta nuspojava.
Therefore, IBRANCE should be taken with food, preferably a meal (see sections 4.2 and 5.2).
Stoga je lijek IBRANCE potrebno uzimati s hranom, po mogućnosti uz obrok (vidjeti dijelove 4.2 i 5.2).
Adverse reactions based on pooled dataset from 3 randomised studies (N=872)
Tablica 4. Nuspojave na temelju objedinjenih podataka iz 3 randomizirana ispitivanja (N=872)
• Enzalutamide to treat prostate cancer.
• enzalutamid, koji se koristi za liječenje raka prostate
Therefore, concomitant use of palbociclib with strong CYP3A4 inducers should be avoided.
Stoga istodobnu primjenu palbocikliba sa snažnim induktorima CYP3A4 treba izbjegavati.
In a pharmacokinetic study in healthy volunteers, palbociclib AUCinf and Cmax values were 30% and 35% higher, respectively, in Japanese subjects compared with non-Asian subjects after a single oral dose.
U farmakokinetičkom ispitivanju na zdravim dobrovoljcima vrijednosti AUCinf i Cmax palbocikliba bile su 30% odnosno 35% više u japanskih ispitanika u usporedbi sneazijskim ispitanicima nakon jednokratne peroralne doze.
Effect of acid reducing agents
Učinak lijekova koji smanjuju kiselinu
Partial reversibility of male reproductive organ effects was observed in the rat and dog following a 4- and 12-week nondosing period, respectively.
Djelomična reverzibilnost učinaka na muški reproduktivni organ uočena je u štakora i pasa nakon razdoblja od 4 tjedna odnosno 12 tjedana nedoziranja.
The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Najčešće (≥ 2 %) nuspojave stupnja ≥ 3 palbocikliba bile su neutropenija, leukopenija, infekcije, anemija, povišena aspartat aminotransferaza (AST), umor i povišena alanin aminotransferaza (ALT).
A total of 335 patients in the palbociclib plus fulvestrant arm and 166 patients in the fulvestrant only arm completed the questionnaire at baseline and at least 1 postbaseline visit.
Ukupno 335 bolesnica u skupini koja je primala palbociklib i fulvestrant te 166 bolesnica u skupini koja je primala samo fulvestrant popunila je upitnik na početku i prilikom barem jedne posjete nakon početka.
The effect of palbociclib on the QT interval corrected for heart rate (QTc) interval was evaluated using time matched electrocardiogram (ECG) evaluating the change from baseline and corresponding pharmacokinetic data in 77 patients with advanced breast cancer.
Učinak palbocikliba na QT interval korigiran za srčanu frekvenciju (QTc) procijenjen je na temelju vremenski uparenog (engl. time-matched) EKG-a kojim je procjenjivana promjenae od početne vrijednosti i odgovarajućih farmakokinetičkih podataka u 77 bolesnica s uznapredovalim rakom dojke.
Concomitant use of strong CYP3A inhibitors during treatment with palbociclib should be avoided.
Izbjegavajte istodobnu primjenu snažnih inhibitora CYP3A tijekom liječenja palbociklibom.
Additional efficacy measures (OR and time to response [TTR]) assessed in the sub-groups of patients with or without visceral disease based on the 31-May-2017 updated cutoff date are displayed in Table 7.
Dodatne mjere djelotvornosti (OR i vrijeme do odgovora [engl. time to response, TTR]) ocijenjene u podskupinama bolesnica sa ili bez visceralne bolesti te temeljene na ažuriranom zaključnom datumu prikupljanja podataka od 31. svibnja 2017. prikazane su u Tablici 7.
Overall, neutropenia of any grade was reported in 716 (82.1%) patients receiving IBRANCE regardless of the combination, with Grade 3 neutropenia being reported in 500 (57.3%) patients, and Grade 4 neutropenia being reported in 97 (11.1 %) patients (see Table 4).
Ukupno gledano, neutropenija bilo kojeg stupnja prijavljena je u 716 (82,1%) bolesnica koje su primale IBRANCE neovisno o kombinaciji, s tim da je neutropenija stupnja 3 prijavljena u 500 (57,3 %) bolesnica te neutropenija stupnja 4 prijavljena u 97 (11,1 %) bolesnica (vidjeti Tablicu 4.).
• Pravastatin and rosuvastatin used to treat high cholesterol levels.
• pravastatin i rosuvastatin, koji se koriste za liječenje visokih razina kolesterola.
Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see section 4.4).
Liječenje žena u pre/perimenopauzi sa kombinacijom palbocikliba i inhibitora aromataze uvijek se mora kombinirati sa LHRH agonistom (vidjeti dio 4.4).
There was no obvious trend in the mean palbociclib fu in human plasma in vivo with worsening renal function.
Nije postojao očit trend u srednjoj vrijednosti fu palbocikliba u ljudskoj plazmi in vivo kako se funkcija bubrega pogoršavala.
• difficulty breathing, dry cough or chest pain which could be a sign of inflammation of the lungs.
• otežano disanje, suhi kašalj ili bol u prsnom košu što bi moglo biti znak upale pluća.
Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (28% solution), propylene glycol, simeticone (see section 2 “IBRANCE contains lactose”).
Tinta za označivanje: šelak, titanijev dioksid (E171), amonijev hidroksid (28%-tna otopina), propilenglikol, simetikon (vidjeti dio 2 „IBRANCE sadrži laktozu“).
The median age of patients enrolled in this study was 62 years (range 28-89), 48.3% of patients had received chemotherapy and 56.3% had received antihormonal therapy in the (neo)adjuvant setting prior to their diagnosis of advanced breast cancer while 37.2% of patients had received no prior systemic therapy in the (neo)adjuvant setting.
Medijan dobi bolesnica uključenih u ovo ispitivanje bio je 62 godine (raspon 28-89), 48,3% bolesnica je primalo kemoterapiju, a 56,3% je primalo hormonsku terapiju u sklopu (neo)adjuvantnog liječenja prije dijagnoze uznapredovalog raka dojke, dok 37,2% bolesnica prethodno nije primilo nikakvu sistemsku terapiju u sklopu (neo)adjuvantnog liječenja.
• Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections.
• vorikonazol, itrakonazol, ketokonazol i posakonazol, koji se koriste za liječenje gljivičnih infekcija.
It is not known if IBRANCE is excreted in breast milk.
Nije poznato izlučuje li se lijek IBRANCE u majčino mlijeko.
In addition, food intake significantly reduced the intersubject and intrasubject variability of palbociclib exposure.
Pored toga, unos hrane značajno je smanjio varijabilnost između ispitanika i unutar samih ispitanika kod izloženosti palbociklibu.
Randomised Phase 3 Study PALOMA-2: IBRANCE in combination with letrozole
Faza 3 randomiziranog ispitivanja PALOMA-2: IBRANCE u kombinaciji s letrozolom
Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport.
Na temelju in vitro podataka, predviđa se da će palbociklib inhibirati crijevni P-glikoprotein (P-gp) te transport posredovan proteinom rezistencije raka dojke (BCRP).
Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Ovojnica kapsule: želatina, crveni željezov oksid (E172), žuti željezov oksid (E172), titanijev dioksid (E171).
Prior to the start of treatment with the combination of palbociclib plus fulvestrant, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Prije početka liječenja s kombinacijom palbocikliba i fulvestranta, i tijekom njegovog trajanja, žene u pre/perimenopauzi je potrebno liječiti LHRH agonistima u skladu s lokalnom kliničkom praksom.
Dose reductions or dose modifications due to any adverse reaction occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Smanjenje ili promjene doze zbog bilo koje nuspojave dogodile su se u 38,4 % bolesnica koje su primale IBRANCE u randomiziranim kliničkim ispitivanjima neovisno o kombinaciji.
Palbociclib was assessed for carcinogenicity in a 6-month transgenic mouse study and in a 2-year rat study.
Kancerogenost palbocikliba procjenjivala se u 6-mjesečnom ispitivanju na transgeničnim miševima i 2-godišnjem ispitivanju na štakorima.
The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Ispitivanje je ispunilo svoju primarnu mjeru ishoda - produljenje PFS-a procijenjeno od strane ispitivača - pri interim analizama provedenim na 82% planiranih PFS događaja; rezultati su se križali s prethodno specificiranom granicom djelotvornosti Haybittle-Peto (α=0,00135), dokazujući statistički značajno produljenje u PFS-u i klinički značajan učinak liječenja.
Therefore, men may consider sperm preservation before taking IBRANCE.
Stoga, muškarci trebaju razmisliti o pohrani sperme prije uzimanja lijeka IBRANCE.
† 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.
Nije statistički značajno. p-vrijednost jednostranog log-rang testa stratificiranog prema prisutnosti visceralnih metastaza i osjetljivosti na prethodnu endokrinu terapiju po randomizaciji.
In addition, cardiovascular effects (QTc prolongation, decreased heart rate, and increased RR interval and systolic blood pressure) were identified in telemetered dogs at ≥4 times human clinical exposure based on Cmax.
Pored toga, kardiovaskularni učinci (ispravljeno produljenje QT intervala [QTc], smanjena brzina srčanih otkucaja te povećani interval RR i sistoličkog krvnog tlaka) bili su telemetrijski zabilježeni kod pasa pri dozi ≥ 4 puta većoj od izlaganja ljudi u kliničkim uvjetima na temelju Cmax.
How to take IBRANCE
Kako uzimati IBRANCE
Palbociclib-related neoplastic finding in rats included an increased incidence of microglial cell tumours in the central nervous system of males at 30 mg/kg/day; there were no neoplastic findings in female rats at any dose up to 200 mg/kg/day.
Neoplastični nalaz u štakora povezan s palbociklibom uključivao je povećanu incidenciju tumora stanica mikroglije u središnjem živčanom sustavu mužjaka pri dozi od 30 mg/kg/dan; nije bilo neoplastičnih nalaza u ženki štakora pri bilo kojoj dozi do 200 mg/kg/dan.
The pharmacokinetics of palbociclib have not been studied in patients requiring haemodialysis.
Farmakokinetika palbocikliba nije ispitivana u bolesnika kojima je potrebna hemodijaliza.
WBC decreased Neutrophils decreased Anaemia
Smanjen broj leukocita Smanjen broj neutrofila Anemija
The dose of sensitive CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.
Doza osjetljivih supstrata CYP3A s uskim terapijskim indeksom (primjerice, alfentanil, ciklosporin, dihidroergotamin, ergotamin, everolimus, fentanil, pimozid, kinidin, sirolimus i takrolimus) možda će se trebati smanjiti kada se primjenjuju istodobno s lijekom IBRANCE, jer IBRANCE može povećati njihovu izloženost.
Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them: Contact your doctor immediately if you have any of these symptoms:
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
If you have any further questions, ask your doctor, pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku, ili ljekarniku ili medicinskoj sestri.
i ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query
IBP/pneumonitis uključuje sve prijavljene preporučene pojmove koji su obuhvaćeni Standardiziranim MedDRA (engl.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
U žena u pre- i perimenopauzi endokrinu terapiju je potrebno kombinirati s agonistom hormona koji oslobađa luteinizirajući hormon (LHRH).
* Secondary endpoints results are based on confirmed and unconfirmed responses according to RECIST 1.1.
* Rezultati sekundarnih mjera ishoda temelje se na potvrđenim i nepotvrđenim odgovorima u skladu s kriterijima RECIST 1.1.
Data from a pharmacokinetic trial in subjects with varying degrees of renal function indicate that total palbociclib exposure (AUCinf) increased by 39%, 42%, and 31% with mild (60 mL/min≤CrCl<90 mL/min), moderate (30 mL/min≤CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal (CrCl ≥90 mL/min) renal function.
Podaci dobiveni farmakokinetičkim ispitivanjem provedenim na ispitanicima s različitim stupnjevima funkcije bubrega pokazuju da se ukupna izloženost palbociklibu (AUCinf) povećala za 39%, 42% odnosno 31% kod ispitanika s blagim (60 ml/min ≤CrCl <90 ml/min), umjerenim (30 ml/min ≤ CrCl <60 ml/min) i teškim (CrCl <30 ml/min) oštećenjem bubrega, u usporedbi s ispitanicima s normalnom (CrCl ≥90 ml/min) funkcijom bubrega.
The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).
Istodobnu primjenu snažnih induktora CYP3A uključujući, ali ne ograničavajući se na: karbamazepin, enzalutamid, fenitoin, rifampicin i gospinu travu je potrebno izbjegavati (vidjeti dijelove 4.3 i 4.4).
Palbociclib is a reversible inhibitor of cyclin-dependent kinases 4 and 6, which are both involved in regulating the cell cycle.
Palbociklib je reverzibilni inhibitor o ciklinu ovisne kinaze 4 i 6, a obje su uključene u reguliranje staničnog ciklusa.
• Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV
• lopinavir, indinavir, nelfinavir, ritonavir, telaprevir i sakvinavir, koji se koriste za liječenje HIV infekcije (SIDA-e).
The capsule length is 18.0 ± 0.3 mm.
Duljina kapsule je 18,0 ± 0,3 mm.
Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6.
Paklociklib je visoko selektivan, reverzibilni inhibitor o ciklinu ovisnih kinaza (engl. cyclin-dependent kinases, CDK) 4 i 6.
Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
Ablacija jajnika ili supresija LHRH agonistom je neophodna kada se ženama u pre/perimenopauzi primjenjuje IBRANCE u kombinaciji s inhibitorom aromataze, zbog njihovog mehanizma djelovanja.
The geometric mean apparent oral clearance (CL/F) of palbociclib was 63 L/h, and the mean plasma elimination half-life was 28.8 hours in patients with advanced breast cancer.
Srednja vrijednost providnog, geometrijskog peroralnog klirensa (CL/F) palbocikliba iznosila je 63 l/sat, a srednja vrijednost poluživota u plazmi iznosila je 28,8 sati u bolesnica s uznapredovalim rakom dojke.
In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 40 patients had mild hepatic impairment based on National Cancer Institute (NCI) classification (total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the pharmacokinetics of palbociclib.
Nadalje, na temelju populacijske farmakokinetičke analize koja je uključivala 183 bolesnika s uznapredovalim rakom, gdje je 40 bolesnika imalo blago oštećenje jetre na temelju klasifikacije Nacionalnog instituta za rak (ukupni bilirubin ≤ gornja granica normale (GGN) i aspartat aminotransferaza (AST) > GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN i bilo koja vrijednost AST-a), blago oštećenje jetre nije imalo učinka na farmakokinetiku palbocikliba.
Based on a population pharmacokinetic analysis in 183 patients with cancer (50 male and 133 female patients, age ranging from 22 to 89 years, and body weight ranging from 38 to 123 kg), gender had no effect on the exposure of palbociclib, and age and body weight had no clinically important effect on the exposure of palbociclib.
Na temelju analize farmakokinetičke populacije u 183 bolesnika s rakom (50 muških i 133 ženskih bolesnika, u rasponu dobi od 22 do 89 godina i pri rasponu tjelesne težine od 38 do 123 kg), spol nije imao utjecaja na izlaganje palbociklibu te dob i tjelesna težina nisu imali klinički važan učinak na izlaganje palbociklibu.
The capsule length is 19.4 ± 0.3 mm.
Duljina kapsule je 19,4 ± 0,3 mm.
Effect of CYP3A inhibitors
Učinak inhibitora CYP3A
Primary Analysis (26 February 2016 Cutoff)
Primarna analiza (Zaključni datum je 26. veljače 2016.)
• St. John's Wort, an herbal product used to treat mild depression and anxiety.
• gospina trava, biljni pripravak koji se koristi za liječenje blage depresije i tjeskobe.
100 mg/day
100 mg/dan
125 mg/day
125 mg/dan
Secondary endpoints included OR, CBR, overall survival (OS), safety, and time-to-deterioration (TTD) in pain endpoint.
Sekundarne mjere ishoda uključivale su OR, CBR (odgovor kliničke koristi), ukupno preživljenje (engl. overall survival, OS), sigurnost i vrijeme do pogoršanja ishoda boli (engl. time-to-deterioration, TTD).
Efficacy results - PALOMA-3 study (investigator assessment, intent-to-treat population)
- Rezultati djelotvornosti iz ispitivanja PALOMA-3 (procjena ispitivača, populacija predviđena za liječenje)
These findings were observed in rats and/or dogs at exposures  9 times or subtherapeutic compared to human clinical exposure based on AUC, respectively.
Ti su nalazi uočeni kod štakora i/ili pasa pri izlaganjima  9 puta većim od onih u usporedbi s izlaganjem ljudi u kliničkim uvjetima na temelju AUC.
Palbociclib works by blocking proteins called cyclin-dependent kinase 4 and 6, which regulate cell growth and division.
Palbociklib djeluje blokadom bjelančevina zvanih o ciklinu ovisne kinaze 4 i 6, koje reguliraju rast i diobu stanica.
The concomitant use of strong CYP3A inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4).
Istodobna primjena snažnih inhibitora CYP3A uključujući, ali ne ograničavajući se na: klaritromicin, indinavir, itrakonazol, ketokonazol, lopinavir/ritonavir, nefazodon, nelfinavir, posakonazol, sakvinavir, telaprevir, telitromicin i vorikonazol te grejp i sok od grejpa je potrebno izbjegavati (vidjeti dijelove 4.2 i 4.4).
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy or on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to palbociclib plus fulvestrant or placebo plus fulvestrant and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Ukupno 521 pre/peri i postmenopauzalna žena čija je bolest napredovala tijekom ili unutar 12 mjeseci od dovršetka adjuvantne endokrine terapije, ili tijekom ili unutar 1 mjesec od prethodne endokrine terapije za uznapredovalu bolest, bile su randomizirane u omjeru 2:1 na palbociklib i fulvestrant ili placebo i fulvestrant i stratificirane dokazanom osjetljivošću na prethodnu hormonsku terapiju, menopauzalni status pri ulasku u ispitivanje (pre/peri naspram postmenopauzalnih) i prisutnost visceralnih metastaza.
The adverse reactions are listed by system organ class and frequency category.
Nuspojave su navedene prema klasifikaciji organskih sustava i kategoriji učestalosti.
DDI studies of palbociclib with oral contraceptives have not been conducted (see section 4.6).
Ispitivanja interakcija između palbocikliba i oralnih kontraceptiva nisu provedena (vidjeti dio 4.6).
In the event of a palbociclib overdose, both gastrointestinal (e.g., nausea, vomiting) and haematological (e.g., neutropenia) toxicity may occur and general supportive care should be provided.
U slučaju predoziranja palbociklibom mogu se javiti i gastrointestinalna (primjerice mučnina, povraćanje) i hematološka toksičnost (primjerice neutropenija) te se mora osigurati opća suportivna skrb.
PAL=palbociclib; LET=letrozole; PCB=placebo.
PAL=palbociklib; LET=letrozol; PCB=placebo
Palbociclib is a weak, time-dependent inhibitor of CYP3A following daily 125 mg dosing at steady state.
Palbociklib je slabi, o vremenu ovisan inhibitor CYP3A nakon dnevne doze od 125 mg u stanju dinamičke ravnoteže.
Secondary endpoint results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Rezultati sekundarne mjere ishoda temelje se na potvrđenim i nepotvrđenim odgovorima u skladu s kriterijima RECIST 1.1.
Permanent discontinuation due to an adverse reaction occurred in 5.2% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Trajni prekid zbog bilo koje nuspojave dogodio se u 5,2 % bolesnica koje su primale IBRANCE u randomiziranim kliničkim ispitivanjima neovisno o kombinaciji.