FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate (30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function.
Croatian: Na temelju farmakokinetičke analize populacije, blago (CrCl od 60 ml/min do manje od 90 ml/min; N=590) i umjereno (CrCl od 30 ml/min do manje od 60 ml/min; N=218) oštećenje funkcije bubrega nije izmijenilo farmakokinetiku dakomitiniba, u odnosu na ispitanike s normalnom (CrCl ≥ 90 ml/min; N=567) funkcijom bubrega.
English: In a clinical study, one patient (0.4%) had a fatal outcome (see section 4.4).
Croatian: U kliničkom ispitivanju je smrtni ishod prijavljen u jednog bolesnika (0,4 %) (vidjeti dio 4.4).
English: Fertility studies have not been performed with dacomitinib.
Croatian: Ispitivanja plodnosti nisu provedena s dakomitinibom.
English: In vitro, dacomitinib has a low potential to inhibit the activities of drug transporters P-gp (systemically), organic anion transporters (OAT)1 and OAT3, OCT2, organic anion transporting polypeptide (OATP)1B1, and OATP1B3, but may inhibit the activity of P-gp (in the GI tract), BCRP (systemically and GI tract), and OCT1 at clinically relevant concentrations.
Croatian: In vitro dakomitinib ima mali potencijal za inhibiciju aktivnosti prijenosnika lijekova P-gp (sistemski), transportera organskog aniona (OAT)1 i OAT3, OCT2, polipeptida koji prenosi organski anion (OATP)1B1 i OATP1B3, ali može inhibirati P-gp aktivnost (u gastrointestinalnom traktu), BCRP-a (sistemski i u gastrointestinalnom traktu) i OCT1 pri klinički relevantnim koncentracijama.
English: • If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib.
Croatian: • Ako osip, eritematozna ili eksfolijativna stanja kože stupnja 2 traju 72 sata unatoč liječenju: privremeno prekinite primjenu dakomitiniba.
English: Limited data are available in patients with severe renal impairment (CrCl < 30 mL/min).
Croatian: Podaci su ograničeni za bolesnike s teškim oštećenjem bubrega (CrCl < 30 ml/min).
English: (Cyprus Branch) Τηλ: +357 22 817690
Croatian: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22 817690
English: • Procainamide, used to treat heart arrhythmias
Croatian: • prokainamid koji se koristi za liječenje srčanih aritmija (nepravilnih otkucaja srca),
English: The most common (> 20%) adverse reactions in patients receiving dacomitinib were diarrhoea (88.6%), rash (79.2%), stomatitis (71.8%), nail disorder (65.5%), dry skin (33.3%), decreased appetite (31.8%), conjunctivitis (24.7%), weight decreased (24.3%), alopecia (23.1%), pruritus (22.4%), transaminases increased (22.0%), and nausea (20.4%).
Croatian: (79,2 %), stomatitis (71,8 %), poremećaj noktiju (65,5 %), suha koža (33,3 %), smanjen apetit (31,8 %), konjunktivitis (24,7 %), smanjenje tjelesne težine (24,3 %), alopecija (23,1 %), pruritus (22,4 %), povišene transaminaze (22,0 %) i mučnina (20,4 %).
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5).
Croatian: Istodobnu primjenu lijekova koji se pretežno metaboliziraju putem CYP2D6 potrebno je izbjegavati osim ako se primjena takvih lijekova smatra nužnom (vidjeti dio 4.5).
English: No starting dose adjustments are required when administering Vizimpro to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min).
Croatian: Nisu potrebne prilagodbe početne doze kada se lijek Vizimpro primjenjuje u bolesnika s blagim ili umjerenim oštećenjem bubrega (klirens kreatinina [CrCl] ≥ 30 ml/min).
English: Vizimpro 15 mg tablet: each tablet contains 15 mg dacomitinib Vizimpro 30 mg tablet: each tablet contains 30 mg dacomitinib Vizimpro 45 mg tablet: each tablet contains 45 mg dacomitinib
Croatian: Vizimpro 15 mg tableta: jedna tableta sadrži 15 mg dakomitiniba Vizimpro 30 mg tableta: jedna tableta sadrži 30 mg dakomitiniba Vizimpro 45 mg tableta: jedna tableta sadrži 45 mg dakomitiniba
English: In addition, hepatocellular necrosis with transaminase increases and hepatocellular vacuolation were observed in rats only.
Croatian: Nadalje, samo je u štakora opažena hepatocelularna nekroza s povećanjima razina transaminaza i hepatocelularna vakuolizacija.
English: Limited pharmacokinetic data are available in patients with severe renal impairment (CrCl < 30 mL/min) (N=4).
Croatian: Dostupni su ograničeni farmakokinetički podaci u bolesnika s teškim oštećenjem funkcije bubrega (CrCl < 30 ml/min) (N=4).
English: Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
Croatian: Monoterapija lijekom Vizimpro indicirana je za prvu liniju liječenja odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama receptora epidermalnog čimbenika rasta (engl. epidermal growth factor receptor, EGFR).
English: OS results from the final analysis (data cut-off date of 17-Feb-2017) when 48.7% of events had occurred showed a HR of 0.760 (95% CI: 0.582, 0.993) and a gain of 7.3 months in median OS (median OS: 34.1 months [95% CI: 29.5, 37.7] and 26.8 months [95% CI: 23.7, 32.1] in the dacomitinib and gefitinib arm, respectively).
Croatian: Rezultati OS-a dobiveni konačnom analizom (na temelju podataka prikupljenih do 17.veljače 2017.), kada se pojavilo 48,7 % događaja, pokazali su HR od 0,760 (95 % CI: 0,582; 0,993) i produljenje medijana OS-a za 7,3 mjeseci (medijan OS-a: 34,1 mjesec [95 % CI: 29,5; 37,7] u skupini liječenoj dakomitinibom i 26,8 mjeseci [95 % CI: 23,7; 32,1] u skupini liječenoj gefitinibom).
English: Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobnu primjenu inhibitora protonske pumpe (IPP) s dakomitinibom (vidjeti dio 4.5).
English: Upon recovery to Grade ≤ 1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level.
Croatian: Nakon oporavka na stupanj ≤ 1 nastavite s primjenom iste razine doze dakomitiniba ili razmotrite smanjenje za jednu razinu doze.
English: c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Croatian: Intersticijska plućna bolest uključuje sljedeće preporučene pojmove: intersticijska plućna bolest, pneumonitis.
English: If you miss a dose or vomit, take your next dose as scheduled.
Croatian: Ako propustite dozu ili povraćate, nemojte uzeti dodatnu dozu već sljedeću dozu uzmite sutra prema uobičajenom rasporedu.
English: For prevention of dry skin, initiate treatment with moisturizers, and upon development of rash, initiate treatment with topical antibiotics, emollients, and topical steroids.
Croatian: Za prevenciju suhe kože započnite liječenje sa sredstvima za hidrataciju kože, dok je u slučaju pojave osipa potrebno započeti liječenje topikalnim antibioticima, emolijensima i topikalnim steroidima.
English: Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib.
Croatian: Ozbiljne nuspojave zabilježene su u 6,7 % bolesnika liječenih dakomitinibom.
English: In non-Asian patients, median PFS was 9.3 months for dacomitinib arm and 9.2 months for gefitinib arm.
Croatian: U neazijskih bolesnika je medijan PFS-a iznosio 9,3 mjeseca za skupinu liječenu dakomitinibom i 9,2 mjeseca za skupinu liječenu gefitinibom.
English: In embryo-foetal development studies in rats and rabbits, pregnant animals received oral doses up to approximately 2.4 times and 0.3 times, respectively, the unbound AUC at the recommended human dose during the period of organogenesis.
Croatian: U ispitivanjima embrio-fetalnog razvoja u štakora i pasa, gravidne životinje su tijekom razdoblja organogeneze primale peroralne doze koje odgovaraju do približno 2,4-strukoj, odnosno 0,3-strukoj vrijednosti AUC-a nevezanog lijeka u ljudi pri preporučenoj dozi.
English: Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis.
Croatian: Konjunktivitis uključuje sljedeće preporučene pojmove: blefaritis, konjunktivitis, suho oko, neinfektivni konjunktivitis.
English: In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Croatian: In vitro dakomitinib ima mali potencijal za indukciju CYP1A2, CYP2B6 ili CYP3A4 pri klinički relevantnim koncentracijama.
English: In humans, dacomitinib undergoes oxidation and glutathione conjugation as the major metabolic pathways.
Croatian: U ljudi dakomitinib podliježe oksidaciji i konjugaciji s glutationom kao primarnim metaboličkim putevima.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Croatian: Pfizer Europe MA EEIG (logo nositelja odobrenja)
English: Table 5.
Croatian: Tablica 5.
English: Each pack contains 30 film-coated tablets.
Croatian: Jedno pakiranje sadrži 30 filmom obloženih tableta.
English: Co-administration of dacomitinib with agents that increase gastric pH
Croatian: Istodobna primjena dakomitiniba s lijekovima koji povećavaju želučani pH
English: Co-administration of single 45 mg oral dose of dacomitinib increased the mean exposure (AUClast and Cmax) of dextromethorphan, a probe CYP2D6 substrate, 855% and 874%, respectively, compared with administration of dextromethorphan alone.
Croatian: Istodobna primjena jedne peroralne doze dakomitiniba od 45 mg povećala je prosječnu izloženost (AUClast i Cmax) dekstrometorfanu, supstratu enzima CYP2D6, 855 % odnosno 874 %, u usporedbi s primjenom dekstrometorfana samog.
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-To-Treat; N=total number; PFS=progression-free survival.
Croatian: Kratice: CI=interval pouzdanosti; HR=omjer hazarda; IRC=neovisna središnja radiološka procjena; ITT=populacija predviđena za liječenje; N=ukupan broj; PFS=preživljenje bez progresije bolesti.
English: Adverse reactions leading to permanent discontinuation were reported in 6.7% of patients treated with dacomitinib.
Croatian: Nuspojave koje su dovele do trajnog prekida primjene zabilježene su u 6,7 % bolesnika liječenih dakomitinibom.
English: Transaminases increasedj Weight decreased
Croatian: Povišene transaminaze Smanjenje težine
English: Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with Cmax occurring 5 to 6 hours after oral dosing.
Croatian: Nakon primjene dakomitinib tableta u jednokratnoj dozi od 45 mg, srednja peroralna bioraspoloživost dakomitiniba iznosila je 80 % (raspon: 65% do 100%) u usporedbi s intravenskom primjenom, s Cmax koji se pojavljuje 5 do 6 sati nakon peroralnog doziranja.
English: • For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib.
Croatian: • U slučaju proljeva stupnja 2: potrebno je privremeno prekinuti primjenu dakomitiniba ako se stanje ne poboljša na stupanj ≤ 1 u roku od 24 sata tijekom primjene lijekova protiv proljeva (npr. loperamida) i uz odgovarajući peroralni unos tekućine.
English: i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative rash, Skin exfoliation.
Croatian: Eksfolijacija kože (poznata i pod nazivom eksfolijativna stanja kože) uključuje sljedeće preporučene pojmove: eksfolijativni osip, eksfolijacija kože.
English: Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4).
Croatian: Eksfolijativna stanja kože stupnja 3 zabilježena su u 0,8 % bolesnika (vidjeti dio 4.4).
English: In repeat-dose toxicity studies with dacomitinib, effects on reproductive organs were observed in female rats given approximately 0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to reversible epithelial atrophy in the cervix and vagina.
Croatian: U ispitivanjima toksičnosti ponovljene doze s dakomitinibom opaženi su učinci na reproduktivne organe u ženki štakora pri koncentraciji nevezanog AUC-a koja je odgovarala približno 0,3-strukoj vrijednosti u ljudi pri preporučenoj dozi (tijekom 6 mjeseci) te su bili ograničeni na reverzibilnu epitelnu atrofiju u vratu maternice i rodnici.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate (see section 2 Vizimpro contains lactose and sodium).
Croatian: - Drugi sastojci su: Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat, magnezijev stearat (vidjeti dio 2 Vizimpro sadrži laktozu i natrij).
English: Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib versus gefitinib.
Croatian: Djelotvornost i sigurnost lijeka Vizimpro ispitivana je u ispitivanju (ARCHER 1050) faze 3 provedenom u bolesnika s lokalno uznapredovalim NSCLC-om, koji nije odgovorio na kurativni kirurški zahvat ili radioterapiju, ili u bolesnika s metastatskim NSCLC-om s aktivirajućim mutacijama EGFR-a, kako bi se pokazala superiornost dakomitiniba naspram gefitiniba.
English: In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when compared to subjects with normal hepatic function (N=8).
Croatian: U posebnom ispitivanju oštećenja funkcije jetre se izloženost dakomitinibu (AUCinf i Cmax) nije promijenila nakon pojedinačne jednokratne doze od 30 mg lijeka Vizimpro kod blagog oštećenja funkcije jetre (Child-Pugh A; N=8) te se smanjila za 15 %, odnosno 20 % kod umjerenog oštećenja funkcije jetre (Child-Pugh B; N=9), u usporedbi s ispitanicima s normalnom funkcijom jetre (N=8).
English: Dacomitinib has not been studied in patients with severe (Child-Pugh class C) hepatic impairment.
Croatian: Dakomitinib nije ispitivan u bolesnika s teškim (Child-Pugh stadij C) oštećenjem jetre.
English: Metabolism and nutrition disorders Decreased appetite Hypokalemia b
Croatian: Poremećaji metabolizma i prehrane Smanjen apetit
English: Exposure response relationships
Croatian: Veze između izloženosti i odgovora
English: Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids).
Croatian: Započnite ili nastavite s liječenjem kožnih poremećaja i/ili omogućite dodatno liječenje (npr. peroralnim ili intravenskim antibioticima širokog spektra i topikalnim steroidima).
English: Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).
Croatian: Možda će biti potrebno prekinuti doziranje i/ili smanjiti dozu dakomitiniba u bolesnika (vidjeti dio 4.2).
English: Thirty percent had baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 and 70% had ECOG PS 1; 59% had an exon 19 deletion, and 41% had a L858R mutation in exon 21.
Croatian: Eastern Cooperative Oncology Group, ECOG) iznosio 0, dok je u 70 % njih ECOG PS iznosio 1; 59 % je imalo deleciju u egzonu 19, a 41 % mutaciju L858R u egzonu 21. Što se tiče rase, bilo je 23 % pripadnika bijele rase, 77 % Azijata i < 1 % pripadnika crne rase.
English: • Dry skin
Croatian: Suha koža
English: Early treatment of skin rash is important.
Croatian: Važno je rano započeti s liječenjem osipa na koži.
English: Recommended dose modifications for Vizimpro adverse reactions Dose level
Croatian: Preporučene prilagodbe doze lijeka Vizimpro zbog nuspojava
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4).
Croatian: Istodobnu primjenu lijekova koje se pretežno metaboliziraju putem CYP2D6 treba izbjegavati (vidjeti dio 4.4).
English: How to take Vizimpro
Croatian: Kako uzimati lijek Vizimpro
English: Interstitial lung disease (ILD/Pneumonitis)
Croatian: Intersticijska plućna bolest (engl. interstitial lung disease, ILD) (ILD/pneumonitis)
English: Dacomitinib was clastogenic in the in vitro human lymphocyte chromosome aberration assay at cytotoxic concentrations.
Croatian: Dakomitinib je bio klastogen u in vitro testu aberacije kromosoma humanih limfocita pri citotoksičnim koncentracijama.
English: Transaminases increased
Croatian: Povišene transaminaze
English: Efficacy results from ARCHER 1050 in patients with previously untreated NSCLC with EGFR-activating mutations - ITT population Dacomitinib N=227
Croatian: Rezultati djelotvornosti za ispitivanje ARCHER 1050 u bolesnika s prethodno neliječenim NSCLC-om s aktivirajućim mutacijama EGFR-a - populacija predviđena za liječenje
English: Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21.
Croatian: Dakomitinib je inhibitor pan-humanih receptora epidermalnog čimbenika rasta (HER) (EGFR/HER1, HER2 i HER4) koji djeluje na mutirani EGFR s delecijama u egzonu 19 ili supstitucijom L858R u egzonu 21. Dakomitinib se selektivno i nepovratno veže na svoja ciljna mjesta koja pripadaju HER obitelji i time omogućuje produljenu inhibiciju.
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with Vizimpro (see section 4.8).
Croatian: Tijekom liječenja lijekom Vizimpro prijavljene su povišene transaminaze (povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišene transaminaze) (vidjeti dio 4.8).
English: No clear relationship between dacomitinib exposure and efficacy could be characterised over the exposure range studied.
Croatian: Iz ispitivanog raspona izloženosti ne može se definirati jasna veza između izloženosti dakomitinibu i djelotvornosti.
English: The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea
Croatian: Najčešće zabilježeni (> 5 %) razlozi za smanjenja doze zbog bilo koje od nuspojava u bolesnika koji su primali dakomitinib bili su: osip (32,2 %), poremećaj noktiju (16,5 %) i proljev
English: The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time to the worst episode of ILD/pneumonitis was 16 weeks in patients receiving dacomitinib.
Croatian: Medijan vremena do prve epizode bilo kojeg stupnja ILD-a/pneumonitisa iznosio je 16 tjedana, a medijan vremena do najgore epizode ILD-a/pneumonitisa iznosio je 16 tjedana u bolesnika koji su primali dakomitinib.
English: a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.
Croatian: Hipokalijemija uključuje sljedeće preporučene pojmove: smanjena razina kalija u krvi, hipokalijemija.
English: • For Grade 1 or 2 toxicity, no dose modification is required.
Croatian: • U slučaju toksičnosti stupnja 1 ili 2: nije potrebna prilagodba doze.
English: In particular, the hazard ratios (HRs) for PFS per IRC review in Asian and non-Asian patients were 0.509 (95% CI: 0.391, 0.
Croatian: Osobito su omjeri hazarda (engl. hazard ratio, HR) za PFS prema procjeni IRC-a u azijskih i neazijskih bolesnika iznosili 0,509 (95 % CI: 0,391; 0, 662), odnosno 0,889 (95 % CI: 0,568; 1,391).
English: The median duration of any grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4).
Croatian: Medijan trajanja proljeva bilo kojeg stupnja iznosio je 20 tjedana, odnosno 1 tjedan za proljev stupnja ≥ 3 (vidjeti dio 4.4).
English: A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomised to dacomitinib compared with those randomised to gefitinib, see Table 5 and Figure 1.
Croatian: Statistički značajno poboljšanje PFS-a utvrđeno IRC-om dokazano je za bolesnike randomizirane u skupinu liječenu dakomitinibom u usporedbi s bolesnicima randomiziranima u skupinu liječenu gefitinibom, vidjeti tablicu 5 i sliku 1. Analize PFS-a u podskupina, prema procjeni IRC-a, na temelju početnih karakteristika, podudarale su se s rezultatima primarne analize PFS-a.
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: Sindrom palmarnoplantarne eritrodizestezije
English: The median time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to the worst episode of exfoliative skin conditions was 6 weeks.
Croatian: Medijan vremena do prve epizode bilo kojeg stupnja eksfolijativnih stanja kože iznosio je 6 tjedana, a medijan vremena do najgore epizode eksfolijativnih stanja kože iznosio je 6 tjedana.
English: Progression-Free Survival (per IRC) Number of patients with event, n (%) Median PFS in months (95% CI) HR (95% CI)
Croatian: Broj bolesnika s odgovorom na terapiju prema procjeni IRC-a, n (%) Medijan DoR-a u mjesecima (95 % CI) HR (95% CI) p-vrijednost dvostranog testa
English: Immediate treatment of diarrhoea is important.
Croatian: Važno je odmah započeti s liječenjem proljeva.
English: The median duration of any grade and Grade ≥ 3 transaminases increased was 11 weeks and 1 week, respectively.
Croatian: Medijan trajanja povišenih transaminaza bilo kojeg stupnja iznosio je 11 tjedana, a kod stupnja ≥ 3 iznosio je 1 tjedan.
English: The pharmacokinetics in patients requiring haemodialysis have not been studied.
Croatian: Farmakokinetika nije ispitivana u bolesnika kojima je potrebna hemodijaliza.
English: Dry skin includes the following PTs: Dry skin, Xerosis.
Croatian: Suha koža uključuje sljedeće preporučene pojmove: suha koža, kseroza.
English: It is important to treat the rash early.
Croatian: Važno je da što ranije počnete liječiti osip.
English: The most common (> 0.5%) reasons for permanent discontinuations associated with adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), and diarrhoea (0.8%).
Croatian: Najčešći (> 0,5 %) razlozi za trajne prekide primjene povezani s nuspojavama u bolesnika koji su primali dakomitinib bili su: osip (2,4 %), intersticijska plućna bolest (2,0 %) i proljev
English: Dacomitinib pharmacokinetics has not been studied in subjects with severe hepatic impairment (Child-Pugh class C).
Croatian: Farmakokinetika dakomitiniba nije ispitivana u ispitanika s teškim (Child-Pugh stadij C) oštećenjem funkcije jetre.
English: • if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, light-coloured bowel movements (stools).
Croatian: • imate bilo koje simptome problema s jetrom koji mogu uključivati: žutilo kože ili bjeloočnica
English: PPIs should be avoided while receiving treatment with dacomitinib (see section 4.4).
Croatian: Primjena IPP-ova bi se trebala izbjegavati tijekom liječenja dakomitinibom (vidjeti dio 4.4).
English: Patients with a history of ILD have not been studied.
Croatian: Bolesnici s anamnezom ILD-a nisu bili ispitivani.