FrancophonIA/ELRC3.0 huggingface dataset:
English: Careful assessment of all patients with an acute onset or unexplained worsening of pulmonary symptoms (e.g., dyspnoea, cough, fever) should be performed to exclude ILD/pneumonitis.
Croatian: Potrebno je pažljivo procijeniti sve bolesnike u kojih se pojavilo akutno ili neobjašnjivo pogoršanje plućnih simptoma (npr. dispneje, kašlja, vrućice) kako bi se isključio ILD/pneumonitis.
English: • Inflammation of the lungs (common, may affect up to 1 in 10 people) Difficulty in breathing, shortness of breath, possibly with a cough or fever.
Croatian: • upala pluća (često, može se javiti u do 1 na 10 osoba) Otežano disanje, nedostatak zraka, vjerojatno s kašljem ili vrućicom.
English: Hepatotoxicity and transaminases increased
Croatian: Hepatotoksičnost i povišene transaminaze
English: Data based on pool of 255 patients who received Vizimpro 45 mg once daily as starting dose for first-line treatment of NSCLC with EGFR-activating mutations across clinical studies.
Croatian: Temeljeno na objedinjenim podacima od 255 bolesnika koji su uzimali lijek Vizimpro 45 mg jednom na dan kao početnu dozu za prvu liniju liječenja NSCLC-a s aktivirajućim mutacijama EGFR-a u kliničkim ispitivanjima.
English: Skin-related adverse reactions were Grades 1 to 3.
Croatian: Nuspojave povezane s kožom kretale su se u rasponu od stupnja 1 do stupnja 3.
English: • Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Croatian: • Potrebno je privremeno prekinuti primjenu dakomitiniba tijekom dijagnostičke procjene ILD-a/pneumonitisa.
English: • For Grade ≥ 3 toxicity, withhold dacomitinib until symptoms resolve to Grade ≤ 2.
Croatian: • U slučaju toksičnosti stupnja ≥ 3: privremeno prekinite primjenu dakomitiniba dok se simptomi ne povuku na stupanj ≤ 2.
English: Environmental risk assessment studies have shown that dacomitinib has the potential to be very persistent, bioaccumulative and toxic to the environment (see section 6.6).
Croatian: Ispitivanja s procjenom rizika za okoliš pokazala su da dakomitinib ima potencijal biti vrlo perzistentan, bioakumulativan i toksičan za okoliš (vidjeti dio 6.6).
English: You should have an anti-diarrhoeal medicine available before you start taking Vizimpro.
Croatian: Trebate imati dostupan lijek protiv proljeva prije nego započnete uzimati lijek Vizimpro.
English: O-desmethyl dacomitinib accounted for 16% of human plasma radioactivity and is formed mainly by CYP2D6 and to a lesser extent CYP2C9.
Croatian: O-dezmetil dakomitinib činio je 16 % radioaktivnosti u ljudske plazme te je uglavnom formiran putem CYP2D6 te u manjoj mjeri putem CYP2C9.
English: Vizimpro may increase exposure (or decrease exposure of active metabolites) of other medicinal products metabolised by CYP2D6.
Croatian: Lijek Vizimpro može povećati izloženost (ili smanjiti izloženost aktivnim metabolitima) drugim lijekovima koji se metaboliziraju putem CYP2D6.
English: No data are available in patients requiring haemodialysis.
Croatian: Nisu dostupni podaci za bolesnike kojima je potrebna hemodijaliza.
English: Rash, erythematous and exfoliative skin condition adverse reactions were reported in 79.2% and 5.5%, respectively, of patients receiving Vizimpro.
Croatian: Osip, eritematozna i eksfolijativna stanja kože zabilježena su kao nuspojave u 79,2 %, odnosno 5,5 % bolesnika koji su primali lijek Vizimpro.
English: • Hair loss
Croatian: • Gubitak kose
English: Thus no dosing recommendations can be made for either patient population (see section 5.2).
Croatian: Stoga se ne može dati preporuka za doziranje za nijednu od navedenih populacija bolesnika (vidjeti dio 5.2).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: How to store Vizimpro 6.
Croatian: Kako čuvati lijek Vizimpro 6.
English: Vizimpro is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer'.
Croatian: Vizimpro se koristi za liječenje odraslih osoba s vrstom raka pluća poznatom pod nazivom „rak pluća nemalih stanica“.
English: C] radiolabeled dacomitinib, a median of 82% of the total administered radioactivity was recovered in 552 hours; faeces (79% of dose) was the major route of excretion, with 3% of the dose recovered in urine, of which < 1% of the administered dose was unchanged dacomitinib.
Croatian: C] radioaktivno označenog dakomitiniba, medijan od 82 % ukupne primijenjene radioaktivnosti pronađen je nakon 552 sata; stolica (79 % doze) je bila glavni put izlučivanja sa 3 % doze nađene u urinu, pri čemu je nepromijenjeni dakomitinib sačinjavao < 1 % primijenjene doze.
English: These results suggest that dacomitinib may increase exposure of other medicinal products (or decrease exposure to active metabolites) primarily metabolised by CYP2D6.
Croatian: Ti rezultati ukazuju na to da dakomitinib može povećati izloženost drugim lijekovima (ili smanjiti izloženost aktivnim metabolitima) koji se prvenstveno metaboliziraju putem CYP2D6.
English: Based on its mechanism of action, dacomitinib may cause foetal harm when administered to a pregnant woman.
Croatian: Zbog svojih mehanizama djelovanja dakomitinib može izazvati oštećenja fetusa kada se daje trudnici.
English: Grade 3 rash and erythematous skin condition adverse reactions were the most frequently reported Grade 3 adverse reactions (25.5%).
Croatian: Osip i eritematozna stanja kože stupnja 3 bile su najčešće zabilježene nuspojave stupnja 3 (25,5 %).
English: The maternally toxic dose was foetotoxic in rats, resulting in reduced foetal body weights and higher incidence of unossified metatarsals.
Croatian: Doza toksična za majku bila je fetotoksična u štakora što je dovelo do smanjene tjelesne težine fetusa i veće incidencije neokoštalog metatarzusa.
English: Effect of dacomitinib on drug transporters
Croatian: Učinak dakomitiniba na prijenosnike lijekova
English: Co-administration of dacomitinib and CYP2D6 substrates
Croatian: Istodobna primjena dakomitiniba i supstrata CYP2D6
English: In vitro studies indicated that CYP2D6 was the major CYP isozyme involved in the formation of O-desmethyl dacomitinib, while CYP3A4 contributed to the formation of other minor oxidative metabolites.
Croatian: In vitro ispitivanja su pokazala da je CYP2D6 bio glavni CYP izoenzim uključen u stvaranje O-dezmetil dakomitiniba, dok je CYP3A4 pridonio stvaranju drugih manjih oksidativnih metabolita.
English: There are no data on the use of dacomitinib in pregnant women.
Croatian: Nema podataka o primjeni dakomitiniba u trudnica.
English: If ILD/pneumonitis is confirmed, dacomitinib should be permanently discontinued and appropriate treatment instituted as necessary (see section 4.2).
Croatian: Ako je potvrđen ILD/pneumonitis, potrebno je trajno prekinuti primjenu dakomitiniba i, prema potrebi, započeti s odgovarajućim liječenjem (vidjeti dio 4.2).
English: Start oral antibiotics and topical steroids in patients who develop exfoliative skin conditions.
Croatian: Započnite s primjenom peroralnih antibiotika i topikalnih steroida u bolesnika u kojih se pojave eksfolijativna stanja kože.
English: If you take more Vizimpro than you should If you have taken too much Vizimpro, see a doctor or go to a hospital immediately.
Croatian: Ako ste uzeli previše lijeka Vizimpro, odmah posjetite liječnika ili idite u bolnicu.
English: ARCHER 1050 - Kaplan-Meier curve for PFS per IRC review - ITT population
Croatian: Ispitivanje ARCHER 1050 - Kaplan-Meierova krivulja za PFS prema procjeni IRCa - populacija predviđena za liječenje
English: Grade 4
Croatian: Stupanj 4
English: Very common adverse reactions in patients occurring in at least 10% of patients in Study ARCHER 1050 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4.
Croatian: Vrlo česte nuspojave u bolesnika, koje su se pojavile u najmanje 10 % bolesnika u ispitivanju ARCHER 1050, sažete su prema stupnjevima Zajedničkih kriterija toksičnosti Nacionalnog instituta za rak (engl.
English: Breast-feeding Do not breast-feed while taking this medicine because it is not known if it can harm your baby.
Croatian: Dojenje Ne smijete dojiti tijekom liječenja ovih lijekom jer nije poznato može li naškoditi Vašem djetetu.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving Vizimpro.
Croatian: Potrebno je savjetovati žene reproduktivne dobi da izbjegavaju trudnoću tijekom liječenja lijekom Vizimpro.
English: If concomitant use of such medicinal products is considered necessary, they should follow their respective labels for dose recommendation regarding co-administration with strong CYP2D6 inhibitors.
Croatian: Ako se istodobna primjena takvih lijekova smatra nužnom treba se pridržavati preporuka za doziranje vezanih uz istodobnu primjenu sa snažnim inhibitorima CYP2D6, navedenim u njihovim informacijama o lijeku.
English: Key secondary endpoints included objective response rate (ORR), duration of response (DoR), and overall survival (OS).
Croatian: Objective Response Rate, ORR), trajanje odgovora (engl. duration of response, DoR) i ukupno preživljenje (engl. overall survival, OS).
English: Dacomitinib was tested using a series of genetic toxicology assays.
Croatian: Dakomitinib je ispitivan pomoću serije testova genotoksičnosti.
English: The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review.
Croatian: Primarna mjera ishoda ispitivanja bilo je preživljavanje bez progresije bolesti (engl. progression-free survival, PFS) kako je utvrđeno zaslijepljenom neovisnom središnjom radiološkom procjenom (engl.
English: Dacomitinib is not directly reactive toward DNA as evidenced by the negative response in the bacterial reverse mutation assay and did not induce chromosome damage in a bone marrow micronucleus assay at concentrations up to approximately 60-70 times the unbound AUC or Cmax at the recommended human dose.
Croatian: Dakomitinib nije izravno reaktivan prema DNA što je dokazano negativnim odgovorom u bakterijskom testu reverzne mutacije i nije inducirao oštećenje kromosoma u mikronukleus testu koštane srži pri koncentracijama do približno 60-70 puta većim od AUC-a ili Cmax nevezanog lijeka pri preporučenim dozama za ljude.
English: This metabolite exhibited in vitro pharmacologic activity that was similar to that of dacomitinib in the in vitro biochemical assays.
Croatian: Metabolit je pokazao in vitro farmakološku aktivnost koja je bila slična aktivnosti dakomitiniba u in vitro biokemijskim testovima.
English: Patients with brain metastases or leptomeningeal disease or ECOG PS ≥ 2 were excluded from the trial.
Croatian: Bolesnici s metastazama na mozgu, leptomeningalnom bolešću ili ECOG PS-om koji je iznosio ≥ 2 bili su isključeni iz ispitivanja.
English: • Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, indigestion and heartburn).
Croatian: • lijekovi s produženim djelovanjem za smanjenje kiseline u želucu poput inhibitora protonske pumpe (za čireve, lošu probavu i žgaravicu).
English: • Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to fluid loss (common), low blood potassium (very common), and worsening kidney function and can be fatal.
Croatian: • Proljev (vrlo često, može se javiti u više od 1 na 10 osoba) Proljev može uzrokovati gubitak tekućine (često), smanjenu razinu kalija u krvi (vrlo često) i pogoršanje funkcije bubrega te može biti smrtonosan.
English: j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased.
Croatian: Povišene transaminaze uključuju sljedeće preporučene pojmove: povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišene transaminaze.
English: Following dacomitinib 45 mg daily dosing, steady-state was reached within 14 days.
Croatian: Nakon dnevne doze dakomitiniba od 45 mg, stanje dinamičke ravnoteže bilo je postignuto unutar 14 dana.
English: Adverse reactions reported in dacomitinib clinical studies (N=255) System organ class
Croatian: Nuspojave prijavljene u kliničkim ispitivanjima dakomitiniba (N=255)
English: All Grades
Croatian: Svi stupnjevi
English: Proactive management of diarrhoea should start at the first sign of diarrhoea especially within the first 2 weeks of starting dacomitinib, including adequate hydration combined with anti-diarrhoeal medicinal products and continued until loose bowel movements cease for 12 hours.
Croatian: Treba započeti proaktivno liječenje proljeva pri pojavi prvog znaka proljeva, osobito tijekom prva 2 tjedna od početka liječenja dakomitinibom, te uključiti odgovarajuću hidraciju u kombinaciji s lijekovima protiv proljeva i nastaviti s liječenjem sve dok se ne postigne 12 sati bez pojave mekane stolice.
English: • Flushed or painful palms or soles
Croatian: • Crveni ili bolni dlanovi ili tabani
English: What you need to know before you take Vizimpro
Croatian: Što morate znati prije nego počnete uzimati lijek Vizimpro
English: It is available in blister packs of 30 film-coated tablets (tablets).
Croatian: Dostupan je u blister pakiranjima od 30 filmom obloženih tableta (tablete).
English: Dacomitinib is extensively distributed throughout the body with a mean steady-state volume of distribution of 27 L/kg (patient of 70 kg) [coefficient of variation (CV%): 18%] following intravenous administration.
Croatian: Dakomitinib se opsežno distribuira čitavim tijelom sa srednjim volumenom distribucije u stanju dinamičke ravnoteže od 27 l/kg (u bolesnika s tjelesnom težinom od 70 kg) [koeficijent varijacije (%): 18%] nakon intravenske primjene.
English: Significant exposure-safety relationship was defined for Grade ≥ 3 rash/dermatitis acneiform, other skin toxicities, diarrhoea and Grade ≥ 1 stomatitis.
Croatian: Definirana je značajna veza između izloženosti i sigurnosti za osip/akneiformni dermatitis, druga toksična oštećenja kože i proljev stupnja ≥ 3 te stomatitis stupnja ≥ 1.
English: Tell your doctor if a rash starts.
Croatian: Obavijestite svog liječnika ako dobijete osip.
English: Second dose reduction
Croatian: Drugo smanjenje doze
English: No clinical studies have been conducted in patients with impaired renal function.
Croatian: Nisu provedena klinička ispitivanja u bolesnika s oštećenjem funkcije bubrega.
English: Carcinogenicity studies have not been performed with dacomitinib.
Croatian: Ispitivanja kancerogenosti nisu provedena s dakomitinibom.
English: There was no effect on reproductive organs in male rats given ≤ 2 mg/kg/day for 6 months (approximately 1.1 times the unbound AUC at the recommended human dose), or in dogs given ≤ 1 mg/kg/day for 9 months (approximately 0.3 times the unbound AUC at the recommended human dose).
Croatian: Nije bilo učinaka na reproduktivne organe mužjaka štakora koji su primali ≤ 2 mg/kg/dan tijekom 6 mjeseci (što približno odgovara 1,1-strukoj vrijednosti AUC-a nevezanog lijeka u ljudi pri preporučenoj dozi) ili u pasa koji su primali ≤ 1 mg/kg/dan tijekom 9 mjeseci (što odgovara približno 0,3-strukoj vrijednosti AUC-a nevezanog lijeka u ljudi pri preporučenoj dozi).
English: Elderly population No starting dose adjustment of Vizimpro in elderly (≥ 65 years of age) patients is required (see section
Croatian: Nije potrebno prilagođavati početnu dozu lijeka Vizimpro kod starijih (≥ 65 godina) bolesnika (vidjeti dio 5.2).
English: Based on pooled data in patients, there was no apparent effect of histamine-2 (H2) receptor antagonists on steady-state trough concentration of dacomitinib (geometric mean ratio of 86% (90% CI: 73; 101).
Croatian: Na temelju objedinjenih podataka bolesnika, nije se pokazao vidljiv učinak antagonista histaminskih receptora tipa 2 (H2) na najniže koncentracije dakomitiniba u stanju dinamičke ravnoteže (omjer srednje geometrijske vrijednosti od 86 % (90 % CI: 73; 101).
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 3, with the majority Grade 1 (18.4%) (see section 4.4).
Croatian: Povišene transaminaze (povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišene transaminaze) zabilježene su u 22,0 % bolesnika koji su primali lijek Vizimpro te su se kretala od stupnja 1 do stupnja 3, pri čemu je većina njih bila stupnja 1 (18,4 %) (vidjeti dio 4.4).
English: ILD/pneumonitis adverse reactions were reported in 2.7% of patients receiving Vizimpro, and Grade ≥ 3 ILD/pneumonitis adverse reactions were reported in 0.8%, including a fatal event (0.4%) (see section 4.4).
Croatian: Nuspojave ILD/pneumonitisa zabilježene su u 2,7 % bolesnika koji su primali lijek Vizimpro, dok su nuspojave ILD/pneumonitisa stupnja ≥ 3 zabilježene u 0,8 % bolesnika, uključujući događaj sa smrtnim ishodom (0,4 %) (vidjeti dio 4.4).
English: Data from a study in 24 healthy subjects indicated that co-administration of a single 45 mg dacomitinib dose with the PPI rabeprazole 40 mg once daily for 7 days decreased dacomitinib Cmax, AUC0-96h (area under the concentration-time curve from time 0 to 96 hours), and AUCinf (AUC from time 0 to infinity) (n=14) by approximately 51%, 39%, and 29%, respectively, when compared to a single 45 mg dose of dacomitinib administered alone.
Croatian: Podaci iz ispitivanja u 24 zdrava ispitanika pokazuju da je istodobna primjena jednokratne doze dakomitiniba od 45 mg s IPP-om rabeprazolom od 40 mg primjenjenim jednom na dan tijekom 7 dana smanjila vrijednost Cmax dakomitiniba za približno 51 %, vrijednost AUC0-96h (područje ispod krivulje koncentracija-vrijeme od 0 do 96 sati) za približno 39 % i AUCinf (AUC od vremena 0 do beskonačnosti) 29 %, (n=14), u odnosu na jednokratnu dozu dakomitiniba od 45 mg kada je primjenjen sam.
English: See leaflet for further information.
Croatian: Vidjeti uputu o lijeku za više informacija.
English: Non-clinical safety studies showed reversible epithelial atrophy in the cervix and vagina of rats (see section 5.3).
Croatian: Neklinička ispitivanja sigurnosti pokazala su reverzibilnu epitelnu atrofiju u vratu maternice i rodnici štakora (vidjeti dio 5.3).
English: • if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Vizimpro: • ako ste alergični na dakomitinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib.
Croatian: Možda će biti potrebno bolesnicima prekinuti doziranje i/ili smanjiti dozu dakomitiniba.
English: In vitro, dacomitinib has a low potential to inhibit uridine-diphosphate glucuronosyltransferase (UGT)1A4, UGT1A6, UGT1A9, UGT2B7, and UGT2B15.
Croatian: In vitro dakomitinib ima mali potencijal za inhibiciju uridin-difosfat glukuronoziltransferaze (UGT)1A4, UGT1A6, UGT1A9, UGT2B7 i UGT2B15.
English: Table 3 presents adverse reactions for Vizimpro.
Croatian: Tablica 3 prikazuje nuspojave za lijek Vizimpro.
English: • Abnormal liver enzyme blood tests
Croatian: • Odstupanja u rezultatima krvnih pretraga jetrenih enzima
English: First dose reduction
Croatian: Prvo smanjenje doze
English: The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Croatian: Topljivost dakomitiniba u vodi ovisi o pH vrijednostima na način da nizak (kiseli) pH rezultira većom topljivosti.
English: Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate.
Croatian: Prilagodba doze (npr. loperamidom) i odgovarajućim peroralnim unosom tekućine ili, prema potrebi, intravenskom primjenom tekućina ili elektrolita.
English: Dacomitinib is a substrate for the membrane transport proteins P-gp and BCRP.
Croatian: Dakomitinib je supstrat za membranske proteine s funkcijom prijenosa, P-gp i BCRP.
English: Interstitial lung disease (ILD)/Pneumonitis
Croatian: Intersticijska plućna bolest (ILD)/pneumonitis
English: In Asian patients, median PFS was 16.5 months for dacomitinib arm and 9.3 months for gefitinib arm.
Croatian: U azijskih bolesnika je medijan PFS-a iznosio 16,5 mjeseci za skupinu liječenu dakomitinibom i 9,3 mjeseca za skupinu liječenu gefitinibom.
English: Dacomitinib was not mutagenic in a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone marrow micronucleus assay in male and female rats.
Croatian: Dakomitinib nije bio mutagen u Amesovom bakterijskom testu reverzne mutacije niti klastogen ni aneugeničan u in vivo mikronukleus testu koštane srži u mužjaka i ženki štakora.
English: Encourage adequate oral fluid intake during diarrhoea.
Croatian: Potrebno je potaknuti odgovarajući peroralni unos tekućine tijekom trajanja proljeva.
English: Repeated-dose toxicity
Croatian: Toksičnost ponovljene doze
English: Danmark Pfizer ApS Tlf: +45 44 20 11 00
Croatian: Pfizer ApS Tlf: +45 44 20 11 00
English: Patients experiencing fatigue or ocular adverse reactions while taking dacomitinib should exercise caution when driving or operating machinery.
Croatian: Bolesnici koji osjete umor ili očne nuspojave za vrijeme liječenja dakomitinibom moraju biti oprezni kada upravljaju vozilima ili rade sa strojevima.
English: Diarrhoea was the most frequently reported adverse reaction in patients receiving Vizimpro (88.6%) and Grade ≥ 3 diarrhoea adverse reactions were reported in 9.4% of patients.
Croatian: Proljev je bio najčešće zabilježena nuspojava u bolesnika koji su primali lijek Vizimpro (88,6 %), a proljev stupnja ≥ 3 zabilježen je u 9,4 % bolesnika.
English: Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451) Dacomitinib (N=227)
Croatian: Vrlo česte nuspojave u ispitivanju ARCHER 1050 (N=451) faze 3
English: Abbreviations: CI=confidence interval; EGFR=epidermal growth factor receptor; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-to-treat; IWRS=interactive web response system; N/n=total number; NSCLC=non-small cell lung cancer; PFS=progression-free survival; DoR=Duration of Response.
Croatian: Kratice: CI=interval pouzdanosti; EGFR=receptor epidermalnog čimbenika rasta; HR=omjer hazarda; IRC=neovisna središnja radiološka procjena; ITT=populacija predviđena za liječenje; IWRS=interaktivni sustav mrežnog odgovora; N/n=ukupan broj; NSCLC=rak pluća nemalih stanica; PFS=preživljenje bez progresije bolesti; DoR=trajanje odgovora.
English: In faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a mono-oxygenated metabolite of dacomitinib were the major drug-related components.
Croatian: U stolici su dakomitinib, O-dezmetil dakomitinib, dakomitinib u obliku konjugata s cisteinom i mono-oksigenirani metabolit dakomitiniba bile glavne komponente povezane s lijekom.
English: Adverse reactions leading to dose reductions were reported in 52.2% of patients treated with dacomitinib.
Croatian: Nuspojave koje su dovele do smanjenja doze zabilježene su u 52,2 % bolesnika liječenih dakomitinibom.
English: The median duration of any grade and Grade ≥ 3 ILD/pneumonitis was 13 weeks and 1.5 weeks, respectively (see section 4.4).
Croatian: Medijan trajanja ILD-a/pneumonitisa bilo kojeg stupnja i ILD-a/pneumonitisa stupnja ≥ 3 iznosio je 13 tjedana, odnosno 1,5 tjedana (vidjeti dio 4.4).
English: The most frequently (≥ 1%) reported serious adverse reactions in patients receiving dacomitinib were diarrhoea (2.0%), interstitial lung disease (1.2%), rash (1.2%), and decreased appetite (1.2%).
Croatian: Najčešće (≥ 1 %) zabilježene ozbiljne nuspojave u bolesnika koji su primali dakomitinib bile su: proljev (2,0 %), intersticijska plućna bolest (1,2 %), osip (1,2 %) i smanjen apetit (1,2 %).