FrancophonIA/ELRC3.0 huggingface dataset:
English: - antacid medicines - the dose of these medicines and Nerlynx should be separated by at least 3 hours.
Croatian: - antacidi - doza tih lijekova i lijeka Nerlynx trebaju se uzimati u razmaku od barem 3 sata.
English: Left ventricular dysfunction has been associated with HER2 inhibition.
Croatian: Disfunkcija lijeve klijetke povezana je s inhibicijom proteina HER2.
English: Tell your doctor or pharmacist if you notice any of the following side effects:
Croatian: Obavijestite svog liječnika ili ljekarnika ako primijetite bilo koju od sljedećih nuspojava:
English: In the clinical trial setting, adverse reactions associated with overdose were most commonly diarrhoea, with or without nausea, vomiting and dehydration.
Croatian: U kliničkim ispitivanjima nuspojave povezane s predoziranjem najčešće su bile proljev, sa ili bez mučnine, povraćanje i dehidracija.
English: • rifampicin (antimycobacterial)
Croatian: • rifampicin (antimikobakterijski lijek)
English: Diarrhoea, vomiting, nausea, abdominal pain, abdominal pain upper, and stomatitis1
Croatian: Proljev, povraćanje, mučnina, bol u abdomenu, bol u gornjem dijelu abdomena i stomatitis1
English: - The other ingredients are: - Tablet core: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate - Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172)
Croatian: - Jezgra tablete: manitol (E421), mikrokristalična celuloza, krospovidon, povidon, koloidni bezvodni silicijev dioksid, magnezijev stearat - Ovojnica tablete: poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E172)
English: In HER2-positive breast cancer, the cancer cells have a large amount of HER2 receptors on their surface.
Croatian: Kod raka dojke pozitivnog na HER2, na površini stanica raka nalaze se velike količine receptora HER2.
English: If grade 3 toxicity does not recover within 3 weeks, discontinue Nerlynx permanently.
Croatian: Ako ne dođe do oporavka od toksičnosti 3. stupnja u roku od 3 tjedna, trajno obustaviti primjenu lijeka Nerlynx.
English: Nerlynx has not been studied in patients with less than lower limit of normal left ventricular ejection fraction (LVEF) or with significant cardiac history.
Croatian: Lijek Nerlynx nije ispitivan u bolesnika s ejekcijskom frakcijom lijeve klijetke (engl. left ventricular ejection fraction, LVEF) ispod donje granice normale ili sa značajnom kardiološkom anamnezom.
English: The mass balance after administration of a single oral dose of 200 mg of neratinib was studied in six healthy subjects.
Croatian: Masena bilanca nakon primjene pojedinačne peroralne doze od 200 mg neratiniba ispitana je na šest zdravih osoba.
English: - Your doctor will also tell you if you need to change the dose of Nerlynx because of diarrhoea.
Croatian: Također će Vam reći trebate li promijeniti dozu lijeka Nerlynx zbog proljeva.
English: This results in the cancer cells dividing and growing faster.
Croatian: To dovodi do brže podjele i rasta stanica raka.
English: The MedDRA frequency convention and system organ class database has been utilised for the classification of frequency: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data)
Croatian: često (≥ 1/100 i < 1/10) manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i < 1/1000) vrlo rijetko (< 1/10 000)
English: A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Croatian: Jedna doza neratiniba od 240 mg u kombinaciji s lansoprazolom smanjila je AUC za do 70 %.
English: Patients who are treated with BCRP inhibitors (e.g., rosuvastatin and sulfasalazine) should be monitored carefully.
Croatian: Potrebno je pažljivo nadzirati bolesnike koji se liječe inhibitorima BCRP-a (npr. rosuvastatinom i sulfasalazinom).
English: Neratinib binds to the HER2 receptor, reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and potently inhibits tumour cell proliferation in vitro.
Croatian: Neratinib se vezuje za receptor HER2, smanjuje autofosforilaciju EGFR i HER2 i aktivaciju nizvodnih signalnih puteva MAPK i AKT te snažno inhibira proliferaciju stanica tumora in vitro.
English: Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Croatian: Metabolizam neratiniba provodi se prvenstveno u jetrenim mikrosomima putem CYP3A4 te u manjoj mjeri putem flavin-monooksigenaze (FMO).
English: The safety of Nerlynx and how effective it is has not been studied in this age group.
Croatian: Sigurnost i djelotvornost lijeka Nerlynx nije ispitana u ovoj dobnoj skupini.
English: Patients with symptomatic skin and subcutaneous tissue disorders should be carefully monitored (see Section 4.8).
Croatian: Potrebno je pažljivo pratiti bolesnike sa simptomatičnim poremećajima kože i potkožnog tkiva (vidjeti dio 4.8).
English: Patients who are treated concomitantly with therapeutic agents whose metabolism involves P-gp substrates in the gastrointestinal tract should be monitored carefully.
Croatian: Potrebno je pažljivo pratiti bolesnike koji se istodobno liječe terapijskim tvarima čiji metabolizam uključuje P-gp supstrate u gastrointestinalnom traktu.
English: Secondary endpoints of the study included disease-free survival (DFS) including ductal carcinoma in situ (DFS-DCIS), time to distant recurrence (TTDR), distant disease-free survival (DDFS), cumulative incidence of central nervous system recurrence and overall survival (OS).
Croatian: Sekundarne mjere ishoda ispitivanja obuhvaćale su preživljenje bez simptoma bolesti (DFS), uključujući duktalni karcinom in situ (DFS-DCIS), razdoblje do recidiva bolesti na udaljenom mjestu (TTDR), preživljenje bez bolesti na udaljenom mjestu (DDFS), ukupnu pojavnost recidiva u središnjem živčanom sustavu i ukupno preživljenje (OS).
English: The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Croatian: Učestalost poremećaja 1. stupnja bila je 6,2 %, a 2. stupnja 1,4 %.
English: In patients that were hormone receptor negative, regardless of time from trastuzumab therapy, the hazard ratio for iDFS at 2 years was 0.93, with 95% CI (0.60, 1.43).
Croatian: Kod bolesnica koje su bile negativne na hormonske receptore, neovisno o razdoblju proteklom od liječenja trastuzumabom, omjer hazarda za iDFS pri 2 godine iznosio je 0,93 uz 95 % CI (0,60;
English: - lansoprazole, omeprazole or similar medicines called ‘proton pump inhibitors' or PPIs and ranitidine, cimetidine or similar medicines called ‘H2 receptor antagonists' are not recommended.
Croatian: - lijekove za želučane probleme, kao što su: - lansoprazol, omeprazol ili slični lijekovi koji se nazivaju „inhibitori protonske pumpe” ili PPI te rantidin, cimetidin ili slični lijekovi koji se nazivaju „antagonisti H2 receptora” se ne preporučuju.
English: 1 Event-free rates for all endpoints, except for CNS recurrence for which cumulative incidence is reported.
Croatian: 1 Stope bez događaja za sve mjere ishoda, osim za recidiv u CNS-u za koji je prijavljena ukupna pojavnost.
English: Patients who experience ≥ Grade 3 diarrhoea requiring IV fluid treatment or any signs or symptoms of hepatotoxicity, such as worsening of fatigue, nausea, vomiting, jaundice, right upper quadrant pain or tenderness, fever, rash, or eosinophilia, should be evaluated for changes in liver function tests.
Croatian: Kod bolesnika kod kojih se pojave proljev ≥ 3. stupnja koji zahtijeva liječenje intravenskom nadoknadom tekućine ili bilo koji znakovi ili simptomi hepatotoksičnosti, kao što su pogoršanje umora, mučnina, povraćanje, žutica, bol ili osjetljivost u gornjem desnom kvadrantu, vrućica, osip ili eozinofilija treba provjeriti moguće promjene u rezultatima ispitivanja funkcije jetre.
English: Following oral administration of 240 mg neratinib, absorption was slow and peak plasma concentrations of neratinib occurred around 7 hours after administration.
Croatian: Nakon peroralne primjene 240 mg neratiniba, apsorpcija je bila spora, a do vršnih koncentracija neratiniba u plazmi došlo je oko 7 sati nakon primjene.
English: Pooled safety data of 1710 patients treated with Nerlynx monotherapy showed a higher incidence of dermatologic toxicities in Asian patients (57.1%) versus Caucasian patients (34.6%).
Croatian: Skupni podaci o sigurnosti za 1710 bolesnika liječenih samo lijekom Nerlynx ukazuju na veću učestalost dermatoloških toksičnosti u Azijata (57,1 %) u odnosu na bijelce (34,6 %).
English: Grade 3 ALT or bilirubin occurs again despite one dose reduction, permanently discontinue Nerlynx.
Croatian: ALT-a ili bilirubina 3. stupnja unatoč jednom smanjenju doze, potrebno je trajno obustaviti liječenje lijekom Nerlynx.
English: What Nerlynx is and what it is used for What Nerlynx is
Croatian: Što je Nerlynx i za što se koristi Što je Nerlynx
English: Left ventricular function
Croatian: Funkcija lijeve klijetke
English: Nerlynx contains the active substance ‘neratinib'.
Croatian: Nerlynx sadržava djelatnu tvar „neratinib”.
English: In a dose escalation study in healthy volunteers, single oral doses of Nerlynx up to 800 mg were administered.
Croatian: U ispitivanju povećanja doze u zdravih dobrovoljaca primijenjena je po jedna peroralna doza lijeka Nerlynx od najviše 800 mg.
English: If you take more Nerlynx than you should, contact a doctor or a hospital straight away.
Croatian: Ako uzmete veću dozu lijeka Nerlynx nego biste trebali, odmah se obratite liječniku ili idite u bolnicu.
English: • If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
Croatian: • Ako se težina proljeva smanji na 0.-1. stupanj u roku duljem od tjedan dana, nastaviti liječenje lijekom Nerlynx u smanjenoj dozi (vidjeti tablicu 1).
English: How to take Nerlynx
Croatian: Kako uzimati Nerlynx
English: • Patient information pack
Croatian: • Paket s informacijama za bolesnika
English: Abdominal distension, dry mouth and dyspepsia
Croatian: Distenzija abdomena, suha usta i dispepsija
English: You should take an anti-diarrhoea medicine so that your diarrhoea does not become severe, and to prevent you from getting dehydrated during treatment with Nerlynx.
Croatian: Trebate uzeti lijek protiv proljeva kako proljev ne bi postao težak te kako biste spriječili dehidraciju tijekom liječenja lijekom Nerlynx.
English: Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
Croatian: Neratinib se većinom vezao za HSA i ljudski alfa-1 kiseli glikoprotein (AAG).
English: Dose reductions occurred in 24.7% of Nerlynx-treated patients.
Croatian: Do smanjenja doze došlo je u 24,7 % bolesnika liječenih lijekom Nerlynx.
English: Median time from the last adjuvant trastuzumab treatment to randomization was 4.5 months.
Croatian: Medijan vremena od posljednjeg adjuvantnog liječenja trastuzumabom do randomizacije iznosio je
English: Figure 2:
Croatian: Slika 2:
English: A single dose of 240 mg neratinib taken with food increased Cmax and AUC by approximately 17% and 23%, respectively, compared with administration in the fasting state.
Croatian: Pojedinačna doza od 240 mg neratiniba uzeta s hranom povećala je Cmax i AUC za oko 17 %, odnosno 23 %, u usporedbi s primjenom natašte.
English: No significant changes in fertility parameters in male and female rats were detected in dosing up to 12 mg/kg/day (see Section 5.3).
Croatian: Kod doza do 12/mg/kg dnevno nisu uočene značajne promjene u parametrima plodnosti u mužjaka i ženki štakora (vidjeti dio 5.3).
English: The following side effects may happen with this medicine:
Croatian: Kod uzimanja ovog lijeka može doći do sljedećih nuspojava:
English: The most common Grade 3-4 adverse reactions were diarrhoea (Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade 4, 0.1%).
Croatian: Najčešće nuspojave 3.-4. stupnja bile su proljev (3. stupanj, 36,9 % i 4. stupanj, 0,2 %) i povraćanje (3. stupanj, 3,4 % i 4. stupanj, 0,1 %).
English: In healthy subjects, digoxin increased Cmax by 54% and AUC increased by 32% when co-administered with multiple oral doses of neratinib 240 mg compared with exposures of digoxin alone.
Croatian: U zdravih ispitanika digoksinu se povećao Cmax za 54 % te AUC za 32 % kada se primjenjivao zajedno s višestrukim peroralnim dozama neratiniba od 240 mg u usporedbi s izloženosti samom digoksinu.
English: Nerlynx 40 mg film-coated tablets
Croatian: Nerlynx 40 mg filmom obložene tablete
English: Concomitant use of strong CYP3A4/P-gp inhibitors (e.g. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, and voriconazole) should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu snažnih inhibitora CYP3A4/Pgp (npr. atazanavira, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, ketokonazola, itrakonazola, klaritromicina, telitromicina i vorikonazola).
English: After discontinuation of a strong CYP3A4/P-gp inhibitor, resume previous dose of Nerlynx 240 mg (see Section 4.4 and Section 4.5).
Croatian: Nakon prestanka primjene snažnog inhibitora CYP3A4/Pgp, nastaviti s prethodnom dozom lijeka Nerlynx od 240 mg (vidjeti dio 4.4 i dio 4.5).
English: Very Common Decreased appetite Common
Croatian: Smanjen apetit
English: Neratinib is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).
Croatian: (ERBB) tirozin kinaze (TKI) koji blokira transdukciju signala za mitogeni faktor rasta putem kovalentne veze visokog afiniteta za mjesto vezanja ATP-a 3 receptora epidermalnog faktora rasta (EGFR-ovi): EGFR (kojeg kodira ERBB1), HER2 (kojeg kodira ERBB2) i HER4 (kojeg kodira ERBB4) ili njihovih aktivnih heterodimera s HER3 (kojeg kodira ERBB3).
English: Nerlynx has not been studied in patients with severe renal impairment including patients on dialysis.
Croatian: Liječenje lijekom Nerlynx nije ispitano u bolesnika s teškim oštećenjem funkcije bubrega, uključujući bolesnike koji se liječe dijalizom.
English: Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
Croatian: Muškarci bi trebali koristiti mehaničku kontracepcijsku metodu tijekom liječenja te 3 mjeseca nakon prestanka liječenja.
English: Nail disorder3, skin fissures and dry skin
Croatian: Poremećaj noktiju3, raspukline na koži i suha koža
English: This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
Croatian: To dovodi do trajne inhibicije tih putova za promicanje rasta kod prekomjerno izraženih hormonskih receptora HER2 ili kod karcinoma dojke s mutacijom HER2.
English: Following the administration of a single radiolabelled dose of 200 mg neratinib oral solution, 97.1% and 1.1% of the administered dose was recovered in the faeces and urine, respectively.
Croatian: Nakon primjene pojedinačne radioaktivno obilježene doze oralne otopine od 200 mg neratiniba, 97,1 % odnosno 1,1 % primijenjene doze izlučeno je kroz stolicu i mokraću.
English: Prior to launch of Nerlynx in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Nerlynx u svakoj državi članici nositelj odobrenja za stavljanje lijeka u promet mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskog programa,
English: Neratinib represents the most prominent component in plasma and systemic exposure to the metabolites (M3, M6, M7 and M11) after oral administration of neratinib is between 10% and 33% lower than parent in healthy subjects.
Croatian: Bolje s placebom sastavnicu u plazmi i sistemska izloženost metabolitima (M3, M6, M7 i M11) nakon peroralne primjene neratiniba je između 10 % i 33 % niža od izloženosti ishodišnom spoju u zdravih ispitanika.
English: If you forget to take Nerlynx
Croatian: Ako ste zaboravili uzeti Nerlynx
English: • Diet modifications
Croatian: • Promjene načina prehrane
English: Nerlynx treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Nerlynx treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Silica, colloidal anhydrous Magnesium stearate
Croatian: Silicijev dioksid, koloidni, bezvodni Magnezijev stearat
English: Concomitant treatment with inhibitors of CYP3A4 and P-gp Concomitant treatment with strong CYP3A4 and P-gp inhibitors should be avoided due to risk of increased exposure to neratinib (see Section 4.2 and Section 4.5).
Croatian: Istodobno liječenje inhibitorima CYP3A4 i P-gp Potrebno je izbjegavati istodobno liječenje snažnim inhibitorima CYP3A4 i P-gp zbog rizika od povećane izloženosti neratinibu (vidjeti dio 4.2 i dio 4.5).
English: Grade 3 diarrhoea was reported in 37.5% of Nerlynx patients.
Croatian: Proljev 3. stupnja prijavljen je u 37,5 % bolesnika liječenih lijekom Nerlynx.
English: Both rash and nail disorders led to treatment discontinuation in 0.6% of Nerlynx-treated patients.
Croatian: I osip i poremećaji noktiju doveli su do prekida liječenja kod 0,6 % bolesnika liječenih lijekom
English: Women should avoid becoming pregnant while taking Nerlynx and for up to 1 month after ending treatment.
Croatian: Žene ne bi smjele zatrudnjeti dok uzimaju Nerlynx te mjesec dana nakon završetka liječenja.
English: The film-coated tablets are red oval shaped and debossed with ‘W104' on one side and plain on the other side.
Croatian: Filmom obložene tablete su crvene, ovalnog oblika i imaju oznaku ‘W104' utisnutu na jednoj strani, dok na drugoj strani nemaju nikakvu oznaku.
English: In vitro studies demonstrated that neratinib is a substrate for P-glycoprotein (P-gp).
Croatian: In vitro ispitivanja pokazala su da je neratinib supstrat za P-glikoprotein (P-gp).
English: If you become pregnant while taking this medicine, the doctor will assess the potential benefit to you and the risk to the foetus, of continuing this medicine.
Croatian: Ako zatrudnite tijekom uzimanja ovog lijeka, liječnik će ocijeniti moguću korist za Vas i rizik za fetus prije nastavka liječenja ovim lijekom.
English: The Cmax of neratinib increased by 3.2 fold and AUC increased by 4.8 fold when coadministered with ketoconazole, compared with neratinib administered alone.
Croatian: Cmax neratiniba povećan je za 3,2 puta, a AUC je povećan za 4,8 puta kada se uzimao zajedno s ketokonazolom u usporedbi s neratinibom kada se primjenjuje samostalno.
English: 52.3 years (59.9% was ≥50 years old, 12.3% was ≥65 years old); 81.0% were Caucasian, 2.6% black or African American, 13.6% Asian and 2.9% other.
Croatian: Medijan dobi u populaciji predviđenoj za liječenje (engl. intention to treat, ITT) bio je 52,3 godine (59,9 % bolesnica bilo je staro ≥50 godina, 12,3 % bilo je staro ≥65 godina); 81,0 % bolesnica bile su bjelkinje, 2,6 % crnkinje ili Afroamerikanke, 13,6 % Azijatkinje, a 2,9 % ostalo.
English: In rabbits, there were no effects on mating or the ability of animals to become pregnant, but embryofoetal lethality and foetal morphologic anomalies (e.g. domed head, dilation of brain ventricles and misshapen anterior fontanelles and enlarged anterior and/or posterior fontanelles) were observed at doses that may be considered to be clinically relevant.
Croatian: U kunića nisu uočeni učinci na parenje ili sposobnost životinja da postanu skotne, ali pri dozama koje se mogu smatrati klinički relevantnima uočeni su mortalitet embrija i fetusa te morfološke anomalije fetusa (npr. kupolasta glava, širenje moždanih klijetki i izobličene prednje fontanele te povećane prednje i/ili stražnje fontanele).
English: • fluconazole (antifungal)
Croatian: • flukonazol (antimikotik)
English: The clearance values of digoxin were equivalent following digoxin and digoxin plus neratinib.
Croatian: Vrijednosti klirensa digoksina bile su jednakovrijedne nakon digoksina te digoksina plus neratiniba.
English: - Start taking anti-diarrhoea medicine with the first dose of Nerlynx.
Croatian: - Počnite uzimati lijek protiv proljeva s prvom dozom lijeka Nerlynx.
English: Circulating metabolites include neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine N-oxide (M7) and traces of
Croatian: Cirkulirajući metaboliti uključuju neratinib piridin N-oksid (M3), N-dezmetilneratinib (M6), neratinib dimetilamin N-oksid (M7) i tragove hidroksil neratinib N-oksida i neratinib bis-N-oksida (M11).
English: Dose modifications for hepatotoxicity Severity of hepatotoxicity*
Croatian: Tablica 4: Prilagodbe doze za hepatotoksičnost Težina hepatotoksičnosti*
English: - Keep taking anti-diarrhoea medicine during the first one to two months of Nerlynx treatment.
Croatian: - Nastavite s uzimanjem lijeka protiv proljeva tijekom prvih mjesec dana do dva mjeseca liječenja lijekom Nerlynx.
English: Nodal Status
Croatian: Status čvorova
English: Nerlynx 40 mg film-coated tablets neratinib
Croatian: Nerlynx 40 mg filmom obložene tablete neratinib
English: • Evaluate alternative causes • Resume Nerlynx at the next lower dose level if recovery to ≤ Grade 1 occurs within 3 weeks.
Croatian: • Nastaviti liječenje lijekom Nerlynx pri sljedećoj nižoj dozi ako u roku od 3 tjedna dođe do oporavka na ≤ 1. stupanj.
English: There was no Grade 3 or 4 adverse reactions of blood bilirubin increased.
Croatian: Nisu prijavljene nuspojave povišene razine bilirubina u krvi 3. ili 4. stupnja.
English: Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Croatian: Nerlynx je indiciran za produljeno adjuvantno liječenje odraslih bolesnika s rakom dojke u ranoj fazi pozitivnim na prekomjerno izražene hormonske receptore HER2 kod kojih je adjuvantno liječenje koje se temelji na trastuzumabu završilo prije manje od godinu dana.
English: The most common adverse reactions of any grade were diarrhoea (93.6%), nausea (42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%), rash (15.4%), decreased appetite (13.7%), abdominal pain upper (13.2%), stomatitis (11.2%), and muscle spasms (10.0%).
Croatian: Najčešće nuspojave bilo kojeg stupnja bili su proljev (93,6 %), mučnina (42,5 %), umor (27,3 %), povraćanje (26,8 %), bol u abdomenu (22,7 %), osip (15,4 %), smanjeni apetit (13,7 %), bol u gornjem dijelu abdomena (13,2 %), stomatitis (11,2 %) i grčevi u mišićima (10,0 %).
English: Hormone receptor positive patients, disease-free survival by patient subgroup
Croatian: Bolesnice s bolesti pozitivnom na hormonske receptore, preživljenje bez progresije bolesti po podskupini bolesnica
English: It is not known whether neratinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se neratinib u ljudskom mlijeku.
English: Diarrhoea management requires the correct use of an anti-diarrhoeal medicinal product, dietary changes, and appropriate dose modifications of Nerlynx.
Croatian: Prilagodbe doze za proljev Zbrinjavanje proljeva zahtijeva pravilnu primjenu lijeka protiv proljeva, promjene u načinu prehrane i prikladne prilagodbe doze lijeka Nerlynx.
English: Diarrhoea usually happens early in treatment with Nerlynx and may be severe, causing you to get dehydrated.
Croatian: Proljev se obično javlja u ranoj fazi liječenja lijekom Nerlynx i može biti težak te dovesti do dehidracije.
English: The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year.
Croatian: Preporučena doza lijeka Nerlynx iznosi 240 mg (šest tableta od 40 mg) peroralno jednom dnevno,