FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Nerlynx.
Croatian: Ako se išta od gore navedenog odnosi na Vas (ili ako niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije početka uzimanja lijeka Nerlynx.
English: What Nerlynx looks like and contents of the pack
Croatian: Kako Nerlynx izgleda i sadržaj pakiranja
English: Hormonal contraceptives
Croatian: Hormonska kontracepcijska sredstva
English: Clinical studies with BCRP substrates have not been conducted.
Croatian: Nisu provedena klinička ispitivanja sa supstratima BCRP-a.
English: Do not use Nerlynx if you notice any signs of damage to the packaging or if there are any signs of tampering (e.g., inner seal is broken).
Croatian: Nemojte uzimati Nerlynx ako primijetite znakove oštećenja ambalaže ili ako postoje znakovi neovlaštenog korištenja (npr. ako je oštećena unutarnja zaštita).
English: It belongs to a group of medicines called ‘tyrosine kinase inhibitors' used to block cancer cells and treat breast cancer.
Croatian: Ubraja se u skupinu lijekova pod nazivom „inhibitori tirozin kinaze”, koji se koriste za blokiranje stanica raka i liječenje raka dojke.
English: Severe hepatic impairment (Child-Pugh C).
Croatian: Teška oštećenja funkcije jetre (Child-Pugh C).
English: • Grade 4 diarrhoea [life-threatening consequences; urgent intervention indicated]
Croatian: • Proljev 4. stupnja [posljedice opasne po život; indicirana je hitna intervencija]
English: Distribution Binding of neratinib to human plasma proteins, including covalent binding to human serum albumin (HSA), was greater than 98% and independent of concentration.
Croatian: Vezivanje neratiniba za proteine iz ljudske plazme, uključujući kovalentno vezivanje za albumin iz ljudskog krvnog seruma (HSA), bilo je veće od 98 % i neovisno o koncentraciji.
English: 2 Unstratified Cox proportional hazards model 3 Unstratified 2-sided log-rank test for all endpoints, except for CNS recurrence for which Gray's method was used.
Croatian: 2 Nestratificirani Coxov model proporcionalnog hazarda 3 Nestratificirani 2-strani log-rang test za sve mjere ishoda, osim za recidiv u CNS-u, za koji je korištena Grayeva metoda.
English: P-glycoprotein transporters
Croatian: P-glikoproteinski transporteri
English: • Relevant information of Gastrointestinal toxicity (diarrhoea) (e.g. signs and symptoms to be detailed (seriousness, severity, frequency, time to onset, duration, risks and consequences))
Croatian: • Relevantne informacije o gastrointestinalnoj toksičnosti (proljev) (npr. znakovi i simptomi koje je potrebno navesti (ozbiljnost, težina, učestalost, vrijeme do početka, trajanje, rizici i posljedice))
English: The MAH shall ensure that in each Member State where Nerlynx is marketed, all healthcare professionals who are expected to prescribe/dispense Nerlynx, as well as all patients/carers who are expected to use Nerlynx, have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora osigurati da u svakoj državi članici u kojoj se Nerlynx stavlja u promet svi zdravstveni radnici za koje se očekuje da će propisivati/izdavati Nerlynx, kao i svi bolesnici/njegovatelji za koje se očekuje da će uzimati Nerlynx, imaju pristup/dobiju sljedeći edukacijski paket:
English: CARTON AND BOTTLE
Croatian: KUTIJA I BOCA
English: Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Croatian: Dodatne kliničke situacije mogu dovesti do prilagodbi doze kako je klinički indicirano (npr. nepodnošljive toksičnosti, trajne nuspojave 2. stupnja itd.).
English: The primary endpoint of the study was invasive disease-free survival (iDFS).
Croatian: Primarna mjera ishoda ispitivanja bilo je preživljenje bez invazivne bolesti (iDFS).
English: Breast cancer resistance protein inhibitors
Croatian: Inhibitori proteina rezistencije raka dojke
English: It helps control how a healthy breast cell grows.
Croatian: Pomaže u kontroli rasta zdravih stanica dojke.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Croatian: Nuspojave koje nisu uočene u kliničkim ispitivanjima, ali su uočene u životinja pri razinama izloženosti koje su slične kliničkim razinama izloženosti te uz moguću relevantnost za kliničku primjenu bile su sljedeće:
English: Population pharmacokinetic modelling revealed that creatinine clearance did not explain the variability between patients, hence, no dose modifications are recommended for patients with mild to moderate renal impairment.
Croatian: Populacijsko farmakokinetičko modeliranje pokazalo je da klirens kreatinina nije objasnio varijabilnost među bolesnicima, zbog čega se ne preporučuju prilagodbe doze za bolesnike s blagim do umjerenim oštećenjem funkcije bubrega.
English: • Diarrhoea recurs to Grade 2 or higher at 120 mg per day
Croatian: • Proljev se vraća u 2. stupanj ili viši pri 120 mg dnevno
English: Nerlynx has minor or moderate influence on the ability to drive and use machines.
Croatian: Nerlynx malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Single doses of Nerlynx greater than 800 mg have not been administered in the clinical studies.
Croatian: Pojedinačne doze lijeka Nerlynx veće od 800 mg nisu primjenjivane u kliničkim ispitivanjima.
English: Therefore, women using systemically acting hormonal contraceptives should add a barrier method (see Section 4.6).
Croatian: Prema tome, žene koje koriste hormonalne kontraceptive koji djeluju sistemski također trebaju uvesti mehaničku metodu (vidjeti dio 4.6).
English: Your doctor will tell you if you need to keep taking anti-diarrhoea medicine after the first two months to control your diarrhoea.
Croatian: Vaš će Vam liječnik reći trebate li nastaviti uzimati lijek protiv proljeva nakon prva dva mjeseca radi kontrole proljeva.
English: In the event of an overdose, administration should be withheld and general supportive measures undertaken.
Croatian: U slučaju predoziranja potrebno je obustaviti primjenu lijeka i poduzeti opće potporne mjere.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Nerlynx, taking into account the importance of Nerlynx to the mother and the benefit of breast-feeding to the child.
Croatian: Mora se donijeti odluka o prestanku dojenja ili prekidu liječenja lijekom Nerlynx, uzimajući u obzir važnost lijeka Nerlynx za majku i korist dojenja za dijete.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of breast carcinoma.
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja u svim podskupinama pedijatrijske populacije u liječenju karcinoma dojke.
English: Estimated 2 year event free rates1 (%)
Croatian: Procijenjene 2-godišnje stope bez događaja1 (%)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: Diarrhoea generally occurred in the first month, with 83.6% of patients reporting this toxicity in the first week, 46.9% in the second week, 40.2% in the third week and 43.2% in the fourth week (median time to first onset was 2 days).
Croatian: Do proljeva je najčešće dolazilo tijekom prvog mjeseca, pri čemu je 83,6 % bolesnika prijavilo ovu toksičnost u prvom tjednu, 46,9 % u drugom tjednu, 40,2 % u trećem tjednu i 43,2 % u četvrtom tjednu (medijan vremena do prve pojave bio je 2 dana).
English: - if you are allergic to neratinib or any of the other ingredients of this medicine (listed in
Croatian: - ako ste alergični na neratinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Each bottle contains 180 film-coated tablets.
Croatian: Jedna bočica sadrži 180 filmom obloženih tableta.
English: Patients should initiate treatment within 1 year after completion of trastuzumab therapy.
Croatian: Liječenje bolesnika treba započeti u roku od godinu dana nakon završetka liječenja trastuzumabom.
English: In subjects with severe pre-existing hepatic impairment (Child-Pugh Class C) without cancer, the clearance of neratinib was decreased by 36% and exposure to neratinib increased by about 3-fold as compared to healthy volunteers.
Croatian: U ispitanika s teškim postojećim oštećenjem funkcije jetre (Child Pugh C) bez karcinoma, klirens neratiniba smanjen je za 36 %, a izloženost neratinibu povećana je oko tri puta u usporedbi sa zdravim dobrovoljcima.
English: Each bottle contains 180 tablets.
Croatian: Jedna bočica sadrži 180 tableta.
English: This is because Nerlynx can affect the way some other medicines work.
Croatian: Razlog tome jest činjenica da Nerlynx može utjecati na djelovanje nekih drugih lijekova.
English: Neratinib at 10 µM appeared to inhibit the BCRP efflux transporter.
Croatian: Čini se da neratinib pri 10 µM inhibira efluksni transporter BCRP.
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Croatian: Ovojnica tablete Poli(vinilni alkohol) Titanijev dioksid (E171) Makrogol
English: Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated (see Section 4.2).
Croatian: Ispitivanja funkcije jetre, uključujući alanin aminotransferazu (ALT), aspartat aminotransferazu (AST) i ukupni bilirubin potrebno je pratiti nakon 1 tjedna, a potom na mjesečnoj osnovi tijekom prva 3 mjeseca i svakih 6 tjedana nakon toga tijekom liječenja ili kako je klinički indicirano (vidjeti dio 4.2).
English: In patients with known cardiac risk factors, conduct cardiac monitoring, including assessment of LVEF, as clinically indicated.
Croatian: Kod bolesnika s poznatim faktorima rizika za srčane bolesti potrebno je pratiti srčanu funkciju, uključujući procjenu LVEF-a, kako je klinički indicirano.
English: The median cumulative duration of any grade diarrhoea was 59 days and the median cumulative duration of Grade 3 diarrhoea was 5 days.
Croatian: Medijan kumulativnog trajanja proljeva bilo kojeg stupnja bio je 59 dana, a medijan kumulativnog trajanja proljeva 3. stupnja iznosio je 5 dana.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE45
Croatian: Farmakoterapijska skupina: Antineoplastici, ostali antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE45
English: The tablets should be swallowed whole preferably with water and should not be crushed or dissolved, and should be taken with food, preferably in the morning (see Section 5.2).
Croatian: Potrebno je progutati tablete čitave, po mogućnosti s vodom, a tablete se ne smiju drobiti ili otapati i moraju se uzimati uz obrok, po mogućnosti ujutro (vidjeti dio 5.2).
English: There is no specific antidote, and the benefit of haemodialysis in the treatment of Nerlynx overdose is unknown.
Croatian: Ne postoji posebni antidot, a korist od hemodijalize u liječenju predoziranja lijekom Nerlynx nije poznata.
English: Carton 2D barcode carrying the unique identifier included.
Croatian: Kutija: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: There was no difference in frequency of SAEs in the Skin SOC between Asian and Caucasian subgroups.
Croatian: Nije uočena razlika u učestalosti ozbiljnih štetnih događaja u SOC-u Koža između podskupina Azijata i bijelaca.
English: The median duration of a single episode of any grade diarrhoea was 2 days.
Croatian: Medijan trajanja jedne epizode proljeva bilo kojeg stupnja bio je 2 dana.
English: • erythromycin (antibiotic)
Croatian: • eritromicin (antibiotik)
English: The primary analysis of the study after 2 years post-randomisation demonstrated that Nerlynx significantly reduced the risk of invasive disease recurrence or death by 34% (HR=0.66 with 95% CI (0.49, 0.90), two-sided p = 0.008) in the ITT population.
Croatian: Primarna analiza ispitivanja 2 godine nakon randomizacije pokazala je da je Nerlynx značajno smanjio rizik od invazivnog recidiva bolesti ili smrti za 34 % (HR=0,66 s 95 % CI (0,49; 0,90), dvostrano p = 0,008) u populaciji ITT.
English: Carton nerlynx 40 mg
Croatian: Kutija: nerlynx 40 mg
English: Nerlynx works by blocking the HER2 receptors on the cancer cells.
Croatian: Nerlynx djeluje blokiranjem receptora HER2 na stanicama raka.
English: • Fluid intake of ~2 L should be maintained to avoid dehydration
Croatian: • Potrebno je održavati unos tekućine od ~2 l kako bi se izbjegla dehidracija
English: • carbamazepine, phenobarbital, phenytoin (antiepileptics)
Croatian: • karbamazepin, fenobarbital, fenitoin (antiepileptici)
English: For the full list of excipients, see Section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Your doctor will discuss with you the benefits and risks of taking Nerlynx during this time.
Croatian: Vaš će liječnik razgovarati s Vama o koristima i rizicima lijeka Nerlynx tijekom tog razdoblja.
English: The patient educational material:
Croatian: Edukacijski materijal za bolesnika:
English: Elderly patients (≥65 years of age) are at a higher risk of renal insufficiency and dehydration which may be a complication of diarrhoea and these patients should be carefully monitored.
Croatian: Stariji bolesnici (≥65 godina) izloženi su većem riziku od bubrežne insuficijencije i dehidracije, koje mogu biti komplikacija proljeva; te je bolesnike potrebno pažljivo pratiti.
English: The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
Croatian: Preporučena doza lijeka Nerlynx je 6 tableta jednom dnevno (ukupno 240 mg).
English: Studies in animals have shown embryo-foetal lethality and foetal morphological anomalies (see Section 5.3).
Croatian: Ispitivanja provedena na životinjama pokazala su mortalitet embrija i fetusa te morfološke anomalije fetusa (vidjeti dio 5.3).
English: Also some other medicines can affect the way Nerlynx works.
Croatian: Neki drugi lijekovi također mogu utjecati na djelovanje lijeka Nerlynx.
English: 1236 patients were <65 years, 172 were ≥65 years, of whom 25 were 75 years or older.
Croatian: 65 ili više godina, od čega je njih 25 imalo 75 ili više godina.
English: It appeared that the inhibitory effect of neratinib was primarily on P-gp activity in the gastrointestinal tract as a result of pre-systemic inhibition.
Croatian: Čini se da neratinib ima inhibitorski učinak prvenstveno na djelovanje P-gp-a u gastrointestinalnom traktu uslijed presistemske inhibicije.
English: Oval, red film-coated tablet with ‘W104' debossed on one side.
Croatian: Ovalne, crvene filmom obložene tablete s oznakom ‘W104' utisnutom na jednoj strani.
English: The diarrhoea may be severe and associated with dehydration.
Croatian: Proljev može biti težak i povezan s dehidracijom.
English: Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Croatian: Neratinib nije djelovao kao inhibitor prema transporterima unosa, OATP1B1*1a, OATP1B3, OAT1, OAT3 i OCT2; prijavljene vrijednosti IC50 iznosile su > 10 µM.
English: If neratinib is used during pregnancy, or if the patient becomes pregnant while taking Nerlynx, the patient should be informed of the potential hazard to the foetus.
Croatian: Ako se neratinib primjenjuje tijekom trudnoće ili ako bolesnica zatrudni dok uzima Nerlynx, bolesnicu treba obavijestiti o mogućem riziku za fetus.
English: • Grade 2 diarrhoea lasting 5 days or longer‡
Croatian: • Proljev 2. stupnja koji traje 5 ili više dana‡
English: Diarrhoea was also the most common adverse reaction leading to discontinuation, 14.4 % of patients treated with Nerlynx without loperamide prophylaxis discontinued treatment due to diarrhoea.
Croatian: Proljev je također bio najčešća nuspojava koja je dovela do prekida terapije; 14,4 % bolesnika liječenih lijekom Nerlynx bez profilakse loperamidom prekinulo je liječenje zbog proljeva.
English: It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Croatian: Trenutačno nije poznato smanjuje li Nerlynx učinkovitost hormonalnih kontraceptiva koji djeluju sistemski.
English: It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method.
Croatian: Trenutačno nije poznato može li neratinib smanjiti djelotvornost sistemski djelujućih hormonalnih kontraceptiva, zbog čega žene koje koriste sistemski djelujuće hormonalne kontraceptive trebaju uvesti i mehaničku metodu.
English: The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Croatian: Učestalost događaja 3. stupnja bila je slična u Azijata i bijelaca (1,6 %, odnosno 1,0 %).
English: This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
Croatian: Ova presistemska interakcija neratiniba s digoksinom može biti klinički relevantna za supstrate P-gp-a s uskim terapijskim indeksom (npr. dabigatran, digoksin i feksofenadin).
English: Nerlynx can cause changes in liver function - these are shown in blood tests.
Croatian: Nerlynx može uzrokovati promjene u funkciji jetre, koje će biti vidljive u krvnim pretragama.
English: For hormone receptor positive patients, the relative treatment benefit of Nerlynx within pre-specified patient subgroups is presented in Figure 2.
Croatian: Za bolesnice pozitivne na hormonske receptore relativna korist od liječenja lijekom Nerlynx unutar prethodno utvrđenih podskupina bolesnica prikazana je na slici 2.
English: Other medicines and Nerlynx
Croatian: Drugi lijekovi i Nerlynx
English: Nerlynx is associated with skin and subcutaneous tissue disorders.
Croatian: Nerlynx je povezan s poremećajima kože i potkožnog tkiva.
English: • Grade 3 diarrhoea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days
Croatian: ≥ 7 stolica dnevno u odnosu na polazno stanje; inkontinencija, indicirana hospitalizacija; ograničena sposobnost obavljanja aktivnosti njege za samog sebe u svakodnevnom životu] u trajanju od ≤ 2 dana
English: There are no data from the use of Nerlynx in pregnant women.
Croatian: Nema podataka o primjeni lijeka Nerlynx u trudnica.
English: Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent.
Croatian: Proljev se najčešće pojavljuje rano tijekom prvog ili drugog tjedna liječenja lijekom Nerlynx i može se ponavljati.
English: Blood creatinine increased
Croatian: Povišena razina kreatinina u krvi
English: If you stop taking Nerlynx
Croatian: Ako prestanete uzimati Nerlynx
English: The physician educational material should contain:
Croatian: Edukacijski materijal za liječnika treba sadržavati sljedeće:
English: Approximately 10% of patients had Stage I tumours, approximately 40% had Stage II tumours and approximately 30% had Stage III tumours.
Croatian: I. faze, približno 40 % imalo je tumore II. faze, a približno 30 % imalo je tumore III. faze.
English: The frequency and severity of gastrointestinal disorders (diarrhoea, abdominal pain, nausea and vomiting) appeared to be dose-related.
Croatian: Čini se da su učestalost i težina gastrointestinalnih poremećaja (proljev, bol u abdomenu, mučnina i povraćanje) bili povezani s dozom.
English: The table below lists adverse reactions observed with neratinib based on the assessment of pooled data from 1,710 patients.
Croatian: U tablici u nastavku prikazane su nuspojave uočene kod uzimanja neratiniba na temelju ocjenjivanja podataka prikupljenih od 1710 bolesnika.
English: 1-3 Positive Nodes
Croatian: 1-3 pozitivna čvora
English: Then resume Nerlynx at the next lower dose level.
Croatian: Nakon toga nastaviti liječenje lijekom Nerlynx na razini sljedeće niže doze.
English: The side effects of Nerlynx (for example, dehydration and dizziness resulting from diarrhoea, fatigue, and fainting) may affect how tasks that require judgment, motor or cognitive skills are carried out.
Croatian: Nuspojave lijeka Nerlynx (primjerice, dehidracija i omaglica zbog proljeva, umor i nesvjestica) mogu utjecati na provedbu zadataka koji zahtijevaju prosudbu, motoričke ili kognitivne vještine.
English: What you need to know before you take Nerlynx 3.
Croatian: Što morate znati prije nego počnete uzimati Nerlynx
English: Diarrhoea has been reported during treatment with Nerlynx (see Section 4.2 and Section 4.8).
Croatian: Proljev je prijavljen tijekom liječenja lijekom Nerlynx (vidjeti dio 4.2 i dio 4.8).
English: Patients with a significant chronic gastrointestinal disorder Patients with a significant chronic gastrointestinal disorder with diarrhoea as a major symptom were not included in the pivotal study, and should be carefully monitored.
Croatian: Bolesnici sa značajnim kroničnim poremećajem gastrointestinalnog sustava Bolesnici sa značajnim kroničnim gastrointestinalnim poremećajem kod kojeg je proljev značajan simptom nisu obuhvaćeni ključnim ispitivanjem i potrebno ih je pažljivo pratiti.
English: - Your doctor will tell you how to take the anti-diarrhoea medicine.
Croatian: - Vaš će Vam liječnik reći kako uzimati lijek protiv proljeva.
English: • Fail to recover to Grade 0 to 1 from treatment-related toxicity,
Croatian: • koji se ne oporave do 0. ili 1. stupnja toksičnosti povezane s liječenjem,
English: The neratinib metabolites M3, M6, M7 and M11 were shown to have similar potencies to neratinib in either in vitro enzyme (binding assays) or cell based assays against cells expressing ERBB1, ERBB2 (HER2) and ERBB4.
Croatian: Pokazalo se da metaboliti neratiniba M3, M6, M7 i M11 imaju potenciju sličnu neratinibu u in vitro enzimskim testovima (testovi vezanja) ili u ispitivanjima na stanicama koje izražavaju ERBB1, ERBB2 (HER2) i ERBB4.
English: Neratinib was not a potent inhibitor of human BSEP efflux transporter activity in vitro, with a reported IC50 value of > 10µM.
Croatian: Neratinib nije bio snažan inhibitor aktivnosti ljudskog efluksnog transportera BSEP in vitro, uz prijavljenu vrijednost IC50 od > 10 µM.
English: If you are pregnant, the doctor will assess the potential benefit to you and risk to the foetus before giving this medicine to you.
Croatian: Ako ste trudni, liječnik će ocijeniti moguću korist za Vas i rizik za fetus prije nego što vam propiše lijek.
English: Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Croatian: Preliminarno profiliranje metabolita u ljudskoj plazmi pokazuje da neratinib nakon peroralne primjene prolazi kroz oksidativni metabolizam putem CYP3A4.
English: Neratinib metabolites M3, M6, M7 and M11 are negative in the standard battery of in vitro genotoxicity studies.
Croatian: Metaboliti neratiniba M3, M6, M7 i M11 negativni su u standardnoj seriji in vitro ispitivanja genotoksičnosti.
English: Elderly No dose adjustment is required.
Croatian: Nije potrebna prilagodba doze.
English: Paediatric population There is no relevant use of Nerlynx in the paediatric population in the indication breast cancer.
Croatian: Ne postoji relevantna primjena lijeka Nerlynx u pedijatrijskoj populaciji za indikaciju raka dojke.
English: Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive.
Croatian: Prije primjene lijeka Nerlynx moraju se provesti ispitivanja kako bi se vidjelo je li Vaš rak HER2