FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic-associated adverse reactions in the pivotal phase III study, ExteNET (3004), were reported more frequently in the Nerlynx arm compared to the placebo arm (12.4% vs. 6.6%), due primarily to alanine aminotransferase (ALT) increased (8.5% vs. 3.2%), aspartate aminotransferase (AST) increased (7.4 vs 3.3%) and blood alkaline phosphatase increased (2.1% vs. 1.1%).
Croatian: Hepatotoksičnost Nuspojave povezane s funkcijom jetre u ključnom ispitivanju faze III, ExteNET (3004), češće su prijavljene u skupini koja je primala Nerlynx u usporedbi sa skupinom koja je primala placebo (12,4 % u odnosu na 6,6 %), prvenstveno zbog povišene alanin aminotransferaze (ALT) (8,5 % u odnosu na 3,2 %), povišene aspartat aminotransferaze (AST) (7,4 % u odnosu na 3,3 %) i povišene alkalne fosfataze u krvi (2,1 % u odnosu na 1,1 %).
English: The clinical status of the patient should be considered when assessing the patient's ability to perform tasks that require judgment, motor, or cognitive skills.
Croatian: Prilikom ocjenjivanja sposobnosti bolesnika da obavlja zadatke koji zahtijevaju donošenje odluka, motoričke ili kognitivne sposobnosti potrebno je razmotriti klinički status bolesnika.
English: There were 0.2% of Nerlynx treated patients who experienced Grade 3 nail disorder.
Croatian: 0,2 % bolesnika liječenih lijekom Nerlynx doživjelo je poremećaj noktiju 3. stupnja.
English: In the analysis of pooled safety data, the majority of TEAEs in the Skin and Subcutaneous Disorders SOC in Asians were Grade 1 (43.3%) and Grade 2 (12.3%); in Caucasians, the incidence of Grade 1 and Grade 2 events was 25.6% and 7.8%, respectively.
Croatian: U analizi skupnih podataka o sigurnosti, većina TEAE-ova u klasifikaciji organskih sustava poremećaja kože i potkožnog tkiva u Azijata odgovarala je 1. stupnju (43,3 %) i 2. stupnju (12,3 %); u bijelaca, učestalost događaja 1. i 2. stupnja iznosila je 25,6 %, odnosno 7,8 %.
English: Placebo) HR (95% CI)
Croatian: HR (95 % CI)
English: • Stop Nerlynx until recovery to ≤ Grade 1
Croatian: • Prekinuti liječenje lijekom Nerlynx do poboljšanja na ≤ 1. stupanj
English: 0.2% of patients had diarrhoea classified as Grade 4.
Croatian: 0,2 % bolesnika imalo je proljev 4. stupnja.
English: Nerlynx dose modifications and management - general toxicities* Severity of toxicity†
Croatian: Tablica 2: Prilagodbe doze lijeka Nerlynx i zbrinjavanje - opće toksičnosti*
English: • St John's wort (Hypericum perforatum) (herbal product)
Croatian: • gospina trava (Hypericum perforatum) (biljni lijek)
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Nerlynx Lijek čuvajte izvan pogleda i dohvata djece.
English: Grapefruit juice should be avoided during treatment with Nerlynx (see Section 4.5).
Croatian: Tijekom liječenja lijekom Nerlynx potrebno je izbjegavati sok od grejpa (vidjeti dio 4.5).
English: If an antacid is taken, separate the dosing of Nerlynx and the antacid by at least 3 hours.
Croatian: Ako se uzima antacid, potrebno je odvojiti doziranje lijeka Nerlynx i antacida za barem 3 sata.
English: Patients should be instructed to initiate prophylactic treatment with an anti-diarrhoeal medicinal product with the first dose of Nerlynx, and maintain regular dosing of the anti-diarrhoeal medicinal product during the first 1-2 months of Nerlynx treatment, titrating to 1-2 bowel movements per day.
Croatian: Bolesnike je potrebno uputiti da započnu s profilaktičkim liječenjem lijekom protiv proljeva s prvom dozom lijeka Nerlynx te da održavaju redovito doziranje lijeka protiv proljeva tijekom prva 1 ili
English: Patients with renal impairment are at a higher risk of complications of dehydration if they develop diarrhoea, and these patients should be carefully monitored (see Section 4.2).
Croatian: Oštećenje funkcije bubrega Bolesnici s oštećenjem funkcije bubrega izloženi su većem riziku od komplikacija koje nastaju zbog dehidracije ako dobiju proljev i potrebno je pažljivo pratiti te bolesnike (vidjeti dio 4.2).
English: - you are having diarrhoea that does not go away - they can advise how to control your diarrhoea.
Croatian: Obratite se svojem liječniku ako: - imate proljev koji ne prestaje - liječnik Vas može savjetovati o načinu kontrole proljeva.
English: No dose adjustment is required in patients with Child-Pugh A or B (mild to moderate) hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre (Child Pugh A ili B).
English: Nerlynx dose
Croatian: Doza lijeka Nerlynx
English: Effects of neratinib on other substances
Croatian: Učinci neratiniba na druge tvari
English: At baseline, 57.4% had hormone receptor positive disease (defined as ER-positive and/or PgR-positive), 23.6% were node negative, 46.8% had one to three positive nodes and 29.6% had four or more positive nodes.
Croatian: pozitivna), 23,6 % bolesnica imalo je negativne limfne čvorove, 46,8 % imalo je jedan do tri pozitivna čvora, a 29,6 % imalo je četiri ili više pozitivnih čvorova.
English: Following single doses of neratinib, the mean apparent plasma half-life of neratinib was 17 hours in patients.
Croatian: Nakon pojedinačnih doza neratiniba, srednja vrijednost prividnog poluvijeka neratiniba u plazmi iznosila je 17 sati u bolesnika.
English: Nerlynx film-coated tablets are packaged in a white, high-density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal for a tamper-evident seal.
Croatian: Filmom obložene tablete lijeka Nerlynx isporučuju se u bijeloj okrugloj boci izrađenoj od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu i unutarnjom sigurnosnom folijom.
English: Concurrent use of neratinib with potent CYP3A4/P-gp inducers (e.g. phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St John's Wort/Hypericum perforatum) should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu sa snažnim induktorima CYP3A4/Pgp (npr. fenitoinom, karbamazepinom, rifampicinom, fenobarbitalom ili biljnim pripravcima koji sadrže gospinu travu/Hypericum perforatum).
English: In the Nerlynx monotherapy group, 7.8% patients experience nail disorders.
Croatian: U skupini bolesnika liječenih samo lijekom Nerlynx 7,8 % bolesnika doživjelo je poremećaje noktiju.
English: In in-vitro studies, neratinib is an inhibitor of P-glycoprotein (P-gp) substrates.
Croatian: U in vitro ispitivanjima neratinib je inhibitor P-glikoproteina (P-gp).
English: Some side effects associated with taking more Nerlynx than you should are: diarrhoea, nausea, vomiting and dehydration.
Croatian: Neke od nuspojava povezanih s uzimanjem prevelike količine lijeka Nerlynx jesu: proljev, mučnina, povraćanje i dehidracija.
English: - you feel dizzy or weak from diarrhoea - alternatively go to the hospital immediately.
Croatian: - ako osjećate omaglicu ili slabost zbog proljeva - javite se liječniku ili odmah idite u bolnicu.
English: See Section 3 for more information about the anti-diarrhoea medicine you need to take at the same time as Nerlynx.
Croatian: Za više informacija o lijeku protiv proljeva koji morate uzeti istovremeno kad i Nerlynx pogledajte dio 3.
English: Neratinib inhibited EGFR and/or HER2-expressing carcinoma cell lines with a cellular IC50 <100 nM.
Croatian: Neratinib je inhibirao stanične linije tumora koje izražavaju EGFR i/ili HER2 pri staničnoj koncentraciji IC50 <100 nM.
English: Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450:
Croatian: Istodobna primjena sa sljedećim lijekovima koji su snažni induktori CYP3A4/Pgp izoformi citokroma
English: Of the 1,660 patients treated with Nerlynx monotherapy without loperamide prophylaxis, 94.6% experienced at least 1 episode of diarrhoea.
Croatian: Proljev Od 1660 bolesnika liječenih monoterapijom lijekom Nerlynx bez profilakse loperamidom, njih 94,6 %
English: Separate dosing of Nerlynx and antacids by at least 3 hours.
Croatian: Potrebno je odvojiti doziranje lijeka Nerlynx i antacida za barem 3 sata.
English: Kaplan-Meier plot of disease-free survival - hormone receptor positive population who are less than one year from completion of trastuzumab therapy
Croatian: Kaplan-Meierova krivulja za preživljenje bez bolesti - skupina bolesnica s bolesti pozitivnom na hormonske receptore koja je završila liječenje trastuzumabom prije manje od godinu dana
English: Treatment-emergent adverse reactions leading to hospitalisation in the Nerlynx arms versus the placebo arm was 6.3% vs 4.9% in the <65 years-old group and 8.7% vs. 8.1% in the ≥65 years-old group.
Croatian: Učestalost nuspojava opaženih tijekom liječenja koje su dovele do hospitalizacije u skupini liječenoj lijekom Nerlynx u odnosu na skupinu koja je primala placebo iznosila je 6,3 % u odnosu na 4,9 % u dobnoj skupini <65 godina te 8,7 % u odnosu na 8,1 % u dobnoj skupini od ≥65 godina.
English: How Nerlynx works
Croatian: Kako Nerlynx djeluje
English: Do not take grapefruit while you are taking Nerlynx - this includes eating them, drinking the juice or taking a supplement that might contain them.
Croatian: Nemojte uzimati grejp tijekom uzimanja lijeka Nerlynx - nemojte ga jesti, piti njegov sok ili uzimati dodatke prehrani koji bi mogli sadržavati grejp. Razlog tomu jest činjenica da grejp može doći u interakciju s lijekom Nerlynx i utjecati na način da koji lijek djeluje.
English: Tell your doctor or pharmacist if you notice any of the side effects above.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako primijetite bilo koju od prethodno navedenih nuspojava.
English: Treatment of patients with severe renal impairment or on dialysis is not recommended (see Section 5.2).
Croatian: Ne preporučuje se liječenje bolesnika s teškim oštećenjem funkcije bubrega ili bolesnika koji se liječe dijalizom (vidjeti dio 5.2).
English: Sequential
Croatian: Sekvencijski
English: • Adjust anti-diarrhoeal treatment
Croatian: • Prilagoditi liječenje protiv proljeva
English: • Interrupt Nerlynx treatment
Croatian: • Prekinuti liječenje lijekom Nerlynx
English: • Grade 3 ALT (>5-20 x ULN)
Croatian: • ALT 3. stupnja (>5-20 x GGN)
English: * Refer to Table 3 and Table 4 below for management of diarrhoea and hepatotoxicity † Per CTCAE v4.0
Croatian: * Vidjeti tablicu 3 i tablicu 4 u nastavku za zbrinjavanje proljeva i hepatotoksičnosti
English: If
Croatian: ILI
English: Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking Nerlynx and for 1 month after stopping treatment.
Croatian: Prema tome, žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Nerlynx te mjesec dana nakon prestanka liječenja.
English: Fractionated bilirubin and prothrombin time should also be collected during hepatotoxicity evaluation.
Croatian: Tijekom vrednovanja hepatotoksičnosti također treba bilježiti ukupni i direktni bilirubin i protrombinsko vrijeme.
English: Proton pump inhibitors, H2-receptor antagonists and antacids The solubility of neratinib is pH-dependent.
Croatian: Inhibitori protonske pumpe, antagonisti H2 receptora i antacidi Topljivost neratiniba ovisi o pH vrijednosti.
English: Neratinib Better
Croatian: Bolje s neratinibom
English: Section 6), - if you have a severe liver problem, - if you are taking fluconazole (a medicine for fungal infections), - if you are taking rifampicin (a medicine for tuberculosis (TB)), - if you are taking erythromycin (antibiotic for infections), - if you are taking carbamazepine, phenobarbital, or phenytoin (medicines for seizures), - if you are taking diltiazem or verapamil (medicines for high blood pressure and chest pain), - if you are taking St. John's wort (herbal product for depression).
Croatian: - ako uzimate rifampicin (lijek za tuberkulozu), - ako uzimate eritromicin (antibiotik za infekcije), - ako uzimate karbamazepin, fenobarbital ili fenitoin (lijekovi za napadaje), - ako uzimate diltiazem ili verapamil (lijekovi za visok krvni tlak i bol u prsima) - ako uzimate gospinu travu (biljni lijek za depresiju).
English: There was a higher frequency of treatment discontinuations due to adverse reactions in the ≥65 years age group than <65 years age group; in the Nerlynx arm, the respective percentages were 44.8% compared with 25.2%, respectively.
Croatian: Uočena je veća učestalost prekida liječenja zbog nuspojava u dobnoj skupini ≥65 godina nego u dobnoj skupini <65 godina; u skupini liječenoj lijekom Nerlynx ti su postotci iznosili 44,8 %, odnosno
English: Neratinib produced inhibitory activity in OCT1 uptake transporter, with an IC50 of 2.9 µM.
Croatian: Neratinib je djelovao kao inhibitor transportera unosa OCT1, uz IC50 u vrijednosti od 2,9 µM.
English: • Grade 2 diarrhoea [increase of 4-6 stools per day over baseline] lasting < 5 days
Croatian: 4-6 stolica dnevno u odnosu na polazno stanje] u trajanju od < 5 dana
English: Adverse reactions reported as serious included diarrhoea (1.9%), vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine aminotransferase increased (0.4%), aspartate aminotransferase increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and decreased appetite (0.2%).
Croatian: Nuspojave prijavljene kao ozbiljne uključivale su proljev (1,9 %), povraćanje (1,3 %), dehidraciju (1,1 %), mučninu (0,5 %), povišenu alanin aminotransferazu (0,4 %), povišenu aspartat aminotransferazu
English: Blood bilirubin increased
Croatian: Povišena razina bilirubina u krvi
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines: - ketoconazole or fluconazole - medicines for fungal infections - erythromycin or clarithromycin - medicines for bacterial infections - rifampicin - a medicine for tuberculosis (TB) - protease inhibitors - antiviral medicines - carbamazepine, phenobarbital, or phenytoin - medicines for seizures - St John's wort - an herbal product for depression - diltiazem or verapamil - medicines for high blood pressure and chest pain - digoxin - a medicine for heart problems - medicines for stomach problems such as:
Croatian: - eritromicin ili klaritromicin - lijekovi za bakterijske infekcije - rifampicin - lijek za tuberkulozu (TB) - inhibitore proteaze - antivirusne lijekove - karbamazepin, fenobarbital ili fenitoin - lijekovi za napadaje - gospinu travu - biljni lijek za depresiju - diltiazem ili verapamil - lijekovi za visok krvni tlak i bol u prsima - digoksin - lijek za probleme sa srcem
English: Use of CYP3A4/P-gp inhibitors If the inhibitor cannot be avoided, reduce Nerlynx dose to 40 mg (one 40 mg tablet) taken once daily with a strong CYP3A4/P-gp inhibitor.
Croatian: Upotreba inhibitora CYP3A4/Pgp Ako se inhibitor ne može izbjeći, smanjiti dozu lijeka Nerlynx na 40 mg (jedna tableta od 40 mg)
English: What Nerlynx is used for
Croatian: Za što se Nerlynx koristi
English: Neratinib is extensively metabolised in the liver.
Croatian: Neratinib se brzo metabolizira u jetri.
English: In the multicentre, randomised, double-blind, placebo-controlled, pivotal phase III study, ExteNET (3004), 2,840 women with early-stage HER2-positive breast cancer (as confirmed locally by assay)
Croatian: Klinička djelotvornost i sigurnost U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ključnom ispitivanju faze III, ExteNET (3004), 2840 žena s HER2-pozitivnim rakom dojke u ranoj fazi (kao što je lokalno potvrđeno analizom) koje su dovršile adjuvantno liječenje trastuzumabom randomizirano je u omjeru 1:1 u skupinu koja prima Nerlynx ili placebo svakodnevno tijekom godinu dana.
English: Pregnancy Neratinib may cause foetal harm when administered to pregnant women (see Section 4.6).
Croatian: Kada se primjenjuje u trudnica, neratinib može štetno djelovati na fetus (vidjeti dio 4.6).
English: Do not crush or dissolve.
Croatian: Nemojte drobiti ili otapati tablete.
English: White, 60 mL high density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal.
Croatian: Bijela okrugla bočica izrađena od polietilena visoke gustoće (HDPE) zapremnine 60 ml s polipropilenskim zatvaračem sigurnim za djecu i unutarnjom sigurnosnom folijom.
English: How much Nerlynx to take
Croatian: Koliko lijeka Nerlynx uzeti
English: Invasive disease-free survival Disease-free survival including ductal carcinoma in situ
Croatian: Preživljenje bez bolesti, uključujući duktalni karcinom in situ
English: 16 vs. 23
Croatian: 16 u odnosu na
English: CYP3A4/P-gp inducers
Croatian: Induktori CYP3A4/Pgp
English: Diarrhoea led to hospitalisation in 1.9% of Nerlynx-treated patients.
Croatian: Proljev je doveo do hospitalizacije u 1,9
English: In patients with severe hepatic impairment (Child-Pugh C) there is a 2.8-fold increase of exposure to neratinib (see Section 5.2).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) izloženost neratinibu je 2,8 puta veća
English: Pharmacokinetic studies in patients with renal impairment or undergoing dialysis have not been carried out.
Croatian: Nisu provedena farmakokinetička ispitivanja u bolesnika s oštećenjem funkcije bubrega ili bolesnika koji se liječe dijalizom.
English: The incidence of serious adverse reactions in the Nerlynx arm vs placebo arm was 7.0% vs. 5.7% (<65 years-old) and 9.9% vs. 8.1% (≥65 years-old).
Croatian: Incidencija ozbiljnih nuspojava u skupini liječenoj lijekom Nerlynx u odnosu na skupinu koja je primala placebo iznosila je 7,0 % u odnosu na 5,7 % (<65 godina) te 9,9 % u odnosu na 8,1 %
English: 1 Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, and mucosal inflammation.
Croatian: 1 Obuhvaća stomatitis, aftozni stomatitis, ulkuse u ustima, plikove na oralnoj sluznici i upalu sluznice.
English: Hormone receptor positive population who are less than one year from completion of trastuzumab
Croatian: Populacija s bolesti pozitivnom na hormonske receptore koja je završila liječenje trastuzumabom prije manje od godinu dana
English: Women of childbearing potential/Contraception in females and males Based on findings in animals, neratinib may cause foetal harm when administered to pregnant women.
Croatian: Na temelju rezultata ispitivanja na životinjama, neratinib može štetno djelovati na fetus kada se primjenjuje u trudnica.
English: Adverse drug reactions due to Nerlynx in monotherapy breast cancer studies
Croatian: Tablica 5: Nuspojave kod uzimanja lijeka Nerlynx u ispitivanjima monoterapijskog liječenja raka dojke
English: 240 mg daily
Croatian: 240 mg dnevno
English: Hepatotoxicity has been reported in patients treated with Nerlynx.
Croatian: U bolesnika liječenih lijekom Nerlynx prijavljena je hepatotoksičnost.
English: The diarrhoea may be severe, and you may get dehydrated.
Croatian: Proljev može biti težak i može doći do dehidracije.
English: Dose modifications for diarrhoea
Croatian: Prilagodbe doza zbog nuspojava
English: This helps to stop the cells from dividing and growing.
Croatian: To pomaže u zaustavljanju podjele i rasta stanica raka.
English: Nerlynx is used for patients who have early stage breast cancer which: - is human epidermal growth factor receptor 2-positive (HER2-positive) and - has previously been treated with another medicine called ‘trastuzumab'.
Croatian: Nerlynx se primjenjuje u bolesnika s rakom dojke u ranoj fazi koji: - je pozitivan na receptor humanog epidermalnog faktora rasta 2 (HER2) i
English: >=4 Positive Nodes
Croatian: ≥4 pozitivna čvora
English: * Per CTCAE v4.0 † Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia ‡ Despite being treated with optimal medical therapy
Croatian: † Složene značajke obuhvaćaju dehidraciju, vrućicu, hipotenziju, zatajenje bubrega ili neutropeniju 3. ili
English: Co-administration with moderate CYP3A4/P-gp inhibitors:
Croatian: Istodobna primjena s umjerenim inhibitorima CYP3A4/P-gp:
English: • Key messages on how to prevent and minimise GI toxicity through appropriate monitoring (with reference to treatment journal) and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o when to alert HCP and the importance of it for further treatment adjustment
Croatian: • Ključne poruke o načinu sprječavanja i svođenja gastrointestinalne toksičnosti na najmanju moguću mjeru putem prikladnog praćenja (uz upućivanje na dnevnik liječenja) i zbrinjavanja:
English: Nerlynx should not be used during pregnancy unless the clinical condition of the woman requires treatment with neratinib.
Croatian: Osim ako kliničko stanje žene zahtijeva liječenje neratinibom, Nerlynx se ne smije uzimati tijekom trudnoće.
English: Primary efficacy analyses - ITT and hormone receptor positive populations who are less than one year from completion of trastuzumab therapy
Croatian: Tablica 6: Primarne analize djelotvornosti - ITT populacija i populacija s bolesti pozitivnom na hormonske receptore koje su završile liječenje trastuzumabom prije manje od godinu dana Varijabla
English: • Grade 3 bilirubin (>3-10 x ULN)
Croatian: • Bilirubin 3. stupnja (>3-10 x GGN)
English: • Grade 4 ALT (>20 x ULN)
Croatian: • ALT 4. stupnja (>20 x GGN)
English: 120 mg daily
Croatian: 120 mg dnevno
English: Carcinogenesis, mutagenesis Nerlynx was neither clastogenic nor mutagenic in the standard battery of genotoxicity studies.
Croatian: Nerlynx se nije pokazao klastogenim ili mutagenim.
English: In the pivotal phase III study, ExteNET (3004), the frequency of Treatment Emergent Adverse Events (TEAEs) in the Skin and Subcutaneous Disorders System Organ Class (SOC) in Asian patients treated with Nerlynx was higher than in Caucasian patients (56.4% vs. 34.5%) but comparable in placebo patients (24.9% vs. 22.8%).
Croatian: Organ Class, SOC) poremećaja kože i potkožnog tkiva u Azijata liječenih lijekom Nerlynx bila je viša nego u bijelaca (56,4 % u odnosu na 34,5 %), ali usporediva u bolesnika koji su primali placebo (24,9 % u odnosu na 22,8 %).
English: Guidelines for dose adjustment of Nerlynx in the event of liver toxicity are shown in Table 4.
Croatian: Prilagodbe doze za hepatotoksičnost U tablici 4 prikazane su smjernice za prilagodbu doza lijeka Nerlynx u slučaju hepatotoksičnosti
English: Nerlynx is for oral use.
Croatian: Način primjene Nerlynx je namijenjen za peroralnu primjenu.
English: Women who can become pregnant must use an effective method of contraception, including a barrier method: - while taking Nerlynx and - for one month after treatment has finished.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije, uključujući mehaničku metodu: - tijekom uzimanja lijeka Nerlynx i
English: Co-administration of a single oral dose of 240 mg of neratinib in the presence of ketoconazole (400 mg once daily for 5 days), a strong CYP3A4/P-gp inhibitor, increased neratinib systemic exposure.
Croatian: (400 mg jednom dnevno tijekom 5 dana), snažnog inhibitora CYP3A4/Pgp, povećala je sistemsku izloženost neratinibu.
English: 160 mg daily
Croatian: 160 mg dnevno
English: Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3.
Croatian: U tablici 3 prikazane su smjernice za prilagodbu doza lijeka Nerlynx kod zbrinjavanja proljeva.
English: Stop Nerlynx until recovery to Grade ≤1 or baseline within 3 weeks of stopping treatment.
Croatian: ≤1. stupanj ili polazno stanje u roku od 3 tjedna od prekida liječenja.
English: • Grade 4 bilirubin (>10 x ULN)
Croatian: • Bilirubin 4. stupnja (>10 x GGN)
English: • Remark on importance of reading the PIL • Remarks on the importance of reporting ADRs
Croatian: • Napomene o važnosti prijavljivanja nuspojava lijeka
English: A single oral dose of 240 mg neratinib taken with a meal high in fat increased both Cmax and AUC by approximately 100%.
Croatian: Pojedinačna peroralna doza od 240 mg neratiniba uzeta uz obrok bogat masnoćama povećala je Cmax i
English: The patient information pack should contain: o Patient information leaflet o A patient/carer treatment guide o “My Treatment Journal” The Patient/carer guide shall contain the following key messages (in lay language)
Croatian: Vodič za liječenje za bolesnika/njegovatelja mora sadržavati sljedeće ključne poruke (u laičkim izrazima) • Naziv lijeka, djelatnu tvar i odobrenu indikaciju lijeka