FrancophonIA/ELRC3.0 huggingface dataset:
English: Missed doses should not be replaced and treatment should resume with the next scheduled daily dose (see Section 4.9).
Danish: Glemte doser bør ikke erstattes, idet behandlingen bør fortsætte med den næste planlagte daglige dosis (se pkt.
English: Nerlynx works by blocking the HER2 receptors on the cancer cells.
Danish: Nerlynx virker ved at blokere HER2-receptorerne på kræftcellerne.
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.
Danish: Det vides ikke på nuværende tidspunkt, om neratinib kan mindske virkningen af systemisk virkende hormonelle præventionsmidler, og derfor skal kvinder, der benytter systemisk virkende hormonel prævention, også bruge en barrieremetode.
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Danish: Tabletovertræk Polyvinylalkohol Titandioxid (E171) Macrogol
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.
Danish: 2 Ikke-stratificeret Cox-proportional hazard-model 3 Ikke-stratificeret tosidet log rank-test for alle endepunkter, undtagen CNS-recidiv, for hvilket Grays metode blev anvendt.
English: • Fluid intake of ~2 L should be maintained to avoid dehydration
Danish: • Der bør sørges for indtagelse af ~ 2 l væske for at undgå dehydrering
English: The following side effects may happen with this medicine:
Danish: Dette lægemiddel kan give følgende bivirkninger:
English: Talk to your doctor or pharmacist before taking Nerlynx.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Nerlynx.
English: Approximately 10% of patients had Stage I tumours, approximately 40% had Stage II tumours and approximately 30% had Stage III tumours.
Danish: Ca. 10 % af patienterne havde stadie 1-tumorer, ca. 40 % havde stadie 2-tumorer, og ca. 30 % havde stadie 3-tumorer.
English: The diarrhoea may be severe and associated with dehydration.
Danish: Diarréen kan være svær og forbundet med dehydrering.
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
Danish: * I henhold til CTCAE v4.0 † Komplikationer omfatter dehydrering, feber, hypotension, nyresvigt eller neutropeni af grad 3-4 ‡ På trods af optimal medicinsk behandling
English: There was no Grade 3 or 4 adverse reactions of blood bilirubin increased.
Danish: Der sås ingen grad 3- eller grad 4-tilfælde af forhøjet bilirubin i blodet.
English: Hazard ratio (95% CI)2
Danish: Hazard ratio (95 %-KI)2
English: Carton nerlynx 40 mg
Danish: nerlynx 40 mg
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.
Danish: Bivirkningerne ved Nerlynx (f.eks. dehydrering og svimmelhed som følge af diarré, udmattelse og besvimelsesanfald) kan indvirke på den måde, som opgaver, der kræver dømmekraft eller motoriske eller kognitive evner, udføres på.
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).
Danish: Der blev ikke observeret signifikante ændringer i fertilitetsparametre hos han- og hunrotter ved doser på op til 12 mg/kg/dag (se pkt.
English: Nerlynx dose
Danish: Nerlynx-dosis
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.
Danish: Hvis neratinib anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen med Nerlynx, bør patienten advares om den mulige risiko for fosteret.
English: Of the 1,660 patients treated with Nerlynx monotherapy without loperamide prophylaxis, 94.6% experienced at least 1 episode of diarrhoea.
Danish: Af de 1.660 patienter, der blev behandlet med Nerlynx-monoterapi uden forebyggende loperamid, oplevede 94,6 % mindst 1 tilfælde af diarré.
English: You may or may not have signs or symptoms of liver problems (e.g., yellow skin and/or eyes, dark urine, or light-colour stools).
Danish: Du kan muligvis få tegn eller symptomer på leverproblemer (f.eks. gulfarvning af huden og/eller øjnene, mørk urin eller lys afføring).
English: Diarrhoea management requires the correct use of an anti-diarrhoeal medicinal product, dietary changes, and appropriate dose modifications of Nerlynx.
Danish: Behandling af diarré kræver korrekt brug af et lægemiddel mod diarré, kostændringer og passende dosisjustering af Nerlynx.
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.
Danish: Ældre patienter (65 år og derover) har en højere risiko for nyresvigt og dehydrering, hvilket kan være en komplikation til diarré, og disse patienter bør overvåges nøje.
English: The mass balance after administration of a single oral dose of 200 mg of neratinib was studied in six healthy subjects.
Danish: Massebalancen efter administration af en enkelt oral dosis på 200 mg neratinib blev undersøgt hos seks raske forsøgspersoner.
English: P-value3
Danish: P-værdi3
English: While the treatment benefit of Nerlynx over placebo was maintained at five years, the effect size cannot be reliably estimated.
Danish: placebo blev fastholdt over fem år, kan der ikke laves et pålideligt estimat af effektstørrelsen.
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'.
Danish: Nerlynx anvendes til patienter, der har brystkræft i tidligt stadie, og: - som er såkaldt HER2-positive (human epidermal vækstfaktorreceptor 2-positive), og - som tidligere er blevet behandlet med et andet lægemiddel, der hedder trastuzumab.
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.
Danish: Diarré var også den hyppigste bivirkning, der medførte seponering, idet 14,4 % af de patienter, der blev behandlet med Nerlynx uden forebyggende loperamid, seponerede behandlingen på grund af diarré.
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).
Danish: Diarré-tilfældene sås generelt i løbet af den første måned, idet 83,6 % af patienterne rapporterede om diarré i løbet af den første uge, 46,9 % i den anden uge, 40,2 % i den tredje uge og 43,2 % i den fjerde uge (den mediane tid til første forekomst var 2 dage).
English: The frequency and severity of gastrointestinal disorders (diarrhoea, abdominal pain, nausea and vomiting) appeared to be dose-related.
Danish: Hyppigheden og sværhedsgraden af gastrointestinale lidelser (diarré, mavesmerter, kvalme og opkastning) syntes at være dosisrelateret.
English: Nerlynx dose modifications and management - general toxicities* Severity of toxicity†
Danish: Dosisjusteringer og behandling - generelle toksiciteter* Sværhedsgrad af toksicitet†
English: Your doctor will discuss with you the benefits and risks of taking Nerlynx during this time.
Danish: Din læge vil sammen med dig drøfte fordele og risici ved at tage Nerlynx under amning.
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)
Danish: Informationsmaterialet til patienter bør omfatte: o Indlægsseddel o En behandlingsvejledning til patienter/omsorgspersoner o "Min behandlingsjournal" Vejledningen til patienter/omsorgspersoner skal indeholde følgende vigtige oplysninger (i lægmandssprog)
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).
Danish: Denne præsystemiske interaktion af neratinib med digoxin kan være klinisk relevant for P-gp-substrater med et snævert terapeutisk vindue (f.eks. dabigatran, digoxin og fexofenadin).
English: The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Danish: Hyppigheden af grad 3-tilfælde var omtrent den samme blandt asiatiske og kaukasiske patienter (1,6 % og 1,0 %).
English: There is no specific antidote, and the benefit of haemodialysis in the treatment of Nerlynx overdose is unknown.
Danish: Der findes ingen specifik antidot, og en eventuel fordel ved hæmodialyse til behandling af overdosering af Nerlynx kendes ikke.
English: It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Danish: Det vides på nuværende tidspunkt ikke, om Nerlynx reducerer virkningen af systemisk virkende hormonelle præventionsmidler.
English: Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent.
Danish: Diarré forekommer generelt i løbet af den første eller anden uges behandling med Nerlynx og kan recidivere.
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.
Danish: Ved baseline havde 57,4 % hormonreceptor-positiv sygdom (defineret som ER-positiv og/eller PgR-positiv), 23,6 % var knude-negative, 46,8 % havde 1-3 positive knuder, og 29,6 % havde fire eller flere positive knuder.
English: Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Danish: Foreløbig metabolit-profilering i humant plasma indikerer, at neratinib efter oral administration undergår oxidativ metabolisering gennem CYP3A4.
English: Therefore, women using systemically acting hormonal contraceptives should add a barrier method (see Section 4.6).
Danish: Kvinder, der bruger systemisk virkende hormonelle præventionsmidler, bør derfor også bruge en barrieremetode (se pkt.
English: - Your doctor will tell you how to take the anti-diarrhoea medicine.
Danish: - Lægen vil fortælle dig, hvordan du skal tage lægemidlet mod diarré.
English: Stop Nerlynx until recovery to Grade ≤1 or baseline within 3 weeks of stopping treatment.
Danish: Seponér Nerlynx indtil bedring til grad ≤ 1 eller baseline-niveau inden for 3 uger efter seponering.
English: • Grade 3 diarrhoea lasting between 2 days and 3 weeks‡
Danish: • Grad 3-diarré, der varer mellem 2 dage og 3 uger‡
English: Nerlynx has minor or moderate influence on the ability to drive and use machines.
Danish: Nerlynx påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Nerlynx can cause diarrhoea early during treatment.
Danish: Nerlynx kan medføre diarré tidligt i behandlingen.
English: Invasive disease-free survival Disease-free survival including ductal carcinoma in situ
Danish: Invasiv sygdoms-fri overlevelse Sygdomsfri overlevelse, herunder duktalt carcinom in situ
English: Women should avoid becoming pregnant while taking Nerlynx and for up to 1 month after ending treatment.
Danish: Kvinder bør undgå at blive gravide, mens de tager Nerlynx og i op til 1 måned efter behandlingens afslutning.
English: What you need to know before you take Nerlynx 3.
Danish: Det skal du vide, før du begynder at tage Nerlynx 3.
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.
Danish: Den primære analyse af studiet 2 år efter randomisering viste, at Nerlynx reducerede risikoen for recidiverende invasiv sygdom eller død signifikant med 34 % (HR = 0,66 med 95 %-KI (0,49-0,90), tosidet p = 0,008) i ITT-populationen.
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.
Danish: Du bør tage et lægemiddel mod diarré, så diarréen ikke bliver alvorlig, og så du ikke bliver dehydreret under behandlingen med Nerlynx.
English: Also some other medicines can affect the way Nerlynx works.
Danish: Nogle lægemidler kan også påvirke den måde, Nerlynx virker på.
English: Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Danish: Neratinib medførte ingen hæmmende aktivitet over for uptaketransportørerne OATP1B1*1a, OATP1B3, OAT1, OAT3 og OCT2 med rapporterede IC50-værdier > 10 mikroM.
English: The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Danish: Incidensen af grad 1- og grad 2-tilfælde var hhv. 6,2 % og 1,4 %.
English: The patient educational material:
Danish: Informationsmateriale til patienter:
English: Each bottle contains 180 film-coated tablets.
Danish: Hver beholder indeholder 180 filmovertrukne tabletter.
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.
Danish: Hos kaniner blev der ikke observeret nogen effekt på parring eller dyrenes evne til at blive drægtige, men der blev observeret embryoføtal dødelighed og føtale morfologiske anomalier (f.eks. kuppelformet hoved, udvidelse af hjernens ventrikler og misdannede anteriore fontaneller og forstørrede anteriore og/eller posteriore fontaneller) ved doser, der kan anses for klinisk relevante.
English: This is because Nerlynx can affect the way some other medicines work.
Danish: Nerlynx kan nemlig påvirke den måde, visse andre lægemidler virker på.
English: Hazard (95% CI)2 P-value3
Danish: Hazard (95 %-KI)2 P-værdi3
English: * Refer to Table 3 and Table 4 below for management of diarrhoea and hepatotoxicity † Per CTCAE v4.0
Danish: * Se tabel 3 og 4 nedenfor mht. behandling af diarré og levertoksicitet † I henhold til CTCAE v4.0
English: • erythromycin (antibiotic)
Danish: • erythromycin (antibiotikum).
English: 0.2% of patients had diarrhoea classified as Grade 4.
Danish: 0,2 % af patienterne havde diarré af grad 4.
English: The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
Danish: Den anbefalede dosis Nerlynx er 6 tabletter én gang dagligt (i alt 240 mg).
English: See Section 3 for more information about the anti-diarrhoea medicine you need to take at the same time as Nerlynx.
Danish: 3 for yderligere oplysninger om den medicin mod diarré, som du skal tage samtidigt med Nerlynx.
English: Effects of other substances on neratinib
Danish: Indvirkningen af andre stoffer på neratinib
English: • Permanently discontinue Nerlynx • Evaluate alternative causes
Danish: • Seponér Nerlynx permanent • Undersøg eventuelle andre årsager
English: Grapefruit juice should be avoided during treatment with Nerlynx (see Section 4.5).
Danish: Grapefrugtjuice bør undgås under behandling med Nerlynx (se pkt.
English: In patients with known cardiac risk factors, conduct cardiac monitoring, including assessment of LVEF, as clinically indicated.
Danish: Hos patienter med kendte risikofaktorer relateret til hjertet bør der foretages overvågning af hjertefunktionen, herunder vurdering af LVEF som klinisk indiceret.
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.
Danish: Patienterne skal have at vide, at de skal påbegynde forebyggende behandling med et middel mod diarré sammen med den første Nerlynx-dosis og fastholde regelmæssig dosering af midlet mod diarré i de første 1-2 måneder af Nerlynx-behandlingen med titrering til 1-2 afføringer pr. dag.
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).
Danish: Leverfunktionstest, herunder alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) og total bilirubin, bør monitoreres efter 1 uge og derefter en gang månedligt i de første 3 måneder og derefter hver 6. uge, så længe behandlingen fortsætter, eller det er klinisk indiceret (se pkt.
English: Very Common Muscle spasms
Danish: Meget almindelig Muskelspasmer
English: Then resume Nerlynx at the next lower dose level.
Danish: Genoptag derefter Nerlynxbehandling på det næste, lavere dosisniveau.
English: Following oral administration of 240 mg neratinib, absorption was slow and peak plasma concentrations of neratinib occurred around 7 hours after administration.
Danish: Efter oral administration af 240 mg neratinib var absorptionen langsom, og peak plasmakoncentrationer af neratinib sås ca. 7 timer efter indgivelse.
English: If you stop taking Nerlynx
Danish: Hvis du holder op med at tage Nerlynx
English: Dose reductions occurred in 24.7% of Nerlynx-treated patients.
Danish: Dosis blev reduceret hos 24,7 % af de Nerlynx-behandlede patienter.
English: What you need to know before you take Nerlynx Do not take Nerlynx
Danish: Det skal du vide, før du begynder at tage Nerlynx Tag ikke Nerlynx
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).
Danish: Hos patienter, der var hormonreceptor-negative, uanset tid fra trastuzumab-behandling, var hazard ratio for iDFS efter 2 år 0,93 (95 %-KI: 0,60-1,43).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE45
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE45
English: • Interrupt Nerlynx treatment
Danish: • Afbryd Nerlynx-behandlingen
English: The table below lists adverse reactions observed with neratinib based on the assessment of pooled data from 1,710 patients.
Danish: Oversigten nedenfor opstiller de bivirkninger, der er observeret ved neratinib under gennemgangen af de puljede data for 1.710 patienter.
English: Each bottle contains 180 tablets.
Danish: Hver beholder indeholder 180 tabletter.
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.
Danish: Hvis du er gravid, vil lægen vurdere den mulige fordel for dig og risikoen for fostret, før du får dette lægemiddel.
English: Discontinue Nerlynx for patients who:
Danish: Seponér behandlingen med Nerlynx hos patienter, som:
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%).
Danish: Puljede sikkerhedsdata for 1.710 patienter, der blev behandlet med Nerlynx alene, viste en højere forekomst af dermatologisk toksicitet hos asiatiske patienter (57,1 %) end hos kaukasiske patienter (34,6 %).
English: Patients who are treated with BCRP inhibitors (e.g., rosuvastatin and sulfasalazine) should be monitored carefully.
Danish: Patienter, der behandles med BCRPhæmmere (f.eks. rosuvastatin og sulfasalazin), bør overvåges nøje.
English: All Patients
Danish: Antal patienter
English: Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive.
Danish: Før Nerlynx-behandlingen påbegyndes, skal det ved undersøgelser være vist, at din kræft er HER2positiv.
English: Left ventricular function
Danish: Venstre ventrikel dysfunktion
English: Studies in animals have shown embryo-foetal lethality and foetal morphological anomalies (see Section 5.3).
Danish: Dyreforsøg har vist embryoføtal dødelighed og føtale morfologiske anomalier (se pkt.
English: Fatigue, dizziness, dehydration, and syncope have been reported as adverse reactions with neratinib.
Danish: Udmattelse, svimmelhed, dehydrering og synkope er rapporteret som bivirkninger ved neratinib.
English: Following single doses of neratinib, the mean apparent plasma half-life of neratinib was 17 hours in patients.
Danish: Efter enkeltdoser af neratinib var den gennemsnitlige tilsyneladende plasma-halveringstid for neratinib 17 timer hos patienterne.
English: Alanine aminotransferase increased, and aspartate aminotransferase increased
Danish: Forhøjet alaninaminotransferase og forhøjet aspartataminotransferase Ikke almindelig Forhøjet blodbilirubin
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.
Danish: Neratinib udgør den største komponent i plasma, og den systemiske eksponering for metabolitterne (M3, M6, M7 og M11) efter oral administration af neratinib er 10-33 % lavere end for moderstoffet hos raske forsøgspersoner.
English: Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Danish: Neratinib metaboliseres primært i levermikrosomerne af CYP3A4 og i mindre grad af flavinholdig monooxygenase (FMO).
English: Fractionated bilirubin and prothrombin time should also be collected during hepatotoxicity evaluation.
Danish: Fraktioneret bilirubin og protrombintid bør også tjekkes i forbindelse med undersøgelsen for levertoksicitet.
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)
Danish: - Øvrige indholdsstoffer: Tabletkerne: mannitol (E421), mikrokrystallinsk cellulose, crospovidon, povidon, kolloid vandfri silica, magnesiumstearat Tabletovertræk: polyvinylalkohol, titandioxid (E171), macrogol, talcum, rød jernoxid (E172)
English: • Diet modifications
Danish: • Kostændringer
English: Hormonal contraceptives
Danish: Hormonelle præventionsmidler
English: The median duration of a single episode of any grade diarrhoea was 2 days.
Danish: Den mediane varighed af et tilfælde af diarré, uanset grad, var 2 dage.
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).
Danish: Hos patienter med svært nedsat leverfunktion (Child-Pugh C) ses en stigning i eksponeringen for neratinib på 2,8 gange (se pkt.
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.
Danish: Du skal undgå grapefrugt, mens du tager Nerlynx; du må ikke spise grapefrugt eller drikke grapefrugtjuice eller tage kosttilskud, der indeholder denne frugt.
English: Silica, colloidal anhydrous Magnesium stearate
Danish: Silica, kolloid vandfri Magnesiumstearat
English: Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
Danish: Mænd bør bruge en barrieremetode under behandlingen og i 3 måneder efter behandlingens afslutning.