FrancophonIA/ELRC3.0 huggingface dataset:
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:
Danish: Det er især vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager et af nedenstående lægemidler: - ketoconazol eller fluconazol - lægemidler mod svampeinfektioner - erythromycin eller clarithromycin - lægemidler mod bakterielle infektioner - rifampicin - et lægemiddel mod tuberkulose - proteasehæmmere - lægemidler mod virus - carbamazepin, phenobarbital eller phenytoin - lægemidler mod krampeanfald - prikbladet perikon - et naturlægemiddel mod nedtrykthed, modløshed og tristhed - diltiazem eller verapamil - lægemidler mod forhøjet blodtryk og brystsmerter - digoxin - et lægemiddel mod hjerteproblemer - lægemidler mod maveproblemer som f.eks.:
English: Circulating metabolites include neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine N-oxide (M7) and traces of
Danish: Cirkulerende metabolitter omfatter neratinibpyridin-N-oxid (M3), N-desmethyl-neratinib (M6), neratinib-dimethylamin-N-oxid (M7) og spor af hydroxyl-neratinib-N-oxid og neratinib-bis-N-oxid (M11).
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.
Danish: Cmax for neratinib steg 3,2 gange, og AUC steg 4,8 gange ved samtidig administration af ketoconazol sammenholdt med administration af neratinib alene.
English: 1-3 Positive Nodes
Danish: 1-3 positive knuder ≥ 4 positive knuder
English: Neratinib inhibited EGFR and/or HER2-expressing carcinoma cell lines with a cellular IC50 <100 nM.
Danish: Neratinib hæmmede EGFR- og/eller HER2-positive carcinom cellelinjer med en cellulær IC50 < 100 nM.
English: Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Nail disorder3, skin fissures and dry skin
Danish: Neglelidelser3, revner i huden og tør hud
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.
Danish: En enkeltdosis på 240 mg neratinib taget sammen med mad øgede Cmax og AUC med hhv. ca. 17 % og 23 % sammenholdt med administration i fastende tilstand.
English: Men must use an effective barrier method of contraception such as a condom: - while taking Nerlynx and - for three months after treatment has finished.
Danish: Mænd skal bruge en sikker barrieremetode såsom kondom: - mens de tager Nerlynx og - i tre måneder efter behandlingens afslutning.
English: Patients with symptomatic skin and subcutaneous tissue disorders should be carefully monitored (see Section 4.8).
Danish: Patienter med symptomatisk sygdom i huden og det subkutane væv bør overvåges nøje (se pkt.
English: Excretion of neratinib is primary via the faeces
Danish: Udskillelse af neratinib sker primært via fæces
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.
Danish: I analysen af de puljede sikkerhedsdata var størstedelen af de behandlingsrelaterede bivirkninger i systemorganklassen "Hud og subkutane væv" blandt asiater af grad 1 (43,3 %) og grad 2 (12,3 %); blandt kaukasere var forekomsten af grad 1- og grad 2-tilfælde hhv. 25,6 % og 7,8 %.
English: Dose modifications for diarrhoea Severity of diarrhoea*
Danish: Dosisjustering ved diarré Sværhedsgrad af diarré*
English: In a dose escalation study in healthy volunteers, single oral doses of Nerlynx up to 800 mg were administered.
Danish: I et dosiseskaleringsstudie med raske forsøgspersoner blev der givet enkeltdoser af oralt Nerlynx på op til 800 mg.
English: A single oral dose of 240 mg neratinib taken with a meal high in fat increased both Cmax and AUC by approximately 100%.
Danish: En enkeltdosis på 240 mg oralt neratinib taget sammen med et måltid med højt fedtindhold øgede både Cmax og AUC med ca. 100 %.
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%).
Danish: De hyppigste grad 3-4-bivirkninger var diarré (grad 3: 36,9 %; grad 4: 0,2 %) og opkastning (grad 3: 3,4 %; grad 4: 0,1%).
English: The diarrhoea may be severe, and you may get dehydrated.
Danish: Diarréen kan være kraftig, og du kan blive dehydreret.
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%).
Danish: Alvorlige bivirkninger omfattede diarré (1,9 %), opkastning (1,3 %), dehydrering (1,1 %), kvalme (0,5 %), forhøjet alaninaminotransferase (0,4 %), forhøjet aspartataminotransferase (0,4 %), mavesmerter (0,3 %), udmattelse (0,3 %) og nedsat appetit (0,2 %).
English: Single doses of Nerlynx greater than 800 mg have not been administered in the clinical studies.
Danish: Der er i de kliniske studier ikke givet enkeltdoser af Nerlynx på over 800 mg.
English: Kaplan-Meier plot of disease-free survival - hormone receptor positive population who are less than one year from completion of trastuzumab therapy
Danish: Kaplan-Meier-diagram over sygdomsfri overlevelse - hormonreceptor-positiv population, som har afsluttet trastuzumab-behandling for mindre end ét år siden
English: Discontinue Nerlynx permanently.
Danish: Seponér Nerlynx permanent.
English: No dose adjustment is required in patients with Child-Pugh A or B (mild to moderate) hepatic impairment.
Danish: Dosisjustering hos patienter med let til moderat nedsat leverfunktion (Child-Pugh A eller B) er ikke nødvendig.
English: Treatment of patients with severe renal impairment or on dialysis is not recommended (see Section 5.2).
Danish: Behandling af patienter med svært nedsat nyrefunktion eller af patienter i dialyse anbefales ikke (se pkt.
English: If an antacid is taken, separate the dosing of Nerlynx and the antacid by at least 3 hours.
Danish: Hvis patienten tager et antacid, bør administration af Nerlynx og antacidet ske med mindst 3 timers mellemrum.
English: • If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
Danish: • Hvis diarréen bedres til grad 0-1, efter at der er gået mere end en uge, bør Nerlynx genoptages ved en lavere dosis (se tabel 1).
English: Very Common Rash2 Common
Danish: Meget almindelig Udslæt2 Almindelig
English: If you take more Nerlynx than you should, contact a doctor or a hospital straight away.
Danish: Hvis du har taget for mange Nerlynx tabletter, skal du straks kontakte en læge eller tage på skadestuen.
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.
Danish: Der var en højere forekomst af behandlingsophør på grund af bivirkninger i gruppen af patienter på 65 år eller derover end i gruppen af patienter under 65 år; i Nerlynx-gruppen var andelen hhv. 44,8 % og 25,2 %.
English: White, 60 mL high density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal.
Danish: Hvid, rund 60 ml-beholder af højdensitetspolyetylen (HDPE) med børnesikret lukning af polypropylen og indvendig varmeinduceret folieforsegling.
English: CARTON AND BOTTLE
Danish: ÆSKE OG BEHOLDER
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%).
Danish: I det pivotale fase 3-studie (ExteNET (3004)) var hyppigheden af behandlingsrelaterede bivirkninger (TEAE'er) i systemorganklassen "Hud og subkutane væv" højere blandt de asiatiske patienter, der fik Nerlynx, end blandt de kaukasiske patienter (56,4 % vs. 34,5 %), men på omtrent samme niveau hos placebo-behandlede patienter (24,9 % vs. 22,8 %).
English: Nerlynx 40 mg film-coated tablets neratinib
Danish: Nerlynx 40 mg filmovertrukne tabletter neratinib
English: Invasive disease-free survival Disease-free survival including ductal carcinoma in situ Distant disease-free survival Time to distant recurrence CNS recurrence CNS = central nervous system.
Danish: Invasiv sygdoms-fri overlevelse Sygdomsfri overlevelse, herunder duktalt karcinom in situ Metastasefri overlevelse Tid til metastaserecidiv Centralnervesystem-recidiv CNS = centralnervesystem.
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%).
Danish: De hyppigste bivirkninger, uanset grad, var diarré (93,6 %), kvalme (42,5 %), udmattelse (27,3 %), opkastning (26,8 %), mavesmerter (22,7 %), udslæt (15,4 %), nedsat appetit (13,7 %), smerter i den øvre del af maven (13,2 %), stomatitis (11,2 %) og muskelspasmer (10,0 %).
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).
Danish: Efter seponering af en stærk CYP3A4/Pgp-hæmmer skal den tidligere Nerlynx-dosis på 240 mg genoptages (se pkt.
English: Guidelines for dose adjustment of Nerlynx in the event of liver toxicity are shown in Table 4.
Danish: Dosisjustering ved levertoksicitet Retningslinjer for justering af Nerlynx-dosen i tilfælde af levertoksicitet er vist i tabel 4.
English: • fluconazole (antifungal)
Danish: • fluconazol (svampemiddel)
English: Common: may affect up to 1 in 10 people - burning sensation during urination and frequent, and urgent need to urinate, (may be symptoms of urinary tract infection) - dehydration - nosebleed - mild stomach upset - dry mouth - changes in liver blood test results - nail problems including nail splitting or colour change - dry skin including cracked skin - changes in kidney function test - weight loss
Danish: Almindelige bivirkninger: kan forekomme hos op til 1 ud af 10 patienter - brændende fornemmelse ved vandladning og hyppig og akut trang til at lade vandet (kan være symptomer på urinvejsinfektion) - dehydrering - næseblod - ubehag i maven - mundtørhed - ændringer i leverværdierne - negleproblemer, herunder flossede og misfarvede negle
English: Prior Trastuzumab
Danish: Tidligere trastuzumab
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.
Danish: Hos raske forsøgspersoner steg Cmax og AUC for digoxin med hhv. 54 % og 32 % ved samtidig administration af flere orale neratinib doser på 240 mg sammenholdt med eksponering for digoxin alene.
English: Do not crush or dissolve.
Danish: Tabletterne må ikke knuses eller opløses.
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%).
Danish: I det pivotale fase 3-studie (ExteNET (3004)) blev leverrelaterede bivirkninger rapporteret oftere i Nerlynx-gruppen end i placebo-gruppen (12,4 % vs. 6,6 %), primært som følge af forhøjet alaninaminotransferase (ALAT) (8,5 % vs. 3,2 %), forhøjet aspartataminotransferase (ASAT) (7,4 % vs. 3,3 %) og forhøjet basisk fosfatase i blodet (2,1 % vs. 1,1 %).
English: 1 Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, and mucosal inflammation.
Danish: 1 Omfatter stomatitis, aftøs stomatitis, mundsår, blisterdannelse i mundslimhinden og slimhindebetændelse.
English: What Nerlynx is used for
Danish: Hvad anvendes Nerlynx til?
English: The incidence of Grade 1 and Grade 2 was 13.3% and 2.9% respectively; 0.4% of Nerlynx-treated patients experienced Grade 3 rash.
Danish: Incidensen af grad 1- og grad 2tilfælde var hhv. 13,3 % og 2,9 %; 0,4 % af de Nerlynx-behandlede patienter fik grad 3-udslæt.
English: What Nerlynx is and what it is used for What Nerlynx is
Danish: Virkning og anvendelse Hvad er Nerlynx?
English: The most common TEAEs in the Skin SOC that occurred more frequently in Asian patients than in Caucasian patients were rash (29.4% vs. 13.5%), Palmar-plantar erythrodysaesthesia syndrome (9.9% vs. 1.0%), and dermatitis acneiform (6.0 vs. 1.0%).
Danish: De hyppigste behandlingsrelaterede bivirkninger i systemorganklassen "Hud og subkutane væv", som sås oftere blandt asiatiske patienter end blandt kaukasiske patienter, var udslæt (29,4 % vs. 13,5 %), hånd-fod-syndrom (9,9 % vs. 1,0 %) og aknelignende dermatitis (6,0 % vs. 1,0 %).
English: Very common: may affect more than 1 in 10 people - diarrhoea - stomach pain, feeling or being sick, low appetite - dry or inflamed mouth, including blisters or mouth ulcers - rash - muscle spasms or cramps - feeling very tired
Danish: Meget almindelige bivirkninger: kan forekomme hos flere end 1 ud af 10 patienter - diarré - mavesmerter, kvalme eller opkastning, nedsat appetit - mundtørhed eller betændelse i munden, herunder blister eller sår i munden - udslæt - muskelspasmer eller -kramper - usædvanlig træthed
English: Some side effects associated with taking more Nerlynx than you should are: diarrhoea, nausea, vomiting and dehydration.
Danish: Nogle af de bivirkninger, der er forbundet med at tage for mange Nerlynx tabletter, er diarré, kvalme, opkastning og dehydrering.
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.
Danish: Tabletterne er pakket i en hvid, rund beholder af højdensitetspolyetylen (HDPE) med børnesikret lukning af polypropylen og indvendig folieforsegling (anbrudsindikerende forsegling).
English: Other medicines and Nerlynx
Danish: Brug af anden medicin sammen med Nerlynx
English: You need to take an anti-diarrhoea medicine when you start Nerlynx
Danish: Du skal tage et lægemiddel mod diarré, når du begynder at bruge Nerlynx
English: Grade 3 ALT or bilirubin occurs again despite one dose reduction, permanently discontinue Nerlynx.
Danish: Hvis et nyt tilfælde af grad 3-ALAT ellerbilirubin ses på trods af en dosisreduktion, bør Nerlynx seponeres permanent.
English: • Grade 1 diarrhoea [increase of < 4 stools per day over baseline]
Danish: • Grad 1-diarré [stigning på < 4 afføringer om dagen ift.
English: Hormone receptor positive population who are less than one year from completion of trastuzumab
Danish: Hormonreceptor-positiv population, der har afsluttet trastuzumab-behandling for mindre end ét år siden
English: Carton PC:
Danish: PC: SN: NN:
English: CYP3A4/P-gp inducers
Danish: CYP3A4/P-gp-inducere
English: Dose modifications for diarrhoea
Danish: Dosisjustering ved diarré
English: - Keep taking anti-diarrhoea medicine during the first one to two months of Nerlynx treatment.
Danish: - Du skal fortsætte med at tage et lægemiddel mod diarré de første 1-2 måneder af Nerlynx behandlingen.
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.
Danish: Samtidig brug af neratinib og potente CYP3A4/P-gp-inducere (f.eks. phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler indeholdende prikbladet perikum (Hypericum perforatum)) bør undgås.
English: Sequential
Danish: Sekventiel
English: - Start taking anti-diarrhoea medicine with the first dose of Nerlynx.
Danish: - Du skal begynde at tage et lægemiddel mod diarré samtidig med den første Nerlynx-dosis.
English: In the Nerlynx monotherapy group, 16.7% of patients experienced rash.
Danish: I den gruppe, der kun fik Nerlynx, fik 16,7 % af patienterne udslæt.
English: Neratinib is extensively metabolised in the liver.
Danish: Neratinib metaboliseres i udstrakt grad i leveren.
English: Treatment of patients with Child-Pugh C hepatic impairment is not recommended (see Section 5.2).
Danish: Behandling af patienter med svært nedsat nyrefunktion (Child-Pugh C) anbefales ikke (se pkt.
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.
Danish: Baseret på fund i dyreforsøg kan neratinib forårsage fosterskader, hvis det gives til gravide kvinder.
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.
Danish: Hvis hæmmeren ikke kan undværes, reduceres Nerlynx-dosen til 40 mg (én 40 mg tablet), der tages én gang dagligt sammen med en stærk CYP3A4/P-gp-hæmmer.
English: In in-vitro studies, neratinib is an inhibitor of P-glycoprotein (P-gp) substrates.
Danish: Det er i in vitro-studier påvist, at neratinib er en hæmmer af P-glykoprotein (P-gp)-substrater.
English: • Adjust anti-diarrhoeal treatment
Danish: • Justér diarrébehandlingen
English: Separate dosing of Nerlynx and antacids by at least 3 hours.
Danish: Administration af Nerlynx og antacider bør ske med mindst 3 timers mellemrum.
English: Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists is not recommended.
Danish: Samtidig administration af protonpumpehæmmere og H2-receptor antagonister anbefales ikke.
English: An HDPE desiccant canister with 1 g silica gel is enclosed with the tablets in each bottle.
Danish: Hver beholder indeholder en HDPE-beholder med tørremiddel (1 g silica-gel) sammen med tabletterne.
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).
Danish: Incidensen af alvorlige bivirkninger i Nerlynx-gruppen og placebo-gruppen var hhv. 7,0 % og 5,7 % (for patienter under 65 år) og 9,9 % og 8,1 % (for patienter på 65 år eller derover).
English: In the Nerlynx monotherapy group, 7.8% patients experience nail disorders.
Danish: I den gruppe, der kun fik Nerlynx, fik 7,8 % af patienterne neglelidelser.
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).
Danish: Tabletterne bør synkes hele, helst med vand, og de må ikke knuses eller opløses.
English: Proton pump inhibitors, H2-receptor antagonists and antacids Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists are not recommended.
Danish: Protonpumpehæmmere, H2-receptor antagonister og antacider Samtidig administration af protonpumpehæmmere og H2-receptor antagonister anbefales ikke.
English: How to take Nerlynx
Danish: Sådan skal du tage Nerlynx
English: Adverse drug reactions due to Nerlynx in monotherapy breast cancer studies
Danish: Bivirkninger ved Nerlynx som monoterapi i brystkræftstudier Systemorganklasse
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
Danish: baseline, inkontinens, indlæggelse indiceret, begrænsning af dagligdagens selvpleje]
English: • St John's wort (Hypericum perforatum) (herbal product)
Danish: • prikbladet perikum (Hypericum perforatum, et naturlægemiddel)
English: • Grade 3 ALT (>5-20 x ULN)
Danish: • Grad 3-ALAT (> 5-20 x den øvre normalgrænse)
English: Primary efficacy analyses - ITT and hormone receptor positive populations who are less than one year from completion of trastuzumab therapy
Danish: Primære effektanalyser - ITT-population og hormonreceptor-positiv population, som har afsluttet trastuzumab-behandling for mindre end ét år siden
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:
Danish: Disse bivirkninger er ikke observeret i kliniske studier, men er muligvis klinisk relevante:
English: • Grade 2 diarrhoea [increase of 4-6 stools per day over baseline] lasting < 5 days
Danish: • Grad 2-diarré [stigning på 4-6 afføringer om dagen ift.
English: Nerlynx dose modifications for adverse reactions
Danish: Justeringer af Nerlynx-dosen i tilfælde af bivirkninger
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)
Danish: I det randomiserede, dobbeltblindede, placebokontrollerede pivotale fase 3-multicenterstudie (ExteNET (3004)) blev 2.840 kvinder med HER2-positiv brystkræft i tidligt stadie (som bekræftet lokalt ved analyse), som havde afsluttet adjuverende behandling med trastuzumab, randomiseret i forholdet 1:1 til at få enten Nerlynx eller placebo dagligt i et år.
English: Placebo) HR (95% CI)
Danish: Antal hændelser (neratinib vs. placebo) HR (95 %-KI)
English: 240 mg daily
Danish: 240 mg dagligt
English: • Grade 3 bilirubin (>3-10 x ULN)
Danish: • Grad 3-bilirubin (> 3-10 x den øvre normalgrænse)
English: - you feel dizzy or weak from diarrhoea - alternatively go to the hospital immediately.
Danish: - hvis du har diarré, som ikke stopper; lægen kan fortælle dig, hvordan du skal kontrollere diarréen - hvis du føler dig svimmel eller svag pga. diarré; alternativt skal du tage på skadestuen med det samme.
English: 1236 patients were <65 years, 172 were ≥65 years, of whom 25 were 75 years or older.
Danish: I det pivotale fase 3-studie (ExteNET (3004)) var gennemsnitsalderen 52 år i Nerlynx-gruppen; 1.236 patienter var under 65 år, mens 172 patienter var 65 år eller derover (blandt disse var 25 patienter 75 år eller ældre).
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.
Danish: Behandlingsrelaterede bivirkninger, der medførte indlæggelse, sås hos 6,3 % og 4,9 % af de hhv. Nerlynx- og placebo-behandlede patienter i gruppen under 65 år og hos hhv. 8,7 % og 8,1 % i gruppen af patienter på 65 år eller derover.
English: • Grade 4 bilirubin (>10 x ULN)
Danish: • Grad 4-bilirubin (> 10 x den øvre normalgrænse)
English: Neratinib Better
Danish: Neratinib bedst
English: 120 mg daily
Danish: 120 mg dagligt
English: CYP3A4/P-gp inhibitors
Danish: CYP3A4/P-gp-hæmmere
English: Diarrhoea has been reported during treatment with Nerlynx (see Section 4.2 and Section 4.8).
Danish: Der er rapporteret om diarré ved behandling med Nerlynx (se pkt.
English: Co-administration with moderate CYP3A4/P-gp inhibitors:
Danish: Samtidig administration af moderate CYP3A4/P-gp-hæmmere:
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.
Danish: - lansoprazol, omeprazol eller lignende lægemidler, der kaldes "protonpumpehæmmere",
English: 160 mg daily
Danish: 160 mg dagligt