natgillin/translations-raw huggingface dataset:
Patienter, der behandles med BCRPhæmmere (f.eks. rosuvastatin og sulfasalazin), bør overvåges nøje. 
Patients who are treated with BCRP inhibitors (e.g., rosuvastatin and sulfasalazine) should be monitored carefully.
Antal patienter 
All Patients
Før Nerlynx-behandlingen påbegyndes, skal det ved undersøgelser være vist, at din kræft er HER2positiv. 
Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive.
Venstre ventrikel dysfunktion 
Left ventricular function
Dyreforsøg har vist embryoføtal dødelighed og føtale morfologiske anomalier (se pkt. 
Studies in animals have shown embryo-foetal lethality and foetal morphological anomalies (see Section 5.3).
Udmattelse, svimmelhed, dehydrering og synkope er rapporteret som bivirkninger ved neratinib. 
Fatigue, dizziness, dehydration, and syncope have been reported as adverse reactions with neratinib.
Efter enkeltdoser af neratinib var den gennemsnitlige tilsyneladende plasma-halveringstid for neratinib 17 timer hos patienterne. 
Following single doses of neratinib, the mean apparent plasma half-life of neratinib was 17 hours in patients.
Forhøjet alaninaminotransferase og forhøjet aspartataminotransferase Ikke almindelig Forhøjet blodbilirubin 
Alanine aminotransferase increased, and aspartate aminotransferase increased
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. 
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.
Neratinib metaboliseres primært i levermikrosomerne af CYP3A4 og i mindre grad af flavinholdig monooxygenase (FMO). 
Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Fraktioneret bilirubin og protrombintid bør også tjekkes i forbindelse med undersøgelsen for levertoksicitet. 
Fractionated bilirubin and prothrombin time should also be collected during hepatotoxicity evaluation.
- Øvrige indholdsstoffer: Tabletkerne: mannitol (E421), mikrokrystallinsk cellulose, crospovidon, povidon, kolloid vandfri silica, magnesiumstearat Tabletovertræk: polyvinylalkohol, titandioxid (E171), macrogol, talcum, rød jernoxid (E172) 
- 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)
• Kostændringer 
• Diet modifications
Hormonelle præventionsmidler 
Hormonal contraceptives
Den mediane varighed af et tilfælde af diarré, uanset grad, var 2 dage. 
The median duration of a single episode of any grade diarrhoea was 2 days.
Hos patienter med svært nedsat leverfunktion (Child-Pugh C) ses en stigning i eksponeringen for neratinib på 2,8 gange (se pkt. 
In patients with severe hepatic impairment (Child-Pugh C) there is a 2.8-fold increase of exposure to neratinib (see Section 5.2).
Du skal undgå grapefrugt, mens du tager Nerlynx; du må ikke spise grapefrugt eller drikke grapefrugtjuice eller tage kosttilskud, der indeholder denne frugt. 
Do not take grapefruit while you are taking Nerlynx - this includes eating them, drinking the juice or taking a supplement that might contain them.
Silica, kolloid vandfri Magnesiumstearat 
Silica, colloidal anhydrous Magnesium stearate
Mænd bør bruge en barrieremetode under behandlingen og i 3 måneder efter behandlingens afslutning. 
Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
Neratinib er en irreversibel pan-erythroblastisk, leukæmi virus onkogen homolog (ERBB)tyrosinkinasehæmmer, der blokerer mitogen vækstfaktorsignal transduktion ved kovalent høj-affin binding til ATP-bindingsstedet på 3 epidermale vækstfaktorreceptorer (EGFR'er): EGFR (kodet fra ERBB1 genet), HER2 (kodet fra ERBB2 genet) og HER4 (kodet fra ERBB4 genet) eller af deres aktive heterodimere med HER3 (kodet fra ERBB3 genet). 
Neratinib is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).
Neratinib-metabolitterne M3, M6, M7 og M11 er negative i standardbatteri af genotoksiske in vitrostudier. 
Neratinib metabolites M3, M6, M7 and M11 are negative in the standard battery of in vitro genotoxicity studies.
Neratinib ved 10 mikroM syntes at hæmme BCRP-efflukstransportøren. 
Neratinib at 10 µM appeared to inhibit the BCRP efflux transporter.
• diltiazem, verapamil (calciumantagonister) 
• diltiazem, verapamil (calcium-channel blockers)
Det fremgik, at neratinibs hæmmende virkning primært gjaldt P-gp-aktiviteten i mave-tarm-kanalen som følge af præsystemisk hæmning. 
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.
Neratinib var ikke en potent hæmmer af human BSEP-efflukstransportør-aktivitet in vitro og havde en rapporteret IC50-værdi på > 10 mikroM. 
Neratinib was not a potent inhibitor of human BSEP efflux transporter activity in vitro, with a reported IC50 value of > 10µM.
• Vigtige oplysninger om, hvordan man forebygger og minimerer gastrointestinal toksicitet gennem relevant overvågning (med henvisning til behandlingsjournalen) og behandling: o forebyggende behandling med et middel mod diarré o kostændringer o hvornår man skal kontakte en sundhedsperson og betydningen af dette for justering af den videre behandling 
• 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
Patienter med betydelig kronisk sygdom i mave-tarm-kanalen Patienter med betydelig kronisk sygdom i mave-tarm-kanalen og diarré som et alvorligt symptom indgik ikke i det pivotale studie, og de bør overvåges nøje. 
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.
Grad 3-diarré blev rapporteret hos 37,5 % af Nerlynxpatienterne. 
Grade 3 diarrhoea was reported in 37.5% of Nerlynx patients.
Hvis du har glemt at tage Nerlynx 
If you forget to take Nerlynx
Nerlynx er ikke undersøgt hos patienter med en venstre ventrikel uddrivningsfraktion (LVEF), der ligger under nedre normalgrænse, eller hos patienter med tidligere betydelig hjertesygdom. 
Nerlynx has not been studied in patients with less than lower limit of normal left ventricular ejection fraction (LVEF) or with significant cardiac history.
Abdominal distension, mundtørhed og dyspepsi 
Abdominal distension, dry mouth and dyspepsia
Graviditet Neratinib kan forårsage fosterskader, hvis det gives til gravide kvinder (se pkt. 
Pregnancy Neratinib may cause foetal harm when administered to pregnant women (see Section 4.6).
Nerlynx er ikke undersøgt hos patienter med svært nedsat nyrefunktion, herunder patienter i dialyse. 
Nerlynx has not been studied in patients with severe renal impairment including patients on dialysis.
Efter administration af en enkelt radioaktivt mærket dosis på 200 mg neratinib som oral opløsning blev 97,1 % og 1,1 % af den administrerede dosis genfundet i hhv. fæces og urin. 
Following the administration of a single radiolabelled dose of 200 mg neratinib oral solution, 97.1% and 1.1% of the administered dose was recovered in the faeces and urine, respectively.
Nerlynx er indiceret til forlænget adjuverende behandling af voksne patienter med tidlige stadier af hormonreceptor-positiv brystkræft med overudtryk af HER2, som har afsluttet en adjuverende trastuzumab-baseret behandling for mindre end et år siden.. 
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
De filmovertrukne tabletter er røde, ovale og præget med "W104" på den ene side og ingenting på den anden side. 
The film-coated tablets are red oval shaped and debossed with ‘W104' on one side and plain on the other side.
o Produktresuméet o Vejledning til sundhedspersoner o Informationsmateriale til patienter Vejledningen til sundhedspersoner skal indeholde følgende hovedelementer: o Produktnavn, aktivt stof og godkendt indikation for produktet o Relevante oplysninger om sikkerhedsproblemet "gastrointestinal toksicitet (diarré)" (f.eks. alvorlighed, sværhedsgrad, hyppighed, tid til debut, varighed, bivirkningens reversibilitet hvis relevant) o Oplysninger om den population, der har særligt høj risiko for at få diarré o Hovedbudskab om at instruere patienterne i, hvordan de skal forebygge og minimere gastrointestinal toksicitet gennem relevant overvågning og behandling: o forebyggende behandling med et middel mod diarré o kostændringer o dosisjustering (med vejledning i dosisjustering)/behandlingsophør o Betydningen af at overdrage informationsmaterialet til patienterne/omsorgspersonerne efter rådgivningen o Understregning af betydningen af at indberette bivirkninger. 
o The Summary of Product Characteristics o Guide for healthcare professionals o Patient educational material The Guide for healthcare professionals shall contain the following key elements: o Name of the product, active substance and approved indication of the product o Relevant information on the safety concern “Gastrointestinal toxicity (diarrhoea)” (e.g. seriousness, severity, frequency, time to onset, duration, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern o Key message to convey in patients counselling on how to prevent and minimise Gastrointestinal toxicity through appropriate monitoring and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o dose modification (with guideline to adjust doses)/ discontinuation of treatment o The importance of handing over the educational material to the patients/carers at the end of counselling o Remarks on the importance of reporting ADRs
Estimeret frekvens for hændelsesfri 2 årsperiode1 (%) 
Estimated 2 year event free rates1 (%)
Patienter, der oplever diarré af grad 3 eller derover, og som kræver intravenøs væskebehandling, eller som har tegn eller symptomer på levertoksicitet som f.eks. forværring af udmattelse, kvalme, opkastning, gulsot, smerter eller ømhed i den øvre højre kvadrant, feber, udslæt eller eosinofili, bør undersøges for ændringer i leverfunktionstest. 
Patients who experience ≥ Grade 3 diarrhoea requiring IV fluid treatment or any signs or symptoms of hepatotoxicity, such as worsening of fatigue, nausea, vomiting, jaundice, right upper quadrant pain or tenderness, fever, rash, or eosinophilia, should be evaluated for changes in liver function tests.
• Grad 2-diarré, der varer i 5 dage eller længere‡ 
• Grade 2 diarrhoea lasting 5 days or longer‡
Retningslinjer for justering af Nerlynx-dosen i tilfælde af diarré er vist i tabel 3. 
Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3.
Der er ikke udført farmakokinetiske studier hos patienter med nedsat nyrefunktion eller i dialyse. 
Pharmacokinetic studies in patients with renal impairment or undergoing dialysis have not been carried out.
Dette medfører vedvarende hæmning af disse vækstfaktor afhængige signalveje ved HER2-positiv eller HER2-muteret brystkræft. 
This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
Meget almindelig Udmattelse 
Very common Fatigue
• rifampicin (antimykobakterielt middel). 
• rifampicin (antimycobacterial)
Det skal besluttes, om amning skal ophøre eller behandling med Nerlynx seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de treapeutiske forele for for moderen. 
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.
Patienter med nedsat nyrefunktion har en højere risiko for komplikationer som følge af dehydrering, hvis de får diarré, og disse patienter bør overvåges nøje (se pkt. 
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).
Patienter, der samtidigt behandles med terapeutiske stoffer, hvis metabolisering involverer P-gp-substrater i mave-tarm-kanalen, bør overvåges nøje. 
Patients who are treated concomitantly with therapeutic agents whose metabolism involves P-gp substrates in the gastrointestinal tract should be monitored carefully.
Sekundære endepunkter i studiet omfattede sygdomsfri overlevelse (DFS), herunder duktalt carcinom in situ (DFS-DCIS), tid til metastaserecidiv (TTDR), metastasefri overlevelse (DDFS), kumulativ forekomst af centralnervesystem-recidiv og samlet overlevelse (OS). 
Secondary endpoints of the study included disease-free survival (DFS) including ductal carcinoma in situ (DFS-DCIS), time to distant recurrence (TTDR), distant disease-free survival (DDFS), cumulative incidence of central nervous system recurrence and overall survival (OS).
Den mediane alder i intention-to-treat (ITT)-populationen var 52,3 år (59,9 % var 50 år eller derover, 12,3 % var 65 år eller derover); 81,0 % var kaukasere, 2,6% var sorte eller afro-amerikanere, 13,6 % var asiater, og 2,9 % havde anden etnisk baggrund. 
52.3 years (59.9% was ≥50 years old, 12.3% was ≥65 years old); 81.0% were Caucasian, 2.6% black or African American, 13.6% Asian and 2.9% other.
Neratinib bandt fortrinsvis til HSA og humant alfa-1-syreglykoprotein (AAG). 
Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
I de kliniske studier var de bivirkninger, der blev forbundet med overdosering, i de fleste tilfælde diarré, med eller uden kvalme, opkastning og dehydrering. 
In the clinical trial setting, adverse reactions associated with overdose were most commonly diarrhoea, with or without nausea, vomiting and dehydration.
Efter samtidig administration af gentagne 600 mg-doser rifampicin, der er en stærk CYP3A4/P-gpinducer, faldt eksponeringen for neratinib signifikant med gennemsnitlige værdier, der var 24 % og 13 % af referenceværdierne (neratinib administreret alene) for hhv. Cmax og AUC. 
Following concomitant administration with repeated doses of 600 mg rifampicin, a strong CYP3A4/Pgp inducer, neratinib exposures were significantly decreased with mean values that were 24% and 13% of reference values (neratinib administered alone) for Cmax and AUC, respectively.
Samtidig administration af følgende lægemidler, der er stærke inducere af CYP3A4/P-gp-isoformen af cytokrom P450: 
Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450:
Der er anført en 2D-stregkode, som indeholder en entydig identifikator. 
Carton 2D barcode carrying the unique identifier included.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Lægen vil fortælle dig, om du fortsat skal tage et lægemiddel mod diarré efter de første to måneder. 
Your doctor will tell you if you need to keep taking anti-diarrhoea medicine after the first two months to control your diarrhoea.
Hvis en toksicitet af grad 3 ikke bedres inden for 3 uger, skal Nerlynx seponeres permanent. 
If grade 3 toxicity does not recover within 3 weeks, discontinue Nerlynx permanently.
Både udslæt og neglelidelser medførte seponering af behandlingen hos 0,6 % af de Nerlynxbehandlede patienter. 
Both rash and nail disorders led to treatment discontinuation in 0.6% of Nerlynx-treated patients.
Samtidig brug af stærke CYP3A4/P-gp-hæmmere (f.eks. atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, ketoconazol, itraconazol, clarithromycin, telithromycin og voriconazol) bør undgås. 
Concomitant use of strong CYP3A4/P-gp inhibitors (e.g. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, and voriconazole) should be avoided.
Neratinib kan hæmme brystkræftresistent protein (BCRP) i moderat grad i henhold til in vitro-studier. 
Neratinib may inhibit breast cancer resistance protein (BCRP) moderately as suggested by in vitro studies.
- syreneutraliserende lægemidler - indtagelse af disse lægemidler og Nerlynx bør foregå med mindst 3 timers mellemrum. 
- antacid medicines - the dose of these medicines and Nerlynx should be separated by at least 3 hours.
Pakningsstørrelser og yderligere oplysninger Nerlynx indeholder: 
Contents of the pack and other information What Nerlynx contains
Figur 2: 
Figure 2:
Det er påvist, at neratinib-metabolitterne M3, M6, M7 og M11 i både in vitro-enzymanalyser (bindingsanalyser) og cellebaserede analyser har samme potens som neratinib mod celler, der udtrykker ERBB1, ERBB2 (HER2) og ERBB4. 
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.
En enkeltdosis på 240 mg neratinib i kombination med lansoprazol reducerede AUC med op til 70 %. 
A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000) 
The MedDRA frequency convention and system organ class database has been utilised for the classification of frequency: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data)
Protonpumpehæmmere, H2-receptor antagonister og antacider Opløseligheden af neratinib er pH-afhængig. 
Proton pump inhibitors, H2-receptor antagonists and antacids The solubility of neratinib is pH-dependent.
Nerlynx 40 mg filmovertrukne tabletter 
Nerlynx 40 mg film-coated tablets
Hæmmere af brystkræftresistent protein 
Breast cancer resistance protein inhibitors
Neratinib binder til HER2-receptoren, reducerer EGFR- og HER2-autophosphorylering samt MAPK- og AKT (downstream) signalering, og hæmmer i kraftig grad tumorcellevækst in vitro. 
Neratinib binds to the HER2 receptor, reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and potently inhibits tumour cell proliferation in vitro.
Så meget Nerlynx skal du tage 
How much Nerlynx to take
In vitro-studier har påvist, at neratinib er et substrat for Pglykoprotein (P-gp). 
In vitro studies demonstrated that neratinib is a substrate for P-glycoprotein (P-gp).
Den anbefalede dosis Nerlynx er 240 mg (seks 40 mg tabletter), der tages én gang dagligt i et år. 
The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year.
Diarré, opkastning, kvalme, mavesmerter, smerter i den øvre del af maven og stomatitis1 
Diarrhoea, vomiting, nausea, abdominal pain, abdominal pain upper, and stomatitis1
Der er rapporteret om levertoksicitet hos patienter, der behandles med Nerlynx. 
Hepatotoxicity has been reported in patients treated with Nerlynx.
Ikke almindelige bivirkninger: kan forekomme hos op til 1 ud af 100 patienter - Nyresvigt - ændringer i leverværdierne (f.eks. forhøjet bilirubin i blodet) 
Uncommon: may affect up to 1 in 100 people - kidney failure - changes in liver blood test results (i.e., blood bilirubin increased)
Samtidig administration af en enkeltdosis oralt neratinib (240 mg) og ketoconazol (400 mg én gang dagligt i fem dage), en stærk CYP3A4/P-gp-hæmmer, øgede den systemiske neratinibeksponering. 
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.
0,2 % af de Nerlynx-behandlede patienter oplevede neglelidelser af grad 3. 
There were 0.2% of Nerlynx treated patients who experienced Grade 3 nail disorder.
Hos patienter med svært nedsat leverfunktion (ChildPugh C) uden kræft faldt neratinib-clearance med 36 %, og eksponeringen for neratinib steg ca. 3 gange sammenholdt med hos raske forsøgspersoner. 
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.
Nerlynx kan medføre diarré tidligt i behandlingen, medmindre du samtidigt tager et lægemiddel mod diarré for at forebygge eller mindske dette. 
Nerlynx can cause diarrhoea early during treatment unless anti-diarrhoeal medicines are taken to prevent or reduce diarrhoea.
ALAT = alaninaminotransferase * I henhold til CTCAE v4.0 
ULN=Upper Limit Normal; ALT= Alanine Aminotransferase * Per CTCAE v4.0
• Hvis diarréen bedres til grad 0-1 i løbet af en uge eller derunder, bør Nerlynx genoptages i samme dosis. 
• If diarrhoea resolves to Grade 0-1 in one week or less, then resume Nerlynx treatment at the same dose.
Diarréen opstår typisk tidligt i behandlingen med Nerlynx og kan være så kraftig, at du dehydrerer. 
Diarrhoea usually happens early in treatment with Nerlynx and may be severe, causing you to get dehydrated.
• ikke kan tåle 120 mg dagligt. 
• For patients that are unable to tolerate 120 mg daily
Hvis du bliver gravid under behandlingen, vil lægen vurdere den mulige fordel for dig og risikoen for fostret ved at fortsætte behandlingen. 
If you become pregnant while taking this medicine, the doctor will assess the potential benefit to you and the risk to the foetus, of continuing this medicine.
Nerlynx indeholder det aktive stof neratinib. 
Nerlynx contains the active substance ‘neratinib'.
Hver filmovertrukket tablet indeholder neratinibmaleat svarende til 40 mg neratinib. 
Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib.
Kvinder, der kan blive gravide, skal bruge en sikker præventionsmetode, herunder en barrieremetode: - mens de tager Nerlynx og - i en måned efter behandlingens afslutning. 
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.
Fortæl det til lægen eller apotekspersonalet, hvis du oplever en eller flere af nedenstående bivirkninger: 
Tell your doctor or pharmacist if you notice any of the following side effects:
De hyppigst indberettede alvorlige bivirkninger i gruppen af patienter på 65 år eller derover var opkastning (2,3 %), diarré (1,7 %), dehydrering (1,2 %) og nyresvigt (1,2 %). 
The serious adverse reactions most frequently reported in the ≥65 years-old group were vomiting (2.3%), diarrhoea (1.7%), dehydration (1.2%), and renal failure (1.2%).
- Aktivt stof: neratinib. 
- The active substance is neratinib.
Sværhedsgrad af diarré* 
Severity of diarrhoea*
Neratinib medførte hæmmende aktivitet over for OCT1-uptake-transportøren med en IC50 på 2,9 mikroM. 
Neratinib produced inhibitory activity in OCT1 uptake transporter, with an IC50 of 2.9 µM.