FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat-dose toxicity studies with dacomitinib, effects on reproductive organs were observed in female rats given approximately 0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to reversible epithelial atrophy in the cervix and vagina.
Danish: I forsøg, der undersøgte dacomitinibs toksicitet ved gentagne doser, blev der observeret påvirkning af reproduktionsorganerne hos hunrotter, der fik ca. 0,3 gange det ubundne AUC ved den anbefalede humane dosis (i 6 måneder), og disse var begrænset til reversibel atrofi i epitelet i cervix og vagina.
English: Adverse reactions leading to dose reductions were reported in 52.2% of patients treated with dacomitinib.
Danish: Bivirkninger, der medførte dosisreduktioner, blev rapporteret hos 52,2% af patienterne, der blev behandlet med dacomitinib.
English: Based on pooled data in patients, there was no apparent effect of histamine-2 (H2) receptor antagonists on steady-state trough concentration of dacomitinib (geometric mean ratio of 86% (90% CI: 73; 101).
Danish: Baseret på puljede patientdatasæt, havde histamin-2 (H2)-receptorantagonister ingen tilsyneladende virkning på dacomitinibs laveste steady state koncentration (geometrisk middelratio på 86% (90% konfidensinterval: 73-101).
English: In addition, hepatocellular necrosis with transaminase increases and hepatocellular vacuolation were observed in rats only.
Danish: Derudover blev der udelukkende hos rotter observeret hepatocellulær nekrose med forhøjet transaminase og hepatocellulær vakuolation.
English: Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with Cmax occurring 5 to 6 hours after oral dosing.
Danish: Efter administration af en enkelt dosis dacomitinib tabletter på 45 mg er den gennemsnitlige orale biotilgængelighed af dacomitinib 80% (interval: 65% til 100%) sammenlignet med intravenøs administration, hvor Cmax opnås 5 - 6 timer efter oral dosering.
English: Thus no dosing recommendations can be made for either patient population (see section 5.2).
Danish: Derfor kan der ikke gives nogen dosisanbefalinger for disse patientpopulationer (se pkt.
English: No starting dose adjustments are required when administering Vizimpro to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min).
Danish: Det er ikke nødvendigt at justere startdosis, når Vizimpro gives til patienter med let eller moderat nedsat nyrefunktion (kreatininclearance [CrCl] ≥30 ml/min).
English: Adverse reactions are listed according to system organ class (SOC).
Danish: Bivirkningerne er angivet efter systemorganklasse.
English: Based on population pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate (30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function.
Danish: Baseret på farmakokinetiske populationsanalyser havde let (60 ml/min ≤CrCl <90 ml/min; N=590) og moderat (30 ml/min ≤ CrCl <60 ml/min; N=218) nedsat nyrefunktion ingen indvirkning på dacomitinibs farmakokinetik sammenlignet med forsøgspersoner med normal (CrCl ≥ 90 ml/min; N=567) nyrefunktion.
English: No starting dose adjustments are required when administering Vizimpro to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Danish: Det er ikke nødvendigt at justere startdosis, når Vizimpro gives til patienter med let (Child-Pugh klasse A) eller moderat (Child-Pugh klasse B) nedsat leverfunktion.
English: j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased.
Danish: Forhøjede transaminaser omfatter følgende foretrukne termer: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser.
English: Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4).
Danish: Eksfoliative hudsygdomme af grad 3 blev rapporteret hos 0,8% af patienterne (se pkt.
English: OS results from the final analysis (data cut-off date of 17-Feb-2017) when 48.7% of events had occurred showed a HR of 0.760 (95% CI: 0.582, 0.993) and a gain of 7.3 months in median OS (median OS: 34.1 months [95% CI: 29.5, 37.7] and 26.8 months [95% CI: 23.7, 32.1] in the dacomitinib and gefitinib arm, respectively).
Danish: De endelige resultater for samlet overlevelse (OS) (data cut-off 17- Feb-2017) da 48,7% af hændelserne havde fundet sted viste en hazard-ratio (HR) på 0,760 (95% CI: 0,582- 0,993) og en forbedring på 7,3 måneder i median OS (median OS: 34,1 måneder (95% CI: 29,5-37,7) og 26,8 måneder (95% CI: 23,7-32,1) i henholdsvis dacomitinib-armen og gefitinib-armen).
English: In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Danish: In vitro har dacomitinib lavt potentiale for at inducere CYP1A2, CYP2B6 eller CYP3A4 ved klinisk relevante koncentrationer.
English: Based on population pharmacokinetic analyses, patient age, race (Asian and non-Asian), gender, and body weight do not have a clinically relevant effect on predicted steady-state exposure of dacomitinib.
Danish: Patientalder, race (asiatere og ikke-asiatere), køn og kropsvægt har ingen klinisk relevant indflydelse på forventet eksponering for dacomitinib ved steady state, baseret på farmakokinetiske populationsanalyser.
English: i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative rash, Skin exfoliation.
Danish: Hudeksfoliation (også omtalt som eksfoliative hudlidelser) omfatter følgende foretrukne termer: eksfoliativt udslæt, hudeksfoliation.
English: ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8).
Danish: ILS/pneumonitis, som kan være letal, er rapporteret hos patienter, der får Vizimpro (se pkt.
English: Dacomitinib was not mutagenic in a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone marrow micronucleus assay in male and female rats.
Danish: Dacomitinib var ikke mutagent i en bakteriel tilbagemutationstest (Ames test), og det var ikke klastogent eller aneugent i en mikronukleustest in vivo i knoglemarv fra han- og hunrotter.
English: Limited data are available in patients with severe renal impairment (CrCl < 30 mL/min).
Danish: Der er kun begrænsede data tilgængelige for patienter med svært nedsat nyrefunktion (CrCl <30 ml/min).
English: • if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, light-coloured bowel movements (stools).
Danish: Det kan være: gulfarvning af huden eller af det hvide i øjnene (gulsot), mørk eller brun (tefarvet) urin, lys afføring.
English: Dacomitinib has not been studied in patients with severe (Child-Pugh class C) hepatic impairment.
Danish: Dacomitinib er ikke blevet undersøgt hos patienter med svært (Child-Pugh klasse C) nedsat leverfunktion.
English: The most frequently (≥ 1%) reported serious adverse reactions in patients receiving dacomitinib were diarrhoea (2.0%), interstitial lung disease (1.2%), rash (1.2%), and decreased appetite (1.2%).
Danish: De hyppigst (≥1%) rapporterede alvorlige bivirkninger hos patienter, der fik dacomitinib, var diarré (2,0%), interstitiel lungesygdom (1,2%), udslæt (1,2%) og nedsat appetit (1,2%).
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5).
Danish: Undgå samtidig administration af lægemidler, som hovedsageligt metaboliseres via CYP2D6 medmindre disse produkter er nødvendige (se pkt.
English: Dacomitinib pharmacokinetics has not been studied in subjects with severe hepatic impairment (Child-Pugh class C).
Danish: Dacomitinibs farmakokinetik er ikke blevet undersøgt hos forsøgspersoner med svært nedsat leverfunktion (ChildPugh klasse C).
English: Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).
Danish: Det kan være nødvendigt at afbryde og/eller nedsætte dosis til patienterne i forbindelse med dacomitinib-behandlingen (se afsnit 4.2).
English: Repeated-dose toxicity
Danish: Toksicitet ved gentagne doser
English: Efficacy results from ARCHER 1050 in patients with previously untreated NSCLC with EGFR-activating mutations - ITT population Dacomitinib N=227
Danish: Resultater fra ARCHER 1050 hos patienter med tidligere ubehandlet NSCLC med EGFR-aktiverende mutationer - ITT-population
English: What you need to know before you take Vizimpro
Danish: Det skal du vide, før du begynder at tage Vizimpro
English: • Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Danish: • Dacomitinib skal seponeres midlertidigt under diagnostisk udredning af ILS/pneumonitis.
English: c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Danish: Interstitiel lungesygdom omfatter følgende foretrukne termer: Interstitiel lungesygdom, pneumonitis.
English: Effect of dacomitinib and O-desmethyl dacomitinib on CYP enzymes In vitro, dacomitinib and its metabolite O-desmethyl dacomitinib have a low potential to inhibit the activities of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5 at clinically relevant concentrations.
Danish: Effekt af dacomitinib og O-desmethyl-dacomitinib på CYP-enzymer In vitro har dacomitinib og dets metabolit O-desmethyl-dacomitinib lavt potentiale for hæmning af CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19- eller CYP3A4/5-aktiviet i koncentrationer, der er klinisk relevante.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Det bør ikke anvendes til patienter med hereditære galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4).
Danish: Samtidig brug af lægemidler, der hovedsageligt metaboliseres af CYP2D6 bør undgås (se pkt.
English: Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5).
Danish: Anvendelse af protonpumpehæmmere (PPI'er) sammen med dacomitinib skal undgås (se pkt.
English: Interstitial lung disease (ILD)/Pneumonitis
Danish: Interstitiel lungesygdom (ILS)/pneumonitis
English: It is available in blister packs of 30 film-coated tablets (tablets).
Danish: Vizimpro findes i blisterpakninger med 30 filmovertrukne tabletter (tabletter).
English: How to store Vizimpro 6.
Danish: Sådan skal du tage Vizimpro 4.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Danish: Pfizer Europe MA EEIG (som logo for indehaveren af markedsføringstilladelsen)
English: Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis.
Danish: Konjunktivitis omfatter følgende foretrukne termer: Blefaritis, konjunktivitis, tørre øjne, ikke-infektiøs konjunktivitis.
English: • For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib.
Danish: • Dacomitinib skal seponeres midlertidigt ved diarré af grad 2, hvis der ikke ses en forbedring til grad ≤ 1 indenfor 24 timer, mens der anvendes behandling med anti-diarré lægemidler (fx loperamid), og der er sørget for tilstrækkelig oral væskeindtagelse.
English: The median duration of any grade and Grade ≥ 3 transaminases increased was 11 weeks and 1 week, respectively.
Danish: Den mediane varighed af enhver grad og grad ≥3 af forhøjede transaminaser var henholdsvis 11 uger og 1 uge.
English: Objective Response Rate (per IRC) Objective Response Rate % (95% CI)
Danish: Objektiv responsrate (ifølge IRC) Objektiv responsrate i % (95% CI) 2-sidet p-værdi
English: Tel: +34 91 490 99 00
Danish: Tél: +34 91 490 99 00
English: Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids).
Danish: Start eller fortsæt behandling og/eller giv yderligere behandling (fx bredspektret oral eller intravenøs antibiotika og topikale steroider).
English: • Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, indigestion and heartburn).
Danish: • Langtidsvirkende lægemidler, der nedsætter produktionen af mavesyre såsom syrepumpehæmmere (til mavesår, fordøjelsesbesvær og halsbrand).
English: Dose modification and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and
Danish: Vejledning for dosisjustering og behandling i forbindelse med specifikke bivirkninger er vist i tabel 2 (se pkt.
English: As an alternative, you can take a short-acting medicine, such as an antacid, or an H2 blocker medicine.
Danish: Som alternativ kan du tage et korttidsvirkende lægemiddel, fx syreneutraliserende medicin eller et lægemiddel, der nedsætter produktionen af mavesyre, en såkaldt ”H2-blokker”.
English: In addition, based on a population pharmacokinetic analysis using data from 1381 patients, that included 158 patients with mild hepatic impairment defined by National Cancer Institute (NCI) criteria [total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST; N=158], mild hepatic impairment had no effect on the pharmacokinetics of dacomitinib.
Danish: Derudover havde let nedsat leverfunktion ingen effekt på dacomitinibs farmakokinetik, hvilket var baseret på en farmakokinetisk populationsanalyse med data fra 1381 patienter, som inkluderede 158 patienter med let nedsat leverfunktion, hvilket var defineret ifølge kriterierne fra National Cancer Institute (NCI) (total bilirubin ≤ den øvre grænse for normalområdet (ULN) og aspartataminotransferase (ASAT) > ULN eller total bilirubin >1,0 til 1,5 × ULN og en hvilken som helst ASAT; N=158).
English: Adverse reactions leading to permanent discontinuation were reported in 6.7% of patients treated with dacomitinib.
Danish: Bivirkninger, der medførte permanent seponering, blev rapporteret hos 6,7% af patienterne, der blev behandlet med dacomitinib.
English: Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib versus gefitinib.
Danish: Virkning og sikkerhed af Vizimpro blev undersøgt i et fase 3studie (ARCHER 1050), der blev udført hos patienter med lokalt fremskreden NSCLC, der ikke kunne behandles med helbredende/radikal kirurgi eller strålebehandling, eller metastatisk NSCLC med aktiverende EGFR-mutationer, med henblik på at demonstrere superioriteten af dacomitinib versus gefitinib.
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with Vizimpro (see section 4.8).
Danish: Der er rapporteret om forhøjede transaminaser (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser) under behandling med Vizimpro (se pkt.
English: In vitro, dacomitinib has a low potential to inhibit the activities of drug transporters P-gp (systemically), organic anion transporters (OAT)1 and OAT3, OCT2, organic anion transporting polypeptide (OATP)1B1, and OATP1B3, but may inhibit the activity of P-gp (in the GI tract), BCRP (systemically and GI tract), and OCT1 at clinically relevant concentrations.
Danish: In vitro har dacomitinib lavt potentiale for hæmning af aktiviteten af lægemiddeltransportører, P-gp (systemisk), organiske anion-transportører (OAT)1 og OAT3, OCT2, det organiske aniontransporterende polypeptid (OATP)1B1 og OATP1B3, men dacomitinib hæmmer muligvis aktiviteten af P-gp (i mave-tarmkanalen), BCRP (systemisk og i mave-tarmkanalen) og OCT1 ved klinisk relevante koncentrationer.
English: In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when compared to subjects with normal hepatic function (N=8).
Danish: I et studie, der undersøgte nedsat leverfunktion, var eksponeringen for dacomitinib (AUCinf og Cmax) uændret ved let nedsat leverfunktion (Child-Pugh A; N=8) efter en enkelt oral dosis Vizimpro 30 mg, og den faldt med henholdsvis 15% og 20% ved moderat nedsat leverfunktion (Child-Pugh B; N=9), når der blev sammenlignet med forsøgspersoner med normal leverfunktion (N=8).
English: No data are available in patients requiring haemodialysis.
Danish: Der foreligger ingen data for patienter, der har behov for hæmodialyse.
English: a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.
Danish: Hypokaliæmi omfatter følgende foretrukne termer: Nedsat kaliumindhold i blodet, hypokaliæmi.
English: The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea
Danish: De hyppigst rapporterede (>5%) årsager til dosisreduktioner som følge af bivirkninger hos patienter, der fik dacomitinib, var udslæt (32,2%), neglesygdom (16,5%) og diarré
English: A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a multicentre, multinational, randomised, open-label Phase 3 study.
Danish: I et multicenter, multinationalt, randomiseret, åbent fase 3-studie, blev i alt 452 patienter randomiseret 1:1 til at modtage dacomitinib eller gefitinib.
English: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 3, with the majority Grade 1 (18.4%) (see section 4.4).
Danish: Der blev rapporteret forhøjede transaminaser (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser) hos 22,0% af patienterne, der fik Vizimpro, og disse var grad 1 til 3.
English: Transaminases increased
Danish: Forhøjede transaminaser
English: The most common (> 0.5%) reasons for permanent discontinuations associated with adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), and diarrhoea (0.8%).
Danish: De mest almindelige (>0,5%) årsager til permanent seponering i forbindelse med bivirkninger hos patienter, der fik dacomitinib, var udslæt (2,4%), interstitiel lungesygdom (2,0%) og diarré (0,8%).
English: Based on in vitro data, dacomitinib may have the potential to inhibit the activity of P-glycoprotein (P-gp) (in the gastrointestinal [GI] tract), Breast Cancer Resistance Protein (BCRP) (systemically and GI tract), and organic cation transporter (OCT)1 at clinically relevant concentrations (see section 5.2).
Danish: Effekt af dacomitinib på lægemiddeltransportører Baseret på data in vitro, kan dacomitinib potentielt hæmme aktiviteten af P-glycoprotein (P-gp) (i mave-tarm-kanalen), brystkræft-resistent protein (BCRP) (systemisk og i mave-tarmkanalen) og organisk kation-transportør (OCT)1 ved klinisk relevante koncentrationer (se pkt.
English: Hepatotoxicity and transaminases increased
Danish: Levertoksicitet og forhøjede transaminaser
English: In a clinical study, one patient (0.4%) had a fatal outcome (see section 4.4).
Danish: Der blev indberettet et dødeligt tilfælde (0,4%) i et klinisk studie (se pkt.
English: Microcrystalline cellulose Sodium starch glycolate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Natriumstivelsesglycolat Magnesiumstearat
English: • if you develop skin rash.
Danish: • Hvis du får hududslæt.
English: Diarrhoea* Stomatitis d
Danish: Diarré* Stomatitis Opkastning Kvalme
English: Rash, erythematous and exfoliative skin conditions have been reported in patients treated with Vizimpro (see section 4.8).
Danish: Der er rapporteret om udslæt, erytematøse og eksfoliative hudsygdomme hos patienter, der behandles med Vizimpro (se pkt.
English: Interstitial lung disease (ILD/Pneumonitis)
Danish: Interstitiel lungesygdom (ILS/pneumonitis)
English: • For Grade 1 or 2 toxicity, no dose modification is required.
Danish: • Dosisjustering er ikke nødvendig i forbindelse med toksicitet af grad 1 eller grad 2.
English: Hypertrichosis
Danish: Hudeksfoliation hypertrichose
English: Limited pharmacokinetic data are available in patients with severe renal impairment (CrCl < 30 mL/min) (N=4).
Danish: Der er få tilgængelige data fra patienter med svært nedsat nyrefunktion (CrCl <30 ml/min) (N=4).
English: e Rash (also referred to as Rash and erythematous skin conditions) includes the following PTs: Acne, Dermatitis acneiform, Erythema, Erythema multiforme, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular.
Danish: Udslæt (også omtalt som udslæt og erytematøse hudlidelser) omfatter følgende foretrukne termer: Acne, acneiform dermatitis, erytem, erythema multiforme, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt.
English: For prevention of dry skin, initiate treatment with moisturizers, and upon development of rash, initiate treatment with topical antibiotics, emollients, and topical steroids.
Danish: Start behandling med fugtgivende midler for at forebygge tør hud og behandling med topikale antibiotika, blødgørende midler og topikale steroider efter udvikling af udslæt.
English: In faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a mono-oxygenated metabolite of dacomitinib were the major drug-related components.
Danish: Dacomitinib, Odesmethyl-dacomitinib, et dacomitinib-cysteinkonjungat og en mono-oxygeneret metabolit af
English: C] radiolabeled dacomitinib, a median of 82% of the total administered radioactivity was recovered in 552 hours; faeces (79% of dose) was the major route of excretion, with 3% of the dose recovered in urine, of which < 1% of the administered dose was unchanged dacomitinib.
Danish: Fæces var hovedeliminationsvejen (79% af dosis), 3% af dosis blev genfundet i urin, af hvilken <1% af den administrerede dosis dacomitinib var uforandret.
English: Recommended dose modifications for Vizimpro adverse reactions Dose level
Danish: Anbefalede dosisjusteringer ved bivirkninger i forbindelse med Vizimpro
English: Stratification factors at randomisation were race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21).
Danish: Stratifikationsfaktorerne ved randomisering var race (japanere versus kinesere fra fastlandet versus andre østasiatere versus ikke-østasiatere, som anført af patienten) og EGFR-mutationsstatus (exon 19deletion versus L858R-mutationen i exon 21).
English: In patients who develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted (see section 4.2).
Danish: Behandlingen skal afbrydes hos patienter, der udvikler svært forhøjede transaminaser under behandling med dacomitinib (se pkt.
English: EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4).
Danish: Inden behandlingen med dacomitinib påbegyndes skal EGFR-mutationsstatus bestemmes (se pkt.
English: • For Grade 1 diarrhoea, no dose modification is required.
Danish: • Dosisjustering er ikke nødvendig i forbindelse med diarré af grad 1.