FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of lapatinib were examined in patients with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control patients.
Danish: Farmakokinetikken for lapatinib blev undersøgt hos patienter med moderat (n = 8) eller svært (n = 4) nedsat leverfunktion (Child-Pugh-score på hhv. 7-9 eller højere end 9) og hos 8 raske kontrolpersoner.
English: Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 70% of cases.
Danish: Nedsat uddrivningsfraktion fra venstre ventrikel (LVEF) er rapporteret hos ca. 1 % af de patienter, der har fået lapatinib, og var asymptomatisk i mere end 70 % af tilfældene.
English: • verapamil - a medicine used to treat high blood pressure or heart problems (angina)
Danish: • verapamil - medicin, der bruges til at behandle for højt blodtryk eller hjerteproblemer
English: Caution should be taken if Tyverb is to be administered to patients with conditions that could impair left ventricular function (including coadministration with potentially cardiotoxic medicinal products).
Danish: Der skal udvises forsigtighed, hvis Tyverb gives til patienter med tilstande, der kan hæmme venstre ventrikels funktion (herunder samtidig administration af potentielt kardiotoksiske lægemidler).
English: The safe use of Tyverb during breast-feeding has not been established.
Danish: Sikker anvendelse af Tyverb under amning er ikke etableret.
English: In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
Danish: I den HER2-negative population var der ingen forbedring af PFS ved behandling med letrozol og Tyverb i forhold til behandling med letrozol og placebo (se Tabel 6).
English: Symptoms may include skin rash, blisters and skin peeling.
Danish: Symptomerne kan inkludere hududslæt, blistre og hudafskalning.
English: Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Danish: Lapatinib gennemgår omfattende metabolisering, primært via CYP3A4 og CYP3A5 med mindre bidrag fra CYP2C19 og CYP2C8, til en række oxiderede metabolitter, hvor ingen af metabolitterne udgør mere end 14 % af den dosis, der blev fundet i fæces, eller 10 % af lapatinib-koncentrationen i plasma.
English: Co-administration of Tyverb with orally administered midazolam resulted in an approximate 45% increase in the AUC of midazolam.
Danish: Samtidig administration af Tyverb med oralt administreret midazolam resulterede i en ca. 45 % stigning i AUC af midazolam.
English: Evaluation of cardiac function, including LVEF determination, should be conducted for all patients prior to initiation of treatment with Tyverb to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
Danish: Hjertefunktionen, herunder LVEF, skal måles hos alle patienter før initiering af behandling med Tyverb for at sikre, at patienten har en baseline-LVEF, der ligger inden for normalområdet.
English: Lapatinib has also been shown in vitro to inhibit these efflux transporters, as well as the hepatic uptake transporter OATP 1B1, at clinically relevant concentrations (IC50 values were equal to 2.3 µg/ml).
Danish: Lapatinib er også in vitro fundet at hæmme disse effluxtransportører samt leveroptagelsestransportøren OATP 1B1 ved klinisk relevante koncentrationer (IC50-værdier svarede til 2,3 µg/ml).
English: Caution is advised in patients with severe renal impairment as there is no experience of Tyverb in this population (see section 5.2).
Danish: Der bør udvises forsigtighed ved patienter med svært nedsat nyrefunktion, da der ikke er erfaring med Tyverb hos denne population (se pkt.
English: • in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
Danish: • I kombination med en aromatasehæmmer til postmenopausale kvinder med hormonreceptorpositiv metastatisk sygdom, som det på nuværende tidspunkt ikke er hensigtsmæssigt at behandle med kemoterapi.
English: Very common Hot flush Respiratory, thoracic and mediastinal disorders Very common Epistaxis
Danish: Meget almindelig Hedeture Luftveje, thorax og mediastinum Meget almindelig Epistaxis
English: †, arthralgia General disorders and administration site conditions Very common Fatigue, mucosal inflammation*, asthenia * These adverse reactions were observed when lapatinib was administered in combination with capecitabine.
Danish: †, artralgi Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed, slimhindebetændelse*, asteni * Disse bivirkninger blev observeret, når lapatinib blev administreret i kombination med capecitabin.
English: Caution should be taken if Tyverb is administered to patients with conditions that could result in prolongation of QTc (including hypokalemia, hypomagnesemia, and congenital long QT syndrome), co-administration of other medicinal product known to cause QT prolongation, or conditions that increase the exposure of lapatinib, such as co-administration of strong CYP3A4 inhibitors.
Danish: Der skal udvises forsigtighed, hvis Tyverb administreres til patienter med tilstande, som kan medføre QTc-forlængelse (herunder hypokaliæmi, hypomagnesiæmi og medfødt langt QT-syndrom), samtidig administration af andre lægemidler, der kan medføre QT-forlængelse eller tilstande der øger eksponeringen for lapatinib, såsom samtidig administration af stærke inhibitorer af CYP3A4).
English: On the combination arm, there were 4 (2%) progressions in the central nervous system as compared with the 13 (6%) progressions on the capecitabine alone arm.
Danish: I kombinationsgruppen var der 4 tilfælde (2 %) af progression i centralnervesystemet sammenlignet med 13 tilfælde (6 %) af progression i gruppen med capecitabin alene.
English: Tyverb is prescribed to be taken in combination with another anti-cancer medicine.
Danish: Tyverb skal tages i kombination med et andet lægemiddel til behandling af kræft.
English: Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
Danish: Spørg lægen eller på apoteket, inden du begynder behandling med Tyverb, hvis der er noget, du er i tvivl om.
English: Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3-fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively, as compared with administration in the fasted state.
Danish: AUC-værdierne for lapatinib var ca. 3 og 4 gange højere (Cmax ca. 2,5 og 3 gange højere), når lapatinib blev administreret sammen med henholdsvis et måltid med lavt fedtindhold (5 % fedt [500 kalorier]) og et måltid med højt fedtindhold (50 % fedt [1000 kalorier]) i forhold til administration i fastende tilstand.
English: Kaplan-Meier estimates
Danish: Kaplan-Meier-estimat
English: Lapatinib did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ml).
Danish: Lapatinib hæmmede ikke i signifikant grad følgende enzymer i humane levermikrosomer: CYP1A2, CYP2C9, CYP2C19 og CYP2D6 eller UGT-enzymer (in vitro-IC50værdierne var højere end eller lig med 6,9 µg/ml).
English: Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, and erythromycin) and inducers (rifampicin and St John's Wort) of these proteins may alter the exposure and/or distribution of lapatinib (see section 5.2).
Danish: Inhibitorer (ketoconazol, itraconazol, kinidin, verapamil, ciclosporin og erythromycin) og induktorer (rifampicin og perikon) af disse proteiner kan ændre optagelsen og/eller fordelingen af lapatinib (se pkt.
English: LVEF was evaluated in all patients (using echocardiogram [Echo] or multi gated acquisition scan [MUGA]) prior to initiation of treatment with Tyverb to ensure baseline LVEF was within the institutions normal limits.
Danish: LVEF blev evalueret hos alle patienter (vha. ekkokardiogram [ECHO] eller multiple gated acquisition [MUGA]) før initiering af behandling med Tyverb for at sikre, at baseline-LVEF lå inden for normalområdet.
English: If erythema multiforme or life-threatening reactions such as Stevens-Johnson syndrome, or toxic epidermal necrolysis (e.g. progressive skin rash often with blisters or mucosal lesions) are suspected, discontinue treatment with Tyverb.
Danish: Hvis der er mistanke om erythema multiforme eller livstruende lidelser såsom Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse (som progressivt hududslæt ofte med blistre eller mucosale læsioner) skal Tyverbbehandlingen diskontinueres.
English: LVEF decreases resolved or improved in more than 70 % of cases, in approximately 60 % of these on discontinuation of treatment with lapatinib, and in approximately 40 % of cases lapatinib was continued.
Danish: Fald i LVEF blev normaliseret eller forbedret i over 70 % af tilfældene, heraf ca. 60 % ved seponering af behandlingen med lapatinib og ca. 40 % ved fortsat behandling med lapatinib.
English: Tyverb has been studied in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive (oestrogen receptor [ER] positive and / or progesterone receptor [PgR] positive) advanced or metastatic breast cancer.
Danish: Tyverb er undersøgt i kombination med letrozol til behandling af postmenopausale kvinder med hormonreceptorpositiv (østrogenreceptorpositiv [ER-positiv] og/eller progesteronreceptorpositiv [PgR-positiv]) avanceret eller metastatisk brystcancer.
English: In the phase III clinical study of Tyverb in combination with letrozole, of the total number of hormone receptor positive metastatic breast cancer patients (Intent to treat population N= 642), 44 % were ≥ 65 years of age.
Danish: I et klinisk fase III-studie med Tyverb i kombination med letrozol var 44 % af det samlede antal patienter med hormonreceptorpositiv metastatisk brystcancer ≥ 65 år (intent to treat (ITT)-population: n = 642).
English: Effects of lapatinib on other medicinal products
Danish: Lapatinibs virkning på andre lægemidler
English: Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
Danish: Lapatinib hæmmer ErbB-drevet tumorcellevækst in vitro og i forskellige dyremodeller.
English: In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
Danish: In vitro-studier indikerer, at lapatinib er substrat for transportørerne BCRP (ABCG1) og p-glykoprotein (ABCB1).
English: • If you become pregnant during treatment with Tyverb, tell your doctor.
Danish: • Hvis du bliver gravid, mens du er i behandling med Tyverb, skal du fortælle det til lægen.
English: (95% CI), p-value b
Danish: (95% CI), p-værdi b
English: • ritonavir, saquinavir - medicines used to treat HIV
Danish: • ritonavir, saquinavir - medicin, der bruges til at behandle hiv
English: There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥60 mg/kg/day (4 times the expected human clinical exposure).
Danish: Der sås ingen teratogen effekt, dog var der mindre anomalier (venstresidig umbilicus-arterie, cervikalt ribben og tidlig knogledannelse) hos rotter ved ≥ 60 mg/kg/døgn (4 gange den forventede, kliniske optagelse hos mennesker).
English: OUTER CARTON AND BOTTLE LABEL
Danish: YDRE KARTON OG ETIKET PÅ BEHOLDER
English: Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ml and AUC values of 36.2 (79%) µg*hr/ml.
Danish: En daglig dosering på 1250 mg medfører geometriske middel-(variationskoefficient) Cmax-værdier ved steady state på 2,43 (76 %) µg/ml og AUC-værdier på 36,2 (79 %) µg∙time/ml.
English: There was an increased incidence of cardiac toxicity, but these events were comparable in nature and severity to those reported from the lapatinib clinical programme (see section 4.4cardiac toxicity).
Danish: Der var en øget forekomst af kardiel toksicitet, men disse bivirkninger havde samme karakter og sværhedsgrad som dem, der blev rapporteret i forbindelse med lapatinibs kliniske program (se pkt.
English: However, when lapatinib was administered in combination with trastuzumab in the metastatic setting, the incidence of cardiac events including LVEF decreases was higher (7%) versus the lapatinib alone arm (2%) in the pivotal trial.
Danish: Når lapatinib blev administreret i kombination med trastuzumab mod metastatisk sygdom i det pivotale studie var incidencen af kardielle bivirkninger, herunder fald i LVEF, imidlertid højere (7 %) i forhold til lapatinib administreret alene (2 %).
English: These effects are described in section 4, ‘Possible side effects'.
Danish: Bivirkningerne er beskrevet i punkt 4.
English: b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine.
Danish: b. Pike-estimat af behandlings hazard ratio, hvor < 1 indikerer en lavere risiko ved Tyverb plus capecitabin sammenlignet med trastuzumab + capecitabin.
English: In a large, randomised clinical trial of Tyverb monotherapy (n=1,194), the cumulative frequency of severe liver injury (ALT >5 times the upper limit of normal, NCI CTCAE grade 3) at 1 year of treatment was 2.8% overall.
Danish: I et stort randomiseret klinisk studie med Tyverb-monoterapi (n=1.194) var den kumulative frekvens af alvorlige leverskader (ALAT > 5-gange øvre normalgrænse, NCI CTCAE grad 3) samlet set 2,8 % efter 1 års behandling.
English: Cardiac toxicity
Danish: Kardiel toksicitet
English: While you are taking Tyverb
Danish: Mens du tager Tyverb
English: Very common Headache
Danish: Meget almindelig Hovedpine Almindelig
English: Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity.
Danish: Patienter, som er bærere af HLA-allellerne DQA1*02:01 og DRB1*07:01, har øget risiko for Tyverb-associeret levertoksicitet.
English: Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ml) and CYP2C8 (0.3 µg/ml) in vitro at clinically relevant concentrations.
Danish: Lapatinib hæmmer CYP3A (Ki 0,6-2,3 µg/ml) og CYP2C8 (0,3 µg/ml) in vitro ved klinisk relevante koncentrationer.
English: Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, use of antibiotics such as fluoroquinolones (especially if diarrhoea is persistent beyond 24 hours, there is fever, or grade 3 or 4 neutropenia) and interruption or discontinuation of Tyverb therapy (see section 4.2 - dose delay and dose reduction -diarrhoea).
Danish: Svære tilfælde af diarré kan nødvendiggøre indgift af orale eller intravenøse elektrolytter og væsker, brug af antibiotika såsom fluoroquinoloner (specielt, hvis diarréen har varet over 24 timer, eller hvis der er feber eller grad 3 eller 4 neutropeni) og afbrydelse eller seponering af Tyverb-behandlingen (se pkt.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL ELLER SAMT AFFALD HERAF
English: Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer).
Danish: Tyverb bruges til at behandle visse former for brystkræft (brystkræft med HER2-positive kræftceller), som har spredt sig ud over den oprindelige tumor eller til andre organer (avanceret eller metastatisk brystkræft).
English: 8.9 mos (6.7, 11.8)
Danish: 8,9 måneder (6,7; 11,8)
English: Do not take Tyverb
Danish: Tag ikke Tyverb:
English: There is more advice on reducing the risk of skin rash at the end of section 4.
Danish: Du kan finde råd om, hvordan du nedsætter risikoen for udslæt i slutningen af punkt 4.
English: Lapatinib is predominantly eliminated through metabolism by CYP3A4/5.
Danish: Lapatinib udskilles overvejende gennem metabolisering af CYP3A4/5.
English: OUTER CARTON (28-DAY, MULTIPACK)
Danish: YDRE KARTON (28-DAGS-MULTIPAKNING)
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere tiltag bør være som klinisk indiceret eller efter anbefalinger fra Giftlinjen.
English: Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
Danish: Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Available data suggest that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Eksisterende data tyder på, at det ikke er nødvendigt med dosisændringer til patienter med mild til moderat nedsat nyrefunktion.
English: Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.
Danish: Ovale, bikonvekse, gule filmovertrukne tabletter, der er præget "GS XJG" på den ene side.
English: In healthy volunteers receiving carbamazepine, a CYP3A4 inducer, at 100 mg twice daily for 3 days and 200 mg twice daily for 17 days, systemic exposure to lapatinib was decreased approximately 72%.
Danish: Hos raske frivillige, der fik carbamazepin, en CYP3A4-induktor, i en dosis på 100 mg to gange daglig i 3 dage og 200 mg to gange daglig i 17 dage, faldt den systemiske optagelse af lapatinib med ca. 72 %.
English: In the Tyverb plus capecitabine arm 8 patients (3.2%) experienced CNS as site of first progression, compared with 12 patients (4.8%) in the trastuzumab plus capecitabine arm.
Danish: I armen med Tyverb plus capecitabin var CNS det første sted med progression hos 8 patienter (3,2 %) sammenlignet med 12 patienter (4,8 %) i armen med trastuzumab plus capecitabin.
English: Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged**
Danish: Ventrikulære arytmier/Torsades de Pointes, QT-forlængelse på elektrokardiogram
English: It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2).
Danish: Det kan ikke udelukkes, at lapatinib påvirker farmakokinetikken af substrater for BCRP (f.eks. topotecan) og OATP1B1 (f.eks. rosuvastatin) (se pkt.
English: The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients who received lapatinib in combination with capecitabine, 149 patients who received lapatinib in combination with trastuzumab and 654 patients who received lapatinib in combination with letrozole (see section 5.1).
Danish: Sikkerheden ved lapatinib som monoterapi eller i kombination med andre kemoterapeutika mod forskellige cancerformer er blevet undersøgt hos over 20.000 patienter, herunder 198 patienter, som fik lapatinib i kombination med capecitabin, 149 patienter, som fik lapatinib i kombination med trastuzumab, og 654 patienter, som fik lapatinib i kombination med letrozol (se pkt.
English: There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily.
Danish: Der er også set en forøgelse af nyreinfarkt og papillær nekrose hos hunrotter ved eksponeringer, der var 7-10 gange større sammenlignet med mennesker, som fik 1250 mg lapatinib en gang daglig.
English: Lapatinib effect on CNS metastasis
Danish: Lapatinibs virkning på CNS-metastaser
English: 70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets
Danish: 70 filmovertrukne tabletter 84 filmovertrukne tabletter 105 filmovertrukne tabletter 140 filmovertrukne tabletter
English: Furthermore, depending on type of food the bioavailability is approximately 2-3 times higher when lapatinib is taken 1 hour after food compared with 1 hour before the first meal of the day (see sections 4.2 and 5.2).
Danish: Ydermere, afhængigt af hvilken type mad der indtages, er lapatinibs biotilgængelighed ca. 2-3 gange højere, når lapatinib indtages 1 time efter fødeindtagelse sammenlignet med indtagelse 1 time før dagens første måltid (se pkt.
English: Co-administration of lapatinib with orally administered digoxin resulted in an approximate 80% increase in the AUC of digoxin.
Danish: Samtidig administration af lapatinib og oralt administreret digoxin resulterede i ca. 80 % øgning af digoxins AUC.
English: • in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
Danish: • I kombination med trastuzumab til patienter med hormonreceptor-negativ metastatisk sygdom, som er progredieret under tidligere behandling(er) med trastuzumab i kombination med kemoterapi (se pkt.
English: Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Danish: Uomdannet lapatinib i fæces udgør i gennemsnit (median) 27 % (interval 3-67 %) af en oral dosis.
English: Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
Danish: Farmakokinetikken for lapatinib er ikke undersøgt specifikt for patienter med nedsat nyrefunktion eller patienter, der får hæmodialyse.
English: Information about these medicines is described in separate patient information leaflets.
Danish: Information om de nævnte lægemidler findes i de respektive indlægssedler.
English: OUTER CARTON (14 DAY, SINGLE PACK)
Danish: YDRE KARTON (ENKELT 14-DAGS-PAKNING)
English: A concentration dependent increase in QTcF (maximum mean ΔΔQTcF 8.75 ms; 90% CI 4.08, 13.42) was observed in a dedicated QT study in patients with advanced solid tumours (see section 4.4).
Danish: En koncentrationsafhængig forlængelse af QTcF (maksimalt gennemsnit ΔΔQTcF 8,75 ms; 90 % CI 4,08; 13,42) blev observeret i et specifikt QT-studie hos patienter med fremskredne, solide tumorer (se pkt.
English: In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/kg/day.
Danish: Hos kaniner er lapatinib blevet forbundet med toksicitet hos moderen ved 60 og 120 mg/kg/døgn (hhv. 8 % og 23 % af den forventede, kliniske optagelse hos mennesker) og aborter ved 120 mg/kg/døgn.
English: Tyverb dosing should be permanently discontinued in patients with diarrhoea which is NCI CTCAE grade 4.
Danish: Tyverb skal seponeres permanent hos patienter, der får diarré NCI CTCAE grad 4.
English: Letrozole 2.5 mg /day + placebo N=108
Danish: letrozol 2,5 mg /dag + placebo n = 108
English: Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
Danish: Indtagelse af grapefrugtjuice bør undgås under behandling med Tyverb (se pkt.
English: An increase in the incidence and severity of diarrhoea and neutropenia has been observed with this combination in clinical studies.
Danish: En øgning af hyppigheden og sværhedsgraden af diarré og neutropeni er blevet observeret ved kombination af lapatinib og paclitaxel i kliniske studier.
English: • rosuvastatin - a medicine used to treat high cholesterol
Danish: • rosuvastatin - medicin, der bruges til at behandle et højt kolesteroltal
English: The results for the pharmacodynamics population (n=52) were consistent with those from the evaluable population (maximum ΔΔQTcF (90% CI) of 7.91 ms (4.13, 11.68) observed 10 hours after ingestion of the third dose of lapatinib 2000 mg).
Danish: Resultaterne for den farmakodynamiske population (n=52) var konsistente med resultaterne fra den evaluérbare population (maksimal ΔΔQTcF (90 % CI) på 7,91 ms (4,13; 11,68), observeret 10 timer efter indtagelse af den tredje dosis lapatinib på 2000 mg).