FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swallow the tablets whole with water, one after the other, at the same time each day.
Danish: • Synk tabletterne hele, én efter én, sammen med vand på samme tidspunkt hver dag.
English: Contact a doctor or pharmacist immediately.
Danish: Kontakt lægen eller apoteket med det samme.
English: • use sunscreen (Sun Protection Factor [SPF] 30 or higher).
Danish: • brug solcreme (beskyttelsesfaktor [SPF] 30 eller højere).
English: Tyverb is for oral use.
Danish: Tyverb er til oral anvendelse.
English: It can affect the way the medicine works.
Danish: Det kan påvirke den måde, medicinen virker på.
English: Assessments were undertaken by the study investigators and by an independent review panel, blinded to treatment.
Danish: Evalueringerne blev foretaget af studiets investigatorer og af et uafhængigt panel, der var blindet over for behandlingen.
English: Table 5 Summary of PFS and OS in studies with hormone receptor negative
Danish: Tabel 5 Sammendrag af PFS og OS i studier med hormonreceptornegative kvinder
English: • pain in hands and feet
Danish: • smerter i hænder og fødder
English: 1, months
Danish: 1, måneder
English: • drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks or other clear liquids
Danish: • drik rigelig væske (8-10 glas om dagen), f.eks. vand, sportsdrik eller andre klare væsker
English: The highest no-effect dose for this study was 20 mg/kg/day.
Danish: Den højeste dosis uden effekt i dette studie var 20 mg/kg/døgn.
English: The potential risk for humans is not known.
Danish: Den potentielle risiko for mennesker er ukendt.
English: 1, weeks
Danish: 1, uger
English: Your doctor will advise you whether an alternative is available.
Danish: Lægen vil informere dig om, hvorvidt et andet alternativ skal bruges.
English: HER2 status should be determined using accurate and validated methods.
Danish: Patientens HER2-status skal bestemmes ved brug af nøjagtige og validerede metoder.
English: Clinical benefit rate was defined as complete plus partial response plus stable disease for 6 months.
Danish: Den kliniske benefit-rate defineres som komplet og partiel respons samt stabil sygdom i  6 måneder.
English: The effect on human fertility is unknown.
Danish: Virkningen på human fertilitet er ukendt.
English: ** Adverse reactions from spontaneous reports and literature
Danish: ** Bivirkninger fra spontane indberetninger og litteraturen.
English: Interactions with food and drink
Danish: Interaktioner med mad og drikke
English: • if you have diarrhoea (see section 4).
Danish: • hvis du har diarré (se punkt 4).
English: Ninety-four percent (94%) were Caucasian.
Danish: 94 % var kaukasiske.
English: • severe allergic reactions (see the beginning of section 4)
Danish: • alvorlige overfølsomhedsreaktioner (se begyndelsen af punkt 4).
English: However, the occurrence of docetaxel-induced neutropenia was increased.
Danish: Imidlertid ses en øget forekomst af docetaxel-induceret neutropeni.
English: The following convention 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) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende konvention er anvendt til klassifikation af frekvenserne: meget almindelig ( 1/10), almindelig ( 1/100, < 1/10), ikke almindelig ( 1/1000, < 1/100), sjælden ( 1/10.000, < 1/1000) og meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: Take the prescribed dose every day for as long as your doctor tells you to.
Danish: Tag den ordinerede dosis hver dag og lige så længe, som lægen siger.
English: Tyverb can cause severe diarrhoea
Danish: Tyverb kan forårsage alvorlig diarré
English: Capecitabine should be taken with food or within 30 minutes after food.
Danish: Capecitabin bør tages sammen med mad eller inden for 30 minutter efter et måltid.
English: Take Tyverb at the same time in relation to food each day - for example, you could always take your tablet one hour before breakfast.
Danish: Tag Tyverb på samme tid hver dag i forhold til måltiderne - du kunne for eksempel altid tage din tablet én time inden morgenmaden.
English: Carriage of the HLA risk alleles is common (15 to 25%) in Caucasian, Asian, African and Hispanic populations but lower (1%) in Japanese populations.
Danish: Bærere af HLA-risiko-alleller er almindeligt forekommende (15-25 %) i kaukasiske, asiatiske, afrikanske og latinamerikanske populationer, men lavere (1 %) i japanske populationer.
English: If you get other side effects
Danish: Hvis du får andre bivirkninger
English: Microcrystalline cellulose Povidone (K30)
Danish: Mikrokrystallinsk cellulose Povidon (K30)
English: The combination of lapatinib and trastuzumab may offer complementary mechanisms of action as well as possible non-overlapping mechanisms of resistance.
Danish: Kombination af lapatinib og trastuzumab kan forårsage komplementære virkningsmekanismer samt ikke-overlappende resistensmekanismer.
English: To care for sensitive skin:
Danish: Du kan pleje følsom hud på følgende måde:
English: HER2 overexpression = IHC 3+ and/or FISH positive; HER2 negative = IHC 0, 1+ or 2+ and/or FISH negative
Danish: HER2-overekspression = IHC 3+ og/eller FISH-positiv; HER2-negativ = IHC 0, 1+ eller 2+ og/eller FISH-negativ
English: The clinical status of the patient and the safety profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Danish: Patientens kliniske tilstand og lapatinibs sikkerhedsprofil skal tages i betragtning, når patientens evne til at udføre opgaver, der kræver dømmekraft, motoriske eller kognitive færdigheder, skal vurderes.
English: The clinical significance of these effects on the pharmacokinetics of other medicinal products or the pharmacological activity of other anti-cancer medicinal products is not known.
Danish: Den kliniske signifikans ved disse virkninger på farmakokinetikken af andre lægemidler eller den farmakologiske aktivitet ved andre lægemidler mod cancer kendes ikke.
English: Number (%) with event
Danish: Antal (%) med hændelse
English: Died
Danish: Døde
English: The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC).
Danish: Den absolutte biotilgængelighed af lapatinib efter oral administration er ukendt, men den er ufuldstændig og variabel (ca. 70 % variationskoefficient i AUC).
English: Most patients in both treatment arms had visceral disease (215 [73%] patients overall).
Danish: Størstedelen af patienterne i begge behandlingsarme havde visceral sygdom (215 [73 %] af det samlede antal patienter).
English: Hypokalemia or hypomagnesemia should be corrected prior to treatment.
Danish: Der skal korrigeres for hypokaliæmi eller hypomagnesiæmi før behandlingen.
English: Fatal cases have been reported, causality of the deaths is uncertain.
Danish: Der er rapporteret om letale tilfælde, hvor dødsårsagen er uvis.
English: Tyverb should not be used during pregnancy unless clearly necessary.
Danish: Tyverb bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Do not store above 30ºC.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it.
Danish: Lægen vil fortælle dig, hvor meget du skal tage af din anden kræftmedicin, og hvordan du skal tage den.
English: At ≥60 mg/kg/day there were decreased foetal body weights, and minor skeletal variations.
Danish: Ved ≥ 60 mg/dag sås lavere fostervægt og mindre skeletvariationer.
English: • pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)
Danish: • pulmonal arteriel hypertension (øget blodtryk i arterierne (blodårerne) i lungerne)
English: CI= confidence interval
Danish: CI = konfidensinterval
English: Investigator-assessed PFS
Danish: Investigators vurdering af PFS
English: Pulmonary arterial hypertension**.
Danish: Pulmonal arteriel hypertension**
English: Other very common side effects
Danish: Andre meget almindelige bivirkninger
English: The Phase III study (EGF30008) was randomised, double-blind, and placebo controlled.
Danish: Fase III-studiet (EGF30008) var randomiseret, dobbeltblindet og placebokontrolleret.
English: The precise mechanism of this interaction is unknown, but it is assumed to be due to inhibition of one or more transport proteins by lapatinib.
Danish: Den præcise mekanisme for denne interaktion kendes ikke, men det antages, at interaktionen skyldes lapatinibs hæmning af et eller flere transportproteiner.
English: PFS event is Progressed or Died and OS event is Died due to any cause.
Danish: PFS-hændelse er progression eller død, og OS-hændelse er død uanset årsag.
English: • Depending on the side effects you experience, your doctor may recommend lowering your dose or temporarily stopping your treatment.
Danish: • Afhængigt af de bivrkninger, du får, vil lægen måske nedsætte din dosis eller midlertidigt stoppe behandlingen.
English: You should not use Tyverb if you are pregnant unless your doctor specifically recommends it.
Danish: Du må ikke tage Tyverb, mens du er gravid, medmindre lægen specifikt anbefaler det.
English: This usually lasts 4-5 days.
Danish: Diarréen varer normal 4-5 dage.
English: Number (%) with event Kaplan-Meier estimate, months a
Danish: Antal (%) med hændelse Kaplan-Meierestimat, måneder a
English: In potentially severe cases of diarrhoea the measuring of neutrophil counts and body temperature should be considered.
Danish: I potentielt alvorlige tilfælde af diarré skal måling af neutrofiltal og kropstemperatur overvejes.
English: The relevance of these findings for humans is uncertain.
Danish: Betydningen af disse observationer for mennesker er usikker.
English: A detrimental effect on such activities cannot be predicted from the pharmacology of lapatinib.
Danish: En negativ påvirkning af sådanne aktiviteter kan ikke forudsiges ud fra lapatinibs farmakologi.
English: If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath.
Danish: Hvis du oplever symptomer, der er relateret til denne bivirkning, vil det sandsynligvis være uregelmæssig hjerterytme eller åndenød.
English: Asymptomatic and symptomatic cases of overdose have been reported in patients being treated with Tyverb.
Danish: Asymptomatiske og symptomatiske tilfælde af overdosering er rapporteret hos patienter i behandling med Tyverb.
English: The safety and efficacy of Tyverb in children below the age of 18 years have not yet been established.
Danish: Tyverbs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: • irregular heart-beat (change in the electrical activity of the heart)
Danish: • uregelmæssige hjerteslag (ændring i den elektriske aktivitet af hjertet)
English: Results of an updated analysis of the overall survival data to 28 September 2007 are presented in Table 2.
Danish: Tabel 2 viser resultaterne af en opdateret analyse af de samlede overlevelsesdata frem til den 28. september 2007.
English: Patients with extensive or persistent skin reactions should be referred to a dermatologist.
Danish: Patienter med omfattende eller vedvarende hudreaktioner bør henvises til en dermatolog.
English: However, daily dosing of lapatinib results in achievement of steady state within 6 to 7 days, indicating an effective half-life of 24 hours.
Danish: Men daglig dosis af lapatinib resulterer i steady state i løbet af 6-7 dage, hvilket indikerer en effektiv halveringstid på 24 timer.
English: Lapatinib has in terms of objective responses demonstrated modest activity in the treatment of established CNS metastases.
Danish: Lapatinib har i form af objektivt respons vist beskeden aktivitet i behandlingen af etablerede CNSmetastaser.
English: The median number of prior trastuzumab-containing regimens was three.
Danish: Det gennemsnitlige antal tidligere behandlingsregimer med trastuzumab var tre.
English: Cardiac events
Danish: Kardielle hændelser
English: Don't pass it on to others.
Danish: Lad derfor være med at give medicinen til andre.
English: This previous treatment for metastatic breast cancer must have included trastuzumab.
Danish: Den tidligere behandling mod metastatisk brystkræft skal have inkluderet trastuzumab.
English: There was no evidence of carcinogenicity in mice.
Danish: Der var ingen evidens for karcinogenicitet hos mus.
English: The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 mg once daily.
Danish: Den maksimale orale dosis lapatinib, der er administreret i kliniske studier, er 1800 mg en gang daglig.
English: Your doctor will check your skin before and during treatment.
Danish: Lægen vil undersøge din hud før og under behandlingen.
English: In most cases, the effect on your heart will not have any symptoms.
Danish: I de fleste tilfælde vil denne påvirkning af hjertefunktionen ikke medføre symptomer.
English: There is a positive relationship between lapatinib plasma concentrations and ΔΔQTcF.
Danish: Der er en positiv korrelation mellem plasmakoncentrationer af lapatinib og ΔΔQTcF.
English: No overall differences in efficacy and safety of the combination of Tyverb and letrozole were observed between these patients and patients < 65 years of age.
Danish: Der blev ikke observeret overordnede forskelle i effekten af og sikkerheden ved kombinationen af Tyverb og letrozol mellem disse patienter og patienter < 65 år.
English: Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose (see section 4.9).
Danish: Glemte doser skal ikke erstattes, og behandlingen skal genoptages ved næste planlagte daglige dosis (se pkt.
English: At the time of the final PFS analysis (with median follow-up of 2.64 years), the overall survival data were not mature and there was no significant difference between treatment groups in the HER2-positive population; this had not changed with additional follow-up (>7.5 years median followup time; Table 7).
Danish: Ved tidspunktet for den endelige PFS analyse (med median follow-up på 2,64 år) var der ikke tilstrækkelige data vedrørende den samlede overlevelse, og der var ingen signifikant forskel mellem behandlingsgrupperne i den HER2-positive population; dette havde ikke ændret sig ved en senere follow-up (median follow-up på > 7,5 år, se tabel 7).
English: Serum concentrations appear after a median lag time of 0.25 hours (range 0 to 1.5 hours).
Danish: Der forekommer serumkoncentrationer efter en median forsinkelse (lag time) på 0,25 timer (interval 0 - 1,5 timer).
English: It is not known whether lapatinib is excreted in human milk.
Danish: Det vides ikke, om lapatinib udskilles i human mælk.
English: If a skin reaction occurs a full body examination should be performed at every visit until one month after resolution.
Danish: Hvis patienten får en hudreaktion, skal hele kroppen undersøges ved hvert besøg indtil en måned efter, reaktionen er forsvundet.
English: The hepatotoxicity may occur days to several months after initiation of treatment.
Danish: Levertoksicitet kan forekomme dage til flere måneder efter behandlingens påbegyndelse.
English: HER2-overexpressing population HER2-negative population N = 111
Danish: HER2-negativ population n = 111
English: When clinically indicated, e.g. after initiation of a concomitant treatment that might affect QT or that may interact with lapatinib, ECG measurement should also be considered.
Danish: Hvis klinisk indiceret, f.eks. efter opstart af en samtidig behandling, som kan påvirke QT eller som kan interagere med lapatinib, bør en ECG-måling også overvejes.
English: †, dyspnoea
Danish: †, dyspnø
English: Blister packs 2 years
Danish: Blisterpakninger 2 år
English: Just take the next dose at the scheduled time.
Danish: Tag næste dosis som planlagt.
English: During the 4-day treatment period, three doses of matching placebo were administered 12 hours apart in the morning and evening on Day 1 and in the morning on Day 2.
Danish: I løbet af den 4-dages behandlingsperiode blev der administreret tre doser af matchende placebo med 12 timers mellemrum; om morgenen og aftenen på dag 1 og om morgenen på dag 2.
English: Subgroup analysis results based on predefined stratification factor (hormone receptor status) is also shown in Table 5.
Danish: Resultaterne af en delgruppeanalyse af foruddefineret stratifikationsfaktor (hormonreceptorstatus) er vist i tabel 5.
English: Tell your doctor if any of these apply to you.
Danish: Fortæl det til lægen, hvis noget af dette gælder for dig.
English: Because of the possible side effects of Tyverb, your ability to drive or operate machines could be affected.
Danish: På grund af de mulige bivirkninger ved Tyverb kan din evne til at køre eller bruge maskiner være påvirket.
English: Peak plasma concentrations (Cmax) of lapatinib are achieved approximately 4 hours after administration.
Danish: Maksimal lapatinibkoncentration i plasma (Cmax) opnås ca. fire timer efter administration.
English: [folding box only] PC:
Danish: [kun på ydre karton] PC:
English: Pulmonary toxicity may be severe and lead to respiratory failure.
Danish: Pulmonal toksicitet kan være svær og medføre respirationsinsufficiens.
English: Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before the initiation of treatment and monthly thereafter, or as clinically indicated.
Danish: Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres, før behandlingen påbegyndes og månedligt derefter, eller som klinisk indiceret.
English: Most cases of diarrhoea were grade 1 or 2 and did not result in discontinuation of treatment with lapatinib.
Danish: De fleste tilfælde af diarré var grad 1 eller 2, og medførte ikke afbrydelse af behandlingen med lapatinib.
English: • unusual wheezing, or difficulty in breathing
Danish: • usædvanlig hvæsen eller besvær med at trække vejret
English: CI = confidence interval a. PFS was defined as the time from randomisation to the earliest date of disease progression or death from any cause, or to the date of censor.
Danish: a. PFS blev defineret som tiden fra randomiseringen til den tidligste dato for sygdomsprogression eller dødsfald uanset årsagen, eller til datoen for censurering.
English: Also tell your doctor immediately if your diarrhoea worsens.
Danish: Fortæl også straks lægen, hvis din diarré bliver værre.
English: The majority of LVEF decreases (greater than 60 % of events) were observed during the first nine weeks of treatment, however limited data was available for long term exposure.
Danish: De fleste fald i LVEF (mere end 60 % af tilfældene) sås i løbet af de første 9 ugers behandling, imidlertid fandtes der begrænsede data på langtidsanvendelse.
English: Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Danish: Behandling med Tyverb bør kun igangsættes af en læge, der har erfaring i brugen af lægemidler mod cancer.
English: It may slow or stop cancer cells from growing, or may kill them.
Danish: Tyverb kan stoppe eller nedsætte kræftcellernes vækst, eller det kan slå kræftcellerne ihjel.
English: Tablet coating Hypromellose Titanium dioxide (E171) Macrogol (400) Polysorbate 80
Danish: Tabletovertræk Hypromellose Titandioxid (E171) Macrogol (400) Polysorbat 80
English: OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK without blue box)
Danish: YDRE KARTON (14-DAGS-PAKNING, DEL AF 28-DAGS-MULTIPAKNING uden blue box)
English: There are limited data on the use of Tyverb / capecitabine and Tyverb / trastuzumab in patients aged ≥ 65 years.
Danish: Der er begrænset information om brug af Tyverb / capecitabin og Tyverb / trastuzumab hos patienter på ≥ 65 år.
English: Electrocardiograms with QT measurement should be performed prior to and one to two weeks after the start of Tyverb therapy.
Danish: Elektrokardiogram med QTmåling bør foretages før og én til to uger efter opstart af behandling med Tyverb.
English: Tell your doctor if your diarrhoea continues.
Danish: Fortæl det til lægen, hvis diarréen fortsætter.
English: • erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin,
Danish: • erythromycin, ketoconazol, itraconazol, posaconazol, voriconazol, rifabutin, rifampicin,
English: Prescribing physicians are advised to perform a skin examination prior to treatment and regularly during treatment.
Danish: Det anbefales, at den ordinerende læge udfører en undersøgelse af huden før behandlingsstart og regelmæssigt under behandlingen.
English: Proactive management of diarrhoea with anti-diarrhoeal medicinal product is important.
Danish: Pro-aktiv behandling af diarré med obstipantia er vigtigt.
English: The bioavailability and thereby the plasma concentrations of lapatinib are increased by food, in relation to the content and timing of the meal.
Danish: Biotilgængeligheden og derved plasmakoncentrationen af lapatinib øges ved fødeindtagelse, hvad angår indholdet og tidspunktet for måltidet.
English: • severe skin reaction that might include: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever or any combination of these
Danish: • alvorlig hudreaktion som kan inkludere: udslæt, rød hud, blærer på læberne, øjnene eller munden, hudafskalning, feber eller en kombination af nogen af disse
English: Table 3 Analyses of investigator-assessed progression-free survival and overall survival
Danish: Tabel 3 Analyser af investigators vurdering af progressionsfri overlevelse (PFS) og samlet overlevelse
English: • If you are pregnant or planning to become pregnant, tell your doctor.
Danish: • Hvis du er gravid eller planlægger at blive gravid, skal du fortælle det til lægen.
English: Nail disorders including paronychia.
Danish: Neglelidelser, herunder paronychia
English: There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation.
Danish: Der findes ingen specifik antidot til hæmning af EGFR (ErbB1)- og/eller HER2 (ErbB2)-tyrosinphosphorylering.
English: No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Danish: Der er ingen data for effekten af denne kombination i forhold til trastuzumab i kombination med en aromatasehæmmer hos denne patientpopulation.
English: • Take Tyverb either at least one hour before or at least one hour after food.
Danish: • Tag Tyverb mindst én time før eller mindst én time efter et måltid.
English: • if you are allergic to lapatinib or any of the other ingredients of this medicine (listed in
Danish: • hvis du er allergisk over for lapatinib eller et af de øvrige indholdsstoffer i Tyverb (angivet i punkt 6).
English: HER2 receptor status was retrospectively determined by central laboratory testing.
Danish: Patienternes HER2receptorstatus blev bestemt retrospektivt på centrallaboratoriet.
English: Patients experiencing skin reactions should be encouraged to avoid exposure to sunlight and apply broad spectrum sunscreens with a Sun Protection Factor (SPF)  30.
Danish: Patienter, som får hudreaktioner, skal rådes til at undgå sollys og til at anvende solcreme med en beskyttelsesfaktor (SPF) på  30.
English: • collapse or blackout.
Danish: • kollaps (besvimelse) eller blackout.
English: Adverse reactions should be carefully monitored if Tyverb is co-administered with irinotecan, and a reduction in the dose of irinotecan should be considered.
Danish: Bivirkninger bør monitoreres tæt, hvis Tyverb administreres samtidig med irinotecan, og dosisreduktion af irinotecan bør overvejes.
English: Median overall survival
Danish: Median overlevelse
English: A summary of efficacy endpoints and overall survival data is provided in Table 4.
Danish: Et resumé af effekt-endepunkter og samlet overlevelse er vist i tabel 4.