FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and treatment discontinued in patients who experience symptoms which are NCI CTCAE grade 3 or greater.
Danish: Patienterne bør monitoreres for pulmonal toksicitet (dyspnø, hoste, feber), og behandlingen skal seponeres hos patienter, som får symptomer af NCI CTCAE-grad 3 eller derover.
English: Other toxicities
Danish: Anden toksicitet
English: Co-administration of Tyverb with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
Danish: Indgift af Tyverb samtidig med moderate inhibitorer af CYP3A4 bør ske med forsigtighed, og kliniske bivirkninger bør monitoreres omhyggeligt.
English: • a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
Danish: • en hudreaktion på håndfladerne eller fodsålerne (herunder prikken, følelsesløshed, smerter,
English: 8.2 wks (7.4, 9.3)
Danish: 8,2 uger (7,4; 9,3)
English: In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
Danish: I studier i forbindelse med lapatinibs kliniske udviklingsprogram er der rapporteret kardielle bivirkninger hos ca. 1 % af patienterne, herunder fald i LVEF.
English: The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole.
Danish: Følgende bivirkninger er indberettet som havende en årsagsmæssig sammenhæng med lapatinib alene eller med lapatinib i kombination med capecitabin, trastuzumab eller letrozol.
English: A concentration-dependent increase of the QTc interval was demonstrated in a dedicated placebo-controlled crossover study in subjects with advanced solid tumours.
Danish: Der blev vist en koncentrationsafhængig forlængelse af QT-intervallet i et specifikt placebokontrolleret, crossover-studie hos forsøgspersoner med fremskredne, solide tumorer.
English: - The active substance in Tyverb is lapatinib.
Danish: - Aktivt stof: Lapatinib.
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.
Danish: Lægen vil foretage undersøgelser for at tjekke, om dit hjerte fungerer, som det skal før og under din behandling med Tyverb.
English: In the rat preand postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/kg/day or higher (5 times the expected human clinical exposure).
Danish: Ved udviklingsstudier med rotter før og efter fødslen sås et fald i overlevelse hos afkommet mellem fødsel og dag 21 efter doser på 60 mg/kg/døgn eller højere (5 gange den forventede, kliniske optagelse hos mennesker).
English: What you need to know before you take Tyverb
Danish: Det skal du vide, før du begynder at tage Tyverb
English: It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines.
Danish: Det er særlig vigtigt, at du fortæller lægen, hvis du bruger eller for nylig har brugt noget af den nedenfor listede medicin.
English: • tiredness, feeling weak
Danish: • træthed, svaghed
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib.
Danish: Der blev observeret symptomatisk fald i LVEF hos ca. 0,3 % af de patienter, der fik lapatinib.
English: Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Danish: Tabel 4 Progressionsfri overlevelse og samlet overlevelse (Tyverb / trastuzumab)
English: Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease.
Danish: Samtidig behandling med stoffer, der øger gastrisk pH, bør undgås, idet opløseligheden og absorptionen af lapatinib kan reduceres.
English: Headache*
Danish: Hovedpine*
English: EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets
Danish: EU/1/07/440/001 70 tabletter EU/1/07/440/003 84 tabletter
English: Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment.
Danish: 77 (52 %) af de 148 patienter, som fik monoterapi, blev ved sygdomsprogression udvalgt til at få kombinationsbehandling.
English: Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine.
Danish: Der foreligger data om effekten af og sikkerheden ved Tyverb i kombination med capecitabin i forhold til trastuzumab i kombination med capecitabin.
English: The efficacy and safety of lapatinib in combination with trastuzumab in metastatic breast cancer were evaluated in a randomised trial.
Danish: Lapatinibs effekt og sikkerhed i kombination med trastuzumab ved metastatisk brystcancer blev evalueret i et randomiseret studie.
English: In patients with HER2-overexpressing MBC, investigator-determined progression-free survival (PFS) was significantly greater with letrozole plus Tyverb compared with letrozole plus placebo.
Danish: Hos patienter med metastatisk brystcancer med overekspression af HER2 var den progressionsfrie overlevelse (PFS) efter investigators vurdering signifikant længere ved behandling med letrozol og Tyverb end ved behandling med letrozol og placebo.
English: The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%.
Danish: Den kumulative frekvens var 10,3 % hos bærere af allellerne DQA1*02:01 og DRB1*07:01 og 0,5 % hos ikke-bærere.
English: Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.
Danish: Beholdere Tyverb fås også i plastikbeholdere med 70, 84, 105 eller 140 tabletter.
English: Co-administration of lapatinib with intravenously administered docetaxel did not significantly affect the AUC or Cmax of either active substance.
Danish: Samtidig administration af lapatinib og intravenøst administreret docetaxel påvirkede ikke i signifikant grad AUC eller Cmax af hverken lapatinib eller docetaxel.
English: Systemic exposure to lapatinib is increased when administered with food.
Danish: Systemisk eksponering for lapatinib øges, når lapatinib indtages sammen med føde.
English: Other uncommon side effects include:
Danish: Andre ikke almindelige bivirkninger:
English: Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Danish: Der findes ikke tilstrækkelige data fra patienter med nedsat leverfunktion til at kunne anbefale en bestemt dosisjustering (se pkt.
English: Tyverb dosing should be interrupted in patients with diarrhoea which is NCI CTCAE grade 3 or grade 1 or 2 with complicating features (moderate to severe abdominal cramping, nausea or vomiting greater than or equal to NCI CTCAE grade 2, decreased performance status, fever, sepsis, neutropenia, frank bleeding or dehydration) (see sections 4.4 and 4.8).
Danish: Behandling med Tyverb skal afbrydes hos patienter med diarré NCI CTCAE grad 3 eller med grad 1 eller grad 2 med komplikationer (moderate til svære abdominale kramper, kvalme eller opkastning mere end eller lig med NCI CTCAE grad 2, nedsat performance-status, feber, sepsis, neutropeni, synlig blødning eller dehydrering) (se pkt.
English: 140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.
Danish: 140 filmovertrukne tabletter Multipakning: 140 (2 pakninger af 70) filmovertrukne tabletter.
English: Eligible patients were women with Stage IV ErbB2 gene amplified (or protein overexpressing) metastatic breast cancer who had been exposed to treatment with anthracyclines and taxanes.
Danish: Egnede patienter var kvinder med stadie-IV ErbB2 metastatisk brystcancer med gen-amplifikation (eller protein-overekspression), som tidligere var blevet behandlet med antracykliner eller taxaner.
English: Do not use this medicine after the expiry date which is stated on the blister or bottle and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen eller beholderen og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Randomisation was stratified by sites of disease and by time from discontinuation of prior adjuvant anti-oestrogen therapy.
Danish: Randomiseringen var stratificeret efter sygdomsramte områder og tid siden seponering af tidligere, adjuverende antiøstrogenbehandling.
English: Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Danish: Udslættet var generelt let og resulterede ikke i afbrydelse af behandlingen med lapatinib.
English: These adverse reactions were observed when lapatinib was administered in combination with letrozole.
Danish: Disse bivirkninger blev observeret, når lapatinib blev administreret i kombination med letrozol.
English: Co-administration of Tyverb with strong inhibitors of CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Danish: Indgift af Tyverb samtidig med stærke inhibitorer af CYP3A4 (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon) bør undgås.
English: Patients eligible for enrolment had HER2-overexpressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
Danish: Patienter egnede til inklusion havde lokalt avanceret eller metastatisk brystcancer med overekspression af HER2, progredierende efter tidligere behandling, der inkluderede taxan, antracyklin og trastuzumab.
English: Tyverb is supplied in either blisters packs or bottles:
Danish: Tyverb fås enten i blisterpakninger eller i beholdere:
English: • quinidine, digoxin - medicines used to treat certain heart problems
Danish: • kinidin, digoxin - medicin, der bruges til at behandle visse hjerteproblemer
English: The recommended dose of trastuzumab is 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/kg intravenous weekly (see section 5.1).
Danish: Den anbefalede dosis af trastuzumab er 4 mg/kg administreret som en intravenøs støddosis efterfulgt af 2 mg/kg intravenøs ugentlig (se pkt.
English: • blood tests results that show changes in liver function (usually mild and temporary) Rare side effects (may affect up to 1 in 1,000 people):
Danish: • blodprøveresultater, som viser ændringer i leverfunktionen (oftest milde og forbigående).
English: Number of TTP events 121 Median TTP, weeks Hazard Ratio (95% CI) p value
Danish: Antal TTP-forekomster Median TTP, uger Hazard ratio (95 % CI) p-værdi
English: Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
Danish: Patienterne blev randomiseret til 2,5 mg letrozol en gang daglig og 1500 mg Tyverb en gang daglig eller letrozol i kombination med placebo.
English: When lapatinib is taken in combination with strong CYP3A4 inhibitors the QTc interval can be expected to be prolonged by 16.1 ms (12.6-20.3 ms) as demonstrated in a model-based prediction (see section 4.4).
Danish: En modelbaseret prognose viste, at når lapatinib tages i kombination med stærke inhibitorer af CYP3A4, kan QTc-intervallet forventes at blive forlænget med 16,1 ms (12,6-20,3 ms) (se pkt.
English: Diarrhoea generally occurs early during Tyverb treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days.
Danish: Diarré optrådte inden for de første 6 dage af behandlingen hos næsten halvdelen af de patienter, som fik diarré.
English: • pimozide - a medicine used to treat certain mental health problems
Danish: • pimozid - medicin, der bruges til at behandle visse mentale lidelser
English: Relative to dosing 1 hour before a low fat breakfast, mean AUC values were approximately 2- and 3-fold higher when lapatinib was administered 1 hour after a low fat or high fat meal, respectively.
Danish: I forhold til administration 1 time før et morgenmåltid med lavt fedtindhold var de gennemsnitlige AUC-værdier ca. 2 og 3 gange højere, når lapatinib blev administreret 1 time efter henholdsvis et måltid med lavt fedtindhold og et måltid med højt fedtindhold.
English: Tell your doctor if you are taking, or have recently taken, any of these.
Danish: Fortæl det til lægen, hvis du bruger, eller for nylig har brugt, noget af denne medicin.
English: • if you have any liver problems
Danish: • hvis du har leverproblemer
English: Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG' marked on one side.
Danish: Tyverb er ovale, bikonvekse, gule, filmovertrukne tabletter, der er præget "GS XJG" på den ene side.
English: Tyverb dosing should be discontinued if changes in liver function are severe and patients should not be retreated.
Danish: Behandlingen med Tyverb bør afbrydes ved alvorlige ændringer i leverfunktionen, og behandlingen bør ikke genoptages hos disse patienter.
English: The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1).
Danish: Patienterne i registreringsstudiet var ikke tidligere blevet behandlet med trastuzumab eller en aromatasehæmmer (se pkt.
English: Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Danish: Tabel 6 Progressionsfri overlevelse fra studie EGF30008 (Tyverb/letrozol)
English: Patients were randomised to receive either oral lapatinib 1000 mg once daily plus trastuzumab 4 mg/kg administered as an intravenousloading dose, followed by 2 mg/kg intravenous weekly (N = 148), or oral lapatinib 1500 mg once daily (N = 148).
Danish: Patienterne blev randomiseret til enten oral lapatinib 1000 mg en gang om dagen og trastuzumab 4 mg/kg administreret som intravenøs støddosis efterfulgt af 2 mg/kg intravenøs ugentlig (n = 148) eller til oral lapatinib 1500 mg en gang om dagen (n = 148).
English: Multipacks contain 140 (2 packs of 70) film-coated tablets.
Danish: Multipakninger indeholder 140 (2 pakker af 70 stk.) filmovertrukne tabletter.
English: The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 (see section 4.4).
Danish: Risikoen for lapatinib-induceret levertoksicitet var associeret med bærertilstand af HLA-allellerne DQA1*02:01 og DRB1*07:01 (se pkt.
English: In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6-fold, and half-life increased 1.7-fold.
Danish: Hos raske frivillige, der fik ketoconazol, en stærk CYP3A4-inhibitor, i en dosis på 200 mg to gange daglig i 7 dage, øgedes den systemiske optagelse af lapatinib (100 mg/dag) med ca. 3,6 gange og halveringstiden øgedes 1,7 gange.
English: Investigator analysis on data at the end of enrolment is presented in Table 1.
Danish: Tabel 1 viser investigators analyse af data ved inklusionsafslutning.
English: Discontinuation or interruption of dosing with Tyverb may be considered when a patient develops toxicity greater than or equal to grade 2 on the NCI CTCAE.
Danish: Det bør overvejes at ophøre eller midlertidigt afbryde behandlingen med Tyverb, hvis en patient udvikler toksicitet, der ifølge NCI CTCAE svarer til eller er større end grad 2.
English: Effects of other medicinal products on lapatinib
Danish: Andre lægemidlers virkning på lapatinib
English: Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Jernoxid, gul (E172) Jernoxid, rød (E172)
English: Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tyverb and for at least 5 days after the last dose.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception og undgå at blive gravide under behandlingen med Tyverb og i mindst 5 dage efter den sidste dosis.
English: Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with Tyverb.
Danish: Grapefrugtjuice kan hæmme CYP3A4 i tarmvæggen og dermed øge biotilgængeligheden af lapatinib.
English: pain, swelling or reddening)
Danish: hævelse eller rødme)
English: Of all patients randomised to treatment, 219 patients had tumours overexpressing the HER2 receptor, and this was the pre-specified primary population for the analysis of efficacy.
Danish: Af det samlede antal patienter, der var randomiseret til behandling, havde 219 patienter tumorer med overekspression af HER2-receptoren.
English: Decreased left ventricular ejection fraction and QT interval prolongation
Danish: Nedsat uddrivningsfraktion fra venstre ventrikel og forlængelse af QT-intervallet
English: Serious skin reactions have been seen with Tyverb.
Danish: Alvorlige hudlidelser er set ved brug af Tyverb.
English: Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine)
Danish: Tabel 1 Tid til progression (TTP) fra studie EGF100151 (Tyverb/capecitabin)
English: There are no adequate data from the use of Tyverb in women of childbearing potential.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af Tyverb til kvinder i den fertile alder.
English: • phenytoin, carbamazepine - medicines used to treat seizures
Danish: • phenytoin, carbamazepin - medicin, der bruges til at behandle krampeanfald
English: Please refer to the full prescribing information of trastuzumab.
Danish: Se endvidere produktinformationen for trastuzumab.
English: Tell your doctor immediately if you get any of these symptoms.
Danish: Fortæl det til lægen med det samme, hvis du får nogen af disse symptomer.
English: Tyverb is supplied in either blister packs or bottles.
Danish: Tyverb fås både i blisterpakninger og i beholdere.
English: Tyverb should be discontinued in patients with symptoms associated with decreased left ventricular ejection fraction (LVEF) that are National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or greater or if their LVEF drops below the institutions lower limit of normal (see section 4.4).
Danish: Behandlingen med Tyverb skal afbrydes hos patienter, der får symptomer associeret med nedsat uddrivningsfraktion fra venstre ventrikel (Left ventricular ejection fraction (LVEF)), der ifølge ”National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)” svarer til eller er større end grad 3, eller hvis patienternes LVEF falder til under normalområdets nedre grænse (se pkt.
English: Please refer to the full prescribing information of the co-administered aromatase inhibitor for dosing details.
Danish: Se produktinformationen for den samtidigt administrerede aromatasehæmmer for nærmere oplysninger om dosering.
English: No additional adverse reactions were reported to be associated with lapatinib in combination with trastuzumab.
Danish: Der blev ikke rapporteret om yderligere bivirkninger forbundet med lapatinib i kombination med trastuzumab.
English: Reducing the risk of diarrhoea and skin rash
Danish: Nedsættelse af risikoen for diarré og udslæt
English: Tell your doctor as soon as possible if you get any of these symptoms.
Danish: Fortæl det til lægen så hurtigt som muligt, hvis du oplever nogle af disse symptomer.
English: Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine)
Danish: Tabel 2 Samlet overlevelse fra studie EGF100151 (Tyverb/capecitabin)
English: An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment.
Danish: I tiden fra interim-analysen og til inklusionen standsede blev der inkluderet yderligere 75 patienter i studiet.
English: Dose delay and dose reduction
Danish: Midlertidig afbrydelse af behandling og nedsættelse af dosis
English: Tyverb may be reintroduced at a lower dose (reduced from 1000 mg/day to 750 mg/day, from 1250 mg/day to 1000 mg/day or from 1500 mg/day to 1250 mg/day) when diarrhoea resolves to grade 1 or less.
Danish: Tyverb kan eventuelt genoptages ved en lavere dosis (nedsat fra 1000 mg/dag til 750 mg/dag, fra 1250 mg/dag til 1000 mg/dag eller fra 1500 mg/dag til 1250 mg/dag), når diarréen er bedret til grad 1 eller mindre.
English: Tyverb 1500 mg / day + Letrozole 2.5 mg /day N=111
Danish: Tyverb 1500 mg / dag + letrozol 2,5 mg /dag n = 111
English: Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment when lapatinib was administered in combination with capecitabine, or with letrozole.
Danish: Diarré var den bivirkning, der hyppigst medførte seponering af behandlingen, når lapatinib blev givet i kombination med capecitabin eller letrozol.
English: Co-administration of Tyverb with known inducers of CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) should be avoided.
Danish: Indgift af Tyverb samtidig med kendte induktorer af CYP3A4 (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon (hypericum perforatum)) bør undgås.
English: In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk.
Danish: Der sås en vækstreduktion hos rotteyngel, der fik lapatinib gennem modermælk.
English: • if you have lung disease
Danish: • hvis du har en lungesygdom
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib monotherapy or in combination with other anti-cancer medicinal products.
Danish: Der blev observeret symptomatiske fald i LVEF hos ca. 0,3 % af de patienter, der fik lapatinib som monoterapi eller i kombination med andre lægemidler til behandling af cancer.
English: • nefazodone - a medicine used to treat depression
Danish: • nefazodon - medicin, der bruges til at behandle depression
English: The incidence of PPE was similar in the lapatinib plus capecitabine and capecitabine alone treatment arms.
Danish: Forekomsten af PPE var sammenlignelig i behandlingsarmen med lapatinib og capecitabin og i behandlingsarmen med capecitabin alene.
English: Diarrhoea occurred in approximately 65 % of patients who received lapatinib in combination with capecitabine, in 64 % of patients who received lapatinib in combination with letrozole and in 62 % of patients who received lapatinib in combination with trastuzumab.
Danish: Diarré opstod hos ca. 65 % af de patienter, der blev behandlet med lapatinib i kombination med capecitabin, hos 64 % af de patienter, som fik lapatinib i kombination med letrozol, og hos 62 % af de patienter, som fik lapatinib i kombination med trastuzumab.
English: Lapatinib has been associated with reports of decreases in LVEF (see section 4.8).
Danish: Lapatinib har været associeret med fald i LVEF (se pkt.
English: 70 film-coated tablets 84 film-coated tablets
Danish: 70 filmovertrukne tabletter 84 filmovertrukne tabletter
English: There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/kg/day (females) and up to 180 mg/kg/day (males) (8 and 3 times the expected human clinical exposure, respectively).
Danish: Der var ingen virkning på gonadefunktion hos han- eller hunrotter, parring eller fertilitet ved doser på op til 120 mg/kg/døgn (hunrotter) og op til 180 mg/kg/døgn (hanrotter) (hhv. 8 og 3 gange den forventede, kliniske optagelse hos mennesker).
English: No dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Det er ikke nødvendigt med dosisændringer til patienter med let til moderat nedsat nyrefunktion.
English: Food effects on lapatinib exposure
Danish: Effekt af fødeindtag på lapatinibs eksponering
English: Response rate, % (95% CI)
Danish: Responsrate, % (95 % CI)
English: If you suffer from diarrhoea while taking Tyverb:
Danish: Hvis du får diarré, mens du er i behandling med Tyverb, kan du gøre følgende:
English: The study enrolled patients who had not received prior therapy for their metastatic disease.
Danish: Forsøgsdeltagerne var ikke tidligere blevet behandlet for metastatisk sygdom.