FrancophonIA/ELRC3.0 huggingface dataset:
English: A randomised Phase III study (EGF111438) (N=540) compared the effect of the two regimens on the incidence of CNS as site of first relapse in women with HER2 overexpressing metastatic breast cancer.
Danish: Et randomiseret fase III-studie (EGF111438) (n=540) sammenlignede effekten af de to regimer på incidensen af CNS som det første sted med recidiv hos kvinder med metastatisk brystcancer med overekspression af HER2.
English: • eat cooked vegetables instead of raw vegetables and remove the skin from fruits before eating
Danish: • spis tilberedte grøntsager frem for rå og skræl frugt, før du spiser den
English: Sodium starch glycolate (Type A) Magnesium stearate
Danish: Natriumstivelsesglycolat (type A) Magnesiumstearat
English: There was no clinically meaningful increase in AUC when midazolam was dosed intravenously.
Danish: Der var ingen klinisk betydningsfuld stigning i AUC ved intravenøs administration af midazolam.
English: Lapatinib alone (N=148 )
Danish: Lapatinib alene (n = 148)
English: • cyclosporine - a medicine used to suppress the immune system for example after organ transplantations
Danish: • ciclosporin - medicin, der bruges til at undertrykke immunforsvaret, f.eks. efter organtransplantationer
English: b. P-value from Cox regression model, stratifying for site of disease and prior anti-adjuvant therapy at screening.
Danish: b. P-værdi fra Cox-regressionsmodellen, stratificeret efter, hvor sygdommen har siddet og tidligere adjuverende behandling ved screeningen.
English: • eat low-fat, high protein foods instead of fatty or spicy foods
Danish: • spis fedtfattig mad med et højt proteinindhold frem for fedtholdig eller krydret mad
English: Some medicines may affect the way Tyverb works or Tyverb may affect how other medicines work.
Danish: Noget medicin kan påvirke virkningen af Tyverb, og Tyverb kan påvirke virkningen af anden medicin.
English: In the clinical study LVEF was monitored at approximately eight week intervals during treatment with Tyverb to ensure it did not decline to below the institutions lower limit of normal.
Danish: I det kliniske studie blev LVEF monitoreret med ca. 8 ugers intervaller under behandling med Tyverb for at sikre, den ikke faldt til under normalområdets nedre grænse.
English: Patients should be instructed to promptly report any change in bowel patterns.
Danish: Patienterne skal informeres om øjeblikkeligt at indberette eventuelle ændringer i afføringsmønsteret.
English: The half-life of lapatinib measured after single doses increases with increasing dose.
Danish: Halveringstiden af lapatinib målt efter enkeltdoser forlænges med stigende dosis.
English: • avoid herbal supplements (some may cause diarrhoea).
Danish: • undgå naturlægemidler (nogle typer kan give diarré).
English: Observed adverse reactions included dyspnoea, cardiac failure and palpitations.
Danish: De observerede bivirkninger inkluderer dyspnø, hjerteinsufficiens og palpitationer.
English: Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
Danish: Lapatinib er stærkt bundet (mere end 99 %) til albumin og alfa-1-syre-glykoprotein.
English: A severe allergic reaction is a rare side effect (may affect up to 1 in 1,000 people) and may develop rapidly.
Danish: En alvorlig overfølsomhedsreaktion er en sjælden bivirkning (kan forekomme hos op til 1 ud af 1.000 personer) og kan opstå hurtigt.
English: There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
Danish: I alt 952 patienter havde HER2-negative tumorer, og hos i alt 115 patienter kunne tumorernes HER2-status ikke bekræftes (ingen tumorprøve, intet analyseresultat eller anden årsag).
English: The solubility of lapatinib is pH-dependent.
Danish: Opløseligheden af lapatinib er pH-afhængig.
English: There is more advice on reducing the risk of diarrhoea at the end of section 4.
Danish: Du kan finde råd om, hvordan du nedsætter risikoen for diarré i slutningen af punkt 4.
English: At the initiation of treatment, patients should be advised of the potential for hepatotoxicity.
Danish: Ved behandlingsstart skal patienterne informeres om risikoen for levertoksicitet.
English: • swollen eyelids, lips or tongue
Danish: • hævede øjenlåg, læber eller tunge
English: Co-administration of Tyverb with irinotecan (when administered as part of the FOLFIRI regimen) resulted in an approximate 40% increase in the AUC of SN-38, the active metabolite of irinotecan.
Danish: Samtidig administration af Tyverb med irinotecan (når det blev administreret som en del af FOLFIRIregimet) resulterede i en ca. 40 % stigning i AUC af SN-38 - den aktive metabolit af irinotecan.
English: The study was halted as the interim analysis (N=475) showed a low incidence of CNS events and, superior efficacy of the trastuzumab plus capecitabine arm in terms of progression-free survival and overall survival (see results of final analysis in Table 3).
Danish: Studiet blev afbrudt, da interimanalysen (n = 475) viste en lav incidens af CNSrelaterede hændelser og bedre effekt i armen med trastuzumab plus capecitabin med hensyn til progressionsfri overlevelse og samlet overlevelse (se resultaterne af den endelige analyse i tabel 3).
English: Don't drink grapefruit juice while you are being treated with Tyverb.
Danish: Du må ikke drikke grapejuice, mens du er i behandling med Tyverb.
English: HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Danish: Tumorer med overekspression af HER2 (ErbB2) er karakteriseret ved IHC3+ eller IHC2+ med genamplifikation eller gen-amplifikation alene.
English: Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy.
Danish: Data har vist, at Tyverb i kombination med kemoterapi er mindre effektivt end trastuzumab i kombination med kemoterapi.
English: The independent assessment of the data also demonstrated that Tyverb when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95 % CI 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Danish: Den uafhængige vurdering af data viste også, at når Tyverb blev givet sammen med capecitabin, blev tiden til progression øget signifikant (hazard ratio 0,57 [95 % CI 0,43; 0,77], p = 0,0001) sammenlignet med capecitabin alene.
English: Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Danish: Lapatinib blev undersøgt hos gravide rotter og kaniner, der fik orale doser på 30, 60 og 120 mg/kg/døgn.
English: Taking your tablets
Danish: Sådan skal du tage dine tabletter
English: Lapatinib retained significant activity against HER2-amplified breast cancer cell lines selected for long-term growth in trastuzumab-containing medium in vitro and was synergistic in combination with trastuzumab in these cell lines.
Danish: Lapatinib bevarede betydelig aktivitet over for HER2amplificerende brystcancercellelinjer selekteret til langtidsvækst i trastuzumab-holdigt medium in vitro, og i kombination med trastuzumab var der en synergistisk virkning i disse cellelinjer.
English: Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Danish: Mindre end 2 % af den indgivne orale dosis blev udskilt i urinen (som lapatinib og metabolitter).
English: Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
Danish: Tyverb er indiceret til behandling af voksne patienter med brystcancer, hvis tumorer har overekspression af HER2 (ErbB2):
English: Pre-planned OS analysis (conducted at the time of the final PFS analysis, 03 June 2008) Median follow-up (yrs)
Danish: Forhåndsplanlagt OS-analyse (foretaget på tidspunktet for den endelige PFS-analyse, 03. juni
English: Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in patients with moderate and severe hepatic impairment, respectively.
Danish: Systemisk optagelse (AUC) af lapatinib efter en enkelt 100 mg dosis øgedes hhv. ca. 56 % og 85 % hos patienterne med moderat og svært nedsat leverfunktion.
English: However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Danish: Der er dog set få tilfælde af akut nyresvigt, hvilket er opstået som følge af svær dehydrering pga. diarré.
English: The effect of Tyverb during pregnancy is not known.
Danish: Virkningen af Tyverb på graviditet kendes ikke.
English: Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Danish: Palmoplantar erytrodysæstesi (PPE) (hånd-fod-syndrom) var også almindeligt (> 25 %), når lapatinib blev administreret i kombination med capecitabin.
English: Tyverb has no influence on the ability to drive and use machines.
Danish: Tyverb påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Tyverb should be taken either at least one hour before, or at least one hour after food.
Danish: Tyverb skal tages enten mindst en time før eller mindst en time efter et måltid.
English: Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported.
Danish: Diarré kan potentielt være livstruende, hvis der opstår dehydrering, nyreinsufficiens, neutropeni og /eller ubalance i elektrolytter, og tilfælde med dødelig udgang er rapporteret.
English: In some cases, LVEF decrease may be severe and lead to cardiac failure.
Danish: I nogle tilfælde kan fald i LVEF være svære og medføre hjerteinsufficiens.
English: In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed.
Danish: I et enkelt tilfælde, hvor en patient tog 9000 mg Tyverb, sås sinus-takykardi (patienten havde et ellers normalt ekg).
English: Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal.
Danish: Levertoksicitet er set ved brug af Tyverb og kan i sjældne tilfælde være letal.
English: The effect of lapatinib on the QT-interval was evaluated in a single-blind, placebo-controlled, single sequence (placebo and active treatment) crossover study in patients with advanced solid tumours (EGF114271) (n=58).
Danish: Lapatinibs virkning på QT-intervallet blev evalueret i et enkeltblindet, placebo-kontrolleret, enkeltsekvens (placebo og aktiv behandling) crossover-studie hos patienter med fremskredne, solide tumorer (EGF114271) (n=58).
English: Lapatinib has not been evaluated in patients with symptomatic cardiac failure.
Danish: Lapatinib er ikke undersøgt hos patienter med symptomatisk hjerteinsufficiens.
English: If you take too much Tyverb
Danish: Hvis du har taget for meget Tyverb
English: EU/1/07/440/004 70 tablets EU/1/07/440/005 140 tablets EU/1/07/440/006 84 tablets EU/1/07/440/007 105 tablets
Danish: EU/1/07/440/004 70 tabletter EU/1/07/440/005 140 tabletter EU/1/07/440/006 84 tabletter EU/1/07/440/007 105 tabletter
English: Final OS analysis (post-hoc analysis, 07 August 2013) Median follow-up (yrs) Deaths (%) Hazard ratio (95% CI), p-value Median values from Kaplan-Meier analysis; HR and p-values from Cox regression models adjusting for important prognostic factors.
Danish: Endelig OS-analyse (post-hoc-analyse, 07. august 2013) Median follow-up (år) Døde (%) Hazard ratio (95% CI), p-værdi Medianværdier fra Kaplan-Meier-analyser; HR (hazard ratio) og p-værdier fra Coxregressionsmodeller, korrigeret for vigtige prognostiske faktorer.
English: The most common adverse reactions (>25%) during therapy with lapatinib were gastrointestinal events (such as diarrhoea, nausea, and vomiting) and rash.
Danish: De almindeligste bivirkninger (> 25 %) undervejs i behandlingen med lapatinib var gastrointestinale hændelser (f.eks. diarré, kvalme og opkastning) samt udslæt.
English: If you forget to take Tyverb
Danish: Hvis du har glemt at tage Tyverb
English: Bottles 3 years
Danish: Beholdere 3 år
English: In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls.
Danish: Hos rotter var forekomsten af benign hæmangiom i mesenteriallymfeknuder højere i nogle grupper end i sideløbende kontrolgrupper.
English: Tyverb-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in <10% and <1% of patients, respectively.
Danish: Diarré på grund af Tyverb er normalt af lav grad, alvorlig diarré NCI CTCAE grad 3 og 4 ses hos henholdsvis < 10 % og < 1 % af patienterne.
English: In addition, per the protocol, patients were to be reported by the investigators as having progressed on their most recent trastuzumab containing regimen in the metastatic setting.
Danish: I tillæg hertil, og som beskrevet i protokollen, skulle investigatorerne have rapporteret patienterne som værende progredieret under deres seneste trastuzumabholdige regime for metastatisk sygdom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tyverb in all subsets of the paediatric population in the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Tyverb i alle undergrupper af den pædiatriske population ved behandling af brystkræft (se pkt.
English: 17.2 mos (13.9, 19.2)
Danish: 17,2 måneder (13,9; 19,2)
English: Table 7 Overall survival (OS) results from study EGF30008 (in the HER2-positive population only)
Danish: Tabel 7 Resultatet for samlet overlevelse (OS) fra studie EGF30008 (kun i HER2-positiv population)
English: It is not known whether Tyverb passes into breast-milk.
Danish: Det vides ikke, om Tyverb går over i modermælken.
English: Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4.
Danish: elektrokardiogrammer (EKG'er) og farmakokinetiske prøver ved baseline samt på de samme tidspunkter på dag 2 og dag 4.
English: Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Danish: Hver filmovertrukken tablet indeholder lapatinibditosylatmonohydrat svarende til 250 mg lapatinib.
English: Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%).
Danish: Forudgående behandling med en protonpumpehæmmer (esomeprazol) nedsatte lapatinib-eksponeringen med i gennemsnit 27 % (interval: 6 % til 49 %).
English: • wash with a soap-free cleanser
Danish: • vask huden med et renseprodukt uden sæbe
English: These data are based on exposure to this combination in 149 patients in the pivotal trial.
Danish: Disse data er baseret på 149 patienter, der blev behandlet med denne kombination i det pivotale studie.
English: Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy.
Danish: Patienter, som viste objektiv sygdomsprogression efter mindst 4 ugers behandling med lapatinib-monoterapi, var egnede til at overgå til kombinationsbehandling.
English: a. Estimate of the treatment hazard ratio, where <1 indicates a lower risk with letrozole 2.5 mg + lapatinib 1500 mg compared with letrozole 2.5 mg + placebo.
Danish: a. Estimat af behandlings-hazard-ratio, hvor < 1 indikerer en lavere risiko med letrozol 2,5 mg + lapatinib 1500 mg sammenlignet med letrozol 2,5 mg + placebo.
English: There are no adequate data from the use of Tyverb in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Tyverb hos gravide kvinder.
English: - The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, povidon (K30), natriumstivelsesglycolat (Type A), magnesiumstearat, hypromellose, titandioxid (E171), macrogol (400), polysorbat 80, jernoxid gul (E172) og jernoxid rød (E172).
English: The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Danish: Den væksthæmmende effekt af lapatinib blev vurderet i trastuzumab-konditionerede cellelinjer.
English: The primary route of excretion for lapatinib and its metabolites is in faeces.
Danish: Den primære udskillelsesvej for lapatinib og dets metabolitter er med fæces.
English: Systemic exposure to lapatinib is also affected by the timing of administration in relation to food intake.
Danish: Den systemiske eksponering for lapatinib påvirkes også af administrationstidspunktet i forhold til fødeindtagelsen.
English: Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
Danish: Samtidig administration af lapatinib og intravenøst paclitaxel øgede paclitaxel-eksponeringen med 23 % på grund af lapatinibs hæmning af CYP2C8 og/eller Pgp.
English: The cardiac events observed in this study were comparable in nature and severity to those previously seen with lapatinib.
Danish: De kardielle bivirkninger set i dette studie havde samme karakter og sværhedsgrad som dem, der tidligere er set med lapatinib.
English: LVEF should continue to be evaluated during treatment with Tyverb to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
Danish: LVEF bør evalueres, så længe der behandles med Tyverb for at sikre, at LVEF ikke falder til et uacceptabelt niveau (se pkt.
English: Each foil has a perforation down the middle and can be divided into two blisters with 5 or 6 tablets in each, depending on the pack size.
Danish: Hver blisterpakning er perforeret på midten og kan opdeles i to dele med 5 eller 6 tabletter i hver, afhængigt af pakningsstørrelsen.
English: Serious skin reactions
Danish: Alvorlige hudlidelser
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, proteinkinase-hæmmere, ATC-kode: L01XE07
English: The study was halted based on the results of a pre-specified interim analysis that showed an improvement in TTP for patients receiving Tyverb plus capecitabine.
Danish: Studiet blev standset på grund af resultaterne af en planlagt interim-analyse, der viste en forbedring i TTP hos de patienter, der fik Tyverb og capecitabin.
English: Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease.
Danish: Randomiseringen blev stratificeret efter tidligere behandling med trastuzumab og antallet af tidligere behandlinger mod metastatisk sygdom.
English: telithromycin - medicines used to treat infections
Danish: telithromycin - medicin, der bruges til at behandle infektioner
English: Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
Danish: Indgift af Tyverb til patienter med moderat til svært nedsat leverfunktion bør ske med forsigtighed pga. øget eksponering for lægemidlet.
English: Ask your doctor to give you information about these other medicines.
Danish: Spørg lægen, hvis du vil vide mere om disse lægemidler.
English: Tyverb with food and drink
Danish: Brug af Tyverb sammen med mad og drikke
English: At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea.
Danish: Ved behandlingsstart bør patientens afføringsmønster og eventuelle andre symptomer (f.eks. feber, krampelignende mavesmerter, kvalme, opkastning, svimmelhed og tørst) fastlægges for at gøre det muligt at opdage ændringer under behandlingen og gøre det nemmere at identificere patienter med øget risiko for diarré.
English: The bioavailability of lapatinib is increased up to about 4 times by food, depending on e.g. the fat content in the meal.
Danish: Lapatinibs biotilgængelighed øges op til fire gange, når det indtages sammen med mad afhængigt af f.eks. fedtindholdet i måltidet.
English: Lapatinib produced a maximum mean concentration of 3920 (3450-4460) ng/ml (geometric mean/95% CI), exceeding the geometric mean Cmax.ss and 95% CI values observed following the approved dosing regimens.
Danish: Lapatinib viste en maksimal middelkoncentration på 3920 (3450-4460) ng/ml (geometrisk middelværdi/95 % CI), der oversteg geometrisk middel- Cmax.ss og 95 % CI værdier, som blev observeret efter godkendte doseringer.
English: To minimise variability in the individual patient, administration of Tyverb should be standardised in relation to food intake, for example always to be taken one hour before a meal (see sections 4.5 and 5.2 for information on absorption).
Danish: For at minimere variationen hos den enkelte patient bør indtagelsen af Tyverb standardiseres i forhold til måltiderne, så Tyverb f.eks. altid tages en time før et måltid (for oplysninger om absorption, se pkt.
English: Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.
Danish: Lægen fastlægger doseringen af Tyverb på baggrund af den type brystkræft, der skal behandles.
English: Concomitant administration of Tyverb with capecitabine, letrozole or trastuzumab did not meaningfully alter the pharmacokinetics of these medicinal products (or the metabolites of capecitabine) or lapatinib.
Danish: Samtidig administration af Tyverb og capecitabin, letrozol eller trastuzumab ændrede ikke farmakokinetikken for disse lægemidler (eller metabolitterne af capecitabin) eller lapatinib i betydelig grad.
English: Median (95% CI) Stratified Hazard ratio b
Danish: Median (95 % CI) Stratificeret hazard ratio b
English: The efficacy and safety of Tyverb in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomised, phase III study.
Danish: Effekten og sikkerheden ved Tyverb i kombination med capecitabin til brystcancerpatienter med god performance status blev evalueret i et randomiseret fase III-studie.
English: • topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
Danish: • topotecan, paclitaxel, irinotecan, docetaxel - medicin, der bruges til at behandle visse former for kræft
English: • pains in muscles or joints
Danish: • smerter i muskler eller led
English: This was followed by three doses of lapatinib 2000 mg administered in the same way.
Danish: Dette blev efterfulgt af en tilsvarende administration af tre doser lapatinib på 2000 mg. Der blev foretaget målinger inkl.
English: • liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.
Danish: • leverproblemer, som kan medføre kløe, at dine øjne og din hud bliver gul (gulsot), mørkfarvning af urinen, smerter eller ubehag i den højre side af den øverste maveregion
English: What Tyverb contains
Danish: Tyverb indeholder:
English: Immune system disorders Rare
Danish: Immunsystemet Sjælden
English: The full prescribing information of the co-administered medicinal product should be consulted for relevant details of their posology including any dose reductions, contraindications and safety information.
Danish: Der henvises til produktinformationen for lægemidler, der administreres samtidig med Tyverb, for relevante oplysninger om dosering, herunder eventuelle dosisreduktioner, kontraindikationer og sikkerhedsoplysninger.