FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have liver problems, your doctor may reduce how often you take your dose to every other day (i.e. one 1340 microgram capsule every other day).
Danish: Hvis du har leverproblemer, kan din læge reducere hyppigheden for indtagelse af din dosis til hver anden dag (dvs. en 1340 mikrogram kapsel hver anden dag).
English: OS was a key secondary endpoint in the pivotal study and the analysis included data from all randomized patients, including those who progressed on sorafenib and crossed over to receive tivozanib as part of the extension study.
Danish: OS var et vigtigt sekundært endepunkt i den centrale undersøgelse og analysen omfattede data fra alle randomiserede patienter, inklusiv dem, der havde progression med sorafenib og skiftede over til tivozanib som en del af den udvidede undersøgelse.
English: Gastrointestinal perforation/fistula
Danish: Gastrointestinal perforation/fistel
English: Within each SOC, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver SOC er bivirkningerne opstillet i rækkefølge efter aftagende sværhedsgrad.
English: Treatment with Fotivda may raise the risk of developing a blood clot (thrombus) in your blood vessels that could break loose and be carried by the blood stream to block another blood vessel.
Danish: Behandlingen med Fotivda kan øge risikoen for at udvikle en blodprop (trombose) i dine blodkar, som kunne rive sig løs og blive ført med blodstrømmen og blokere et andet blodkar.
English: Clearance is similar between acute and chronic dosing indicating no time dependent changes in PK.
Danish: Clearance er den samme for akut og kronisk dosering, hvilket angiver, at der ikke er tidsafhængige ændringer i PK.
English: • Very high blood pressure leading to a stroke; flushed skin.
Danish: • Meget højt blodtryk som fører til et slagtilfælde; rød hud.
English: Fotivda is for oral use.
Danish: Fotivda er til oral administration.
English: Direct N-glucoronidation of tivozanib was a minor pathway of metabolism in vitro.
Danish: Direkte N-glucoronidering af tivozanib var en mindre pathway for metabolisme in vitro.
English: The primary endpoint of the study was progression-free survival (PFS) by blinded independent radiology review; key secondary endpoints included overall survival (OS) and objective response rate (ORR) by independent radiology review.
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS) ved blindet uafhængig radiologisk bedømmelse; de vigtigste sekundære endepunkter omfattede samlet overlevelse (OS) og objektiv responsrate (ORR) ved uafhængig radiologisk bedømmelse.
English: • Memory loss.
Danish: • Hukommelsestab.
English: Moderate CYP3A4 inducers are not expected to have a clinically relevant effect on tivozanib exposure.
Danish: Moderate CYP3A4-induktorer forventes ikke at have en klinisk relevant effekt på tivozanib-eksponering.
English: Contraindication of concomitant use
Danish: Kontraindikation for samtidig brug
English: In vitro metabolism studies have shown that CYP3A4 and CYP1A1 are capable of metabolising tivozanib.
Danish: In vitro studier af metabolisme har vist, at CYP3A4 og CYP1A1 er i stand til at metabolisere tivozanib.
English: Tivozanib may have a minor influence on the ability to drive and use machines.
Danish: Tivozanib kan have en mindre indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold beholderen godt lukket for at beskytte mod fugt.
English: Patients taking an oral BCRP substrate with a clinically-relevant efflux interaction in the gut should ensure that a suitable time window (e.g. 2 hours) is applied between administration of tivozanib and the BCRP substrate.
Danish: Patienter, som tager et oralt BCRP-substrat med en klinisk relevant effluks-interaktion i tarmene, bør sørge for, at der observeres et passende tidsvindue (f.eks. 2 timer) mellem administration af tivozanib og BCRP-substratet.
English: Objective Response Rate (95% CI), ITT Population
Danish: Objektiv responsrate (95% CI), ITT population
English: The efficacy of tivozanib in the treatment of advanced RCC was studied in the following randomised clinical study.
Danish: Virkningen af tivozanib i behandlingen af avanceret RCC er blevet undersøgt i følgende randomiserede, kliniske studie.
English: Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Danish: Tivozanib viste en statistisk signifikant forbedring af PFS og ORR i forhold til sorafenib ved uafhængig radiologisk bedømmelse (Tabel 2 og Figur 1).
English: Talk to your doctor if you are already breastfeeding.
Danish: Fortæl det til din læge, hvis du allerede ammer.
English: If tivozanib is used during pregnancy, or if the patient becomes pregnant while receiving tivozanib, the potential hazard to the foetus must be explained to the patient.
Danish: Hvis tivozanib bruges under graviditet eller hvis patienten bliver gravid i løbet af tivozanib-terapien, skal den potentielle risiko for fostret forklares til patienten.
English: • Blood clot in a deep vein such as in the leg.
Danish: • Blodprop i en dyb vene som f.eks. i ben.
English: Discontinuation of treatment should be considered in cases of persistent severe hypertension, posterior reversible encephalopathy syndrome (see below), or other complications of hypertension.
Danish: En afbrydelse af behandlingen bør overvejes i tilfælde af vedvarende svær hypertension, posterior reversibelt encefalopati-syndrom (se nedenfor) eller andre komplikationer af hypertension.
English: Alternatively, a statin not subject to restriction of intestinal absorption by BCRP should be considered.
Danish: Alternativt bør man overveje en statin med en tarm-absorbering, der ikke er begrænset af BCRP.
English: Fotivda is used to treat adults with advanced kidney cancer.
Danish: Fotivda bruges til at behandle voksne med avanceret nyrekræft.
English: • Lack of blood flow through the heart blood vessels.
Danish: • Manglende blodstrøm gennem hjertets blodkar.
English: Hazard Ratio (95% CI)
Danish: Risikoforhold (95% CI)
English: Studies in pregnant rabbits showed no effect on maternal health or embryo foetal development at doses approximately 0.6 times the human exposure at the recommended dose.
Danish: Studier med drægtige kaniner viste ingen effekter på maternel sundhed eller embryo-føtal udvikling ved doser, der var omkring 0,6 gange den menneskelige eksponering ved den anbefalede dosis.
English: Risk factors for hypothyroidism include prior history of hypothyroidism and use of anti-thyroid medications.
Danish: Risikofaktorer for hypothyreoidisme omfatter tidligere sygehistorie med hypothyreoidisme og anvendelse af antithyreoide midler.
English: Persistent severe hypertension (‘hypertensive crisis') was an adverse reaction in 1.0%, CTC Grade 3 or higher in 0.9%.
Danish: Persistent svær hypertension (“hypertensiv krise”) var en bivirkning hos 1,0%, CTC Grad 3 eller højere hos 0,9%.
English: Your doctor may recommend that you temporarily stop taking Fotivda if you have an operation or surgery, as it could affect wound healing.
Danish: Din læge kan anbefale, at du holder op med at tage Fotivda midlertidigt, hvis du skal have en operation eller et kirurgisk indgreb, da denne behandling kan have indflydelse på sårheling.
English: Persistent severe hypertension12
Danish: Vedvarende svær hypertension12
English: Hypothyroidism has been observed to occur at any time during treatment with tivozanib, developing as early as within two months of treatment initiation.
Danish: Forekomsten af hypothyreoidisme er blevet observeret på ethvert tidspunkt i løbet af behandlingen med tivozanib, og den har udviklet sig så tidligt som inden for to måneder efter initiering af behandlingen.
English: Fotivda may be taken with or without food (see section 5.2).
Danish: Fotivda kan indtages med eller uden mad (se pkt.
English: Management of patients experiencing HFSR may include topical therapies for symptomatic relief with consideration of temporary interruption and/or reduction in treatment dose or, in severe or persistent cases, permanent discontinuation of treatment.
Danish: Varetagelsen af patienter, som oplever HFSR, kan omfatte topiske terapier for symptomatisk lindring med overvejelse af midlertidig afbrydelse og/eller reduktion af behandlingsdosis eller, i alvorlige eller vedvarende tilfælde, permanent standsning af behandling.
English: Each hard capsule contains trace amounts of tartrazine (E102) (8-12% of the yellow printing ink composition) (see section 4.4).
Danish: Hver hård kapsel indeholder spormængder af tartrazin (E102) (8-12 % af den gule tryksværtesammensætning) (se pkt.
English: The study included patients who had all undergone prior nephrectomy, and who had received either no prior therapy or no more than one prior systemic therapy in the metastatic setting (immunotherapy/chemotherapy); prior treatment with VEGF or mechanistic Target of Rapamycin (mTOR) targeted therapy was not allowed.
Danish: Studiet omfattede patienter, som alle havde gennemgået tidligere nefrektomi og som enten ikke havde modtaget en tidligere terapi eller ikke mere end én tidligere systemisk terapi på grund af metastater (immunoterapi/kemoterapi); en målrettet terapi var ikke tilladt før behandling med VEGF eller mekanistisk Target of Rapamycin (mTOR).
English: In vitro studies conducted in human liver microsomes and hepatocytes evaluating the activity of CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 suggested that tivozanib is a weak inhibitor of CYP2B6 and CYP2C8.
Danish: In vitro studier med anvendelse af humane levermikrosomer og hepatocytter, som har evalueret af aktiviteten af CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4, tyder på, at tivozanib er en svag hæmmer af CYP2B6 og CYP2C8.
English: The next most potently inhibited kinase is c-kit which is 8-fold less sensitive to inhibition by tivozanib compared to VEGFR 1, 2 and 3.
Danish: Den næstmest potent hæmmede kinase er c-kit, som er 8 gange mindre sensitiv over for hæmning af tivozanib sammenlignet med VEGFR 1, 2 og 3.
English: Alopecia Rash24 Acne25
Danish: Alopeci Udslæt24 Acne25
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows.
Danish: I det nedenstående er anført bivirkninger, som ikke blev observeret i kliniske studier, men set hos dyr ved eksponeringsniveauer lignende kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse.
English: Get medical help straightaway if you experience confusion, changes in your mental state or headaches.
Danish: Søg øjeblikkeligt lægehjælp, hvis du oplever forvirring, ændring af din mentale tilstand eller hovedpine.
English: It is currently unknown whether tivozanib may reduce the effectiveness of hormonal contraceptives and therefore women using hormonal contraceptives should add a barrier method.
Danish: Det vides på indeværende tidspunkt ikke, om tivozanib kan reducere effektiviteten af hormonale kontraceptiva, og derfor bør kvinder, som bruger hormonale kontraceptiva tilføje en barrieremetode.
English: For the 30% of patients receiving prior treatment, the predominant therapy was interferon alpha as monotherapy which was received by 75 patients in the tivozanib arm and 62 patients in the sorafenib arm.
Danish: Hvad angår de 30% af patienterne, som havde modtaget en tidligere behandling, var den fremherskende terapi interferon-alfa som monoterapi, som var blevet taget af 75 patienter i tivozanib-armen og 62 patienter i sorafenib-armen.
English: All patients should have liver function tests evaluated, including aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase (AP), to determine hepatic function before starting and during treatment with tivozanib.
Danish: Alle patienter bør have deres leverfunktion evalueret med tests, inklusiv aminotransferase (ALT), aspartat aminotransferase (AST), bilirubin og alkalisk fosfatase (AP) for at bestemme leverfunktion før behandlingens start og i løbet af behandlingen med tivozanib.
English: • Loss of appetite; weight loss.
Danish: • Tab af appetit; vægttab.
English: • Difficulty speaking
Danish: • Taleproblemer
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Der findes yderligere oplysninger om dette lægemiddel på det Europæiske Lægemiddelagenturs websted: http://www.ema.europa.eu.
English: There were no [14C]-containing metabolites present in faeces at greater than 10% of the dose.
Danish: Der var ingen [14C]-metabolitter i fæces med en tilstedeværelse på over 10% af dosis.
English: 2 Peripheral neuropathy including hyperaesthesia, hypoaesthesia, mononeuropathy, neuropathy peripheral, peripheral sensory neuropathy and paraesthesia
Danish: 2 Perifer neuropati omfatter hyperæstesi, hypæstesi, mononeuropati, perifer neuropati, perifer sensorisk neuropati og paræstesi
English: In the case of a missed dose a replacement dose must not be taken to make up for a forgotten dose.
Danish: Hvis der glemmes en dosis, må der ikke tages en erstatningsdosis for at kompensere for den glemte dosis.
English: Caution is advised in patients with severe renal impairment due to limited experience and in patients undergoing dialysis as there is no experience of tivozanib in this patient population.
Danish: Der skal udvises forsigtighed hos patienter med svær nedsat nyrefunktion på grund af begrænset erfaring og hos patienter, som er i dialyse, da der ikke foreligger erfaring med tivozanib i denne patientgruppe.
English: The most common adverse reactions of any grade include hypertension (47.6%), dysphonia (26.9%), fatigue (25.8%) and diarrhoea (25.5%).
Danish: De mest almindelige bivirkninger af enhver grad omfatter hypertension (47,6%), dysfoni (26,9%), træthed (25,8%) og diarré (25,5%).
English: Adverse reactions from clinical studies are presented using frequencies for all-causality adverse events.
Danish: Bivirkninger fra kliniske studier er præsenteret ved hjælp af frekvenser for bivirkninger med alle årsagssammenhænge.
English: Exposure is dose proportional between 890 and 1340 microgram and dose related over the wider range of 450 mg and 1790 microgram.
Danish: Eksponering er dosisproportionel mellem 890 og 1340 mikrogram og dosisrelateret over et bredere område fra 450 mg til 1790 mikrogram.
English: Caution should be exercised if tivozanib is co-administered with rosuvastatin.
Danish: Der skal udvises forsigtighed, hvis tivozanib administreres samtidig med rosuvastatin.
English: VEGF is a potent mitogenic factor that plays a central role in angiogenesis and vascular permeability of tumour tissues.
Danish: VEGF er en potent mitogen faktor, som spiller en central rolle i tumorvævenes angiogenese og vaskulære permeabilitet.
English: What you need to know before you take Fotivda
Danish: Det skal du vide, før du begynder at tage Fotivda
English: The decision to resume tivozanib therapy after surgery should be based on clinical judgment of adequate wound healing.
Danish: Beslutningen om at genoptage tivozanib-terapien efter det kirurgiske indgreb bør være baseret på en klinisk bedømmelse af passende sårheling.
English: Clinical studies with tivozanib were conducted in RCC patients with serum creatinine concentration ≤ 2 times the upper limit of normal, including those who may have had a prior nephrectomy.
Danish: Der er udført kliniske studier med tivozanib hos RCC-patienter med en serum-kreatinin koncentration ≤ 2 gange den øvre normalgrænse, herunder patienter som muligvis havde haft en tidligere nefrektomi.
English: 3 Dysgeusia including ageusia, dysgeusia and hypogeusia 4 Memory impairment including amnesia and memory impairment 5 PRES was not observed in patients treated with tivozanib in the five RCC monotherapy studies.
Danish: 3 Smagsforstyrrelser omfatter ageusi, dysgeusi og hypogeusi 4 Hukommelsesforstyrrelser omfatter amnesi og hukommelsesforstyrrelser 5 PRES blev ikke observeret hos patienter behandlet med tivozanib i de fem RCC monoterapi-studier.
English: The central tendency change for all measured days and across all time points was 2.2 ms. No subjects had a new > 500 ms change in QTcF; 2 patients (4%) had QTcF values > 480 ms. One subject (2%) had a > 60 ms change from baseline in QTcF and 6 subjects (12%) had a 30 ms to 60 ms change from baseline (see section 4.4 and section 4.8).
Danish: Den centrale tendens-ændring for alle målte dage og på tværs af alle tidspunkter var 2,2 ms. Ingen patienter havde en ny > 500 ms ændring i QTcF; 2 patienter (4%) havde QTcF værdier > 480 ms. En patient (2%) havde en > 60 ms ændring fra baseline i QTcF og 6 patienter (12%) havde en 30 ms til 60 ms ændring fra baseline (se pkt.
English: • if you get shortness of breath or ankle swelling
Danish: • Hvis du får åndenød eller hævede ankler
English: Blood pressure should be well controlled prior to initiating tivozanib.
Danish: Blodtrykket bør være velkontrolleret, før tivozanib startes.
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and not known (cannot be estimated from available data).
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: If you are already taking a medicine to treat high blood pressure, and your doctor reduces the dose of Fotivda or interrupts or stops treatment, you will be regularly checked for low blood pressure.
Danish: Hvis du allerede tager en medicin for at behandle højt blodtryk, og din læge reducerer dosis af Fotivda eller afbryder eller standser behandlingen, vil du jævnligt blive kontrolleret for lavt blodtryk.
English: AST, ALT, bilirubin, and AP should be monitored before initiation of and periodically throughout treatment with tivozanib because of the potential risk of hepatotoxicity (see section 4.2).
Danish: AST, ALT, bilirubin og AP bør monitoreres før initieringen af og med jævne mellemrum under hele behandlingen med tivozanib på grund af den potentielle risiko for hepatotoksicitet (se pkt.
English: Excipients with known effect
Danish: Hjælpestoffer med kendt virkning
English: Figure 1: Kaplan-Meier plot of progression free survival, independent radiological review (ITT Population)
Danish: Figur 1: Kaplan-Meier plot for progressionfri overlevelse, uafhængig radiologisk bedømmelse (ITT population)
English: Animal studies indicate that male and female fertility may be affected by treatment with tivozanib (see section 5.3).
Danish: Undersøgelser med dyr peger på, at mandlig og kvindelig fertilitet kan være påvirket af behandling med tivozanib (se pkt.
English: The clinical effects of strong CYP3A4 inducers on repeated daily dosing of tivozanib has not been studied but potentially the average time to reach steady-state and the average steady-state serum concentration of tivozanib may be reduced, due to the reduction in half-life.
Danish: De kliniske effekter af potente CYP3A4-induktorer på gentagne daglige doseringer af tivozanib er ikke blevet undersøgt, men den gennemsnitlige tid for at nå steady-state og den gennemsnitlige steady-state-serumkoncentration af tivozanib kan potentielt være reduceret på grund af reduceringen af halveringstiden.
English: Posterior Reversible Encephalopathy Syndrome (PRES) PRES (also known as reversible posterior leukoencephalopathy syndrome (RPLS)) was confirmed in one non-RCC patient after approximately 8 weeks on tivozanib.
Danish: PRES (også kendt som reversibelt posterior leukoencefalopati-syndrom (RPLS)) blev bekræftet hos en non-RCC patient efter omkring 8 uger med tivozanib.
English: Results from a single dose study to evaluate the pharmacokinetics, safety and tolerability of tivozanib in subjects with hepatic impairment show that across the entire measurement period, tivozanib was eliminated more slowly in subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Danish: Resultater fra et enkeltdosis studie for at evaluere farmakokinetik, sikkerhed og tolerabilitet af tivozanib hos personer med nedsat leverfunktion viser, at på tværs af hele målingsperioden blev tivozanib elimineret mere langsomt hos personer med moderat (Child-Pugh klasse B) eller svær (Child-Pugh klasse C) nedsat leverfunktion.
English: Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favour of tivozanib; e p-value for subgroup analyses based on unstratified log-rank test.
Danish: Når vi formoder proportionelle risici, angiver et risikoforhold på mindre end 1 en reduktion af risikoforholdet til fordel for tivozanib; e p-værdi for undergruppeanalyser baseret på ikke-stratificeret logrank test.
English: median OS was 28.2 months (95% CI 22.5, 33.0) in the tivozanib arm compared to 30.8 months (95% CI 28.4, 33.3) in the sorafenib arm (HR=1.147, p=0.276).
Danish: Median OS var 28,2 måneder (95% CI 22,5, 33,0) i tivozanib-armen sammenlignet med 30,8 måneder (95% CI 28,4, 33,3) i sorafenib-armen (HR=1,147, p=0,276).
English: 0.520e a Hazard ratio for tivozanib arm vs. sorafenib arm, based on stratified Cox proportional hazards model.
Danish: 0,520e a Risikoforhold for tivozanib-arm vs. sorafenib-arm baseret på stratificeret Cox proportional risikomodel.
English: Dysphonia, diarrhoea, fatigue, weight decreased, appetite decreased and hypothyroidism occurred more commonly in patients ≥ 65 years of age.
Danish: Dysfoni, diarré, træthed, vægttab, manglende appetit og hypothyreoidisme var mere almindelige bivirkninger hos patienter ≥ 65 år.
English: Your doctor will check your blood pressure regularly during treatment with Fotivda.
Danish: Din læge vil kontrollere dit blodtryk jævnligt i løbet af behandlingen med Fotivda.
English: Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Danish: Fotivda er indiceret til første linje behandling af voksne patienter med avanceret renalcellecarcinom (RCC) samt til voksne patienter, som er VEGFR og mTOR pathway-hæmmer-naive som følge af sygdomsprogression efter en tidligere behandling med cytokine terapi for avanceret RCC.
English: Risk factors for ATE include malignant disease, age > 65 years, hypertension, diabetes mellitus, smoking, hypercholesterolaemia, and prior thromboembolic disease.
Danish: Risikofaktorer for ATE omfatter malign sygdom, alder > 65 år, hypertension, diabetes mellitus, rygning, hyperkolesterolæmi og tidligere tromboembolisk sygdom.
English: Pancreatitis17 Dysphagia18 Vomiting Gastrooesophageal reflux disease Abdominal distension Glossitis19 Gingivitis20 Dyspepsia Constipation Dry mouth Flatulence
Danish: Pancreatitis17 Dysfagi18 Opkastning Gastroøsofageal reflukssygdom Abdominal distension Glossitis19 Gingivitis20 Dyspepsi Konstipation Tør mund Flatulens
English: If you forget to take Fotivda
Danish: Hvis du har glemt at tage Fotivda
English: If PRES is diagnosed, your doctor will stop treatment with Fotivda.
Danish: Hvis PRES diagnosticeres, vil din læge standse behandlingen med Fotivda.
English: It is recommended that tivozanib be used with caution in patients with a history of QT interval prolongation or other relevant pre-existing cardiac disease and those receiving other medications known to increase the QT interval.
Danish: Det anbefales at bruge tivozanib med forsigtighed hos patienter med en sygehistorie med forlængelse af QT-interval eller andre relevante eksisterende hjertesygdomme og hos patienter, som modtager andre lægemidler, der er kendt for at øge QT-intervallet.