FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that symptoms of gastrointestinal perforation or fistula should be periodically monitored throughout treatment with tivozanib and that tivozanib should be used with caution in patients at risk for GI perforation or fistula.
Danish: Det anbefales at monitorere symptomer på gastrointestinal perforation eller fistel med jævne mellemrum under hele behandlingen med tivozanib og at bruge tivozanib med forsigtighed hos patienter med en risiko for GI perforation eller fistel.
English: In the case of persistent hypertension despite use of anti-hypertensive therapy, the tivozanib dose should be reduced, or the treatment interrupted and re-initiated at a lower dose once the blood pressure is controlled, according to clinical judgment (see section 4.2).
Danish: I tilfælde af vedvarende hypertension på trods af anvendelse af antihypertensiva, bør dosis af tivozanib reduceres eller behandlingen afbrydes og startes op igen, når blodtrykket er kontrolleret i henhold til en klinisk bedømmelse (se pkt.
English: When dose reduction is necessary, the tivozanib dose can be reduced to 890 microgram once daily with the normal treatment schedule of 21 days of dosing, followed by a 7-day rest period.
Danish: Når en dosisreduktion er nødvendig, kan dosis af tivozanib reduceres til 890 mikrogram én gang om dagen med det normale behandlingsskema med en dosering i 21 dage efterfulgt af en hvileperiode på 7 dage.
English: If the patient develops Grade 4 proteinuria (nephrotic syndrome) tivozanib has to be discontinued.
Danish: Hvis patienten udvikler en grad 4 proteinuri (nefrotisk syndrom) skal tivozanib standses.
English: Progression-Free Survival [median, months (95% CI)], ITT Population
Danish: Progressionsfri overlevelse [median, måneder (95% CI)], ITT population
English: Patients should be advised to be cautious when driving or using machines if they experience asthenia, fatigue, and/or dizziness during treatment with tivozanib (see section 4.8).
Danish: Patienter bør rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, hvis de oplever asteni, træthed og/eller svimmelhed i løbet af behandlingen med tivozanib (se pkt.
English: Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2).
Danish: Stratifikationsfaktorer er antal tidligere behandlinger (0 eller 1) og antal involverede metastatiske steder/organer (1 eller ≥2).
English: Furthermore, tivozanib was not an in vitro inhibitor of OAT1, OAT3, OCT2, MATE1 and MATE2-K or substrate of MRP2 and BCRP.
Danish: Desuden var tivozanib ikke en hæmmer in vitro af OAT1, OAT3, OCT2, MATE1 og MATE2-K eller et substrat for MRP2 og BCRP.
English: QT/QTc prolongation
Danish: Forlængelse af QT/QTc-interval
English: Package leaflet: Information for the patient Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules tivozanib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Fotivda 890 mikrogram hårde kapsler Fotivda 1340 mikrogram hårde kapsler tivozanib Dette lægemiddel er underlagt supplerende overvågning.
English: If you get bleeding problems (with painful swollen stomach (abdomen), vomiting blood, coughing up blood, black stools, blood in your urine, headache or changes in your mental state), tell your doctor right away.
Danish: Hvis du får problemer med blødning (med en smertefuld opsvulmet mave (abdomen), opkastning med blod, ophostning af blod, sort afføring, blod i din urin, hovedpine eller ændringer i din mentale tilstand), skal du straks fortælle det til din læge.
English: After chronic dosing of tivozanib in RCC patients for 21 days followed by 7 days without administration of tivozanib, tivozanib Cmin is approximately 16.0 to 30.9 ng/mL.
Danish: Efter en kronisk dosering af tivozanib hos RCC patienter i 21 dage efterfulgt af 7 dage uden administration af tivozanib, er tivozanib Cmin på omkring 16,0 til 30,9 ng/ml.
English: Tivozanib was shown to be teratogenic, embryotoxic and foetotoxic in pregnant rats at dose levels 5 times lower than the recommended clinical dose (based on a 60 kg human).
Danish: Tivozanib har vist sig at være teratogen, embryotoksisk og føtotoksisk hos drægtige rotter ved dosisniveauer, der var 5 gange lavere end den anbefalede kliniske dosis (baseret på et menneske på 60 kg).
English: Swelling in the lungs caused by fluid build-up.
Danish: Hævelse i lungerne på grund af ophobning af væske.
English: • Paleness and tiredness from excess bleeding.
Danish: • Bleghed og træthed pga. overdreven blødning.
English: Patients receiving anti-hypertensive medication should still be monitored for hypotension when tivozanib is either interrupted or discontinued.
Danish: Patienter, som modtager en antihypertensiv behandling, bør stadig monitoreres for hypotension efter afbrydelse eller standsning af tivozanib.
English: In vitro studies have shown that metabolites of tivozanib can undergo UGT mediated biotransformation via the UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9, and UGT1A10 pathways.
Danish: In vitro studier har vist, at metabolitter af tivozanib kan undergå UGT-medieret biotransformation via UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9 og UGT1A10 pathways.
English: A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking 3 doses of 1340 microgram tivozanib in one day (total 4020 microgram).
Danish: En patient med en sygehistorie med hypertension havde en forværret ukontrolleret hypertension, som var fatal efter at have taget 3 doser af 1340 mikrogram tivozanib på én dag (i alt 4020 mikrogram).
English: Contraceptives
Danish: Kontraceptiva
English: Tell your doctor right away if you have symptoms such as headache, seizure (fit), lack of energy, confusion, blindness or other visual and neurologic disturbances such as weakness in an arm or a leg.
Danish: Fortæl det straks til din læge, hvis du har symptomer som f.eks. hovedpine, slagtilfælde (anfald), manglende energi, forvirring, blindhed eller andre visuelle og neurologiske forstyrrelser som f.eks. svaghed i en arm eller et ben.
English: Single dose AUC0-inf for healthy volunteers dosed with 1340 microgram tivozanib was 1,950 to 2,491 ng.hr/mL.
Danish: Enkelt dosis AUC0-inf for sunde frivillige, som havde modtaget 1340 mikrogram tivozanib, var 1.950 til 2.491 ng.hr/ml.
English: Blood pressure should be well controlled prior to initiating tivozanib and patients should be monitored for hypertension during treatment (see section 4.4).
Danish: Blodtrykket bør være velkontrolleret, før tivozanib startes og patienterne bør monitoreres for hypertension i løbet af behandlingen (se pkt.
English: Pharmacotherapeutic group: antineoplastic agents, protein-kinase inhibitors, ATC code: L01XE34
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE34
English: According to the population pharmacokinetic analysis of tivozanib exposure, no dose adjustment is required in patients with mild or moderate renal impairment.
Danish: I henhold til en farmakokinetisk populationsanalyse af eksponering for tivozanib, kræves der ingen dosisjustering hos patienter med mild eller moderat nedsat leverfunktion.
English: confusion, altered consciousness or sense of awareness, rapid, shallow breathing, a racing heart or excessive sweating.
Danish: angst, forvirring, ændret bevidsthed eller følelse af årvågenhed, hurtig, overfladisk vejrtrækning, et galoperende hjerte eller overdreven sveden.
English: Fotivda 890 microgram hard capsules EU/1/17/1215/001
Danish: Fotivda 890 mikrogram kapsler, hårde EU/1/17/1215/001
English: Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (e.g. with blood tests), and if necessary may need to reduce how often you take Fotivda.
Danish: Din læge vil jævnligt overvåge, hvor godt din lever fungerer før og i løbet af behandlingen med Fotivda (f.eks. med blodprøver), og han/hun vil muligvis reducere, hvor ofte du tager Fotivda.
English: No significant increase in exposure was observed in patients with mild (Child-Pugh Class A) hepatic impairment (mean AUC0-∞ by 1.2-fold).
Danish: Der blev ikke observeret en signifikant stigning af eksponeringen hos patienter med mild (Child-Pugh klasse A) nedsat leverfunktion (gennemsnitlig AUC0-∞ med 1,2 gange).
English: Two patients received excessive doses of tivozanib during the monotherapy studies.
Danish: To patienter havde modtaget en for stor dosis tivozanib i løbet af monoterapistudierne.
English: Proteinuria Blood creatinine increased
Danish: Proteinuri Øget blodkreatinin
English: In repeat-dose toxicity studies in rats, abnormalities were noted in growing incisors (thin brittle teeth, tooth loss, malocclusions) at doses approximately 2-fold greater than the calculated human equivalent dose and growth plate hypertrophy was observed at doses approximately 0.7- to 7-fold greater than the calculated human equivalent dose.
Danish: I studier med toksicitet efter gentagne doser hos rotter blev der noteret abnormiteter i forbindelse med voksende fortænder (tynde skøre tænder, tab af tænder, okklusionsafvigelser) ved doser, der var ca. 2 gange større end den beregnede ækvivalente dosis til mennesker, og der blev observeret vækstplade hypertrofi ved doser omkring 0,7 til 7 gange større end den beregnede ækvivalente dosis til mennesker.
English: • if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: • Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: Skin exfoliation Erythema22 Pruritus23
Danish: Hudeksfoliation Erytem22 Pruritus23
English: Fotivda 1340 microgram hard capsules EU/1/17/1215/002
Danish: Fotivda 1340 mikrogram kapsler, hårde EU/1/17/1215/002
English: Based on the in vitro IC50 and in vivo unbound Cmax, tivozanib was unlikely to interact in a clinically relevant manner with active substances that are metabolised by these enzyme pathways.
Danish: På baggrund af in vitro IC50 og in vivo ubundet Cmax, er det ikke sandsynligt, at tivozanib interagerer på en klinisk relevant måde med aktive stoffer, som metaboliseres af disse enzym-pathways.
English: Increased testis weights were observed at a dose 7-fold higher than the recommended clinical dose.
Danish: Øget testikelvægt blev observeret ved en dosis, der var 7 gange højere end den anbefalede kliniske dosis.
English: In a cardiac safety study of 50 patients with advanced solid tumours treated with tivozanib at 1340 microgram daily for 21 days, the mean change from baseline in QTcF was 6.8 ms on day 21 of dosing.
Danish: I et hjerte-sikkerhedsstudie med 50 patienter med avancerede solide tumorer behandlet med tivozanib ved 1340 mikrogram pr. dag i 21 dage, var middelændringen fra baseline i QTcF 6,8 ms på doseringens dag 21.
English: Symptoms include severe headaches, blurred vision, shortness of breath, changes in your mental state, such as feeling anxious, confused or disorientated
Danish: Symptomer omfatter stærk hovedpine, sløret syn, åndenød, ændringer i din mentale tilstand som f.eks. at du føler dig urolig, forvirret eller desorienteret.
English: Tivozanib inhibits the transporter protein BCRP in vitro, at concentrations that are likely to restrict the effect to intestinal BCRP activity in vivo.
Danish: Tivozanib hæmmer transport-proteinet BCRP in vitro ved koncentrationer, der sandsynligvis vil begrænse effekten til intestinal BCRP aktivitet in vivo.
English: If you stop taking Fotivda
Danish: Hvis du holder op med at tage Fotivda
English: • Rapid heart rate; tightness of the chest; heart attack/reduced blood flow to heart; blood clot in an artery (blood vessel).
Danish: • Hurtig hjertefrekvens; trykken i brystet; hjerteanfald/reduceret blodstrøm til hjertet; blodprop i en arterie (blodkar).
English: In case you experience severe side effects, your doctor may decide to interrupt Fotivda therapy and/or lower the dose to:
Danish: Hvis du oplever alvorlige bivirkninger, kan din læge beslutte at afbryde Fotivda-terapien og/eller sænke dosis til:
English: • if you suffer from a disease of the brain, called posterior reversible encephalopathy syndrome (PRES)
Danish: • Hvis du lider af en sygdom i hjernen, kaldet posterior reversibelt encefalopati-syndrom
English: The baseline demographic and disease characteristics were generally well balanced across the tivozanib and sorafenib arms with regard to age (mean age 58.2 vs 58.4 years respectively), gender (71.2% vs 73.5% male respectively), race (95.8% vs 96.9% white respectively), geographic region (88.1% vs 88.7% from Central/Eastern Europe respectively) and prior treatment for metastatic RCC (69.6% vs 70.8% treatment naïve respectively).
Danish: Demografiske karakteristika og sygdomskarakteristika ved baseline var generelt velafbalanceret mellem tivozanib-armen og sorafenib-armen, hvad angår alder (gennemsnitlig alder 58,2 vs. 58,4 år), køn (71,2% vs. 73.5% mænd), race (95,8% vs. 96,9% hvide patienter), geografisk område (88,1% vs. 88,7% fra henholdsvis Centraleuropa/Østeuropa) og tidligere behandling for metastatisk RCC (69,6% vs. 70,8% behandlingsnaive patienter).
English: Tivozanib was shown to cause growth plate hypertrophy, absence of active corpora lutea and no maturing follicles in cynomolgus monkeys at dose levels that produced exposures equivalent to those seen at the recommended clinical dose.
Danish: Tivozanib har vist sig at forårsage vækstplade hypertrofi, mangel på aktiv corpora lutea og ingen modning af follikel hos cynomolgus aber ved dosisniveauer, som producerede eksponeringer ækvivalent med dem, der observeres ved den anbefalede kliniske dosis.
English: Baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within the normal range is recommended.
Danish: Ved baseline og derefter med jævne mellemrum anbefales det at monitorere elektrokardiogrammer og kontrollere, at elektrolytter (f.eks. calcium, magnesium, kalium) bevarer normale værdier.
English: Frequencies are defined as follows: very common (≥ 1/10);
Danish: Hyppighed defineres som: meget almindelig
English: There is no relevant use of tivozanib in the paediatric population in the indication advanced renal cell carcinoma.
Danish: Det er ikke relevant at anvende tivozanib hos den pædiatriske population ved en indikation af avanceret renalcellecarcinom.
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 (see section 4.6).
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 (se pkt.
English: • if you have had problems with blood clots.
Danish: • Hvis du har haft problemer med blodpropper.
English: Your doctor will monitor your blood pressure regularly and, if it is too high, may either give you a medicine to lower it, or reduce your dose of Fotivda.
Danish: Din læge vil overvåge dit blodtryk regelmæssigt og, hvis det er for højt, kan han/hun enten give dig en medicin for at sænke det eller reducere din dosis af Fotivda.
English: It is recommended that concomitant administration of tivozanib with strong CYP3A4 inducers, if used, should be undertaken with caution.
Danish: Det anbefales at udvise forsigtighed i tilfælde af samtidig administration af tivozanib og potente CYP3A4-induktorer, hvis anvendt.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og beholderen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This controlled clinical study was a Phase 3 multi-centre, open-label, international, randomised study comparing tivozanib with sorafenib in patients with advanced RCC. Five hundred and seventeen (517) patients with recurrent or metastatic RCC with a clear cell component were randomised (1:1) to receive either tivozanib 1340 microgram once daily on a schedule of 3 weeks on treatment followed by 1 week off (schedule 3/1) or sorafenib 400 mg twice a day.
Danish: Dette kontrollerede, kliniske studie var en Fase 3 multicenter, open-label, international, randomiseret studie, som sammenlignede tivozanib med sorafenib hos patienter med avanceret RCC. Femhundrede og sytten (517) patienter med tilbagevendende eller metastatisk RCC med en klar cellekomponent blev randomiseret (1:1) til at modtage enten tivozanib 1340 mikrogram én gang om dagen iht.
English: During treatment, patients should be monitored for hypertension and treated as needed with anti-hypertensive therapy according to standard medical practice.
Danish: Patienterne bør monitoreres for hypertension i løbet af behandlingen og behandles efter behov med antihypertensiva i henhold til standard medicinsk praksis.
English: 1 Goitre including goitre and toxic nodular goitre
Danish: 1 Struma omfatter struma og toksisk nodulær struma
English: The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor.
Danish: Det aktive stof i Fotivda er tivozanib, som er en proteinkinasehæmmer.
English: Thyroid function should be monitored before initiation of, and periodically throughout treatment with tivozanib.
Danish: Thyreoidefunktionen bør monitoreres før initiering af behandlingen og med jævne mellemrum under hele behandlingen med tivozanib.
English: • If you are taking St. John's Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety).
Danish: • Hvis du tager perikon (også kendt som Hypericum perforatum, et naturlægemiddel, der bruges til behandling af depression og uro).
English: Experience of tivozanib use in patients with severe renal impairment is limited and caution is advised.
Danish: Erfaringen med brug af tivozanib hos patienter med svær nedsat nyrefunktion er begrænset og det tilrådes at udvise forsigtighed.
English: Treatment with Fotivda may cause your thyroid gland to work less well than usual.
Danish: Behandlingen med Fotivda kan medføre, at din skjoldbruskkirtel fungerer mindre godt.
English: Tivozanib should be used with caution in patients with moderate hepatic impairment and the dose reduced to one 1340 microgram capsule every other day.
Danish: Tivozanib bør bruges med forsigtighed hos patienter med moderat nedsat leverfunktion og dosisreduceres til en 1340 mikrogram kapsel hver anden dag.
English: Mild to severe hypertension may be present (see section 4.4).
Danish: Mild til svær hypertension kan være til stede (se pkt.
English: Your doctor will regularly monitor you for these symptoms during your treatment with Fotivda.
Danish: Din læge vil regelmæssigt overvåge, om du har disse symptomer i løbet af din behandling med Fotivda.
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Danish: • En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: Signs or symptoms of cardiac failure should be periodically monitored throughout treatment with tivozanib.
Danish: Tegn eller symptomer på hjertesvigt bør monitoreres med jævne mellemrum under hele behandlingen med tivozanib.
English: After once daily dosing of 1340 microgram tivozanib for 21 or 28 days in RCC patients, Cmax was 67.5 to 94.3 ng/mL and AUC0-24 was 1,180 to 1,641 ng.hr/mL.
Danish: Efter en daglig dosis på 1340 mikrogram tivozanib i 21 eller 28 dage hos RCC patienter, var Cmax 67,5 til 94,3 ng/ml og AUC0-24 1.180 til 1.641 ng.hr/ml.
English: Table 1: Tabulated list of adverse reactions (presented using frequencies for all-causality adverse events)
Danish: Tabel 1: Opsummering af bivirkninger (præsenteret ved hjælp af hyppighed for alle bivirkninger med årsagssammenhæng)
English: In cases of suspected overdose, tivozanib should be discontinued and the patient monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Danish: I tilfælde af mistanke om overdosering bør tivozanib standses og patienten skal monitoreres for hypertension og behandles efter behov med standard antihypertensiv behandling.
English: Tivozanib must be used with caution in patients who are at risk for, or who have a history of these events (such as myocardial infarction, stroke).
Danish: Der skal udvises forsigtighed ved brug af Tivozanib hos patienter, som har en risiko for eller en sygehistorie med disse hændelser (såsom myokardieinfarkt, slagtilfælde).
English: Tivozanib must be used with caution in patients who are at risk for, or who have a history of bleeding.
Danish: Tivozanib skal bruges forsigtigt hos patienter, som har en risiko for eller en sygehistorie med blødning.
English: In the core RCC studies some adverse reaction occurred more commonly in the elderly (see section
Danish: I kerne RCC-studierne var nogle bivirkninger mere almindelige hos ældre patienter (se pkt.
English: Fotivda 890 microgram and Fotivda 1340 microgram are available as packs of 21 capsules in HDPE-bottles with child-resistant closure.
Danish: Fotivda 890 mikrogram og Fotivda 1340 mikrogram kan fås i pakninger med 21 kapsler i HDPE-beholdere med børnesikret lukning.
English: Elderly patients No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).
Danish: Ældre patienter Ingen dosisjustering er påkrævet hos patienter på 65 år eller ældre (se pkt.
English: Although the impact of further impairment of renal function on the overall disposition of tivozanib is unknown, a clinical study has shown that no unchanged tivozanib is excreted in the urine indicating that tivozanib does not undergo renal excretion..
Danish: Skønt indvirkningen af en yderligere reduktion af nyrefunktionen på den generelle disponering af tivozanib er ukendt, har et klinisk studie vist, at der ikke udskilles uændret tivozanib i urinen, hvilket angiver, at tivozanib ikke udskilles af nyrerne.
English: • If you have or are treated for an abnormal rate and rhythm of the heartbeat (arrhythmia).
Danish: • Hvis du har eller er behandlet for en unormal hjertefrekvens eller hjerterytme (arytmi).
English: Tivozanib should be used with caution in patients with mild and moderate hepatic impairment with close monitoring of tolerability.
Danish: Tivozanib bør bruges med forsigtighed hos patienter med mild og moderat nedsat leverfunktion med omhyggelig monitorering af tolerabilitet.
English: Women of childbearing potential/contraception in males and females Women of childbearing potential should avoid becoming pregnant while on tivozanib.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Kvinder i den fertile alder bør undgå at blive gravide, mens de tager tivozanib.
English: Studies conducted in vitro have shown that tivozanib is not a potent inhibitor of UGT (UDP-glucuronosyltransferase) metabolic activities and clinically relevant drug-drug interactions are unlikely with medicinal products metabolised by these pathways.
Danish: Studier kørt in vitro har vist, at tivozanib ikke er en potent hæmmer af UGT (UDP-glucuronosyltransferase) metaboliske aktiviteter og klinisk relevante lægemiddel interaktioner er ikke sandsynlige med lægemiddelprodukter, som metaboliseres af disse pathways.
English: Medicinal products for which intestinal absorption is restricted by BCRP Tivozanib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown (see section 5.2).
Danish: Lægemidler med en tarm-absorbering, der er begrænset af BCRP Tivozanib hæmmer transportørproteinet BCRP in vitro, men den kliniske relevans af dette fund er ukendt (se pkt.
English: Swallow the capsule whole.
Danish: Kapslen skal sluges hel.