FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinaseinhibitor, ATC-kode: L01XE21
English: In addition, 56 placebo plus BSC patients received open-label Stivarga after cross-over following disease progression and a total of 41 Stivarga plus BSC patients continued Stivarga treatment after disease progression.
Danish: Desuden fik 56 patienter i placebo plus BSC-armen open-label Stivarga efter overkrydsning efter sygdomsprogression, og i alt 41 patienter i Stivarga plus BSC-armen fortsatte behandlingen med Stivarga efter sygdomsprogression.
English: Patients continued therapy until disease progression or unacceptable toxicity.
Danish: Patienterne fortsatte behandlingen indtil sygdomsprogression eller uacceptabel toksicitet.
English: In case of hypertensive crisis, Stivarga should be discontinued.
Danish: I tilfælde af hypertensiv krise skal Stivarga seponeres.
English: Increased Lipase
Danish: Øget lipase
English: A diagnosis of PRES requires confirmation by brain imaging.
Danish: En PRES-diagnose skal bekræftes med hjernescanning.
English: Measures for the prevention of HFSR include control of calluses and use of shoe cushions and gloves to prevent pressure stress to soles and palms.
Danish: Foranstaltninger til forebyggelse af HFSR inkluderer forebyggende behandling af hård hud og brug af skoindlæg og handsker for at forebygge trykbelastninger på fodsåler og håndflader.
English: Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with Stivarga.
Danish: Screening for og efterfølgende behandling af esofagale varicer hos patienter med levercirrhose bør være standardbehandling før opstart af behandling med Stivarga.
English: In cases of severe or persistent hypertension despite adequate medical management, treatment should be temporarily interrupted and/or the dose reduced at the discretion of the physician (see section 4.2).
Danish: I tilfælde med svær eller vedvarende hypertension på trods af tilstrækkelig medicinsk behandling, bør behandlingen afbrydes midlertidigt, og/eller dosis reduceres efter lægens skøn (se pkt.
English: When re-starting treatment, decrease dose by 40 mg (one tablet).
Danish: Når behandlingen genstartes, reduceres dosis med 40 mg (én tablet).
English: The exposure for regorafenib was increased by 48% when administered with a high-fat breakfast, and 36% when administered with a low fat breakfast, compared to fasting.
Danish: Eksponeringen for regorafenib var øget med 48 % efter administration af morgenmad med højt fedtindhold og 36 % efter administration af fedtfattig morgenmad, sammenlignet med fastende tilstand.
English: Stivarga 40 mg tablets are available in packs containing one bottle or three bottles.
Danish: Stivarga 40 mg tabletter findes i pakninger som indeholder én tabletbeholder eller tre tabletbeholdere.
English: In addition, regorafenib reduced the levels of tumour associated macrophages and has shown anti-metastatic effects in vivo.
Danish: Regorafenib har desuden reduceret niveauet af tumorassocierede makrofager og vist anti-metastatisk virkning in vivo.
English: The pharmacokinetics of regorafenib has not been studied in patients with end-stage renal disease.
Danish: Regorafenibs farmakokinetik er ikke blevet undersøgt hos patienter med nyresygdom i slutstadiet.
English: Clinical data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.
Danish: Kliniske data tyder på, at regorafenib ikke har indvirkning på digoxins farmakokinetik, og det kan derfor gives samtidig med P-glykoproteinsubstrater, som f.eks. digoxin, uden klinisk relevant lægemiddelinteraktion.
English: In patients developing PRES, discontinuation of Stivarga, along with control of hypertension and supportive medical management of other symptoms is recommended.
Danish: Hos patienter, der udvikler PRES, anbefales seponering af Stivarga samt kontrol af hypertension og understøttende medicinsk behandling af andre symptomer.
English: Cardiac electrophysiology/QT prolongation
Danish: Kardiel elektrofysiologi/QT-forlængelse
English: This indicates that co-administration of regorafenib may increase systemic exposure to UGT1A1 and UGT1A9 substrates.
Danish: Det indikerer, at samtidig administration af regorafenib kan øge systemisk eksponering for UGT1A1- og UGT1A9-substrater.
English: >20 times ULN (Grade 4)
Danish: > 20 gange ULN (grad 4)
English: Limited data in patients with moderate hepatic impairment (Child-Pugh B) indicate similar exposure, compared to patients with normal hepatic function after a single 100 mg dose of regorafenib.
Danish: Begrænsede data hos patienter med moderat nedsat leverfunktion (Child-Pugh B) indikerer en lignende eksponering sammenlignet med patienter med normal leverfunktion efter en enkelt 100 mg dosis af regorafenib.
English: Based on its mechanism of action regorafenib is suspected to cause foetal harm when administered during pregnancy.
Danish: Baseret på regorafenibs virkningsmekanisme er stoffet under mistanke for at medføre medfødte misdannelser, når det anvendes under graviditeten.
English: The desiccant is a moisture absorbing material filled in a small container to protect the tablets from moisture.
Danish: Tørremidlet er et fugtabsorberende materiale, som er fyldt i en lille beholder for at beskytte tabletterne mod fugt
English: Arterial hypertension
Danish: Arteriel hypertension
English: Grade b
Danish: Grad b
English: If your liver function is severely impaired, you should not be treated with Stivarga, as there are no data on the use of Stivarga in patients with a severely impaired liver function.
Danish: Hvis din leverfunktion er svært nedsat, bør du ikke behandles med Stivarga, da der ikke foreligger data om brugen af Stivarga hos patienter med svært nedsat leverfunktion.
English: NA Best Supportive Care Hazard ratio < 1 favours Stivarga ** based on investigator's assessment of tumour response by modified RECIST Response rate (complete or partial response), DCR (complete response, partial response and stable disease maintained for 6 weeks)
Danish: NA § Bedste understøttende behandling * Hazard ratio < 1: Stivarga er bedre end placebo ** baseret på investigatorens bedømmelse af tumorrespons ved modificeret RECIST # Tumorresponsrate (helt eller delvist respons), DCR (helt respons, delvist respons og stabil sygdom opretholdt i 6 uger)
English: This indicates that co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin).
Danish: Dette tyder på, at samtidig administration af regorafenib kan øge plasmakoncentrationerne af andre BCRP-substrater, som gives samtidig (f.eks. methotrexat, fluvastatin, atorvastatin).
English: Patients were eligible to participate in the study if they experienced radiological disease progression during treatment with sorafenib and if they had a liver function status of Child-Pugh class A. Patients who permanently discontinued sorafenib therapy due to sorafenib-related toxicity or who tolerated less than 400 mg sorafenib once daily prior to withdrawal were excluded from the study.
Danish: Patienterne var berettiget til at deltage i studiet, hvis de oplevede radiologisk sygdomsprogression under behandlingen med sorafenib, og hvis de havde nedsat leverfunktion status Child-Pugh A. De patienter, som helt stoppede behandlingen med sorafenib grundet sorafenib-relateret toksicitet eller som tålte mindre end 400 mg sorafenib dagligt, inden de trak sig fra studiet, blev ekskluderet fra studiet.
English: Approximately 90% of the radioactive dose was recovered within 12 days after administration, with about 71% of the dose excreted in faeces (47% as parent compound, 24% as metabolites), and about 19% of the dose excreted in urine as glucuronides.
Danish: Ca. 90 % af den radioaktive dosis genvindes inden for 12 dage fra administration, hvor ca. 71 % af dosis udskilles i fæces (47 % som moderforbindelse, 24 % som metabolitter) og ca. 19 % af dosis udskilles i urin som glucuronider.
English: (asthenia/fatigue) - pain - fever - weight loss.
Danish: (asteni/udmattelse) - smerte - feber - vægttab.
English: Signs and symptoms of PRES include seizures, headache, altered mental status, visual disturbance or cortical blindness, with or without associated hypertension.
Danish: Tegn og symptomer på PRES inkluderer krampeanfald, hovedpine, ændret mentalstatus, synsforstyrrelse eller kortikal blindhed, med eller uden associeret hypertension.
English: In the event of severe bleeding necessitating urgent medical intervention, permanent discontinuation of Stivarga should be considered.
Danish: I tilfælde af svær blødning, der kræver akut lægebehandling, bør permanent seponering af Stivarga overvejes.
English: Environmental risk assessment studies have shown that regorafenib has the potential to be persistent, bioaccumulative and toxic to the environment and may pose a risk to the surface water and to the sediment compartment (see section 6.6).
Danish: Studier med henblik på miljørisikovurdering har vist, at regorafenib potentielt kan være persisterende, bioakkumulerende og toksisk for miljøet og kan udgøre en risiko for overfladevand og for sediment (se pkt.
English: Ask your doctor for advice before taking Stivarga.
Danish: Spørg din læge til råds, før du tager Stivarga.
English: The tablets should be swallowed whole with water after a light meal that contains less than 30% fat.
Danish: Tabletterne bør sluges hele sammen med vand efter et let måltid med et fedtindhold på under 30 %.
English: Bile saltsequestering agents such as cholestyramine and cholestagel may interact with regorafenib by forming insoluble complexes which may impact absorption (or reabsorption), thus resulting in potentially decreased exposure.
Danish: Galdesaltsekvestrerende stoffer såsom colestyramin og cholestagel kan interagere med regorafenib ved at danne uopløselige komplekser, der kan påvirke optagelsen (eller genoptagelsen), og derved medføre potentielt nedsat eksponering.
English: The primary site of disease was colon (65%), rectum (29%), or both (6%).
Danish: Den primære diagnose var coloncancer (65 %), rektumcancer (29 %) eller begge (6 %).
English: Both women of childbearing potential and men should use effective contraception during treatment and for at least eight weeks after completion of treatment.
Danish: Både kvinder i den fertile alder og mænd skal anvende sikker kontraception under behandlingen og i mindst otte uger efter behandlingens afslutning.
English: Patients receiving placebo who experienced disease progression were offered open-label regorafenib (cross-over option).
Danish: Patienter, der fik placebo og oplevede sygdomsprogression, blev tilbudt open-label regorafenib (mulighed for overkrydsning).
English: It is unknown whether regorafenib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om regorafenib eller metabolitter herfra udskilles i human mælk.
English: There is insufficient data on patients who discontinued sorafenib therapy due to sorafenib-related toxicity or only tolerated a low dose (< 400 mg daily) of sorafenib.
Danish: Der er ikke tilstrækkeligt data fra de patienter, som stoppede behandlingen med sorafenib grundet sorafenibrelateret toksicitet eller som kun tålte en lav dosis sorafenib (< 400 mg dagligt).
English: In cases of worsening infection events, interruption of Stivarga treatment should be considered.
Danish: I tilfælde af forværring af episoder med infektioner bør ophør af behandlingen med Stivarga overvejes.
English: Blood pressure should be controlled prior to initiation of treatment with Stivarga.
Danish: Blodtrykket skal kontrolleres, inden behandlingen med Stivarga indledes.
English: - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies.
Danish: - metastaserende kolorektal cancer (KRC), som tidligere er blevet behandlet med, eller som ikke anses for egnet til behandling med de tilgængelige behandlinger.
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between elderly (aged 65 years and above) and younger patients (see also section 5.2).
Danish: I kliniske studier blev der ikke observeret relevante forskelle i eksponering, sikkerhed eller virkning mellem ældre (65 år og derover) og yngre patienter (se også pkt.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must be informed that regorafenib may cause foetal harm.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Kvinder i den fertile alder skal informeres om, at regorafenib kan medføre medfødte misdannelser.
English: These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)
Danish: Disse omfatter fluorpyrimidin-baseret kemoterapi, anti-VEGF-behandling og anti-EGFR-behandling (se section 5.1)
English: Tell your doctor if you are breast-feeding or planning to breast-feed.
Danish: Fortæl lægen, hvis du ammer eller planlægger at amme.
English: Patients with a history of ischaemic heart disease should be monitored for clinical signs and symptoms of myocardial ischaemia.
Danish: Patienter med iskæmisk hjertesygdom i anamnesen bør kontrolleres for kliniske tegn og symptomer på myokardieiskæmi.
English: If you notice any changes contact your doctor.
Danish: Kontakt lægen, hvis du bemærker ændringer.
English: An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat).
Danish: Et eksempel på et let (fedtfattigt) måltid kunne være 1 portion morgenmads-kornprodukt (ca. 30 g), 1 glas skummetmælk, 1 skive toast med syltetøj, 1 glas æblejuice og 1 kop kaffe eller te (520 kalorier, 2 g fedt).
English: However, a potential of regorafenib to adversely affect male and female reproduction has to be considered based on morphological changes in the testes, ovaries, and the uterus observed after repeated dosing in rats and dogs at exposures below the anticipated human exposure (based on AUC comparison).
Danish: Det skal dog tages i betragtning, at regorafenib potentielt kan have negativ indvirkning på mandlig og kvindelig reproduktion baseret på morfologiske ændringer i testikler, ovarier og uterus, hvilket blev observeret efter gentagne doser hos rotter og hunde ved en eksponering som er lavere end den forventede humane eksponering (baseret på AUC-sammenligning).
English: In clinical studies, no relevant differences in exposure or efficacy were observed between patients of different ethnic groups.
Danish: I kliniske studier blev der ikke observeret relevante forskelle i eksponering eller effekt mellem patienter fra forskellige etniske grupper.
English: These effects occurred at systemic exposures in the range of or below the anticipated human exposure (based on AUC comparison).
Danish: Disse bivirkninger forekom ved systemiske eksponeringer indenfor eller lavere end den forventede human eksponering (baseret på AUC-sammenligning).
English: The safety profile of regorafenib in these studies was consistent with the safety results of a phase III B study conducted in 2872 patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.
Danish: Regorafenibs sikkerhedsprofil i disse studier var i overensstemmelse med sikkerhedsresultaterne fra et fase III B-studie udført med 2872 patienter med metastatisk kolorektalkræft, hvor patienternes sygdom havde udviklet sig efter standardbehandling.
English: Inhibitors and inducers of BCRP and P-glycoprotein may interfere with the exposure of M-2 and M-5.
Danish: Inhibitorer og induktorer af BCRP og P-glykoprotein kan påvirke eksponeringen af M-2 og M-5.
English: Women of childbearing potential and men should ensure effective contraception during treatment and up to 8 weeks after completion of therapy.
Danish: Kvinder i den fertile alder og mænd skal anvende effektiv prævention under behandlingen og i op til 8 uger efter behandlingens afslutning.
English: There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.
Danish: Der var ingen tegn på genotoksisk virkning af regorafenib baseret på standardanalyser in vitro og in vivo hos mus.
English: The main circulating metabolites of regorafenib in human plasma are M-2 (N-oxide) and M-5 (N-oxide and N-desmethyl), which are pharmacologically active and have similar concentrations as regorafenib at steady state.
Danish: Regorafenibs vigtigste cirkulerende metabolitter i humant plasma er M-2 (N-oxid) og M-5 (N-oxid og N-desmethyl), som er farmakologisk aktive og har lignende koncentrationer som regorafenib ved steady state.
English: As medicinal products with anti-angiogenic properties may suppress or interfere with wound healing, temporary interruption of Stivarga is recommended for precautionary reasons in patients undergoing major surgical procedures.
Danish: Da lægemidler med antiangiogene egenskaber kan hæmme eller påvirke sårheling, anbefales det at afbryde Stivarga midlertidigt hos patienter, der gennemgår større operationer.
English: Subgroup analyses for OS and PFS according to age (<65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation status showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Danish: Subgruppe-analyser af OS og PFS i forhold til alder (< 65; ≥ 65), køn, ECOG PS, primærtumors lokalisation, tid fra diagnose af metastaserende sygdom, tidligere kræftbehandling, tidligere behandlingslinjer for metastaserende sygdom og KRAS-mutationsstatus viste en behandlingseffekt, der var til fordel for regorafenib-behandlede patienter sammenlignet med placebobehandlede patienter.
English: - dry mouth - decreased appetite - high blood pressure (hypertension) - excessive tiredness (fatigue).
Danish: - mundsår (slimhindeinflammation) - tør mund - nedsat appetit - højt blodtryk (hypertension) - overdreven træthed (udmattelse).
English: The decision to resume treatment with Stivarga following major surgical intervention should be based on clinical judgment of adequate wound healing.
Danish: Beslutningen om at genoptage behandlingen med Stivarga efter en større operation bør derfor baseres på et klinisk skøn om tilstrækkelig sårheling.
English: Hyperbilirubinaemia Increase in transaminases
Danish: Hyperbilirubinæmi Stigning i transaminaser
English: Once the bottle is opened the medicinal product has shown to be stable for 7 weeks.
Danish: Når tabletbeholderen er anbrudt, er lægemidlet stabilt i 7 uger.
English: The recommended daily dose in adults is 4 tablets of Stivarga 40 mg (160 mg regorafenib).
Danish: Den anbefalede daglige dosis til voksne er 4 tabletter med Stivarga 40 mg (160 mg regorafenib).
English: Gastrointestinal stromal tumours (GIST)
Danish: Gastrointestinale stromale tumorer (GIST)
English: Table 6: Efficacy results from the GRID study Efficacy parameter
Danish: Tabel 6: Virkningsresultater fra GRID-studiet Virknings parameter
English: Plasma concentration-time profiles for regorafenib as well as for the major circulating metabolites showed multiple peaks across the 24-hour dosing interval, which are attributed to enterohepatic circulation.
Danish: Koncentrations-/tidsprofilerne for regorafenib i plasma samt for de vigtigste cirkulerende metabolitter viste flere toppe i doseringsintervallet på 24 timer, som skyldes enterohepatisk cirkulation.
English: The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Stivarga (41.0% vs. 14.9%, p<0.000001, 1 sided).
Danish: DCR (fuldstændigt respons eller delvist respons eller stabil sygdom) var signifikant højere hos patienter i behandling med Stivarga (41,0 % vs. 14,9 %, p<0,000001, 1-sidet).
English: - if you have high blood pressure Stivarga can raise your blood pressure.
Danish: - Hvis du har højt blodtryk.
English: Hypokalaemia Hypophosphatemia Hypocalcaemia Hyponatraemia Hypomagnesaemia Hyperuricaemia Dehydration
Danish: Hypokaliæmi Hypofosfatæmi Hypokalcæmi Hyponatriæmi Hypomagnesiæmi Hyperurikæmi Dehydrering
English: There is no relevant use of Stivarga in children and adolescents in the indication of colon or rectal cancer that has spread to other parts of the body.
Danish: Der er ingen relevant anvendelse af Stivarga til børn og unge for indikationen kræft i tyktarmen eller endetarmen, der har spredt sig til andre dele af kroppen.
English: The response rate (complete response or partial response) was 1% and 0.4% for Stivarga and placebo treated patients, respectively (p=0.188432, 1-sided).
Danish: Responsraten (komplet respons eller delvist respons) var hhv. 1 % og 0,4 % for Stivargaog placebobehandlede patienter (p=0,188432, 1-sidet).
English: Administration of regorafenib with a 5-day break prior to administration of irinotecan resulted in an increase of approximately 44% in AUC of SN-38, a substrate of UGT1A1 and an active metabolite of irinotecan.
Danish: Administration af regorafenib med en 5 dages pause inden administration af irinotecan resulterede i en stigning på ca. 44 % i AUC for SN-38, et substrat af UGT1A1 og en aktiv metabolit af irinotecan.
English: Dose modifications are to be applied in 40 mg (one tablet) steps.
Danish: Dosismodifikationer skal foretages i trin på 40 mg (én tablet).
English: In most cases of severe liver injury, liver dysfunction had an onset within the first 2 months of therapy, and was characterized by a hepatocellular pattern of injury with transaminase elevations >20xULN, followed by bilirubin increase.
Danish: I de fleste tilfælde med svær leverskade opstod den nedsatte leverfunktion inden for de første 2 måneders behandling, og var karakteriseret ved et hepatocellulært skadesmønster med transaminaseforhøjelser > 20 x ULN efterfulgt af en bilirubinforhøjelse.
English: The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients with metastatic colorectal cancer (CRC), 132 patients with gastrointestinal stromal tumours (GIST) and 374 patients with hepatocellular carcinoma (HCC).
Danish: Stivargas samlede sikkerhedsprofil er baseret på data fra flere end 4.800 behandlede patienter i kliniske studier, inklusive placebokontrollerede fase III-data fra 636 patienter med metastaserende kolorektal cancer (KRC), 132 patienter med gastrointestinale stromale tumorer (GIST) og 374 patienter med hepatocellulært karcinom (HCC).
English: In patients who develop cardiac ischaemia and/or infarction, interruption of Stivarga is recommended until resolution.
Danish: Hos patienter, der udvikler hjerteiskæmi og/eller hjerteinfarkt, anbefales det at afbryde Stivarga indtil resolution.
English: Abnormalities of liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with Stivarga.
Danish: Påvirkede leverfunktionsprøver (alanin-aminotransferase [ALAT], aspartataminotransferase [ASAT] og bilirubin) er blevet observeret hyppigt hos patienter som behandles med Stivarga.
English: This includes medicines obtained without a prescription or even over-the-counter medicines, such as vitamins, dietary supplements or herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer, kosttilskud eller mineraler.