FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not take Stivarga together with grapefruit juice (see also section ‘Taking Stivarga with food and drink').
Danish: Du bør ikke tage Stivarga sammen med grapefrugtjuice (se også punkt Brug af Stivarga sammen med mad og drikke).
English: Most patients (52%) received 3 or fewer previous lines of treatment for metastatic disease.
Danish: De fleste patienter (52 %) fik 3 eller færre tidligere behandlingslinjer for metastaserende sygdom.
English: Stivarga should not be used during pregnancy unless clearly necessary and after careful consideration of the benefits for the mother and the risk to the foetus.
Danish: Stivarga bør ikke anvendes under graviditeten, medmindre det tydeligvist er nødvendigt og efter omhyggelig overvejelse af fordelene for moderen og risikoen for fosteret.
English: You may need treatment for them and extra tests may be done (see also section 4 ‘Possible side effects').
Danish: Du skal muligvis behandles for det, og der kan udføres ekstra test (se også punkt 4, Bivirkninger)
English: Your doctor will discuss with you the potential risks of taking Stivarga during pregnancy.
Danish: Din læge vil tale med dig om de potentielle risici ved at tage Stivarga under graviditeten.
English: The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Danish: Den mediane sekundære PFS (målt efter investigatorens bedømmelse) var hhv. 5,0 og 4,5 måneder.
English: Increased INR*
Danish: Øget INR*
English: The tolerability of Stivarga in these patients has not been established.
Danish: Tolerancen af Stivarga er ikke fastsat hos disse patienter.
English: Laboratory parameter, (in % of samples investigated)
Danish: Laboratorieparameter (i % af undersøgte prøver)
English: Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates.
Danish: Det anbefales derfor at overvåge patienten nøje for tegn og symptomer på øget eksponering for BCRP-substrater.
English: Specific studies on fertility have not been performed.
Danish: Der er ikke udført specifikke fertilitets studier.
English: Frequency groups are defined by the following convention: very common (≥1/10); 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 the available data).
Danish: Hyppighedsgrupper defineres som følger: Meget almindelig (> 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000) og Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data)
English: The decision to re-start Stivarga therapy should be based on careful consideration of the potential benefits and risks of the individual patient.
Danish: Beslutningen om at genstarte behandlingen med Stivarga bør være baseret på nøje overvejelse af de potentielle fordele og risici for den enkelte patient.
English: Pregnancy, breast-feeding and fertility Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant as Stivarga should not be used during pregnancy unless clearly necessary.
Danish: Graviditet, amning og frugtbarhed Fortæl det til din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, da Stivarga ikke bør bruges under graviditeten, medmindre det tydeligvis er nødvendigt.
English: Urinary excretion of glucuronides decreased below 10% under steady-state conditions.
Danish: Udskillelse af glucuronider i urinen faldt under 10 % under steady state-betingelser.
English: • Loco-regional transarterial embolisation or chemoinfusion procedures: 61%
Danish: • Loco-regional transarterial embolisering eller kemoinfusionsprocedurer: 61 %
English: P-value (one-sided)
Danish: P-værdi (ensidet)
English: There are no data on the use of regorafenib in pregnant women.
Danish: Der er ingen data for anvendelse af regorafenib til gravide kvinder.
English: Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
Danish: Samlet udviklede ca. 4,6 % af patienterne i behandling med Stivarga hypotyroidisme, der krævede hormonsubstitutionsbehandling.
English: Elderly Age did not affect the regorafenib pharmacokinetics over the studied age range (29 - 85 years).
Danish: Ældre Alder påvirkede ikke regorafenibs farmakokinetik i det undersøgte aldersområde (29-85 år).
English: There is limited data in patients with PS ≥2.
Danish: Der er begrænsede data for patienter med PS ≥ 2.
English: It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Danish: Det er et lægemiddel, der bruges til at behandle kræft ved at hæmme kræftcellernes vækst og spredningen af kræftceller og afskære den blodforsyning, der gør at cellerne kan vokse.
English: There is no specific antidote for Stivarga overdose.
Danish: Der er ingen specifik antidot mod en Stivarga overdosis.
English: There is limited data on regorafenib in the black patient population.
Danish: Der er begrænsede data om regorafenib hos den negroide patientpopulation.
English: The exposure of regorafenib in various Asian populations (Chinese, Japanese, Korean) is within the same range as seen in Caucasians.
Danish: Eksponeringen for regorafenib af forskellige asiatiske populationer (kinesisk, japansk, koreansk) ligger inden for det samme område som hos kaukasere.
English: You may require medical attention and your doctor may tell you to stop taking Stivarga.
Danish: Du kan få brug for lægehjælp, og din læge kan bede dig holde op med at tage Stivarga.
English: Tell your doctor immediately if you have taken more than your prescribed dose.
Danish: Fortæl det straks til lægen, hvis du har taget mere end den ordinerede dosis.
English: Regorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Danish: Regorafenib udskilles hovedsageligt via leveren, og eksponeringen kan være øget hos denne patientpopulation.
English: • Absence of both macroscopic vascular invasion and extra-hepatic tumour spread: 19%
Danish: • Fravær af både makroskopisk vaskulær invasion og ekstrahepatisk tumorspredning: 19 %
English: Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary.
Danish: Din læge vil eventuelt reducere din dosis eller beslutte at afbryde eller stoppe behandlingen permanent, hvis det er nødvendigt.
English: The clinical significance of these potential interactions is unknown, but may result in a decreased efficacy of regorafenib.
Danish: Den kliniske signifikans af disse potentielle interaktioner er ukendt, men kan resultere i en nedsat virkning af regorafenib.
English: Avoid becoming pregnant while being treated with Stivarga, as this medicine may harm your unborn baby.
Danish: Undgå at blive gravid, mens du behandles med Stivarga, da dette lægemiddel kan skade det ufødte barn.
English: Patients with performance status (PS) 2 or higher were excluded from clinical studies.
Danish: Patienter med performance status (PS) 2 eller derover var ekskluderet fra kliniske studier.
English: The abnormalities are generally of mild to moderate severity, not associated with clinical manifestations, and do not usually require dose interruptions or reductions.
Danish: Forstyrrelserne er generelt af mild til moderat sværhedsgrad, ikke associeret med kliniske manifestationer og kræver sædvanligvis ingen dosisafbrydelser eller dosisreduktioner.
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 13%; BCLC stage C: 87%
Danish: • Barcelona Clinic leverkræft (BCLC) stadie B: 13 %; BCLC stadie C: 87 %
English: UGT1A1 and UGT1A9 substrates
Danish: UGT1A1- og UGT1A9-substrater
English: Before initiating Stivarga, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Stivarga bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: The analysis of the primary efficacy endpoint Progression-Free Survival (PFS) was conducted after 144 PFS events (central blinded assessment).
Danish: Analyse af det primære endepunkt for virkning, progressionsfri overlevelse (PFS) blev udført efter 144 PFS-hændelser (central blindet bedømmelse).
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Danish: Før ikke motorkøretøj og betjen ikke værktøj eller maskiner, hvis du oplever behandlingsrelaterede symptomer, der påvirker din koncentrations- og reaktionsevne.
English: There are no data on the effect of Stivarga on human fertility.
Danish: Der foreligger ingen data om virkningen af Stivarga på menneskets fertilitet.
English: In vitro protein binding of regorafenib to human plasma proteins is high (99.5%).
Danish: In vitro-proteinbinding af regorafenib til humane plasmaproteiner er høj (99,5 %).
English: The primary efficacy endpoint was OS.
Danish: Det primære endepunkt for virkning var OS.
English: Your doctor will monitor your blood pressure prior to and during treatment and may give you a medicine to treat high blood pressure.
Danish: Din læge vil kontrollere dit blodtryk før og under behandlingen og kan give dig et lægemiddel til behandling af højt blodtryk.
English: If you get this side effect, your doctor may change your dose or stop your treatment until your condition improves.
Danish: Hvis du får denne bivirkning, vil din læge eventuelt ændre din dosis eller standse din behandling, indtil din tilstand forbedres.
English: Two major and six minor metabolites of regorafenib have been identified in plasma.
Danish: Der er identificeret to større og seks mindre metabolitter af regorafenib i plasma.
English: Secondary endpoints including Time To Progression (TTP) and Overall Survival (OS (interim analysis) were also assessed.
Danish: Sekundære endepunkter, herunder tid til progression (TTP) og samlet overlevelse (OS) (interimanalyse), blev også bedømt.
English: Grade a
Danish: Grad a
English: Studies on the carcinogenic potential of regorafenib have not been performed.
Danish: Der er ikke udført studier af regorafenibs karcinogene potentiale.
English: The Asian patients treated with Stivarga in clinical studies were primarily from East Asia (~90%).
Danish: De asiatiske patienter, der blev behandlet med Stivarga i kliniske studier, var primært fra Østasien (~90 %).
English: Metabolite M-5 is a weak BCRP-substrate.
Danish: Metabolit M-5 er et svagt BCRP-substrat.
English: Of these events, 35.6% in the Stivarga arm and 54.5% in the placebo arm have been reported as not recovered/not resolved.
Danish: Ud af disse hændelser er 35,6 % af hændelserne i Stivarga-armen og 54,5 % i placeboarmen blevet rapporteret som ikke helbredt/ikke afklaret.
English: One case of Grade 4 hypertension was reported in the GIST trial.
Danish: Et tilfælde af grad 4 hypertension blev rapporteret i GIST-studiet.
English: Alterations of teeth and bones and adverse effects in the reproductive system were more pronounced in young and growing animals as well as in juvenile rats and indicate a potential risk for children and adolescents.
Danish: Ændringer af tænder og knogler samt negative virkninger på reproduktionssystemet var mere udtalt hos unge og ikke udvoksede dyr samt hos juvenile rotter og indikerer en potentiel risiko for børn og unge.
English: If you forget to take Stivarga
Danish: Hvis du har glemt at tage Stivarga
English: It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of treatment with Stivarga and monitor closely (at least every two weeks) during the first 2 months of treatment.
Danish: Det anbefales at tage leverfunktionsprøver (ALAT, ASAT og bilirubin) inden behandlingen med Stivarga indledes og kontrollere nøje (mindst hver anden uge) i løbet af de første 2 måneder af behandlingen.
English: The mean elimination half-life for the metabolite M-5 is approximately 60 hours (range from 40 to 100 hours).
Danish: Den gennemsnitlige halveringstid for metabolitten M-5 er ca. 60 timer (ligger mellem 40-100 timer).
English: This medicinal product may pose a risk to the environment (see section 5.3).
Danish: Dette lægemiddel kan udgøre en potentiel risiko for miljøet (se pkt.
English: You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
Danish: Sikkerhedsprofilen for Stivarga plus BSC i CONCUR-studiet var sammenlignelig med sikkerhedsprofilen i CORRECTstudiet.
English: 0.005178 6.4 months
Danish: 0,005178 6,4 måneder
English: PS ≥2 was reported during Stivarga treatment in 11.4% of patients.
Danish: PS ≥2 blev rapporteret under behandling med Stivarga hos 11,4 % af patienterne.
English: Percentages
Danish: Procent
English: Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all 573 randomised patients:
Danish: Karakteristika af demografi og sygdomsniveau var sammenlignelige mellem de Stivarga- og placebobehandlede grupper og er vist her under for alle 573 randomiserede patienter:
English: Other side effects with Stivarga listed by frequency:
Danish: Andre bivirkninger med Stivarga opstillet efter hyppighed:
English: No QTc prolonging effects were observed after administration of 160 mg regorafenib at steady state in a dedicated QT study in male and female cancer patients.
Danish: Der blev ikke observeret nogen QTc-forlængelse efter administration af 160 mg regorafenib ved steady state i et dedikeret QT-studie hos mandlige og kvindelige cancerpatienter.
English: Decreased appetite and food intake
Danish: Nedsat appetit og fødeindtagelse
English: In the event of suspected overdose, Stivarga should be discontinued immediately, with best supportive care initiated by a medical professional, and the patient should be observed until clinical stabilisation.
Danish: I tilfælde af mistanke om overdosis skal Stivarga omgående seponeres, med den bedste understøttende behandling, som skal indledes af en læge, og patienten skal observeres indtil klinisk stabilisering.
English: If you have a mildly or moderately impaired liver function while you are being treated with Stivarga, your doctor should monitor you closely.
Danish: Hvis du har let eller moderat nedsat leverfunktion, mens du er i behandling med Stivarga, bør din læge overvåge dig nøje.
English: Following single doses of 60 mg or 100 mg, the average relative bioavailability of tablets compared to an oral solution was 69% and 83%, respectively.
Danish: Efter enkelte doser på 60 mg eller 100 mg, var tabletternes gennemsnitlige relative biotilgængelighed sammenlignet med en oral opløsning hhv. 69 % og 83 %.
English: Polyvinyl alcohol, partially hydrolysed Talc
Danish: Polyvinylalkohol, delvist hydrolyseret Talcum
English: Contains sodium and lecithin (derived from soya).
Danish: Indeholder natrium og lecithin (deriveret fra soja).
English: Only 59.5 % of patients enrolled in the CONCUR study were also previously treated with VEGF- or EGFR-targeted agents.
Danish: Kun 59,5 % af de patienter, der indgik i CONCUR-studiet, var tidligere blevet behandlet med farmaka målrettet mod VEGF eller EGFR.
English: This can affect the way Stivarga works.
Danish: Det kan påvirke den måde, Stivarga virker på.
English: Some medicines may affect the way Stivarga works or Stivarga may affect how other medicines work and cause serious side effects.
Danish: Nogle former for medicin kan påvirke Stivargas virkningsmåde eller Stivarga kan påvirke anden medicins virkningsmåde og give alvorlige bivirkninger.
English: • Aetiology included Hepatitis B (38%), Hepatitis C (21%), Non-Alcoholic Steato Hepatitis
Danish: • Ætiologi inklusive hepatitis B (38 %), hepatitis C (21 %), non-alcoholic steatohepatitis (NASH,
English: Following oral administration, mean elimination half-life for regorafenib and its metabolite M-2 in plasma ranges from 20 to 30 hours in different studies.
Danish: Efter oral administration ligger den gennemsnitlige halveringstid for regorafenib og dets metabolit M-2 i plasma på mellem 20-30 timer i forskellige studier.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonens og tabletbeholderens etiket efter angiv forkortelsen for udløbsdatoen.
English: Dermatological toxicity
Danish: Dermatologisk toksicitet
English: Observed elevations of ALT and/or AST Occurrence
Danish: Observerede stigninger i ALAT og/eller ASAT
English: Once the bottle is opened the medicine is to be discarded after 7 weeks.
Danish: Når tabletbeholderen er blevet åbnet, skal lægemidlet bortskaffes efter 7 uger.
English: You must not breast-feed your baby during Stivarga treatment, as this medicine may interfere with the growth and development of your baby.
Danish: Du må ikke amme dit barn under behandlingen med Stivarga, da denne medicin kan påvirke barnets vækst og udvikling.
English: The highest dose of Stivarga studied clinically was 220 mg per day.
Danish: Den højeste dosis af Stivarga, der er undersøgt klinisk, var 220 mg pr. dag.
English: If patients experience symptoms affecting their ability to concentrate and react during treatment with Stivarga, it is recommended that they do not drive or use machines until the effect subsides.
Danish: Hvis patienterne oplever symptomer, der påvirker deres koncentrations- og reaktionsevne i løbet af behandlingen med Stivarga, anbefales det, at de ikke fører motorkøretøj og betjener maskiner indtil virkningen forsvinder.
English: - if you had or have any bleeding problems and if you are taking warfarin, phenprocoumon or another medicine that thins the blood to prevent blood clots.
Danish: - Hvis du har haft eller har blødningsproblemer, og hvis du tager warfarin, phenprocoumon eller et andet lægemiddel, der fortynder blodet for at forhindre blodpropper.
English: Main findings consisted of malformations of the urinary system, the heart and major vessels, and the skeleton.
Danish: De vigtigste fund bestod af misdannelser i urinsystemet, hjertet og større kar, samt skelettet.
English: A slightly increased incidence of thickening of the atrioventricular valves of the heart was seen in the 26 week repeat-dose toxicity study in rats.
Danish: En let forhøjet forekomst af fortykkelse af atrioventrikulære klapper i hjertet blev set i det 26-ugers toksicitetsstudie med gentagne doser hos rotter.
English: However, patients could continue Stivarga therapy past progression at the discretion of the investigator.
Danish: Patienterne kunne imidlertid fortsætte behandlingen med Stivarga efter progression på investigatorens skøn.
English: These may be signs of severe stomach or bowel problems.
Danish: Det kan være tegn på alvorlige mave- eller tarmproblemer.
English: The clinical significance of these findings is unknown (see also section 5.2).
Danish: Den kliniske betydning af disse fund kendes ikke (se også pkt.
English: Stivarga contains the active substance regorafenib.
Danish: Stivarga indeholder det aktive stof regorafenib.
English: CYP isoform-selective substrates
Danish: CYP-selektive substrater
English: Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy.
Danish: Stivarga bør ordineres af læger med erfaring i anti-cancerbehandling.
English: - if you are allergic to regorafenib or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for regorafenib eller et af de øvrige indholdsstoffer i Stivarga (angivet i punkt 6).
English: If a dose is missed, then it should be taken on the same day as soon as the patient remembers.
Danish: Hvis patienten glemmer at tage en dosis, skal den tages samme dag, så snart patienten kommer i tanke om det.
English: In vitro protein binding of M-2 and M-5 is higher (99.8% and 99.95%, respectively) than that of regorafenib.
Danish: In vitro-proteinbinding af M-2 og M-5 er højere (hhv. 99,8 % og 99,95 %) end for regorafenib.
English: Stivarga is indicated as monotherapy for the treatment of adult patients with
Danish: Stivarga er indiceret som monoterapi til behandling af voksne patienter med:
English: These may be signs of bleeding.
Danish: Det kan være tegn på blødning.
English: In case of vomiting after regorafenib administration, the patient should not take additional tablets.
Danish: Ved opkastning efter administration af regorafenib, må patienten ikke tage ekstra tabletter.
English: Nail disorder Erythema multiforme
Danish: Negleforandringer Erythema multiforme
English: The study was un-blinded after this planned interim analysis of OS had crossed the pre-specified efficacy boundary.
Danish: Studiet blev afblindet efter denne planlagte interimanalyse af den samlede overlevelse (OS) havde nået det forud specificerede effektmål.
English: ALT increased § Best Supportive Care * Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
Danish: Forhøjet ALAT § Bedste understøttende behandling * Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
English: Patients continued therapy with Stivarga until clinical or radiological disease progression or unacceptable toxicity.
Danish: Patienterne fortsatte behandlingen med Stivarga indtil klinisk eller radiologisk sygdomsprogression eller uacceptabel toksicitet.
English: The lowest recommended daily dose is 80 mg.
Danish: Den lavest anbefalede daglige dosis er 80 mg.
English: In case of vomiting after regorafenib administration, you should not take additional tablets and you should inform your doctor.
Danish: Hvis du kaster op efter administration af regorafenib, bør du ikke tage ekstra tabletter, og du bør fortælle det til lægen.
English: Contains sodium and lecithin (derived from soya), see leaflet for further information.
Danish: Indeholder natrium og lecithin (deriveret fra soja), se indlægssedlen for yderligere information.
English: Regorafenib could harm infant growth and development (see section 5.3).
Danish: Regorafenib kan skade spædbarnets vækst og udvikling (se pkt.
English: Hepatic effects
Danish: Hepatiske virkninger
English: >3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
Danish: > 3 gange ULN (grad 2 eller højere) med samtidig bilirubin > 2 gange ULN
English: M-5 is finally excreted via M-4 as M-6 (carboxylic acid) in faeces.
Danish: M-5 udskilles til sidst via M-4 som M-6 (carboxylsyre) i fæces.
English: - The active substance is regorafenib.
Danish: - Aktivt stof: Regorafenib.
English: Metastatic colorectal cancer (CRC)
Danish: Metastaserende kolorektal cancer (KRC)
English: Restart: If the potential benefit outweighs the risk of hepatotoxicity, re-start Stivarga treatment, reduce dose by 40 mg (one tablet), and monitor liver function weekly for at least 4 weeks.
Danish: Genstart Stivarga: Hvis den potentielle fordel opvejer risikoen for levertoksicitet, kan behandlingen med Stivarga genstartes, dosis reduceres med 40 mg (én tablet), og leverfunktionen overvåges ugentligt i mindst 4 uger.
English: Stivarga 40 mg tablets are light pink and oval, marked with “BAYER” on one side and “40” on the other side.
Danish: Stivarga 40 mg tabletter er lyserøde og ovale, mærket med ”BAYER” på den ene side og ”40” på den anden side.
English: The patient should not take two doses on the same day to make up for a missed dose.
Danish: Patienten må ikke tage en dobbeltdosis samme dag som erstatning for en glemt dosis.
English: StevensJohnson syndrome Toxic epidermal necrolysis
Danish: StevensJohnsons syndrom Toksisk epidermal nekrolyse