FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with observed worsening of liver function tests considered related to treatment with Stivarga (i.e. where no alternative cause is evident, such as post-hepatic cholestasis or disease progression), the dose modification and monitoring advice in Table 2 should be followed (see section 4.2).
Danish: 4.2) for patienter med forværring/påvirkning af leverfunktionsprøver, der anses for at være relateret til behandlingen med Stivarga (dvs. hvor der ikke er nogen anden tydelig årsag, f.eks. post-hepatisk kolestase eller sygdomsprogression).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Stivarga in all subsets of the paediatric population in the treatment of hepatocellular carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Stivarga i alle undergrupper af den pædiatriske population ved behandling af hepatocellulært karcinom (se pkt.
English: Most cases of bleeding events in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 15.2%), most notably epistaxis (6.1%).
Danish: De fleste blødningshændelser hos patienter i behandling med Stivarga var lette til moderate i sværhedsgrad (grad 1 og 2: 15,2 %), hovedsageligt næseblod (6,1 %).
English: Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4).
Danish: En daglig dosis på 160 mg indeholder1,68 mg lecithin (deriveret fra soja) (se pkt.
English: Get medical help immediately if you get the following symptoms: - yellowish discolouration of the skin and the whites of the eyes - dark urine - confusion and/or disorientation.
Danish: Få omgående akuthjælp, hvis du får følgende symptomer: - gullig misfarvning af huden og det hvide i øjnene - mørk urin - forvirring og/eller desorientering.
English: In total, 199 patients with GIST were randomised 2:1 to receive either 160 mg regorafenib plus Best Supportive Care (BSC) (N=133) orally once daily or matching placebo plus BSC (N=66) for 3 weeks on therapy followed by 1 week off therapy.
Danish: I alt blev 199 patienter med GIST randomiseret i forholdet 2:1 til enten 160 mg regorafenib plus bedste understøttende behandling (BSC, N=133) oralt én gang dagligt eller matchende placebo plus BSC (N=66) i 3 uger, efterfulgt af 1 uge uden behandling.
English: The most serious adverse drug reactions in patients receiving Stivarga are severe liver injury, haemorrhage, gastrointestinal perforation and infection.
Danish: De alvorligste lægemiddelbivirkninger hos patienter, der får Stivarga, er svær leverskade, blødning, mave-tarm-perforation og infektion.
English: - if you recently had, or are going to have, a surgical procedure Stivarga might affect the way your wounds heal and treatment may need to be stopped until your wound have healed.
Danish: Stivarga kan påvirke sårhelingen, og det kan være nødvendigt at stoppe behandlingen med Stivarga, indtil dit sår er helet.
English: The hazard ratio (95% CI) of OS was 0.653 (0.476 to 0.895) for patients with KRAS wild-type tumours and 0.867 (0.670 to 1.123) for patients with KRAS mutant tumours, with no evidence of heterogeneity in treatment effect (non-significant interaction test).
Danish: patienter med KRAS-wildtype tumorer og 0,867 (0,670-1,123) for patienter med en KRAS-mutation i tumor uden påviselig heterogeneitet i behandlingseffekt (ikke-signifikant interaktionstest).
English: Figure 2: Kaplan-Meier curves of PFS
Danish: Figur 2: Kaplan-Meier kurver for PFS
English: Interrupt therapy for a minimum of 7 days until toxicity resolves to Grade 0-1.
Danish: Afbryd behandlingen i mindst 7 dage, indtil toksiciteten er forsvundet eller forbedret til grad 0-1.
English: TSH post baseline >4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3% of patients receiving placebo.
Danish: TSH >4 gange ULN efter start på behandling blev rapporteret hos 6,5 % af patienterne, der blev behandlet med Stivarga, og hos 1,3 % af patienterne, der fik placebo.
English: Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Danish: Det anbefales at kontrollere den samlede sikkerhed nøje hos patienter med let til moderat nedsat leverfunktion (se også pkt.
English: Very common side effects (may affect more than 1 in 10 users)
Danish: Meget almindelige bivirkninger (kan opstå hos flere end 1 ud af 10 brugere)
English: TTP was significantly longer in patients receiving regorafenib plus BSC than in patients receiving placebo plus BSC with a hazard ratio of 0.248 [95% CI 0.170, 0.364], and median TTP of 5.4 months vs. 0.9 months (p<0.000001) (see Table 6).
Danish: TTP var signifikant længere hos patienter, der fik regorafenib plus BSC, end hos patienter, der fik placebo plus BSC, med en hazard ratio på 0,248 [95 % CI 0,170; 0,364], og en median TTP på 5,4 måneder vs. 0,9 måneder (p<0,000001) (se tabel 6).
English: In clinical trials, a higher incidence of HFSR was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Danish: I kliniske studier blev der observeret en højere forekomst af HFSR hos asiatiske patienter behandlet med Stivarga (især japanske) sammenlignet med kaukasiske patienter (se pkt.
English: 5.0 months
Danish: 5,0 måneder
English: These may be signs of an infection.
Danish: Det kan være tegn på alvorlig leverskade.
English: - signs/symptoms of an allergic reaction which may include widespread severe rash, feeling sick, fever, breathlessness, jaundice, changes in chemicals produced by the liver
Danish: - symptomer på en allergisk reaktion, som kan omfatte udbredt alvorligt udslæt, kvalme, feber,
English: Regorafenib plus BSC resulted in significantly longer PFS, compared to placebo plus BSC with a hazard ratio of 0.268 [95% CI 0.185, 0.388] and a median PFS of 4.8 months vs. 0.9 months (p < 0.000001).
Danish: Regorafenib plus BSC førte til en signifikant længere PFS sammenlignet med placebo plus BSC med en hazard ratio på 0,268 [95 % CI 0,185; 0,388] og en median PFS på 4,8 måneder vs. 0,9 måneder (p<0,000001).
English: - shortness of breath - burning/pain when urinating - unusual vaginal discharge or irritation - redness, swelling and/or pain in any part of the body.
Danish: - stakåndethed - brændende fornemmelse/smerte ved vandladning - usædvanligt udflåd fra skeden eller irritation - rødme, hævelse og/eller smerter vilkårlige steder på kroppen Det kan være tegn på en infektion.
English: The relative risk of disease progression or death was reduced by approximately 73.2% in regorafenib-treated patients, compared to placebo treated patients (see Table 6, Figure 2).The increase in PFS was consistent independent of age, sex, geographic region, prior lines of treatment, ECOG PS.
Danish: Den relative risiko for sygdomsprogression eller død var reduceret med ca. 73,2 % hos regorafenib-behandlede patienter sammenlignet med placebobehandlede patienter (se tabel 6, figur 2).
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (CORRECT) in patients with metastatic colorectal cancer who have progressed after failure of standard therapy.
Danish: Stivargas kliniske virkning og sikkerhed er blevet undersøgt i et internationalt, randomiseret, dobbeltblindet, placebokontrolleret, fase III-multicenterstudie (CORRECT) hos patienter med metastaserende kolorektal cancer, hvis sygdom var progredieret efter svigt af standardbehandling.
English: Myocardial infarction Myocardial ischaemia
Danish: Myokardieinfarkt Myokardieiskæmi
English: Stivarga has been associated with an increased incidence of infection events, some of which were fatal (see section 4.8).
Danish: Stivarga er blevet associeret med en øget forekomst af episoder med infektioner, heraf også nogle med dødelig udgang (se pkt.
English: How to store Stivarga
Danish: Sådan skal du tage Stivarga
English: - if you experience skin problems Stivarga can cause redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
Danish: Stivarga kan forårsage rødme, smerte, hævelse eller blærer på håndfladerne og fodsålerne.
English: Gastrointestinal perforation and fistula
Danish: Mave-tarm-perforation og fistel
English: Contents of the pack and other information What Stivarga contains
Danish: Pakningsstørrelser og yderligere oplysninger Stivarga indeholder:
English: Before you start taking Stivarga your doctor may decide to do blood tests.
Danish: Din læge kan beslutte at tage blodprøver, inden du starter med at tage Stivarga.
English: Other medicines and Stivarga
Danish: Brug af anden medicin sammen med Stivarga
English: The addition of Stivarga to BSC resulted in a significantly longer survival, compared to placebo plus BSC with a hazard ratio of 0.550 (p = 0.000159 stratified log rank test) and a median OS of 8.8 months vs. 6.3 months [95% CI 0.395, 0.765].
Danish: Tillæg af Stivarga til BSC resulterede i signifikant længere overlevelse sammenlignet med placebo plus BSC med en hazard ratio på 0,550 (p = 0,000159 stratificeret log rank test) og en median OS på 8,8 måneder vs. 6,3 måneder [95 % CI 0,395; 0,765].
English: Rare side effects (may affect up to 1 in 1,000 users)
Danish: Sjældne bivirkninger (kan opstå hos op til 1 ud af 1.000 brugere)
English: Get medical help immediately, if you get the following symptoms: passing blood in the stools or passing black stools, passing blood in the urine, stomach pain, coughing/vomiting up blood.
Danish: Få straks medicinsk hjælp, hvis du får følgende symptomer: blod i afføringen eller sort afføring, blod i urinen, mavesmerter, hoste/opkastning af blod.
English: Interrupt Stivarga treatment.
Danish: Afbryd behandlingen med Stivarga.
English: The median treatment duration and daily dose, as well as the rate of dose modification and dose reduction were similar to those observed in patients with a reported
Danish: Median behandlingsvarighed og daglige dosis, samt hyppigheden af dosismodifikationer var sammenlignelige med placebobehandlede patienter med PS≥2 (8,3 %).
English: The addition of Stivarga to BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with a hazard ratio of 0.624 [95% CI 0.498, 0.782], p=0.000017 stratified log rank test, and a median OS of 10.6 months vs. 7.8 months (see Table 7 and Figure 4).
Danish: Behandling med Stivarga plus BSC resulterede i signifikant forbedring i OS sammenlignet med placebo plus BSC med en hazard ratio på 0,624 [95 % CI 0,498, 0,782], p=0,000017 stratificeret log rank test, og en gennemsnitlig OS på 10,6 måneder vs. 7,8 måneder (se tabel 7 og fig. 4).
English: The mean daily regorafenib dose received was 147 mg.
Danish: Den gennemsnitlige daglige regorafenibdosis var 147 mg.
English: Take special care with Stivarga
Danish: Vær ekstra forsigtig med Stivarga
English: 1st occurrence
Danish: 1. forekomst
English: Talk to your doctor or pharmacist before taking Stivarga.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før du tager Stivarga.
English: - if you develop a severe and persistent headache, visual disturbances, seizures or altered mental status (such as confusion, memory loss or loss of orientation) please contact your doctor immediately.
Danish: - Kontakt omgående lægen, hvis du får en alvorlig og vedvarende hovedpine, synsforstyrrelser, krampeanfald eller ændret mental tilstand (såsom forvirring,
English: Before you start taking Stivarga and during treatment your doctor will check how well your heart is working.
Danish: Din læge vil undersøge, hvor godt dit hjerte fungerer, inden du starter med at tage Stivarga og under behandlingen.
English: The mean daily regorafenib dose received was 144 mg.
Danish: Den gennemsnitlige daglige regorafenibdosis var 144 mg.
English: Mucosal inflammation
Danish: Slimhindebetændelse
English: Median (95% CI) Stivarga plus BSC§ (N=379)
Danish: Gennemsnit (95 % CI) Stivarga plus BSC§ (N=379)
English: In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Danish: I kliniske studier med Stivarga blev der observeret en højere forekomst af svære anomalier i leverfunktionsprøver og leverdysfunktion hos asiatiske patienter behandlet med Stivarga (især japanske) sammenlignet med kaukasiske patienter (se pkt.
English: Iron oxide red (E172) Iron oxide yellow (E172) Lecithin (derived from soya) Macrogol 3350
Danish: Lecithin (deriveret fra soja) Macrogol 3350
English: Hazard ratio* (95% CI)
Danish: (95% CI)
English: Discontinue treatment with Stivarga permanently.
Danish: Seponer permanent behandlingen med Stivarga.
English: Grade
Danish: Overtræk
English: Taste disorders Dry mouth Gastrooesophageal reflux Gastroenteritis
Danish: Smagsforstyrrelser Tør mund Gastroøsofageal refluks
English: Investigations Weight loss
Danish: Undersøgelser Vægttab
English: 2nd occurrence
Danish: 2. forekomst
English: The mean daily regorafenib dose received was 140 mg.
Danish: Den gennemsnitlige daglige regorafenibdosis var 140 mg.
English: The majority of patients with PS ≥2 discontinued treatment for progressive disease.
Danish: Størstedelen af patienterne med PS ≥2
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Get medical help immediately, if you get the following symptoms: - passing blood in the stools or passing black stools - passing blood in the urine - stomach pain - coughing/vomiting up blood.
Danish: Få omgående akuthjælp, hvis du får følgende symptomer: - blod i afføringen eller sort afføring - blod i urinen - mavesmerter - blodigt ophost/blodigt opkast.
English: If you miss a dose, take it as soon as you remember on that day.
Danish: Hvis du glemmer en dosis, skal du tage den så snart, du kommer i tanke om det på den dag, du skulle have taget den. Du må ikke tage en dobbeltdosis Stivarga som erstatning for en glemt dosis fra den forrige dag.
English: 3rd occurrence
Danish: 3. forekomst
English: In particular, tell your doctor if you are taking anything in this list or any other medicines: - some medicines to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole and voriconazole) - some medicines to treat pain (e.g. mefenamic acid, diflunisal, and niflumic acid) - some medicines to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin) - medicines typically used to treat epilepsy (seizures) (e.g. phenytoin, carbamazepine or phenobarbital) - methotrexate, a medicine typically used to treat cancer - rosuvastatin, fluvastatin, atorvastatin, medicines typically used to treat high cholesterol - warfarin or phenprocoumon, medicines typically used to thin your blood - St. John's wort (medicine obtained also without a prescription), a herbal treatment for depression.
Danish: carbamazepin eller phenobarbital) - methotrexat, et lægemiddel, der typisk bruges til at behandle kræft - rosuvastatin, fluvastatin, atorvastatin, lægemidler, der typisk bruges til behandling af forhøjet kolesterol - warfarin eller phenprocoumon, lægemidler, der typisk bruges til at fortynde blodet - perikon (et lægemiddel, der også fås uden recept), et naturlægemiddel mod depression.
English: Co-administration with neomycin, a poorly absorbed antimicrobial agent used for eradicating the gastrointestinal microflora (which may interfere with the enterohepatic circulation of regorafenib) had no effect on the regorafenib exposure, but there was an approximately 80% decrease in the exposure of the active metabolites M-2 and M-5 which showed in vitro and in vivo comparable pharmacological activity as regorafenib.
Danish: Administration sammen med neomycin, et antimikrobielt stof, der absorberes i ringe grad og anvendes til at eliminere mikrofloraen i mave-tarm-kanalen (hvilket kan påvirke regorafenibs enterohepatiske cirkulation), havde ingen indvirkning på eksponeringen for regorafenib.
English: Figure 3: Kaplan-Meier curves of OS
Danish: Figur 3: Kaplan-Meier kurver for OS
English: Common side effects (may affect up to 1 in 10 users)
Danish: Almindelige bivirkninger (kan opstå hos op til 1 ud af 10 brugere)
English: (hypersensitivity reaction) - heart attack, chest pain (myocardial infarction and ischaemia) - severely elevated blood pressure causing headache, confusion, blurry vision, nausea, vomiting,
Danish: åndenød, gulsot, ændringer i stoffer, der dannes i leveren (overfølsomhedsreaktion) - hjerteanfald, brystsmerter (myokardieinfarkt og iskæmi) - alvorligt forhøjet blodtryk, der medfører hovedpine, forvirring, sløret syn, kvalme, opkastning og krampeanfald (hypertensiv krise) - betændelse i bugspytkirtlen karakteriseret ved smerter i det område af maven, kvalme,
English: Keep the bottle tightly closed.
Danish: Tabletbeholderen skal opbevares tæt tillukket.
English: Uncommon side effects (may affect up to 1 in 100 users)
Danish: Ikke almindelige bivirkninger (kan opstå hos op til 1 ud af 100 brugere)
English: Gastrointestinal perforation* Gastrointestinal fistula Pancreatitis
Danish: Mave-tarmperforation* Mave-tarmfistel
English: Hepatic impairment
Danish: Hovedpine Tremor
English: Table 7: Efficacy results from the RESORCE study
Danish: Tabel 7: Resultater fra RESORCEstudiet Virkningsparameter Hazard ratio*
English: In vitro data indicate that regorafenib is metabolized by cytochrome CYP3A4 and uridine diphosphate glucuronosyl transferase UGT1A9.
Danish: CYP3A4- og UGT1A9-inhibitorer/CYP3A4-induktorer In vitro-data indikerer, at regorafenib metaboliseres af cytokrom CYP3A4 og af uridindiphosphat-glucuronosyltransferase UGT1A9.
English: Figure 4: Kaplan-Meier curve of OS
Danish: Figur 4: Kaplan-Maier kurver for OS
English: Bayer S.p.A. Tel: +39-02-397 81
Danish: Tel: +39-02-397 81
English: Prior to and during treatment with Stivarga, your doctor will do blood tests to monitor your liver function.
Danish: Din læge vil tage blodprøver for at overvåge din leverfunktion inden og i løbet af behandling med Stivarga.
English: Posology adjustments
Danish: Doseringsjustering
English: What Stivarga looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: - certain skin cancers (keratoacanthoma/squamous cell carcinoma of the skin) - headache, confusion, seizures and visual loss associated with or without high blood pressure (posterior reversible encephalopathy syndrome/PRES) - serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis).
Danish: - visse former for hudkræft (keratoakantom/pladecellecancer i huden) - hovedpine, forvirring, krampeanfald og synstab associeret med eller uden højt blodtryk
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ} Andre informationskilder
English: Figure 1: Kaplan-Meier curve of OS
Danish: Fig. 1: Kaplan-Meier kurver for OS
English: Keep the desiccant in the bottle.
Danish: Tørremidlet skal forblive i tabletbeholderen.
English: (NASH, 7%)
Danish: (95 % CI)
English: Efficacy parameter
Danish: Bivirkninger
English: About 51% of those given Rydapt and 43% of those given placebo were still alive after 5 years.
Danish: Ca. 51 % af dem, der fik Rydapt, og ca. 43 % af dem, der fik placebo, var stadig i live efter 5 år.
English: The full EPAR for Rydapt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rydapt findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rydapt.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rydapt.
English: Other information about Rydapt
Danish: Andre oplysninger om Rydapt
English: What is Rydapt and what is it used for?
Danish: Hvad er Rydapt, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Rydapt?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rydapt?
English: Why is Rydapt approved?
Danish: Hvorfor blev Rydapt godkendt?
English: If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Danish: Hvis en patient får visse alvorlige bivirkninger, kan lægen beslutte at nedsætte de efterfølgende doser eller udskyde eller standse behandlingen.
English: It is not intended to provide practical advice on how to use Rydapt.
Danish: Det er ikke en praktisk vejledning i, hvordan Rydapt bør anvendes.
English: Overall, using the most stringent, up-to-date criteria, the disease responded to treatment in about 28% of patients (32 of 113).
Danish: Ud fra de mest stringente, tidssvarende kriterier reagerede disse sygdomme samlet set på behandlingen hos ca. 28 % af patienterne (32 ud af 113).
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Rydapt can be found on the Agency's website:
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Rydapt findes på agenturets websted:
English: Treatment is continued for up to 12 cycles depending on how patients respond.
Danish: Behandlingen fortsættes i op til 12 cyklusser alt efter patientens reaktion på behandlingen.
English: The safety of the medicine was acceptable in such a severe condition and was considered manageable.
Danish: Lægemidlets sikkerhed er acceptabel for så alvorlig en sygdom og vurderes at være håndterbar.
English: The European Medicines Agency therefore decided that Rydapt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Rydapt opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Rydapt was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Danish: Da antallet af patienter med disse sygdomme er lavt, betragtes de som "sjældne", og Rydapt blev udpeget som "lægemiddel til sjældne sygdomme" på forskellige datoer (se nedenfor).
English: What are the risks associated with Rydapt?
Danish: Hvilke risici er der forbundet med Rydapt?
English: When looked at separately the response rate was highest (60%) in those with aggressive systemic mastocytosis.
Danish: Hvis man ser på sygdommene hver for sig, var responsraten højest (60 %) hos de patienter, der havde aggressiv systemisk mastocytose.
English: Rydapt can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer medicines.
Danish: Rydapt udleveres kun efter recept, og behandlingen skal iværksættes af en læge med erfaring i brug af kræftlægemidler.
English: Rydapt is available as capsules containing 25 mg of midostaurin.
Danish: Rydapt fås som kapsler, der indeholder 25 mg midostaurin.
English: acute myeloid leukaemia mastocytosis.
Danish: akut myeloid leukæmi mastocytose.
English: Although Rydapt had not been compared with other treatments, given the rarity of the conditions and the unmet medical need of patients who have them, the clinical benefits were clear, and the adverse effects acceptable.
Danish: Selvom Rydapt ikke er blevet sammenlignet med andre behandlinger, da der er tale om sjældne sygdomme og et uopfyldt medicinsk behov for de pågældende patienter, var den kliniske nytte åbenlys, og bivirkningerne var acceptable.