FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP1A2 and CYP3A4 activities were not altered after treatment of cultured human hepatocytes with sorafenib, indicating that sorafenib is unlikely to be an inducer of CYP1A2 and CYP3A4.
Danish: CYP1A2- og CYP3A4-aktiviteter blev ikke ændret efter behandling af opdyrkede humane hepatocytter med sorafenib, hvilket indikerer, at sorafenib sandsynligvis ikke inducerer CYP1A2 og CYP3A4.
English: RAF kinases are serine/threonine kinases, whereas c-KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß are receptor tyrosine kinases.
Danish: RAF-kinaser er serin/threonin-kinaser, hvorimod c-KIT, FLT-3, VEGFR-2, VEGFR-3 og PDGFR-β er receptor-tyrosinkinaser.
English: Dose reductions were only partially successful in alleviating adverse reactions.
Danish: Dosisreduktion lindrede kun delvist bivirkningerne.
English: Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on sorafenib therapy.
Danish: Sjældent forekommende blødninger eller stigning i International Normalized Ratio (INR) er rapporteret hos nogle patienter, der har taget warfarin samtidig med sorafenib.
English: If the patient intends to have a high-fat meal, sorafenib tablets should be taken at least 1 hour before or 2 hours after the meal.
Danish: Hvis patienten vil indtage et måltid med højt fedtindhold, bør sorafenibtabletterne tages mindst 1 time før eller 2 timer efter måltidet.
English: Steady state plasma sorafenib concentrations are achieved within 7 days, with a peak to trough ratio of mean concentrations of less than 2.
Danish: Steady state plasmakoncentrationer for sorafenib opnås i løbet af 7 dage med en top, hvor forholdet mellem de gennemsnitlige koncentrationer var mindre end 2.
English: Overall Survival (OS) [median, weeks (95%
Danish: Total overlevelse (OS) [median, uger (95 % CI)]
English: After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Danish: Når de ikke-hæmatologiske bivirkninger er bedret, kan dosis af Nexavar øges.
English: Sorafenib was not genotoxic in the Ames test or in the in vivo mouse micronucleus assay.
Danish: Sorafenib var ikke genotoksisk i Ames test eller i mikronukleus-testen in vivo på mus.
English: No dose adjustment is required in patients with mild, moderate or severe renal impairment.
Danish: Der kræves ingen dosisreduktion for patienter med let, moderat eller svært nedsat nyrefunktion.
English: The pharmacokinetics (PK) of sorafenib in Child-Pugh A and B non-HCC patients were similar to the PK in healthy volunteers.
Danish: Farmakokinetiken (PK) for sorafenib hos nonHCC-patienter med Child-Pugh A og B svarer til PK hos raske frivillige.
English: - If you have poor kidney function.
Danish: - hvis De har dårlig nyrefunktion.
English: When using sorafenib in these patients, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium, calcium) should be considered.
Danish: Når sorafenib anvendes til disse patienter, bør periodisk monitorering af ekg og elektrolytter (magnesium, kalium, calcium) overvejes under behandlingen.
English: Multiple dosing of sorafenib for 7 days resulted in a 2.5- to 7-fold accumulation compared to single dose administration.
Danish: Gentagen dosering med sorafenib i 7 dage resulterede i en 2,5- til 7-gange akkumulering sammenlignet med en enkeltdosis.
English: However, patients taking warfarin or phenprocoumon should have their INR checked regularly (see section 4.4).
Danish: Men patienter, der tager warfarin eller phenprocoumon, bør have kontrolleret deres INR regelmæssigt (se pkt.
English: In cases of severe or persistent hypertension, or hypertensive crisis despite institution of antihypertensive therapy, permanent discontinuation of sorafenib should be considered (see section 4.8).
Danish: I tilfælde af svære eller vedvarende hypertension eller hypertensiv krise trods indsættelse med antihypertensiv behandling, bør permanent seponering af sorafenib overvejes (se pkt.
English: - If you experience skin problems.
Danish: - hvis De får hudproblemer.
English: If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of sorafenib should be considered (see section 4.8).
Danish: I tilfælde hvor blødning nødvendiggør medicinsk indgriben, anbefales det at overveje permanent ophør af sorafenib (se pkt.
English: Repeat-dose toxicity studies revealed changes (degenerations and regenerations) in various organs at exposures below the anticipated clinical exposure (based on AUC comparisons).
Danish: Toksicitetsstudier med gentagen dosering viste forandringer (degenerationer og regenerationer) i forskellige organer ved eksponering under den forventede kliniske eksponering (baseret på AUCsammenligninger).
English: Other inducers of CYP3A4 activity and/or glucuronidation (e.g. Hypericum perforatum also known as St. John's wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) may also increase metabolism of sorafenib and thus decrease sorafenib concentrations.
Danish: Andre inducere med CYP3A4-aktivitet og/eller glucuronidation (f.eks. Hypericum perforatum også kendt som perikon, phenytoin, carbamazepin, phenobarbital og dexamethason) kan også øge metabolismen af sorafenib og dermed nedsætte sorafenibkoncentrationer.
English: Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Danish: Ketoconazol, en potent hæmmer af CYP3A4, administreret en gang daglig i 7 dage til raske mandlige frivillige forsøgspersoner forandrede ikke den gennemsnitlige AUC ved en enkelt dosis på 50 mg af sorafenib.
English: Changes consisted in irregular thickening of the femoral growth plate, hypocellularity of the bone marrow next to the altered growth plate and alterations of the dentin composition.
Danish: Forandringerne bestod af irregulær fortykkelse af den femorale epifyseskive, hypocellularitet af knoglemarven ved siden af den fortykkede epifyseskive og forandringer af dentinsammensætningen.
English: Secondary endpoints included overall survival (OS), tumour response rate and duration of response.
Danish: Sekundære endepunkter omfattede samlet overlevelse (overall survival, OS), tumorresponsrate og responsvarighed.
English: It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Danish: Det anbefales, at sorafenib indtages uden for måltiderne eller sammen med et måltid med lavt eller moderat fedtindhold.
English: Hypromellose Macrogol (3350) Titanium dioxide (E 171) Ferric oxide red (E 172)
Danish: Hypromellose Macrogol (3350) Titanoxid (E 171) Jernoxid (E 172)
English: There is no evidence that Nexavar will affect the ability to drive or to operate machines.
Danish: Der er intet, der tyder på, at Nexavar vil påvirke evnen til at køre eller betjene maskiner.
English: The pharmacokinetics of carboplatin were unaffected.
Danish: Carboplatins farmakokinetik var uændret.
English: Sorafenib accounts for approximately 70 - 85 % of the circulating analytes in plasma at steady state.
Danish: Sorafenib udgør ca. 70 - 85 % af de cirkulerende analyserede metabolitter i plasmaet ved steady state.
English: Pregnancy and breast-feeding Avoid becoming pregnant while being treated with Nexavar.
Danish: Undgå at blive gravid under behandling med Nexavar.
English: Temporary interruption of sorafenib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Danish: Midlertidig afbrydelse af sorafenib-behandlingen anbefales af forsigtighedsmæssige årsager til patienter, som skal gennemgå større kirurgiske indgreb.
English: Women of childbearing potential must use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen.
English: Your doctor may decide to interrupt treatment or stop it altogether.
Danish: Deres læge kan beslutte at afbryde behandlingen eller stoppe den helt.
English: Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Danish: Røde, runde, bikonvekse, filmovertrukne tabletter, mærket med Bayerkors på den ene side og ”200” på den anden.
English: Sorafenib conjugates may be cleaved in the gastrointestinal tract by bacterial glucuronidase activity, allowing reabsorption of unconjugated active substance.
Danish: Sorafenibkonjugater kan spaltes i mave-tarm-kanalen via bakteriel glukuronidaseaktivitet, hvilket medfører reabsorption af ukonjugeret aktivt stof.
English: This OS analysis showed a statistically significant advantage for sorafenib over placebo for OS (HR: 0.69, p = 0.00058, see table 3).
Danish: Denne OS analyse viste en statistisk signifikant fordel for sorafenib i forhold til placebo for OS (HR: 0.69, p = 0.00058, se tabel 3).
English: Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients.
Danish: 86 % af patienterne havde metastaser i lungerne, 51 % i lymfeknuderne og 27 % i knoglerne.
English: Contents of the pack and other information What Nexavar contains
Danish: Pakningsstørrelser og yderligere oplysninger Nexavar indeholder:
English: When using sorafenib in DTC patients, close monitoring of TSH level is recommended.
Danish: Når sorafenib anvendes til patienter med DTC, anbefales nøje overvågning af TSH-niveauet.
English: In an overall survival analysis conducted 9 months after the data cut-off for the final PFS analysis there was no statically significant difference in overall survival between the treatment groups (HR=0.884; 95% CI: 0.633, 1.236, one-sided p value of 0.236).
Danish: I en samlet overlevelsesanalyse foretaget 9 måneder efter dataafslutning for den endelige PFS-analyse, var der var ingen statistisk signifikant forskel i samlet overlevelse mellem behandlingsgrupperne (HR=0,884; 95 % CI: 0,633-1,236, ensidet p-værdi på 0,236).
English: Immune system disorders hypersensitivity reactions (including skin reactions and urticaria)
Danish: Immunsystemet overfølsomhedsreaktioner (inklusive hudreaktioner og urticaria)
English: Use sorafenib with caution in patients who have, or may develop prolongation of QTc, such as patients with a congenital long QT syndrome, patients treated with a high cumulative dose of anthracycline therapy, patients taking certain anti-arrhythmic medicines or other medicinal products that lead to QT prolongation, and those with electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia.
Danish: Sorafenib skal anvendes med forsigtighed hos patienter, der har eller er i risiko for at udvikle forlænget QTc, fx patienter med et medfødt langt QT-syndrom, patienter behandlet med en høj akkumuleret dosis af anthracyclin, patienter, der tager visse former for antiarytmika eller andre lægemidler, der medfører QT-forlængelse, samt patienter med elektrolytforstyrrelser som fx hypokaliæmi, hypokalcæmi eller hypomagnesiæmi.
English: Laboratory test abnormalities in HCC (study 3) and RCC (study 1) patients
Danish: Afvigelser i laboratorieanalyser hos patienter med HCC (studie 3) og RCC (studie 1)
English: When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended.
Danish: Når sorafenib anvendes til patienter med DTC, anbefales nøje monitorering af calciumniveauet i blodet.
English: If not, your doctor may interrupt treatment or stop it altogether.
Danish: Hvis det ikke er tilfældet, kan Deres læge beslutte at afbryde behandlingen eller stoppe den helt.
English: In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the foetus.
Danish: På rotter blev det vist, at sorafenib og dens metabolitter passerer placenta, og sorafenib forventes at skade fostret.
English: These data indicate no need for dose adjustments when paclitaxel and carboplatin are co-administered with sorafenib with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration).
Danish: Disse data tyder ikke på, at dosisjustering er nødvendig, når paclitaxel og carboplatin indgives sammen med sorafenib med en 3-dages pause i doseringen af sorafenib (to dage før og på dagen for indgift af paclitaxel/carboplatin).
English: Therefore, clinical pharmacokinetic interactions of sorafenib with substrates of these enzymes are unlikely.
Danish: Klinisk farmakokinetiske interaktioner mellem sorafenib og disse enzymsubstrater er derfor ikke sandsynlige.
English: Differentiated thyroid cancer (DTC)
Danish: Differentieret thyreoideacancer (DTC)
English: An increased incidence of arterial hypertension was observed in sorafenib-treated patients.
Danish: Et øget antal tilfælde af arteriel hypertension blev observeret hos patienter, der blev behandlet med sorafenib.
English: Ear and labyrinth disorders tinnitus
Danish: Øre og labyrint tinnitus
English: The highest dose of sorafenib studied clinically is 800 mg twice daily.
Danish: Den højeste dosis af sorafenib, som er klinisk studeret, er 800 mg to gange daglig.
English: - If you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section
Danish: - hvis De er allergisk over for sorafenib eller et af de øvrige indholdsstoffer i Nexavar (angivet i punkt 6).
English: A post-hoc subgroup analysis by thyroid carcinoma symptoms at baseline showed a treatment effect for PFS in favour of sorafenib over placebo for both symptomatic and asymptomatic patients.
Danish: En post-hoc-undergruppeanalyse i forhold til thyreoideacancersymptomer ved baseline viste en bedre behandlingseffekt (PFS) for sorafenib i forhold til placebo hos både symptomatiske og asymptomatiske patienter.
English: No single cause of death dominated, but higher incidence of respiratory failure, hemorrhages and infectious adverse events were observed in patients treated with sorafenib as add-on to platinum-based chemotherapies.
Danish: Der var ingen enkelt dødsårsag, der var dominerende, men der sås en højere forekomst af respirationssvigt, blødninger og infektioner hos patienter, der blev behandlet med sorafenib som tillæg til platinbaseret kemoterapi.
English: The clinical significance of these small to modest increases in capecitabine and 5-FU exposure when co-administered with sorafenib is unknown.
Danish: Den kliniske betydning af disse små til moderate stigninger i capecitabin- og 5-FU-eksponering, når det indgives sammen med sorafenib, er ikke kendt.
English: In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%.
Danish: Hos raske frivillige personer, der blev behandlet med neomycin i 5 dage, faldt den gennemsnitlige eksponering for sorafenib med 54 %.
English: No data is available in patients requiring dialysis.
Danish: Der er ingen tilgængelig data for dialysekrævende patienter.
English: Sorafenib had no clinically relevant effect on the pharmacokinetics of gemcitabine, cisplatin, carboplatin, oxaliplatin or cyclophosphamide.
Danish: Sorafenib havde ingen klinisk relevant indvirkning på farmakokinetikken af gemcitabin, cisplatin, carboplatin, oxaliplatin eller cyclophosphamid.
English: Demographics and baseline disease characteristics were comparable between the sorafenib and the placebo group with regard to ECOG status (status 0: 54 % vs. 54 %; status 1: 38 % vs. 39 %; status 2: 8 % vs. 7 %), TNM stage (stage I: <1 % vs. <1 %; stage II: 10.4 % vs. 8.3 %; stage III: 37.8 % vs. 43.6 %; stage IV: 50.8 % vs. 46.9 %), and BCLC stage (stage B: 18.1 % vs. 16.8 %; stage C: 81.6 % vs. 83.2 %; stage D: < 1 % vs. 0 %).
Danish: Demografi og baseline sygdomskarakteristika var sammenlignelige mellem sorafenib- og placebogruppen med hensyn til ECOG status (status 0: 54 % vs 54 %; status 1: 38 % vs 39 %; status 2: 8 % vs. 7 %), TNM stadie (stadie I: < 1 % vs < 1 %; stadie II: 10.4 % vs 8.3 %; stadie III: 37.8 % vs 43.6 %; stadie IV: 50.8 % vs 46.9 %), og BCLC stadie (stadie B: 18.1 % vs 16.8 %; stadie C: 81.6 % vs 83.2%; stadie D: < 1 % vs 0 %).
English: In the event of suspected overdose sorafenib should be withheld and supportive care instituted where necessary.
Danish: Ved mistanke om overdosering bør administrering af sorafenib ophøre og understøttende behandling om nødvendigt gives.
English: Sorafenib is metabolised primarily in the liver and undergoes oxidative metabolism, mediated by CYP 3A4, as well as glucuronidation mediated by UGT1A9.
Danish: Sorafenib metaboliseres primært i leveren og gennemgår oxidativ metabolisme medieret af CYP 3A4 såvel som glucuronidation medieret af UGT1A9.
English: Additionally, concomitant treatment with sorafenib and warfarin, a CYP2C9 substrate, did not result in changes in mean PT-INR compared to placebo.
Danish: Desuden medførte samtidig behandling med sorafenib og warfarin, et CYP2C9-substrat, ikke ændringer i det gennemsnitlige INR sammenlignet med placebo.
English: The overall response rate (CR + partial response (PR) per independent radiological assessment was higher in the sorafenib group (24 patients, 12.2%) than in the placebo group (1 patient, 0.5%), one-sided p<0.0001.
Danish: Den samlede responsrate (CR + partiel respons (PR)) ved uafhængig radiologisk vurdering var højere i sorafenib-gruppen (24 patienter, 12,2 %) end i placebogruppen (1 patient, 0,5 %), ensidet p < 0,0001.
English: A second Phase III, international, multi-centre, randomised, double blind, placebo-controlled study (Study 4, 11849) evaluated the clinical benefit of sorafenib in 226 patients with advanced hepatocellular carcinoma.
Danish: Et andet fase III, internationalt, multicenter, randomiseret, dobbeltblindt, placebo-kontrolleret studie (studie 4, 11849) evaluerede den kliniske fordel af sorafenib hos 226 patienter med fremskredent hepatocellulært karcinom.
English: The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Danish: Den cirkulerende hovedmetabolit af sorafenib i plasma, pyridin N-oxid, viser in vitro den samme effekt som den for sorafenib.
English: Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see section 5.1), symptoms related to the disease (see section 5.1) and progression rate.
Danish: Før behandling indledes, anbefales det, at lægen omhyggeligt evaluerer den enkelte patients prognose ved at vurdere den maksimale læsionsstørrelse (se pkt.
English: In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Danish: Sorafenib er vist at hæmme transportproteinet p-glykoprotein (P-pg) in vitro.
English: Nexavar contains sodium
Danish: Nexavar indeholder natrium
English: In hepatocellular carcinoma (HCC) patients with Child-Pugh A or B (mild to moderate) hepatic impairment, exposure values were comparable and within the range observed in patients without hepatic impairment.
Danish: Hos patienter med hepatocellulært karcinom (HCC) og Child-Pugh A eller B (let til moderat) nedsat leverfunktion var eksponeringsværdierne sammenlignelige og inden for det interval, der blev observeret hos patienter uden nedsat leverfunktion.
English: The clinical safety and efficacy of sorafenib have been studied in patients with hepatocellular carcinoma (HCC), in patients with advanced renal cell carcinoma (RCC) and in patients with differentiated thyroid carcinoma (DTC).
Danish: Sorafenibs kliniske virkning og sikkerhed er undersøgt hos patienter med hepatocellulært karcinom (HCC), hos patienter med fremskredent renalcellekarcinom (RCC) og hos patienter med differentieret thyreoideacancer (DTC).
English: Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions.
Danish: At tage en for stor mængde Nexavar øger risikoen for bivirkninger eller svære bivirkninger, især diarré og hududslæt.
English: In a clinical pharmacology study (single dose of 400 mg sorafenib), no relationship was observed between sorafenib exposure and renal function in subjects with normal renal function, mild, moderate or severe renal impairment.
Danish: I et klinisk farmakologistudie (enkeltdosis på 400 mg sorafenib) blev der ikke observeret nogen sammenhæng mellem sorafenibeksponering og nyrefunktion hos forsøgspersoner med normal nyrefunktion, let, moderat eller svært nedsat nyrefunktion.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejersken eller apotekpersonalet.
English: Metabolism and nutrition disorders anorexia hypophosphataemia hypocalcaemia hypokalaemia hyponatraemia hypoglycaemia dehydration
Danish: Metabolisme og ernæring anoreksi hypofosfatæmi hypokalcæmi hypokaliæmi hyponatriæmi hypoglykæmi dehydrering
English: Further information on selected adverse drug reactions
Danish: Yderligere oplysninger om udvalgte bivirkninger
English: Uncommon Rare
Danish: Almindelig Ikke almindelig Sjælden Ikke kendt
English: Nervous system disorders peripheral sensory neuropathy dysgeusia reversible posterior leukoencephalopathy*
Danish: Nervesystemet perifer sensorisk neuropati dysgeusi reversibel posterior leukoencefalopati encephalopati
English: Psychiatric disorders depression
Danish: Psykiske forstyrrelser depression
English: Laboratory test abnormalities in DTC patients (study 5)
Danish: Afvigelser i laboratorieanalyser hos patienter med DTC (studie 5)
English: The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis.
Danish: De vigtigste alvorlige bivirkninger var myokardieinfarkt/myokardieiskæmi, gastrointestinal perforation, lægemiddelinduceret hepatitis, blødning og hypertension/hypertensiv krise.
English: Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see section 4.8).
Danish: Hypokalcæmi af grad 3 og 4 opstod hos 6,8 % og 3,4 % af sorafenibbehandlede DTC-patienter (se pkt.
English: High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1), and benefit-risk in these patients has not been evaluated.
Danish: Højrisikopatienter - i henhold til MSKCC- (Memorial Sloan Kettering Cancer Center) prognosegruppe - var ikke inkluderet i det kliniske fase III-studie for renalcellekarcinom (se studie 1 i pkt.
English: Concomitant administration of sorafenib and midazolam, dextromethorphan or omeprazole, which are substrates for cytochromes CYP3A4, CYP2D6 and CYP2C19 respectively, did not alter the exposure of these agents.
Danish: Samtidig administration af sorafenib og midazolam, dextrometorphan eller omeprazol, som er substrater for henholdsvis CYP3A4, CYP2D6 og CYP2C919, forandrede ikke eksponeringen af disse substanser.
English: Coadministration of neomycin has been shown to interfere with this process, decreasing the mean bioavailability of sorafenib by 54%.
Danish: Samtidig indgift af neomycin har vist sig at påvirke denne proces og nedsætte sorafenibs gennemsnitlige biotilgængelighed med 54 %.
English: Your doctor will monitor blood calcium and thyroid hormone levels.
Danish: Deres læge vil overvåge indholdet af calcium og skjoldbruskkirtel-hormon i blodet.
English: The median duration of therapy in the double-blind period was 46 weeks (range 0.3-135) for patients receiving sorafenib and 28 weeks (range 1.7-132) for patients receiving placebo.
Danish: Den mediane behandlingsvarighed i den dobbeltblindede periode var 46 uger (interval 0,3-135) for patienter, der fik sorafenib, og 28 uger (interval 1,7-132) for patienter, der fik placebo.
English: Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Danish: Nexavar er indiceret til behandling af patienter med progressiv, lokalt fremskreden eller metastaserende differentieret (papillær/follikulær/Hürthle-celle) thyreoideacancer, refraktær over for radioaktivt iod.