FrancophonIA/ELRC3.0 huggingface dataset:
English: You may experience more severe side effects when taking this medicine.
Danish: De kan i så fald få flere svære bivirkninger ved indtagelse af dette lægemiddel.
English: There are no data on the use of sorafenib in pregnant women.
Danish: Der er ingen data fra anvendelse af sorafenib til gravide kvinder.
English: Before initiating Nexavar, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Nexavar bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: PFS was evaluated by blinded independent radiological review using RECIST criteria.
Danish: PFS blev evalueret ved blindet uafhængig radiologisk undersøgelse ved brug af RECIST-kriterier.
English: You may need treatment for them, or your doctor may decide to change your dose of Nexavar, or stop treatment altogether (see also section 4: Possible side effects).
Danish: De kan have brug for behandling for dette, eller Deres læge kan beslutte at ændre Deres dosis af Nexavar eller stoppe behandlingen helt (se også Bivirkninger, punkt 4).
English: There are no clinically relevant differences in pharmacokinetics between Caucasian and Asian subjects.
Danish: Der er ingen klinisk relevante forskelle i farmakokinetikken mellem kaukasiske og asiatiske patienter.
English: Your doctor will monitor your fluid and electrolyte balance.
Danish: Deres læge vil overvåge Deres væske- og elektrolytbalance.
English: CI=Confidence interval, HR=Hazard ratio (sorafenib over placebo) * statistically significant as the p-value was below the prespecified O'Brien Fleming stopping boundary of 0.0077 ** independent radiological review
Danish: CI=Konfidensinterval, HR=Hazard ratio (sorafenib over for placebo) * Statistisk signifikant, da p-værdien var under den præspecificerede O'Brien Fleming stopgrænse på 0,0077 ** Uafhængig radiologisk redegørelse
English: Dogs showed tubular degeneration in the testes and oligospermia.
Danish: Hunde viste tubulær degeneration i testiklerne og oligospermi.
English: The preclinical safety profile of sorafenib was assessed in mice, rats, dogs and rabbits.
Danish: Sorafenibs prækliniske sikkerhedsprofil er blevet bestemt i mus, rotter, hunde og kaniner.
English: After administration of sorafenib tablets the mean relative bioavailability is 38 - 49 % when compared to an oral solution.
Danish: Efter administration af sorafenib-tabletter er den gennemsnitlige, relative biotilgængelighed 38 - 49 % ved sammenligning med en oral opløsning.
English: An increased risk of bleeding may occur following sorafenib administration.
Danish: Øget risiko for blødning kan opstå efter administration af sorafenib.
English: In animals, sorafenib and/or its metabolites were excreted in milk.
Danish: Hos dyr blev sorafenib og/eller dets metabolitter udskilt i mælken.
English: If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued.
Danish: Hvis De bliver gravid under behandlingen, fortæl da øjeblikkeligt dette til Deres læge, som så vil beslutte, om behandlingen skal fortsættes.
English: Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased number of external and visceral malformations.
Danish: Observerede effekter inkluderede reduktion i maternel og føtal kropsvægt, stigning i antallet af føtale resorptioner og et øget antal af ydre og viscerale misdannelser.
English: This metabolite comprises approximately 9 - 16 % of circulating analytes at steady state.
Danish: Denne metabolit udgør ca. 9 - 16 % af de cirkulerende analyserede metabolitter ved steady state.
English: This indicates that sorafenib is neither an inhibitor nor an inducer of these cytochrome P450 isoenzymes.
Danish: Dette viser, at sorafenib hverken er en hæmmer eller en inducer for disse P450isoenzymer.
English: - Fertility.
Danish: - fertilitet.
English: Patients with unstable coronary artery disease or recent myocardial infarction were excluded from these studies.
Danish: Patienter med ustabil conorasygdom eller nylig myokardieinfarkt var ekskluderet i disse studier.
English: Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE.
Danish: Den sorafenibbatch, der blev testet i standardserien af genotoksicitetstudierne, inkluderede desuden 0,34 % PAPE.
English: Table 1: All adverse reactions reported in patients in multiple clinical trials or through postmarketing use
Danish: Tabel 1: Alle bivirkninger rapporteret hos patienter i multiple kliniske studier eller under brug efter markedsføringen
English: Nexavar can cause rashes and skin reactions, especially on the hands and feet.
Danish: Nexavar kan forårsage udslæt og hudreaktioner, især på hænder og fødder.
English: This is equivalent to a daily dose of 800 mg or four tablets a day.
Danish: Dette svarer til en daglig dosis på 800 mg eller fire tabletter om dagen.
English: Environmental Risk Assessment information is available in the EPAR of this medicine (see section 6.6).
Danish: Informationen vedrørende miljørisikovurdering findes i EPAR for dette lægemiddel (se pkt.
English: The highest mean concentration was observed in DTC patients (approximately twice that observed in patients with RCC and HCC), though variability was high for all tumour types.
Danish: Den højeste gennemsnitlige koncentration blev observeret hos patienter med DTC (ca. dobbelt så stor som observeret hos patienter med RCC og HCC), selvom variabiliteten var høj for alle tumortyper.
English: Patients were included in the study if they experienced progression within 14 months of enrollment and had DTC refractory to radioactive iodine (RAI).
Danish: Patienterne blev inkluderet i studiet, hvis de oplevede progression inden for 14 måneder, inden de indgik i studiet, og havde DTC refraktær over for radioaktivt iod (RAI).
English: The adverse events observed at this dose were primarily diarrhoea and dermatological events.
Danish: Bivirkninger observeret ved denne dosis var primært diarré og dermatologiske bivirkninger.
English: At the time of this analysis, about 200 patients had crossed-over to sorafenib from the placebo group.
Danish: På dette tidspunkt i denne analyse havde cirka 200 patienter skiftet til sorafenib fra placebogruppen.
English: The effect of sorafenib on PFS was consistent independent of geographic region, age above or below 60 years, gender, histological subtype, and presence or absence of bone metastasis.
Danish: Sorafenibs virkning på PFS var konsistent og uafhængig af geografisk region, alder over eller under 60 år, køn, histologisk undertype samt tilstedeværelse eller fravær af knoglemetastaser.
English: Nexavar may increase the effects and, in particular, the side effects of these medicines.
Danish: Nexavar kan øge effekten og især bivirkningerne af disse lægemidler.
English: Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Nexavar bør overvåges af en læge,som har erfaring med brugen af anticancerbehandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder .
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: There are limited data from this study in patients with Child Pugh B liver impairment and only one patient with Child Pugh C had been included.
Danish: Der er begrænsede data fra dette studie for patienter med Child Pugh B nedsat leverfunktion og kun én patient med Child Pugh C havde været inkluderet.
English: Hypophosphatemia**
Danish: Hypofosfatæmi**
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandling bør fortsættes så længe klinisk fordel observeres, eller indtil der opstår uacceptable bivirkninger.
English: Hypertension was usually mild to moderate, occurred early in the course of treatment, and was amenable to management with standard antihypertensive therapy.
Danish: Hypertensionen var ofte let til moderat, den optrådte tidligt i behandlingsforløbet og kunne behandles med antihypersiv standardbehandling.
English: The steady-state concentrations of sorafenib administered at 400 mg twice daily were evaluated in DTC, RCC and HCC patients.
Danish: Steady state-koncentrationer af sorafenib administreret med 400 mg to gange dagligt blev evalueret hos patienter med DTC, RCC og HCC.
English: There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Danish: Der er begrænset klinisk erfaring med tidsrammen for genoptagelse af behandlingen efter større kirurgiske indgreb.
English: They come in calendar packs of 112 tablets: four transparent blister packs of 28 tablets each.
Danish: De fås i kalenderpakninger a 112 tabletter: fire transparente blister med 28 tabletter i hver.
English: In a clinical pharmacology study, QT/QTc measurements were recorded in 31 patients at baseline (pre-treatment) and post-treatment.
Danish: I et klinisk farmakologisk studie blev QT/QTc-målinger registreret hos 31 patienter ved baseline (før behandlingen) og efter behandlingen.
English: - If you get any bleeding problems, or are taking warfarin or phenprocoumon.
Danish: - hvis De får blødningsproblemer, eller De behandles med warfarin eller phenprocoumon.
English: Gastrointestinal perforation is an uncommon event and has been reported in less than 1% of patients taking sorafenib.
Danish: Gastrointestinal perforation er en ikke almindeligt forekommende bivirkning, og er indberettet for under 1 % af de patienter, der blev behandlet med sorafenib.
English: Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2.
Danish: Andre klinisk relevante afvigelser i laboratorieanalyser, som blev observeret i studie 5, vises i tabel 2.
English: If you intend to have a high fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Danish: Hvis De har i sinde at indtage et måltid med højt fedtindhold, skal De tage tabletterne mindst 1 time før eller 2 timer efter måltidet.
English: Table 3: Efficacy results from study 3 (study 100554) in hepatocellular carcinoma
Danish: Tabel 3: Effektresultater fra studie 3 (studie 100554) i hepatocellulært karcinom
English: Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see section QT prolongation).
Danish: Svær hypokalcæmi bør korrigeres for at undgå komplikationer som QT-forlængelse eller torsades de pointes (se afsnittet om QT-forlængelse).
English: There is no specific treatment for sorafenib overdose.
Danish: Der findes ingen specifik behandling for overdosering af sorafenib.
English: In case of symptomatic hypoglycaemia, sorafenib should be temporarily interrupted.
Danish: I tilfælde af symptomatisk hypoglykæmi skal sorafenib midlertidigt afbrydes.
English: Exploratory subgroup analyses suggested that patients with distant metastases at baseline derived a less pronounced treatment effect.
Danish: Eksploratoriske undergruppeanalyser antydede, at patienter med fjernmetastaser ved basislinje opnåede en mindre udtalt behandlingseffekt.
English: No specific studies with sorafenib have been conducted in animals to evaluate the effect on fertility.
Danish: Der er ikke udført nogen specifikke studier med sorafenib på dyr for at evaluere effekten på fertilitet.
English: Nexavar may lead to a higher risk of bleeding.
Danish: Behandling med Nexavar kan føre til højere risiko for blødning.
English: Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose.
Danish: Fortæl det øjeblikkeligt til Deres læge, hvis De (eller andre) har taget mere end Deres foreskrevne dosis.
English: Nexavar 200 mg film-coated tablets are red and round with the Bayer cross on one side and “200” on the other side.
Danish: Nexavar 200 mg filmovertrukne tabletter er røde og runde med et Bayer-kors på den ene side og ”200” på den anden side.
English: Sorafenib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures below the clinical exposure.
Danish: Sorafenib har vist sig at være embryotoksisk og teratogent, når det administreres til rotter og kaniner ved eksponering under den kliniske eksponering.
English: Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37 % reduction of sorafenib AUC.
Danish: Administration af rifampicin i 5 dage før administration af en engangsdosis af sorafenib resulterede i en gennemsnitsreduktion på 37 % i sorafenibs AUC.
English: When given with a high-fat meal sorafenib absorption was reduced by 30 % compared to administration in the fasted state.
Danish: Når sorafenib gives samtidig med et måltid med højt fedtindhold reduceres absorptionen med 30 % sammenlignet med administration til fastende tilstand.
English: - The active substance is sorafenib.
Danish: - Aktivt stof: Sorafenib.
English: Female rats showed central necrosis of the corpora lutea and arrested follicular development in the ovaries.
Danish: Hunrotter viste central nekrose af corpora lutea og standsede folliculær udvikling i ovarierne.
English: The median delivered cumulative radioactive iodine activity before enrollment was approximately 14.8 GBq.
Danish: Den mediane kumulative radioaktive iodaktivitet, givet før patienten indgik i studiet, var ca. 14,8 GBq.
English: Carcinogenicity studies have not been conducted with sorafenib.
Danish: Karcinogenicitetsstudier er ikke blevet udført med sorafenib.
English: Increased plasma concentrations of P-gp substrates such as digoxin cannot be excluded with concomitant treatment with sorafenib.
Danish: Øgede plasmakoncentrationer af P-pg-substrater, så som digoxin, kan ikke udelukkes ved samtidig behandling med sorafenib.
English: This study, conducted in China, Korea and Taiwan confirmed the findings of Study 3 with respect to the favourable benefit-risk profile of sorafenib (HR (OS): 0.68, p = 0.01414).
Danish: Studiet, som blev udført i Kina, Korea og Taiwan, bekræftede fundene fra studie 3 hvad angår den favorable risk-benefit profil for sorafenib (HR (OS): 0,68, p=0,01414).
English: You will usually carry on taking this medicine as long as you are getting clinical benefits, and not suffering unacceptable side effects.
Danish: De skal normalt blive ved med at tage dette lægemiddel så længe, De har gavn af behandlingen og ikke har uacceptable bivirkninger.
English: Thus, also the risk for a clinically relevant in vivo inhibition of CYP2C9 by sorafenib may be expected to be low.
Danish: Derfor kan risikoen for en klinisk relevant in vivo-hæmning af CYP2C9 med sorafenib også forventes at være lav.
English: - If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: - hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: Study 2 was a Phase II, discontinuation study in patients with metastatic malignancies, including RCC.
Danish: Studie 2 var et fase II diskontinuerligt studie hos patienter med metastatisk ondartede tumorer, inklusive RCC.
English: In the pre-specified stratification factors (ECOG status, presence or absence of macroscopic vascular invasion and/or extrahepatic tumour spread) of both Study 3 and 4, the HR consistently favoured sorafenib over placebo.
Danish: I de forud specificerede stratifikationsfaktorer (ECOG-status, tilstedeværelse eller fravær af makroskopisk vaskulær invasion og/eller ekstrahepatisk tumorspredning) i både studie 3 og 4, favoriserede HR konsekvent sorafenib over placebo.
English: The safety and efficacy of sorafenib in the treatment of advanced renal cell carcinoma (RCC) were investigated in two clinical studies:
Danish: Sikkerheden og effekten af sorafenib ved behandling af fremskredent renalcellekarcinom (RCC) blev undersøgt i to kliniske studier:
English: Nexavar is a so-called multikinase inhibitor.
Danish: Nexavar er en såkaldt multikinase-hæmmer.
English: Following oral administration sorafenib reaches peak plasma concentrations in approximately 3 hours.
Danish: Efter oral administration når sorafenib højeste plasmakoncentrationer i løbet af ca. 3 timer.
English: Due to the potential risk of bleeding, tracheal, bronchial, and oesophageal infiltration should be treated with localized therapy prior to administering sorafenib in patients with DTC.
Danish: På grund af den mulige blødningsrisiko bør trakeal, bronkial og øsofageal infiltration behandles med lokaliseret terapi før administration af sorafenib til patienter med DTC.
English: This booklet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Only patients with clear cell renal carcinoma and low and intermediate risk MSKCC (Memorial Sloan Kettering Cancer Center) were included.
Danish: Kun patienter med klar fremskredent renalcellekarcinom og lav og mellem risiko MSKCC (Memorial Sloan Kettering Cancer Center) var inkluderet.
English: Rash and hand foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with sorafenib.
Danish: Hududslæt og HFSR er normalt af CTC (Common Toxicity Criteria) grad 1 og 2 og optræder oftest i løbet af de første seks uger af sorafenibbehandlingen.
English: There were no reports of hypokalaemia CTCAE grade 4.
Danish: Der var ingen rapporter om hypokaliæmi CTCAE grad 4.
English: Progression-free survival (PFS) as evaluated by a blinded independent radiological review using RECIST criteria was the primary endpoint of the study.
Danish: Progressionsfri overlevelse (progression-free survival, PFS), vurderet ved en blindet, uafhængig, radiologisk evaluering baseret på RECIST-kriterierne, var studiets primære endepunkt.
English: Therefore, the decision to resume sorafenib therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.
Danish: Derfor bør beslutningen om genoptagelse af sorafenib-behandlingen efter større kirurgiske indgreb baseres på klinisk vurdering af tilstrækkelig sårheling.
English: You will usually be taken off Nexavar if you are having an operation.
Danish: De vil oftest skulle stoppe med at tage Nexavar, hvis De skal opereres.
English: An adverse effect on male and female fertility can however be expected because repeat-dose studies in animals have shown changes in male and female reproductive organs at exposures below the anticipated clinical exposure (based on AUC).
Danish: En uønsket effekt på mandlig og kvindelig fertilitet kan dog forventes, eftersom studier på dyr med gentagen dosering har vist forandringer i mandlige og kvindelige reproduktive organer ved eksponeringer under den forventede kliniske eksponering (baseret på AUC).
English: Unchanged sorafenib, accounting for 51 % of the dose, was found in faeces but not in urine, indicating that biliary excretion of unchanged active substance might contribute to the elimination of sorafenib.
Danish: Uomdannet sorafenib, som udgjorde 51 % af dosis, blev fundet i fæces men ikke i urinen, hvilket indikerer, at biliær udskillelse af uomdannet aktivt stof kan medvirke til eliminationen af sorafenib.
English: Talk to your doctor or pharmacist before taking Nexavar.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Nexavar.
English: When administered with irinotecan, whose active metabolite SN-38 is further metabolised by the UGT1A1 pathway, there was a 67 - 120 % increase in the AUC of SN-38 and a 26 - 42 % increase in the AUC of irinotecan.
Danish: Nexavar, der blev givet samtidigt med irinotecan, hvis aktive metabolit SN-38 metaboliseres yderligere af UGT1A1-systemet, gav en 67 - 120 % stigning i AUC for SN-38 og en 26 - 42 % stigning i AUC for irinotecan.
English: Concomitant treatment with sorafenib resulted in a 21 % increase in the AUC of doxorubicin.
Danish: Samtidig behandling med sorafenib og doxorubicin resulterede i en 21 % stigning af AUC for doxorubicin.
English: These data suggest that sorafenib at the recommended dose of 400 mg twice daily may not be an in vivo inhibitor of CYP2B6 or CYP2C8.
Danish: Disse data tyder på, at sorafenib ved den anbefalede dosis på 400 mg to gange dagligt muligvis ikke er en in vivo-hæmmer af CYP2B6 eller CYP2C8.
English: Typical changes consisted of signs of degeneration and retardation in testes, epididymides, prostate, and seminal vesicles of rats.
Danish: Typiske forandringer består af tegn på degeneration og retardering i testikler, bitestikler, prostata og sædblærer på rotter.
English: Blood sugar levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicine's dosage needs to be adjusted to minimize the risk of low blood sugar.
Danish: Blodsukkerniveauer hos patienter med diabetes skal tjekkes regelmæssigt for at undersøge om dosering af lægemidler mod diabetes skal justeres for at mindske risikoen for lavt blodsukker.
English: Mean Cmax and AUC increased less than proportionally beyond doses of 400 mg administered twice daily.
Danish: Middeltallet for Cmax og AUC øges mindre end proportionelt for doser over 400 mg givet 2 gange dagligt.
English: The standard program of genotoxicity studies was conducted and positive results were obtained as an increase in structural chromosomal aberrations in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity in the presence of metabolic activation was seen.
Danish: Standardprogrammet af genotoksicitetsstudier blev udført og positive resultater var opnået, da der blev set en stigning i strukturel kromosomal afvigelse i en in vitro celletest på pattedyrsceller (ovarier fra kinesiske hamstere) for klastogenicitet under metabolisk aktivering.
English: DTC refractory to RAI was defined as having a lesion without iodine uptake on a RAI scan, or receiving cumulative RAI ≥ 22.2 GBq, or experiencing a progression after a RAI treatment within 16 months of enrollment or after two RAI treatments within 16 months of each other.
Danish: Iod-refraktær DTC blev defineret som én læsion uden iodoptagelse på en RAI-scanning, kumulativ RAI ≥ 22,2-GBq eller progression < 16 måneder efter RAI-behandlingen eller efter to på hinanden følgende RAIbehandlinger inden for et interval på 16 måneder.
English: After repeated dosing to young and growing dogs effects on bone and teeth were observed at exposures below the clinical exposure.
Danish: Efter gentagen dosering til unge og voksende hunde blev effekter på skelet og tænder observeret ved eksponering under den kliniske eksponering.
English: Blood glucose levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicinal product's dosage needs to be adjusted.
Danish: Blodglukoseniveauer hos diabetespatienter skal undersøges regelmæssigt for at vurdere om dosering af antidiabetiske lægemidler skal justeres.
English: Infections and infestations infection folliculitis
Danish: Infektioner og parasitære sygdomme infektion follikulitis
English: The clinical relevance of this finding is unknown (see below and section 4.4).
Danish: Den kliniske relevans af dette fund er ukendt (se nedenfor og pkt.
English: If you forget to take Nexavar
Danish: Hvis De har glemt at tage Nexavar
English: In this case your doctor will interrupt the treatment.
Danish: Hvis dette forekommer, vil Deres læge afbryde behandlingen.
English: The median duration of response was 309 days (95% CI: 226,505 days) in sorafenib treated patients who experienced a PR.
Danish: Den mediane responsvarighed var 309 dage (95 % CI: 226-505 dage) hos sorafenibbehandlede patienter, der oplevede PR.