natgillin/translations-raw huggingface dataset:
Efter gentagen dosering til unge og voksende hunde blev effekter på skelet og tænder observeret ved eksponering under den kliniske eksponering. 
After repeated dosing to young and growing dogs effects on bone and teeth were observed at exposures below the clinical exposure.
Blodglukoseniveauer hos diabetespatienter skal undersøges regelmæssigt for at vurdere om dosering af antidiabetiske lægemidler skal justeres. 
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.
Infektioner og parasitære sygdomme infektion follikulitis 
Infections and infestations infection folliculitis
Den kliniske relevans af dette fund er ukendt (se nedenfor og pkt. 
The clinical relevance of this finding is unknown (see below and section 4.4).
Hvis De har glemt at tage Nexavar 
If you forget to take Nexavar
Hvis dette forekommer, vil Deres læge afbryde behandlingen. 
In this case your doctor will interrupt the treatment.
Den mediane responsvarighed var 309 dage (95 % CI: 226-505 dage) hos sorafenibbehandlede patienter, der oplevede PR. 
The median duration of response was 309 days (95% CI: 226,505 days) in sorafenib treated patients who experienced a PR.
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. 
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.
RAF-kinaser er serin/threonin-kinaser, hvorimod c-KIT, FLT-3, VEGFR-2, VEGFR-3 og PDGFR-β er receptor-tyrosinkinaser. 
RAF kinases are serine/threonine kinases, whereas c-KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß are receptor tyrosine kinases.
Dosisreduktion lindrede kun delvist bivirkningerne. 
Dose reductions were only partially successful in alleviating adverse reactions.
Sjældent forekommende blødninger eller stigning i International Normalized Ratio (INR) er rapporteret hos nogle patienter, der har taget warfarin samtidig med sorafenib. 
Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on sorafenib therapy.
Hvis patienten vil indtage et måltid med højt fedtindhold, bør sorafenibtabletterne tages mindst 1 time før eller 2 timer efter måltidet. 
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.
Steady state plasmakoncentrationer for sorafenib opnås i løbet af 7 dage med en top, hvor forholdet mellem de gennemsnitlige koncentrationer var mindre end 2. 
Steady state plasma sorafenib concentrations are achieved within 7 days, with a peak to trough ratio of mean concentrations of less than 2.
Total overlevelse (OS) [median, uger (95 % CI)] 
Overall Survival (OS) [median, weeks (95%
Når de ikke-hæmatologiske bivirkninger er bedret, kan dosis af Nexavar øges. 
After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Sorafenib var ikke genotoksisk i Ames test eller i mikronukleus-testen in vivo på mus. 
Sorafenib was not genotoxic in the Ames test or in the in vivo mouse micronucleus assay.
Der kræves ingen dosisreduktion for patienter med let, moderat eller svært nedsat nyrefunktion. 
No dose adjustment is required in patients with mild, moderate or severe renal impairment.
Farmakokinetiken (PK) for sorafenib hos nonHCC-patienter med Child-Pugh A og B svarer til PK hos raske frivillige. 
The pharmacokinetics (PK) of sorafenib in Child-Pugh A and B non-HCC patients were similar to the PK in healthy volunteers.
- hvis De har dårlig nyrefunktion. 
- If you have poor kidney function.
Når sorafenib anvendes til disse patienter, bør periodisk monitorering af ekg og elektrolytter (magnesium, kalium, calcium) overvejes under behandlingen. 
When using sorafenib in these patients, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium, calcium) should be considered.
Gentagen dosering med sorafenib i 7 dage resulterede i en 2,5- til 7-gange akkumulering sammenlignet med en enkeltdosis. 
Multiple dosing of sorafenib for 7 days resulted in a 2.5- to 7-fold accumulation compared to single dose administration.
Men patienter, der tager warfarin eller phenprocoumon, bør have kontrolleret deres INR regelmæssigt (se pkt. 
However, patients taking warfarin or phenprocoumon should have their INR checked regularly (see section 4.4).
I tilfælde af svære eller vedvarende hypertension eller hypertensiv krise trods indsættelse med antihypertensiv behandling, bør permanent seponering af sorafenib overvejes (se pkt. 
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).
- hvis De får hudproblemer. 
- If you experience skin problems.
I tilfælde hvor blødning nødvendiggør medicinsk indgriben, anbefales det at overveje permanent ophør af sorafenib (se pkt. 
If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of sorafenib should be considered (see section 4.8).
Toksicitetsstudier med gentagen dosering viste forandringer (degenerationer og regenerationer) i forskellige organer ved eksponering under den forventede kliniske eksponering (baseret på AUCsammenligninger). 
Repeat-dose toxicity studies revealed changes (degenerations and regenerations) in various organs at exposures below the anticipated clinical exposure (based on AUC comparisons).
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. 
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.
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. 
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.
Forandringerne bestod af irregulær fortykkelse af den femorale epifyseskive, hypocellularitet af knoglemarven ved siden af den fortykkede epifyseskive og forandringer af dentinsammensætningen. 
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.
Sekundære endepunkter omfattede samlet overlevelse (overall survival, OS), tumorresponsrate og responsvarighed. 
Secondary endpoints included overall survival (OS), tumour response rate and duration of response.
Det anbefales, at sorafenib indtages uden for måltiderne eller sammen med et måltid med lavt eller moderat fedtindhold. 
It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Hypromellose Macrogol (3350) Titanoxid (E 171) Jernoxid (E 172) 
Hypromellose Macrogol (3350) Titanium dioxide (E 171) Ferric oxide red (E 172)
Der er intet, der tyder på, at Nexavar vil påvirke evnen til at køre eller betjene maskiner. 
There is no evidence that Nexavar will affect the ability to drive or to operate machines.
Carboplatins farmakokinetik var uændret. 
The pharmacokinetics of carboplatin were unaffected.
Sorafenib udgør ca. 70 - 85 % af de cirkulerende analyserede metabolitter i plasmaet ved steady state. 
Sorafenib accounts for approximately 70 - 85 % of the circulating analytes in plasma at steady state.
Undgå at blive gravid under behandling med Nexavar. 
Pregnancy and breast-feeding Avoid becoming pregnant while being treated with Nexavar.
Midlertidig afbrydelse af sorafenib-behandlingen anbefales af forsigtighedsmæssige årsager til patienter, som skal gennemgå større kirurgiske indgreb. 
Temporary interruption of sorafenib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen. 
Women of childbearing potential must use effective contraception during treatment.
Deres læge kan beslutte at afbryde behandlingen eller stoppe den helt. 
Your doctor may decide to interrupt treatment or stop it altogether.
Røde, runde, bikonvekse, filmovertrukne tabletter, mærket med Bayerkors på den ene side og ”200” på den anden. 
Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Sorafenibkonjugater kan spaltes i mave-tarm-kanalen via bakteriel glukuronidaseaktivitet, hvilket medfører reabsorption af ukonjugeret aktivt stof. 
Sorafenib conjugates may be cleaved in the gastrointestinal tract by bacterial glucuronidase activity, allowing reabsorption of unconjugated active substance.
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). 
This OS analysis showed a statistically significant advantage for sorafenib over placebo for OS (HR: 0.69, p = 0.00058, see table 3).
86 % af patienterne havde metastaser i lungerne, 51 % i lymfeknuderne og 27 % i knoglerne. 
Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients.
Pakningsstørrelser og yderligere oplysninger Nexavar indeholder: 
Contents of the pack and other information What Nexavar contains
Når sorafenib anvendes til patienter med DTC, anbefales nøje overvågning af TSH-niveauet. 
When using sorafenib in DTC patients, close monitoring of TSH level is recommended.
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). 
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).
Immunsystemet overfølsomhedsreaktioner (inklusive hudreaktioner og urticaria) 
Immune system disorders hypersensitivity reactions (including skin reactions and urticaria)
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. 
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.
Afvigelser i laboratorieanalyser hos patienter med HCC (studie 3) og RCC (studie 1) 
Laboratory test abnormalities in HCC (study 3) and RCC (study 1) patients
Når sorafenib anvendes til patienter med DTC, anbefales nøje monitorering af calciumniveauet i blodet. 
When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended.
Hvis det ikke er tilfældet, kan Deres læge beslutte at afbryde behandlingen eller stoppe den helt. 
If not, your doctor may interrupt treatment or stop it altogether.
På rotter blev det vist, at sorafenib og dens metabolitter passerer placenta, og sorafenib forventes at skade fostret. 
In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the foetus.
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). 
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).
Klinisk farmakokinetiske interaktioner mellem sorafenib og disse enzymsubstrater er derfor ikke sandsynlige. 
Therefore, clinical pharmacokinetic interactions of sorafenib with substrates of these enzymes are unlikely.
Differentieret thyreoideacancer (DTC) 
Differentiated thyroid cancer (DTC)
Et øget antal tilfælde af arteriel hypertension blev observeret hos patienter, der blev behandlet med sorafenib. 
An increased incidence of arterial hypertension was observed in sorafenib-treated patients.
Øre og labyrint tinnitus 
Ear and labyrinth disorders tinnitus
Den højeste dosis af sorafenib, som er klinisk studeret, er 800 mg to gange daglig. 
The highest dose of sorafenib studied clinically is 800 mg twice daily.
- hvis De er allergisk over for sorafenib eller et af de øvrige indholdsstoffer i Nexavar (angivet i punkt 6). 
- If you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section
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. 
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.
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. 
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.
Den kliniske betydning af disse små til moderate stigninger i capecitabin- og 5-FU-eksponering, når det indgives sammen med sorafenib, er ikke kendt. 
The clinical significance of these small to modest increases in capecitabine and 5-FU exposure when co-administered with sorafenib is unknown.
Hos raske frivillige personer, der blev behandlet med neomycin i 5 dage, faldt den gennemsnitlige eksponering for sorafenib med 54 %. 
In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%.
Der er ingen tilgængelig data for dialysekrævende patienter. 
No data is available in patients requiring dialysis.
Sorafenib havde ingen klinisk relevant indvirkning på farmakokinetikken af gemcitabin, cisplatin, carboplatin, oxaliplatin eller cyclophosphamid. 
Sorafenib had no clinically relevant effect on the pharmacokinetics of gemcitabine, cisplatin, carboplatin, oxaliplatin or cyclophosphamide.
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 %). 
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 %).
Ved mistanke om overdosering bør administrering af sorafenib ophøre og understøttende behandling om nødvendigt gives. 
In the event of suspected overdose sorafenib should be withheld and supportive care instituted where necessary.
Sorafenib metaboliseres primært i leveren og gennemgår oxidativ metabolisme medieret af CYP 3A4 såvel som glucuronidation medieret af UGT1A9. 
Sorafenib is metabolised primarily in the liver and undergoes oxidative metabolism, mediated by CYP 3A4, as well as glucuronidation mediated by UGT1A9.
Desuden medførte samtidig behandling med sorafenib og warfarin, et CYP2C9-substrat, ikke ændringer i det gennemsnitlige INR sammenlignet med placebo. 
Additionally, concomitant treatment with sorafenib and warfarin, a CYP2C9 substrate, did not result in changes in mean PT-INR compared to placebo.
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. 
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.
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. 
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.
Den cirkulerende hovedmetabolit af sorafenib i plasma, pyridin N-oxid, viser in vitro den samme effekt som den for sorafenib. 
The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Før behandling indledes, anbefales det, at lægen omhyggeligt evaluerer den enkelte patients prognose ved at vurdere den maksimale læsionsstørrelse (se pkt. 
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.
Sorafenib er vist at hæmme transportproteinet p-glykoprotein (P-pg) in vitro. 
In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Nexavar indeholder natrium 
Nexavar contains sodium
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. 
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.
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). 
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).
At tage en for stor mængde Nexavar øger risikoen for bivirkninger eller svære bivirkninger, især diarré og hududslæt. 
Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions.
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. 
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.
Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejersken eller apotekpersonalet. 
If you get any side effects, talk to your doctor or pharmacist.
Metabolisme og ernæring anoreksi hypofosfatæmi hypokalcæmi hypokaliæmi hyponatriæmi hypoglykæmi dehydrering 
Metabolism and nutrition disorders anorexia hypophosphataemia hypocalcaemia hypokalaemia hyponatraemia hypoglycaemia dehydration
Yderligere oplysninger om udvalgte bivirkninger 
Further information on selected adverse drug reactions
Almindelig Ikke almindelig Sjælden Ikke kendt 
Uncommon Rare
Nervesystemet perifer sensorisk neuropati dysgeusi reversibel posterior leukoencefalopati encephalopati 
Nervous system disorders peripheral sensory neuropathy dysgeusia reversible posterior leukoencephalopathy*
Psykiske forstyrrelser depression 
Psychiatric disorders depression
Afvigelser i laboratorieanalyser hos patienter med DTC (studie 5) 
Laboratory test abnormalities in DTC patients (study 5)
De vigtigste alvorlige bivirkninger var myokardieinfarkt/myokardieiskæmi, gastrointestinal perforation, lægemiddelinduceret hepatitis, blødning og hypertension/hypertensiv krise. 
The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis.
Hypokalcæmi af grad 3 og 4 opstod hos 6,8 % og 3,4 % af sorafenibbehandlede DTC-patienter (se pkt. 
Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see section 4.8).
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. 
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.
Samtidig administration af sorafenib og midazolam, dextrometorphan eller omeprazol, som er substrater for henholdsvis CYP3A4, CYP2D6 og CYP2C919, forandrede ikke eksponeringen af disse substanser. 
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.
Samtidig indgift af neomycin har vist sig at påvirke denne proces og nedsætte sorafenibs gennemsnitlige biotilgængelighed med 54 %. 
Coadministration of neomycin has been shown to interfere with this process, decreasing the mean bioavailability of sorafenib by 54%.
Deres læge vil overvåge indholdet af calcium og skjoldbruskkirtel-hormon i blodet. 
Your doctor will monitor blood calcium and thyroid hormone levels.
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. 
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.
Nexavar er indiceret til behandling af patienter med progressiv, lokalt fremskreden eller metastaserende differentieret (papillær/follikulær/Hürthle-celle) thyreoideacancer, refraktær over for radioaktivt iod. 
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.
Den kliniske signifikans for disse data er ikke kendt (se pkt. 
The clinical significance of these findings is unknown (see section 4.4).