FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if it feels like your heart is pounding, racing, or beating irregularly, or if you experience dizziness, tiredness, light-headedness, shortness of breath or swelling in the legs.
Danish: Fortæl det straks til lægen, hvis du føler hjertebanken, galopperende hjerte, uregelmæssige hjerteslag, eller hvis du oplever svimmelhed, træthed, ørhed, åndenød eller hævelse i benene.
English: Worst-case QTc prolongation of >60 millisecond (msec) was observed in 3% of dabrafenib-treated subjects (one >500 msec in the integrated safety population).
Danish: De alvorligste tilfælde af QTc-forlængelse på > 60 millisekunder (ms) blev set hos 3 % af de dabrafenib-behandlede patienter (et tilfælde på > 500 ms i den integrerede sikkerhedspopulation).
English: In the integrated safety population of dabrafenib in combination with trametinib (n=1076), 265 patients (25%) were ≥65 years of age, 62 patients (6%) were ≥75 years of age.
Danish: I den integrerede sikkerhedspopulation med dabrafenib i kombination med trametinib (n = 1076) var 265 patienter (25 %) ≥ 65 år og 62 patienter (6 %) ≥ 75 år.
English: Patients were stratified by BRAF mutation status (V600E versus V600K) and stage of disease prior to surgery using the American Joint Committee on Cancer (AJCC) 7th edition Melanoma Staging System (by Stage III sub-stage, indicating different levels of lymph node involvement and primary tumour size and ulceration).
Danish: Patienterne blev stratificeret efter BRAF-mutationsstatus (V600E versus V600K) og sygdomsstadie før operation ved brug af American Joint Committee on Cancer's (AJCC) 7. udgave af stadieklassificering for melanom (efter stadie III-substadie, der indikerer forskellige niveauer af involvering af lymfeknuder og størrelse af primærtumor og ulceration).
English: Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K).
Danish: Forsøgsdeltagerne blev stratificeret efter laktatdehydrogenase (LDH)-niveau (> den øvre normalgrænse (ULN) versus  ULN) og BRAF-mutation (V600E versus V600K).
English: Dry skin Pruritus Rash Erythema h
Danish: Tør hud Pruritus Udslæt Erytem h
English: Therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5ºC (please refer to Table 2 for dose modification guidance).
Danish: Behandlingen med dabrafenib bør afbrydes, hvis patientens temperatur er ≥ 38,5 ºC (se vejledning i dosisjusteringsskema tabel 2).
English: Patients should be routinely monitored for serum creatinine while on therapy.
Danish: Patienternes nyrefunktion skal monitoreres rutinemæssigt med måling af serum-kreatinin under behandlingen.
English: Tell your doctor, pharmacist or nurse if you get any of the signs and symptoms listed.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får nogle af de anførte tegn og symptomer.
English: Your doctor may advise an eye examination before you take Tafinlar in combination with trametinib and while you are taking it.
Danish: Lægen vil måske henvise dig til en øjenundersøgelse, før du begynder at tage Tafinlar i kombination med trametinib, og mens du tager det.
English: Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively.
Danish: De gennemsnitlige forhold mellem metabolit-AUC og moderstof-AUC efter gentagen dosisadministration var 0,9, 11 og 0,7 for henholdsvis hydroxy-, carboxy- og desmethyldabrafenib.
English: Microcrystalline cellulose Magnesium stearate Colloidal silicone dioxide
Danish: Mikrokrystallinsk cellulose Magnesiumstearat Kolloid silica
English: Black iron oxide (E172) Shellac
Danish: Sort jernoxid (E 172) Shellac
English: Following administration of 150 mg twice daily, geometric mean Cmax, AUC(0-) and predose concentration (C) were 1478 ng/ml, 4341 ng*hr/ml and 26 ng/ml, respectively.
Danish: Efter administration af 150 mg to gange dagligt var den geometriske middelværdi af Cmax, AUC(0-) og koncentration før dosering (C) henholdsvis 1.478 ng/ml, 4.341 ng·time/ml og 26 ng/ml.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl cyster og polypper)
English: Skin peeling.
Danish: Askallet hud.
English: P-value is obtained from the two-sided stratified logrank test (stratification factors were disease stage - IIIA vs. IIIB vs. IIIC - and BRAF V600 mutation type - V600E vs. V600K) NE = not estimable
Danish: [2] P-værdien stammer fra den to-sidede stratificerede logrank test (stratificeringsfaktorer var sygdomsstadie - IIIA vs. IIIB vs. IIIC - og BRAF V600-mutationstype - V600E vs. V600K) NE = kan ikke estimeres
English: Similar results were seen in the 45 patients who crossed over from dabrafenib monotherapy to the trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination in Part C of this study.
Danish: Der blev set lignende resultater hos de 45 patienter, som skiftede over fra monoterapi med dabrafenib til kombinationen med trametinib 2 mg en gang daglig og dabrafenib 150 mg to gange dagligt i del C af dette studie.
English: Tafinlar in combination with trametinib can cause problems with your liver which may develop into serious conditions such as hepatitis and liver failure, which may be fatal.
Danish: Tafinlar i kombination med trametinib kan forårsage leverproblemer, som kan udvikle sig til alvorlige tilstande, såsom leverbetændelse og leversvigt, som kan være dødeligt.
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes).
Danish: Enzymer, der kan blive induceret, omfatter CYP3A i leveren og tarmen, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og UGT'er (glukuronidkonjugerende enzymer).
English: N Events Median, months (95% CI) NA (46.9, NA)
Danish: N Hændelser Median, måneder (95 % CI) NA (46,9, NA)
English: The median time to diagnosis of the first occurrence of cuSCC in study MEK115306 was 223 days (range 56 to 510 days) in the combination therapy arm and 60 days (range 9 to 653 days) in the dabrafenib monotherapy arm.
Danish: Mediantiden til diagnosticering af den første forekomst af cuSCC i MEK115306 var 223 dage (interval 56 til 510 dage) i kombinationsbehandlingsarmen og 60 dage (interval 9 til 653 dage) i dabrafenib-monoterapiarmen.
English: • If you take too much Tafinlar or trametinib, immediately contact your doctor, nurse or pharmacist.
Danish: • Hvis du har taget for meget Tafinlar eller trametinib, skal du straks kontakte lægen, sundhedspersonalet eller apotekspersonalet.
English: No data is available in patients with melanoma harbouring BRAF V600 mutations others than V600E and V600K.
Danish: Der findes ikke tilgængelige data om patienter med melanom med andre BRAF V600-mutationer end V600E og V600K.
English: • Antipsychotics (e.g. haloperidol)
Danish: • Antipsykotika (fx haloperidol)
English: • passing blood in the urine
Danish: • blod i urinen
English: Tafinlar when given in combination with trametinib can cause eye problems including blindness.
Danish: Tafinlar i kombination med trametinib kan give øjenproblemer, herunder blindhed.
English: In the integrated safety population of patients with melanoma and advanced NSCLC, cuSCC occurred in 2% (19/1076) of patients receiving dabrafenib in combination with trametinib.
Danish: I den integrerede sikkerhedspopulation af patienter med melanom og fremskreden NSCLC forekom cuSCC hos 2 % (19/1076) af de patienter, der fik dabrafenib i kombination med trametinib.
English: When dabrafenib and trametinib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib.
Danish: Når dabrafenib og trametinib tages i kombination, skal den daglige dosis af trametinib tages på samme tid hver dag sammen med enten morgendosis eller aftendosis af dabrafenib.
English: RAS-associated malignancies have been reported in clinical trials, both with another BRAF inhibitor (chronic myelomonocytic leukaemia and non-cutaneous SCC of the head and neck) as well as with dabrafenib monotherapy (pancreatic adenocarcinoma, bile duct adenocarcinoma) and with dabrafenib in combination with the MEK inhibitor, trametinib (colorectal cancer, pancreatic cancer).
Danish: Der er set RAS-associerede maligne sygdomme i kliniske studier, både med en anden BRAF-hæmmer (kronisk myelomonocytisk leukæmi og ikke-kutan hoved-hals SCC) samt med dabrafenib monoterapi (pancreas-adenokarcinom, adenokarcinom i galdegangen) og med dabrafenib i kombination med MEK-hæmmeren trametinib (kolorektal cancer, pancreas cancer).
English: Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care.
Danish: Patienter, der oplevede alvorlige tilfælde af ikke-infektiøs feber, responderede godt på behandlingspause og/eller dosisreduktion og understøttende behandling.
English: Concomitant administration of dabrafenib with warfarin results in decreased warfarin exposure.
Danish: Samtidig administration af dabrafenib og warfarin resulterer i nedsat warfarineksponering.
English: The onset of these serious non-infectious febrile events was typically within the first month of therapy.
Danish: Disse alvorlige tilfælde af ikkeinfektiøs feber indtraf typisk inden for den første måneds behandling.
English: The majority of subjects had Stage IVM1c disease (67%).
Danish: Størstedelen af forsøgsdeltagerne havde sygdom i stadie IVM1c (67 %).
English: Prior to initiation of treatment patients should undergo a head and neck examination with minimally visual inspection of oral mucosa and lymph node palpation, as well as chest/abdomen computerised tomography (CT) scan.
Danish: Inden behandlingsstart skal patienterne have gennemført klinisk undersøgelse af hoved- og hals-regionen, som minimum ved en visuel inspektion af den orale slimhinde og palpation af lymfeknuder, og computer tomografi (CT)-scanning af brystkassen/maveregionen bør foretages.
English: Dabrafenib exposure (Cmax and AUC) increased in a dose proportional manner between 12 and 300 mg following single-dose administration, but the increase was less than dose-proportional after repeat twice daily dosing.
Danish: Eksponeringen (Cmax og AUC) for dabrafenib steg på dosisproportional vis mellem 12 mg og 300 mg efter administration af enkeltdoser, men stigningen var mindre end dosisproportional ved dosering to gange dagligt.
English: Prior to starting treatment with Tafinlar, talk to your doctor about options to improve your chances to have children in the future.
Danish: Tal med lægen om de muligheder, der er for at forbedre dine chancer for at få børn i fremtiden, inden du starter behandling med Tafinlar.
English: Taking Tafinlar may cause fever in more than 1 in 10 people.
Danish: Det kan give feber hos flere end 1 ud af 10 patienter at tage Tafinlar.
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III clinical trials, MEK115306 (COMBI-d) and MEK116513 (COMBI-v), 435 were treated with the combination in the adjuvant treatment of Stage III BRAF V600 mutant melanoma after complete resection in a randomised Phase III study BRF115532 (COMBI-AD) and 82 were treated with the combination for BRAF V600 mutant NSCLC in a multi-cohort, non-randomised Phase II study BRF113928 (see section 5.1).
Danish: 559 af disse patienter blev behandlet med kombinationen for BRAF V600-muteret melanom i to kliniske randomiserede fase III-forsøg, MEK115306 (COMBI-d) og MEK116513 (COMBI-v), 435 blev behandlet med kombinationen i den adjuverende behandling af stadie III BRAF V600-muteret melanom efter komplet resektion i et randomiseret fase III-studie BRF115532 (COMBI-AD) og 82 blev behandlet med kombinationen for BRAF V600-muteret NSCLC i et ikke-randomiseret fase II-studie med flere kohorter BRF113928 (se pkt.
English: (7.5, NR) a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (≥59%) of investigator-assessed responses were still ongoing e - ORR difference calculated based on the ORR result not rounded f - Updated analysis was not pre-planned and the p-value was not adjusted for multiple testing NR = Not reached
Danish: investigators vurdering) b - Samlet responsrate = samlet respons + partiel respons c - Responsvarighed d - På rapporteringstidspunktet var størstedelen (≥ 59 %) af de af investigator-vurderede responser stadig igangværende e - ORR-difference beregnet ud fra ORR-resultatet ikke afrundet f - Opdateret analyse var ikke planlagt forud, og der blev ikke foretaget en justering af p-værdien ved gentagen afprøvning
English: No studies have been conducted to investigate the pharmacokinetics of dabrafenib in paediatric patients.
Danish: Der er ikke udført studier med henblik på at undersøge farmakokinetikken af dabrafenib hos pædiatriske patienter.
English: A supratherapeutic dose of 300 mg dabrafenib twice daily was administered in 32 subjects with BRAF V600 mutation-positive tumours.
Danish: Der blev administreret en supraterapeutisk dosis på 300 mg dabrafenib 2 gange dagligt hos 32 forsøgspersoner med BRAF V600-mutationspositive tumorer.
English: Dabrafenib should therefore not be used in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC (see sections 4.4 and 5.1).
Danish: Dabrafenib bør derfor ikke anvendes hos patienter med vildtype BRAF-melanom eller vildtype BRAF-NSCLC (se punkt 4.4 og 5.1).
English: If a dose of trametinib is missed, when dabrafenib is given in combination with trametinib, the dose of trametinib should only be taken if it is more than 12 hours until the next scheduled dose.
Danish: Hvis en dosis af trametinib glemmes, når det gives i kombination med dabrafinib, må trametinib-dosen kun tages, hvis der er mere end 12 timer til den næste planlagte dosis.
English: Administration of dabrafenib 150 mg twice daily and warfarin resulted in a decrease in AUC of S- and R- warfarin of 37% and 33%, respectively, compared to administration of warfarin alone.
Danish: Administration af dabrafenib 150 mg to gange daglig og warfarin resulterede i et fald i AUC for S- og R-warfarin på henholdsvis 37 % og 33 % sammenlignet med administration af warfarin alene.
English: Tafinlar can cause serious bleeding problems, especially in your brain when taken in combination with trametinib.
Danish: Tafinlar kan give alvorlige blødningsproblemer, specielt i din hjerne, når det tages i kombination med trametinib.
English: New primary melanoma d
Danish: Nyt primært melanom d
English: • If you do become pregnant while you are taking this medicine, tell your doctor immediately.
Danish: • Fortæl det straks til lægen, hvis du bliver gravid, mens du tager dette lægemiddel.
English: • Dabrafenib in combination with trametinib
Danish: • Dabrafenib i kombination med trametinib
English: • Increase in blood sugar level (hyperglycaemia)
Danish: • højt blodsukker (hyperglykæmi)
English: The majority of patients had a BRAF V600E mutation (91%).
Danish: Størstedelen af patienterne havde en BRAF V600E-mutation (91 %).
English: • some medicines to lower fat (lipids) in the blood stream, such as gemfibrozil
Danish: • visse lægemidler til at sænke fedtindholdet (lipider) i blodet, fx gemfibrozil
English: Frequency (all grades) Adverse reactions
Danish: Hyppighed (alle grader) Bivirkninger
English: Tafinlar in combination with trametinib can result in the breakdown of muscle (rhabdomyolysis).
Danish: Tafinlar, i kombination with trametinib, kan medføre nedbrydning af muskelvæv (rabdomyolyse).
English: • New melanoma
Danish: • nyt melanom
English: Improvements were also observed for ORR and a longer DoR was observed in the combination arm compared to vemurafenib monotherapy (Table 9).
Danish: Forbedringer blev også set i ORR og der blev observeret en længere DoR i kombinatiosnarmen, sammenlignet med vemurafenib monoterapi (tabel 9).
English: Contact your doctor, pharmacist or nurse immediately if you get these symptoms.
Danish: Kontakt straks din læge, apotekspersonalet eller sundhedspersonalet, hvis du får disse symptomer.
English: • Increased sweating, night sweats
Danish: • kraftig svedproduktion, nattesved
English: If possible, show them the Tafinlar and trametinib pack with each leaflet.
Danish: Vis dem om muligt Tafinlar- og trametinib-pakningerne med hver sin indlægsseddel.
English: Tell your doctor as soon as possible if you get any of these symptoms.
Danish: Fortæl det straks til lægen, hvis du får nogen af disse symptomer.
English: efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir and atazanavir
Danish: delavirdine, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir og atazanavir
English: • Decreased appetite
Danish: • nedsat appetit
English: What Tafinlar contains - The active substance is dabrafenib.
Danish: Tafinlar indeholder: - Aktivt stof: dabrafenib.
English: • medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole
Danish: • lægemidler til behandling af svampeinfektioner, fx ketoconazol, itraconazol, voriconazol og posaconazol
English: In a clinical drug interaction study, Cmax and AUC of oral midazolam (a CYP3A4 substrate) decreased by 47% and 65%, respectively with co-administration of repeat-dose dabrafenib.
Danish: I et klinisk interaktionsstudie faldt Cmax og AUC-værdien af oralt midazolam (et CYP3A4-substrat) med henholdsvis 47 % og 65 % ved samtidig administration af gentagne doser af dabrafenib.
English: Red iron oxide (E172) Titanium dioxide (E171) Hypromellose (E464)
Danish: Rødt jernoxid (E 172) Titandioxid (E 171) Hypromellose (E 464)
English: Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose.
Danish: Dabrafenib absorberes oralt, og den maksimale plasmakoncentration nås med en mediantid på 2 timer efter dosering.
English: Grade (CTC-AE)* Recommended dabrafenib dose modifications Used as monotherapy or in combination with trametinib
Danish: Grad (CTC-AE)* Anbefalede justeringer af dabrafenib-dosis Anvendt som monoterapi eller i kombination med trametinib
English: • Unusual hair loss or thinning
Danish: • usædvanligt hårtab eller udtyndning af håret
English: • some calcium channel blockers, used to treat high blood pressure, such as diltiazem,
Danish: • visse calciumantagonister, som bruges til at behandle højt blodtryk, fx diltiazem, felodipin,
English: Complete blood cell counts and blood chemistry should be performed as clinically indicated.
Danish: Blodprøver med komplet hæmatologi og kemi bør foretages når det anses for klinisk indiceret.
English: In clinical trials ophthalmologic reactions, including uveitis, iridocyclitis and iritis, have been reported in patients treated with dabrafenib as monotherapy and in combination with trametinib.
Danish: I kliniske studier er der rapporteret oftalmologiske reaktioner, herunder uveitis, iridocyklitis og iritis hos patienter, behandlet med dabrafenib som monoterapi og i kombination med trametinib.
English: Decreased LVEF has been reported in 6% (65/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Danish: Nedsat LVEF er rapporteret hos 6 % (65/1076) af patienterne i den integrerede sikkerhedspopulation med dabrafenib i kombination med trametinib.
English: • Allergic reactions (hypersensitivity)
Danish: • allergiske reaktioner (overfølsomhed)
English: Trametinib dose* Only when used in combination with dabrafenib
Danish: Trametinib-dosis* Kun ved anvendelse i kombination med dabrafenib
English: In combined female fertility, early embryonic and embryo-foetal development studies in rats numbers of ovarian corpora lutea were reduced in pregnant females at 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), but there were no effects on oestrous cycle, mating or fertility indices.
Danish: I kombinerede studier af fertiliteten hos hunner og den embryonale og embryoføtale udvikling hos rotter blev antallet af corpora lutea i ovarierne reduceret hos drægtige hunrotter ved 300 mg/kg/dag (ca. 3 gange den kliniske eksponering hos mennesker baseret på AUC), men der var ingen effekter på brunstcyklus, parrings- eller fertilitetsindekserne.
English: Improvements were also observed for overall response rate (ORR) and a longer duration of response (DoR) was observed in the combination arm compared to dabrafenib monotherapy (Table 7).
Danish: Forbedringer blev også set i samlet responsrate (ORR) og der blevobserveret en længere responsvarighed (DoR) i kombinationsarmen, sammenlignet med dabrafenib monoterapi (tabel 7).
English: If a patient vomits after taking dabrafenib, the patient should not retake the dose and should take the next scheduled dose.
Danish: Hvis en patient kaster op efter at have taget dabrafenib, skal patienten ikke tage en ny dosis, men vente til den næste planlagte dosis.
English: Focal arterial/perivascular inflammation in various tissues was observed in mice and an increased incidence of hepatic arterial degeneration and spontaneous cardiomyocyte degeneration with inflammation (spontaneous cardiomyopathy) was observed in rats (≥0.5 and 0.6 times clinical exposure for rats and mice respectively).
Danish: Der blev observeret fokal arteriel/perivaskulær inflammation i forskellige væv hos mus, og der blev observeret en øget incidens af degeneration af arterierne i leveren og spontan kardiomyocytdegeneration med inflammation (spontan kardiomyopati) hos rotter (ved ≥ 0,5 og 0,6 gange den kliniske eksponering for henholdsvis rotter og mus).
English: For dabrafenib monotherapy in study MEK115306, cutaneous squamous cell carcinomas (including those classified as keratoacanthoma or mixed keratoacanthoma subtype) occurred in 10% of patients and approximately 70% of the events occurred within the first 12 weeks of treatment with a median time to onset of 8 weeks.
Danish: I MEK115306-studiet med dabrafenib-monoterapi forekom kutane planocellulære karcinomer (herunder dem, der er klassificeret som keratoakantom eller blandet keratoakantom-undertype) hos 10 % af patienterne, og ca. 70 % af tilfældene forekom inden for de første 12 behandlingsuger med en mediantid til indtræden på 8 uger.
English: If signs and symptoms suggestive of SCARs appear, dabrafenib and trametinib should be withdrawn.
Danish: Hvis der opstår tegn og symptomer, der tyder på SCARs, skal dabrafenib og trametinib seponeres.
English: Dabrafenib may impair male and female fertility as adverse effects on male and female reproductive organs have been seen in animals (see section 5.3).
Danish: Dabrafenib kan forringe fertiliteten hos mænd og kvinder, da der er set uønskede effekter på han- og hundyrs reproduktionsorganer (se pkt.
English: Therefore, other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Danish: Andre behandlingsmuligheder skal derfor overvejes, inden patienter, der tidligere har været behandlet med en BRAF-hæmmer, behandles med kombinationen.
English: Tell your doctor immediately if you get the following symptoms of eye problems: blurred vision, loss of vision or other vision changes, coloured dots in your vision or halos (seeing blurred outline around objects) during your treatment.
Danish: Fortæl det straks til lægen, hvis du under behandlingen får følgende symptomer på øjenproblemer: sløret syn, nedsat syn eller andre ændringer i synet, farvede prikker i synsfeltet eller ser haloer (uskarpe konturer omkring genstande).
English: The recommended dose of trametinib, when used in combination with Tafinlar, is 2 mg once a day.
Danish: Den anbefalede dosis af trametinib, anvendt i kombination med Tafinlar, er 2 mg en gang dagligt.
English: Dabrafenib is an enzyme inducer and increases the synthesis of drug-metabolising enzymes including CYP3A4, CYP2Cs and CYP2B6 and may increase the synthesis of transporters.
Danish: Dabrafenib er en enzyminduktor og fremmer syntetiseringen af mange lægemiddel-metaboliserende enzymer herunder CYP3A4, CYP2C and CYP2B6 og kan øge syntesen af transportører.