FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may decide to adjust your dose.
Danish: Lægen vil måske beslutte at ændre din dosis.
English: Overall, 54% of subjects had <3 disease sites at baseline.
Danish: I alt 54 % af forsøgsdeltagerne havde < 3 sygdomssteder ved baseline.
English: Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Spain
Danish: Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Spanien
English: • Lack of energy
Danish: • manglende energi
English: They may arrange for you to see a specialist eye doctor for a complete eye examination.
Danish: Lægen vil måske arrangere, at du kommer til en specialiseret øjenlæge for at få en komplet øjenundersøgelse.
English: • If you get side effects your doctor may decide that you should take lower doses of Tafinlar and / or trametinib.
Danish: • Hvis du får bivirkninger, kan lægen beslutte, at du skal tage en lavere dosis af Tafinlar og/eller trametinib.
English: The reduction in plasma concentrations can lead to lost or reduced clinical effect of these medicinal products.
Danish: Faldet i plasmakoncentrationerne kan føre til manglende eller nedsat klinisk effekt af disse lægemidler.
English: Radiological tumour assessment was conducted every 3 months for the first two years and every 6 months thereafter, until first relapse was observed.
Danish: Der blev udført radiologisk tumorevaluering hver 3. måned i de to første år og hver 6. måned derefter indtil første recidiv blev observeret.
English: These data show that the efficacy of the combination will be lower in these patients (see section 5.1).
Danish: Disse data viser, at effekten af kombinationen vil være lavere hos disse patienter (se pkt.
English: Tafinlar is not recommended during pregnancy, since it may potentially harm an unborn baby.
Danish: Tafinlar må ikke bruges under graviditet, da det muligvis kan skade et ufødt barn.
English: 2 patients had no previous systemic treatment and were included in the analysis for patients enrolled in Cohort C.
Danish: 2 patienter havde ikke tidligere fået systemisk behandling og blev inkluderet i analysen med patienter i kohorte C.
English: Take whole with a full glass of water.
Danish: Skal synkes hele med et helt fyldt glas vand.
English: Table 11 Efficacy in previously untreated patients (BREAK-3 Study, 25 June 2012)
Danish: Tabel 11 Effekt hos tidligere ubehandlede patienter (studiet BREAK-3, 25. juni 2012)
English: A total of 125 patients were enrolled into four cohorts:
Danish: Der blev i alt inkluderet 125 patienter, fordelt på fire kohorter:
English: Because many medicinal products are excreted in human milk, a risk to the breast-feeding child cannot be excluded.
Danish: Da mange lægemidler udskilles i human mælk, kan en påvirkning af det ammede barn ikke udelukkes.
English: When you take Tafinlar and trametinib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).
Danish: Når du tager Tafinlar og trametinib sammen, kan du få en hvilken som helst af de bivirkninger, der er angivet ovenfor, omend hyppigheden kan ændre sig (hyppigere eller sjældnere).
English: If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution.
Danish: Hvis deres terapeutiske effekt er af stor betydning for patienten, og dosisjusteringer ikke er lette at foretage på basis af monitorering af effekt eller plasmakoncentrationer, skal disse lægemidler undgås eller anvendes med forsigtighed.
English: Inhibitory concentration 50 (nM)
Danish: Hæmmende koncentration 50 (nM)
English: The steady-state volume of distribution following intravenous microdose administration is 46 L.
Danish: Fordelingsvolumenet ved steady state efter intravenøs mikrodosisadministration er 46 l.
English: Induction of OATP1B1/1B3 and BCRP is not likely based on the observations from a clinical study with rosuvastatin.
Danish: Induktion af OATP1B1/1B3 og BCRP er ikke sandsynlig, baseret på observationer fra et klinisk studie med rosuvastatin.
English: • digoxin, used to treat heart conditions
Danish: • digoxin, som bruges til behandling af hjerteproblemer
English: Determination of BRAF mutation status
Danish: Bestemmelse af BRAF-mutationsstatus
English: • warfarin and acenocoumarol, medicines used to thin the blood
Danish: • warfarin og acenocoumarol, lægemidler, som bruges til at fortynde blodet
English: Your medicine targets proteins made from this mutated gene and slows down or stops the development of your cancer.
Danish: Dit lægemiddel er rettet mod proteiner, der er lavet fra dette muterede gen og hæmmer eller stopper udviklingen af din kræft.
English: If necessary, your doctor may decide to interrupt your treatment or to stop it altogether.
Danish: Hvis det bliver nødvendigt, kan lægen beslutte at afbryde din behandling midlertidigt eller stoppe den helt.
English: Hole in the stomach or intestine (perforation)
Danish: Hul i maven eller tarmen (perforation)
English: The safety and efficacy of dabrafenib have not yet been established in children and adolescents (<18 years).
Danish: Dabrafenibs sikkerhed og virkning hos børn og unge (< 18 år) er endnu ikke klarlagt.
English: The transport protein Pgp may also be induced as well as other transporters, e.g. MRP-2.
Danish: Transportproteinet Pgp kan muligvis også blive induceret såvel som andre transportører, fx MRP-2.
English: Cmax of S- and R-warfarin increased 18% and 19%.
Danish: Cmax af S- og R-warfarin steg henholdsvis 18 % og 19 %.
English: You need to know about important signs and symptoms to look out for while you're taking this medicine.
Danish: Det er nødvendigt, at du kender til vigtige tegn og symptomer, som du skal holde øje med, mens du tager dette lægemiddel.
English: No new primary melanoma was reported from the Phase II NSCLC study (BRF113928).
Danish: Der blev ikke rapporteret nye primære melanomer i fase II-NSCLC-studiet (BRF113928).
English: The ORR results assessed by IRC were consistent with the investigator assessment.
Danish: ORR-resultaterne, der blev vurderet af IRC, var konsistente med investigatorvurderingen.
English: Elderly No adjustment of the initial dose is required in patients >65 years of age.
Danish: Ældre Det er ikke nødvendigt at justere startdosis hos patienter > 65 år.
English: Changes in your skin which may indicate new skin cancer Your doctor will check your skin before you start taking this medicine and regularly while you are taking it. Tell your doctor immediately if you notice any changes to your skin while taking this medicine or after treatment (see also section 4).
Danish: Ændringer i din hud, som kan være tegn på ny hudkræft Lægen vil undersøge din hud, inden du begynder at tage dette lægemiddel, og derefter regelmæssigt, så længe du tager det. Fortæl det omgående til lægen, hvis du bemærker nogen forandringer i huden, mens du tager dette lægemiddel eller efter behandlingen (se også punkt 4).
English: These pharmacokinetic differences were not considered clinically relevant.
Danish: Disse farmakokinetiske forskelle blev ikke anset for at være klinisk relevante.
English: In vitro evaluation of drug-drug interaction potential
Danish: In vitro-evaluering af potentielle lægemiddelinteraktioner
English: Symptoms may include:
Danish: Symptomerne kan være:
English: Monitoring for skin lesions should occur as described for cuSCC.
Danish: Monitorering for hudlæsioner bør foretages som beskrevet i forbindelse med cuSCC.
English: Each bottle contains either 28 or 120 hard capsules.
Danish: Hver beholder indeholder enten 28 eller 120 hårde kapsler.
English: Baseline characteristics were balanced between treatment groups.
Danish: Baselinekarakteristika var velbalanceret mellem de to behandlingsgrupper.
English: The increased Cmax of rosuvastatin is unlikely to have clinical relevance.
Danish: Den øgede Cmax af rosuvastatin har sandsynligvis ikke klinisk relevans.
English: Part B of study BRF113220 included a cohort of 26 patients that had progressed on a BRAF inhibitor.
Danish: Del B af studiet BRF113220 omfattede en kohorte på 26 patienter, der var progredieret på en BRAF-hæmmer.
English: Dose modification exceptions (where only one of the two therapies is dose reduced) for selected adverse reactions
Danish: Undtagelser i forbindelse med dosisjustering (hvor kun dosis af en af de to behandlinger reduceres) for udvalgte bivirkninger
English: Results for the primary analysis of RFS are presented in Table 14.
Danish: Resultaterne for den primære analyse af RFS er vist i tabel 14.
English: Do not take a double dose to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Check with your doctor if you think this applies to you.
Danish: Tal med lægen, hvis du tror dette gælder for dig.
English: Data as of December 19, 2011
Danish: Data ved 19. december 2011
English: and a type of white blood cells (leukopenia)
Danish: og en type hvide blodlegemer (leukopeni)
English: In addition, older patients experienced more serious adverse reactions compared to younger patients (41% versus 22%).
Danish: Derudover oplevede ældre patienter flere alvorlige bivirkninger sammenlignet med yngre patienter (41 % i forhold til 22 %).
English: Efficacy results are summarised in Table 10.
Danish: Effektresulaterne er opsummeret i tabel 10.
English: Your doctor will also check your head, your neck, your mouth, your lymph glands and you will have scans of your chest and stomach area (called CT scans) regularly.
Danish: Lægen vil også tjekke dit hoved, din hals, din mund og dine lymfekirtler og der vil blive foretaget scanning af din brystkasse og maveregionen (kaldet CT-scanning) regelmæssigt.
English: These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
Danish: Disse alvorlige hududslæt kan være forudgået af feber og influenza-lignende symptomer (Stevens-Johnsons syndrom).
English: By IRC
Danish: Af IRC
English: Acrochordon (skin tags)
Danish: Akrokordon (skin tags)
English: Some medicines may affect how Tafinlar works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Tafinlar eller gøre det mere sandsynligt, at du får bivirkninger.
English: * The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events (CTC-AE) v4.0
Danish: *Intensiteten af kliniske bivirkninger gradinddelt i henhold til Common Terminology Criteria for Adverse Events (CTC-AE) v4.0.
English: Body weight and gender
Danish: Legemsvægt og køn
English: Therapy should be interrupted if the patient's temperature is ≥38.5ºC.
Danish: Behandlingen skal afbrydes, hvis patientens temperatur er ≥ 38,5 ºC.
English: There are no data from the use of dabrafenib in pregnant women.
Danish: Der er ingen data fra anvendelse af dabrafenib til gravide kvinder.
English: Your doctor may decide that you should take a lower dose if you get side effects.
Danish: Lægen kan beslutte, at du skal tage en lavere dosis, hvis du får bivirkninger.
English: Table 15 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review
Danish: Tabel 15 Resumé af effekt hos kohorterne med kombinationsbehandling baseret på investigatorvurdering og uafhængig radiologisk vurdering
English: Progressive disease or death, n (%)
Danish: Progressiv sygdom eller død, n (%)
English: Grade 1 or Grade 2 (Tolerable)
Danish: Grad 1 eller grad 2 (tolerabel)
English: • halo (seeing a blurred outline around objects)
Danish: • haloer (ser uskarpe konturer omkring genstande)
English: Treatment-naïve patients
Danish: Behandlingsnaive patienter
English: Table 12 Survival data from the primary analysis and post-hoc analyses
Danish: Tabel 12 Overlevelsesdata fra den primære og en post hoc-analyse
English: Some of these symptoms (bleeding, fever, changes to your skin and eye problems) are briefly mentioned in this section, but more detailed information is found in section 4, “Possible side effects”.
Danish: Nogle af disse symptomer (blødning, feber, forandringer i huden og øjenproblemer) er kort beskrevet i dette punkt, men du kan finde mere detaljerede oplysninger i punkt 4 ”Bivirkninger”.
English: CI = Confidence Interval NR = Not reached
Danish: CI = Konfidensinterval NR = Ikke nået
English: All Treated Subjects Population BRAF V600E (Primary)
Danish: Hele den behandlede patientpopulation BRAF V600E (Primær)
English: LVEF reduction/Left ventricular dysfunction
Danish: Reduktion af LVEF/venstre ventrikel dysfunktion
English: Bleeding from various sites, including intracranial bleeding and fatal bleeding g
Danish: Blødning fra forskellige steder, herunder interkraniel blødning og blødning med dødelig udgang g
English: Rare side effects (may affect up to 1 in 1000 people) • A hole (perforation) in the stomach or intestines
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) • et hul (perforation) i maven eller tarmene
English: Time from randomisation (months)
Danish: Tid fra randomisering (måneder)
English: Proportion alive and relapse free
Danish: Andel i live og recidivfri
English: o If it is less than 12 hours to your next scheduled dose of trametinib, which is taken once daily.
Danish: o Hvis der er mindre end 12 timer til din næste planlagte dosis af trametinib, som tages en gang dagligt.
English: The primary endpoint of the study was intracranial response in Cohort A, defined as the percentage of patients with a confirmed intracranial response assessed by the investigator using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Danish: Det primære endepunkt i studiet var intrakranielt respons i kohorte A, defineret som procentdelen af patienter med et bekræftet intrakranielt respons, vurderet af investigator ud fra modificeret Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
English: These changes in dabrafenib AUC and Cmax are considered not clinically meaningful.
Danish: Disse ændringer i dabrafenib AUC og Cmax anses ikke for at være klinisk relevante.
English: Papilloma c
Danish: Papillom c
English: • if you are allergic to dabrafenib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dabrafenib eller et af de øvrige indholdsstoffer i Tafinlar (angivet i punkt 6).
English: Once the fever is controlled, your doctor may recommend that you start taking Tafinlar again.
Danish: Når feberen er under kontrol, kan lægen anbefale, at du igen starter med at tage Tafinlar.
English: • have had a different type of cancer other than melanoma or NSCLC, as you may be at greater risk of developing other skin and non-skin cancers when taking Tafinlar.
Danish: • har haft en anden type kræft end malignt melanom eller NSCLC, da du kan have større risiko for at udvikle anden hudkræft eller kræft, som ikke er hudkræft, når du tager Tafinlar.
English: It is not known whether the ingredients of this medicine can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i dette lægemiddel går over i modermælken.
English: Adverse drug reactions are listed below by MedDRA system organ class ranked by frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne nedenfor er angivet i henhold til MedDRA-systemorganklasse ordnet efter hyppighed baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: In the adjuvant melanoma setting, patients should be treated for a period of 12 months unless there is disease recurrence or unacceptable toxicity.
Danish: I den adjuverende melanombehandling skal patienterne behandles i 12 måneder, medmindre der opstår recidiv eller uacceptabel toksicitet.
English: All patients received study medicinal product as first-line treatment for metastatic disease.
Danish: Alle patienter fik studielægemiddel som førstelinjebehandling for metastatisk sygdom.
English: Dabrafenib should not be administered to pregnant women unless the potential benefit to the mother outweighs the possible risk to the foetus.
Danish: Dabrafenib bør ikke administreres til gravide kvinder, medmindre den potentielle fordel for moderen vejer tungere end den mulige risiko for fosteret.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssytem anført i Appendiks V.
English: Unexplained abdominal pain should be promptly investigated to include measurement of serum amylase and lipase.
Danish: Uforklarlige abdominalsmerter skal omgående undersøges og omfatte måling af serumniveauet af amylase og lipase.
English: Terminal half-life of dabrafenib following an intravenous single microdose is 2.6 hours.
Danish: Den terminale halveringstid af dabrafenib efter en enkelt intravenøs mikrodosis er 2,6 timer.
English: Tafinlar can also affect how some other medicines work.
Danish: Tafinlar kan også påvirke virkningen af andre lægemidler.
English: This is to look for any new skin cancers.
Danish: Dette gøres for at holde øje med nye tilfælde af hudkræft.
English: Read the information about fever, changes in your skin and eye problems in section 4 of this leaflet.
Danish: Læs oplysningerne om feber, forandringer i huden og øjenproblemer i punkt 4 i denne indlægsseddel.
English: The use of oral corticosteroids should be considered in those instances in which anti-pyretics are insufficient.
Danish: Brug af orale kortikosteroider bør overvejes i tilfælde, hvor antipyretika er utilstrækkelige.
English: Analysis
Danish: Analyse
English: • Low levels of white blood cells
Danish: • lavt antal hvide blodlegemer
English: If the fever is severe, your doctor may recommend that you stop taking Tafinlar while they treat the fever with other medicines.
Danish: Hvis feberen er alvorlig, kan lægen anbefale, at du stopper med at tage Tafinlar, mens de behandler feberen med andre lægemidler.
English: Table 1 Recommended dose level reductions
Danish: Tabel 1 Anbefalede dosisreduktioner
English: • Fever (see “Fever” earlier in section 4)
Danish: • feber (se ”Feber” tidligere i punkt 4)
English: Treatment with dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med dabrafenib skal indledes og kontrolleres af en kvalificeret læge med erfaring i brugen af lægemidler mod cancer.
English: The majority of patients had a non-squamous histology.
Danish: Størstedelen af patienterne havde ikke-planocellulær histologi.
English: Efficacy results from the primary analysis and a post-hoc analysis with 6-months additional follow up are summarised in Table 11.
Danish: Effektresultaterne fra den primære analyse med yderligere 6-måneders opfølgning er opsummeret i tabel 11.
English: papilloma (a type of skin tumour which is usually not harmful), wart-like growths, increased sensitivity of the skin to sun (see also “Changes in your skin” earlier in section 4)
Danish: papillom (en form for hudtumor, som normalt ikke er farlig), vortelignende vækster, øget følsomhed af huden over for solen (se også “Forandringer i huden” tidligere i punkt 4)
English: Patients presenting with malignancies with confirmed activating RAS mutations were not eligible.
Danish: Patienter med malignitet med bekræftede aktiverende RAS-mutationer var ikke egnede.
English: Trametinib should be continued at the same dose.
Danish: Trametinib-behandlingen bør fortsættes med samme dosis.
English: Patients on the DTIC arm were allowed to cross over to dabrafenib after independent radiographic confirmation of initial progression.
Danish: Patienterne i DTIC-armen fik lov til at skifte over til dabrafenib efter uafhængig radiologic bekræftelse af første progression.
English: Tafinlar can cause heart problems, or make existing heart problems worse (see also “Heart conditions” in section 4), in people taking Tafinlar in combination with trametinib.
Danish: Tafinlar kan give hjerteproblemer eller forværre allerede eksisterende hjerteproblemer (se også “Hjerteproblemer” i punkt 4), hos personer som tager Tafinlar i kombination med trametinib.
English: Subjects at Risk:
Danish: Antal med risiko::
English: Testicular changes in rat and dog were still present following a 4-week recovery period (see section 4.6).
Danish: Testikelforandringerne hos rotter og hunde var stadig til stede efter en restitutionsperiode på 4 uger (se pkt.
English: BRAF mutations have been identified at a high frequency in specific cancers, including approximately 50% of melanoma.
Danish: BRAF-mutationer er blevet identificeret med en høj hyppighed ved specifikke cancerformer, herunder i ca. 50 % af alle tilfælde af melanom.
English: You should have your eyes examined by your doctor while you are taking this medicine.
Danish: Du skal have undersøgt dine øjne af lægen, mens du tager dette lægemiddel.
English: Alanine aminotransferase increased Aspartate aminotransferase increased
Danish: Forhøjet alaninaminotransferase Forhøjet aspartataminotransferase
English: • Increase in creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
Danish: • stigning i kreatinkinase, et enzym, der hovedsageligt findes i hjertet, hjernen og skeletmuskulaturen
English: The dabrafenib dose should not exceed 150 mg twice daily.
Danish: Dabrafenib-dosis må ikke overstige 150 mg to gange dagligt.
English: Taking the combination of Tafinlar and trametinib may increase the risk of developing holes in the gut wall.
Danish: At tage kombinationen af Tafinlar og trametinib kan øge risikoen for at udvikle huller i tarmvæggen.
English: Non-small cell lung cancer (NSCLC)
Danish: Ikke-småcellet lungecancer (NSCLC)
English: Mean absolute bioavailability of oral dabrafenib is 95% (90% CI: 81, 110%).
Danish: Den gennemsnitlige absolutte biotilgængelighed af oralt dabrafenib er 95 % (90 % CI: 81; 110 %).
English: You and your doctor will decide if you will take this medicine or breast-feed.
Danish: Du og din læge vil sammen afgøre, om du skal tage dette lægemiddel eller amme.
English: Although data in moderate renal impairment are limited these data may indicate no clinically relevant effect.
Danish: Selvom mængden af data ved moderat nedsat nyrefunktion er begrænset, kan de foreliggende data tyde på, at der ikke er nogen klinisk relevant effekt.
English: The clinical status of the patient and the adverse reaction profile of dabrafenib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Danish: Der skal tages hensyn til patientens kliniske status og dabrafenibs bivirkningsprofil i vurderingen af patientens evne til at udføre opgaver, som kræver dømmekraft, motoriske eller kognitive færdigheder.
English: Tell your doctor if you have a heart disorder.
Danish: Fortæl det til lægen, hvis du har problemer med hjertet.
English: Your doctor will check your skin before you start taking Tafinlar, then check it again every month while you are taking this medicine and for 6 months after you stop taking it.
Danish: Lægen vil undersøge din hud, før du begynder at tage Tafinlar, og herefter undersøge den igen hver måned, mens du tager dette lægemiddel, og i 6 måneder efter at du er stoppet med at tage det.
English: • vomit containing blood or that looks like “coffee grounds”
Danish: • opkastning med blod eller som ligner ”kaffegrums”
English: Number of events, n (%) Recurrence Relapsed with distant metastasis
Danish: Antal hændelser, n (%) Recidiv Recidiv med fjernmetastaser
English: A total of 704 subjects were randomised 1:1 to either combination or vemurafenib.
Danish: I alt blev 704 forsøgsdeltagere randomiseret 1:1 til enten kombination eller vemurafenib.