FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient becomes pregnant while taking dabrafenib, the patient should be informed of the potential hazard to the foetus.
Danish: Hvis patienten bliver gravid under behandlingen med dabrafenib, bør patienten informeres om den potentielle risiko for fosteret.
English: • dark urine due to kidney damage
Danish: • mørk urin som følge af nyreskader
English: Tafinlar should only be used to treat melanomas and NSCLC with the BRAF mutation.
Danish: Tafinlar må kun anvendes til behandling af melanomer og NSCLC med BRAF-mutation.
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 1).
Danish: Kaplan-Meier OS kurven, ser ud til at stabiliseres fra 3 til 5 år (se figur 1).
English: • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Danish: • Statiner metaboliseret via CYP3A4 (fx atorvastatin, simvastatin)
English: There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib.
Danish: Der var en stigning på 73 % i AUC for carboxy-dabrafenib og et fald på 30 % i AUC for desmethyl-dabrafenib.
English: Take your morning and evening doses of Tafinlar at the same times every day.
Danish: Tag din morgendosis og din aftendosis af Tafinlar på samme tidspunkter hver dag.
English: Liver monitoring may be continued thereafter as clinically indicated.
Danish: Monitorering af leverfunktionen kan herefter fortsættes som klinisk indiceret.
English: The bottles are opaque white plastic with threaded plastic closures.
Danish: Beholderne er uigennemsigtige hvide plastikbeholdere med plastiklåg med gevind.
English: Neither dabrafenib nor its 3 main metabolites were demonstrated to be inhibitors of Pgp in vitro.
Danish: Det blev påvist, at hverken dabrafenib eller dets 3 hovedmetabolitter var Pgp-hæmmere in vitro.
English: Dabrafenib is a substrate of human P-glycoprotein (Pgp) and human BCRP in vitro.
Danish: Dabrafenib er substrat for humant P-glykoprotein (Pgp) og human BCRP in vitro.
English: All treated patients population
Danish: Population: alle behandlede patienter
English: In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastrointestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone.
Danish: I et studie med hunde, hvor trametinib og dabrafenib blev givet i kombination i 4 uger, blev der observeret tegn på gastrointestinal toksicitet og nedsat lymfoid cellularitet i thymus ved eksponeringer, som var lavere end hos hunde, der kun fik trametinib.
English: The study showed a statistically significant difference for the primary outcome of RFS between treatment arms, with a median RFS of 16.6 months for the placebo arm and not yet reached for the combination arm (HR: 0.47; 95% confidence interval: (0.39, 0.58); p=1.53×10
Danish: Studiet viste en statistisk signifikant forskel i det primære resultat af RFS mellem behandlingsarme med en median RFS på 16,6 måneder for placebo-armen og er endnu ikke nået i kombinationsarmen (HR: 0,47; 95 % konfidensinterval: (0,39; 0,58); p=1,53×10
English: A total of 423 subjects were randomised 1:1 to either combination (N=211) or dabrafenib (N=212).
Danish: I alt blev 423 forsøgdeltagere randomiseret i forholdet 1:1 enten til kombinationen (N = 211) eller dabrafenib (N = 212).
English: August 2016 NE: Not Evaluable Median PFS currently not estimable Event rate for OS calculation was 28% and hence the defined median value still needs to mature
Danish: Median PFS kan ikke estimeres på nuværende tidspunkt Andelen af hændelser for beregning af OS var 28 % og den definerede median-værdi er derfor endnu ikke moden
English: Tafinlar in combination with trametinib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Danish: Tafinlar i kombination med trametinib anvendes også til at behandle en type lungekræft, der kaldes ikke-småcellet lungekræft (NSCLC).
English: • Dehydration (low levels of water or fluid)
Danish: • dehydrering (vand- eller væskemangel)
English: Taking Tafinlar in combination with trametinib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Danish: Indtagelse af Tafinlar i kombinationen med trametinib kan forårsage alvorlig blødning i hjernen, fordøjelsessystemet (såsom maven, endetarmen eller tarmen), lungerne og andre organer og kan medføre døden.
English: Subjects with brain metastases were not included in the trial.
Danish: Forsøgsdeltagere med hjernemetastaser blev ikke inkluderet i studiet.
English: Studies in juvenile animals have shown adverse effects of dabrafenib which had not been observed in adult animals (see section 5.3).
Danish: Studier med unge dyr har vist bivirkninger af dabrafenib, som ikke er set hos voksne dyr (se pkt.
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Danish: MEK-proteiner er komponenter i den ekstracellulært regulerede kinase (ERK)-signalvej.
English: It is recommended that the doses of dabrafenib be taken at similar times every day, leaving an interval of approximately 12 hours between doses.
Danish: Det anbefales, at dabrafenib tages på samme tidspunkt hver dag, hvilket giver et interval på ca.12 timer mellem doserne.
English: 78 patients had previous systemic treatment for their metastatic disease.
Danish: 78 patienter havde tidligere fået systemisk behandling for deres metastatiske sygdom.
English: No relevant change in AUC was noted for hydroxy-dabrafenib.
Danish: Der blev ikke observeret nogen relevant ændring i AUC for hydroxy-dabrafenib.
English: Table 10 Efficacy data by investigator assessment from COMBI-MB study
Danish: Tabel 10 Effektdata vurderet af investigator fra COMBI-MB-studiet
English: Ulcers of mouth, throat, nose, genitals and eyes.
Danish: Sår i munden, halsen, kønsorganerne og øjnene.
English: You may also get additional side effects due to taking trametinib at the same time as Tafinlar.
Danish: Du kan også få yderligere bivirkninger, fordi du tager trametinib samtidig med Tafinlar.
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal silicone dioxide, red iron oxide (E172), titanium dioxide (E171), and hypromellose (E464).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, magnesiumstearat, kolloid silica, rød jernoxid (E172), titandioxid (E171) og hypromellose (E464).
English: The population pharmacokinetic analysis showed no significant differences in the pharmacokinetics of dabrafenib between Asian and Caucasian patients.
Danish: Den populationsfarmakokinetiske analyse viste ikke signifikante forskelle i dabrafenibs farmakokinetik mellem asiatiske og kaukasiske patienter.
English: Hydroxy-dabrafenib terminal half-life parallels that of parent with a half-life of 10 hrs while the carboxy- and desmethyl-metabolites exhibited longer half-lives (21-22 hours).
Danish: Hydroxydabrafenibs terminale halveringstid er parallel med moderstoffets med en halveringstid på 10 timer, mens carboxy- og desmethyl-metabolitterne havde længere halveringstider (21-22 timer).
English: A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect dabrafenib oral clearance.
Danish: En farmakokinetisk populationsanalyse indikerer, at et let forhøjet bilirubin- og/eller ASAT-niveau (baseret på klassifikationen fra National Cancer Institute [NCI]) ikke påvirker clearancen af oralt dabrafenib signifikant.
English: The primary endpoint of the study was progression-free survival (PFS), with a key secondary endpoint of overall survival (OS).
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS), og det sekundære endepunkt var samlet overlevelse (OS).
English: If your doctor decides that you will receive treatment with the combination of Tafinlar and trametinib, read the trametinib leaflet carefully as well as this leaflet.
Danish: Hvis lægen beslutter, at du skal behandles med en kombination af Tafinlar og trametinib, skal du læse både denne indlægsseddel og indlægssedlen for trametinib omhyggeligt.
English: The efficacy of the combination with trametinib was superior when indirectly compared to dabrafenib monotherapy in Cohort A.
Danish: Effekten af kombinationen med trametinib var overlegen, når den blev sammenlignet indirekte med dabrafenib monoterapi i kohorte A.
English: Adjuvant treatment of Stage III melanoma
Danish: Adjuverende behandling af stadie III melanom
English: Upon resolution of pyrexia dabrafenib should be restarted with appropriate anti-pyretic prophylaxis, either 1) at the same dose level, or 2) reduced by one dose level if the pyrexia is recurrent and/or was accompanied by other severe symptoms including dehydration, hypotension or renal failure.
Danish: Når pyreksi ophører, skal dabrafenib-behandlingen genoptages sammen med passende antipyretisk profylakse enten 1) på samme dosisniveau, eller 2) reduceret med ét dosisniveau, hvis pyreksien er tilbagevendende og/eller var ledsaget af andre alvorlige symptomer, herunder dehydrering, hypotension eller nyresvigt.
English: Papilloma, skin papilloma d
Danish: Papillom, hudpapillom d
English: Observed cases were generally associated with pyrexia and dehydration and responded well to dose interruption and general supportive measures.
Danish: De observerede tilfælde var som regel associeret med feber og dehydrering, og disse responderede på behandlingsafbrydelse og generel understøttende behandling.
English: Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively).
Danish: Samtidig administration resulterede i stigninger i AUC for hydroxy- og desmethyldabrafenib (stigninger på henholdsvis 82 % og 68 %).
English: Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.
Danish: Trametinib er en reversibel, højselektiv, allosterisk hæmmer af aktivering og kinaseaktivitet af mitogenaktiveret ekstracellulært signal-reguleret kinase 1 (MEK1) og MEK2.
English: 57 patients had 1-3 lines of previous systemic treatment for their metastatic disease.
Danish: 57 patienter havde tidligere fået 1-3 linjer systemisk behandling for deres metastatiske sygdom.
English: If you stop taking Tafinlar
Danish: Hvis du holder op med at tage Tafinlar
English: If you forget to take Tafinlar
Danish: Hvis du har glemt at tage Tafinlar
English: Treatment with anti-pyretics such as ibuprofen or acetaminophen/paracetamol should be initiated.
Danish: Behandling med antipyretika, som fx ibuprofen eller paracetamol, bør initieres.
English: Before you take Tafinlar in combination with trametinib your doctor also needs to know if you:
Danish: Inden du tager Tafinlar i kombination med trametinib, skal lægen vide:
English: Anal examinations and pelvic examinations are recommended before and at the end of treatment or when considered clinically indicated.
Danish: Anal-undersøgelse og underlivsundersøgelse anbefales før og ved afslutning af behandlingen, eller når det anses for klinisk indiceret.
English: In studies of up to 13 weeks, decreases in reticulocyte counts and/or red cell mass were observed in dogs and rats (≥10 and 1.4 times clinical exposure, respectively).
Danish: I studier af op til 13 ugers varighed blev der observeret fald i reticulocyttallene og/eller nedsat masse af røde blodceller hos hunde og rotter (ved henholdsvis ≥ 10 og 1,4 gange den kliniske eksponering).
English: • change of a mole in size or colour
Danish: • en skønhedsplet, der ændrer størrelse eller farve
English: Alternative agents should be considered during administration with dabrafenib when possible.
Danish: Andre lægemidler bør overvejes ved samtidig administration med dabrafenib, når det er muligt.
English: Administration of dabrafenib with food reduced the bioavailability (Cmax and AUC decreased by 51% and 31% respectively) and delayed absorption of dabrafenib capsules when compared to the fasted state.
Danish: Administration af dabrafenib med føde nedsatte biotilgængeligheden (Cmax og AUC-værdien faldt med henholdsvis 51 % og 31 %) og forsinkede absorptionen af dabrafenib-kapsler sammenlignet med ved fastende tilstand.
English: Myocarditis
Danish: Myokarditis
English: 3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon)
Danish: 3) Følgende bivirkning forekom i MEK116513 og BRF115532, men ikke i MEK115306 og BRF113928: Rabdomyolyse (ikke almindelig).
English: Cases of new primary melanoma can be managed with excision and do not require treatment modification.
Danish: Nye primære melanomer kan fjernes kirurgisk og kræver ikke ændring af behandlingen.
English: • Birth control medicines containing hormones (such as pills, injections or patches) may not work as well while you are taking Tafinlar or combination treatment (Tafinlar as well as trametinib).
Danish: • Svangerskabsforebyggende lægemidler, der indeholder hormoner (fx piller, injektioner eller plastre), vil muligvis ikke være sikre, mens du tager Tafinlar eller kombinationsbehandlingen (Tafinlar såvel som trametinib).
English: If the missed dose is less than 6 hours late, take it as soon as you remember.
Danish: Hvis den glemte dosis skulle være taget for mindre end 6 timer siden, skal du tage den, så snart du kommer i tanke om det.
English: Monitoring should continue for 6 months following discontinuation of dabrafenib or until initiation of another anti-neoplastic therapy.
Danish: Kontrol skal fortsættes i 6 måneder efter seponering af dabrafenib eller indtil påbegyndelse af anden anti-neoplastisk behandling.
English: Dabrafenib is an inducer of metabolising enzymes which may lead to loss of efficacy of many commonly used medicinal products (see examples in section 4.5).
Danish: Dabrafenib er en induktor af metaboliserende enzymer, som kan føre til nedsat effekt af mange almindeligt brugte lægemidler (se eksempler under pkt.
English: Do not change your dose or stop Tafinlar or trametinib unless your doctor, nurse or pharmacist tells you to.
Danish: Du må ikke ændre din dosis eller stoppe med at tage Tafinlar eller trametinib, medmindre lægen, sundhedspersonalet eller apotekspersonalet beder dig om det.
English: • Low blood pressure (hypotension)
Danish: • lavt blodtryk (hypotension)
English: NA = Not applicable
Danish: NA = Ikke relevant
English: felodipine, nicardipine, nifedipine or verapamil
Danish: nicardipin, nifedipin eller verapamil
English: Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl-dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, and dabrafenib and its desmethyl metabolite were found to be inhibitors of organic cation transporter 2 (OCT2) in vitro, the risk of a drug-drug interaction at these transporters is minimal based on clinical exposure of dabrafenib and its metabolites.
Danish: Selvom dabrafenib og dets metabolitter, hydroxydabrafenib, carboxydabrafenib og desmethyldabrafenib, hæmmer de humane organisk anion-transportører (OAT) 1 og OAT3 in vitro, og dabrafenib og dets desmethylmetabolit hæmmer organisk kation-transportør 2 (OCT2) in vitro, er risikoen for lægemiddelinteraktion ved disse transportører minimal, baseret på den kliniske eksponering af dabrafenib og dets metabolitter.
English: The assay was specifically designed to differentiate between the V600E and V600K mutations.
Danish: Analysen var specifikt designet til at kunne skelne mellem V600E- og V600K-mutationerne.
English: Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 8.
Danish: Median OS og estimerede 1-års, 2-års, 3-års, 4-års og 5-års overlevelseshyppigheder er angivet i tabel 8.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dabrafenib in one or more subsets of the paediatric population in melanoma and solid malignant tumours (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med dabrafenib i en eller flere undergrupper af den pædiatriske population ved melanom og maligne solide tumorer (se pkt.
English: Limited safety and efficacy data have been collected on dabrafenib in non-Caucasian patients.
Danish: Der er indsamlet begrænsede data for dabrafenibs sikkerhed og virkning hos ikke-kaukasiske patienter.
English: Primary tumour or tumour from a metastatic site was tested with an investigational use only assay (IUO).
Danish: Væv fra den primære tumor eller tumorvæv fra en metastase blev testet med en analyse, som kun var til forskningsbrug (IUO; investigational use only).
English: Concomitant administration of dabrafenib with digoxin may result in decreased digoxin exposure.
Danish: Samtidig administration af dabrafenib og digoxin kan resultere i nedsat eksponering af digoxin.
English: Patients ≥65 years were more likely to experience SAEs and AEs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
Danish: Patienter ≥ 65 år oplevede i højere grad alvorlige bivirkninger og bivirkninger, der førte til permanent seponering af lægemidlet, dosisreduktion eller midlertidig behandlingsafbrydelse, end patienter < 65 år.
English: • floating spots before the eyes
Danish: • svævende prikker for øjnene.
English: Dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives and an effective alternative method of contraception should be used (see section 4.5).
Danish: Dabrafenib kan nedsætte effekten af orale eller systemiske hormonale kontraceptiva, og der skal anvendes en anden sikker kontraceptionsmetode (se pkt.
English: How to take it Swallow the capsules whole with water, one after the other.
Danish: Sådan skal du tage Tafinlar Synk kapslerne hele med vand, og en ad gangen.
English: indinavir, lopinavir, nelfinavir, saquinavir, tipranavir)
Danish: fosamprenavir, indinavir, lopinavir, nelfinavir, saquinavir, tipranavir)
English: If a dose of dabrafenib is missed, it should not be taken if it is less than 6 hours until the next scheduled dose.
Danish: Hvis en dosis af dabrafenib glemmes, bør den ikke tages, hvis der er mindre end 6 timer til den næste planlagte dosis.
English: Please also read the trametinib package leaflet for details of the side effects you may get with trametinib.
Danish: Læs også indlægssedlen for trametinib, hvor der er oplysninger om de bivirkninger, du kan få af trametinib.
English: The primary endpoint of the study was overall intracranial response rate (OIRR) in the V600E patient population, as assessed by investigators.
Danish: Det primære endepunkt i dette studie var den samlede intrakranielle respons-rate (OIRR) i henhold til investigators vurdering hos patientpopulationen med V600E.
English: As of 25 June 2012 cut-off, thirty five subjects (55.6%) of the 63 randomised to DTIC had crossed over to dabrafenib and 63% of subjects randomised to dabrafenib and 79% of subjects randomised to DTIC had progressed or died.
Danish: Ved skæringsdatoen den 25. juni 2012 havde 35 patienter (55,6 %) af de 63, der var randomiseret til DTIC, skiftet over til dabrafenib, og 63 % af patienterne, der var randomiseret til at få dabrafenib og 79 % af patienterne, der var randomiseret til at få DTIC, var progredieret eller var døde.
English: Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2-receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib.
Danish: Lægemidler, der ændrer pH i det øverste af mave-tarmkanalen (fx protonpumpehæmmere, H2-receptorantagonister, antacida), forventes ikke at reducere biotilgængeligheden af dabrafenib.
English: Tafinlar in combination with trametinib is also used to prevent melanoma from coming back after it has been removed by surgery.
Danish: Tafinlar i kombination med trametinib anvendes også til at forebygge tilbagefald af melanom efter, at det er blevet fjernet ved operation.
English: The side effects that you may see when you take Tafinlar in combination with trametinib are as follows:
Danish: De bivirkninger, du måske vil få, når du tager Tafinlar i kombination med trametinib, er følgende:
English: These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body.
Danish: Dette foretages for at opdage om andre former for kræft, som fx pladecellekarcinom, udvikles inde i kroppen.
English: Dabrafenib is an inhibitor of RAF kinases.
Danish: Dabrafenib er en hæmmer af RAF-kinaser.
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Danish: Rækkefølgen af behandlinger efter progression på behandling med en BRAF-hæmmer er ikke fastlagt.
English: Patients should be monitored as clinically appropriate.
Danish: Patienterne bør kontrolleres efter klinisk behov.
English: Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS).
Danish: Sekundære endepunkter inkluderede samlet overlevelse (OS som vigtigste sekundære endepunkt), recidivfrihed (FFR) og overlevelse fri for fjernmetastaser (DMFS).
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with Tafinlar in combination with trametinib.
Danish: Lægen vil foretage nogle undersøgelser for at kontrollere, om dit hjerte fungerer, som det skal, før og under behandlingen med Tafinlar i kombination med trametinib.
English: No dabrafenib dose adjustment is needed in Asian patients.
Danish: Dosisjustering er ikke nødvendig hos asiatiske patienter.
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second line or higher patients and 68 years in the first line patients.
Danish: Ud af de i alt 93 patienter, der blev inkluderet i kohorte B og C med kombinationsbehandling, var de fleste kaukasiske (>90 %) og ligeligt fordelt mht. kvinder versus mænd (54 % versus 46 %) med en medianalder på 64 år hos patienter i anden eller højere linje og 68 år hos førstelinjepatienter.
English: Subjects were enrolled into Cohort A (subjects with no prior local therapy for brain metastasis) or Cohort B (subjects who received prior local therapy for brain metastasis).
Danish: Patienterne blev inkluderet i kohorte A (patienter, der ikke tidligere havde fået lokal behandling mod hjernemetastase) eller kohorte B (patienter, der tidligere havde fået lokal behandling mod hjernemetastase).
English: When an individual's adverse reactions are under effective management, dose re-escalation following the same dosing steps as de-escalation may be considered.
Danish: Når en persons bivirkninger er under effektiv kontrol, kan det overvejes at øge dosis igen ved at følge de samme doseringstrin som ved dosisreduktion.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: During treatment patients should be monitored as clinically appropriate which may include a head and neck examination every 3 months and a chest/abdomen CT scan every 6 months.
Danish: Under behandlingen skal patienterne kontrolleres som det findes klinisk relevant, hvilket kan indbefatte klinisk undersøgelse af hoved-hals regionen hver 3. måned og CT-scanning af brystkassen/maven hver 6. måned.
English: Patients taking Tafinlar alone can uncommonly (may affect up to 1 in 100 people) develop an eye problem called uveitis, which could damage your vision if it is not treated.
Danish: Patienter, der tager Tafinlar alene, kan udvikle et øjenproblem, der kaldes uveitis, hvilket kan ødelægge dit syn, hvis det ikke behandles.