FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 870 patients were randomised to the combination therapy (n=438) and placebo (n=432) arms.
Danish: I alt blev 870 patienter randomiseret til armene kombinationsbehandling (n=438) og placebo (n=432).
English: Most patients (94%) enrolled in the combination therapy treated cohorts had an ECOG performance status of 0 or 1.
Danish: De fleste patienter (94 %), der blev inkluderet i kohorterne med kombinationsbehandling, havde ECOG-performancestatus 0 eller 1.
English: The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.
Danish: Risikoen for leverskade efter administration af paracetamol formodes at være højere hos patienter, der samtidigt behandles med enzyminduktorer.
English: Enrollment required complete resection of melanoma with complete lymphadenectomy within 12 weeks prior to randomisation.
Danish: Inklusion krævede komplet resektion af melanom med komplet lymfadenektomi inden for 12 uger før randomisering.
English: The management of adverse reactions may require treatment interruption, dose reduction, or treatment discontinuation (see Tables 1 and 2).
Danish: Håndteringen af bivirkninger kan kræve pausering, dosisreduktion eller seponering af behandlingen (se tabel 1 og 2).
English: It is not known whether dabrafenib is excreted in human milk.
Danish: Det er ukendt, om dabrafenib udskilles i human mælk.
English: • after eating, you must wait at least 2 hours before taking Tafinlar.
Danish: • efter at du har spist, skal du vente mindst 2 timer, før du tager Tafinlar
English: The Tafinlar doses should be about 12 hours apart.
Danish: Tafinlar-doserne skal tages ca. 12 timer fra hinanden.
English: Time since Randomisation (Months)
Danish: Tid efter randomisering (måneder)
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Cases were managed with excision and did not require treatment modification (see section 4.4).
Danish: Tilfældene blev håndteret med eksision og krævede ikke ændring af behandlingen (se pkt.
English: Don't take the morning and evening doses of Tafinlar at the same time.
Danish: Tag ikke morgen- og aftendosen af Tafinlar samtidigt.
English: Tell your doctor immediately if you notice any changes to your skin (see section 4 for symptoms to be aware of).
Danish: Fortæl det straks til lægen, hvis du bemærker forandringer i huden (se punkt 4 for symptomer du bør være opmærksom på).
English: Results were also consistent across stratification factors for disease stage and BRAF V600 mutation type.
Danish: Resultaterne var også konsistente på tværs af stratificeringsfaktorer for sygdomsstadie og BRAF V600 mutationstype.
English: The potential effect of dabrafenib on QT prolongation was assessed in a dedicated multiple dose QT study.
Danish: Den mulige virkning af dabrafenib på QT-forlængelse blev undersøgt i et specifikt flerdosis QT-studie.
English: • Bleeding, at various sites in the body, which may be mild or serious (haemorrhage)
Danish: • blødninger forskellige steder på kroppen, som kan være lette eller alvorlige
English: • Appearance of new skin cancer (melanoma)
Danish: • fremkomst af ny hudkræft (melanom)
English: • after taking Tafinlar, you must wait at least 1 hour before eating, or
Danish: • efter at du har taget Tafinlar, skal du vente mindst 1 time, før du spiser, eller
English: BRF115532 (n=1076)
Danish: BRF115532 (n=1076) (n = 641)
English: The median time to onset of the first occurrence of cuSCC in the combination arm of the adjuvant treatment study was approximately 18 weeks and was 33 weeks in the placebo arm.
Danish: Mediantiden til start på første forekomst af cuSCC i kombinationsarmen i studiet med adjuverende behandling var cirka 18 måneder og var 33 måneder i placebo-armen.
English: Talk to your doctor, before taking Tafinlar.
Danish: Kontakt lægen, før du tager Tafinlar.
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with dabrafenib.
Danish: Patienter med LVEF lavere end den laveste grad af normalniveauet blev ikke inkluderet i kliniske studier med dabrafenib.
English: It is very important to tell your doctor, pharmacist or nurse immediately if you develop these symptoms, especially if you have a painful, red eye that does not clear up quickly.
Danish: Det er meget vigtigt at fortælle det til lægen, apotekspersonalet eller sundhedspersonalet med det samme, hvis du får disse symptomer, især hvis du har et rødt øje med smerter, som ikke bedres hurtigt.
English: Contains desiccant, do not remove or eat.
Danish: Indeholder tørremiddel, må ikke tages ud eller spises.
English: Desmethyl-dabrafenib may also be formed in the gut and reabsorbed.
Danish: Desmethyldabrafenib kan også dannes i tarmen og blive genabsorberet.
English: Tafinlar is a medicine that contains the active substance dabrafenib.
Danish: Tafinlar er et lægemiddel, der indeholder det aktive stof dabrafenib.
English: The confirmed OIRR and other efficacy results per investigator assessment are presented in Table 13.
Danish: Den bekræftede OIRR og andre effektresultater i henhold til investigators vurdering er vist i tabel 13.
English: Even your disease, symptoms and treatment situation may affect your ability to drive or use machines.
Danish: Selv din sygdom, dine symptomer og din behandlingssituation kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Unresectable or metastatic melanoma
Danish: Inoperabelt eller metastatisk melanom
English: Some people taking Tafinlar may also notice that new melanomas have appeared.
Danish: Nogle personer, der tager Tafinlar, kan også få nye melanomer.
English: Dabrafenib should be taken at least one hour before, or at least 2 hours after a meal.
Danish: Dabrafenib skal tages mindst 1 time før eller 2 timer efter et måltid.
English: Your doctor may ask you to stop taking trametinib or refer you to a specialist, if you develop signs and symptoms in your vision that include:
Danish: Lægen vil måske stoppe din behandling med trametinib eller henvise dig til en specialist, hvis du udvikler tegn og symptomer på øjenproblemer, der omfatter:
English: • Joint pain, muscle pain, or pain in the hands or feet
Danish: • ledsmerter, muskelsmerter eller smerter i hænder eller fødder
English: Gemfibrozil had no clinically relevant effect on the systemic exposure to dabrafenib metabolites (≤13%).
Danish: Gemfibrozil havde ingen klinisk relevant indvirkning på den systemiske eksponering af dabrafenibs metabolitter (≤ 13 %).
English: NR = Not reached, NA = Not applicable
Danish: NR = Ikke nået, NA = Ikke relevant
English: Others may develop a type of skin cancer called basal cell carcinoma (BCC).
Danish: Andre kan udvikle en form for hudkræft, som kaldes basal celle karcinom (BCC).
English: Animal studies have shown that the active substance dabrafenib may permanently reduce male fertility.
Danish: Det er i dyrestudier set, at det aktive stof dabrafenib kan nedsætte mænds frugtbarhed permanent.
English: • have any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue.
Danish: • om du har eller har haft lunge- eller vejrtrækningsproblemer, herunder åndedrætsbesvær, som ofte er ledsaget af tør hoste, åndenød og træthed.
English: Tafinlar are also available as 50 mg capsules if a dose reduction is recommended.
Danish: Tafinlar fås også i kapsler med 50 mg, hvis lægen anbefaler en mindre dosis.
English: In the previously treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease.
Danish: I den behandlingserfarne population havde 38 patienter (67 %) fået en linje systemisk anti-cancerbehandling for metastatisk sygdom.
English: No overall differences in efficacy were observed between these subjects and younger subjects.
Danish: Der blev ikke observeret nogen overordnet forskel i effekt mellem de ældre patienter og de yngre patienter.
English: The primary endpoint was ORR using the RECIST 1.1 assessed by the investigator.
Danish: Det primære endepunkt var ORR, vurderet af investigator ud fra RECIST 1.1.
English: Possible side effects in patients taking Tafinlar alone
Danish: Bivirkninger hos patienter, der tager Tafinlar alene
English: A drug utilisation review (DUR) is therefore essential when initiating dabrafenib treatment.
Danish: En medicingennemgang (drug utilisation review [DUR]) er derfor af afgørende betydning, når behandling med dabrafenib indledes.
English: The desiccant must be kept inside the bottle and must not be eaten.
Danish: Tørremidlet skal forblive i beholderen og må ikke spises.
English: These results did not meet the pre-specified boundary to claim statistical significance at this first OS interim analysis (HR=0.50; p=0.000019).
Danish: Disse resultater mødte ikke den præspecificerede grænse for statistisk signifikans ved denne første OS-interimanalyse (HR=0,50; p=0,000019).
English: Reversible haematological effects have been observed in dogs and rats given dabrafenib.
Danish: Reversible hæmatologiske effekter er blevet observeret hos hunde og rotter, der fik dabrafenib.
English: In some cases, people with fever may develop low blood pressure, dizziness or other symptoms.
Danish: I nogle tilfælde kan personer med feber udvikle lavt blodtryk, svimmelhed eller andre symptomer.
English: Therefore before starting treatment your doctor will test for this mutation.
Danish: Lægen vil derfor teste for denne mutation, inden behandlingen bliver startet.
English: The median duration of follow-up (time from randomisation to last contact or death) was 2.83 years in the dabrafenib and trametinib combination arm and 2.75 years in the placebo arm.
Danish: Median varighed af opfølgning (tid fra randomisering til sidste kontakt eller død) var 2,83 år i armen med dabrafenib og trametinib i kombination og 2,75 år i placebo-armen.
English: Stevens-Johnson syndrome Drug reaction with eosinophilia and systemic symptoms Dermatitis exfoliative generalised
Danish: Stevens-Johnsons syndrom Lægemiddelreaktion med eosinofili og systemiske symptomer Generaliseret eksfoliativ dermatitis
English: HR for recurrence = 0.49 95% CI (0.40, 0.59)
Danish: HR for recidiv = 0,49 95 % CI (0,40; 0,59)
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively).
Danish: Estimater for overlevelse ved 1 og 2 år fra randomisering var henholdsvis 97 % og 91 % i kombinationsarmen og 94 % og 83 % i placebo-armen.
English: It is used either on its own or in combination with another medicine containing trametinib in adults to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery.
Danish: Det anvendes enten alene eller i kombination med et lægemiddel, der indeholder trametinib, til at behandle en form for hudkræft hos voksne, der kaldes melanom, som har spredt sig til andre dele af kroppen eller ikke kan fjernes ved operation.
English: Carboxy-dabrafenib can be decarboxylated via a non-enzymatic process to form desmethyl-dabrafenib.
Danish: Carboxydabrafenib kan decarboxyleres via en ikke-enzymatisk proces, så der dannes desmethyldabrafenib.
English: Common side effects that may show up in your blood tests
Danish: Almindelige bivirkninger, der kan ses i blodprøver
English: • Inflammation of the eye (uveitis, see “Eye problems” earlier in section 4))
Danish: • betændelse i øjet (uveitis, se ”Øjenproblemer” tidligere i punkt 4)
English: Patients should be evaluated for signs and symptoms of infection.
Danish: Patienterne bør vurderes for tegn og symptomer på infektion.
English: The primary endpoint was investigator-assessed relapse-free survival (RFS), defined as the time from randomisation to disease recurrence or death from any cause.
Danish: Det primære endepunkt var investigatorvurderet recidivfri overlevelse (RFS), defineret som tid fra randomisering til sygdomsrecidiv eller død af enhver årsag.
English: Dabrafenib has minor influence on the ability to drive and use machines.
Danish: Dabrafenib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: These met the statistical significance to reject the null hypothesis that the ORR of dabrafenib in combination with trametinib for this NSCLC population was less than or equal to 30%.
Danish: Disse opfyldte kravet til statistisk signifikans for afvisning af nulhypotesen: at ORR for dabrafenib i kombination med trametinib for NSCLC-populationen var mindre end eller lig med 30 %.
English: Take Tafinlar capsules and trametinib tablets with you when possible.
Danish: Tag Tafinlar-kapslerne og trametinib-tabletterne med dig, hvis det er muligt.
English: Tell your doctor immediately if you get a temperature above 38.5ºC while you are taking this medicine.
Danish: Fortæl det straks til lægen, hvis du får feber over 38,5 ºC, mens du tager dette lægemiddel.
English: In addition, men who are taking Tafinlar may have a reduced sperm count and their sperm count may not return to normal levels after they stop taking this medicine.
Danish: Derudover kan mænd, der tager Tafinlar, få et lavere sædtal og deres sædtal vil muligvis ikke vende tilbage til det samme niveau, som før behandlingen, efter at de er holdt op med at tage dette lægemiddel.
English: However, these transporters have minimal impact on dabrafenib oral bioavailability and elimination and the risk for clinically relevant drug-drug interactions with inhibitors of Pgp or BCRP is low.
Danish: Disse transportører har dog minimal indflydelse på den orale biotilgængelighed og eliminationen af dabrafenib, og risikoen for klinisk relevante lægemiddelinteraktioner med Pgp- og BCRP-hæmmere er lille.
English: • Take Tafinlar and trametinib on an empty stomach, at least one hour before or two hours after a meal.
Danish: • Tag Tafinlar og trametinib på tom mave mindst en time før eller to timer efter et måltid.
English: Pregnancy, breast-feeding and fertility Tafinlar is not recommended during pregnancy.
Danish: Graviditet, amning og frugtbarhed Du må ikke bruge Tafinlar under graviditet.
English: Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics).
Danish: Dabrafenibs terminale halveringstid efter en oral enkeltdosis er 8 timer på grund af absorptionshastighedsbegrænset eliminering efter oral administration (flip-flop-farmakokinetik).
English: The most commonly observed BRAF mutation is V600E which accounts for approximately 90% of the BRAF mutations that are seen in melanoma.
Danish: De mest almindeligt observerede BRAF-mutationer er V600E, som udgør ca. 90 % af de BRAF-mutationer, der ses ved melanom.
English: Although limited by the low number of patients, median OS appeared consistent with data in patients with BRAF V600E positive tumours.
Danish: På trods af det begrænsede antal patienter syntes den mediane overlevelse at være i overensstemmelse med data fra patienterne med BRAF V600E-positive tumorer.
English: • Inflammation of the heart muscle (myocarditis) which can result in breathlessness, fever,
Danish: • inflammation i hjertemusklen (myokarditis), hvilket kan medføre kortåndethed, feber,
English: Hard capsule (capsule).
Danish: Kapsel, hård (kapsel).
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Danish: Af prøverne fra de ikke-kliniske og kliniske forsøg (n = 876), der var mutationspositive i henhold til THxID BRAF-analysen og efterfølgende blev sekventeret ved brug af referencemetoden, var specificiteten af analysen 94 %.
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 2).
Danish: Kaplan-Meier OS kurven, ser ud til at stabiliseres fra 3 til 5 år (se figur 2).
English: Dabrafenib is an in vitro inhibitor of human organic anion transporting polypeptide (OATP) 1B1 (OATP1B1), OATP1B3 and BCRP.
Danish: Dabrafenib hæmmer in vitro de humane organiske anion-transport-polypeptider (OATP) 1B1 (OATP1B1), OATP1B3 og BCRP.
English: • Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot),
Danish: • nedsat antal røde blodlegemer (anæmi), blodplader (celler, der hjælper blodet med at størkne)
English: • If you are a woman who could become pregnant you must use a reliable birth control method while you are taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks following the last dose of trametinib when given in combination with Tafinlar.
Danish: • Hvis du er kvinde og kan blive gravid, skal du bruge en sikker præventionsmetode, mens du tager Tafinlar og i mindst 2 uger, efter at du er holdt op med at tage det, og i mindst 16 uger efter den sidste dosis af trametinib, hvis det gives i kombination med Tafinlar.
English: Table 13 Efficacy data in patients with brain metastases (BREAK-MB Study)
Danish: Tabel 13 Effektdata hos patienter med hjernemetastaser (studiet BREAK-MB)
English: The bottles also include a silica gel desiccant in a small cylinder shaped container.
Danish: Beholderne indeholder også et tørremiddel bestående af silicagel i en lille cylinderformet beholder.
English: Subsequently, all patient samples were re-tested using the bioMerieux (bMx) THxID BRAF validated assay, which has CE marking.
Danish: Dernæst blev alle prøver fra patienterne testet igen ved brug af den validerede bioMerieux (bMx) THxID BRAF-analyse, der er CE-mærket.
English: Both cancers have a particular change (mutation) in a gene called BRAF at the V600 position.
Danish: Begge kræfttyper har en bestemt ændring (mutation) ved position V600 i et gen, der kaldes BRAF.
English: Hypersensitivity e
Danish: Overfølsomhed e
English: Animal studies have shown reproductive toxicity and embryo-foetal developmental toxicities, including teratogenic effects (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet og toksiske påvirkninger af den embryoføtale udvikling, herunder teratogene effekter (se pkt.
English: Potent inducers of these enzymes should be avoided when possible as these agents may decrease the efficacy of dabrafenib (see section 4.5).
Danish: Kraftige induktorer af disse enzymer bør om muligt undgås, da disse midler kan nedsætte effekten af dabrafenib (se pkt.
English: Taking Tafinlar or the combination of Tafinlar and trametinib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4).
Danish: Behandling med Tafinlar eller med kombinationen af Tafinlar og trametinib kan forårsage feber, men risikoen er størst, hvis du tager kombinationsbehandlingen (se også punkt 4).
English: Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old.
Danish: En alder højere end 75 år var en signifikant indikator for plasmakoncentrationer af carboxy- og desmethyldabrafenib med en 40 % større eksponering hos patienter ≥ 75 år i forhold til patienter < 75 år.
English: Take Tafinlar in the morning and evening, about 12 hours apart.
Danish: Tafinlar skal tages om morgenen og aftenen med ca. 12 timers mellemrum.
English: Data as of June 25, 2012
Danish: Data ved 25. juni 2012
English: Very common side effects that may show up in your blood tests • Abnormal blood test results related to the liver
Danish: Meget almindelige bivirkninger, der kan ses i blodprøver • unormale blodprøveresultater for leverfunktionen
English: The proportion of patients experiencing AEs was similar in those aged <65 years and those aged ≥65 years in all clinical trials.
Danish: Andelen af patienter, der oplevede bivirkninger, var den samme i gruppen < 65 år og i gruppen ≥ 65 år i alle kliniske forsøg.
English: Otherwise, similar toxicities were observed as in comparable monotherapy studies.
Danish: I andre henseender blev der observeret tilsvarende toksicitet som i sammenlignelige monoterapistudier.
English: Tell your doctor, pharmacist or nurse immediately if you get a fever (temperature 38.5ºC or above) while you are taking this medicine.
Danish: Fortæl det omgående til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får feber (temperatur på 38,5 ºC eller derover), mens du tager dette lægemiddel.
English: OS data from a further post-hoc analysis based on a 18 December 2012 data cut are shown in Figure 3.
Danish: Data med OS fra en anden post hoc-analyse, hvor skæringen for dataindsamling var 18. december 2012, er vist i figur 3.
English: Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Danish: Ikke-kliniske og kliniske forsøg med retrospektive bidirektionelle Sanger-sekvensanalyser har vist, at testen også identificerer den ikke så almindelige BRAF V600D-mutation og V600E/K601E-mutation med lavere følsomhed.
English: There is no specific treatment for an overdose of dabrafenib.
Danish: Der findes ingen specifik behandling mod overdosering med dabrafenib.
English: A decrease in exposure was observed with repeat dosing, likely due to induction of its own metabolism.
Danish: Der blev observeret et fald i eksponeringen ved gentagen dosering, sandsynligvis på grund af induktion af dabrafenibs egen metabolisering.
English: Abbreviations: CI: confidence interval; DTIC: dacarbazine; HR: hazard ratio; NR: not reached a
Danish: Forkortelser: CI: konfidensinterval, DTIC: dacarbazin, HR: hazard ratio.
English: These melanomas are usually removed by surgery and treatment with Tafinlar can be continued without interruption.
Danish: Disse melanomer fjernes normalt ved operation, og behandlingen med Tafinlar kan fortsættes uden afbrydelse.
English: Thus, trametinib and dabrafenib inhibit two kinases in this pathway, MEK and RAF, and therefore the combination provides concomitant inhibition of the pathway.
Danish: Trametinib og dabrafenib hæmmer således to kinaser i denne signalvej, MEK og RAF, og derfor medfører kombinationen samtidig hæmning af signalvejen.
English: Keep a list of the medicines you take, so you can show it to your doctor, pharmacist or nurse.
Danish: Hav en liste over de lægemidler, du tager, på dig, så du kan vise den til lægen, apotekspersonalet eller sundhedspersonalet.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE23
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmer, ATC-kode: L01XE23
English: The primary objective for this study was to evaluate the efficacy of dabrafenib compared to DTIC with respect to PFS per investigator assessment.
Danish: Det primære formål med dette studie var at vurdere effekten af dabrafenib sammenlignet med DTIC med hensyn til PFS, hvor tidspunktet for progression blev bestemt af investigators vurdering.
English: • increased sensitivity to light
Danish: • øget lysfølsomhed
English: The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Danish: Analysen var designet til at identificere BRAF V600E- og V600K-mutationerne med høj følsomhed (ned til 5 % V600E- og V600K-sekvens i en baggrund af vildtype sekvens ved brug af DNA ekstraheret fra FFPE væv).
English: In some cases, people with fever may develop low blood pressure and dizziness.
Danish: I nogle tilfælde kan personer med feber få lavt blodtryk og blive svimle.
English: Malignant melanoma, metastatic malignant melanoma, and superficial spreading melanoma stage III
Danish: Malignt melanom, metastatisk malignt melanom og melanom med overfladisk spredning stadie III