FrancophonIA/ELRC3.0 huggingface dataset:
English: • skin sore or reddish bump that bleeds or does not heal
Danish: • øm hud eller en rødlig bule, der bløder eller ikke heler
English: Further, the capsules are printed with black ink that contains black iron oxide (E172) shellac and propylene glycol.
Danish: Endvidere har kapslerne tryk med sort blæk, der indeholder sort jernoxid (E172), shellac og propylenglycol.
English: It is recommended that skin examination be performed prior to initiation of therapy with dabrafenib and monthly throughout treatment and for up to six months after treatment for cuSCC.
Danish: Det anbefales, at der foretages en undersøgelse af huden, før der indledes behandling med dabrafenib, og hver måned under hele behandlingsforløbet samt op til seks måneder efter behandling for cuSCC.
English: A decrease of 16% in AUC was noted for carboxy-dabrafenib.
Danish: Der blev set et fald på 16 % i AUC for carboxy-dabrafenib.
English: At the pre-specified analysis with a 19 December 2011 data cut, a significant improvement in the primary endpoint of PFS (HR=0.30; 95% Cl 0.18, 0.51; p < 0.0001) was achieved.
Danish: Ved den forudspecificerede analyse, hvor skæringen for dataindsamling var 19. december 2011, var der opnået en signifikant forbedring i det primære endepunkt PFS (HR = 0,30, 95 % CI 0,18; 0,51, p < 0,0001).
English: Male patients taking dabrafenib as monotherapy or in combination with trametinib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible.
Danish: Mandlige patienter, der tager dabrafenib som monoterapi eller i kombination med trametinib, bør informeres om den potentielle risiko for forringet sædudvikling, som kan være irreversibel.
English: Table 4 Adverse reactions reported in the integrated safety population of dabrafenib in combination with trametinib in the studies MEK115306, MEK116513
Danish: Tabel 4 Bivirkninger rapporteret i den integrerede sikkerhedspopulation med dabrafenib i kombination med trametinib i studierne MEK115306, MEK116513
English: In vitro experiments have demonstrated paradoxical activation of mitogen-activated protein kinase (MAP kinase) signalling in BRAF wild-type cells with RAS mutations when exposed to BRAF inhibitors.
Danish: In vitro forsøg har vist paradoks aktivering af mitogen-aktiveret proteinkinase (MAP-kinase) signalering i vildtype BRAF-celler med RAS-mutationer, når de blev eksponeret for BRAF-hæmmere.
English: A decision should be made whether to discontinue breast-feeding or discontinue dabrafenib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med dabrafenib skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Two of these patients had a QTcB Grade 3 increase (>500 msec) that was also an increase >60 msec from baseline.
Danish: Af disse havde 2 patienter QTcB grad 3-forlængelse (> 500 ms), som også var en stigning på > 60 ms i forhold til baseline.
English: It is recommended that patients receiving treatment with dabrafenib in combination with trametinib have liver function monitored every four weeks for 6 months after treatment initiation with trametinib.
Danish: Det anbefales, at patienter, der behandles med dabrafenib i kombination med trametinib, får monitoreret leverfunktionen hver 4. uge i 6 måneder efter opstart af behandling med trametinib.
English: Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations.
Danish: Lægemidler, der er kraftige hæmmere eller induktorer af CYP2C8 eller CYP3A4, henholdsvis øger eller nedsætter derfor sandsynligvis koncentrationen af dabrafenib.
English: Changes in your skin Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib (frequency not known).
Danish: Forandringer i huden Der er rapporteret tilfælde af alvorlige hudreaktioner hos personer, der tog Tafinlar i kombination med trametinib (hyppigheden er ukendt).
English: • Swelling of the hands or feet (oedema peripheral)
Danish: • hævede hænder eller fødder (perifert ødem)
English: In addition, mild hepatic impairment as defined by bilirubin and AST did not have a significant effect on dabrafenib metabolite plasma concentrations.
Danish: Endvidere havde let nedsat leverfunktion defineret ved bilirubin og ASAT ikke en signifikant effekt på plasmakoncentrationerne af dabrafenibs metabolitter.
English: One of the events occurred on the first day of dabrafenib dosing of a metastatic melanoma patient and recurred following re-challenge at a reduced dose.
Danish: Ét af tilfældene sås på den første dag med dabrafenib-behandling hos en metastatisk melanompatient og opstod igen ved efterfølgende forsøg på genopstart af behandlingen med reduceret dosis.
English: Women of childbearing potential must use effective methods of contraception during therapy and for 2 weeks following discontinuation of dabrafenib and 16 weeks following the last dose of trametinib when given in combination with dabrafenib.
Danish: Kvinder i den fertile alder skal anvende sikre kontraceptionsmetoder under behandlingen og i 2 uger efter behandlingsophør af dabrafenib og 16 uger efter den sidste dosis trametinib, når det gives i kombination med dabrafenib.
English: • coloured dots in your vision
Danish: • farvede prikker i dit synsfelt
English: Tafinlar 50 mg and 75 mg hard capsules are available in packs containing 28 or 120 capsules.
Danish: Tafinlar 50 mg og 75 mg hårde kapsler fås i pakninger med 28 eller 120 kapsler.
English: • Blurred vision, eyesight problems, inflammation of the eye (uveitis)
Danish: • sløret syn, synsproblemer, betændelse i øjet (uveitis)
English: Tell your doctor immediately if you get eye redness and irritation, blurred vision, eye pain or other vision changes during your treatment (see also section 4).
Danish: Fortæl det omgående til lægen, hvis du får røde eller irriterede øjne, sløret syn, øjensmerter eller andre ændringer i synet under behandlingen (se også punkt 4).
English: Before starting treatment, tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Før du starter behandlingen, skal du fortælle lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Based on exposure, relative potency, and pharmacokinetic properties, both hydroxy- and desmethyl-dabrafenib are likely to contribute to the clinical activity of dabrafenib while the activity of carboxy-dabrafenib is not likely to be significant.
Danish: Baseret på eksponering, relativ potens og farmakokinetiske egenskaber synes både hydroxy- og desmethyldabrafenib at bidrage til den kliniske effekt af dabrafenib, mens aktiviteten af carboxydabrafenib ikke synes at være signifikant.
English: The benefits and risks should be considered before administering dabrafenib in patients with a prior or concurrent cancer associated with RAS mutations.
Danish: Fordele og risici bør overvejes før administration af dabrafenib til patienter med tidligere eller nuværende cancer, associeret med RAS-mutationer.
English: Patients should be evaluated for signs and symptoms of infection and if necessary treated in line with local practice (see section 4.4).
Danish: Patienter bør undersøges for tegn og symptomer på infektion og, om nødvendigt, behandles i henhold til lokale retningslinier (se pkt.
English: Based on 153 events (60 [14%] in the combination arm and 93 [22%] in the placebo arm) corresponding to a 26% information fraction of the total target of 597 OS events, the estimated hazard ratio for OS was 0.57 (95% CI: 0.42, 0.79; p=0.0006).
Danish: Baseret på 153 hændelser (60 [14 %] i kombinationsarmen og 93 [22 %] i placebo-armen), svarende til en informationsfraktion på 26 % af de i alt 597 OS-hændelser, der er målet, var den estimerede hazard ratio for OS 0,57 (95 % CI: 0,42; 0,79; p=0,0006).
English: It should be noted that approximately half of these occurrences with dabrafenib monotherapy (4%) and 1% with dabrafenib in combination with trametinib were Grade 3 in severity.
Danish: Det skal bemærkes, at ca. halvdelen af disse tilfælde med dabrafenib som monoterapi (4 %) og 1 % med dabrafenib i kombination med trametinib var af grad 3.
English: If you are breast-feeding, or planning to breast-feed, you must tell your doctor.
Danish: Hvis du ammer eller planlægger at amme, skal du fortælle det til lægen.
English: IV plasma clearance is 12 l/hr.
Danish: Plasmaclearancen efter intravenøs administration er 12 l/t.
English: Based on the population pharmacokinetic analysis, gender and weight were found to influence dabrafenib oral clearance; weight also impacted oral volume of distribution and distributional clearance.
Danish: På basis af den farmakokinetiske populationsanalyse viste køn og vægt sig at have indflydelse på clearancen af oralt dabrafenib; vægten påvirkede også fordelingsvolumenet og den interkompartmentelle clearance.
English: Tafinlar can have side effects that may affect your ability to drive or use machines.
Danish: Tafinlar kan give bivirkninger, der kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Table 5 Kinase inhibitory activity of dabrafenib against RAF kinases
Danish: Tabel 5 Dabrafenibs kinasehæmmende aktivitet mod RAF-kinaser
English: Patients should take dabrafenib as monotherapy or in combination with trametinib at least one hour prior to or two hours after a meal due to the effect of food on dabrafenib absorption (see section 5.2).
Danish: Patienterne skal tage dabrafenib, som monoterapi eller i kombination med trametinib, mindst en time før eller mindst 2 timer efter et måltid på grund af mads indvirkning på absorptionen af dabrafenib (se pkt.
English: The incidence and severity of pyrexia are increased with combination therapy.
Danish: Forekomsten og sværhedsgraden af feber øges ved kombinationsbehandling.
English: Abdominal pain g
Danish: Abdominalsmerter g
English: Neutropenia Anaemia
Danish: Neutropeni Anæmi
English: Included in these clinical trials were in total 402 subjects with BRAF V600E and 49 subjects with BRAF V600K mutation.
Danish: I disse kliniske forsøg var der i alt inkluderet 402 patienter med BRAF V600E-mutationen og 49 patienter med BRAF V600K-mutationen.
English: Based on the population pharmacokinetic analysis, age had no significant effect on dabrafenib pharmacokinetics.
Danish: På basis af den farmakokinetiske populationsanalyse havde alder ingen signifikant effekt på dabrafenibs farmakokinetik.
English: If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time.
Danish: Hvis den glemte dosis skulle være taget for mere end 6 timer siden, skal du springe den dosis over og tage din næste dosis på det sædvanlige tidspunkt.
English: Possible side effects when Tafinlar and trametinib are taken together
Danish: Bivirkninger, når Tafinlar og trametinib tages sammen
English: Taking Tafinlar with trametinib: trametinib may impair fertility in both men and women.
Danish: Anvendelse af Tafinlar sammen med trametinib: Trametinib kan nedsætte frugtbarheden hos både mænd og kvinder.
English: Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 6.
Danish: Median samlet overlevelse (OS) og estimerede 1-års, 2-års, 3-års, 4-års og 5-års overlevelseshyppigheder er angivet i tabel 6.
English: Subjects at Risk
Danish: Antal med risiko
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Danish: De fleste forsøgsdeltagere havde LDH ≤ULN (65 %), Eastern Cooperative Oncology Group (ECOG) performance-status 0 (72 %) og visceral sygdom (73 %) ved baseline.
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Danish: Alternativt afbryd behandlingen, indtil toksiciteten er grad 0 til 1, og reducer med ét dosisniveau, når behandlingen genoptages.
English: Patients should be routinely monitored for visual signs and symptoms (such as change in vision, photophobia and eye pain) while on therapy.
Danish: Patienterne bør rutinemæssigt monitoreres for øjenproblemer (som fx ændret syn, fotofobi og øjensmerter), mens de er i behandling.
English: Bleeding problems
Danish: Blødningsproblemer
English: Compared with younger subjects (<65), more subjects 65 years old had adverse reactions that led to study drug dose reductions (22% versus 12%) or interruptions (39% versus 27%).
Danish: Sammenlignet med yngre patienter (< 65 år) havde flere patienter  65 år bivirkninger, der førte til reduktioner i dosen af forsøgsmedicinen (22 % i forhold til 12 %) eller pausering af behandlingen (39 % i forhold til 27 %).
English: Most patients were Caucasian (99%) and male (55%), with a median age of 51 years (18% were ≥65 years).
Danish: De fleste patienter var kaukasiske (99 %) og mænd (55 %) med en median alder på 51 år (18 % var ≥65 år).
English: • Inflamed, flaky skin (exfoliative dermatitis)
Danish: • betændt, skællende hud (eksfoliativ dermatitis)
English: • have any liver problems.
Danish: • har leverproblemer.
English: Carboxy-dabrafenib is excreted in bile and urine.
Danish: Carboxydabrafenib udskilles i galden og urinen.
English: Patients with a history of prior malignancy, if disease-free for at least 5 years, were eligible.
Danish: Patienter med malignitet i anamnesen var egnede, hvis de havde været sygdomsfri i mindst 5 år.
English: The bMx THxID BRAF assay is an allele-specific PCR performed on DNA extracted from FFPE tumour tissue.
Danish: bMx THxID BRAF-analysen er en allel-specifik PCR-analyse udført på DNA ekstraheret fra FFPE tumorvæv.
English: Efficacy of dabrafenib in subjects previously treated with a protein kinase inhibitor has not been investigated.
Danish: Effekten af dabrafenib hos patienter, der tidligere er blevet behandlet med en proteinkinasehæmmer, er ikke undersøgt.
English: • Hormonal contraceptives (see section 4.6)
Danish: • Hormonale kontraceptiva (se pkt.
English: Tell your doctor, pharmacist or nurse if you are taking any of these (or if you are not sure).
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager nogen af ovenstående præparater (eller hvis du ikke er sikker).
English: In the integrated safety population for dabrafenib in combination with trametinib, 2% of patients developed cuSCC and the events occurred later than with dabrafenib monotherapy with a median time to onset of 18-31 weeks.
Danish: I den integrerede sikkerhedspopulation med dabrafenib i kombination med trametinib udviklede 2 % af patienterne cuSCC, og hændelserne forekom senere end med dabrafenib-monoterapi med en mediantid til indtræden på 18-31 uger.
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at Baseline.
Danish: De fleste forsøgsdeltagere havde LDH ≤ ULN (67 %), ECOG-performance status 0 (70 %) og visceral sygdom (78 %) ved baseline.
English: Following discontinuation of dabrafenib, monitoring for non-cutaneous secondary/recurrent malignancies should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Danish: Efter seponering af dabrafenib bør monitorering af ikke-kutane sekundære/recidiverende maligne sygdomme fortsætte i op til 6 måneder eller indtil start af anden antineoplastisk behandling.
English: Tafinlar can affect how well your heart pumps blood when taken in combination with trametinib.
Danish: Tafinlar kan påvirke, hvor godt dit hjerte pumper blod, når det tages i kombination med trametinib.
English: Abdominal pain upper and abdominal pain lower h
Danish: Øvre og nedre abdominalsmerter h
English: Figure 4 Kaplan-Meier RFS curves for Study BRF115532 (ITT population, updated results)
Danish: Figur 4 Kaplan-Meier RFS-kurver for studie BRF115532 (ITT population, opdaterede resultater)
English: Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.
Danish: Fortæl det hurtigst muligt til lægen, hvis du får nogen af disse symptomer - enten for første gang, eller hvis de bliver værre.
English: Activation of MAP-kinase signalling in BRAF wild type cells which are exposed to BRAF inhibitors may lead to increased risk of non-cutaneous malignancies, including those with RAS mutations (see section 4.4).
Danish: Aktivering af MAP-kinase-signalering i BRAF-vildtype celler, der eksponeres for BRAF-hæmmere, kan medføre øget risiko for ikke-kutane maligne sygdomme, herunder maligne sygdomme med RAS-mutationer (se pkt.
English: The majority of subjects had Stage IV M1c disease (61% overall).
Danish: Størstedelen af forsøgsdeltagerne havde sygdom i stadie IV M1c (i alt 61 %).
English: Preclinical data generated in biochemical assays demonstrated that dabrafenib inhibits BRAF kinases with activating codon 600 mutations (Table 5).
Danish: Prækliniske data genereret i biokemiske analyser viste, at dabrafenib hæmmer BRAF-kinaser med aktiverende codon 600-mutationer (tabel 5).
English: BRAF V600 testing
Danish: BRAF V600-analyse
English: (8.3, NE) NE (6.9, NE)
Danish: NE2 (8,3; NE) NE (6,9; NE)
English: Usually, these skin changes remain local and can be removed with surgery and treatment with Tafinlar can be continued without interruption.
Danish: Normalt forbliver disse forandringer i huden i et afgrænset område på huden og kan fjernes ved operation, og behandlingen med Tafinlar kan fortsættes uden afbrydelse.
English: • red or black stools that look like tar
Danish: • rød afføring eller sort afføring, som kan ligne tjære.
English: • Heart rate that is lower than the normal range and/or a decrease in heart rate
Danish: • puls, der er under det normale interval og/eller nedsat puls
English: • headaches, dizziness, or weakness
Danish: • hovedpine, svimmelhed eller svaghed
English: OS data from a further post-hoc analysis based on the 18 December 2012 data cut demonstrated a 12-month OS rate of 63% and 70% for DTIC and dabrafenib treatments, respectively.
Danish: OS-data fra en anden post hoc-analyse baseret på skæringsdatoen 18. december 2012 viste en 12-måneders OS (overall survival)-rate på 68 % og 70 % for henholdsvis DTIC- og dabrafenibbehandling.
English: Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Danish: Undtagelser, hvor det kun er nødvendigt at justere dosis for en af de to behandlinger, er angivet nedenfor for pyreksi, uveitis, RAS-mutationspositive ikke-kutane maligniteter (primært relateret til dabrafenib), reduktion af venstre ventrikels ejektionsfraktion (LVEF), retinal veneokklusion (RVO), løsning af retinalt pigmentepitel (RPED) og interstitiel lungesygdom (ILD)/pneumonitis (primært relateret til trametinib).
English: • some medicines for tuberculosis (TB), such as rifampicin
Danish: • visse lægemidler mod tuberkulose (TB), fx rifampicin
English: Bronchoalveolar inflammation of the lungs was observed in several dogs at ≥20 mg/kg/day (≥9 times human clinical exposure based on AUC) and was associated with shallow and/or laboured breathing.
Danish: Der blev observeret bronkoalveolær inflammation hos flere hunde ved ≥ 20 mg/kg/dag (9 gange den kliniske eksponering hos mennesker baseret på AUC), som var forbundet med overfladisk og/eller besværet vejrtrækning.
English: • some medicines used to treat certain psychiatric conditions, such as haloperidol
Danish: • visse lægemidler som bruges til at behandle visse former for psykiske lidelser, fx haloperidol
English: If treatment-related toxicities occur when dabrafenib is used in combination with trametinib, then both treatments should be simultaneously dose reduced, interrupted or discontinued.
Danish: Hvis der opstår behandlingsrelateret toksicitet, når dabrafenib anvendes i kombination med trametinib, skal dosis i begge behandlinger samtidigt reduceres, pauseres eller seponeres.
English: What you need to know before you take Tafinlar
Danish: Det skal du vide, før du begynder at tage Tafinlar
English: Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by standard therapy as appropriate.
Danish: Blodtrykket skal måles ved baseline og kontrolleres løbende under behandlingen.
English: • Lack of energy, feeling weak
Danish: • manglende energi, svaghed
English: • have eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid leakage (chorioretinopathy).
Danish: • om du har øjenproblemer, herunder blokering af den vene, der leder væske fra øjet (retinal veneokklusion) eller hævelse i øjet, som kan være forårsaget af væskeophobning (korioretinopati).
English: Dabrafenib can be restarted once the fever resolves with appropriate prophylaxis using non-steroidal anti-inflammatory medicinal products or paracetamol.
Danish: Når feberen er ophørt, kan behandling med dabrafenib genoptages med relevant profylakse med nonsteroide antiinflammatoriske lægemidler eller paracetamol.
English: Dabrafenib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay and in vivo at doses ≥100 mg/kg (>44 times clinical exposure based on Cmax) in an oral phototoxicity study in hairless mice.
Danish: Dabrafenib var fototoksisk i en 3T3 Neutral Red Uptake (NRU)-analyse udført in vitro på fibroblaster fra mus og ved doser ≥ 100 mg/kg (> 44 gange den kliniske eksponering, baseret på Cmax) i et oralt fototoksicitetsstudie udført in vivo med hårløse mus.
English: Papilloma
Danish: Papillom
English: Includes drug hypersensitivity f
Danish: Inkluderer overfølsomhed over for lægemidlerne f
English: Dabrafenib in combination with trametinib should be used with caution in patients with conditions that could impair left ventricular function.
Danish: Dabrafenib i kombination med trametinib bør anvendes med forsigtighed hos patienter med tilstande, der kan nedsætte funktionen af venstre ventrikel.
English: • Skin effects including infection of the skin (cellulitis), inflammation of hair follicles in the skin,
Danish: • hudreaktioner, herunder betændelse i huden (cellulitis), betændelse i hudens hårsække,
English: • Acne-like problems
Danish: • aknelignende problemer
English: However, in repeat dose studies, testicular degeneration/depletion was seen in rats and dogs (≥0.2 times the human clinical exposure based on AUC).
Danish: I studier med gentagne doser blev der dog set degeneration i/depletion af testiklerne hos rotter og hunde (ved ≥ 0,2 gange den kliniske eksponering hos mennesker baseret på AUC).
English: This may occur commonly (may affect up to 1 in 10 people) in patients taking Tafinlar in combination with trametinib.
Danish: Frekvensen er almindelig (op til 1 ud af 10 personer) hos patienter, der tager Tafinlar i kombination med trametinib.
English: In clinical trials in unresectable or metastatic melanoma,these cases were identified within the first 5 months of dabrafenib as monotherapy.
Danish: I kliniske studier med inoperabelt eller metastatisk melanom blev disse tilfælde set inden for de første 5 måneder af behandlingen med dabrafenib som monoterapi.
English: Renal failure due to pyrexia-associated pre-renal azotaemia or granulomatous nephritis was uncommon; however dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN).
Danish: Nyresvigt som følge af feber-associeret pre-renal azotæmi eller granulomatøs nefritis var ikke almindeligt forekommende, men dabrafenib er ikke undersøgt hos patienter med nyreinsufficiens (defineret som kreatinin > 1,5 x ULN).