FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of cuSCC (including keratoacanthoma) have been reported in patients treated with trametinib in combination with dabrafenib.
Danish: Der er rapporteret tilfælde af cuSCC (herunder keratoakantom) hos patienter, som blev behandlet med trametinib i kombination med dabrafenib.
English: palpitations and chest pain.
Danish: hjertebanken og brystsmerter
English: The most common adverse reactions (incidence 20%) for trametinib in combination with dabrafenib were: pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.
Danish: De hyppigste bivirkninger (incidens ≥ 20 %) ved trametinib i kombination med dabrafenib var pyreksi, træthed, kvalme, kulderystelser, hovedpine, diarré, opkastning, artralgi og udslæt.
English: • Heart rate that is lower than the normal range and/or a decrease in heart rate
Danish: • puls (hjertefrekvens), der er under det normale interval, og/eller nedsat puls
English: Trametinib inhibits growth of BRAF V600 mutant melanoma cell lines and demonstrates anti-tumour effects in BRAF V600 mutant melanoma animal models.
Danish: Trametinib hæmmer vækst af BRAF V600-muterede melanomcellelinjer og har påvist antitumoreffekt i dyremodeller med BRAF V600-mutationspositivt melanom.
English: If patients report new visual disturbances, such as diminished central vision, blurred vision or loss of vision at any time while on trametinib therapy, a prompt ophthalmological assessment is recommended.
Danish: Hvis patienter rapporterer nye synsforstyrrelser som fx nedsat centralsyn, tågesyn eller synstab på noget tidspunkt under behandling med trametinib, anbefales der en omgående oftalmologisk undersøgelse.
English: Elevations in blood pressure have been reported in association with trametinib as monotherapy and in combination with dabrafenib, in patients with or without pre-existing hypertension.
Danish: Der er set blodtryksforhøjelse i forbindelse med trametinib, som monoterapi og i kombination med dabrafenib, hos patienter med eller uden allerede eksisterende hypertension.
English: Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Danish: Trametinib i kombination med dabrafenib er indiceret til adjuverende behandling af voksne patienter med stadie III melanom med en BRAF V600-mutation efter komplet resektion.
English: Patients should be made aware of potential for fatigue, dizziness or eye problems that might affect these activities.
Danish: Patienterne bør gøres opmærksom på, at de mulige bivirkninger med træthed, svimmelhed og øjenproblemer kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The dabrafenib doses should be about 12 hours apart.
Danish: Der skal være ca. 12 timer mellem dabrafenib-doserne.
English: Oedema peripheral Pyrexia
Danish: Træthed Perifert ødem Pyreksi
English: Trametinib in combination with dabrafenib in patients with brain metastases
Danish: Trametinib i kombination med dabrafenib hos patienter med hjernemetastaser
English: No data are available in patients with moderate or severe hepatic impairment.
Danish: Der er ingen tilgængelige data om patienter med moderat til svært nedsat leverfunktion.
English: • dark urine due to kidney damage
Danish: • mørk urin (på grund af skader i nyrerne).
English: Effect of food on trametinib
Danish: Indvirkning af føde på trametinib
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI) P value Overall Response Rate (%)
Danish: Median-PFS (måneder) (95 % CI) Hazard Ratio (95 % CI) P-værdi Samlet responsrate (%)
English: Blood pressure should be measured at baseline and monitored during treatment with trametinib, with control of hypertension by standard therapy as appropriate.
Danish: Blodtrykket skal måles ved baseline og monitoreres løbende under behandlingen.
English: EU/1/14/931/005 7 film-coated tablets EU/1/14/931/006 30 film-coated tablets
Danish: EU/1/14/931/005 7 filmovertrukne tabletter EU/1/14/931/006 30 filmovertrukne tabletter
English: How should you take Mekinist in combination with dabrafenib
Danish: Sådan skal du tage Mekinist i kombination med dabrafenib
English: EU/1/14/931/001 7 film-coated tablets EU/1/14/931/002 30 film-coated tablets
Danish: EU/1/14/931/001 7 filmovertrukne tabletter EU/1/14/931/002 30 filmovertrukne tabletter
English: • Swelling of nerves at the back of the eye (papilloedema) (see also “Eye (vision) problems”
Danish: • hævelse af nerverne i øjets bagre del (papilødem) (se også “Øjenproblemer (synsproblemer)”
English: Tablet: mannitol (E421), microcrystalline cellulose (E460), hypromellose (E464), croscarmellose sodium (E468), magnesium stearate (E470b), sodium laurilsulfate and colloidal silicon dioxide (E551).
Danish: Tablet: mannitol (E421), mikrokrystallinsk cellulose (E460), hypromellose (E464), croscarmellosenatrium (E468), magnesiumstearat (E470b), natriumlaurilsulfat og kolloid silica (E551).
English: • Thickening of the outer layer of the skin (hyperkeratosis), patches of thick, scaly, or crusty skin
Danish: • fortykkelse af det yderste hudlag (hyperkeratose), tykke, skællede eller skorpede pletter på huden (aktinisk keratose), sprukken eller revnet hud
English: The efficacy and safety of trametinib in combination with dabrafenib were studied in a Phase III, multicentre, randomised, double-blind, placebo-controlled study in patients with Stage III (Stage IIIA [lymph node metastasis >1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection.
Danish: Effekten og sikkerheden af trametinib i kombination med dabrafenib blev undersøgt i et randomiseret, dobbeltblindet, placebo-kontrolleret, fase III multicenter-studie hos patienter med stadie III (stadie IIIA [metastaser i lymfeknuderne > 1 mm], IIIB eller IIIC) kutant melanom med en BRAF V600 E/K-mutation efter komplet resektion.
English: Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Danish: Trametinib i kombination med dabrafenib er indiceret til behandling af voksne patienter med fremskreden ikke-småcellet lungecancer med BRAF V600-mutation.
English: Patients (N=322) who were treatment naïve or may have received one prior chemotherapy treatment in the metastatic setting [Intent to Treat (ITT) population] were randomised 2:1 to receive trametinib 2 mg once daily or chemotherapy (dacarbazine 1000 mg/m every 3 weeks or paclitaxel 175 mg/m every 3 weeks).
Danish: Tidligere ubehandlede patienter (N = 322) eller patienter, der tidligere havde fået én behandling med kemoterapi på grund af metastasering (Intent to Treat [ITT]-population), blev randomiseret i forholdet 2:1 til at få 2 mg trametinib en gang daglig eller kemoterapi (en dosis dacarbazin på 1.000 mg/m hver
English: How to take Mekinist
Danish: Sådan skal du tage Mekinist
English: In clinical trials uveitis and iridocyclitis have also been reported in patients treated with trametinib in combination with dabrafenib.
Danish: I kliniske studier er der også rapporteret uveitis og iridocyklitis hos patienter, der fik trametinib i kombination med dabrafenib.
English: Trametinib monotherapy has not been compared with a BRAF inhibitor in a clinical study in patients with BRAF V600 mutation positive unresectable or metastatic melanoma.
Danish: Trametinib som monoterapi er ikke blevet sammenlignet med en BRAF-hæmmer i et klinisk studie hos patienter med inoperabelt eller metastatisk BRAF V600-mutationspositivt melanom.
English: Total dose recovery was low after a 10-day collection period (<50%) following administration of a single oral dose of radiolabelled trametinib as a solution, due to the long elimination half-life.
Danish: Den samlede genfinding af dosis efter en enkelt radioaktivt mærket oral dosis trametinib givet som en opløsning var lav efter en indsamlingsperiode på 10 dage (< 50 %).
English: As metabolism and biliary excretion are the primary routes of elimination of trametinib, administration of trametinib should be undertaken with caution in patients with moderate to severe hepatic impairment (see section 4.2).
Danish: Da trametinib primært elimineres via metabolisering og biliær udskillelse, bør trametinib administreres med forsigtighed hos patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Liver monitoring may be continued thereafter as clinically indicated.
Danish: Leverfunktionen bør herefter monitoreres som klinisk indiceret.
English: If RPED is diagnosed, follow the dose modification schedule in Table 3 below for trametinib (see section 4.4).
Danish: Hvis RPED diagnosticeres, følges skemaet for justering af trametinib-dosis, der er vist i tabel 3 nedenfor (se pkt.
English: Disorders associated with visual disturbance, including RPED and RVO, may occur with trametinib as monotherapy and in combination with dabrafenib.
Danish: Tilstande forbundet med synsforstyrrelser, herunder RPED og RVO, kan forekomme ved behandling med trametinib som monoterapi og i kombination med dabrafenib.
English: • Changes in how the heart pumps blood (left ventricular dysfunction) (see also “Heart conditions” earlier in section 4)
Danish: • ændringer i, hvordan hjertet pumper blod (dårlig funktion af venstre hjertekammer) (se også
English: • Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)
Danish: • nedbrydning af muskelvæv, hvilket kan give muskelsmerter og nyreskade (rabdomyolyse)
English: The safety and efficacy of the combination of trametinib and dabrafenib have been evaluated in a multi-cohort, open-label, Phase II study in patients with BRAF V600 mutant melanoma with brain metastases.
Danish: Sikkerheden og effekten af kombinationen trametinib og dabrafenib er blevet evalueret i et åbent, multikohorte fase II-studie hos patienter med BRAF V600-mutationspositivt melanom med hjernemetastaser.
English: The efficacy and safety of trametinib in combination with dabrafenib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Danish: Patienter med hjernemetastaser Effekten og sikkerheden af trametinib i kombination med dabrafenib hos patienter med BRAF mutationspositivt melanom med hjernemetastaser blev undersøgt i et ikke-randomiseret, åbent, multicenter fase II-studie (COMBI-MB-studiet).
English: Fatal intracranial haemorrhages occurred in the integrated safety population of trametinib in combination with dabrafenib in <1% (8/1076) of patients.
Danish: Intrakranielle blødninger med dødelig udgang forekom hos <1 % (8/1076) af patienterne i den integrerede sikkerhedspopulation med trametinib i kombination med dabrafenib.
English: Before taking trametinib or the combination with dabrafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Danish: Før behandling med trametinib eller kombinationen med dabrafenib startes, skal patienterne have konstateret en BRAF V600-mutation i tumor ved hjælp af en valideret test.
English: New malignancies, cutaneous and non-cutaneous, can occur when trametinib is used in combination with dabrafenib.
Danish: Der kan forekomme nye maligniteter, kutane og ikke-kutane, når trametinib anvendes i kombination med dabrafenib.
English: Mekinist can result in the breakdown of muscle (rhabdomyolysis).
Danish: Mekinist kan medføre nedbrydning af muskelvæv (rabdomyolyse).
English: There are no data in humans for trametinib as monotherapy or in combination with dabrafenib.
Danish: Der er ingen data om anvendelse af trametinib hos mennesker som monoterapi eller i kombination med dabrafenib.
English: • Separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) (see also “Eye (vision) problems” earlier in section 4).
Danish: tidligere i punkt 4) • løsgørelse af den lysfølsomme membran på bagsiden af øjet (nethinden) fra dens understøttende lag (nethindeløsning) (se også “Øjenproblemer (synsproblemer)” tidligere i punkt 4)
English: Mekinist as monotherapy or in combination with dabrafenib can cause rash or acne-like rash.
Danish: Mekinist, som monoterapi eller i kombination med dabrafenib, kan give udslæt eller aknelignende udslæt.
English: Pulmonary embolism or deep vein thrombosis can occur when trametinib is used as monotherapy or in combination with dabrafenib.
Danish: Lungeemboli og dyb venetrombrose kan opstå, når trametinib anvendes som monoterapi eller i kombination med dabrafenib.
English: Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
Danish: Inden patienten opstarter trametinib, skal BRAF V600-mutation i tumor være bekræftet ved anvendelse af en valideret test.
English: The proportion of subjects experiencing adverse reactions (AR) and serious adverse reactions (SAR) was similar in the subjects aged <65 years and those aged ≥65 years.
Danish: Andelen af personer, der oplevede bivirkninger og alvorlige bivirkninger, var af samme størrelsesorden i gruppen på < 65 år og i gruppen på ≥ 65 år.
English: • Take Mekinist in combination with dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Danish: • Tag Mekinist i kombination med dabrafenib nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
English: Trametinib monotherapy compared to BRAF inhibitors
Danish: Trametinib-monoterapi sammenlignet med BRAF-hæmmere
English: The efficacy results in the primary efficacy population were consistent with those in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 11.
Danish: Effektresultaterne i den primære effekt-population stemte overens med resultaterne i ITT-populationen.
English: Trametinib dose Used as monotherapy or in combination with dabrafenib
Danish: Tramatenib-dosis Anvendt som monoterapi eller i kombination med dabrafenib
English: Possible serious side effects
Danish: Svære kutane bivirkninger
English: Trametinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity.
Danish: Trametinib hæmmer BRAFs aktivering af MEK og hæmmer MEK's kinaseaktivitet.
English: The Mekinist 2 mg film-coated tablets are pink, round, biconvex, with “GS” debossed on one face and “HMJ” on the opposing face.
Danish: De filmovertrukne 2 mg Mekinist-tabletter er lyserøde, runde, bikonvekse med “GS” påtrykt på den ene side og “HMJ” på den anden side.
English: New primary melanoma was reported in patients receiving trametinib in combination with dabrafenib.
Danish: Der er rapporteret nye primære melanomer hos patienter, som fik trametinib i kombination med dabrafenib.
English: MEK115306 was a Phase III, randomised, double-blinded study comparing the combination of dabrafenib and trametinib to dabrafenib and placebo in first-line therapy for subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.
Danish: MEK115306 var et randomiseret, dobbeltblindet fase III-studie, hvor kombinationen dabrafenib og trametinib blev sammenlignet med dabrafenib og placebo som førstelinjebehandling hos forsøgsdeltagere med inoperabelt (stadie IIIC) eller metastatisk (stadie IV) BRAF V600E-/Kmutationspositivt kutant melanom.
English: Always take Mekinist exactly as your doctor, nurse or pharmacist has told you.
Danish: Tag altid Mekinist nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
English: Bleeding from various sites, including intracranial bleeding and fatal bleeding g Abdominal pain upper and abdominal pain lower h
Danish: Inkluderer overfølsomhed over for lægemidlerne f Blødning fra forskellige steder, herunder interkraniel blødning og blødning med dødelig udgang g
English: Film coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, iron oxide yellow (E172) (for 0.5 mg tablets), polysorbate 80 (E433) and iron oxide red (E172) (for 2 mg tablets).
Danish: Filmovertræk: hypromellose (E464), titandioxid (E171), polyethylenglycol, gul jernoxid (E172) (0,5 mg tabletter), polysorbat 80 (E433) og rød jernoxid (E172) (2 mg tabletter).
English: Pink, round, biconvex, film-coated tablets, approximately 7.5 mm, with “GS” debossed on one face and “HMJ” on the opposing face.
Danish: Lyserøde, runde, bikonvekse, filmovertrukne tabletter, ca. 7,5 mm, påtrykt “GS” på den ene side og “HMJ” på den anden side.
English: Efficacy in patients with ocular or mucosal melanoma has not been assessed.
Danish: Effekten hos patienter med øjen- eller slimhindemelanom er ikke undersøgt.
English: Take the doses of Mekinist and dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Danish: Tag doserne af Mekinist og dabrafenib nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
English: The Mekinist 0.5 mg film-coated tablets are yellow, modified oval, biconvex, with “GS” debossed on one face and “TFC” on the opposing face.
Danish: De filmovertrukne 0,5 mg Mekinist-tabletter er gule, bikonvekse, med modificeret oval form og “GS” påtrykt på den ene side og “TFC” på den anden side.
English: Aspartate aminotransferase increased
Danish: Forhøjet niveau af aspartataminotransferase (ASAT)
English: Trametinib should be used with caution in patients with moderate or severe hepatic impairment when administered as monotherapy or in combination with dabrafenib.
Danish: Trametinib bør anvendes med forsigtighed hos patienter med moderat eller svært nedsat leverfunktion, når det administreres som monoterapi eller i kombination med dabrafenib.
English: The recommended dose of trametinib, either used as monotherapy or in combination with dabrafenib, is 2 mg once daily.
Danish: Den anbefalede dosis af trametinib, enten som monoterapi eller i kombination med dafrafenib, er 2 mg en gang daglig.
English: Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and
Danish: Trametinib som monoterapi eller i kombination med dabrafenib er indiceret til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation (se pkt.
English: The 5-year overall survival rate was 40% (95% CI: 31.2, 48.4) in the combination arm versus 33% (95% CI: 25.0, 41.0) in the dabrafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 8.4, 26.0) in the combination arm versus 14% (95% CI: 6.8, 23.1) in the dabrafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Danish: 5 års samlet overlevelsesrate var 40% (95% CI: 31,2; 48,4) i kombinationsarmen versus 33% (95% CI: 25,0; 41,0) i dabrafenib monoterapiarmen, for patienter der havde normal laktatdehydrogenaseniveau ved baseline, og 16% (95% CI: 8,4; 26,0) i kombinationsarmen versus
English: Alanine aminotransferase increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased a
Danish: Forhøjet basisk fosfatase i blodet Forhøjet gamma-glutamyltransferase Forhøjet kreatinkinase i blodet a
English: Trametinib should be permanently discontinued for patients diagnosed with treatment-related ILD or pneumonitis (see section 4.2).
Danish: Trametinib skal seponeres permanent hos patienter, der diagnosticeres med behandlingsrelateret ILD eller pneumonitis (se pkt.
English: The efficacy and safety of trametinib in combination with dabrafenib was studied in a Phase II, three-cohort, multicentre, non-randomised and open-label study in which patients with Stage IV BRAF V600E mutant NSCLC were enrolled.
Danish: Effekten og sikkerheden af trametinib i kombination med dabrafenib blev undersøgt i et ikke randomiseret, åbent fase II-multicenterstudie med 3 kohorter, hvor der blev inkluderet patienter med stadie IV BRAF V600E-muteret NSCLC.
English: The recommended dose of dabrafenib, when used in combination with trametinib, is 150 mg twice daily.
Danish: Den anbefalede dosis af dafrafenib, når det anvendes i kombination med trametinib, er 150 mg to gange dagligt.
English: • Trametinib monotherapy
Danish: Trametinib-monoterapi
English: Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Danish: Colitis og gastrointestinal perforation, inklusive med fatalt udfald, har været rapporteret hos patienter, der tog trametinib som monoterapi og i kombination med dabrafenib (se pkt.
English: Elevations in blood pressure have been reported in association with trametinib as monotherapy and in combination with dabrafenib, in patients with or without pre-existing hypertension (see section 4.8).
Danish: Der er rapporteret forhøjelse af blodtrykket i forbindelse med trametinib som monoterapi og i kombination med dabrafenib hos patienter med eller uden eksisterende hypertension (se pkt.
English: Number of deaths
Danish: Skæringsdato Behandling Antal dødsfald
English: In the integrated safety population of trametinib in combination with dabrafenib, decreased LVEF has been reported in 6% (65/1076) of patients, with most cases being asymptomatic and reversible.
Danish: I den integrerede sikkerhedspopulation med trametinib i kombination med dabrafenib er der rapporteret reduceret LVEF hos 6 % af patienterne (65/1076).
English: Trametinib has been reported to decrease LVEF when used as monotherapy or in combination with dabrafenib.
Danish: Det er rapporteret, at trametinib har reduceret LVEF, når det anvendes som monoterapi eller i kombination med dabrafenib.
English: Men taking trametinib in combination with dabrafenib
Danish: Mænd, der tager trametinib i kombination med dabrafenib
English: No dose modification of dabrafenib is required when taken in combination with trametinib following diagnosis of RVO or RPED.
Danish: Justering af dabrafenib-dosis er ikke nødvendig, når det tages i kombination med trametinib ved diagnoserne RVO og RPED.
English: Trametinib must be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Danish: Behandlingen med trametinib skal afbrydes hos patienter med formodet ILD eller pneumonitis, herunder patienter med nye eller tiltagende symptomer fra lungerne og parakliniske fund, herunder hoste, dyspnø, hypoksi, pleuraekssudat eller infiltrater, der afventer kliniske undersøgelser.
English: Vision blurred Periorbital oedema Visual impairment
Danish: Sløret syn Periorbitalt ødem Nedsat syn
English: Trametinib should be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Danish: Behandlingen med trametinib skal pauséres hos patienter med formodet ILD eller pneumonitis, herunder patienter med nye eller tiltagende symptomer fra lungerne og parakliniske fund, herunder hoste, dyspnø, hypoksi, pleuraekssudat eller infiltrater, der afventer kliniske undersøgelser.
English: Cardiac failure
Danish: Hjerteproblemer
English: Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.
Danish: Mekinist 2 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 2 mg trametinib.
English: Pancreatitis has been reported in patients treated with trametinib in combination with dabrafenib in clinical trials.
Danish: Der er rapporteret pancreatitis hos patienter, som blev behandlet med trametinib i kombination med dabrafenib i kliniske forsøg.
English: Pancreatitis has been reported with dabrafenib in combination with trametinib.
Danish: Der er rapporteret pancreatitis ved dabrafenib i kombination med trametinib.