FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of dabrafenib in combination with trametinib 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: Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Danish: Dabrafenib som monoterapi eller i kombination med trametinib er indiceret til voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation (se pkt.
English: • Low levels of phosphate (hypophosphataemia) in the blood
Danish: • lavt indhold af fosfat i blodet (hypofosfatæmi)
English: • Inflammation of the pancreas (causing strong abdominal pain)
Danish: • betændelse i bugspytkirtlen (pancreatitis) (hvilket giver stærke mavesmerter)
English: Cohort B N=18
Danish: Kohorte B N = 18
English: Pain in extremity Muscle spasms i
Danish: Ekstremitetssmerter Muskelspasmer i
English: 75 mg twice daily
Danish: 75 mg to gange dagligt
English: Cohort C N=16
Danish: Kohorte C N=16
English: Hypophosphataemia
Danish: Hypofosfatæmi
English: No dose adjustment is required for patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Renal failure has been identified in <1% of patients treated with dabrafenib alone and in ≤1% of patients treated with dabrafenib in combination with trametinib.
Danish: Nyresvigt er set hos < 1 % af patienterne, behandlet med dabrafenib som monoterapi, og hos ≤ 1 % af patienterne, behandlet med kombinationen dabarfenib og trametinib.
English: Effect of food on dabrafenib
Danish: Indvirkning af føde på dabrafenib
English: • Swelling of the face
Danish: • hævelse af ansigtet
English: Constipation
Danish: Forkølelse
English: Deep vein thrombosis/Pulmonary embolism
Danish: Dyb venetrombrose/lungeemboli
English: • Inflammation of the lung (pneumonitis)
Danish: • inflammation (betændelseslignende tilstand) i lungerne (pneumonitis)
English: No dose modification of dabrafenib is required when taken in combination with trametinib for cases of ILD or pneumonitis.
Danish: Justering af dabrafenib-dosis er ikke nødvendig, når det tages i kombination med trametinib ved ILD eller pneumonitis.
English: Always take Tafinlar exactly as your doctor, pharmacist or nurse has told you to.
Danish: Tag altid Tafinlar nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: 1 mg once daily
Danish: 1 mg en gang daglig
English: • Cardiac glycosides (e.g. digoxin, see section 4.4)
Danish: • Hjerteglycosider (fx digoxin, se pkt.
English: • Infection of the urinary system
Danish: • urinvejsinfektion
English: • Heart pumping less efficiently
Danish: • nedsættelse af hjertets pumpeevne
English: • some immunosuppressants, such as cyclosporin, tacrolimus and sirolimus
Danish: • visse immunundertrykkende lægemidler (immunsuppressiva), fx ciclosporin, tacrolimus og sirolimus
English: • Cohort B: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 59 patients enrolled.
Danish: • Kohorte B: Kombinationsbehandling (dabrafenib 150 mg to gange dagligt og trametinib 2 mg en gang dagligt), 59 patienter inkluderet.
English: Cases of RAS-driven malignancies have been seen with dabrafenib as monotherapy and in combination with trametinib.
Danish: Der er set tilfælde af RAS-drevne maligne sygdomme ved brug af dabrafenib som monoterapi og i kombination med trametinib.
English: Dry mouth Stomatitis
Danish: Mundtørhed Stomatitis
English: • Cohort C: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 34 patients.
Danish: • Kohorte C: Kombinationsbehandling (dabrafenib 150 mg to gange dagligt og trametinib 2 mg en gang dagligt), 34 patienter.
English: 1st dose reduction
Danish: 1. dosisreduktion
English: Seborrhoeic keratosis
Danish: Seboroisk keratose
English: Overall responsea % (95% CI) Duration of response Median, months (95% CI)
Danish: % (95 % CI) Responsvarighed Median, måneder (95 % CI)
English: Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”.
Danish: Uigennemsigtige mørkepink kapsler, ca. 19 mm lange, påtrykt ”GS LHF” og ”75 mg” på kapselskallen.
English: Table 8 Overall Survival results for Study MEK116513 (COMBI-v)
Danish: Tabel 8 Resultater for samlet overlevelse fra studie MEK116513 (COMBI-v)
English: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”.
Danish: Uigennemsigtige mørkerøde kapsler, ca. 18 mm lange, påtrykt ”GS TEW” og ”50 mg” på kapselskallen.
English: Abnormal findings should be managed according to clinical practices.
Danish: Unormale fund bør håndteres som klinisk indiceret.
English: If uveitis does not respond to local ocular therapy, withhold dabrafenib until resolution of ocular inflammation and then restart dabrafenib reduced by one dose level.
Danish: Hvis uveitis ikke responderer på lokal okulær behandling, pauseres dabrafenib indtil resolution af den okulære inflammation.
English: Concomitant use of dabrafenib with medicinal products that are sensitive substrates of certain metabolising enzymes or transporters (see section 4.5) should generally be avoided if monitoring for efficacy and dose adjustment is not possible.
Danish: Samtidig brug af dabrafenib og lægemidler, der er følsomme substrater for visse metaboliserende enzymer eller transportører (se pkt.
English: Table 9 Efficacy results for Study MEK116513 (COMBI-v)
Danish: Tabel 9 Effektresultater for studiet MEK116513 (COMBI-v)
English: Table 7 Efficacy results for Study MEK115306 (COMBI-d)
Danish: Tabel 7 Effektresultater for studiet MEK115306 (COMBI-d)
English: • Constipation
Danish: • træthed
English: Median PFS Months (95% CI)
Danish: Median PFS måneder (95 % CI)
English: 3rd dose reduction
Danish: 3. dosisreduktion
English: • Sore mouth or mouth ulcers, inflammation of mucous membranes
Danish: • ømhed eller blærer i munden, betændelse af slimhinder
English: 2 mg once daily
Danish: 2 mg en gang daglig
English: What Tafinlar looks like and contents of the pack Tafinlar 50 mg hard capsules are opaque dark red and imprinted with “GS TEW” and “50 mg”.
Danish: Tafinlar 50 mg hårde kapsler er uigennemsigtige, mørkerøde og påtrykt ”GS TEW” og ”50 mg”.
English: Median DoR Months (95% CI)
Danish: Median DoR måneder (95 % CI)
English: In the adjuvant treatment of melanoma trial, pancreatitis was reported in <1% (1/435) of patients receiving dabrafenib in combination with trametinib, and no patients receiving placebo.
Danish: Pankreatitis blev rapporteret hos < 1 % (1/435) af de patienter, der fik dabrafenib i kombination med trametinib i forsøget med den adjuverende behandling af melanom, og hos ingen af patienterne, der fik placebo.
English: No dose modification of dabrafenib is required when taken in combination with trametinib.
Danish: Justering af dabrafenib-dosis er ikke nødvendig, når det tages i kombination med trametinib.
English: Constipation Diarrhoea Nausea Vomiting
Danish: Obstipation Diarré Kvalme Opkastning
English: Dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN) therefore caution should be used in this setting (see section 5.2).
Danish: Dabrafenib er ikke undersøgt hos patienter med nedsat nyrefunktion (defineret som serum-kreatinin > 1,5 xULN).
English: Table 6 Overall Survival results for Study MEK115306 (COMBI-d)
Danish: Tabel 6 Resultater for samlet overlevelse fra studie MEK115306 (COMBI-d)
English: If uveitis does not respond to local ocular therapy, dabrafenib should be withheld until resolution of ocular inflammation and then dabrafenib should be restarted reduced by one dose level.
Danish: Hvis uveitis ikke responderer på lokal okulær behandling, skal dabrafenib pauseres indtil bedring af den okulære inflammation.
English: Pulmonary embolism or deep vein thrombosis can occur when dabrafenib is used in combination with trametinib.
Danish: Lungeemboli og dyb venetrombrose kan opstå, når dabrafenib anvendes som monoterapi eller i kombination med trametinib.
English: Cohort B N=16
Danish: Kohorte B N=16
English: • Inflammation of kidneys
Danish: • inflammation i nyrerne
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg or 75 mg of dabrafenib.
Danish: Hver hård kapsel indeholder dabrafenibmesilat svarende til 50 mg eller 75 mg dabrafenib.
English: Overall survival, median, months (95% CI)
Danish: Samlet overlevelse, median, måneder (95 % CI)
English: (95% CI: 22.5, 34.6) in the vemurafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 9.3, 23.3) in the combination arm versus 10% (95% CI: 5.1, 17.4) in the vemurafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Danish: 5 års samlet overlevelsesrate var 46% (95% CI: 38,8; 52,0) i kombinationsarmen versus 28% (95% CI: 22,5; 34,6) i vemurafenib monoterapiarmen, for patienter der havde normal laktatdehydrogenaseniveau ved baseline, og 16% (95% CI: 9,3; 23,3) i kombinationsarmen versus 10% (95% CI: 5,1; 17,4) i vemurafenib monoterapiarmen, for patienter med forhøjet laktatdehydrogenaseniveau ved baseline.
English: No dose modification of trametinib is required when taken in combination with dabrafenib.
Danish: Justering af trametinib-dosis er ikke nødvendig, når det tages 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 diagnosen RVO eller RPED.
English: Tell your doctor, pharmacist or nurse as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Danish: Skal du hurtigst muligt fortælle det til lægen, apotekspersonalet eller sundhedspersonalet - både hvis de optræder for første gang, eller hvis de bliver værre.
English: 5-year OS analysis (data cut-off: 10-Dec-2018)
Danish: 5-års analyse (skæringsdato for dataindsamling: 10-dec-2018)
English: Effect of other medicinal products on dabrafenib
Danish: Andre lægemidlers effekt på dabrafenib
English: Skin fissures
Danish: Hudfissurer
English: EU/1/13/865/001 28 capsules EU/1/13/865/002 120 capsules
Danish: EU/1/13/865/001 28 kapsler EU/1/13/865/002 120 kapsler
English: EU/1/13/865/003 28 capsules EU/1/13/865/004 120 capsules
Danish: EU/1/13/865/003 28 kapsler EU/1/13/865/004 120 kapsler
English: Median PFS (months) (95% CI)
Danish: Median PFS (måneder) (95 % CI)
English: (months) Median (95% CI)
Danish: (måneder) Median (95 % CI)
English: In the Phase III study BRF115532 (COMBI-AD) in the adjuvant treatment of melanoma, 1% (6/435) of patients receiving dabrafenib in combination with trametinib as compared to 1% (5/432) of patients receiving placebo developed cuSCC.
Danish: 1 % (6/435) af de patienter, der fik dabrafenib i kombination med trametinib, sammenlignet med 1 % (5/432) af de patienter, der fik placebo, udviklede cuSCC i fase III-studiet BRF115532 (COMBI-AD) med den adjuverende behandling af melanom.
English: Overall survival estimate, % (95% CI)
Danish: Estimater for samlet overlevelse, % (95% CI)
English: Overall response,% (95% CI)
Danish: Samlet respons, % (95 % CI)
English: Effect of dabrafenib on other medicinal products
Danish: Dabrafenibs virkning på andre lægemidler
English: Renal failure Nephritis
Danish: Nyresvigt Nefritis
English: In the Phase II and III clinical trials, screening for eligibility required central testing for BRAF V600 mutation using a BRAF mutation assay conducted on the most recent tumour sample available.
Danish: Før behandling med dabrafenib eller kombinationen med trametinib startes, skal patienterne have konstateret en BRAF V600-mutation i tumor ved hjælp af en valideret test. I de kliniske fase II- og fase III-studier var der i screeningen for egnethed påkrævet en central test for BRAF V600-mutation ved brug af en BRAF-mutationsanalyse udført på den nyeste tilgængelige tumorprøve.
English: Overall intracranial response rate,% (95% CI)
Danish: Samlet rate for intrakraniel respons, % (95 % CI)
English: Tafinlar 50 mg hard capsules
Danish: Tafinlar 50 mg, hård kapsel
English: No dose modification of trametinib is required when taken in combination with dabrafenib (see section 4.4).
Danish: Justering af trametinib-dosis er ikke nødvendig, når det tages i kombination med dabrafenib (se pkt.
English: When dabrafenib is used alone and in combination with trametinib, therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5
Danish: Når dabrafenib anvendes alene eller i kombination med trametinib, og patientens temperatur er oC, skal behandlingen med dabrafenib afbrydes (se tabel 2 for vejledning i dosisjustering).
English: Tafinlar 75 mg hard capsules
Danish: Tafinlar 75 mg, hård kapsel
English: Discuss with your doctor, pharmacist or nurse if you are unsure about anything.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, primidone, valproic acid or carbamazepine
Danish: • lægemidler til behandling af krampeanfald (epilepsi), fx phenytoin, phenobarbital, primidon,
English: No data are available in subjects with severe renal impairment (see section 4.2).
Danish: Der er ingen tilgængelige data om patienter med svært nedsat nyrefunktion (se pkt.
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking dabrafenib in combination with trametinib.
Danish: Der er forekommet blødningshændelser, herunder alvorlige blødningshændelser og blødning med dødeligt udfald, hos patienter, der har taget dabrafenib i kombination med trametinib.
English: Tafinlar 75 mg capsules dabrafenib
Danish: Tafinlar 75 mg kapsler dabrafenib
English: Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction If dabrafenib is being used in combination with trametinib and absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN), please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Danish: 4.2), hvis dabrafenib anvendes i kombination med trametinib, og der optræder et absolut fald på > 10 % i LVEF sammenlignet med baseline, og uddrivningsfraktionen i henhold til retningslinjerne ligger under den nedre normalgrænse.
English: Progression-free survival, median, months (95% CI)
Danish: Progressionsfri overlevelse, median, måneder (95 % CI)
English: • Cohort D: patients with BRAFV600D/E/K/R mutant melanoma with symptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1 or 2.
Danish: • Kohorte D: patienter med BRAF V600D/E/K/R-muteret melanom med symptomatiske hjernemetastaser med eller uden tidligere lokal behandling rettet mod hjernen og ECOG performance status på 0, 1 eller 2.
English: Retinal vein occlusion (RVO) and Retinal pigment epithelial detachment (RPED) If patients report new visual disturbances such as diminished central vision, blurred vision, or loss of vision at any time while on combination therapy with dabrafenib and trametinib, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Danish: 4.2), hvis patienter rapporterer nye synsforstyrrelser, som fx nedsat centralsyn, sløret syn eller synstab på noget tidspunkt under kombinationsbehandling med dabrafenib og trametinib.
English: Tafinlar 50 mg capsules dabrafenib
Danish: Tafinlar 50 mg kapsler dabrafenib
English: When dabrafenib is used in combination with trametinib refer to the guidance for medicinal product interactions found in sections 4.4 and 4.5 of dabrafenib and trametinib SmPC.
Danish: 4.4 og 4.5 i produktresuméet for dabrafenib og trametinib.
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a
Danish: Forhøjet gamma-glutamyltransferase
English: Intracranial response rate, % (95 % CI)
Danish: Intrakraniel responsrate, % (95 % CI)
English: Continue treatment and monitor as clinically indicated.
Danish: Monitorer i forhold til hvad der er klinisk indiceret.
English: Urinary tract infection Cellulitis
Danish: Urinvejsinfektion Cellulitis Folliculitis Paronykie Pustuløst udslæt
English: No dose modification of trametinib is required when taken in combination with dabrafenib following diagnosis of uveitis.
Danish: Justering af trametinib-dosis er ikke nødvendig, når det tages i kombination med dabrafenib ved diagnosen uveitis.
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules dabrafenib
Danish: Tafinlar 50 mg, hårde kapsler Tafinlar 75 mg, hårde kapsler dabrafenib
English: Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib.
Danish: Hver hård kapsel indeholder dabrafenibmesilat svarende til 75 mg dabrafenib.
English: Haemorrhage
Danish: Kulderystelser
English: Cases of cuSCC (including keratoacanthoma) have been reported in patients treated with dabrafenib alone and in combination with trametinib (see section 4.8).
Danish: keratoakantom) hos patienter, som blev behandlet med dabrafenib alene eller i kombination med trametinib (se pkt.
English: Fever has been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib (see section 4.8).
Danish: Feber er rapporteret i kliniske studier med dabrafenib som monoterapi og i kombination med trametinib (se pkt.
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib.
Danish: Hver hård kapsel indeholder dabrafenibmesilat svarende til 50 mg dabrafenib.
English: If possible, show them the Tafinlar pack with this leaflet.
Danish: Vis Tafinlar-pakningen og denne indlægsseddel, hvis det er muligt.
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib.
Danish: Der er rapporteret leverpåvirkninger i kliniske studier med dabrafenib i kombination med trametinib.
English: In patients treated with dabrafenib in combination with trametinib 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, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Danish: 4.2) vedrørende patienter, som behandles med dabrafenib i kombination med trametinib, og som afventer kliniske undersøgelser for formodet ILD eller pneumonitis, herunder patienter med nye eller tiltagende symptomer og tegn fra lungerne, inkl.
English: If you take more Tafinlar than you should
Danish: Hvis du har taget for meget Tafinlar
English: Please refer to the trametinib SmPC (see section 4.4).
Danish: Der henvises til trametinib produktresuméet (se pkt.
English: Most subjects were Caucasian (>96%) and male (55%), with a median age of 55 years (24% were ≥65 years).
Danish: De fleste forsøgsdeltagere var kaukasere (> 96 %) og mænd (55 %).
English: BRF113710 (BREAK-2) was a multicentre, single-arm study that enrolled 92 subjects with metastatic melanoma (Stage IV) with confirmed BRAF V600E or V600K mutation-positive melanoma.
Danish: Patienter, der ikke tidligere var blevet behandlet, eller som havde manglende effekt af mindst en tidligere systemisk behandling (resultater fra fase II-studiet [BREAK-2]) BRF113710 (BREAK-2) var et multicenterstudie med en arm, hvor der var inkluderet 92 patienter med metastatisk melanom (stadium IV) med bekræftet BRAF V600E- eller V600K-mutationspositivt melanom.
English: New primary melanoma
Danish: Nyt primært melanom
English: What Tafinlar is and what it is used for What you need to know before you take Tafinlar How to take Tafinlar
Danish: Det skal du vide, før du begynder at tage Tafinlar Sådan skal du tage Tafinlar Bivirkninger
English: Median OS Months (95% CI)
Danish: Median OS måneder (95 % CI)
English: • Cohort A: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Danish: • Kohorte A: patienter med BRAF V600E-muteret melanom med asymptomatiske hjernemetastaser uden tidligere lokal behandling rettet mod hjernen og ECOG performance status på 0 eller 1.
English: Updated analysis (data cut-off: 12-Jan-2015)
Danish: Opdateret analyse (skæringsdato for dataindsamling: 12-jan
English: • Cohort C: patients with BRAFV600D/K/R mutant melanoma with asymptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Danish: • Kohorte C: patienter med BRAF V600D/K/R-muteret melanom med asymptomatiske hjernemetastaser med eller uden tidligere lokal behandling rettet mod hjernen og ECOG performance status på 0 eller 1.
English: Haemorrhagic events, including major haemorrhagic and fatal haemorrhages, have occurred in patients taking the combination of dabrafenib with trametinib (see section 4.8).
Danish: Blødningshændelser, herunder alvorlige blødningshændelser og blødning med dødeligt udfald, er forekommet hos patienter, der tog dabrafenib i kombination med trametinib (se pkt.
English: 5-year OS analysis (data cut-off: 08-Oct-2018)
Danish: 5-års analyse (skæringsdato for dataindsamling: 8-okt-2018)
English: • Rash, dry skin, itching, skin reddening
Danish: • udslæt, tør hud, kløe, hudrødme
English: Tafinlar 50 mg hard capsules dabrafenib
Danish: Tafinlar 50 mg hårde kapsler dabrafenib
English: Dabrafenib in combination with trametinib has been reported to decrease LVEF (see section 4.8).
Danish: Det er rapporteret, at trametinib i kombination med dabrafenib har medført reduceret LVEF (se pkt.
English: Cutaneous squamous cell carcinoma
Danish: Kutant planocellulært karcinom
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib (see section 4.8).
Danish: Der er rapporteret leverpåvirkninger i kliniske studier med dabrafenib i kombination med trametinib (se pkt.
English: Vision blurred Visual impairment Uveitis
Danish: Korioretinopati Nethindeløsning Periorbitalt ødem
English: Please refer to the trametinib SmPC.
Danish: Se produktresumeet for trametinib.
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules
Danish: Tafinlar 50 mg, kapsel, hård Tafinlar 75 mg, kapsel, hård
English: • feeling lightheaded
Danish: • følelse af ørhed
English: For additional information on warnings and precautions associated with trametinib treatment, please refer to the trametinib SmPC.
Danish: Se produktresuméet for trametinib for yderligere oplysninger om advarsler og forholdsregler i forbindelse med trametinib-behandlingen.
English: *For dosing instructions for treatment with trametinib monotherapy, see trametinib SmPC, Posology and Method of administration.
Danish: *Se Dosering og administration i produktresuméet for trametinib for doseringsvejledning til behandling med trametinib-monoterapi.
English: Tafinlar 75 mg hard capsules dabrafenib
Danish: Tafinlar 75 mg hårde kapsler dabrafenib
English: • widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Danish: • antidepressiva, fx nefazodon og naturlægemidlet perikon (hypericum perforatum).
English: • Cohort B: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases with prior local brain-directed therapy and ECOG performance status of 0 or1.
Danish: • Kohorte B: patienter med BRAF V600E-muteret melanom med asymptomatiske hjernemetastaser med tidligere lokal behandling rettet mod hjernen og ECOG performance status på 0 eller 1.
English: Dry skin Pruritus
Danish: Tør hud