FrancophonIA/ELRC3.0 huggingface dataset:
English: Pancreatitis Colitis
Danish: Pankreatit Colitis
English: Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Danish: En gynækologisk undersøgelse (for kvinder) og en rektal undersøgelse anbefales også før behandlingsstart og ved behandlingens afslutning.
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring is recommended when dabrafenib is used concomitantly with warfarin and at discontinuation of dabrafenib (see section 4.5).
Danish: Der bør udvises forsigtighed, og intensiveret INR (international normaliseret ratio)-monitorering anbefales, når dabrafenib bruges samtidigt med warfarin samt ved seponering af dabrafenib (se pkt.
English: Do not take Tafinlar after the expiry date (EXP) which is stated on the bottle label and the carton.
Danish: Brug ikke Tafinlar efter den udløbsdato, der står på beholderens etiket og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Non-cutaneous malignancies were reported in 1% (6/586) of patients in the integrated safety population of dabrafenib monotherapy, and <1% (8/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Danish: Ikke-kutane maligniteter blev rapporteret hos 1 % (6/586) af patienterne i den integrerede sikkerhedspopulation med dabrafenib-monoterapi og hos < 1 % (8/1076) af patienterne i den integrerede sikkerhedspopulation med dabrafenib i kombination med trametinib.
English: A population pharmacokinetic analysis suggests that mild renal impairment does not affect oral clearance of dabrafenib.
Danish: En farmakokinetisk populationsanalyse tyder på, at let nedsat nyrefunktion ikke påvirker clearance af oralt dabrafenib.
English: d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing NR = Not reached
Danish: investigators vurdering) b - Samlet responsrate = samlet respons + partiel respons c - Responsvarighed d - På rapporteringstidspunktet var størstedelen af responserne (investigatorvurderede) stadig bestående (59 % af dabrafenib+trametinib og 42% af vemurafenib)
English: • Hypnotics (e.g. diazepam, midazolam, zolpidem)
Danish: • Hypnotika (fx diazepam, midazolam, zolpidem)
English: • High blood pressure (hypertension)
Danish: • forhøjet blodtryk (hypertension)
English: If fever is associated with other severe signs or symptoms, dabrafenib should be restarted at a reduced dose once fever resolves and as clinically appropriate (see section 4.2).
Danish: Hvis feberen er forbundet med andre svære tegn eller symptomer, bør behandlingen med dabrafenib genoptages med en reduceret dosis og efter klinisk behov, når feberen er ophørt (se pkt.
English: Only subjects with BRAF V600E or V600K mutation positive tumours were eligible for study participation.
Danish: Kun patienter med tumorer med BRAF V600E- eller V600K-mutationer var egnede til forsøgsdeltagelse.
English: The trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination demonstrated limited clinical activity in patients who had progressed on a BRAF inhibitor.
Danish: Kombinationen med 2 mg trametinib en gang daglig og 150 mg dabrafenib to gange dagligt viste begrænset klinisk aktivitet hos patienter, der var progredieret på en BRAF-hæmmer.
English: Pancreatitis has been reported in <1% of patients treated with dabrafenib as monotherapy and in combination with trametinib in unresectable or metastatic melanoma clinical trials and about 4% of patients treated with dabrafenib in combination with trametinib in the NSCLC clinical trial.
Danish: Der er rapporteret pankreatitis hos < 1 % af de patienter, der blev behandlet med dabrafenib som monoterapi og i kombination med trametinib i kliniske forsøg med inoperabelt eller metastatisk melanom, og hos ca. 4 % af de patienter, der blev behandlet med dabrafenib i kombination med trametinib det i kliniske forsøg med NSCLC.
English: Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib.
Danish: Induktionen synes at starte efter 3 dages gentagen dosering med dabrafenib.
English: Other medicines and Tafinlar
Danish: Brug af anden medicin sammen med Tafinlar
English: Table 3 Adverse reactions reported in the integrated safety population of dabrafenib monotherapy in the studies BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680 (n=578)
Danish: Tabel 3 Bivirkninger rapporteret i den integrerede sikkerhedspopulation med dabrafenib monoterapi i studierne BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220 og BRF112680 (n = 578)
English: Hepatic effects, including hepatocellular necrosis and inflammation, were observed in mice (≥0.6 times clinical exposure).
Danish: Hos mus blev observeret hepatiske effekter, herunder hepatocellulær nekrose og inflammation (ved ≥ 0,6 gange den kliniske eksponering).
English: • Inflammation of the intestines (colitis)
Danish: • inflammation i tarmene (colitis)
English: Dose adjustment for dabrafenib below 50 mg twice daily is not recommended, whether used as monotherapy or in combination with trametinib.
Danish: Justering af dabrafenib-dosis til en dosis lavere end 50 mg to gange dagligt anbefales ikke, hvad enten det anvendes som monoterapi eller i kombination med trametinib.
English: For the primary endpoint of investigator-assessed ORR, the ORR in the first line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously treated population was 66.7% (95% CI, 52.9%, 78.6%).
Danish: Det primære endepunkt, investigatorvurderet ORR, var for førstelinjepopulationen 61,1 % (95 % CI, 43,5 %; 76,9 %) og 66,7 % (95 % CI, 52,9 %; 78,6 %) for den behandlingserfarne population.
English: Use caution if strong inhibitors (e.g. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) are co-administered with dabrafenib.
Danish: Udvis forsigtighed ved samtidig administration af kraftige hæmmere (fx ketoconazol, gemfibrozil, nefazodon, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazol, voriconazol, posaconazol, atazanavir) og dabrafenib.
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III trials and one supportive Phase I/II study.
Danish: Effekten og sikkerheden af den anbefalede dosis af trametinib (2 mg en gang daglig) i kombination med dabrafenib (150 mg to gange dagligt) til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation blev undersøgt i to fase III-forsøg og et understøttende fase I/II-studie.
English: If dabrafenib is being used in combination with trametinib then therapy with dabrafenib may be continued at the same dose.
Danish: Hvis dabrafenib tages i kombination med trametinib, kan behandlingen med dabrafenib fortsættes med samme dosis.
English: This results in reduced plasma levels of medicinal products metabolised by these enzymes, and may affect some transported medicinal products.
Danish: Dette resulterer i reducerede plasmaniveauer af lægemidler, der elimineres via metabolisering, såvel som for nogle lægemidler, der elimineres via transport.
English: Duration of response, median, months (95% CI) N=28 5.1 (3.7, NR)
Danish: Median responsvarighed, måneder (95 % CI) N = 28 5,1 (3,7; NR)
English: Following co-administration of a single dose of rosuvastatin (OATP1B1, OATP1B3 and BCRP substrate) with repeat-dose dabrafenib 150 mg twice daily in 16 patients, Cmax of rosuvastatin increased 2.6-fold whereas the AUC was only minimally changed (7% increase).
Danish: Ved samtidig administration af en enkelt dosis rosuvastatin (OATP1B1-, OATP1B3- og BCRP-substrat) og gentagen dosis af dabrafenib 150 mg to gange daglig hos 16 patienter, steg Cmax af rosuvastatin 2,6 gange, hvorimod AUC kun blev ændret minimalt (7 % stigning).
English: Cutaneous squamous cell carcinoma (cu SCC): SCC, SCC of the skin, SCC in situ (Bowen's disease) and keratoacanthoma c
Danish: Kutant pladecellecarcinom (cuSCC): pladecellekarcinom, pladecellekarcinom på huden, pladecellekarcinom in situ (Bowens sygdom) og keratoakantom c
English: • Increase in blood sugar level
Danish: • højt blodsukker
English: nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles, skin rash with pus-filled blisters, cutaneous squamous cell carcinoma (a type of skin cancer),
Danish: negleforandringer, såsom forandringer i neglelejet, neglesmerter, betændte og hævede neglebånd, hududslæt med pusfyldte blærer, kutant pladecellekarcinom (en form for hudkræft),
English: • Allergic reaction (hypersensitivity)
Danish: • allergisk reaktion (overfølsomhed)
English: • Low levels of sodium (hyponatraemia) or phosphate (hypophosphataemia) in the blood
Danish: • lavt indhold af natrium (hyponatriæmi) eller fosfat (hypofosfatæmi) i blodet
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis.
Danish: Patienterne skal monitores tæt, når behandlingen med dabrafenib genoptages efter en episode med pankreatitis.
English: Before initiating treatment, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Patienter skal rådgives om tegn og symptomer før behandling initieres og monitoreres tæt for hudreaktioner.
English: In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥0.2 times adult human clinical exposure based on AUC).
Danish: I toksicitetsstudier hos unge rotter blev der observeret effekter på væksten (kortere knoglelængde), renal toksicitet (aflejringer i tubuli, øget incidens af kortikale cyster og tubulær basofili og reversible stigninger i urinstof- og/eller kreatininkoncentrationen) og testikeltoksicitet (degeneration og udvidelse af tubuli) (≥ 0,2 gange den kliniske eksponering hos vokne mennesker, baseret på AUC).
English: Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 substrates.
Danish: Dabrafenib er et substrat for de metaboliserende enzymer CYP2C8 og CYP3A4, mens de aktive metabolitter hydroxydabrafenib og desmethyldabrafenib er CYP3A4-substrater.
English: Caution should be used in this setting (see section 4.4).
Danish: Der skal udvises forsigtighed under sådanne omstændigheder (se pkt.
English: The response was durable with median DoR in the previously treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Danish: Der blev opnået et varigt respons med median investigatorvurderet DoR i den behandlingserfarne population på 9,8 måneder (95 % CI, 6,9; 16,0).
English: Patients with melanoma driven by BRAF mutations other than V600E were excluded.
Danish: Patienter med melanom med andre BRAF-mutationer end V600E var ekskluderet.
English: No data are available in patients with moderate to severe hepatic impairment.
Danish: Der er ingen tilgængelige data om patienter med moderat til svært nedsat leverfunktion.
English: • reddish patches on the trunk that are circular or target-shaped, with central blisters.
Danish: • rødlige pletter på kroppen, der er cirkulære eller skydeskiveformet med centrale blærer.
English: Cut-off date
Danish: UDLØBSDATO
English: After an oral dose, the major route of elimination of dabrafenib is metabolism, mediated via CYP3A4 and CYP2C8.
Danish: Efter en oral dosis elimineres dabrafenib primært via metabolisering, medieret via CYP3A4 og CYP2C8.
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesi-syndrom
English: The IUO is an allele-specific polymerase chain reaction (PCR) assay performed on DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumour tissue.
Danish: IUO-analysen er en allel-specifik polymerasekædereaktion (PCR)-analyse udført på DNA ekstraheret fra formalinfikseret, paraffinindstøbt (FFPE) tumorvæv.
English: Developmental toxicity including embryo-lethality and ventricular septal defects and variation in thymic shape were seen at 300 mg/kg/day, and delayed skeletal development and reduced foetal body weight at ≥20 mg/kg/day (≥0.5 times human clinical exposure based on AUC).
Danish: Der blev set udviklingstoksicitet, herunder embryoletalitet og ventrikelseptumdefekter og variation i formen af thymus, ved 300 mg/kg/dag samt forsinket udvikling af skelettet og nedsat fostervægt ved ≥ 20 mg/kg/dag (≥ 0,5 gange den kliniske eksponering hos mennesker baseret på AUC).
English: The onset of these serious non-infectious febrile events was typically within the first month of dabrafenib as monotherapy.
Danish: Disse alvorlige tilfælde af ikke-infektiøs feber indtraf typisk inden for den første måneds behandling med dabrafenib som monoterapi.
English: Primary analysis (Data cut-off: 17Apr-2014)
Danish: Primær analyse (skæringsdato for dataindsamling: 17-apr-2014)
English: Trametinib when given in combination with Tafinlar should be taken with either the morning dose of Tafinlar or the evening dose of Tafinlar.
Danish: Når trametinib anvendes i kombination med Tafinlar, skal trametinib enten tages sammen med morgendosen af Tafinlar eller aftendosen af Tafinlar.
English: The other side effects that you may see when you take Tafinlar alone are as follows:
Danish: Andre bivirkninger, som du kan få, når du tager Tafinlar alene:
English: • Reddening and swelling of the palms, fingers and soles of the feet (see “Changes in your skin”
Danish: • røde og hævede håndflader, fingre og fodsåler (se ”Forandringer i huden” tidligere i punkt 4)
English: Figure 2 Kaplan-Meier overall survival curves for Study MEK116513
Danish: Figur 2 Kaplan-Meier-kurver over samlet overlevelse i studiet MEK116513
English: The investigator-assessed confirmed response rate was 15% (95% CI: 4.4, 34.9) and the median PFS was 3.6 months (95% CI: 1.9, 5.2).
Danish: Den investigatorvurderede bekræftede responsrate var 15 % (95 % CI: 4,4; 34,9), og den mediane PFS var 3,6 måneder (95 % CI: 1,9; 5,2).
English: Please refer to trametinib SmPC for information on method of administration when given in combination with dabrafenib.
Danish: Se produktresuméet for trametinib for yderligere oplysninger om administration, når det gives i kombination med dabrafenib.
English: Duration of intracranial response, median, months (95% CI) N=29 4.6 (2.8, NR)
Danish: Median varighed af intrakraniel respons, måneder (95 % CI) N = 29 4,6 (2,8; NR)
English: Patients were randomised 1:1 to receive either combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily) or two placebos for a period of 12 months.
Danish: Patienterne blev randomiseret 1:1 til enten kombinationsbehandling (dabrafenib 150 mg to gange dagligt og trametinib 2 mg én gang dagligt) eller til to placebo-behandlinger i en periode på 12 måneder.
English: Dabrafenib in combination with trametinib in patients with melanoma who have progressed on a BRAF inhibitor
Danish: Dabrafenib i kombination med trametinib hos patienter med melanom, som har progredieret på en BRAF-hæmmmer
English: Two dabrafenib capsule strengths, 50 mg and 75 mg, are available to effectively manage dose modification requirements.
Danish: Dosisjustering Dabrafenib kapsler fås i to styrker, 50 mg og 75 mg, således at dosisjustering effektivt kan håndteres.
English: Hypertension Haemorrhage f
Danish: Hypertension Blødning f
English: Check your skin regularly whilst taking Tafinlar If you notice any of the following:
Danish: Undersøg regelmæssigt din hud, mens du tager Tafinlar.
English: All patients receiving dabrafenib as monotherapy or in combination with trametinib who developed cuSCC continued on treatment without dose modification.
Danish: Alle patienter, der fik dabrafenib-monoterapi eller kombinationsterapi med trametinib, som udviklede cuSCC, fortsatte behandlingen uden dosisjustering.
English: Hyperkeratosis
Danish: Hyperkeratose
English: In subjects with BRAF V600 mutation positive melanoma, administration of dabrafenib resulted in inhibition of tumour phosphorylated ERK relative to baseline.
Danish: Hos patienter med BRAF V600-mutationspositivt melanom resulterede administration af dabrafenib i hæmning af fosforyleret tumor-ERK i forhold til baseline.
English: • Analgesics (e.g. fentanyl, methadone)
Danish: • Analgetika (fx fentanyl, methadon)
English: Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.
Danish: Dabrafenib hæmmer den downstream farmakodynamiske biomarkør (fosforyleret ERK) i BRAF V600-muterede melanomcellelinjer in vitro og i dyremodeller.
English: Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see section 4.4).
Danish: Dosisjusteringer eller pausering anbefales ikke ved bivirkninger i form af kutant planocellulært karcinom (cuSCC) eller nyt primært melanom (se pkt.
English: Desmethyl-dabrafenib is metabolised by CYP3A4 to oxidative metabolites.
Danish: Desmethyldabrafenib metaboliseres via CYP3A4 til oxiderende metabolitter.
English: • medicines to treat cancer, such as cabazitaxel
Danish: • lægemidler til at behandle kræft, fx cabazitaxel
English: Data cut-off: 8
Danish: data cut-off: 8. august 2016
English: Dermatitis acneiform Actinic keratosis
Danish: Akneiform dermatitis Aktinisk keratose
English: The recommended dose of trametinib, when used in combination with dabrafenib, is 2 mg once daily.
Danish: Den anbefalede dosis af trametinib, når det anvendes i kombination med dabrafenib, er 2 mg en gang dagligt.
English: There are limited data in patients taking the combination of dabrafenib with trametinib who have progressed on a prior BRAF inhibitor.
Danish: Der foreligger begrænsede data for patienter, der tager kombinationen af dabrafenib og trametinib, som har progredieret på en tidligere behandling med en BRAF-hæmmer.
English: • Fever
Danish: • feber
English: The usual dose of Tafinlar either used alone or in combination with trametinib is two 75 mg capsules twice a day (corresponding to a daily dose of 300 mg).
Danish: Den sædvanlige dosis af Tafinlar, enten anvendt alene eller i kombination med trametinib, er to 75 mg kapsler to gange dagligt (svarende til 300 mg dagligt).
English: Dabrafenib is a substrate of CYP2C8 and CYP3A4.
Danish: Dabrafenib er et substrat for CYP2C8 og CYP3A4.
English: Renal failure, acute renal failure Nephritis
Danish: Nyresvigt, akut nyresvigt Nefritis
English: Caution should be exercised and additional monitoring of digoxin is recommended when digoxin (a transporter substrate) is used concomitantly with dabrafenib and at discontinuation of dabrafenib (see section 4.5).
Danish: Der bør udvises forsigtighed og det anbefales, at digoxin (et transporter-substrat) monitoreres yderligere, når det administreres sammen med dabrafenib og ved seponering af dabrafenib (se pkt.
English: Patients with melanoma driven by BRAF mutations other than V600E were excluded from the confirmatory trial and with respect to patients with the V600K mutation in single arm clinical trials the activity appears lower than in V600E tumours.
Danish: Patienter, med melanom drevet af BRAF-mutationer andre end V600E, var ekskluderet fra registrerings-studiet og i det kliniske single arm-forsøg ser effekten ud til at være lavere hos patienter med tumorer med V600K-mutation end V600E-mutation.
English: • eye redness and irritation
Danish: • røde eller irriterede øjne
English: Talk to your doctor if you get a skin rash while taking Tafinlar in combination with trametinib.
Danish: Tal med lægen, hvis du får udslæt, mens du tager Tafinlar i kombination med trametinib.
English: The study included patients with all sub-stages of Stage III disease prior to resection; 18% of these patients had lymph node involvement only identifiable by microscope and no primary tumour ulceration.
Danish: 18 % af disse patienter havde involvering af lymfeknuder, der kun var identificérbare i mikroskop og ingen ulceration af primærtumor.
English: Tafinlar can cause eye problems when taken in combination with trametinib.
Danish: Tafinlar kan give øjenproblemer, når det tages i kombination med trametinib.
English: Cases of cuSCC should be managed by dermatological excision and dabrafenib treatment or, if taken in combination, dabrafenib and trametinib should be continued without any dose adjustment.
Danish: CuSCC bør behandles med ekscision og behandlingen med dabrafenib eller kombinationsbehandlingen med dabrafenib og trametinib fortsættes uden dosisjustering.
English: In 1% of patients receiving dabrafenib as monotherapy in the integrated safety population, serious non-infectious febrile events were identified as fever accompanied by severe rigors, dehydration, hypotension and/or acute renal insufficiency or pre-renal origin in subjects with normal baseline renal function.
Danish: Hos 1 % af patienterne, der fik dabrafenib som monoterapi i den integrerede sikkerhedspopulation, blev der identificeret alvorlige tilfælde af ikke-infektiøs feber som feber ledsaget af svære kulderystelser, dehydrering, hypotension og/eller akut nyreinsufficiens af prærenal oprindelse hos patienter med normal nyrefunktion ved baseline.
English: Due to small sample size reflected by wide 95% CIs, the results in Cohorts B, C, and D should be interpreted with caution.
Danish: De sekundære endepunkter i studiet var intrakranielt respons vurderet af investigator i kohorte B, C og D. Pga. en lille populationsstørrelse, afspejlet ved et bredt 95 % konfidensinterval, bør resultaterne for kohorte B, C og D fortolkes med forsigtighed.
English: Dabrafenib in combination with trametinib in patients with brain metastases
Danish: Dabrafenib i kombination med trametinib hos patienter med hjernemetastaser
English: Improvements for the primary endpoint of PFS were sustained over a 5 year timeframe in the combination arm compared to dabrafenib monotherapy.
Danish: Forbedringeri det primære endepunkt PFS blev opretholdt i en tidsramme på 5 år i kombinationsarmen, sammenlignet med dabrafenib monoterapi.
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Danish: • Antibiotika (fx clarithromycin, doxycyclin)
English: A small decrease in trametinib bioavailability, corresponding to a decrease in AUC of 12%, was estimated when trametinib is administered in combination with dabrafenib, a CYP3A4 inducer, using a population pharmacokinetic analysis.
Danish: Ved en populationsfarmakokinetisk analyse blev der estimeret et lille fald i trametinibs biotilgængelighed, svarende til et fald i AUC på 12 %, når trametinib administreres i kombination med dabrafenib, en CYP3A4-inducer.
English: The metabolism of dabrafenib is primarily mediated by CYP2C8 and CYP3A4 to form hydroxy-dabrafenib, which is further oxidised via CYP3A4 to form carboxy-dabrafenib.
Danish: Metaboliseringen af dabrafenib medieres primært via CYP2C8 og CYP3A4, så der dannes hydroxydabrafenib, som yderligere oxideres via CYP3A4, så der dannes carboxydabrafenib.
English: Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
Danish: Inden patienten opstarter dabrafenib, skal BRAF V600-mutation i tumor være bekræftet ved anvendelse af en valideret test.