FrancophonIA/ELRC3.0 huggingface dataset:
English: Pierre Fabre Médicament 45, place Abel Gance 92100 Boulogne-Billancourt France
Danish: Pierre Fabre Médicament 45, place Abel Gance 92100 Boulogne-Billancourt Frankrig
English: The safety and efficacy of encorafenib have not yet been established in children and adolescents.
Danish: Encorafenibs sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: 1st dose reduction 300 mg once daily 2nd dose reduction 200 mg once daily Subsequent modification
Danish: 1. dosisreduktion 300 mg én gang dagligt 2. dosisreduktion 200 mg én gang dagligt
English: Gastrointestinal disorders
Danish: Gastrointestinale forstyrrelser
English: • Recurrent or intolerable Grade 2 adverse reactions
Danish: • Tilbagevendende eller intolerable bivirkninger af grad 2
English: Encorafenib should be withheld, supportive measures such as topical therapy should be instituted, and the patient should be reassessed weekly.
Danish: Encorafenib skal pauseres og understøttende tiltag såsom topikal behandling iværksættes, og patienten skal revurderes hver uge.
English: Dermatitis acneiform* PPES
Danish: Akneiform dermatitis* PPES
English: Randomisation was stratified by American Joint Committee on Cancer (AJCC) Stage (IIIB, IIIC, IVM1a or IVM1b, vs IVM1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) and prior immunotherapy for unresectable or metastatic disease (yes vs no).
Danish: Randomiseringen blev stratificeret efter AJJC-stadierne fra American Joint Committee on Cancer (IIIB, IIIC, IVM1a eller IVM1b vs. IVM1c) og ECOG-performancestatusserne fra Eastern Cooperative Oncology Group (0 vs. 1) og forudgående immunterapi for inoperabel eller metastatisk sygdom (ja vs. nej).
English: A small decrease in CL/F (≤5%) was predicted for patients with mild and moderate renal impairment, which is unlikely to be clinically relevant.
Danish: Der blev beregnet en lille stigning i CL/F (≥ 5 %) hos patienter med let og moderat nedsat nyrefunktion, som sandsynligvis er uden klinisk relevans.
English: Probability of Overall Survival (%)
Danish: Sandsynlighed for samlet overlevelse (%)
English: Braftovi can affect your ability to drive or use machines.
Danish: Braftovi kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Effects of other medicinal products on encorafenib Encorafenib is primarily metabolised by CYP3A4.
Danish: Andre lægemidlers indvirkning på encorafenib Encorafenib metaboliseres primært af CYP3A4.
English: It should be considered to permanently discontinue encorafenib in patients who develop RAS mutation-positive non-cutaneous malignancies.
Danish: Det bør overvejes at seponere encorafenib permanent hos patienter, der udvikler RAS-mutationspositive ikke-kutane maligniteter.
English: The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with Enco 300 and 6.2 months in patients treated with vemurafenib.
Danish: Medianvarigheden af eksponering var 11,7 måneder hos de patienter, der blev behandlet med Combo 450, 7,1 måneder hos de patienter, der blev behandlet med Enco 300, og 6,2 måneder hos de patienter, der blev behandlet med vemurafenib.
English: Updated analysis, cut-off date: 07 November 2017 PFS
Danish: Opdateret analyse, skæringsdato: 7. november 2017
English: Serious side effects Braftovi may cause serious side effects.
Danish: Alvorlige bivirkninger Braftovi kan forårsage alvorlige bivirkninger.
English: Cutaneous reactions • Grade 2
Danish: Kutane reaktioner • Grad 2
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE46
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE46
English: Probability of Progression Free Survival(%)
Danish: Sandsynlighed for progressionsfri overlevelse (%)
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Encorafenib was found to be a substrate of the P-glycoprotein (P-gp) transporters.
Danish: Encorafenib er et substrat for P-glykoprotein (P-gp).
English: The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC).
Danish: Det primære effektmål var progressionsfri overlevelse (PFS) med Combo 450 sammenlignet med vemurafenib og blev vurderet af en blindet, uafhængig komité (BIRC).
English: The length of the capsule is approximately 22 mm.
Danish: Kapslen er cirka 22 mm lang.
English: At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients.
Danish: Ved encorafenib-doser mellem 600 og 800 mg én gang dagligt blev der observeret renal dysfunktion (hyperkreatinæmi af grad 3) hos 3 ud af 14 patienter.
English: Neoplasms benign, malignant and unspecified
Danish: Benigne, maligne og uspecificerede tumorer
English: Common cuSCC a New Primary Melanoma*
Danish: Almindelig cuSCCa Nyt primært melanom cuSCCa
English: The median age of patients was 56 years (range 20-89), 58% were male, 90% were Caucasian, and 72% of patients had baseline ECOG performance status of 0.
Danish: Patienternes medianalder var 56 år (interval 20-89), 58 % var mænd, 90 % var kaukasiere, og 72 % af patienterne havde ECOG-performancestatus 0 ved baseline.
English: Each pack contains either 42 or 168 hard capsules.
Danish: Hver pakning indeholder enten 42 eller 168 hårde kapsler.
English: Adverse reactions reported by this patient were Grade 1 events of nausea, vomiting and blurred vision; all subsequently resolved.
Danish: De bivirkninger, som denne patient indberettede, var hændelser af grad 1 i form af kvalme, opkastning og sløret syn, som alle aftog efterfølgende.
English: If a dose of encorafenib is missed, the patient should only take the missed dose if it is more than 12 hours until the next scheduled dose.
Danish: Hvis patienten glemmer en dosis af encorafenib, skal patienten kun tage den glemte dosis, hvis der er mere end 12 timer til næste planlagt dosis.
English: 28 hard capsules 112 hard capsules
Danish: 28 hårde kapsler 112 hårde kapsler
English: A decision must be made whether to discontinue breast-feeding or to discontinue encorafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Danish: Det skal besluttes, om amning eller behandling med encorafenib skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The highest administered dose occurred as a dosing error in one patient who took encorafenib at a dose of 600 mg twice daily for 1 day (total dose 1200 mg).
Danish: Den højeste dosis, der blev administreret, blev indtaget som følge af en doseringsfejl, hvor en patient tog encorafenib i en dosis på 600 mg to gange dagligt i 1 dag (total dosis 1200 mg).
English: An analysis of time to definitive 10% deterioration in EORTC QLQ-C30 score provided with similar results.
Danish: En analyse af tiden til definitiv 10 % forværring i EORTC QLQ-C30-scoren viste lignende resultater.
English: Encorafenib does not inhibit RAF/MEK/ERK signalling in cells expressing wild-type BRAF.
Danish: Encorafenib hæmmer ikke RAF/MEK/ERK-signalering i celler, der udtrykker vildtype-BRAF.
English: a Hazard ratio based on a stratified Cox proportional hazard model b Log-rank p-value (2-sided)
Danish: a Hazard ratio baseret på Cox' stratificerede proportionelle risikomodel b P-værdi ved log-rank-test (to-sidet)
English: 42 hard capsules 168 hard capsules
Danish: 42 hårde kapsler 168 hårde kapsler
English: Usually, these skin changes (see also section 2) are confined to a small area and can be removed with surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Danish: Disse hudforandringer (se også afsnit 2) er som regel begrænset til et lille område og kan fjernes ved en operation, og behandlingen med Braftovi (og binimetinib) kan fortsætte uden afbrydelser.
English: For co-administration with CYP3A4 and UGT1A1 substrates that undergo gut extraction, a minor to moderate interaction is expected.
Danish: Ved samtidig administration af CYP3A4 og UGT1A1-substrater, som gennemgår tarmekstraktion, forventes der en mindre til moderat interaktion.
English: Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration.
Danish: De observerede tilfælde af nyresvigt, herunder akut nyreskade og nedsat nyrefunktion, var generelt forbundet med opkastning og dehydrering.
English: Dry skin*
Danish: Tør hud*
English: Ocular toxicities including uveitis, iritis and iridocyclitis can occur when encorafenib is administered.
Danish: Okulær toksicitet, herunder uveitis, iritis og iridocyclitis, kan forekomme ved administration af encorafenib.
English: This is because it could increase Braftovi side effects.
Danish: Det kan nemlig øge bivirkningerne ved Braftovi.
English: Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med encorafenib i kombination med binimetinib skal indledes og kontrolleres af en læge med erfaring i brug af lægemidler mod cancer.
English: Take the next dose as scheduled.
Danish: Tag den næste dosis på det sædvanlige tidspunkt.
English: Also tell your doctor if you have headache, dizziness or weakness.
Danish: Kontakt ligeledes lægen, hvis du har ondt i hovedet, føler dig svimmel eller svag.
English: The length of the capsule is approximately 23 mm.
Danish: Kapslen er cirka 23 mm lang.
English: Patients were permitted to receive prior adjuvant therapy and one prior line of immunotherapy for unresectable locally advanced or metastatic disease.
Danish: Forudgående adjuverende behandling og én forudgående linje af immunterapi for inoperabel lokalt fremskreden eller metastatisk sygdom var tilladt.
English: Most patients had metastatic disease (95%) and were Stage IVM1c (64%); 27% of patients had elevated baseline serum lactate dehydrogenase (LDH), and 45% of patients had at least 3 organs with tumour involvement at baseline and 3.5% had brain metastases.
Danish: De fleste patienter havde metastatisk sygdom (95 %) og var på stadie IVM1c (64 %); 27 % af patienterne havde forhøjet laktatdehydrogenase (LDH) i serum ved baseline, og 45 % af patienterne havde mindst 3 organer med tumorinvolvering ved baseline, og 3,5 % havde hjernemetastaser.
English: Braftovi is not recommended during pregnancy.
Danish: Braftovi bør ikke anvendes i graviditeten.
English: Benefits and risks should be carefully considered before administering encorafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Danish: Fordele og ulemper bør overvejes nøje inden administration af encorafenib hos patienter med tidligere eller samtidig cancer forbundet med RAS-mutation.
English: Polyamide/aluminum/PVC/aluminum blister containing 4 capsules.
Danish: Blister af polyamid/aluminium/PVC/aluminium indeholdende 4 kapsler.
English: Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient.
Danish: Fatal blødning fra mavesår, med multipelt organsvigt som samtidig dødsårsag, forekom hos én patient.
English: Alternative agents with no or minimal CYP3A induction potential should be considered.
Danish: Det bør overvejes at anvende andre stoffer med ingen eller minimal CYP3A-induktion.
English: Polyamide/aluminum/PVC/aluminum blister containing 6 capsules.
Danish: Blister af polyamid/aluminium/ PVC/aluminium indeholdende 6 kapsler.
English: In a population pharmacokinetic analysis, no clear trend in encorafenib CL/F was observed in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) or moderate (eGFR 30 to 59 mL/min/1.73 m2) renal impairment compared with subjects with normal renal function (eGFR ≥90 mL/min/1.73 m2).
Danish: I en populationsfarmakokinetisk analyse blev der ikke set nogen tydelige tendens i CL/F for encorafenib hos patienter med let (eGFR 60 til 90 ml/min/1,73 m2) eller moderat (eGFR 30 til 59 ml/min/1,73 m2) nedsat nyrefunktion i forhold til patienter med normal nyrefunktion (eGFR ≤90 ml/min/1,73 m2).
English: Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.
Danish: Eftersom encorafenib har moderat binding til plasmaproteiner er hæmodialyse sandsynligvis ineffektiv til behandling af overdosering af encorafenib.
English: In vitro, CYP3A4 was predicted to be the major enzyme contributing to total oxidative clearance of encorafenib in human liver microsomes (~83.3%), followed by CYP2C19 and CYP2D6 (~16.0% and 0.71%, respectively).
Danish: In vitro estimeredes CYP3A4 at være det vigtigste enzym for den totale oxidative clearance af encorafenib i humane levermikrosomer (~83,3 %), efterfulgt af CYP2C19 og CYP2D6 (henholdsvis ~16,0 % og 0,71 %).
English: Therefore, in these patients, binimetinib should be used with caution and for any symptomatic left ventricular dysfunction, Grade 3-4 LVEF or for absolute decrease of LVEF from baseline of ≥ 10%, binimetinib and encorafenib should be discontinued and LVEF should be evaluated every 2 weeks until recovery.
Danish: Hos sådanne patienter bør binimetinib derfor anvendes med forsigtighed, og i tilfælde af symptomatisk dysfunktion af venstre ventrikel, LVEF af grad 3-4 eller absolut fald i LVEF ≤ 10 % i forhold til baseline bør binimetinib og encorafenib seponeres, og LVEF vurderes hver 2. uge indtil normalisering.
English: Concomitant use with agents that are substrates of CYP3A4 (e.g., hormonal contraceptives) may result in increased toxicity or loss of efficacy of these agents.
Danish: Samtidig brug af stoffer, som er substrater for CYP3A4 (f.eks. hormonelle kontraceptiva) kan resultere i øget toksicitet eller nedsat virkning af disse stoffer.
English: Inhibition of P-gp is unlikely to result in a clinically important increase in encorafenib concentrations as encorafenib exhibits high intrinsic permeability.
Danish: Hæmning af P-gp vil sandsynligvis ikke resultere i kliniske betydelige fald i encorafenib-koncentrationen, eftersom encorafenib udviser høj intrinsisk permeabilitet.
English: The median duration of treatment was longer for Combo 300 vs Enco 300, 52.1 weeks vs 31.5 weeks.
Danish: Den mediane behandlingsvarighed var længere for Combo 300 vs. Enco 300, 52,1 uger vs. 31,5 uger.
English: Dilatation of the aortic arc was observed in some foetuses.
Danish: Der blev set dilatation af aortabuen hos nogle fostre.
English: If symptoms of new or worsening visual disturbances including diminished central vision, blurred vision or loss of vision are identified, a prompt ophthalmologic examination is recommended.
Danish: Hvis der konstateres symptomer på nye eller forværrede synsforstyrrelser, herunder nedsat centralsyn, sløret syn eller synstab, anbefales det, at patienten omgående får en oftalmologisk undersøgelse.
English: Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Danish: Del 2 af Studie CMEK162B2301 var designet med henblik på at vurdere binimetinibs bidrag i kombinationen af encorafenib og binimetinib.
English: Number of events (progressive disease) (%)
Danish: Antal hændelser (progressiv sygdom) (%)
English: This observation was similar to that described in humans as central serous-like chorioretinopathy or central serous retinopathy.
Danish: Dette fund var ensartet med det, der er beskrevet hos mennesker som central serøs-lignende korioretinopati eller central serøs retinopati.
English: Results from a dedicated clinical study indicate a 25% higher total encorafenib exposures in patients with mild hepatic impairment (Child-Pugh Class A) compared with subjects with normal liver function.
Danish: Resultater fra et dedikeret klinisk studie viser, at den totale eksponering for encorafenib er 25 % højere hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) end hos patienter med normal leverfunktion.
English: Encorafenib has minor influence on the ability to drive or use machines.
Danish: Encorafenib påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Most events were Grade 1 or 2 (14.6%) and 3.3% were Grade 3-4 events.
Danish: De fleste hændelser var af grad 1 eller 2 (14,6 %), og 3,3 % var hændelser af grad 3 eller 4.
English: If you are a woman who could become pregnant, you must use reliable contraception while you are taking Braftovi, and you must continue to use reliable contraception for at least 1 month after taking your last dose.
Danish: Hvis du er kvinde, og du kan blive gravid, skal du bruge sikker prævention, mens du tager Braftovi og i mindst 1 måned efter din sidste dosis.
English: Due to the potential risk for QT prolongation, it is recommended that serum electrolytes abnormalities, including magnesium and potassium, are corrected and risk factors for QT prolongation controlled (e.g. congestive heart failure, bradyarrhythmias) before treatment initiation and during treatment.
Danish: På grund af den potentielle risiko for QT-forlængelse anbefales det, at serumelektrolytforstyrrelser, inklusive magnesium og kalium, korrigeres, og at risikofaktorer for QT-forlængelse kontrolleres (f.eks. kongestivt hjertesvigt, bradyarytmi) inden opstart af behandlingen og under behandlingen.
English: Non-cutaneous malignancies Based on its mechanism of action, encorafenib may promote malignancies associated with activation of RAS through mutation or other mechanisms.
Danish: Med udgangspunkt i stoffets virkningsmekanisme kan encorafenib fremme maligniteter forbundet med aktivering af RAS via mutation eller andre mekanismer.
English: The incidences of liver laboratory abnormalities reported in the pooled Combo 450 population are listed below:
Danish: De indberettede forekomster af abnorme levertal i den samlede Combo 450-population er angivet nedenfor:
English: Study CMEK162B2301, Part 1
Danish: Studie CMEK162B2301, Del 1
English: Dose interruption or modification was reported in 3.7% (8/217) and symptomatic treatment including corticosteroids was reported in 5.1% (11/217) of patients.
Danish: Pausering eller dosisændring blev rapporteret hos 3,7 % (8/217), og symptomatisk behandling, herunder kortikosteroider, blev rapporteret hos 5,1 % (11/217) af patienterne.
English: • Grade 2 (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x ≤5x upper limit of normal (ULN))
Danish: • Grad 2 (aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) > 3x - ≥ 5x øvre normalgrænse (ULN))
English: • QTcF > 500 ms and change ≤ 60 ms from pre-treatment value
Danish: • QTcF > 500 ms og ændring ≥ 60 ms i forhold til værdien inden behandling
English: Contents of the pack and other information What Braftovi contains
Danish: Pakningsstørrelser og yderligere oplysninger Braftovi indeholder:
English: Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment.
Danish: Andre sekundære effektsammenligninger af Combo 450 i forhold til enten vemurafenib eller Enco 300 omfattede samlet overlevelse (OS), objektiv responsrate (ORR), responsvarighed (DoR) og sygdomskontrolrate (DCR) i henhold til BIRC og investigatorvurdering.
English: - Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems.
Danish: - Øjenproblemer: Når Braftovi tages sammen med binimetinib, kan det forårsage alvorlige øjenproblemer.
English: If Grade 1 or 2 uveitis does not respond to specific (e.g. topical) ocular therapy or for Grade 3 uveitis, encorafenib should be withheld and ophthalmic monitoring should be repeated within 2 weeks.
Danish: Hvis uveitis af grad 1 eller 2 ikke responderer på specifik (f.eks. topikal) okulær behandling, eller hvis uveitis er af grad 3, skal encorafenib pauseres, og oftalmisk kontrol skal gentages inden for 2 uger.
English: These melanomas are usually removed by surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Danish: Disse melanomer fjernes som regel ved en operation, og behandlingen med Braftovi (og binimetinib) kan fortsættes uden afbrydelser.
English: Braftovi targets proteins made from this changed BRAF gene.
Danish: Braftovi er rettet mod proteiner, der er lavet fra dette ændrede BRAF-gen.
English: Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine: - Heart problems: Braftovi when taken with binimetinib can make your heart work less well, alter the electrical activity of your heart called “QT interval prolongation” or make existing heart problems worse.
Danish: Fortæl det omgående til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får noget af følgende, mens du tager dette lægemiddel: - Hjerteproblemer: Når Braftovi tages sammen med binimetinib, kan det få hjertet til at arbejde mindre godt, ændre hjertets elektriske aktivitet, der kaldes ”QT-forlængelse”, eller forværre eksisterende hjerteproblemer.
English: If treatment-related toxicities occur, then encorafenib and binimetinib should be simultaneously dose reduced, interrupted or discontinued.
Danish: Hvis der opstår behandlingsrelateret toksicitet, skal doseringen af encorafenib og binimetinib reduceres, pauseres eller seponeres samtidigt.
English: No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of encorafenib.
Danish: Der er ikke udført nogen formelle kliniske studier for at vurdere indvirkningen af nedsat nyrefunktion på encorafenibs farmakokinetik.
English: Do not take Braftovi if you are allergic to encorafenib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for encorafenib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with encorafenib in one or more subsets of the paediatric population in melanoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med encorafenib i en eller flere undergrupper af den pædiatriske population med melanom (se pkt.
English: Panniculitis* Photosensitivity*
Danish: Panniculitis* Lysfølsomhed*
English: Encorafenib should not be used in patients with wild type BRAF malignant melanoma.
Danish: Encorafenib bør ikke anvendes hos patienter med malignt melanom med vildtype-BRAF.
English: For patients in the Phase III study (CMEK162B2301) who developed cuSCC, the median time to onset of the first event of cuSCC (all grades) was 2.3 months (range 0.3 to 12.0 months).
Danish: Hos de patienter i fase III-studiet (CMEK162B2301), som udviklede cuSCC, var mediantiden til indtræden af første cuSCC-hændelse (alle grader) 2,3 måneder (interval 0,3 til 12,0 måneder).
English: Alopecia*
Danish: Alopeci*
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) • Grade 2
Danish: Palmoplantart erythrodysæstesisyndrom (PPES)
English: Some medicines may affect how Braftovi works or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Braftovi eller øge din risiko for at få bivirkninger.
English: The recommended dose of encorafenib is 450 mg (six 75 mg capsules) once daily, when used in combination with binimetinib.
Danish: Den anbefalede dosis af encorafenib er 450 mg (seks 75 mg kapsler) én gang dagligt, når det anvendes i kombination med binimetinib.
English: Visual disturbances have been reported in some patients treated with encorafenib during clinical studies.
Danish: Der er rapporteret om synsforstyrrelser hos nogle patienter, der fik behandling med encorafenib i kliniske studier.