FrancophonIA/ELRC3.0 huggingface dataset:
English: The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically relevant (see section 5.2); however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Danish: 5.2); da dette imidlertid ikke er blevet undersøgt i et formelt klinisk studie, bør samtidig administration af UGT1A1-induktorer (såsom rifampicin og phenobarbital) og -hæmmere (såsom indinavir, atazanavir, sorafenib) ske med forsigtighed.
English: Muscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:
Danish: Muskelproblemer: Mektovi kan forårsage muskelnedbrydning (rabdomyolyse), hvilket kan forårsage nyreskade og være dødelig; tegn og symptomer herpå kan omfatte:
English: • medicine typically used to treat high cholesterol such as pravastatin
Danish: • et lægemiddel, der typisk bruges til behandling af et forhøjet kolesterol såsom pravastatin
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E533b) Iron oxide yellow (E172) Iron oxide black (E172)
Danish: Filmovertræk Polyvinylalkohol (E1203) Macrogol 3350 (E1521) Titandioxid (E171) Talcum (E533b) Jernoxid, gul (E172) Jernoxid, sort (E172)
English: Table 2: Recommended dose modifications for binimetinib (used in combination with encorafenib) for other adverse reactions
Danish: Tabel 2: Anbefalede dosisjusteringer af binimetinib (anvendt i kombination med encorafenib) ved andre bivirkninger
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Danish: • Forhøjede transaminaser: 15,7 % (43/274) samlet - grad 3-4: 5,5 % (15/274)
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0 % (11/274) of patients.
Danish: I den samlede Combo 450-population blev lysfølsomhed observeret hos 4,0 % (11/274) af patienterne.
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when binimetinib is administered in combination with encorafenib (see section 4.8).
Danish: Der er set nye primære maligniteter, både kutane og ikke-kutane, hos patienter i behandling med BRAF-hæmmere, og sådanne maligniteter kan forekomme ved administration af binimetinib i kombination med encorafenib (se pkt.
English: • Tablet film-coat: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), iron oxide yellow (E172) and iron oxide black (E172).
Danish: • Tabletfilmovertræk: polyvinylalkohol (E1203), macrogol 3350 (E1521), titandioxid (E171), talcum (E533b), gul jernoxid (E172) og sort jernoxid (E172).
English: Heart problems: Mektovi can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include:
Danish: Hjerteproblemer: Mektovi kan påvirke hjertets virkning (nedsat ejektionsfraktion i venstre ventrikel); tegn og symptomer herpå kan omfatte:
English: Effect of transporters on binimetinib
Danish: Transportørers indvirkning på binimetinib
English: Effect of binimetinib on transporters
Danish: Binimetinibs indvirkning på transportører
English: • High blood pressure: Mektovi can raise blood pressure.
Danish: • Højt blodtryk: Mektovi kan forhøje blodtrykket.
English: Dermatologic reactions Dermatologic reactions may occur when binimetinib is used in combination with encorafenib.
Danish: Der kan forekomme dermalogiske reaktioner, når binimetinib bruges i kombination med encorafenib.
English: Mektovi 15 mg film-coated tablets
Danish: Mektovi 15 mg filmovertrukne tabletter
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Danish: • Øget GGT: 14,0 % (36/257) samlet - grad 3-4: 4,7 % (12/257)
English: It is not known if Mektovi passes into breast milk.
Danish: Det vides ikke, om binimetinib går over i modermælken.
English: Median, months (95 % CI)
Danish: Median, måneder (95 % CI)
English: VTE led to dose interruptions or dose modifications in 1.1 % (3/274) patients and to additional therapy in 4.7 % (13/274) of patients.
Danish: VTE førte til pausering eller dosisjustering hos 1,1 % (3/274) af patienterne og til yderligere behandling hos 4,7 % (13/274) af patienterne.
English: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review)
Danish: Tabel 4: Studie CMEK162B2301, Del 1: Resultater vedrørende progressionsfri overlevelse og bekræftet samlet respons (uafhængig central gennemgang) Encorafenib + binimetinib
English: In the pooled Combo 450 population, mostly mild asymptomatic blood CK elevation was reported in 27.0 % (74/274) of patients.
Danish: I den samlede Combo 450-population blev der rapporteret om primært milde asymptomatiske CKstigninger hos 27,0 % (74/274) af patienterne.
English: Nausea occurred in 41.6 % (114/274) with Grade 3 or 4 observed in 2.6 % (7/274) of patients.
Danish: Kvalme forekom hos 41,6 % (114/274) med grad 3 eller 4 hos 2,6 % (7/274) af patienterne.
English: The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma, based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1) (hereafter referred to as the pooled Combo 450 population).
Danish: Sikkerheden af binimetinib (45 mg oralt to gange dagligt) i kombination med encorafenib (450 mg oralt én gang dagligt) (herefter benævnt Combo 450) er blevet evalueret hos 274 patienter med inoperabelt eller metastatisk melanom med BRAF V600-mutation på baggrund af to fase II-studier (CMEK162X2110 og CLGX818X2109) og ét fase III-studie (CMEK162B2301, del 1) (herefter benævnt 'samlet Combo 450-population').
English: Bleeding problems: Mektovi can cause serious bleeding problems.
Danish: Blødningsproblemer: Mektovi kan forårsage alvorlige blødningsproblemer.
English: - itching - dry skin - hair loss or thinning (alopecia) - skin rash of various types - thickening of the outer layers of the skin - joint pain (arthralgia) - muscle pain, weakness or spasm - back pain - pain in the extremities - fever - swelling of the hands or feet (peripheral oedema), localised swelling - fatigue - abnormal blood test results for liver function - abnormal blood test result related to blood creatine kinase, indicating damage to heart and muscle
Danish: - blødning forskellige steder i kroppen - problemer med synet (nedsat syn) - mavesmerter - diarré - opkastning - kvalme - forstoppelse - kløe - tør hud - hårtab eller tyndere hår (alopeci) - forskellige typer af hududslæt - fortykkelse af hudens yderste lag - ledsmerter (artralgi) - muskelsmerter, -svaghed eller -sammentrækninger - rygsmerter - smerter i arme og ben - feber - hævelse af hænder eller fødder (perifert ødem), lokal hævelse - træthed - uregelmæssige blodprøveresultater for leverfunktionen - uregelmæssige blodprøveresultater for kreatinkinase, hvilket tyder på skader i hjertet og skeletmuskulaturen
English: Binimetinib in combination with encorafenib 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: Binimetinib i kombination med encorafenib er indiceret til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation (se pkt.
English: The most frequent haemorrhagic events were haematuria in 3.3 % (9/274) of patients, rectal haemorrhage in 2.9 % (8/274) and haematochezia in 2.9 % (8/274) of patients.
Danish: De hyppigste blødningshændelser var hæmaturi hos 3,3 % (9/274) af patienterne, rektal blødning hos 2,9 % (8/274) og hæmatokesi hos 2,9 % (8/274) af patienterne.
English: How to take Mektovi
Danish: Sådan skal du tage Mektovi
English: There are limited efficacy data with the combination of binimetinib and encorafenib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Danish: Der er begrænsede virkningsdata fra kombinationsbehandling med binimetinib og encorafenib hos patienter med melanomer med BRAF V600-mutation, der er metastaseret til hjernen (se pkt.
English: Basal cell carcinoma*
Danish: Basalcellekarcinom*
English: Liver laboratory abnormalities including AST and ALT elevations can occur with binimetinib (see section 4.8).
Danish: Abnorme levertal, herunder ASAT- og ALAT-stigninger, kan forekomme med binimetinib (se pkt.
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Danish: Figur 2 Studie CMEK162B2301, Del 1: Kaplan-Meier plot af foreløbig samlet overlevelse (skæringsdato: 7. november 2017)
English: In patients treated with Combo 450, VTE occurred in 4.7 % (13/274) of patients, including 2.2 % (6/274) of patients who developed pulmonary embolism.
Danish: Hos de patienter, der blev behandlet med Combo 450, forekom VTE hos 4,7 % (13/274) af patienterne, inklusive lungeemboli hos 2,2 % (6/274) af patienterne.
English: Haemorrhagic events were observed in 17.9 % (49/274) of patients in the pooled Combo 450 population.
Danish: Der blev set blødningshændelser hos 17,9 % (49/274) af patienterne i den samlede Combo 450 mgpopulation.
English: If the adverse reaction that resulted in a dose reduction is under effective management, dose re-escalation to 45 mg twice daily may be considered.
Danish: Behandlingen bør seponeres, hvis patienten ikke kan tåle 30 mg oralt to gange dagligt Hvis den bivirkning, der var årsag til dosisreduktionen, kommer under effektiv kontrol, kan det overvejes at øge dosis til 45 mg to gange dagligt.
English: Binimetinib dose should be maintained.
Danish: Binimetinib-dosen skal fastholdes.
English: • blood clots
Danish: • blodpropper
English: In the pooled Combo 450 population, VTE was reported as Grade 1 or 2 in 3.6 % (10/274) of patients and Grade 3 or 4 in 1.1 % (3/274) of patients.
Danish: I den samlede Combo 450population blev VTE rapporteret som grad 1 eller 2 hos 3,6 % (10/274) af patienterne og grad 3 eller 4 hos 1,1 % (3/274) af patienterne.
English: • If resolved within 4 weeks, binimetinib should be resumed at a reduced dose, or
Danish: • Binimetinib skal genoptages i reduceret dosis ved bedring i løbet af 4 uger, eller
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Danish: Tabel 5: Studie CMEK162B2301, Del 1: Interimresultater for samlet overlevelse (skæringsdato: 7. november 2017)
English: VTE can occur when binimetinib is administered (see section 4.8).
Danish: VTE kan forekomme i forbindelse med administration af binimetinib (se pkt.
English: Abdominal pain was reported in 27.4 % (75/274) of patients and was Grade 3 in 2.6 % (7/274) patients.
Danish: Mavesmerter blev indberettet hos 27,4 % (75/274) af patienterne og var af grad 3 hos 2,6 % (7/274) af patienterne.
English: If during treatment patient develops VTE or pulmonary embolism, it should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Danish: Hvis patienten får VTE eller lungeemboli under behandlingen, bør dette håndteres ved at pausere eller reducere doseringen eller seponere behandlingen (se tabel 1 i pkt.
English: Cutaneous squamous cell carcinomaa
Danish: Kutant planocellulært karcinoma
English: Before starting treatment your doctor will check for BRAF mutation.
Danish: Lægen vil undersøge dig for BRAF-mutationen, inden du starter på behandlingen.
English: In the pooled Combo 450 population, anaemia was reported in 19.7 % (54/274) of patients; 4.7 % (13/274) of patients had Grade 3 or 4.
Danish: I den samlede Combo 450-population blev der rapporteret om anæmi hos 19,7 % (54/274) af patienterne; 4,7 % (13/274) af patienterne havde hændelser af grad 3 eller 4.
English: If no improvement within 2 weeks, binimetinib should be withheld until improved to Grade 0 or 1 or to baseline levels, and then resumed at the same dose.
Danish: • Hvis der ikke ses bedring i løbet af 2 uger, skal binimetinib pauseres indtil bedring til grad 0 eller 1, hvorefter samme dosis genoptages.
English: Grade 3-4 LVEF, or absolute decrease of LVEF from baseline of ≥ 10 %, binimetinib 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 seponeres og LVEF vurderes hver 2. uge indtil normalisering.
English: • If improved to Grade 2, binimetinib should be resumed at a lower dose.
Danish: • Ved bedring til grad 2 skal binimetinib genoptages i en lavere dosis.
English: A drug interaction study in healthy subjects indicated that the extent of binimetinib exposure is not altered in the presence of a gastric pH-altering agent (rabeprazole).
Danish: Et interaktionsstudie hos raske forsøgsdeltagere viste, at tilstedeværelse af et pH-ændrende stof (rabeprazol) ikke påvirkede eksponeringsgraden.
English: Mektovi contains lactose.
Danish: Mektovi indeholder lactose.
English: • swelling in your arms and legs
Danish: • hævelse af arme og ben
English: It should be considered to permanently discontinue binimetinib.
Danish: Det bør overvejes at seponere binimetinib permanent.
English: In the pooled Combo 450 population, headache occurred in 21.5% (59/274) of patients including Grade 3 in 1.5% (4/274) of patients.
Danish: I den samlede Combo 450-population forekom der hovedpine hos 21,5 % (59/274) af patienterne, herunder grad 3 hos 1,5 % (4/274) af patienterne.
English: Table 1: Recommended dose modifications for binimetinib (used in combination with encorafenib) for selected adverse reaction Severity of adverse reactiona
Danish: Tabel 1: Anbefalede dosisjusteringer af binimetinib (anvendt i kombination med encorafenib) ved udvalgte bivirkninger Bivirkningens sværhedsgrada
English: Skin papilloma*
Danish: Hudpapillom*
English: Binimetinib undergoes minimal renal elimination.
Danish: Den renale elimination af binimetinib er minimal.
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see below, Table 1 and Table 2).
Danish: Håndteringen af bivirkninger kan kræve dosisreduktion, pausering eller seponering af behandlingen (se tabel 1 og tabel 2 nedenfor).
English: • Bleeding problems: Mektovi may cause serious bleeding problems.
Danish: • Blødningsproblemer: Mektovi kan forårsage alvorlige blødningsproblemer.
English: Very common (may affect more than 1 in 10 people) - reduced red blood cell count (anaemia) - problem with the nerves resulting in pain, loss of sensation or tingling in hands and feet - headache - dizziness - bleeding at various sites in the body - problems with your vision (visual impairment) - stomach pain - diarrhoea - being sick (vomiting) - feeling sick (nausea) - constipation
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede) - nedsat antal røde blodlegemer (anæmi) - nerveproblemer, der resulterer i smerter, nedsat følesans eller snurren i hænder og fødder - hovedpine - svimmelhed
English: The effects of renal impairment on the pharmacokinetics of binimetinib in combination with encorafenib have not been evaluated clinically.
Danish: Der er ikke foretaget kliniske undersøgelser af indvirkningen af nedsat nyrefunktion på farmakokinetikken af binimetinib i kombination med encorafenib.
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt.
English: • First occurrence of Grade 4 adverse reactions
Danish: • Første forekomst af bivirkninger af grad 4
English: • If not improved to Grade 2, binimetinib should be permanently discontinued.
Danish: • Hvis der ikke ses bedring til grad 2, skal binimetinib seponeres permanent.
English: (see section 4.2 of encorafenib SmPC).
Danish: 4.2 i produktresumeet for encorafenib).
English: HRa (95 % CI) (vs Vem) p-value (stratified log-rank) HRa (95 % CI) (vs. Enco 300) p-value (stratified log-rank)
Danish: HRa (95 % CI) (vs. Vem) Nominel p-værdi HRa (95 % CI) (vs. Enco 300) p-værdi (stratificeret log-rank)b
English: Venous thromboembolism
Danish: Venøs tromboembolif
English: • If the LVEF does not recover within 4 weeks, binimetinib should be permanently discontinued.
Danish: • Hvis LVEF ikke normaliseres i løbet af 4 uger, skal binimetinib seponeres permanent.
English: Vomiting occurred in 28.1 % (77/274) of patients with Grade 3 or 4 reported in 2.2 % (6/274) of patients.
Danish: Opkastning forekom hos 28,1 % (77/274) af patienterne og blev indberettet som grad 3 eller 4 hos 2,2 % (6/274) af patienterne.
English: It may cause permanent harm or birth defects to an unborn baby.
Danish: Mektovi kan forårsage permanente fosterskader eller misdannelser.
English: Rash led to treatment discontinuation in 0.4 % (1/274) of patients and to dose interruption or dose modification in 1.1 % (3/274) of patients.
Danish: Udslæt førte til seponering hos 0,4 % (1/274) af patienterne og til pausering eller dosisjustering hos 1,1 % (3/274) af patienterne.
English: Mektovi 15 mg film-coated tablets binimetinib
Danish: Mektovi 15 mg filmovertrukne tabletter binimetinib
English: Effects of other medicinal products on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Danish: Binimetinib metaboliseres primært via UGT1A1-medieret glukuronidering.
English: In the pooled Combo 450 population, rash occurred in 19.7 % (54/274) of patients.
Danish: I den samlede Combo 450-population forekom udslæt hos 19,7 % (54/274) af patienterne.
English: • If improved to Grade 0 or 1, binimetinib should be resumed at same dose.
Danish: • Ved forbedring til grad 0 eller 1 skal binimetinib genoptages i samme dosis.
English: For information on the posology and recommended dose modifications of encorafenib, see section 4.2 of encorafenib SmPC.
Danish: Se oplysninger om dosering og anbefalede dosisjusteringer af encorafenib i pkt.
English: • feeling dizzy, tired or lightheaded
Danish: • svimmelhed, træthed eller omtumlethed
English: Number of events (progressive disease) (%)
Danish: Antal hændelser (%)
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Tal med lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Binimetinib is not recommended in patients with a history of RVO.
Danish: Det frarådes at anvende binimetinib hos patienter med RVO i anamnesen.
English: Binimetinib and encorafenib (a BRAF inhibitor, see section 5.1 of encorafenib SmPC) both inhibit the MAPK pathway resulting in higher anti-tumour activity.
Danish: 5.1 i produktresuméet for encorafenib) hæmmer begge MAPK-signalvejen, hvilket resulterer i højere antitumoraktivitet.
English: The occurrence of symptomatic RPED can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Danish: Symptomatisk RPED kan håndteres med pausering eller reduktion af doseringen eller seponering af behandlingen (se tabel 1 i pkt.
English: • If not improved, binimetinib should be permanently discontinued.
Danish: • Hvis der ikke ses bedring, skal binimetinib seponeres permanent.
English: In the pooled Combo 450 population, diarrhoea was observed in 38 % (104/274) of patients and was Grade 3 or 4 in 3.3 % (9/274) of patients.
Danish: Diarré blev observeret hos 38 % (104/274) af patienterne i den samlede Combo 450-population og var af grad 3-4 hos 3,3 % (9/274) af patienterne.
English: • If not resolved within 4 weeks, binimetinib should be permanently discontinued.
Danish: • Hvis der ikke ses bedring i løbet af 4 uger, skal binimetinib seponeres permanent.
English: • Grade 4 PE
Danish: • PE af grad 4
English: • an herbal treatment for depression: St. John's wort
Danish: • et naturlægemiddel for depression: prikbladet perikon
English: Liver metabolism mainly via glucuronidation is the primary route of elimination of binimetinib (see section 5.2).
Danish: Binimetinib elimineres hovedsageligt via metabolisering i leveren, primært via glukuronidering (se pkt.
English: Facial paresis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Danish: Der blev rapporteret om ansigtsparese, når binimetinib blev brugt i kombination med encorafenib (se pkt, 4.8 i produktresumeet for encorafenib).
English: If rash worsens or does not improve within 2 weeks with treatment, binimetinib should be withheld until improved to Grade 0 or 1 and then resumed at the same dose if first occurrence or resumed at a reduced dose if recurrent Grade2.
Danish: Hvis udslættet bliver værre eller ikke bliver bedre i løbet af 2 uger med behandling, skal binimetinib pauseres indtil bedring til grad 0 eller 1.
English: Number of Events (%) Median, months (95 % CI)
Danish: Antal hændelser (progressiv sygdom) (%) 113 (58,9) Median, måneder (95 % CI)
English: HRa (95 % CI) (vs Enco 300) p value (stratified log-rank)b
Danish: HR (95% CI) (vs. Enco 300) p-værdi (stratificeret log-rank)
English: Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Danish: Abnorme levertal bør håndteres med pausering, dosisreduktion eller seponering af behandlingen (se tabel 1 i pkt.
English: For additional information on warnings and precautions associated with encorafenib treatment, see section 4.4 of encorafenib SmPC.
Danish: 4.4 i produktresuméet for encorafenib vedrørende yderligere oplysninger om advarsler og forsigtighedsregler relateret til behandling med encorafenib.
English: Haemorrhagic events led to discontinuation of treatment in 1.1 % (3/274) of patients.
Danish: Blødningshændelserne førte til seponering af behandlingen hos 1,1 % (3/274) af patienterne.
English: HRa (95% CI) (vs Enco 300)
Danish: HRa (95 % CI) (vs Enco 300) Nominel p-værdi
English: If encorafenib is temporarily interrupted (see section 4.2 of encorafenib SmPC), binimetinib should be interrupted.
Danish: 4.2 i produktresuméet for encorafenib), skal binimetinib seponeres.
English: • Binimetinib should be permanently discontinued.
Danish: • Binimetinib skal seponeres permanent.
English: • eye pain, swelling or redness
Danish: • smerter, hævelse eller rødme i øjet
English: Dizziness*
Danish: Nyresvigt*
English: Binimetinib should be permanently discontinued.
Danish: Binimetinib skal seponeres permanent.
English: Haemorrhages, including major haemorrhagic events, can occur when binimetinib is administered (see section 4.8).
Danish: Blødninger, herunder alvorlige blødningshændelser, kan forekomme i forbindelse med administration af binimetinib (se pkt.
English: • If improved to Grade 0 or 1 or baseline level, binimetinib should be resumed at reduced dose, or
Danish: • Ved bedring til grad 0 eller 1 eller til baselineniveau skal binimetinib genoptages i reduceret dosis
English: • unusual vaginal bleeding
Danish: • usædvanlig blødning fra skeden
English: Binimetinib should be withheld.
Danish: Binimetinib skal pauseres.
English: The occurrence of LVEF decrease can be managed with treatment interruption, dose reduction or with treatment discontinuation (see section 4.2).
Danish: Fald i LVEF kan håndteres ved at pausere eller reducere doseringen eller seponere behandlingen (se pkt.
English: The efficacy and safety of binimetinib in combination with encorafenib have been established only in patients with tumours expressing BRAF V600E and V600K mutations.
Danish: Inden der gives behandling med binimetinib i kombination med encorafenib, skal det bekræftes, at patienten har BRAF V600-mutation ved hjælp af en valideret test. Der er kun påvist virkning og sikkerhed af binimetinib i kombination med encorafenib hos patienter med tumorer, der udtrykker BRAF V600E- og V600K-mutationer.