FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people) - type of skin cancer such as basal cell carcinoma - inflammation of the eye (uveitis) - inflammation of the pancreas (pancreatitis) causing severe abdominal pain - abnormal blood test result for pancreas function (amylase)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - en type hudkræft såsom basalcellekarcinom - betændelse i øjet (uveitis) - betændelse i bugspytkirtlen (pankreatitis), som giver svære mavesmerter - uregelmæssige blodprøveresultater af bugspytkirtelfunktion (amylase)
English: The encorafenib single agent (300 mg orally once daily) safety profile is based on data from 217 patients with unresectable or metastatic BRAF V600-mutant melanoma (hereafter referred to as the pooled encorafenib 300 population).
Danish: Sikkerhedsprofilen af monoterapi med encorafenib (300 mg én gang dagligt) er baseret på data fra 217 patienter med inoperabelt eller metastatisk melanom med BRAF V600-mutation (herefter benævnt 'samlet encorafenib 300-population').
English: In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients.
Danish: I den samlede encorafenib 300-population, blev lysfølsomhed rapporteret hos 4,1 % (9/217) af patienterne.
English: Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8).
Danish: Der er set abnorme levertal, herunder ASAT- og ALAT-stigninger, med encorafenib (se pkt.
English: New primary melanoma has been observed in patients treated with BRAF inhibitors including encorafenib (see section 4.8).
Danish: Der er set nye primære melanomer hos patienter i behandling med BRAF-hæmmere, herunder encorafenib (se pkt.
English: RPED has also been reported in patients treated with encorafenib in combination with binimetinib (see section 4.8).
Danish: Der er også rapporteret om RPED hos patienter, der blev behandlet med encorafenib i kombination med binimetinib (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: The half maximal inhibitory concentration (IC50) of encorafenib against BRAFV600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively.
Danish: Den koncentration af encorafenib, der giver 50 % hæmning (IC50) af enzymerne BRAF V600E, BRAF og CRAF, er fastlagt til hhv. 0,35; 0,47 og 0,30 nM. Encorafenibs dissocieringshalveringstid var > 30 timer og resulterede i langvarig pERK-hæmning.
English: Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up of blood, blood clots, vomit containing blood or that looks like “coffee grounds”, red or black stools that look like tar, passing blood in the urine, stomach (abdominal) pain, unusual vaginal bleeding.
Danish: Kontakt omgående lægen, hvis du får tegn på blødningsproblemer som f.eks. at du hoster blod op, får blodpropper, har opkast, der er blodig eller ligner ”kaffegrums”, har røde eller sorte afføringer, der ligner tjære, har blod i urinen, mavesmerter, usædvanlig blødning fra skeden.
English: Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016)
Danish: Figur 1 Studie CMEK162B2301, Del 1: Kaplan-Meier-kurve over progressionsfri overlevelse i henhold til uafhængig central gennemgang (skæringsdato: 19. maj
English: Encorafenib in combination with binimetinib 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: Encorafenib i kombination med binimetinib er indiceret til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation (se pkt.
English: If not improved despite supportive therapy within 2 weeks, encorafenib should be withheld until improved to Grade 0 or 1 and treatment should be resumed at same dose level or at a reduced dose.
Danish: • Ved manglende bedring i løbet af 2 uger til trods for understøttende behandling skal encorafenib pauseres indtil bedring til grad 0 eller 1, hvorefter behandlingen skal genoptages på samme dosisniveau eller i en reduceret dosis.
English: Uveitis including iritis and iridocyclitis
Danish: Uveitis inklusive iritis og iridocyclitis • Grad 1-3
English: • Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
Danish: • Forhøjede transaminaser: 13,2 % (34/257) samlet - grad 3-4: 5,4 % (14/257)
English: Specifically, encorafenib inhibits in vitro and in vivo BRAFV600E, D and K mutant melanoma cell growth.
Danish: Encorafenib hæmmer specifikt cellevæksten ved melanomer med BRAF V600E, D og K-mutation in vitro og in vivo.
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: In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274).
Danish: I den samlede Combo 450-population blev der rapporteret om uveitis hos 4,4 % (12/274) af patienterne, som var af grad 1 hos 0,4 % (1/274), grad 2 hos 3,6 % (10/274) og grad 3 hos 0,4 % (1/274).
English: In the pooled Combo 450 population, anaemia was reported in 19.7% (54/274) of patients; 4.7% (13/274) patients had a 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: In the Combo 300 arm in Part 2 of the pivotal study, PPES was observed in 3.9% (10/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Danish: I Combo 300-armen i del 2 af det pivotale studie blev PPES observeret hos 3,9 % (10/257) af patienterne med grad 3 rapporteret hos 0,4 % (1/257) af patienterne.
English: Dry skin* Pruritus* Alopecia*
Danish: Hyperkeratose* Udslæt* Tør hud* Pruritus* Alopeci*
English: The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2).
Danish: Sikkerheden af encorafenib (300 mg oralt én gang dagligt) i kombination med binimetinib (45 mg oralt to gange dagligt) er blevet evalueret hos 257 patienter med inoperabelt eller metastatisk melanom med BRAF V600-mutation (herefter benævnt Combo 300-populationen), på baggrund af fase IIIstudiet (CMEK162B2301, del 2).
English: • If not improved, encorafenib should be permanently discontinued.
Danish: • Ved manglende bedring skal encorafenib seponeres permanent.
English: Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520)
Danish: Shellak (E904) Jernoxid, sort (E172) Propylenglycol (E1520)
English: Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see section 4.2).
Danish: Abnorme levertal skal håndteres med pausering, dosisreduktion eller seponering af behandlingen (se pkt.
English: • Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
Danish: • Trykblæk - shellak (E904), sort jernoxid (E172), propylenglycol (E1520)
English: If encorafenib is permanently discontinued, then binimetinib should be discontinued.
Danish: Hvis encorafenib bliver seponeret permanent, skal binimetinib seponeres.
English: Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients.
Danish: Udslæt førte til seponering hos 0,5 % (1/217) af patienterne og til pausering eller dosisjustering hos 7,4 % (16/217) af patienterne.
English: Arthritis *
Danish: Artritis*
English: Each hard capsule contains 50 mg encorafenib.
Danish: Hver hård kapsel indeholder 50 mg encorafenib.
English: Dose modification
Danish: Efterfølgende justering
English: It may cause harm or birth defects to an unborn baby.
Danish: Det kan forårsage fosterskader eller misdannelser.
English: Encorafenib should be withheld (see monitoring in section
Danish: Encorafenib skal pauseres (kontrol i pkt.
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 450population.
English: Encorafenib dose when used in combination with binimetinib
Danish: Encorafenib-dosis ved anvendelse i kombination med binimetinib
English: Caution should be exercised if a moderate CYP3A inhibitor is co-administered with encorafenib.
Danish: Der bør udvises forsigtighed ved samtidig administration af en moderat CYP3A-hæmmer og encorafenib.
English: Table 5: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review)
Danish: Tabel 5: Studie CMEK162B2301, Del 1: Resultater vedrørende progressionsfri overlevelse og bekræftet samlet respons (uafhængig central gennemgang) Encorafenib + binimetinib N = 192 (Combo 450)
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) PPES was reported in 6.2% (17/274) of patients in the pooled Combo 450 population.
Danish: Der blev rapporteret om PPES hos 6,2 % (17/274) af patienterne i den samlede Combo 450population.
English: Each hard capsule contains 75 mg encorafenib.
Danish: Hver hård kapsel indeholder 75 mg encorafenib.
English: Adverse reactions
Danish: Responsvarighed
English: Pancreatitis led to dose interruption or adjustment in (0.4 %) 1/274 of patients.
Danish: Pancreatitis førte til pausering eller dosisjustering hos 0,4 % (1/274) af patienterne.
English: If rash worsens or does not improve within 2 weeks with treatment, encorafenib should be withheld until Grade 0 or 1 and then resumed at the same dose.
Danish: Hvis udslættet bliver værre eller ikke bliver bedre i løbet af 2 uger med behandling, skal encorafenib pauseres indtil bedring til grad 0 eller 1.
English: • Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
Danish: • Kapselskal - gelatine (E441), titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172), sort jernoxid (E172)
English: In the pooled encorafenib 300 population, facial paresis was observed in 7.4% (16/217) of patients.
Danish: I den samlede encorafenib 300-population blev ansigtsparese observeret hos 7,4 % (16/217) af patienterme.
English: Basal cell carcinoma* Skin papilloma*
Danish: Basalcellekarcinom Hudpapillom
English: • If improved to Grade 0 or 1 or to baseline levels, it should be resumed at a reduced dose.
Danish: • Ved bedring til grad 0 eller 1 eller til baselineniveau skal det genoptages med reduceret dosis.
English: Or, encorafenib should be permanently discontinued.
Danish: Eller encorafenib skal seponeres permanent.
English: Administration of encorafenib should be undertaken with caution at a reduced dose in patients with mild hepatic impairment (see section 4.2).
Danish: Encorafenib bør administreres med forsigtighed i reduceret dosis hos patienter med let eller moderat nedsat leverfunktion (se pkt.
English: erythromycin, penicillin) - medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine) - medicines typically used to treat cancer (such as methotrexate, imatinib) - medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin) - an herbal treatment for depression: St. John's wort - some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir, dolutegravir - birth control medicines containing hormones - medicines typically used to treat high blood pressure (such as diltiazem, bosentan, furosemide) - a medicine used to treat an uneven heartbeat: amiodarone.
Danish: atorvastatin) - et naturlægemiddel for depression: prikbladet perikon - visse lægemidler til behandling af HIV såsom ritonavir, amprenavir, raltegravir, dolutegravir - lægemidler til svangerskabsforebyggelse med hormoner - lægemidler, der normalt bruges til behandling af højt blodtryk (såsom diltiazem, bosentan,
English: Moderate CYP3A4 inhibitors should be co-administered with caution.
Danish: Samtidig administration af moderate CYP3A4-hæmmere bør ske med forsigtighed.
English: In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients.
Danish: I den samlede encorafenib 300-population blev der rapporteret om udslæt hos 43,3 % (94/217) af patienterne.
English: Rash led to discontinuation in 0.4% (1/274) 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: Administration of encorafenib at a dose of 450 mg once daily as a single agent is not recommended.
Danish: Det frarådes at administrere encorafenib i en dosis på 450 mg én gang dagligt som monoterapi.
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: In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients.
Danish: I den samlede Combo 450-population forekom der træthed hos 43,8 % (120/274) af patienterne, herunder grad 3 hos 2,9 % (8/274) af patienterne.
English: Effects of other medicinal products on encorafenib.
Danish: Andre lægemidlers indvirkning på encorafenib
English: Encorafenib should be permanently discontinued.
Danish: Encorafenib skal seponeres permanent.
English: • First occurrence of any Grade 4 adverse reaction
Danish: • Første forekomst af bivirkning af grad 4
English: Recommended dose modifications for encorafenib (used in combination with binimetinib) for other adverse reactions Severity of adverse reaction Encorafenib
Danish: Anbefalede dosisjusteringer af encorafenib (anvendt i kombination med binimetinib) ved andre bivirkninger Bivirkningens sværhedsgrad Encorafenib
English: Braftovi may reduce sperm count in males.
Danish: Braftovi kan forårsage nedsat sædtal hos mænd.
English: It is used in adults in combination with another medicine containing binimetinib to treat a type of skin cancer called melanoma when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body, or cannot be removed by surgery
Danish: Det anvendes i kombination med et andet lægemiddel, der indeholder binimetinib, til at behandle en form for hudkræft hos voksne, der kaldes melanom, når det har
English: If binimetinib is temporarily interrupted, encorafenib should be reduced at 300 mg once daily during the time of binimetinib dose interruption (see section 4.2 of binimetinib Summary of Product Characteristics [SmPC]) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.
Danish: Hvis binimetinib pauseres, skal encorafenib reduceres til 300 mg én gang dagligt i perioden med pausering af binimetinib (se pkt.
English: Nausea Vomiting* Constipation
Danish: Kvalme Opkastning* Obstipation
English: • First occurrence of Grade 3 adverse reactions
Danish: • Første forekomst af bivirkninger af grad 3
English: Before starting treatment your doctor will check for the BRAF mutation.
Danish: Lægen vil derfor teste dig for BRAF-mutationen, inden du starter på behandlingen.
English: Neuropathy peripheral* Dizziness*
Danish: Perifer neuropati* Svimmelhed* Hovedpine
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: How to take Braftovi
Danish: Sådan skal du tage Braftovi
English: Braftovi 50 mg hard capsules Each hard capsule contains 50 mg of encorafenib.
Danish: Braftovi 50 mg kapsler, hårde Hver hård kapsel indeholder 50 mg encorafenib.
English: PFS (primary analysis)
Danish: Den investigatorvurderede PFS
English: In the pooled Combo 450 population, diarrhoea was observed in 38% (104/274) of patients and was Grade 3-4 in 3.3% (9/274) 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: 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: Ocular toxicities
Danish: Okulær toksicitet
English: Common (may affect up to 1 in 10 people) - allergic reaction that may include swelling of the face and difficulty in breathing - weakness and paralysis of face muscles - fast heart beat - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - peeling or scaly skin - inflammation of joints (arthritis) - kidney failure - abnormal kidney test results (creatinine elevations) - increased skin sensitivity to sunlight - abnormal blood test result for pancreas function (lipase)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - allergisk reaktion, som kan omfatte hævelse af ansigtet og vejrtrækningsbesvær - svaghed og lammelse af ansigtsmuskler - hurtigt hjerteslag - hududslæt med et fladt misfarvet område eller hævede knuder ligesom akne (akneiform dermatitis) - hudafskalning eller skællet hud - ledbetændelse (artritis) - nyresvigt - uregelmæssige resultater af nyrefunktionstest (stigning i kreatinin) - øget følsomhed i huden over for sollys - uregelmæssige blodprøveresultater af bugspytkirtelfunktion (lipase)
English: Braftovi 75 mg hard capsules Each hard capsule contains 75 mg of encorafenib.
Danish: Braftovi 75 mg kapsler, hårde Hver hård kapsel indeholder 75 mg encorafenib.
English: When Braftovi was used on its own in clinical trials
Danish: Kliniske forsøg med brug af Braftovi alene
English: Encorafenib and binimetinib (a MEK inhibitor, see section 5.1 of binimetinib SmPC) both inhibit the MAPK pathway, resulting in higher anti-tumour activity.
Danish: 5.1 i produktresuméet for binimetinib) hæmmer begge MAPK-signalvejen, hvilket resulterer i højere antitumoraktivitet.
English: No dosing recommendation can be made in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Danish: Der kan ikke gives anbefalinger vedrørende dosering til patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: Recommended dose modifications for encorafenib (used in combination with binimetinib) for selected adverse reactions Severity of adverse reactiona Encorafenib
Danish: Anbefalede dosisjusteringer af encorafenib (anvendt i kombination med binimetinib) ved udvalgte bivirkninger Bivirkningens sværhedsgrada Encorafenib
English: • Recurrent Grade 4 adverse reactions
Danish: • Tilbagevendende bivirkninger af grad 4
English: Creatinine elevation has been commonly reported with encorafenib as single agent or in combination with binimetinib.
Danish: Kreatininstigninger er indberettet med hyppigheden 'almindelig' ved brug af encorafenib som monoterapi eller i kombination med binimetinib.
English: Braftovi 75 mg hard capsules
Danish: Braftovi 75 mg hårde kapsler
English: The hard capsule (capsule) has a flesh coloured opaque cap and white opaque body, with a stylised “A” printed on the cap and “LGX 75mg” printed on the body.
Danish: De hårde kapsler (kapsel) har en kødfarvet, uigennemsigtig overdel og en hvid, uigennemsigtig underdel, og er påtrykt et stiliseret ”A” på overdelen og ”LGX 75mg” på underdelen.
English: Dose interruption or modification was reported in 0.4% (1/274) of patients.
Danish: Pausering eller dosisændring blev rapporteret hos 0,4 % (1/274) af patienterne.
English: • Recurrent Grade 3 adverse reactions
Danish: • Tilbagevendende bivirkninger af grad 3
English: In the pooled Combo 450 population, facial paresis occurred in 0.7% (2/274) of patients including Grade 3 in 0.4% (1/274) of patients.
Danish: I den samlede Combo 450-population forekom ansigtsparese hos 0,7 % (2/274) af patienterne, herunder grad 3 hos 0,4 % (1/274) af patienterne.
English: Dose interruption or dose modification occurred in 1.1% (3/274) of patients.
Danish: Doseringen blev pauseret eller justeret hos 1,1 % (3/274) af patienterne.
English: Hyperkeratosis* Rash*
Danish: Hyperkeratose* Udslæt*
English: Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Danish: Gelatine (E441) Titandioxid (E171) Jernoxid, rød (E172) Jernoxid, gul (E172)
English: Common (may affect up to 1 in 10 people) - some types of skin tumours such as skin papilloma and basal cell carcinoma - allergic reaction that may include swelling of the face and difficulty breathing - changes in the way things taste - inflammation of the eye (uveitis) - blood clots - inflammation of the colon (colitis) - redness, chapping or cracking of the skin - inflammation of the fatty layer under the skin, symptoms include tender skin nodules - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - redness, skin peeling or blisters on hand and feet (palmar-plantar erythrodysesthesia or hand and foot syndrome) - kidney failure - abnormal kidney test results (creatinine elevations) - abnormal blood test results for liver function (blood alkaline phosphatase) - abnormal blood test results for pancreas function (amylase, lipase) - increased skin sensitivity to sunlight
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): - visse typer af tumorer i huden, såsom hudpapillom og basalcellekarcinom - allergisk reaktion, som kan omfatte hævelse af ansigtet og vejrtrækningsbesvær - ændringer i smagssansen - betændelse i øjet (uveitis) - blodpropper - betændelse i tyktarmen (colitis) - rødme, revner eller sprækker i huden - betændelse i fedtlaget under huden; symptomerne omfatter ømme knuder i huden - hududslæt med et fladt misfarvet område eller hævede knuder ligesom akne (akneiform dermatitis) - rødme, hudafskalning eller blæredannelse på hænder og fødder (palmo-plantar erythrodysæstesi eller hånd-fod-syndrom) - nyresvigt - uregelmæssige resultater af nyrefunktionstest (stigning i kreatinin) - uregelmæssige blodprøveresultater af nyrefunktion (basisk fosfatase i blodet) - uregelmæssige blodprøveresultater af bugspytkirtelfunktionen (amylase, lipase) - øget følsomhed i huden over for sollys
English: Treatment Median OS (months)
Danish: Median OS (måneder)
English: Encorafenib in combination with binimetinib in patients who have progressed on a BRAF inhibitor There are limited data for the use of the combination of encorafenib with binimetinib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Danish: Der er begrænsede data for brug af kombinationen af encorafenib og binimetinib til patienter, som er progredieret under tidligere BRAF-hæmmerbehandling, som er givet til behandling af inoperabel eller metastatisk melanom med BRAF V600-mutation.
English: Blood creatine phosphokinase increased
Danish: Forhøjet basisk fosfatase i blodet.
English: There are no data available in patients with severe renal impairment (see sections 4.2 and 5.2).
Danish: Der foreligger ingen data fra patienter med svært nedsat nyrefunktion (se pkt.
English: For information on the posology and recommended dose modifications of binimetinib, see section 4.2 of binimetinib SmPC.
Danish: Se oplysninger om dosering og anbefalede dosisjusteringer af binimetinib pkt.