FrancophonIA/ELRC3.0 huggingface dataset:
English: In rabbits, mortality, maternal physical signs of toxicity, lower gestational body weight and abortion were noted.
Danish: Hos kaniner blev der set mortalitet, fysiske tegn på toksicitet hos moderdyrene, lavere gestationsvægt og abort.
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: It is used in adults in combination with another medicine containing encorafenib to treat a type of skin cancer called melanoma when it has
Danish: Det anvendes i kombination med et andet lægemiddel, der indeholder encorafenib, til at behandle en form for hudkræft hos voksne, der kaldes for melanom, når det har
English: • Blood clots: Mektovi can cause blood clots in your arms or legs, and if a clot travels to your lungs it could lead to death.
Danish: • Blodpropper: Mektovi kan forårsage blodpropper i armene eller benene, og hvis en blodprop føres videre til lungerne kan den medføre døden.
English: It is unknown whether binimetinib or its metabolite are excreted in human milk.
Danish: Det er ukendt, om binimetinib/metabolitter udskilles i human mælk.
English: It should be ensured that patient has adequate hydration.
Danish: Der skal sørges for tilstrækkelig hydrering af patienten.
English: Hypertension, or worsening of pre-existing hypertension, can occur with the use of binimetinib.
Danish: Hypertension eller forværring af eksisterende hypertension kan forekomme i forbindelse med brug af binimetinib.
English: Mektovi can affect your ability to drive or use machines.
Danish: Mektovi kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Administration of a single 45 mg dose of binimetinib with a high-fat, high-calorie meal decreased the maximum binimetinib concentration (Cmax) by 17 %, while the area under the concentration-time curve (AUC) was unchanged.
Danish: Administration af en enkelt dosis binimetinib på 45 mg sammen med et måltid med et højt fedt- og kalorieindhold reducerede den maksimale binimetinib-koncentration (Cmax) med 17 %, hvorimod arealet under koncentrations-tidskurven (AUC) forblev uændret.
English: Exceptions where dose reductions are necessary for encorafenib only (adverse reactions primarily related to encorafenib) are: palmar-plantar erythrodysaesthesia syndrome (PPES), uveitis including iritis and iridocyclitis and QTc prolongation.
Danish: Undtagelser, hvor det kun er nødvendigt at reducere encorafenib-dosen (bivirkningerne er primært relateret til encorafenib): palmoplantart erythrodysæstesisyndrom (PPES), uveitis inklusive iritis og iridocyclitis og QT-forlængelse.
English: Results from a dedicated clinical study with binimetinib only indicate similar exposures in patients with mild impairment (Child-Pugh Class A) and subjects with normal liver function.
Danish: Resultater fra et dedikeret klinisk studie med binimetinib alene viser ensartet eksponering hos patienter med let nedsat leverfunktion (Child Pugh-klasse A) og forsøgsdeltagere med normal leverfunktion.
English: No clinicallly significant drug-drug interactions caused by binimetinib on other transporters is expected.
Danish: Der forventes ingen klinisk signifikante lægemiddelinteraktioner forårsaget af binimetinib på andre transportører.
English: Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The patient should be advised to maintain an adequate fluid intake during treatment.
Danish: Patienten skal informeres om at indtage tilstrækkelig væske under behandlingen.
English: Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) and inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.
Danish: Inducere af CYP1A2-enzymer (såsom carbamazepin og rifampicin) og inducere af P-gp-transport (såsom prikbladet perikon eller fenytoin) kan mindske binimetinib-eksponeringen, hvilket kunne resultere i mindsket virkning.
English: • medicine used to treat depression such as duloxetine
Danish: • et lægemiddel, der bruges til behandling af depression såsom duloxetin
English: Results from a dedicated clinical study showed that patients with severe renal impairment (eGFR ≤ 29 mL/min/1.73 m2), had a 29 % increase in exposure (AUCinf), a 21 % increase in Cmax, and a 22 % decrease in CL/F compared to matching healthy subjects.
Danish: Resultaterne af et dedikeret klinisk studie viste, at patienter med svært nedsat nyrefunktion (eGFR ≤ 29 ml/min/1,73 m2) havde en stigning på 29 % i eksponeringen (AUCinf), en stigning på 21 % i Cmax, og et fald på 22 % i CL/F i forhold til tilsvarende raske forsøgsdeltagere.
English: If you are a woman who could become pregnant, you must use reliable contraception while you are taking Mektovi, and you must continue to use reliable contraception 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 Mektovi og i mindst 1 måned efter din sidste dosis.
English: Since binimetinib is highly bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with binimetinib.
Danish: Eftersom binimetinib har høj binding til plasmaproteiner er hæmodialyse sandsynligvis ineffektiv til behandling af overdosering af binimetinib.
English: • pain in your legs with or without swelling
Danish: • smerter i benet med eller uden hævelse
English: Interstitial lung disease (ILD)/pneumonitis • Grade 2
Danish: Interstitiel lungesygdom (ILD)/pneumonitis • Grad 2
English: Some medicines may affect how Mektovi works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Mektovi eller øge din risiko for at få bivirkninger.
English: Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine:
Danish: Fortæl det omgående til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får noget af følgende, mens du tager dette lægemiddel:
English: Your doctor or nurse will check your blood pressure before and during treatment with Mektovi.
Danish: Lægen eller sundhedspersonalet kontrollerer dit blodtryk før og under behandlingen med Mektovi.
English: The maximum contribution of direct glucuronidation to the clearance of binimetinib was estimated to have been 61.2 %.
Danish: Direkte glukuronidering blev estimeret til at bidrage til binimetinibs clearance med maksimalt 61,2 %.
English: In case of severe hypertension, temporary interruption of binimetinib is recommended until hypertension is controlled (see Table 2 in section 4.2).
Danish: I tilfælde af svær hypertension anbefales det at pausere binimetinib, indtil hypertensionen er under kontrol (se tabel 2 i pkt.
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, which represents less than 20 % of the binimetinib exposure clinically.
Danish: In vitro katalyserer CYP1A2 og CYP2C19 dannelse af den aktive metabolit, som repræsenterer mindre end 20 % af den kliniske eksponering for binimetinib.
English: Hypertension led to dose interruption or adjustment in 2.9 % of patients.
Danish: Hypertension førte til pausering eller dosisjustering hos 2,9 % af patienterne.
English: Rhabdomyolysis was reported in 0.4 % (1/274) of patients treated with encorafenib in combination with binimetinib.
Danish: Rabdomyolyse blev indberettet hos 0,4 % (1/274) af de patienter, der blev behandlet med encorafenib i kombination med binimetinib.
English: Inhibition of P-gp or BCRP is unlikely to result in a clinically important increase in binimetinib concentrations as binimetinib exhibits moderate to high passive permeability.
Danish: Hæmning af P-gp eller BCRP vil sandsynligvis ikke resultere i kliniske betydelige fald i binimetinib-koncentrationen, eftersom binimetinib udviser moderat til høj passiv permeabilitet.
English: LVEF should be evaluated every 2 weeks until recovery.
Danish: LVEF skal vurderes hver 2. uge indtil normalisering.
English: Do not take Mektovi if you are allergic to binimetinib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for binimetinib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Binimetinib treatment in combination with encorafenib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med binimetinib i kombination med encorafenib skal indledes og kontrolleres af en læge med erfaring i brug af lægemidler mod cancer.
English: Binimetinib should be permanently discontinued with the occurrence of RVO (see Table 1 in section 4.2).
Danish: Binimetinib bør seponeres permanent i tilfælde af RVO (se tabel 1 i pkt.
English: Therefore, the extent of drug interactions mediated by UGT1A1 is minimal, and unlikely clinically relevant; however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers or inhibitors should be administered with caution.
Danish: Det potentielle omfang af interaktioner medieret via UGT1A1 er derfor minimal og sandsynligvis uden klinisk relevans; dette er imidlertid ikke blevet vurderet i et formelt klinisk studie, og UGT1A1-induktorer og -hæmmere bør derfor administreres med forsigtighed.
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: The mean LVEF value dropped by 5.9 % in the pooled Combo 450 population, from a mean of 63.9 % at baseline to 58.1 %.
Danish: Den gennemsnitlige LVEF-værdi faldt med 5,9 % i den samlede Combo 450-population fra et gennemsnit på 63,9 % ved baseline til 58,1 %.
English: Fatal gastric ulcer haemorrhage with multiple organ failure as a concurrent cause of death, occurred in one patient.
Danish: Letal blødning fra mavesår, med multipelt organsvigt som samtidig dødsårsag, forekom hos én patient.
English: The main route of hepatic transformation of binimetinib being glucoronidation, the decision for treatement should be made by the treating physician taking into account the individual benefit-risk.
Danish: Eftersom den primære hepatiske transformationsvej for binimetinib er glukuronidering, bør den behandlede læge træffe beslutning om behandling under hensyntagen til fordele og risici hos den enkelte patient.
English: • dark urine
Danish: • mørkfarvet urin
English: Mektovi is not recommended during pregnancy.
Danish: Mektovi bør ikke anvendes i graviditeten.
English: Rhabdomyolysis/Creatine phosphokinase (CK) elevation
Danish: Rabdomyolyse/stigning i kreatinfosfokinase (CK)
English: • Uncomplicated deep vein thrombosis (DVT) or pulmonary embolism (PE) ≤ Grade 3
Danish: • Ukompliceret dyb venetrombose (DVT) eller lungeemboli (PE) ≤ grad 3
English: The median time to first occurrence of LVD (any grade) was 4.4 months (range 0.03 to 21.3 months) in patients who developed an LVEF below 50 %.
Danish: Mediantiden til indtræden af første LVD (alle grader) var 4,4 måneder (interval 0,03 til 21,3 måneder) hos patienter, der fik LVEF under 50 %.
English: Dose reduction below 30 mg twice daily is not recommended.
Danish: Det frarådes at reducere dosis til under 30 mg to gange dagligt.
English: Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2.
Danish: Binimetinib er en ATP-ukompetitiv, reversibel hæmmer af kinaseaktiviteten af mitogen-aktiveret ekstracellulært signalreguleret kinase 1 (MEK1) og MEK2.
English: Most events were reported as retinopathy, retinal detachment, subretinal fluid, macular oedema, and chorioretinopathy and led to dose interruptions or dose modifications in 4.7 % (13/274) of patients.
Danish: De fleste af disse hændelser blev indberettet som retinopati, retinal løsning, subretinal væske, makulaødem og korioretinopati og førte til pausering eller justering af doseringen hos 4,7 % (13/274) af patienterne.
English: The safety of binimetinib has not been established in patients with predisposing factors for RVO including uncontrolled glaucoma, ocular hypertension, uncontrolled diabetes mellitus or a history of hyperviscosity or hypercoagulability syndromes.
Danish: Binimetinibs sikkerhed er ikke blevet klarlagt hos patienter med disponerende faktorer for RVO, herunder ukontrolleret glaukom, okulær hypertension, ukontrolleret diabetes mellitus eller tidligere hyperviskositets- eller hyperkoagulabilitetsyndrom.
English: • heart problems
Danish: • hjerteproblemer
English: The safety of binimetinib in combination with encorafenib has not been established in patients with a baseline LVEF that is either below 50 % or below the institutional LLN.
Danish: Sikkerheden af binimetinib i kombination med encorafenib er ikke blevet klarlagt hos patienter med LVEF ved baseline, som enten er under 50 % eller under LLN.
English: Visual impairment, including vision blurred and reduced visual acuity, occurred in 21.5 % (59/274) of patients.
Danish: Synsnedsættelse, herunder sløret syn og nedsat synsstyrke, forekom hos 21,5 % (59/274) af patienterne.
English: Cutaneous reactions • Grade2
Danish: Kutane reaktioner • Grad 2
English: The median (range) binimetinib terminal half-life (T1/2) was 8.66 h (8.10 to 13.6 h).
Danish: Medianværdien (interval) for binimetinibs terminale halveringstid (T1/2) var 8,66 t (8,10 til 13,6 t).
English: • Lung or breathing problems: This medicine may cause lung or breathing problems including inflammation of the lungs (pneumonitis or interstitial lung disease); signs and symptoms can include: cough, shortness of breath or fatigue.
Danish: • Lunge- eller vejrtrækningsproblemer: Dette lægemiddel kan forårsage lunge- eller vejrtrækningsproblemer, herunder lungebetændelse (pneumonitis eller interstitiel lungesygdom); tegn og symptomer herpå kan omfatte: hoste, stakåndethed eller træthed.
English: • some medicines to treat bacterial infections such as rifampicin, ciprofloxacin
Danish: • visse lægemidler til behandling af bakterieinfektioner såsom rifampicin, ciprofloxin
English: • lung or breathing problems
Danish: • lunge- eller vejrtrækningsproblemer
English: If you stop taking Mektovi
Danish: Hvis du holder op med at tage Mektovi
English: Binimetinib and encorafenib should be continued without any dose modifications.
Danish: Binimetinib og encorafenib bør fortsættes uden dosisjustering.
English: The incidence of Grade 3 or 4 adverse reactions was 5.8 % (16/274).
Danish: Forekomsten af bivirkninger af grad 3 eller 4 var 5,8 % (16/274).
English: Neuropathy peripheral*
Danish: Perifer neuropati*
English: Talk to your doctor immediately if you get blurred vision, loss of vision or other vision changes (such as coloured dots in your vision), halo (seeing blurred outline around objects).
Danish: Kontakt omgående lægen, hvis du får sløret syn, synstab eller andre ændringer af synet (f.eks. farvede pletter i dit synsfelt), korona (ser et sløret omrids rundt om genstande).
English: Pneumonitis/Interstitial lung disease
Danish: Pneumonitis/Interstitiel lungesygdom
English: Other side effects when Mektovi and encorafenib are taken together:
Danish: Andre bivirkninger ved samtidig brug af Mektovi og encorafenib:
English: CK and creatinine levels should be monitored monthly during the first 6 months of treatment and as clinically indicated.
Danish: CK- og kreatininniveauerne bør kontrolleres en gang om måneden i de første 6 måneder af behandlingen og efter klinisk behov.
English: 27 patients (5 %) had received prior checkpoint inhibitors (antiPD1/PDL1 or ipilimumab) (8 patients in Combo 450 arm (4 %); 7 patients in vemurafenib arm (4 %); 12 patients in Enco 300 arm (6 %) including 22 patients in the metastatic setting (6 patients in Combo 450 arm; 5 patients in vemurafenib arm; 11 patients in Enco 300 arm) and 5 patients in the adjuvant setting (2 patients in Combo 450 arm; 2 patients in vemurafenib arm; 1 patient in Enco 300 arm.
Danish: 27 patienter (5 %) havde fået forudgående behandling med checkpoint-hæmmere (anti-PD1/PDL1 eller ipilimumab) (8 patienter i Combo 450-armen (4 %); 7 patienter i vemurafenib-armen (4 %); 12 patienter i Enco 300-armen (6 %)), herunder 22 patienter med metastaser (6 patienter i Combo 450-armen; 5 patienter i vemurafenib-armen; 11 patienter i Enco 300-armen) og 5 patienter, som fik adjuverende behandling, (2 patienter i Combo 450-armen; 2 patienter i vemurafenib-armen; 1 patient i Enco 300-armen.
English: Part 1 of study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Danish: Del 1 af studie CMEK162B2301 blev der påvist en statistisk signifikant forbedring i PFS hos de patienter, der blev behandlet med Combo 450, i forhold til de patienter, der blev behandlet med vemurafenib.
English: Combination with encorafenib
Danish: Kombination med encorafenib
English: • Grade 3 or 4 LVEF decrease or symptomatic left ventricular dysfunction (LVD)
Danish: • Fald i LVEF af grad 3 eller 4 eller symptomatisk dysfunktion af venstre ventrikel (LVD)
English: Your doctor will run blood tests to check for muscle problems before and during treatment.
Danish: Lægen vil tage nogle blodprøver for at kontrollere for muskelproblemer før og under behandlingen.
English: Permanent discontinuation of binimetinib and encorafenib should be considered in patients who develops RAS mutation-positive non-cutaneous malignancies.
Danish: Permanent seponering af binimetinib og encorafenib bør overvejes hos patienter, der udvikler RASmutationspositive ikke-kutane maligniteter.
English: Avoid driving or using machines if you have any problems with your vision or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Mektovi.
Danish: Undlad at føre motorkøretøj og betjene maskiner, hvis du får synsproblemer eller får andre bivirkninger, som kan påvirke din evne til at føre motorkøretøj eller betjene maskiner, mens du tager Mektovi.
English: The median time to onset of the first event was 2.7 months (range: 0.5 to 17.5 months).
Danish: Mediantiden til indtræden af den første hændelse var 2,7 måneder (interval: 0,5 til 17,5 måneder).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with binimetinib 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 binimetinib i en eller flere undergrupper af den pædiatriske population med melanom (se pkt.
English: Binimetinib is a potential inducer of CYP1A2, and caution should be taken when it is used with sensitive substrates (such as duloxetine or theophylline).
Danish: Binimetinib er en potentiel inducer af CYP1A2, og der skal udvises forsigtighed, når det bruges sammen med følsomme substrater (såsom duloxetin eller theophyllin).
English: Effects of binimetinib on other medicinal products
Danish: Virkning af binimetinib på andre lægemidler
English: In cynomolgus monkeys, oral administration of binimetinib was associated with gastro-intestinal intolerance, moderate clinical pathology changes, bone marrow hypercellularity and microscopic findings of gastrointestinal inflammation, reversible at the lowest doses which were below human therapeutic exposures.
Danish: Hos cynomolgus-aber var oral administration af binimetinib forbundet med gastrointestinal intolerans, moderate kliniske patologiske forandringer, hypercellularitet i knoglemarven og mikroskopifund af gastrointestinal inflammation, som var reversible ved de laveste doser, som var under den terapeutiske eksponering hos mennesker.
English: Pneumonitis/ILD can occur with binimetinib.
Danish: Pneumonitis/ILD kan forekomme med binimetinib.
English: • Grade 2 Left ventricular ejection fraction (LVEF) decrease or asymptomatic, absolute decrease in LVEF of greater than 10 % from baseline that is below lower limit of normal (LLN)
Danish: Binimetinib venstre ventrikel (LVEF) af grad 2 eller asymptomatisk, absolut fald i LVEF, der er over 10 % i forhold til baseline, og som er under nedre normalgrænse (LLN)
English: Special attention should be paid to patients with neuromuscular conditions associated with CK elevation and rhabdomyolysis.
Danish: Der bør udvises særlig forsigtighed hos patienter med neuromuskulære tilstande forbundet med CK-stigninger og rabdomyolyse.
English: Binimetinib should be withheld for up to 4 weeks.
Danish: Binimetinib skal pauseres i op til 4 uger.
English: As binimetinib is primarily metabolised and eliminated via the liver, patients with moderate to severe hepatic impairment may have increased exposure.
Danish: Eftersom binimetinib primært metaboliseres og elimineres via leveren, kan eksponeringen være øget hos patienter med moderat til svært nedsat leverfunktion.
English: In addition, simulations to investigate the effect of 400 mg atazanavir (UGT1A1 inhibitor) on the exposure of 45 mg binimetinib predicted similar binimetinib Cmax in the presence or absence of atazanavir.
Danish: Simulationer med henblik på at undersøge indvirkningen af 400 mg atazanavir (UGT1A1-hæmmer) på eksponeringen for 45 mg binimetinib viste desuden ensartede Cmax-værdier for binimetinib, hvad enten atazanavir var til stede eller ej.
English: • a medicine used to treat breathing problems, theophylline.
Danish: • et lægemiddel, der bruges til behandling af vejrtrækningsproblemer, theophyllin
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reaction that may affect their ability to drive and use machines (see sections 4.4 and 4.8).
Danish: Patienter bør rådes til ikke at føre motorkøretøj eller anvende maskiner, hvis de oplever synsforstyrrelser eller andre bivirkninger, der kan påvirke deres evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: Benefits and risks should be carefully considered before administering binimetinib in combination with encorafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Danish: Fordele og ulemper bør overvejes nøje inden administration af binimetinib i kombination med encorafenib hos patienter med tidligere eller samtidig cancer forbundet med RAS-mutation.
English: The median time to definitive 10 % deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95 % CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95 % CI: 0.29, 0.72).
Danish: Mediantiden til definitiv 10 % forværring i FACT-M-scoren blev ikke nået i Combo 450-armen og var 22,1 måneder (95 % CI 15.2, NE) i vemurafenib-armen med en HR for forskellen på 0,46 (95 % CI 0,29; 0,72).
English: Mektovi film-coated tablets are yellow/dark yellow, unscored biconvex, oval film-coated tablets debossed with “A” on one side and “15” on the other side.
Danish: Mektovi filmovertrukne tabletter er gule/mørkegule, bikonvekse, ovale, filmovertrukne tabletter uden delekærv, der er præget med “A” på den ene side og “15” på den anden side.