FrancophonIA/ELRC3.0 huggingface dataset:
English: These data show that the efficacy of the combination would be lower in these patients.
Danish: Disse data viser, at virkningen af kombinationen ville være lavere hos disse patienter.
English: Specific inducers of these enzymes have not been studied and may result in a loss of efficacy.
Danish: specifikke inducere af disse enzymer er ikke blevet undersøgt og kan medføre et tab af effekt.
English: There is no specific treatment of overdose.
Danish: Der er ingen specifik behandling for overdosering.
English: Visual impairment was generally reversible.
Danish: Synsnedsættelse var generelt reversibel.
English: Mektovi is not recommended for children and adolescents under 18 years of age.
Danish: Mektovi bør ikke anvendes til børn og unge under 18 år.
English: Mektovi can be taken with food or between meals.
Danish: Mektovi kan tages sammen med mad eller mellem måltiderne.
English: Gilbert's syndrome
Danish: Gilberts syndrom
English: Frequency (All grades)
Danish: Hyppighed (alle grader)
English: EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
Danish: EU/1/18/1315/001 84 filmovertrukne tabletter EU/1/18/1315/002 168 filmovertrukne tabletter
English: • a particular change (mutation) in a gene responsible for producing a protein called BRAF, and
Danish: • en bestemt forandring (mutation) i et gen, der er ansvarligt for at producere et protein, der kaldes BRAF, og
English: PVC/PVDC/Alu blister containing 12 tablets.
Danish: PVC/PVDC/Alu-blister indeholdende 12 tabletter.
English: Each pack contains either 84 or 168 tablets.
Danish: Hver pakning indeholder enten 84 eller 168 tabletter.
English: Enrolment in Part 2 started after all Part 1 patients were randomised.
Danish: Rekruttering til Del 2 startede, efter at alle Del 1patienter var blevet randomiseret.
English: The tablets are to be swallowed whole with water.
Danish: Tabletterne skal synkes hele med vand.
English: Mektovi is for oral use.
Danish: Mektovi er til oral anvendelse.
English: PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Danish: Den investigatorvurderede PFS (investigatorvurdering) var en understøttende analyse.
English: It is important to take Mektovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Danish: Det er vigtigt, at du tager Mektovi, så længe lægen foreskriver det. Du må ikke stoppe behandlingen, medmindre lægen siger det.
English: No overall differences in safety or efficacy were observed between elderly patients (≥ 65) and younger patients.
Danish: Der blev ikke set nogen overordnede forskelle i sikkerheden eller virkningen mellem ældre patienter (≥65) og yngre patienter.
English: Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2).
Danish: Kontakt straks lægen, hvis du får en af følgende alvorlige bivirkninger for første gang, eller hvis den bliver værre (se også afsnit 2):
English: In humans, the blood-to-plasma ratio is 0.718.
Danish: Hos mennesker er blod-plasma-ratioen 0,718.
English: After oral administration, binimetinib is rapidly absorbed with a median Tmax of 1.5 hours.
Danish: Efter oral administration absorberes binimetinib hurtigt med en median Tmax på 1,5 timer.
English: If necessary, your doctor may interrupt your treatment or stop it altogether.
Danish: Om nødvendigt vil lægen afbryde behandlingen midlertidigt eller stoppe den helt.
English: Age, body weight
Danish: Alder, legemsvægt
English: You will also receive treatment with another medicine, encorafenib.
Danish: Du vil også blive behandlet med et andet lægemiddel, encorafenib.
English: Table 4 and Figure 1 summarise the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
Danish: Tabel 4 og figur 1 opsummerer PFS og andre effektresultater baseret på en central datagennemgang udført af en blindet uafhængig radiologikomité.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Danish: I tilfælde af overdosering bør patienten have understøttende behandling med passende monitorering efter behov.
English: Besides the serious side effects mentioned above, people taking Mektovi and encorafenib together may also get the following side effects.
Danish: Udover ovenstående alvorlige bivirkninger kan personer, der tager Mektovi og encorafenib sammen, også få følgende bivirkninger.
English: In the small group of patients aged ≥ 75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
Danish: I den lille gruppe af patienter, der var ≥75 år (n=15), havde patienterne større sandsynlighed for at opleve alvorlige uønskede hændelser og uønskede hændelser, der førte til seponering af behandlingen.
English: Then continue taking your tablets at regular times as usual.
Danish: Fortsæt så med at tage tabletterne på de normale tidspunkter.
English: CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease.
Danish: CI = konfidensinterval; CR = komplet respons; DCR = sygdomskontrolrate (CR+PR+SD+Non-CR/Non-PD; Non-CR/Non-PD gælder kun patienter uden en target-læsion, som ikke opnåede CR eller havde PD); HR = hazard ratio; NE = ikke-estimerbar; PFS = progressionsfri overlevelse; PR = delvist respons; SD = stabil sygdom.
English: If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently.
Danish: Hvis du får alvorlige bivirkninger (såsom hjerte-, øjen- eller hudproblemer), kan lægen nedsætte din dosis eller stoppe behandlingen midlertidigt eller permanent.
English: LVEF should be evaluated every 2 weeks.
Danish: LVEF skal vurderes hver 2. uge
English: • vomit containing blood or that looks like “coffee grounds”
Danish: • opkastning, der indeholder blod eller ligner ”kaffegrums”
English: • Heart problems: Mektovi can make your heart work less well, or make existing heart problems worse.
Danish: • Hjerteproblemer: Mektovi kan få dit hjerte til at arbejde mindre godt eller forværre eksisterende hjerteproblemer.
English: LVD was generally reversible following dose reduction or dose interruption.
Danish: LVD var generelt reversibelt efter dosisreduktion eller pausering.
English: Mektovi is an anti-cancer medicine that contains the active substance binimetinib.
Danish: Mektovi er et lægemiddel mod kræft, som indeholder det aktive stof binimetinib.
English: Usually, these skin cancers (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can continue without interruption.
Danish: Disse tilfælde af hudkræft (se også afsnit 2) er som regel begrænset til et lille område og kan fjernes ved en operation, og behandlingen med Mektovi (og encorafenib) kan fortsætte uden afbrydelser.
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Danish: Patienterne bør vurderes for symptomer på nye eller forværrede synsforstyrrelser ved alle besøg.
English: In urine, 6.5 % of the radioactivity was excreted as binimetinib.
Danish: I urinen blev 6,5 % af radioaktiviteten udskilt som binimetinib.
English: In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK.
Danish: Ved melanomer og andre cancertyper aktiveres denne signalvej ofte af muterede former af BRAF, som aktiverer MEK.
English: • a cool, pale arm or leg
Danish: • kold, bleg arm eller ben
English: In particular, tell your doctor if you are taking anything in this list or any other medicines:
Danish: Det er særligt vigtigt, at du fortæller det til lægen, hvis du tager noget fra denne liste eller anden medicin:
English: Your doctor will examine your eyes for any problems with your sight while you are taking Mektovi.
Danish: Lægen vil undersøge dine øjne for eventuelle synsproblemer, mens du tager Mektovi.
English: A minimal risk for photosensitisation was shown in vivo at an oral dose providing 3.8-fold higher exposure than that achieved with the recommended dose in humans.
Danish: Der blev påvist en minimal risiko for fotosensibilisering in vivo med en oral dosis, der medførte en eksponering, der var 3,8 gange højere end den eksponering, der opnås hos mennesker ved brug af den anbefalede dosis.
English: Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by standard therapy as appropriate.
Danish: Blodtrykket bør måles ved baseline og overvåges under behandlingen, og hypertension bør kontrolleres med standardbehandling efter behov.
English: The potential embryo-foetal effects of binimetinib were evaluated in rats and rabbits.
Danish: De potentielle embryoføtale virkninger af binimetinib er blevet evalueret hos rotter og kaniner.
English: If you vomit at any time after taking Mektovi, do not take an additional dose.
Danish: Hvis du kaster op, efter du har taget Mektovi, skal du ikke tage en ekstra dosis.
English: As a precaution, drink plenty of fluids during treatment.
Danish: Som forholdsregel skal du drikke rigelig væske under behandlingen.
English: Number of events (progressive disease(PD)) (%)
Danish: Antal hændelser (progressiv sygdom (PD)) (%)
English: 84 film-coated tablets 168 film-coated tablets
Danish: 84 filmovertrukne tabletter 168 filmovertrukne tabletter
English: Binimetinib has phototoxic potential in vitro.
Danish: Binimetinib har fototoksisk potentiale in vitro.
English: • bleeding problems or if you are taking medicines that may cause bleeding
Danish: • blødningsproblemer; eller om du bruger medicin, der kan forårsage blødning
English: 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: Dose modifications recommendations in case of adverse reactions are presented below and in Tables 1 and 2.
Danish: De anbefalede dosisjusteringer i tilfælde af bivirkninger er anført i tabel 1 og 2 nedenfor.
English: • halo (seeing blurred outline around objects)
Danish: • haloer (du ser uskarpe konturer omkring ting)
English: When Mektovi is used in combination with encorafenib (which targets the changed “BRAF” protein), the combination slows down or stops the growth of your cancer.
Danish: Når Mektovi anvendes i kombination med encorafenib (som er rettet mod det ændrede ”BRAF”-protein), hæmmer kombinationen væksten af din kræft eller stopper den.
English: After repeat twice-daily dosing concomitantly with encorafenib, steady-state conditions for binimetinib were reached within 15 days with no major accumulation.
Danish: Efter gentagen dosering to gange dagligt samtidig med encorafenib blev steady-state for binimetinib nået i løbet af 15 dage uden større akkumulation.
English: There are insufficient data to evaluate potential differences in the exposure of binimetinib by race or ethnicity.
Danish: Der er utilstrækkelige data til at evaluere potentielle forskelle i eksponeringen for binimetinib på baggrund af race eller etnicitet.
English: Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each) or 168 tablets (14 blisters of 12 tablets each).
Danish: Mektovi fås i pakninger med 84 tabletter (7 blisterkort med 12 tabletter hver) eller 168 tabletter (14 blisterkort med 12 tabletter hver).
English: Tell your doctor if you have ever had blockage in the vein carrying blood away from the eye (retinal vein occlusion), as Mektovi is not recommended in such cases.
Danish: Fortæl det til lægen, hvis du nogensinde har haft en tilstopning af den blodåre, der fører blodet væk fra øjet (retinal veneokklusion), da Mektovi ikke bør anvendes i sådanne tilfælde.
English: • eye problems including glaucoma or increased pressure in your eyes
Danish: • øjenproblemer, herunder grøn stær eller øget tryk i øjet
English: If binimetinib is used during pregnancy, or if the patient becomes pregnant while taking binimetinib, the patient should be informed of the potential hazard to the foetus.
Danish: Hvis binimetinib anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun tager binimetinib, skal hun oplyses om de mulige risici for fostret.
English: Muscular disorders/Myalgiah
Danish: Muskelforstyrrelser/myalgih
English: Mektovi targets another protein called “MEK” that stimulates cancer cell growth.
Danish: Mektovi er rettet mod et andet protein, der hedder ”MEK”, og som stimulerer væksten af kræftceller.
English: Serious side effects Mektovi may cause serious side effects.
Danish: Alvorlige bivirkninger Mektovi kan forårsage alvorlige bivirkninger.
English: Package leaflet: Information for the patient Mektovi 15 mg film-coated tablets binimetinib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Mektovi 15 mg filmovertrukne tabletter binimetinib Dette lægemiddel er underlagt supplerende overvågning.
English: Tell your doctor right away if you have any unusual bleeding or signs of bleeding, including:
Danish: Kontakt straks lægen, hvis du får usædvanlige blødninger eller tegn på blødning, herunder:
English: These differences were within the variability observed for these parameters in both cohorts of this study (25 % - 49 %) and the variability previously observed in patient clinical studies, hence these differences are unlikely to be clinically relevant.
Danish: Disse forskelle lå inden for den observerede variabilitet for disse parametre i begge kohorter i dette studie (25 % - 49 %) og den variabilitet, der tidligere er set hos patienter i kliniske studier.
English: Most of these cases were Grade 1 or 2 (14.6 %) and 3.3 % were Grade 3 or 4 events.
Danish: De fleste af disse tilfælde var af grad 1 eller 2 (14,6 %), og 3,3 % var hændelser af grad 3 eller 4.
English: See section 2 “Mektovi contains lactose”.
Danish: Se afsnit 2 ”Mektovi indeholder lactose”.
English: Contact your doctor straightaway if you become pregnant while taking Mektovi.
Danish: Kontakt omgående lægen, hvis du bliver gravid, mens du tager Mektovi.
English: Binimetinib dose should be maintained and it should be ensured that patient is adequately hydrated.
Danish: Binimetinib-dosen skal fastholdes, og der skal sørges for tilstrækkelig hydrering af patienten.
English: In vitro experiments indicate that binimetinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: In vitro-undersøgelser viser, at binimetinib er et substrat for P-glykoprotein (P-gp) og brystcancerresistent protein (BCRP).
English: Binimetinib should be withheld for up to 2 weeks and ophthalmic monitoring should be repeated including visual acuity assessment.
Danish: Binimetinib skal pauseres i op til 2 uger, og oftalmisk monitorering, herunder synsstyrkevurdering, skal gentages.
English: The tablets also contain lactose.
Danish: Tabletterne indeholder også lactose.
English: Prior treatment with BRAF/MEK inhibitors was not allowed.
Danish: Forudgående behandling med BRAF-/MEK-hæmmere var ikke tilladt.
English: • some medicines typically used to treat epilepsy such as phenobarbital, phenytoin,
Danish: • visse lægemidler, der typisk bruges til behandling af epilepsi såsom phenobarbital, phenytoin,
English: The number of viable foetuses and foetal body weights were reduced and post-implantation loss and resorptions were increased.
Danish: Antallet af levedygtige fostre og fostrenes kropsvægt var reduceret, og der var øgede postimplantationstab og resorptioner.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES)
Danish: Palmoplantart erythrodysæstesisyndrom (PPES)
English: The mean (CV %) apparent clearance (CL/F) of binimetinib was 28.2 L/h (17.5 %).
Danish: Den gennemsnitlige (CV %) tilsyneladende clearance (CL/F) af binimetinib var 28,2 l/t (17,5 %).
English: A definitive 10% deterioration in FACT-M and in EORTC QLQ-C30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Danish: En definitiv 10 % forværring i FACT-M og EORTC QLQ-C30 blev signifikant udskudt hos de patienter, der blev behandlet med Combo 450, i forhold til andre behandlinger.
English: If a dose of binimetinib is missed, it should not be taken if it is less than 6 hours until the next dose is due.
Danish: Hvis en dosis af binimetinib bliver glemt, skal dosen ikke tages, hvis der er mindre end 6 timer til den næste dosis.
English: Therefore, binimetinib should be used with caution in these patients.
Danish: Binimetinib bør derfor anvendes med forsigtighed hos sådanne patienter.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: These data indicate that there is minimal risk for phototoxicity with binimetinib at therapeutic doses in patients.
Danish: Disse data tyder på, at der er minimal risiko for fototoksicitet ved brug af binimetinib i terapeutiske doser hos patienter.
English: • a medicine for carcinoma treatment called sorafenib
Danish: • et lægemiddel til karcinombehandling kaldet sorafenib
English: Updated analysis, cut-off date: 07 November 2017
Danish: Opdateret analyse, skæringsdato: 7. november 2017 PFS
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: The proportion of patients experiencing adverse events and serious adverse events were similar in patients aged <65 years and those aged > 65 years.
Danish: Andelen af patienter, der oplevede uønskede hændelser og alvorlige uønskede hændelser var ens hos patienter <65 år og patienter ≥65 år.
English: Binimetinib is more distributed in plasma than blood.
Danish: Binimetinib har højere fordeling i plasma end i blod.
English: Based on a population pharmacokinetic analysis, age or body weight do not have a clinically important effect on the systemic exposure of binimetinib.
Danish: Baseret på en populationsfarmakokinetisk analyse har alder eller legemsvægt ingen klinisk betydelig indvirkning på den systemiske eksponering for binimetinib.
English: Carcinogenic potential of binimetinib was not evaluated.
Danish: Binimetinibs karcinogene potentiale blev ikke vurderet.
English: Binimetinib is a weak inhibitor of OAT3.
Danish: Binimetinib er en svag hæmmer af OAT3.
English: Binimetinib has not been evaluated in patients with Gilbert's disease.
Danish: Binimetinib er ikke blevet undersøgt hos patienter med Gilberts sygdom.
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, AR00426032 (M3) by oxidative N-desmethylation.
Danish: In vitro katalyserer CYP1A2 og CYP2C19 dannelse af den aktive metabolit, AR00426032 (M3) via oxidativ N-desmethylering.
English: The safety and efficacy of binimetinib in children and adolescents have not yet been established.
Danish: Pædiatrisk population Binimetinibs sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE41
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE41
English: • Symptomatic RPED (Grade 4) associated with reduced visual acuity (Grade 4)
Danish: • Symptomatisk RPED (grad 4) forbundet med nedsat synsstyrke (grad 4)
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: In clinical study sub-analysis, however, there was no apparent relationship observed between binimetinib exposure and UGT1A1 mutation status.
Danish: I underanalyser i kliniske studier blev der imidlertid ikke set noget tydeligt forhold mellem eksponeringen for binimetinib og UGT1A1-mutationsstatus.
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: Dose re-escalation to 45 mg twice daily is not recommended if the dose reduction is due to left ventricular dysfunction (LVD) or any Grade 4 toxicity.
Danish: Det frarådes at øge dosis til 45 mg to gange dagligt, hvis dosisreduktionen skyldes dysfunktion i venstre ventrikel (LVD) eller toksicitet af grad 4.
English: Binimetinib has minor influence on the ability to drive or use machines.
Danish: Binimetinib påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: What you need to know before you take Mektovi 3.
Danish: Det skal du vide, før du begynder at tage Mektovi 3.
English: For patients receiving 45 mg binimetinib twice daily, the recommended reduced dose of binimetinib is 30 mg twice daily.
Danish: Til patienter, der får 45 mg binimetinib to gange dagligt, er den anbefalede reducerede dosis af binimetinib er 30 mg to gange dagligt.
English: If you miss a dose of Mektovi, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: Transaminase increased*
Danish: Øgede transaminaser*
English: • some medicines to treat HIV such as indinavir, atazanavir
Danish: • visse lægemidler til behandling af hiv såsom indinavir, atazanavir
English: A decision must be made whether to discontinue breast-feeding or to discontinue Mektovi 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 Mektovi skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Your doctor will check your skin before initiation of treatment, every 2 months during treatment, and for up to 6 months after you stop taking these medicines to look for any new skin cancer.
Danish: Lægen vil kontrollere din hud for ny hudkræft inden behandlingen, hver anden måned under behandlingen og i op til seks måneder, efter du er stoppet med at tage disse lægemidler.
English: Binimetinib should be permanently discontinued in patients diagnosed with treatment related pneumonitis or ILD.
Danish: Binimetinib bør seponeres permanent hos patienter, der får diagnosticeret behandlingsrelateret pneumonitis eller ILD.
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: Tell your doctor if you have had a different type of cancer than melanoma, as binimetinib when taken with encorafenib may worsen certain other types of cancers.
Danish: Fortæl det til lægen, hvis du har haft en anden type kræft end melanom, da binimetinib kan forværre visse andre kræfttyper, når det anvendes sammen med encorafenib.
English: The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with encorafenib 300 mg 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 encorafenib 300 mg, og 6,2 måneder hos de patienter, der blev behandlet med vemurafenib.
English: • feeling like your heart is pounding, racing or beating irregularly
Danish: • følelse af, at hjertet hamrer, galoperer eller slår uregelmæssigt