FrancophonIA/ELRC3.0 huggingface dataset:
English: Trametinib should be taken orally with a full glass of water.
Danish: Trametinib skal tages oralt med et helt glas vand.
English: Your doctor or nurse should check your blood pressure during treatment with Mekinist.
Danish: Lægen eller sundhedspersonalet vil måle dit blodtryk under din behandling med Mekinist.
English: Store in a refrigerator in the original bottle.
Danish: Opbevares i køleskab i den originale beholder.
English: Most patients (94%) enrolled in the combination-therapy-treated cohorts had an ECOG performance status of 0 or 1.
Danish: De fleste patienter (94 %), der blev inkluderet i kohorterne med kombinationsbehandling, havde ECOG-performancestatus 0 eller 1.
English: Most of the findings are reversible after drug-free recovery.
Danish: De fleste fund er reversible efter restitution uden lægemidlet.
English: Check with your doctor if you think this applies to you.
Danish: Tal med lægen, hvis du tror, dette gælder for dig.
English: Mekinist can cause heart problems, or make existing heart problems worse (see also “Heart conditions” in section 4) in people taking Mekinist in combination with dabrafenib.
Danish: Mekinist kan give hjerteproblemer eller forværre allerede eksisterende hjerteproblemer (se også “Hjerteproblemer” i punkt 4) hos personer, der tager Mekinist i kombination med dabrafenib.
English: Possible side effects in patients taking Mekinist alone
Danish: Bivirkninger hos patienter, der tager Mekinist alene
English: • have or have ever had kidney problems.
Danish: • har eller har haft nyreproblemer.
English: There are insufficient data to evaluate the potential effect of race on trametinib pharmacokinetics as clinical experience is limited to Caucasians.
Danish: Der er ikke tilstrækkelige data til at vurdere den potentielle effekt af race på trametinibs farmakokinetik, da den kliniske erfaring er begrænset til kaukasere.
English: The management of adverse reactions may require dose reduction, treatment interruption or treatment discontinuation (see Tables 1 and 2).
Danish: Håndteringen af bivirkninger kan kræve dosisreduktion, pausering af behandlingen eller seponering af behandlingen (se tabel 1 og 2).
English: Withhold trametinib for up to 3 weeks.
Danish: Pausér behandlingen med trametinib i op til 3 uger.
English: Grade 2-3 RPED
Danish: RPED af grad 2-3
English: Others may develop a type of skin cancer called basal cell carcinoma (BCC).
Danish: Andre kan udvikle en form for hudkræft, der kaldes basalcellekarcinom (BCC).
English: More frequent dose adjustments (see Tables 1 and 2 above) may be required in patients >65 years of age (see section 4.8).
Danish: Det kan være nødvendigt at justere dosis hyppigere (se tabel 1 og 2 ovenfor) hos patienter > 65 år (se pkt.
English: Of the hepatic adverse reactions, increased ALT and AST were the most common events and the majority were either Grade 1 or 2.
Danish: Af leverpåvirkningerne var forhøjet ALAT og ASAT de hyppigst forekommende, og størstedelen var enten af grad 1 eller 2.
English: Most patients (66%) received no prior chemotherapy for advanced or metastatic disease.
Danish: De fleste patienter (66 %) havde ikke tidligere fået kemoterapi mod fremskreden eller metastatisk sygdom.
English: It is recommended that you do not breast-feed while you are taking Mekinist.
Danish: Det anbefales, at du ikke ammer, mens du tager Mekinist.
English: Your doctor may ask you to stop taking Mekinist or refer you to a specialist, if you develop signs and symptoms in your vision that include:
Danish: Lægen vil måske stoppe din behandling med Mekinist eller henvise dig til en specialist, hvis du udvikler tegn og symptomer på øjenproblemer, der omfatter:
English: Based on the population pharmacokinetic analysis (range 19 to 92 years), age had no relevant clinical effect on trametinib pharmacokinetics.
Danish: På basis af den farmakokinetiske populationsanalyse (interval 19 til 92 år) havde alder ingen relevant klinisk effekt på trametinibs farmakokinetik.
English: It is not known whether trametinib is excreted in human milk.
Danish: Det vides ikke, om trametinib udskilles i human mælk.
English: • If you miss a dose of Mekinist or dabrafenib, take it as soon as you remember: Do not make up for missed doses and just take your next dose at your regular time: o If it is less than 12 hours to your next scheduled dose of Mekinist, which is taken once daily.
Danish: • Hvis du glemmer at tage en dosis af Mekinist eller dabrafenib, skal du tage den, så snart du kommer i tanke om det. Erstat ikke glemte doser, og tag blot din næste dosis på det sædvanlige tidspunkt: o Hvis der er mindre end 12 timer til din næste planlagte dosis af Mekinist, som tages en gang dagligt.
English: Measurement of patients' BRAF V600 mutation status was required.
Danish: Måling af patienternes BRAF V600-mutationsstatus var påkrævet.
English: Patients in the chemotherapy arm were allowed to cross over to the trametinib arm after independent confirmation of progression.
Danish: Patienter i kemoterapi-armen kunne skifte over til trametinib-armen efter uafhængig bekræftelse af sygdomsprogression.
English: Following single and repeated doses of trametinib, trametinib as parent is the main circulating component in plasma.
Danish: Efter enkeltdoser og gentagne doser af trametinib er moderstoffet den primære cirkulerende forbindelse i plasma.
English: Your doctor should check your heart function before and during treatment.
Danish: Din læge bør undersøge din hjertefunktion før og under behandling.
English: When you take Mekinist and dabrafenib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).
Danish: Når du tager Mekinist og dabrafenib sammen, kan du måske få en hvilken som helst af de bivirkninger, der er angivet ovenfor, omend hyppigheden kan ændre sig (hyppigere eller sjældnere).
English: Based on its mechanism of action, dabrafenib may increase the risk of non-cutaneous malignancies when RAS mutations are present.
Danish: Baseret på virkningsmekanismen kan dabrafenib øge risikoen for ikke-kutane maligniteter, når der er RAS-mutationer til stede.
English: A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect trametinib oral clearance.
Danish: En farmakokinetisk populationsanalyse indikerer, at et let forhøjet bilirubin- og/eller ASAT-niveau (baseret på klassifikationen fra National Cancer Institute [NCI]) ikke påvirker clearance af oralt trametinib signifikant.
English: The bottles also include a silica gel desiccant in a small cylinder shaped container.
Danish: Beholderen indeholder også et tørremiddel bestående af silicagel i en lille cylinderformet beholder.
English: Primary tumour or tumour from a metastatic site was tested with a validated polymerase chain reaction (PCR) assay developed by Response Genetics Inc.
Danish: Væv fra den primære tumor eller tumorvæv fra en metastase blev testet med en valideret polymerasekædereaktion (PCR)-analyse udviklet af Response Genetics Inc.
English: This is to look for any new skin cancers.
Danish: Det er for at se, om der er nye forekomster af hudkræft.
English: In the previously-treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease.
Danish: I den behandlingserfarne population havde 38 patienter (67 %) fået en linje systemisk anti-cancerbehandling for metastatisk sygdom.
English: In the clinical trials only patients with cutaneous melanoma were studied.
Danish: I de kliniske forsøg blev kun patienter med kutant melanom undersøgt.
English: Trametinib has a volume of distribution of approximately 1200 L determined following administration of a 5 g intravenous microdose.
Danish: Trametinib har et fordelingsvolumen på ca. 1.200 l bestemt efter intravenøs administration af en mikrodosis på 5 g.
English: Figure 3 Kaplan-Meier curves of overall survival (OS -ad hoc analysis 20 May 2013)
Danish: Figur 3 Kaplan-Meier-kurver over den samlede overlevelse (OS - ad hoc-analyse den 20. maj 2013)
English: • have heart problems such as heart failure (which can cause shortness of breath, difficulty in breathing when lying down, swelling of the feet or legs) or problems with the way your heart beats.
Danish: • har hjerteproblemer, såsom hjertesvigt (som kan forårsage åndenød, vejrtrækningsbesvær, når du ligger ned, og hævede fødder eller ben) eller problemer med den måde, dit hjerte slår på.
English: The following convention has been utilised for the classification of frequency: Very common ≥1/10
Danish: Bivirkningerne er anført nedenfor efter systemorganklasse i henhold til MedDRA. Der er benyttet følgende konvention til klassificering af hyppigheden: Meget almindelig ≥ 1/10
English: Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Danish: En gynækologisk undersøgelse (for kvinder) og en anal undersøgelse anbefales også ved behandlingens start og afslutning.
English: Some people taking Mekinist in combination with dabrafenib may also notice that new melanomas have appeared.
Danish: Nogle personer, der tager Mekinist i kombination med dabrafenib, bemærker muligvis også, at der er opstået nye melanomer.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE25
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmer, ATC-kode: L01XE25
English: Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Danish: Ikke-kliniske og kliniske forsøg med retrospektive bidirektionelle Sanger-sekvensanalyser har vist, at testen også identificerer den ikke så almindelige BRAF V600D-mutation og V600E/K601E-mutation med lavere sensitivitet.
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Danish: MEK-proteiner er komponenter i den ekstracellulært signal-regulerede kinase (ERK)-pathway.
English: Medicinal product interactions
Danish: Interaktioner mellem lægemidler
English: Take Mekinist tablets and dabrafenib capsules with you when possible.
Danish: Tag Mekinist-tabletterne og dabrafenib-kapslerne med dig, hvis det er muligt.
English: In addition, men who are taking dabrafenib may have a reduced sperm count, and their sperm count may not return to normal levels after they stop taking this medicine.
Danish: Derudover kan mænd, som tager dabrafenib, have nedsat sædkvalitet (nedsat antal sædceller), og deres sædkvalitet bliver muligvis ikke normal igen, efter de er holdt op med at tage dette lægemiddel.
English: Subjects at Risk:
Danish: Antal med risiko:
English: • Bleeding, at various sites in the body, which may be mild or serious
Danish: • blødninger forskellige steder i kroppen, som kan være lette eller alvorlige
English: If you forget to take Mekinist
Danish: Hvis du har glemt at tage Mekinist
English: Subsequently, all patient samples were re-tested using the CE-marked bioMerieux (bMx) THxID BRAF validated assay.
Danish: Dernæst blev alle prøver fra patienterne testet igen ved brug af den CE-mærkede validerede bioMerieux (bMx) THxID BRAF-analyse.
English: Trametinib should not be administered to pregnant women.
Danish: Trametinib må ikke administreres til gravide kvinder.
English: Up to 3 in 100 people taking Mekinist in combination with dabrafenib may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Danish: Op til 3 ud af 100 personer, der tager Mekinist i kombination med dabrafenib, kan udvikle en anden form for hudkræft, der kaldes kutant pladecellekarcinom (cuSCC).
English: Mekinist can cause eye problems including blindness.
Danish: Mekinist kan give øjenproblemer, herunder blindhed.
English: In rats, hypertrophy of the physis and increased bone turnover were observed, but the physeal hypertrophy is not expected to be clinically relevant for adult humans.
Danish: Hos rotter blev der observeret hypertrofi af epifyseskiverne og øget knogleomsætning, men hypertrofien forventes ikke at være klinisk relevant for voksne mennesker.
English: Before you take Mekinist in combination with dabrafenib your doctor needs to know if you:
Danish: Inden du tager Mekinist i kombination med dabrafenib, skal lægen vide, om du:
English: The film-coated tablets are supplied in opaque white plastic bottles with threaded plastic closures.
Danish: De filmovertrukne tabletter leveres i uigennemsigtige, hvide plastikbeholdere med plastiklåg med gevind.
English: Chemotherapy a
Danish: Kemoterapi a
English: Your doctor may advise an eye examination before you take Mekinist and while you are taking it.
Danish: Lægen vil måske henvise dig til en øjenundersøgelse, før du begynder at tage Mekinist, og mens du tager det.
English: August 2016 NE: Not Evaluable Median PFS currently not estimable Event rate for OS calculation was 28% and hence the defined median value still needs to mature
Danish: Median PFS kan ikke estimeres på nuværende tidspunkt Andelen af hændelser for beregning af OS var 28 %, og den definerede median-værdi er derfor endnu ikke moden
English: You will be checked for any heart problems while you are taking Mekinist.
Danish: Det vil løbende blive kontrolleret, om du har hjerteproblemer, mens du tager Mekinist.
English: papilloma (a type of skin tumour which is usually not harmful), wart-like growths, increased sensitivity of the skin to sun (see also “Changes in your skin” earlier in section 4)
Danish: papillom (en form for hudtumor, som normalt ikke er farlig), vortelignende vækster, øget følsomhed af huden over for solen (se også ”Forandringer i huden” tidligere i punkt 4)
English: Kaplan-Meier curves of investigator-assessed OS (post-hoc analysis 20 May 2013) is presented in Figure 3.
Danish: Kaplan-Meier-kurver over OS i henhold til investigators vurdering (post hoc-analyse den 20. maj 2013) er vist i figur 3.
English: Your disease symptoms and treatment situation may also affect your ability to drive or use machines.
Danish: Din sygdom, dine symptomer og din behandlingssituation kan også påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: As it cannot be excluded that strong inhibition of hepatic P-gp may result in increased levels of trametinib, caution is advised when co-administering trametinib with medicinal products that are strong inhibitors of P-gp (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole).
Danish: Da det ikke kan udelukkes, at stærk hæmning af hepatisk P-gp kan resultere i øgede trametinibniveauer, anbefales det at udvise forsigtighed, når trametinib administreres sammen med lægemidler, der er potente P-gp-hæmmere (fx verapamil, ciclosporin, ritonavir, kinidin, itraconazol).
English: Table 3 Recommended dose modifications for trametinib for RPED
Danish: Tabel 3 Anbefalede justeringer af trametinibdosis ved RPED
English: Please read the dabrafenib Package Leaflet for details of the side effects you may get when taking this medicine.
Danish: Læs indlægssedlen for dabrafenib med oplysninger om de bivirkninger, du kan få ved at tage dette lægemiddel.
English: Effect of trametinib on other medicinal products
Danish: Trametinibs effekt på andre lægemidler
English: It is used either on its own or in combination with another medicine containing dabrafenib to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery.
Danish: Det anvendes enten alene eller i kombination med et lægemiddel, der indeholder dabrafenib, til at behandle en form for hudkræft, der kaldes malignt melanom, som har spredt sig til andre dele af kroppen eller ikke kan fjernes ved operation.
English: In the Phase III study with trametinib in patients with unresectable or metastatic melanoma (n=211), 49 patients (23%) were ≥65 years of age, and 9 patients (4%) were ≥75 years of age.
Danish: I fase III-studiet med trametinib hos patienter med inoperabelt eller metastatisk melanom (n = 211) var 49 patienter (23 %) ≥ 65 år, og 9 patienter (4 %) var ≥ 75 år.
English: The mean absolute bioavailability of a single 2 mg tablet dose is 72% relative to an intravenous (IV) microdose.
Danish: Den gennemsnitlige absolutte biotilgængelighed af en enkelt 2 mg tablet-dosis er 72 % i forhold til en intravenøs (i.v.)
English: Mekinist should only be used to treat melanomas and NSCLC with the BRAF mutation.
Danish: Mekinist må kun anvendes til behandling af melanomer og NSCLC med BRAF-mutation.
English: Tell your doctor if you have any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue.
Danish: Fortæl det til lægen, hvis du har lunge- eller vejrtrækningsproblemer, herunder vejrtrækningsbesvær, som ofte er ledsaget af en tør hoste, åndenød og træthed.
English: You and your doctor will decide whether you will take Mekinist or breast-feed.
Danish: Du og din læge vil sammen afgøre, om du skal tage Mekinist eller amme.
English: Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.
Danish: Trametinib er en reversibel, høj-selektiv, allosterisk hæmmer af aktivering og kinaseaktivitet af mitogenaktiveret ekstracellulært signal-reguleret kinase 1 (MEK1) og MEK2.
English: The assay was specifically designed to differentiate between the V600E and V600K mutations.
Danish: Analysen var specifikt designet til at kunne skelne mellem V600E- og V600Kmutationerne.
English: Take Mekinist once a day, on an empty stomach (at least 1 hour before a meal or 2 hours after a meal).
Danish: Tag Mekinist en gang om dagen på tom mave (mindst 1 time før et måltid eller mindst 2 timer efter et måltid).
English: The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Danish: Analysen var designet til at identificere BRAF V600E- og V600K-mutationerne med høj sensitivitet (ned til 5 % V600E- og V600K-sekvens i en baggrund af vildtypesekvens ved brug af DNA ekstraheret fra FFPE-væv).
English: It is recommended that the dose of trametinib is taken at a similar time every day.
Danish: Det anbefales, at trametinib tages på omtrent samme tidspunkt hver dag.
English: Contains desiccant, do not remove or eat.
Danish: Indeholder tørremiddel, som ikke må tages ud eller spises.
English: Pack sizes: One bottle contains either 7 or 30 tablets.
Danish: Pakningsstørrelser: Hver beholder indeholder enten 7 eller 30 tabletter.
English: • Swelling around the eyes
Danish: • hævelse omkring øjnene
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with this medicine.
Danish: Lægen vil foretage nogle undersøgelser for at kontrollere, om dit hjerte fungerer, som det skal, før og under behandlingen med dette lægemiddel.
English: Before starting treatment, tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Før du starter behandlingen, skal du fortælle lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Studies in juvenile animals have shown adverse effects of trametinib which were not observed in adult animals (see section 5.3).
Danish: Studier med unge dyr har vist bivirkninger ved trametinib, som ikke blev observeret hos vokne dyr (se pkt.
English: Based on a population pharmacokinetic analysis, gender and body weight were found to influence trametinib oral clearance.
Danish: På basis af en farmakokinetisk populationsanalyse fandt man, at køn og legemsvægt havde indflydelse på clearance af oralt trametinib.
English: If the missed dose is less than 12 hours late, take it as soon as you remember.
Danish: Hvis den glemte dosis skulle være taget for mindre end 12 timer siden, skal du tage den, så snart du kommer i tanke om det.
English: In embryo-foetal developmental toxicity studies in rats and rabbits, trametinib induced maternal and developmental toxicity.
Danish: I studier vedrørende embryoføtal udviklingstoksicitet hos rotter og kaniner inducerede trametinib maternel toksicitet og udviklingstoksicitet.
English: The bMx THxID BRAF assay is an allele-specific PCR performed on DNA extracted from FFPE tumour tissue.
Danish: bMx THxID BRAF-analysen er en allelspecifik PCR-analyse udført på DNA ekstraheret fra FFPE tumorvæv.
English: However, in rat and dog toxicity studies up to 13 weeks in duration, there were no treatment effects observed in male reproductive tissues.
Danish: I toksicitetsstudier af op til 13 ugers varighed hos rotter og hunde blev der dog ikke observeret nogen effekter af behandlingen på hannernes reproduktionsvæv.
English: Do not change your dose or stop Mekinist or dabrafenib unless your doctor, nurse or pharmacist tells you to.
Danish: Du må ikke ændre din dosis eller stoppe med at tage Mekinist eller dabrafenib, medmindre lægen, sundhedspersonalet eller apotekspersonalet beder dig om det.
English: Male patients taking trametinib in combination with dabrafenib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible.
Danish: Mandlige patienter, der tager trametinib i kombination med dabrafenib, skal informeres om den potentielle risiko for forringet spermatogenese, som kan være irreversibel.
English: The proportion of patients experiencing ARs was similar in those aged <65 years and those aged ≥65 years in all studies.
Danish: Andelen af patienter, der oplevede bivirkninger, var den samme i gruppen < 65 år og i gruppen ≥ 65 år i alle studier.
English: Effects on spermatogenesis have been observed in animals given dabrafenib.
Danish: Der er set påvirkning af spermatogenesen hos dyr, der fik dabrafenib.
English: No studies have been conducted to investigate the pharmacokinetics of trametinib in paediatric patients.
Danish: Der er ikke udført studier med henblik på at undersøge farmakokinetikken af trametinib hos pædiatriske patienter.
English: Trametinib is not recommended in patients with a history of RVO.
Danish: Trametinib anbefales ikke hos patienter med tidligere RVO.
English: Table 4 Adverse reactions reported in the integrated safety population of trametinib monotherapy (n=329)
Danish: Tabel 4 Bivirkninger rapporteret i den integrerede sikkerhedspopulation med trametinib-monoterapi (n = 329)
English: Most patients (87%) in the ITT population had BRAF V600E mutation and 12% of patients had BRAF V600K.
Danish: De fleste patienter (87 %) i ITT-populationen havde BRAF V600E-mutationen, og 12 % af patienterne havde BRAF V600K-mutationen.
English: No dose modifications are required for uveitis as long as effective local therapies can control ocular inflammation.
Danish: Det er ikke nødvendigt at dosisjustere ved uveitis, så længe effektiv lokalbehandling kan kontrollere den okulære inflammation.
English: Taking Mekinist or the combination of Mekinist and dabrafenib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Danish: Indtagelse af Mekinist eller kombinationen af Mekinist og dabrafenib kan forårsage alvorlig blødning i hjernen, fordøjelsessystemet (såsom maven, endetarmen eller tarmen), lungerne og andre organer og kan medføre døden.
English: Taking Mekinist or the combination of Mekinist and dabrafenib may increase the risk of developing holes in the gut wall.
Danish: At tage Mekinist eller kombinationen af Mekinist og dabrafenib kan øge risikoen for at udvikle huller i tarmvæggen.
English: Hypersensitivity a
Danish: Overfølsomhed a
English: Only patients with BRAF V600E or V600K mutation positive tumours were eligible for study participation.
Danish: Kun patienter med tumorer med BRAF V600E- eller V600K-mutationer var egnede til at deltage i studierne.