FrancophonIA/ELRC3.0 huggingface dataset:
English: Mekinist can have side effects that may affect your ability to drive or use machines.
Danish: Mekinist kan give bivirkninger, der kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Permanently discontinue trametinib.
Danish: Seponer trametinib permanent.
English: To prevent pregnancy, female patients using hormonal contraception are advised to use an additional or alternative method during treatment and for 16 weeks following discontinuation of trametinib.
Danish: For at forhindre graviditet anmodes kvindelige patienter, der anvender hormonal kontraception, om at bruge en alternativ metode under behandlingen og i 16 uger efter seponering af trametinib.
English: High blood pressure
Danish: Forhøjet blodtryk
English: - The active substance is trametinib.
Danish: - Aktivt stof: trametinib.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with trametinib in all subsets of the paediatric population in melanoma and malignant neoplasms (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med trametinib i alle undergrupper af den pædiatriske population ved melanom og maligne neoplasmer (se pkt.
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second-line or higher patients and 68 years in the first-line patients.
Danish: Ud af de i alt 93 patienter, der blev inkluderet i kohorte B og C med kombinationsbehandling, var de fleste kaukasiske (>90 %) og ligeligt fordelt mht. kvinder versus mænd (54 % versus 46 %) med en medianalder på 64 år hos patienter i anden eller højere linje og 68 år hos førstelinjepatienter.
English: Side effects when Mekinist and dabrafenib are taken together
Danish: Bivirkninger, når Mekinist og dabrafenib tages sammen
English: If a dose of trametinib is missed, it should only be taken if it is more than 12 hours until the next scheduled dose.
Danish: Hvis en dosis af trametinib glemmes, må den kun tages, hvis der er mere end 12 timer til den næste planlagte dosis.
English: Trametinib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay at significantly higher concentrations than clinical exposures (IC50 at 2.92 µg/ml, ≥130 times the clinical exposure based on Cmax), indicating that there is low risk for phototoxicity to patients taking trametinib.
Danish: Trametinib var fototoksisk i en in vitro-musefibroblast-3T3-Neutral Red Uptake (NRU)-test ved signifikant højere koncentrationer end kliniske eksponeringer (IC50 ved 2,92 µg/ml, ≥ 130 gange den kliniske eksponering baseret på Cmax), hvilket indikerer, at der er lav risiko for fototoksisitet hos patienter, der får trametinib.
English: Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility.
Danish: Indtagelse af Mekinist sammen med dabrafenib: Dabrafenib kan muligvis nedsætte mænds frugtbarhed permanent.
English: • Take Mekinist and dabrafenib on an empty stomach, at least one hour before or two hours after a meal.
Danish: • Tag Mekinist og dabrafenib på tom mave mindst en time før eller to timer efter et måltid.
English: The study showed a statistically significant difference for the primary outcome of RFS between treatment arms, with a median RFS of 16.6 months for the placebo arm and not yet reached for the combination arm (HR: 0.47; 95% confidence interval: (0.39, 0.58); p=1.53×10
Danish: Studiet viste en statistisk signifikant forskel i det primære resultat af RFS mellem behandlingsarme med en median RFS på 16,6 måneder i placebo-armen og er endnu ikke nået i kombinationsarmen (HR: 0,47; 95 % konfidensinterval: (0,39; 0,58); p=1,53×10
English: • after eating, you must wait at least 2 hours before taking Mekinist.
Danish: • eller du skal vente mindst 2 timer efter du har spist, før du tager Mekinist.
English: The safety of trametinib in subjects with predisposing factors for RVO, including uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes, has not been established.
Danish: Trametinibs sikkerhed hos personer med disponerende faktorer for RVO, herunder ukontrolleret glaukom eller okulær hypertension, ukontrolleret hypertension, ukontrolleret diabetes mellitus eller hyperviskositets- eller hyperkoagulabilitetssyndromer i anamnesen, er ikke klarlagt.
English: Your doctor may take blood samples to monitor your liver function while you are taking this medicine.
Danish: Lægen vil måske tage blodprøver for at kontrollere din leverfunktion, mens du tager dette lægemiddel.
English: It is currently unknown if hormonal contraceptives are affected by trametinib.
Danish: Det vides ikke om hormonelle præventionsmidler påvirkes af trametinib.
English: Grade 1 RPED
Danish: RPED af grad 1
English: Based on in vitro studies, trametinib is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2D6 and CYP3A4.
Danish: På basis af in vitro-studier er trametinib ikke en hæmmer af CYP1A2, CYP2A6, CYP2B6, CYP2D6 og CYP3A4.
English: If haemorrhage occurs, patients should be treated as clinically indicated.
Danish: Hvis der opstår blødning, skal patienterne behandles som klinisk indiceret.
English: Therefore, before starting treatment your doctor will test for this mutation.
Danish: Lægen vil derfor teste for denne mutation, inden behandlingen bliver startet.
English: Continue treatment with retinal evaluation monthly until resolution.
Danish: Foretag vurdering af retina månedligt indtil remission.
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with trametinib.
Danish: Patienter med LVEF under den nedre grænse af normalområdet i henhold til retningslinjerne blev ikke inkluderet i de kliniske studier med trametinib.
English: • Lack of energy or feeling weak or tired
Danish: • manglende energi eller en følelse af svaghed eller træthed
English: Administration of a single dose of trametinib with a high-fat, high-calorie meal resulted in a 70% and 10% decrease in Cmax and AUC, respectively compared to fasted conditions (see sections 4.2 and 4.5).
Danish: Administration af en enkelt dosis af trametinib sammen med et måltid med højt fedt- og kalorieindhold resulterede i et fald på 70 % og 10 % i henholdsvis Cmax og AUC-værdien sammenlignet med ved fastende tilstand (se pkt.
English: There are no data with trametinib in patients with severe renal impairment; therefore, the potential need for starting dose adjustment cannot be determined.
Danish: Der foreligger ingen data om anvendelse af trametinib hos patienter med svært nedsat nyrefunktion, og derfor kan det ikke afgøres, om det eventuelt er nødvendigt at justere startdosis.
English: Swallow the tablet whole, with a full glass of water.
Danish: Synk tabletten hel med et helt glas vand.
English: The PFS result was consistent in the subgroup of patients with V600K mutation positive melanoma (HR=0.50; [95% CI: 0.18, 1.35], p=0.0788).
Danish: PFS-resultatet var konsistent i undergruppen af patienter med V600K-mutationspositivt melanom (HR = 0,50; [95 % CI: 0,18 - 1,35], p=0,0788).
English: In animals, no fertility studies have been performed, but adverse effects were seen on female reproductive organs (see section 5.3).
Danish: Der er ikke udført fertilitetsstudier hos dyr, men der er set skadelige virkninger på hundyrs reproduktionsorganer (se pkt.
English: Safety data in patients ≥75 years is limited (see section 4.8).
Danish: Der findes kun en begrænset mængde sikkerhedsdata om patienter ≥ 75 år (se pkt.
English: If a patient vomits after taking trametinib, the patient should not retake the dose and should take the next scheduled dose.
Danish: Hvis en patient kaster op efter at have taget trametinib, bør patienten ikke tage en ny dosis, men vente til den næste planlagte dosis.
English: Mekinist in combination with dabrafenib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Danish: Mekinist i kombination med dabrafenib anvendes også til at behandle en type lungekræft, der kaldes ikke-småcellet lungekræft (NSCLC).
English: In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastro-intestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone.
Danish: I et studie med hunde, hvor trametinib og dabrafenib blev givet i kombination i 4 uger, blev der observeret tegn på gastrointestinal toksicitet og nedsat lymfoid cellularitet i thymus ved eksponeringer, som var lavere end hos hunde, der kun fik trametinib.
English: Eye (vision) problems
Danish: Øjenproblemer (synsproblemer)
English: Table 11 Investigator-assessed efficacy results (ITT population)
Danish: Tabel 11 Effektresultater i henhold til investigators vurdering (ITT-population)
English: What you need to know before you take Mekinist
Danish: Det skal du vide, før du begynder at tage Mekinist
English: In adult rats, mineralisation of multiple organs was associated with increased serum phosphorus and was closely associated with necrosis in heart, liver and kidney and haemorrhage in the lung at exposures comparable to the human clinical exposure.
Danish: Hos voksne rotter var mineralisering af flere organer forbundet med et øget serumniveau af fosfor og var tæt forbundet med hjerte-, lever- og nyrenekrose samt blødning i lungerne ved eksponeringer, der svarede til den kliniske eksponering hos mennesker.
English: In vitro and in vivo studies demonstrated that trametinib is metabolised predominantly via deacetylation alone or in combination with mono-oxygenation.
Danish: In vitro- og in vivo-studier viste, at trametinib primært metaboliseres via deacetylering alene eller i kombination med monooxygenering.
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated.
Danish: Tegn eller symptomer på rabdomyolyse skal medføre passende klinisk evaluering og behandling som indiceret.
English: Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Danish: Undtagelser, hvor det kun er nødvendigt at justere dosis for én af de to behandlinger, er angivet nedenfor for pyreksi, uveitis, RAS-mutationspositive ikke-kutane maligniteter (primært relateret til dabrafenib), reduktion af venstre ventrikels ejektionsfraktion (LVEF), retinal veneokklusion (RVO), løsning af retinalt pigmentepitel (RPED) og interstitiel lungesygdom (ILD)/pneumonitis (primært relateret til trametinib).
English: Table 2 Dose modification schedule based on the grade of any adverse reactions
Danish: Tabel 2 Skema for dosisjustering baseret på graden af bivirkninger
English: If RPED worsens follow instructions below and withhold trametinib for up to 3 weeks.
Danish: Hvis RPED forværres, følg da nedenstående anvisninger, og pausér behandlingen med trametinib i op til 3 uger.
English: If the LVEF recovers, treatment with trametinib may be restarted, but the dose should be reduced by one dose level with careful monitoring (see section 4.4).
Danish: Hvis LVEF normaliseres, kan behandlingen med trametinib genoptages, men dosis bør reduceres med ét dosisniveau med tæt monitorering (se pkt.
English: The side effects that you may see when you take Mekinist in combination with dabrafenib are as follows:
Danish: De bivirkninger, du måske vil få, når du tager Mekinist i kombination med dabrafenib, er følgende:
English: Check with your doctor if you think any of these may apply to you.
Danish: Tal med lægen, hvis du tror, at noget af dette gælder for dig.
English: • Bleeding, at various sites in the body, which may be mild or serious (haemorrhage)
Danish: • blødninger forskellige steder i kroppen, som kan være lette eller alvorlige (hæmoragi)
English: Dose modifications are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see dabrafenib SmPC for further details).
Danish: Dosisjustering anbefales ikke ved bivirkninger som kutant pladecellekarcinom (cuSCC) eller nye primære melanomer (se produktresuméet for dabrafenib for yderligere oplysninger).
English: Mekinist in combination with dabrafenib is also used to prevent melanoma from coming back after it has been removed by surgery.
Danish: Mekinist i kombination med dabrafenib anvendes også til at forebygge tilbagefald af melanom efter, at det er blevet fjernet ved operation.
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 6.
Danish: Median samlet overlevelse (OS) og estimerede 1-års, 2-års, 3-års, 4-års og 5-års overlevelseshyppigheder er angivet i tabel 6.
English: In Cohort A of this study, trametinib did not demonstrate clinical activity in patients who had progressed on a prior BRAF inhibitor therapy.
Danish: I kohorte A i dette studie gav trametinib ikke klinisk aktivitet hos patienter, der tidligere havde progredieret på behandling med en BRAF-hæmmer.
English: Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4).
Danish: Behandling med Mekinist eller med kombination af Mekinist og dabrafenib kan forårsage feber, men risikoen er størst, hvis du tager kombinationsbehandlingen (se også punkt 4).
English: One bottle contains either 7 or 30 tablets.
Danish: Hver beholder indeholder enten 7 eller 30 tabletter.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Danish: De fleste forsøgsdeltagere havde LDH ≤ ULN (65 %), Eastern Cooperative Oncology Group (ECOG) performancestatus 0 (72 %) og visceral sygdom (73 %) ved baseline.
English: In more severe cases hospitalisation, interruption or permanent discontinuation of trametinib or trametinib and dabrafenib combination was required.
Danish: I mere alvorlige tilfælde var indlæggelse, midlertidig afbrydelse eller permanent seponering af trametinib eller kombinationen trametinib plus dabrafenib nødvendig.
English: Based on in vitro and in vivo data, trametinib is unlikely to significantly affect the pharmacokinetics of other medicinal products via interaction with CYP enzymes or transporters (see section 5.2).
Danish: På basis af in vitro- og in vivo-data er det ikke sandsynligt, at trametinib påvirker andre lægemidlers farmakokinetik signifikant via interaktion med CYP-enzymer eller transportører (se pkt.
English: However, based on the low dose and low clinical systemic exposure relative to the in vitro potency of inhibition or induction values, trametinib is not considered to be an in vivo inhibitor or inducer of these enzymes or transporters, although transient inhibition of BCRP substrates in the gut may occur (see section 4.5).
Danish: På basis af den lave dosis og lave kliniske systemiske eksponering i forhold til styrken af hæmnings- eller induktionsværdierne in vitro anses trametinib ikke for at være en hæmmer eller induktor af disse enzymer eller transportører in vivo, selvom der kan forekomme en forbigående hæmning af BCRP-substrater i tarmen (se pkt.
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 8.
Danish: Median OSog estimerede 1-års, 2-års, 3-års, 4-års og 5-års overlevelseshyppigheder er angivet i tabel 8.
English: Renal impairment is unlikely to have a clinically relevant effect on trametinib pharmacokinetics given the low renal excretion of trametinib.
Danish: Nedsat nyrefunktion har sandsynligvis ingen klinisk relevant effekt på farmakokinetikken af trametinib på grund af den lave renale udskillelse af trametinib.
English: Trametinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells and micronuclei in the bone marrow of rats.
Danish: Trametinib var ikke genotoksisk i studier, som undersøgte tilbagemutationer i bakterier, kromosomafvigelser i pattedyrsceller og mikronuklei i rotters knoglemarv.
English: Cases of cuSCC can be managed with excision and do not require treatment modification.
Danish: CuSCC kan fjernes kirurgisk og kræver ikke ændring af behandlingen.
English: Trametinib plasma IV clearance is 3.21 L/hr.
Danish: Plasmaclearance af trametinib efter intravenøs administration er 3,21 l/t.
English: The median time to onset of the first occurrence of haemorrhagic events for the combination of trametinib and dabrafenib was 94 days in the melanoma Phase III studies and 75 days in the NSCLC study for the patients who had received prior anti-cancer therapy.
Danish: Mediantiden til indtræden af første blødningshændelse ved kombinationsbehandling med trametinib og dabrafenib var 94 dage i fase III-studiet af melanom og 75 dage i NSCLC-studiet hos patienter, der tidligere havde fået anti-cancerbehandling.
English: P-value is obtained from the two-sided stratified logrank test (stratification factors were disease stage - IIIA vs. IIIB vs. IIIC - and BRAF V600 mutation type - V600E vs. V600K) NE = not estimable
Danish: P-værdien stammer fra den to-sidede stratificerede logrank test (stratificeringsfaktorer var sygdomsstadie - IIIA vs. IIIB vs. IIIC - og BRAF V600-mutationstype - V600E vs. V600K) NE = kan ikke estimeres
English: Trametinib has minor influence on the ability to drive or use machines.
Danish: Trametinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Patients with left ventricular dysfunction, New York Heart Association Class II, III, or IV heart failure, acute coronary syndrome within the past 6 months, clinically significant uncontrolled arrhythmias, and uncontrolled hypertension were excluded from clinical trials; safety of use in this population is therefore unknown.
Danish: Patienter med venstre ventrikel dysfunktion, hjerteinsufficiens i New York Heart Association-klasse II, III, eller IV, akut koronart syndrom inden for de sidste 6 måneder, klinisk signifikante ukontrollerede arytmier og ukontrolleret hypertension var ekskluderet fra de kliniske studier.
English: Treatment with trametinib monotherapy or in combination with dabrafenib should be used with caution in patients with risk factors for gastrointestinal perforation, including history of diverticulitis, metastases to the gastrointestinal tract and concomitant use of medicinal products with a recognised risk of gastrointestinal perforation.
Danish: Behandling med trametinib monoterapi eller i kombination med dabrafenib skal anvendes med forsigtighed hos patienter med risikofaktorer for gastrointestinal perforation, inklusive diverticulitis i anamnesen, metastaser til mave-tarm-kanalen og samtidig brug af lægemidler med en kendt risiko for gastrointestinal perforation.
English: • Birth control using hormones (such as pills, injections or patches) may not work as well if you are taking Mekinist or combination treatment (Mekinist as well as dabrafenib).
Danish: • Svangerskabsforebyggende lægemidler, der indeholder hormoner (fx tabletter, injektioner eller plastre), vil muligvis ikke være sikre, hvis du tager Mekinist eller kombinationsbehandlingen (både Mekinist og dabrafenib).
English: Effect of other medicinal products on trametinib
Danish: Andre lægemidlers effekt på trametinib
English: The secondary endpoints were PFS in the ITT population and OS, ORR, and DoR in the primary efficacy population and ITT population.
Danish: De sekundære endepunkter var PFS i ITT-populationen og samlet overlevelse (OS), ORR og DoR i den primære effekt-population og ITT-populationen.
English: Other medicines and Mekinist
Danish: Brug af anden medicin sammen med Mekinist
English: nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles, skin rash with pus-filled blisters, cutaneous squamous cell carcinoma (a type of skin cancer),
Danish: negleforandringer såsom forandringer i neglelejet, neglesmerter, betændte og hævede neglebånd, hududslæt med pusfyldte blærer, kutant pladecellekarcinom (en form for hudkræft),
English: A decision should be made whether to discontinue breast-feeding or discontinue trametinib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med trametinib seponeres, idet der tages højde for fordelene ved amning i forhold til de terapeutiske fordele for moderen.
English: The mean trametinib concentrations observed following repeat dose administration of 2 mg once daily exceeds the preclinical target concentration over the 24-hr dosing interval, thereby providing sustained inhibition of the MEK pathway.
Danish: De gennemsnitlige koncentrationer af trametinib, der blev observeret efter gentagen administration af doser på 2 mg en gang daglig, overstiger den prækliniske målkoncentration over doseringsintervallet på 24 timer og bevirker derved vedvarende hæmning af MEK-pathway'en.
English: Table 5 Adverse reactions reported in the integrated safety population of trametinib in combination with dabrafenib in the studies MEK115306, MEK116513
Danish: Tabel 5 Bivirkninger rapporteret i den integrerede sikkerhedspopulation med trametinib i kombination med dabrafenib i studierne MEK115306, MEK116513
English: Resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue trametinib in patients taking trametinib 1 mg daily.
Danish: Genoptag behandlingen med trametinib med en lavere dosis (reduceret med 0,5 mg), eller seponer trametinib hos de patienter, der tager 1 mg trametinib dagligt.
English: Uncommon ≥1/1,000 to <1/100 Rare
Danish: Ikke almindelig ≥ 1/1.000 til < 1/100
English: If your doctor decides that you will receive treatment with the combination of Mekinist and dabrafenib, read the dabrafenib leaflet carefully as well as this leaflet.
Danish: Hvis lægen beslutter, at du skal behandles med en kombination af Mekinist og dabrafenib, skal du læse både denne indlægsseddel og indlægssedlen for dabrafenib omhyggeligt.
English: Do not take Mekinist after the expiry date (EXP) which is stated on the bottle label and carton.
Danish: Brug ikke Mekinist efter den udløbsdato, der står på beholderens etiket og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Trametinib is not a substrate of CYP enzymes or of the transporters BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, and MATE1.
Danish: Trametinib er ikke et substrat for CYP-enzymer eller for transportørerne BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2 og MATE1.
English: • Heart pumping less efficiently, causing shortness of breath, extreme tiredness and swelling in ankles and legs (heart failure)
Danish: • hjertet pumper mindre effektivt, hvilket giver åndenød, udtalt træthed og hævede ankler og ben
English: Mekinist should be taken with either the morning dose of dabrafenib or the evening dose of dabrafenib.
Danish: Mekinist skal enten tages sammen med morgendosen af dabrafenib eller aftendosen af dabrafenib.
English: In clinical trials with trametinib monotherapy one case of accidental overdose was reported; a single dose of 4 mg. No AEs were reported following this event of trametinib overdose.
Danish: I de kliniske studier med trametinib-monoterapi blev der rapporteret ét tilfælde af utilsigtet overdosering; en enkeltdosis på 4 mg. Der blev ikke rapporteret nogen bivirkninger efter dette tilfælde af overdosering med trametinib.
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Danish: Alternativt afbryd behandlingen, indtil toksiciteten er af grad 0-1, og reducer med ét dosisniveau, når behandlingen genoptages.