FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on cross-study comparisons, overall survival and progression-free survival data appear to show similar effectiveness between trametinib and BRAF inhibitors; however, overall response rates were lower in patients treated with trametinib than those reported in patients treated with BRAF inhibitors.
Danish: På basis af krydsstudie-sammenligninger synes data om samlet overlevelse og progressionsfri overlevelse at vise, omtrent samme effekt af trametinib og BRAF-hæmmere.
English: 1-year rate (95% CI)
Danish: 1-års rate (95 % CI)
English: Primary analysis (data cutoff: 26-Aug-2013)
Danish: Primær analyse (skæringsdato for dataindsamling: 26-aug
English: Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.
Danish: Mekinist 0,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg trametinib.
English: • Sore mouth or mouth ulcers, inflammation of mucous membranes
Danish: • ømhed eller blærer i munden, inflammation i slimhinderne
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated (see section 4.4).
Danish: Ved tegn eller symptomer på rabdomyolyse bør der foretages en klinisk vurdering og passende behandling opstartes (se pkt.
English: • Reddening, chapping or cracking of the skin
Danish: • hudrødme, sprukken eller revnet hud
English: 3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon) b Cutaneous squamous cell carcinoma (cu SCC): SCC, SCC of the skin, SCC in situ (Bowen's disease) and keratoacanthoma c Papilloma, skin papilloma d
Danish: 3) Følgende bivirkning forekom i MEK116513 og BRF115532, men ikke i MEK115306 og BRF113928: Rabdomyolyse (ikke almindelig).
English: • Feeling weak
Danish: • følelse af svaghed
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Danish: THxID BRAF-analysen og efterfølgende blev sekventeret ved brug af referencemetoden, var specificiteten af analysen 94 %.
English: Mekinist is not recommended while breast-feeding It is not known whether the ingredients of Mekinist can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Mekinist går over i modermælken.
English: • Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
Danish: • neglelidelser, fx forandringer i neglelejet, neglesmerter, betændte og hævede neglebånd
English: Trametinib should be used with caution in patients with severe renal impairment when administered as monotherapy or in combination with dabrafenib.
Danish: Trametinib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion, når det administreres som monoterapi eller i kombination med dabrafenib.
English: • Inflammation of the lung (pneumonitis or interstitial lung disease)
Danish: • inflammation (betændelseslignende reaktion) i lungerne (pneumonitis eller interstitiel lungesygdom)
English: Trametinib should be used with caution in patients with conditions that could impair left ventricular function (see sections 4.2 and 4.4).
Danish: Trametinib bør anvendes med forsigtighed hos patienter med tilstande, der kan nedsætte funktionen af venstre ventrikel (se pkt.
English: Renal failure has been identified in patients treated with trametinib in combination with dabrafenib in clinical trials.
Danish: Der er observeret nyresvigt hos patienter, som blev behandlet med trametinib i kombination med dabrafenib i kliniske forsøg.
English: 3-year rate (95% CI)
Danish: 3-års rate (95 % CI)
English: 2-year rate (95% CI)
Danish: 2-års rate (95 % CI)
English: Mekinist 2 mg tablets trametinib
Danish: Mekinist 2 mg tabletter trametinib
English: Renal failure has been reported with dabrafenib in combination with trametinib.
Danish: Der er rapporteret nyresvigt ved dabrafenib i kombination med trametinib.
English: Hazard ratio (95% CI) p-value
Danish: Hazard ratio (95 % CI) P-værdi
English: If haemorrhage occurs, treat as clinically indicated (see section 4.4).
Danish: Hvis der opstår blødning, skal patienterne behandles som klinisk indiceret (se pkt.
English: Please see the dabrafenib SmPC.
Danish: Se produktresuméet for dabrafenib.
English: Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Danish: Spørg lægen, sundhedspersonalet eller apotekspersonalet, hvis du er i tvivl om noget.
English: Microcrystalline cellulose (E460) Hypromellose (E464) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium laurilsulfate Colloidal silicon dioxide(E551)
Danish: Mikrokrystallinsk cellulose (E 460) Hypromellose (E 464) Croscarmellosenatrium (E 468) Magnesiumstearat (E 470b) Natriumlaurilsulfat
English: Mekinist 0.5 mg tablets trametinib
Danish: Mekinist 0,5 mg tabletter trametinib
English: The bottle contains a desiccant.
Danish: Beholderen indeholder et tørremiddel.
English: No dosage adjustment is required in patients with mild hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (se pkt.
English: No dosage adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: Trametinib may impair fertility in humans.
Danish: Trametinib kan nedsætte fertiliteten hos mennesker.
English: 1) The following adverse reactions have a higher frequency category as compared to MEK115306: muscle spasm (very common); renal failure and lymphoedema (common); acute renal failure (uncommon); 2) The following adverse reactions have occurred in MEK116513 but not in MEK115306: cardiac failure, left ventricular dysfunction, interstitial lung disease (uncommon).
Danish: 2) Følgende bivirkninger forekom i MEK116513, men ikke i MEK115306: Hjertesvigt, dysfunktion af venstre ventrikel, interstitiel lungesygdom (ikke almindelig).
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg of trametinib.
Danish: Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg eller 2 mg trametinib.
English: P value f
Danish: <0,001f
English: • Blockage of the vein draining the eye (retinal vein occlusion) (see also “Eye (vision) problems”
Danish: • blokering af den vene, der fører blodet væk fra øjet (retinal veneokklusion) (se også
English: No data are available in patients with severe renal impairment (see section 4.2).
Danish: Der er ingen tilgængelige data om patienter med svært nedsat nyrefunktion (se pkt.
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Iron oxide yellow(E172)
Danish: Tablet-filmovertræk Hypromellose (E 464) Titandioxid (E 171) Polyethylenglycol Gul jernoxid (E 172)
English: No dose modification of trametinib is required for RAS mutation positive malignancies when taken in combination with dabrafenib.
Danish: Det er ikke nødvendigt at justere trametinib-dosis ved RAS-mutationspositive maligniteter, når det tages i kombination med dabrafenib.
English: Face oedema Mucosal inflammation Asthenia
Danish: Ansigtsødem Slimhindeinflammation Asteni
English: • after taking Mekinist, you must wait at least 1 hour before eating, or
Danish: • du skal vente mindst 1 time, før du spiser efter du har taget Mekinist
English: Adjusted hazard ratio (95% CI) p-value
Danish: Hazard ratio (95% CI) p-værdi
English: Hepatic adverse reactions have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib.
Danish: Der er rapporteret leverpåvirkninger i kliniske studier med trametinib som monoterapi og i kombination med dabrafenib.
English: May present with symptoms such as fever, rash, increased liver transaminases, and visual disturbances b Events include but are not limited to: epistaxis, haematochezia, gingival bleeding, haematuria, and rectal, haemorrhoidal, gastric, vaginal, conjunctival, intracranial and post-procedural haemorrhage.
Danish: bOmfatter, men er ikke begrænset til: næseblod, frisk blødning fra rectum i forbindelse med defækation, gingival blødning, hæmaturi samt rektal, hæmorroidal, gastrisk, vaginal, konjunktival og intrakraniel blødning og blødning efter procedure.
English: Overall response rate, % (95% CI)
Danish: Samlet responsrate, % (95 % CI)
English: Trametinib may impair female fertility in humans, as in repeat-dose studies, increases in cystic follicles and decreases in corpora lutea were observed in female rats at exposures below the human clinical exposure based on AUC.
Danish: I studier med gentagne doser blev der set et øget antal follikelcyster og et reduceret antal corpora lutea hos hunrotter ved eksponeringer, der lå under den kliniske eksponering hos mennesker baseret på AUC.
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets
Danish: Mekinist 0,5 mg filmovertrukne tabletter Mekinist 2 mg filmovertrukne tabletter
English: • Inflammation of the kidneys
Danish: • inflammation i nyrerne
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 (E433) Iron oxide red (E172)
Danish: Tablet-filmovertræk Hypromellose (E 464) Titandioxid (E 171) Polyethylenglycol Polysorbat 80 (E 433) Rød jernoxid (E 172)
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg trametinib.
Danish: Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 2 mg trametinib.
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 7 months longer than for dabrafenib monotherapy (25.8 months versus 18.7 months) with 5-year survival rates of 32% for the combination versus 27% for dabrafenib monotherapy (Table 6, Figure 1).
Danish: 18,7 måneder) med 5-års overlevelsesrater på 32% for kombinationen, versus 27% for dabrafenib monoterapi (tabel 6, figur 1).
English: If you take more Mekinist than you should
Danish: Hvis du har taget for meget Mekinist
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets trametinib
Danish: Mekinist 0,5 mg filmovertrukne tabletter Mekinist 2 mg filmovertrukne tabletter trametinib
English: No dose modification of dabrafenib is required when trametinib is taken in combination with dabrafenib.
Danish: Justering af dabrafenib-dosis er ikke nødvendig, når trametinib tages i kombination med dabrafenib.
English: e - ORR difference calculated based on the ORR result not rounded f - Updated analysis was not pre-planned and the p-value was not adjusted for multiple testing NR = Not reached
Danish: investigators vurdering) b - Samlet responsrate = samlet respons + partiel respons c - Responsvarighed d - På rapporteringstidspunktet var størstedelen (≥59 %) af de af investigator vurderede responser stadig igangværende e - ORR-difference beregnet ud fra ORR-resultatet ikke afrundet f - Opdateret analyse var ikke planlagt forud, og der blev ikke foretaget en justering af p-værdien ved gentagen afprøvning
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg trametinib.
Danish: Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg trametinib.
English: Trametinib has been reported to decrease LVEF, when used as monotherapy or in combination with dabrafenib (see section 4.8).
Danish: Det er rapporteret, at trametinib har medført reduceret LVEF, når det anvendes som monoterapi eller i kombination med dabrafenib (se pkt.
English: Vomiting Constipation Abdominal pain Dry mouth
Danish: Opkastning Obstipation Abdominalsmerter Mundtørhed
English: Trametinib should be used with caution in patients with severe renal impairment (see sections 4.2 and
Danish: Trametinib skal anvendes med forsigtighed til patienter med svært nedsat nyrefunktion (se pkt.
English: When trametinib is used in combination with dabrafenib see sections 4.4 and 4.5 of the dabrafenib SmPC for interactions.
Danish: 4.4 og 4.5 i produktresuméet for dabrafenib vedrørende interaktioner.
English: Mekinist 2 mg film-coated tablets
Danish: Mekinist 2 mg filmovertrukne tabletter
English: What Mekinist is and what it is used for What you need to know before you take Mekinist How to take Mekinist
Danish: Det skal du vide, før du begynder at tage Mekinist Sådan skal du tage Mekinist Bivirkninger
English: The median age was 54 years (22% were 65 years); all patients had an ECOG performance score of 0 or 1; and 3 % had history of brain metastases.
Danish: Alle patienter havde en ECOG Performance Status på 0 eller 1, og 3 % havde hjernemetastaser i anamnesen.
English: In patients receiving trametinib in combination with dabrafenib, there have been occasional reports of acute, severe left ventricular dysfunction due to myocarditis.
Danish: Der har været lejlighedsvise rapporter om akut, alvorlig dysfunktion af ventre ventrikel på grund af myokarditis hos patienter, der fik trametinib i kombination med dabrafenib.
English: Mekinist 2 mg film-coated tablets trametinib
Danish: Mekinist 2 mg filmovertrukne tabletter trametinib
English: Unopened bottle
Danish: Ikke anbrudt beholder
English: Mekinist 0.5 mg film-coated tablets
Danish: Mekinist 0,5 mg filmovertrukne tabletter
English: Trametinib should be used with caution in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Danish: 5.2) Trametinib skal anvendes med forsigtighed hos patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesi-syndrom Hudlæsion
English: earlier in section 4)
Danish: (synsproblemer)” tidligere i punkt 4)
English: Seborrhoeic keratosis
Danish: Seborroisk keratose
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, occurred in patients taking trametinib as monotherapy and in combination with dabrafenib.
Danish: Der forekom blødningshændelser, herunder større blødningshændelser og blødninger med dødelig udgang, hos patienter, der tog trametinib som monoterapi og i kombination med dabrafenib.
English: For additional information on warnings and precautions associated with dabrafenib treatment, please refer to the dabrafenib SmPC.
Danish: Se produktresuméet for dabrafenib for yderligere oplysninger om advarsler og forholdsregler i forbindelse med dabrafenib-behandlingen.
English: Please refer to the dabrafenib SmPC.
Danish: Der henvises til produktresuméet for dabrafenib pkt.
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Danish: Blødningshændelser, herunder større blødningshændelser og blødninger med dødelig udgang, er forekommet hos patienter, der tog trametinib som monoterapi eller i kombination med dabrafenib (se pkt.
English: Mekinist 0.5 mg film-coated tablets trametinib
Danish: Mekinist 0,5 mg filmovertrukne tabletter trametinib
English: In patients who are diagnosed with RVO, treatment with trametinib should be permanently discontinued.
Danish: Trametinib bør seponeres permanent hos patienter, der diagnosticeres med RVO.
English: Fever has been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Danish: Der er rapporteret feber i forbindelse med kliniske studier med trametinib som monoterapi og i kombination med dabrafenib (se pkt.
English: Talk to your doctor before taking your medicine.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager dette lægemiddel.
English: If you have any further questions on the effect of this medicine on fertility, ask your doctor, nurse or pharmacist.
Danish: Spørg lægen, sundhedspersonalet eller apotekspersonalet, hvis du har flere spørgsmål om virkningen af dette lægemiddel på fertiliteten.
English: Hepatic adverse reactions have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Danish: Der er rapporteret leverpåvirkning i kliniske studier med trametinib som monoterapi og i kombination med dabrafenib (se pkt.
English: Rhabdomyolysis has been reported in patients taking trametinib as monotherapy or in combination with dabrafenib (see section 4.8).
Danish: Der er rapporteret rabdomyolyse hos patienter, der tager trametinib som monoterapi eller i kombination med dabrafenib (se pkt.
English: • Swelling in the eye caused by fluid leakage (chorioretinopathy) (see also “Eye (vision)
Danish: • hævelse i øjet forårsaget af væskeophobning (korioretinopati) (se også “Øjenproblemer
English: Percent survival at 12 months (95% CI)
Danish: 12 måneder, procent (95 % CI)
English: Mekinist 2 mg film-coated tablets Tablet core
Danish: Mekinist 2 mg filmovertrukne tabletter Tabletkerne
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Danish: De fleste forsøgsdeltagere var kaukasere (>99 %) og mænd (53 %).
English: • Shortness of breath
Danish: • følelse af ørhed
English: Mekinist 0.5 mg film-coated tablets Tablet core
Danish: Mekinist 0,5 mg filmovertrukne tabletter Tabletkerne
English: Symptoms such as blurred vision, decreased acuity, and other visual phenomena have been reported in the clinical trials with trametinib (see section 4.8).
Danish: I de kliniske studier med trametinib er der rapporteret symptomer som fx tågesyn, nedsat skarpsyn og andre synsforstyrrelser (se pkt.
English: When trametinib is used in combination with dabrafenib please refer to the dabrafenib SmPC (section 4.4).
Danish: Når trametinib anvendes i kombination med dabrafenib, se pkt.
English: Updated analysis (data cutoff: 12-Jan-2015)
Danish: Opdateret analyse (skæringsdato for dataindsamling: 12-jan
English: It is recommended that patients receiving treatment with trametinib monotherapy or in combination with dabrafenib have liver function monitored every four weeks for 6 months.
Danish: Det anbefales, at leverfunktionen monitoreres hver 4. uge i 6 måneder hos patienter, der behandles med trametinib alene eller i kombination med dabrafenib.
English: Dose level
Danish: mikrodosis.
English: The expiry date refers to the last day of that month.
Danish: Dette skyldes den lange eliminationshalveringstid.
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a The safety profile from MEK116513 is generally similar to that of MEK115306 with the following exceptions:
Danish: Sikkerhedsprofilen fra MEK116513 svarer generelt til den for MEK115306 med følgende undtagelser: 1) Følgende bivirkninger har en højere frekvenskategori sammenlignet med MEK115306: Muskelspasmer (meget almindelig), nyresvigt og lymfødem (almindelig), akut nyresvigt (ikke almindelig).
English: • Inflammation of pancreas
Danish: • betændelse af slimhinder
English: If RPED is diagnosed, the dose modification schedule in Table 3 should be followed (see section 4.2); if uveitis is diagnosed, please refer to dabrafenib SmPC section 4.4.
Danish: Hvis RPED diagnosticeres, skal vejledningerne for dosisændring i tabel 3 følges (se pkt.
English: • usually over 90 minutes
Danish: • normalt over 90 minutter
English: No safety data are available for administration > 28 days.
Danish: Der foreligger ingen sikkerhedsdata for administration > 28 dage.
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke beregnes ud fra tilgængelige data
English: Date of first authorisation: 25 October 2005 Date of latest renewal: 25 October 2010
Danish: Dato for første markedsføringstilladelse: 25. oktober 2005 Dato for seneste fornyelse: 25. oktober 2010
English: Children (< 18 years)
Danish: Børn (< 18 år)
English: Includes other less common species or species unknown
Danish: Inkluderer andre mindre almindelige eller ukendte arter
English: Variations of colour within this range do not affect the quality of the product.
Danish: Farvevariationer inden for denne skala påvirker ikke produktets kvalitet.
English: • mental problems such as hearing voices or seeing things that are not there
Danish: • psykiske problemer såsom at høre stemmer eller at se ting, som ikke er der
English: Elderly ( 65 years)
Danish: Ældre ( 65 år)
English: Fixed-time period
Danish: Fixed-time periode
English: • being completely or partially unable to talk
Danish: • helt eller delvist ude af stand til at tale
English: These findings are not necessarily indicative of a potential for functional changes in humans.
Danish: Disse fund indikerer ikke nødvendigvis et potentiale for funktionelle forandringer hos mennesker.
English: • Tablets may be taken with or without food.
Danish: • Tabletter kan indtages med eller uden mad.
English: • have or have ever had liver problems.
Danish: • har eller nogensinde har haft problemer med leveren.
English: ) was prolonged from approximately 27 hours up to ~43 hours in respective groups.
Danish: ) blev forlænget fra ca. 27 timer op til ~43 timer i de respektive grupper.
English: The oral suspension must be shaken well before use.
Danish: Den orale suspension skal rystes godt før anvendelse.
English: • problems with co-ordination or balance
Danish: • koordinationsproblemer eller problemer med balancen
English: Carcinogenicity studies did not reveal special hazards for humans.
Danish: Karcinogenicitetsstudier viste ingen speciel risiko for mennesker.
English: After first opening the container: 4 weeks
Danish: Efter første åbning af beholderen: 4 uger
English: d: All randomised e: All treated
Danish: d: Alle randomiserede patienter e: Alle behandlede patienter
English: Unopened container: 3 years
Danish: Uåbnet beholder: 3 år
English: Q1 Q2 Q3 Q4
Danish: K1 K2 K3 K4
English: External control group
Danish: Ekstern kontrolgruppe
English: pCav: predicted Cav
Danish: pCav: formodet Cav
English: The clinical response rates from the above study are shown in the Table 4 below.
Danish: De kliniske responsrater fra ovennævnte studie er vist i tabel 4 nedenfor.
English: • high or low blood sugar levels
Danish: • høje eller lave blodsukkerniveauer
English: long QT syndrome
Danish: langt QT-syndrom
English: • Once prepared, the product should be used immediately.
Danish: • Når lægemidlet er tilberedt, skal det anvendes med det samme.
English: Manufacturer SP Labo N.V.
Danish: SP Labo N.V.
English: However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Danish: Dette var imidlertid ikke et prospektivt randomiseret kontrolleret studie, og derfor skal alle sammenligninger med den eksterne kontrolgruppe vurderes med forsigtighed.
English: After administration of
Danish: Efter administration af
English: • Existing symptomatic arrhythmias
Danish: • Eksisterende symptomatiske arytmier
English: Serum creatinine levels should be closely monitored in these patients (see section 4.4).
Danish: Creatininniveauer i serum bør monitoreres nøje hos disse patienter (se pkt 4.4).
English: Children Noxafil should not be used in children (17 years of age and younger).
Danish: Børn Noxafil må ikke anvendes til børn (17 år eller yngre).
English: The clinical significance of this finding is unknown.
Danish: Den kliniske signifikans af dette fund er ukendt.
English: • develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
Danish: • udvikler alvorlig diarré eller kaster op, da disse forhold kan begrænse virkningen af dette lægemiddel.
English: Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).
Danish: Sørg for at fortælle din læge om alle de lægemidler, du tager (både receptpligtige og ikke-receptpligtige).
English: EUCAST ECOFF values:
Danish: EUCAST ECOFF-værdier:
English: • some patients have also reported feeling confused after using Noxafil.
Danish: • nogle patienter har også oplevet at føle sig forvirrede efter brug af Noxafil.