natgillin/translations-raw huggingface dataset:
Sikkerheden og effekten af kombinationen trametinib og dabrafenib er blevet evalueret i et åbent, multikohorte fase II-studie hos patienter med BRAF V600-mutationspositivt melanom med hjernemetastaser.
The safety and efficacy of the combination of trametinib and dabrafenib have been evaluated in a multi-cohort, open-label, Phase II study in patients with BRAF V600 mutant melanoma with brain metastases.
Patienter med hjernemetastaser Effekten og sikkerheden af trametinib i kombination med dabrafenib hos patienter med BRAF mutationspositivt melanom med hjernemetastaser blev undersøgt i et ikke-randomiseret, åbent, multicenter fase II-studie (COMBI-MB-studiet).
The efficacy and safety of trametinib in combination with dabrafenib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Intrakranielle blødninger med dødelig udgang forekom hos <1 % (8/1076) af patienterne i den integrerede sikkerhedspopulation med trametinib i kombination med dabrafenib.
Fatal intracranial haemorrhages occurred in the integrated safety population of trametinib in combination with dabrafenib in <1% (8/1076) of patients.
Før behandling med trametinib eller kombinationen med dabrafenib startes, skal patienterne have konstateret en BRAF V600-mutation i tumor ved hjælp af en valideret test.
Before taking trametinib or the combination with dabrafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Der kan forekomme nye maligniteter, kutane og ikke-kutane, når trametinib anvendes i kombination med dabrafenib.
New malignancies, cutaneous and non-cutaneous, can occur when trametinib is used in combination with dabrafenib.
Mekinist kan medføre nedbrydning af muskelvæv (rabdomyolyse).
Mekinist can result in the breakdown of muscle (rhabdomyolysis).
Der er ingen data om anvendelse af trametinib hos mennesker som monoterapi eller i kombination med dabrafenib.
There are no data in humans for trametinib as monotherapy or in combination with dabrafenib.
tidligere i punkt 4) • løsgørelse af den lysfølsomme membran på bagsiden af øjet (nethinden) fra dens understøttende lag (nethindeløsning) (se også “Øjenproblemer (synsproblemer)” tidligere i punkt 4)
• Separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) (see also “Eye (vision) problems” earlier in section 4).
Mekinist, som monoterapi eller i kombination med dabrafenib, kan give udslæt eller aknelignende udslæt.
Mekinist as monotherapy or in combination with dabrafenib can cause rash or acne-like rash.
Lungeemboli og dyb venetrombrose kan opstå, når trametinib anvendes som monoterapi eller i kombination med dabrafenib.
Pulmonary embolism or deep vein thrombosis can occur when trametinib is used as monotherapy or in combination with dabrafenib.
Inden patienten opstarter trametinib, skal BRAF V600-mutation i tumor være bekræftet ved anvendelse af en valideret test.
Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
Andelen af personer, der oplevede bivirkninger og alvorlige bivirkninger, var af samme størrelsesorden i gruppen på < 65 år og i gruppen på ≥ 65 år.
The proportion of subjects experiencing adverse reactions (AR) and serious adverse reactions (SAR) was similar in the subjects aged <65 years and those aged ≥65 years.
• Tag Mekinist i kombination med dabrafenib nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
• Take Mekinist in combination with dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Trametinib-monoterapi sammenlignet med BRAF-hæmmere
Trametinib monotherapy compared to BRAF inhibitors
Effektresultaterne i den primære effekt-population stemte overens med resultaterne i ITT-populationen.
The efficacy results in the primary efficacy population were consistent with those in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 11.
Tramatenib-dosis Anvendt som monoterapi eller i kombination med dabrafenib
Trametinib dose Used as monotherapy or in combination with dabrafenib
Svære kutane bivirkninger
Possible serious side effects
Trametinib hæmmer BRAFs aktivering af MEK og hæmmer MEK's kinaseaktivitet.
Trametinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity.
De filmovertrukne 2 mg Mekinist-tabletter er lyserøde, runde, bikonvekse med “GS” påtrykt på den ene side og “HMJ” på den anden side.
The Mekinist 2 mg film-coated tablets are pink, round, biconvex, with “GS” debossed on one face and “HMJ” on the opposing face.
Der er rapporteret nye primære melanomer hos patienter, som fik trametinib i kombination med dabrafenib.
New primary melanoma was reported in patients receiving trametinib in combination with dabrafenib.
MEK115306 var et randomiseret, dobbeltblindet fase III-studie, hvor kombinationen dabrafenib og trametinib blev sammenlignet med dabrafenib og placebo som førstelinjebehandling hos forsøgsdeltagere med inoperabelt (stadie IIIC) eller metastatisk (stadie IV) BRAF V600E-/Kmutationspositivt kutant melanom.
MEK115306 was a Phase III, randomised, double-blinded study comparing the combination of dabrafenib and trametinib to dabrafenib and placebo in first-line therapy for subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.
Tag altid Mekinist nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
Always take Mekinist exactly as your doctor, nurse or pharmacist has told you.
Inkluderer overfølsomhed over for lægemidlerne f Blødning fra forskellige steder, herunder interkraniel blødning og blødning med dødelig udgang g
Bleeding from various sites, including intracranial bleeding and fatal bleeding g Abdominal pain upper and abdominal pain lower h
Filmovertræk: hypromellose (E464), titandioxid (E171), polyethylenglycol, gul jernoxid (E172) (0,5 mg tabletter), polysorbat 80 (E433) og rød jernoxid (E172) (2 mg tabletter).
Film coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, iron oxide yellow (E172) (for 0.5 mg tablets), polysorbate 80 (E433) and iron oxide red (E172) (for 2 mg tablets).
Lyserøde, runde, bikonvekse, filmovertrukne tabletter, ca. 7,5 mm, påtrykt “GS” på den ene side og “HMJ” på den anden side.
Pink, round, biconvex, film-coated tablets, approximately 7.5 mm, with “GS” debossed on one face and “HMJ” on the opposing face.
Effekten hos patienter med øjen- eller slimhindemelanom er ikke undersøgt.
Efficacy in patients with ocular or mucosal melanoma has not been assessed.
Tag doserne af Mekinist og dabrafenib nøjagtigt efter lægens, sundhedspersonalets eller apotekspersonalets anvisning.
Take the doses of Mekinist and dabrafenib exactly as your doctor, nurse or pharmacist tells you.
De filmovertrukne 0,5 mg Mekinist-tabletter er gule, bikonvekse, med modificeret oval form og “GS” påtrykt på den ene side og “TFC” på den anden side.
The Mekinist 0.5 mg film-coated tablets are yellow, modified oval, biconvex, with “GS” debossed on one face and “TFC” on the opposing face.
Forhøjet niveau af aspartataminotransferase (ASAT)
Aspartate aminotransferase increased
Trametinib bør anvendes med forsigtighed hos patienter med moderat eller svært nedsat leverfunktion, når det administreres som monoterapi eller i kombination med dabrafenib.
Trametinib should be used with caution in patients with moderate or severe hepatic impairment when administered as monotherapy or in combination with dabrafenib.
Den anbefalede dosis af trametinib, enten som monoterapi eller i kombination med dafrafenib, er 2 mg en gang daglig.
The recommended dose of trametinib, either used as monotherapy or in combination with dabrafenib, is 2 mg once daily.
Trametinib som monoterapi eller i kombination med dabrafenib er indiceret til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation (se pkt.
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and
5 års samlet overlevelsesrate var 40% (95% CI: 31,2; 48,4) i kombinationsarmen versus 33% (95% CI: 25,0; 41,0) i dabrafenib monoterapiarmen, for patienter der havde normal laktatdehydrogenaseniveau ved baseline, og 16% (95% CI: 8,4; 26,0) i kombinationsarmen versus
The 5-year overall survival rate was 40% (95% CI: 31.2, 48.4) in the combination arm versus 33% (95% CI: 25.0, 41.0) in the dabrafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 8.4, 26.0) in the combination arm versus 14% (95% CI: 6.8, 23.1) in the dabrafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Forhøjet basisk fosfatase i blodet Forhøjet gamma-glutamyltransferase Forhøjet kreatinkinase i blodet a
Alanine aminotransferase increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased a
Trametinib skal seponeres permanent hos patienter, der diagnosticeres med behandlingsrelateret ILD eller pneumonitis (se pkt.
Trametinib should be permanently discontinued for patients diagnosed with treatment-related ILD or pneumonitis (see section 4.2).
Effekten og sikkerheden af trametinib i kombination med dabrafenib blev undersøgt i et ikke randomiseret, åbent fase II-multicenterstudie med 3 kohorter, hvor der blev inkluderet patienter med stadie IV BRAF V600E-muteret NSCLC.
The efficacy and safety of trametinib in combination with dabrafenib was studied in a Phase II, three-cohort, multicentre, non-randomised and open-label study in which patients with Stage IV BRAF V600E mutant NSCLC were enrolled.
Den anbefalede dosis af dafrafenib, når det anvendes i kombination med trametinib, er 150 mg to gange dagligt.
The recommended dose of dabrafenib, when used in combination with trametinib, is 150 mg twice daily.
Trametinib-monoterapi
• Trametinib monotherapy
Colitis og gastrointestinal perforation, inklusive med fatalt udfald, har været rapporteret hos patienter, der tog trametinib som monoterapi og i kombination med dabrafenib (se pkt.
Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Der er rapporteret forhøjelse af blodtrykket i forbindelse med trametinib som monoterapi og i kombination med dabrafenib hos patienter med eller uden eksisterende hypertension (se pkt.
Elevations in blood pressure have been reported in association with trametinib as monotherapy and in combination with dabrafenib, in patients with or without pre-existing hypertension (see section 4.8).
Skæringsdato Behandling Antal dødsfald
Number of deaths
I den integrerede sikkerhedspopulation med trametinib i kombination med dabrafenib er der rapporteret reduceret LVEF hos 6 % af patienterne (65/1076).
In the integrated safety population of trametinib in combination with dabrafenib, decreased LVEF has been reported in 6% (65/1076) of patients, with most cases being asymptomatic and reversible.
Det er rapporteret, at trametinib har reduceret LVEF, når det anvendes som monoterapi eller i kombination med dabrafenib.
Trametinib has been reported to decrease LVEF when used as monotherapy or in combination with dabrafenib.
Mænd, der tager trametinib i kombination med dabrafenib
Men taking trametinib in combination with dabrafenib
Justering af dabrafenib-dosis er ikke nødvendig, når det tages i kombination med trametinib ved diagnoserne RVO og RPED.
No dose modification of dabrafenib is required when taken in combination with trametinib following diagnosis of RVO or RPED.
Behandlingen med trametinib skal afbrydes hos patienter med formodet ILD eller pneumonitis, herunder patienter med nye eller tiltagende symptomer fra lungerne og parakliniske fund, herunder hoste, dyspnø, hypoksi, pleuraekssudat eller infiltrater, der afventer kliniske undersøgelser.
Trametinib must be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Sløret syn Periorbitalt ødem Nedsat syn
Vision blurred Periorbital oedema Visual impairment
Behandlingen med trametinib skal pauséres hos patienter med formodet ILD eller pneumonitis, herunder patienter med nye eller tiltagende symptomer fra lungerne og parakliniske fund, herunder hoste, dyspnø, hypoksi, pleuraekssudat eller infiltrater, der afventer kliniske undersøgelser.
Trametinib should be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Hjerteproblemer
Cardiac failure
Mekinist 2 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 2 mg trametinib.
Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.
Der er rapporteret pancreatitis hos patienter, som blev behandlet med trametinib i kombination med dabrafenib i kliniske forsøg.
Pancreatitis has been reported in patients treated with trametinib in combination with dabrafenib in clinical trials.
Der er rapporteret pancreatitis ved dabrafenib i kombination med trametinib.
Pancreatitis has been reported with dabrafenib in combination with trametinib.
På basis af krydsstudie-sammenligninger synes data om samlet overlevelse og progressionsfri overlevelse at vise, omtrent samme effekt af trametinib og BRAF-hæmmere.
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.
1-års rate (95 % CI)
1-year rate (95% CI)
Primær analyse (skæringsdato for dataindsamling: 26-aug
Primary analysis (data cutoff: 26-Aug-2013)
Mekinist 0,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg trametinib.
Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.
• ømhed eller blærer i munden, inflammation i slimhinderne
• Sore mouth or mouth ulcers, inflammation of mucous membranes
Ved tegn eller symptomer på rabdomyolyse bør der foretages en klinisk vurdering og passende behandling opstartes (se pkt.
Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated (see section 4.4).
• hudrødme, sprukken eller revnet hud
• Reddening, chapping or cracking of the skin
3) Følgende bivirkning forekom i MEK116513 og BRF115532, men ikke i MEK115306 og BRF113928: Rabdomyolyse (ikke almindelig).
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
• følelse af svaghed
• Feeling weak
THxID BRAF-analysen og efterfølgende blev sekventeret ved brug af referencemetoden, var specificiteten af analysen 94 %.
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%.
Det vides ikke, om indholdsstofferne i Mekinist går over i modermælken.
Mekinist is not recommended while breast-feeding It is not known whether the ingredients of Mekinist can pass into breast milk.
• neglelidelser, fx forandringer i neglelejet, neglesmerter, betændte og hævede neglebånd
• Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
Trametinib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion, når det administreres som monoterapi eller i kombination med dabrafenib.
Trametinib should be used with caution in patients with severe renal impairment when administered as monotherapy or in combination with dabrafenib.
• inflammation (betændelseslignende reaktion) i lungerne (pneumonitis eller interstitiel lungesygdom)
• Inflammation of the lung (pneumonitis or interstitial lung disease)
Trametinib bør anvendes med forsigtighed hos patienter med tilstande, der kan nedsætte funktionen af venstre ventrikel (se pkt.
Trametinib should be used with caution in patients with conditions that could impair left ventricular function (see sections 4.2 and 4.4).
Der er observeret nyresvigt hos patienter, som blev behandlet med trametinib i kombination med dabrafenib i kliniske forsøg.
Renal failure has been identified in patients treated with trametinib in combination with dabrafenib in clinical trials.
3-års rate (95 % CI)
3-year rate (95% CI)
2-års rate (95 % CI)
2-year rate (95% CI)
Mekinist 2 mg tabletter trametinib
Mekinist 2 mg tablets trametinib
Der er rapporteret nyresvigt ved dabrafenib i kombination med trametinib.
Renal failure has been reported with dabrafenib in combination with trametinib.
Hazard ratio (95 % CI) P-værdi
Hazard ratio (95% CI) p-value
Hvis der opstår blødning, skal patienterne behandles som klinisk indiceret (se pkt.
If haemorrhage occurs, treat as clinically indicated (see section 4.4).
Se produktresuméet for dabrafenib.
Please see the dabrafenib SmPC.
Spørg lægen, sundhedspersonalet eller apotekspersonalet, hvis du er i tvivl om noget.
Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Mikrokrystallinsk cellulose (E 460) Hypromellose (E 464) Croscarmellosenatrium (E 468) Magnesiumstearat (E 470b) Natriumlaurilsulfat
Microcrystalline cellulose (E460) Hypromellose (E464) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium laurilsulfate Colloidal silicon dioxide(E551)
Mekinist 0,5 mg tabletter trametinib
Mekinist 0.5 mg tablets trametinib
Beholderen indeholder et tørremiddel.
The bottle contains a desiccant.
Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (se pkt.
No dosage adjustment is required in patients with mild hepatic impairment (see section 5.2).
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (se pkt.
No dosage adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Trametinib kan nedsætte fertiliteten hos mennesker.
Trametinib may impair fertility in humans.
2) Følgende bivirkninger forekom i MEK116513, men ikke i MEK115306: Hjertesvigt, dysfunktion af venstre ventrikel, interstitiel lungesygdom (ikke almindelig).
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).
Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg eller 2 mg trametinib.
Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg of trametinib.
<0,001f
P value f
• blokering af den vene, der fører blodet væk fra øjet (retinal veneokklusion) (se også
• Blockage of the vein draining the eye (retinal vein occlusion) (see also “Eye (vision) problems”
Der er ingen tilgængelige data om patienter med svært nedsat nyrefunktion (se pkt.
No data are available in patients with severe renal impairment (see section 4.2).
Tablet-filmovertræk Hypromellose (E 464) Titandioxid (E 171) Polyethylenglycol Gul jernoxid (E 172)
Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Iron oxide yellow(E172)
Det er ikke nødvendigt at justere trametinib-dosis ved RAS-mutationspositive maligniteter, når det tages i kombination med dabrafenib.
No dose modification of trametinib is required for RAS mutation positive malignancies when taken in combination with dabrafenib.
Ansigtsødem Slimhindeinflammation Asteni
Face oedema Mucosal inflammation Asthenia
• du skal vente mindst 1 time, før du spiser efter du har taget Mekinist
• after taking Mekinist, you must wait at least 1 hour before eating, or
Hazard ratio (95% CI) p-værdi
Adjusted hazard ratio (95% CI) p-value
Der er rapporteret leverpåvirkninger i kliniske studier med trametinib som monoterapi og i kombination med dabrafenib.
Hepatic adverse reactions have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib.
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.
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.
Samlet responsrate, % (95 % CI)
Overall response rate, % (95% CI)
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.
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.
Mekinist 0,5 mg filmovertrukne tabletter Mekinist 2 mg filmovertrukne tabletter
Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets
• inflammation i nyrerne
• Inflammation of the kidneys
Tablet-filmovertræk Hypromellose (E 464) Titandioxid (E 171) Polyethylenglycol Polysorbat 80 (E 433) Rød jernoxid (E 172)
Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 (E433) Iron oxide red (E172)
Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 2 mg trametinib.
Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg trametinib.
18,7 måneder) med 5-års overlevelsesrater på 32% for kombinationen, versus 27% for dabrafenib monoterapi (tabel 6, figur 1).
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).
Hvis du har taget for meget Mekinist
If you take more Mekinist than you should
Mekinist 0,5 mg filmovertrukne tabletter Mekinist 2 mg filmovertrukne tabletter trametinib
Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets trametinib
Justering af dabrafenib-dosis er ikke nødvendig, når trametinib tages i kombination med dabrafenib.
No dose modification of dabrafenib is required when trametinib is taken in combination with dabrafenib.
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
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
Hver filmovertrukken tablet indeholder trametinibdimethylsulfoxid svarende til 0,5 mg trametinib.
Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg trametinib.