FrancophonIA/ELRC3.0 huggingface dataset:
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 after treatment initiation with trametinib.
Croatian: U bolesnika koji se liječe trametinibom kao monoterapijom ili u kombinaciji s dabrafenibom preporučuje se nadzirati jetrenu funkciju svaka četiri tjedna tijekom 6 mjeseci nakon početka liječenja trametinibom.
English: Malignant melanoma, metastatic malignant melanoma, and superficial spreading melanoma Stage III e Includes drug hypersensitivity f
Croatian: Papilom, kožni papilom d Maligni melanom, metastatski maligni melanom, i površinsko šireći melanom stadija III
English: In patients who are diagnosed with RVO, treatment with trametinib, whether given as monotherapy or in combination with dabrafenib, should be permanently discontinued.
Croatian: U bolesnika kojima se dijagnosticira okluzija mrežnične vene (RVO), liječenje trametinibom, bilo kao monoterapijom ili u kombinaciji s dabrafenibom, mora se trajno obustaviti.
English: The most common adverse reactions (incidence 20%) for trametinib in combination with dabrafenib were: pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.
Croatian: Najčešće nuspojave (incidencija ≥ 20%) za trametinib u kombinaciji s dabrafenibom bile su: pireksija, umor, mučnina, zimica, glavobolja, proljev, povraćanje, artralgija i osip.
English: • If you take too much Mekinist or dabrafenib, immediately contact your doctor, nurse or pharmacist.
Croatian: • Ako uzmete previše Mekinista ili dabrafeniba, odmah se obratite svom liječniku, medicinskoj sestri ili ljekarniku.
English: Yellow, modified oval, biconvex, film-coated tablets, approximately 4.8 x 8.9 mm, with “GS” debossed on one face and “TFC” on the opposing face.
Croatian: Žute, modificirano ovalne, bikonveksne, filmom obložene tablete, dimenzija približno 4,8 x 8,9 mm, s utisnutom oznakom „GS“ na jednoj i „TFC“ na suprotnoj strani.
English: Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Croatian: Razgovarajte sa svojim liječnikom, medicinskom sestrom ili ljekarnikom ako Vam nešto nije jasno.
English: The safety of trametinib monotherapy has been evaluated in the integrated safety population of 329 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with trametinib 2 mg once daily in studies MEK114267, MEK113583, and MEK111054.
Croatian: Sigurnost monoterapije trametinibom procijenjena je u objedinjenoj populaciji u kojoj se ispitivala sigurnost, a koju je činilo 329 bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom liječenih trametinibom u dozi od 2 mg jedanput na dan u ispitivanjima MEK114267, MEK113583, i MEK111054.
English: Trametinib is an in vitro substrate of the efflux transporter P-gp.
Croatian: Trametinib je in vitro supstrat efluksnog prijenosnika P-gp-a.
English: In clinical trials, the median time to first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 to 5 months.
Croatian: U kliničkim je ispitivanjima medijan vremena do prve pojave disfunkcije lijeve klijetke, zatajenja srca i smanjenja LVEF bio između 2 i 5 mjeseci.
English: Pulmonary embolism or deep vein thrombosis can occur when trametinib is used as monotherapy or in combination with dabrafenib.
Croatian: Plućna embolija ili duboka venska tromboza mogu se javiti kada se trametinib koristi kao monoterapija ili u kombinaciji s dabrafenibom.
English: The efficacy and safety of trametinib have not been evaluated in patients whose melanoma tested negative for the BRAF V600 mutation.
Croatian: Djelotvornost i sigurnost trametiniba nisu ispitivane u bolesnika u kojih je nalaz testa pokazao da je melanom negativan na mutaciju BRAF V600.
English: Trametinib should be used with caution in patients with impaired left ventricular function.
Croatian: Trametinib treba primjenjivati uz oprez u bolesnika s narušenom funkcijom lijeve klijetke.
English: In patients who are diagnosed with RVO, treatment with trametinib should be permanently discontinued.
Croatian: U bolesnika kojima se dijagnosticira okluzija mrežnične vene, liječenje trametinibom se mora trajno obustaviti.
English: • dark urine due to kidney damage
Croatian: • mokraću tamne boje zbog oštećenja bubrega
English: Measurement of patients' BRAF V600 mutation status was required.
Croatian: U bolesnika je bilo potrebno odrediti status mutacije BRAF V600.
English: Effect of other medicinal products on trametinib
Croatian: Učinak drugih lijekova na trametinib
English: Tell your doctor or nurse as soon as possible if you get any skin rash, or if you have a rash that gets worse.
Croatian: Obavijestite svog liječnika ili medicinsku sestru što je prije moguće ako se pojavi kožni osip ili pogorša već postojeći osip.
English: Dose adjustment for dabrafenib below 50 mg twice daily is not recommended when used in combination with trametinib.
Croatian: Ne preporučuje se prilagodba doze za dabrafenib ispod 50 mg dvaput na dan, kada se primjenjuje u kombinaciji s trametinibom.
English: If haemorrhage occurs, patients should be treated as clinically indicated.
Croatian: Nastupi li krvarenje, bolesnike se mora liječiti sukladno kliničkoj slici.
English: Table 3 Recommended dose modifications for trametinib for RPED
Croatian: Tablica 3 Preporučena prilagodba doze trametiniba u slučaju RPED-a RPED 1. stupnja
English: EU/1/14/931/005 7 film-coated tablets EU/1/14/931/006 30 film-coated tablets
Croatian: EU/1/14/931/005 7 filmom obloženih tableta EU/1/14/931/006 30 filmom obloženih tableta
English: (95% CI) ORR difference (95% CI)
Croatian: (95% CI) Razlika u ORR-u (95% CI)
English: 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
Croatian: Trametinib kao monoterapija ili u kombinaciji s dabrafenibom indiciran je za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom (vidjeti dijelove 4.4 i 5.1).
English: • Take Mekinist in combination with dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Croatian: • Uzimajte Mekinist u kombinaciji s dabrafenibom točno onako kako Vam Vaš liječnik, medicinska sestra ili ljekarnik kažu.
English: Grade (CTC-AE)* Recommended trametinib dose modifications Used as monotherapy or in combination with dabrafenib
Croatian: Stupanj (CTC-AE)* Preporučene prilagodbe doze trametiniba kada se primjenjuje kao monoterapija ili u kombinaciji s dabrafenibom
English: EU/1/14/931/001 7 film-coated tablets EU/1/14/931/002 30 film-coated tablets
Croatian: EU/1/14/931/001 7 filmom obloženih tableta EU/1/14/931/002 30 filmom obloženih tableta
English: New primary melanoma was reported in patients receiving trametinib in combination with dabrafenib.
Croatian: Novi primarni melanom bio je prijavljen u bolesnika koji su primali trametinib u kombinaciji s dabrafenibom.
English: In Cohort A of this study, trametinib did not demonstrate clinical activity in patients who had progressed on a prior BRAF inhibitor therapy.
Croatian: A ovoga ispitivanja, trametinib nije pokazao kliničku aktivnost u bolesnika u kojih je nastupila progresija tijekom prethodne terapije BRAF inhibitorom.
English: The side effects that you may see when you take Mekinist in combination with dabrafenib are as follows:
Croatian: Sljedeće nuspojave mogli biste primijetiti kada uzimate Mekinist u kombinaciji s dabrafenibom:
English: The following convention has been utilised for the classification of frequency: Very common ≥1/10
Croatian: Učestalost je klasificirana na sljedeći način: vrlo često često
English: • passing blood in the urine
Croatian: • krv u mokraći
English: • Skin rash with pus-filled blisters (see also “Changes in your skin” earlier in section 4)
Croatian: • kožni osip s gnojnim mjehurićima (pogledajte i odlomak “Kožne promjene“ ranije u dijelu 4)
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.
Croatian:  65 godina); svi su bolesnici imali ECOG status 0 ili 1; a 3% bolesnika imalo je moždane metastaze u anamnezi.
English: No data are available in patients with severe renal impairment (see section 4.2).
Croatian: Nema dostupnih podataka o bolesnicima s teškim oštećenjem bubrežne funkcije (vidjeti dio 4.2).
English: Percent survival at 12 months (95% CI)
Croatian: Postotak preživljenja nakon 12 mjeseci (95% CI)
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI) P value Overall Response Rate (%)
Croatian: Medijan PFS-a (mjeseci) (95% CI) Omjer rizika (95% CI) P- vrijednost Stopa ukupnog odgovora (%)
English: Mekinist as monotherapy or in combination with dabrafenib can cause rash or acne-like rash.
Croatian: Mekinist kao monoterapija ili u kombinaciji s dabrafenibom može izazvati osip ili osip nalik aknama.
English: • 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).
Croatian: • odvajanje membrane osjetljive na svjetlost u stražnjem dijelu oka (mrežnica) od slojeva koji je podupiru (odvajanje mrežnice) (pogledajte i odlomak „Tegobe s očima (vidom)“ ranije u dijelu 4)
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.
Croatian: U bolesnika koji se liječe trametinibom kao monoterapijom ili u kombinaciji s dabrafenibom preporučuje se nadzirati jetrenu funkciju svaka četiri tjedna tijekom 6 mjeseci.
English: • Trametinib in combination with dabrafenib
Croatian: • Trametinib u kombinaciji s dabrafenibom
English: Patients should take trametinib as monotherapy or in combination with dabrafenib at least one hour prior to or two hours after a meal due to the effect of food on trametinib absorption (see section 4.2 and 5.2).
Croatian: Budući da hrana utječe na apsorpciju trametiniba, bolesnici moraju uzimati trametinib kao monoterapiju ili u kombinaciji s dabrafenibom najmanje jedan sat prije ili dva sata nakon obroka (vidjeti dijelove 4.2 i 5.2).
English: 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.
Croatian: Primjenu trametiniba treba odgoditi u bolesnika u kojih se sumnja na IBP ili pneumonitis, uključujući bolesnike u kojih se pojave novi ili progrediraju postojeći plućni simptomi i nalazi, uključujući kašalj, dispneju, hipoksiju, pleuralni izljev ili infiltrate, sve dok se ne provedu kliničke pretrage.
English: How to store Mekinist
Croatian: Kako čuvati Mekinist
English: Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Croatian: Trametinib u kombinaciji s dabrafenibom indiciran je za adjuvantno liječenje odraslih bolesnika s melanomom stadija III s BRAF V600 mutacijom, nakon potpune resekcije.
English: Trametinib in combination with dabrafenib in patients with brain metastases
Croatian: Trametinib u kombinaciji s dabrafenibom u bolesnika s metastazama u mozgu
English: *Please refer to the dabrafenib SmPC, Posology and method of administration, for dosing instructions for treatment with dabrafenib monotherapy.
Croatian: *Pogledajte Sažetak opisa svojstava lijeka za dabrafenib, Doziranje i način primjene, za upute o doziranju u liječenju monoterapijom dabrafenibom.
English: • Swelling of nerves at the back of the eye (papilloedema) (see also “Eye (vision) problems”
Croatian: • oticanje živaca u stražnjem dijelu oka (papiloedem) (pogledajte i odlomak „Tegobe s očima
English: The safety of trametinib in combination with dabrafenib has been evaluated in the integrated safety population of 1,076 patients with BRAF V600 mutant unresectable or metastatic melanoma, Stage III BRAF V600 mutant melanoma following complete resection (adjuvant treatment) and advanced NSCLC treated with trametinib 2 mg once daily and dabrafenib 150 mg twice daily.
Croatian: Sigurnost trametiniba u kombinaciji s dabrafenibom procijenjena je u objedinjenoj populaciji u kojoj se ispitivala sigurnost, a koju je činilo 1076 bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom, melanomom stadija III s BRAF V600 mutacijom nakon potpune resekcije (adjuvantno liječenje) i uznapredovalim NSCLC-om s BRAF V600 mutacijom liječenih trametinibom u dozi od 2 mg jedanput na dan i dabrafenibom u dozi od 150 mg dvaput na dan.
English: The recommended dose of dabrafenib, when used in combination with Mekinist, is 150 mg twice daily.
Croatian: Preporučena doza dabrafeniba, kada se uzima u kombinaciji s Mekinistom, iznosi 150 mg dvaput na dan.
English: If a patient vomits after taking trametinib, the patient should not retake the dose and should take the next scheduled dose.
Croatian: Ako bolesnik povrati nakon uzimanja trametiniba, ne smije uzeti još jednu dozu nego treba uzeti sljedeću dozu prema uobičajenom rasporedu.
English: Rash has been observed in about 60% of patients in trametinib monotherapy studies and in about 24% of patients when trametinib is used in combination with dabrafenib (see section 4.8).
Croatian: Osip je primijećen u približno 60% bolesnika u ispitivanjima monoterapije trametinibom te u oko 24% bolesnika kada se trametinib primjenjivao u kombinaciji s dabrafenibom (vidjeti dio 4.8).
English: Lung or breathing problems
Croatian: Plućne ili dišne tegobe
English: 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.
Croatian: Primjena trametiniba mora se odgoditi u bolesnika u kojih se sumnja na intersticijsku bolest pluća (IBP) ili pneumonitis, uključujući bolesnike u kojih se pojave novi ili progrediraju postojeći plućni simptomi i nalazi uključujući kašalj, dispneju, hipoksiju, pleuralni izljev ili infiltrate, sve dok se ne provedu kliničke pretrage.
English: 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.
Croatian: Udio ispitanika u kojih su se pojavile nuspojave i ozbiljne nuspojave bio je sličan i među ispitanicima mlađima od 65 godina i među onima u dobi
English: The combination of trametinib with dabrafenib has shown anti-tumour activity in BRAF V600 mutation positive melanoma cell lines in vitro and delays the emergence of resistance in vivo in BRAF V600 mutation positive melanoma xenografts.
Croatian: Kombinacija trametiniba s dabrafenibom je pokazala antitumorsku aktivnost u staničnoj liniji melanoma s pozitivnom BRAF V600 mutacijom in vitro i odgađa pojavu rezistencije in vivo u ksenograftima melanoma s pozitivnom BRAF V600 mutacijom.
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Croatian: Ispitanici su većinom bili bijele rase (> 99%) i muškarci (53%), medijana starosti od 56 godina (28% je imalo ≥ 65 godina).
English: Continue treatment with retinal evaluation monthly until resolution.
Croatian: Nastaviti liječenje uz mjesečne preglede mrežnice do povlačenja RPED-a.
English: Tell your doctor immediately if it feels like your heart is pounding, racing, or beating irregularly, or if you experience dizziness, tiredness, light-headedness, shortness of breath or swelling in the legs.
Croatian: Odmah obavijestite svog liječnika ako osjetite lupanje srca te ubrzane ili nepravilne otkucaje srca ili ako se pojave omaglica, umor, ošamućenost, nedostatak zraka ili oticanje nogu.
English: When trametinib is given in combination with dabrafenib, the SmPC of dabrafenib must be consulted prior to initiation of treatment.
Croatian: Kada se trametinib daje u kombinaciji s dabrafenibom, mora se pročitati Sažetak opisa svojstava lijeka za dabrafenib prije započinjanja liječenja.
English: Trametinib is not a substrate of CYP enzymes or of the transporters BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, and MATE1.
Croatian: Trametinib nije supstrat za CYP enzime niti za prijenosnike BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, i MATE1.Trametinib je in vitro supstrat BSEP-a i efluksnog prijenosnika P-gp-a.
English: Trametinib monotherapy has not been compared with a BRAF inhibitor in a clinical study in patients with BRAF V600 mutation positive unresectable or metastatic melanoma.
Croatian: Monoterapija trametinibom nije uspoređivana s BRAF inhibitorom u kliničkom ispitivanju u bolesnika koji su imali neoperabilan ili metastatski melanom pozitivan na mutaciju BRAF V600.
English: Trametinib inhibits growth of BRAF V600 mutant melanoma cell lines and demonstrates anti-tumour effects in BRAF V600 mutant melanoma animal models.
Croatian: Trametinib inhibira rast staničnih linija melanoma s mutacijom BRAF V600 te pokazuje antitumorski učinak na melanom s mutacijom BRAF V600 u životinjskim modelima.
English: • Eyesight problems (see also “Eye (vision) problems” earlier in section 4)
Croatian: • tegobe s vidom (pogledajte i odlomak „Tegobe s očima (vidom)“ ranije u dijelu 4)
English: As metabolism and biliary excretion are the primary routes of elimination of trametinib, administration of trametinib should be undertaken with caution in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Budući da su metabolizam i izlučivanje putem žuči primarni putovi eliminacije trametiniba, lijek se mora primjenjivati uz oprez u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
English: Trametinib may result in transient inhibition of BCRP substrates (e.g. pitavastatin) in the gut, which may be minimised with staggered dosing (2 hours apart) of these agents and trametinib.
Croatian: Trametinib može uzrokovati prolaznu inhibiciju supstrata za protein koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) (npr. pitavastatina) u crijevima, što se može minimizirati odvojenom primjenom tih lijekova i trametiniba (s razmakom od 2 sata).
English: Bleeding from various sites, including intracranial bleeding and fatal bleeding g Abdominal pain upper and abdominal pain lower h
Croatian: Uključuje preosjetljivost na lijek f Krvarenje iz raznih mjesta, uključujući intrakranijalno krvarenje i smrtonosno krvarenje g
English: • coughing / vomiting up blood
Croatian: • kašljanje / povraćanje krvi
English: Trametinib suppressed levels of phosphorylated ERK in BRAF mutant melanoma tumour cell lines and melanoma xenograft models.
Croatian: Trametinib je suprimirao razine fosforiliziranog ERK u staničnim linijama melanoma s BRAF mutacijom i modelima s ksenotransplantatom melanoma.
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).
Croatian: Sigurnosni profil iz MEK116513 je općenito sličan onome iz MEK115306 sa sljedećim iznimkama: 1) Sljedeće nuspojave imaju veću učestalost u usporedbi s MEK115306: spazam mišića (vrlo često); zatajenje bubrega i limfedem (često); akutno zatajenje bubrega (manje često); 2) Sljedeće nuspojave su se pojavile u MEK116513, ali ne u MEK 115306: zatajenje srca, disfunkcija lijeve klijetke, intersticijska bolest pluća (manje često).
English: Take the doses of Mekinist and dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Croatian: Uzimajte doze Mekinista i dabrafeniba točno onako kako Vam kažu Vaš liječnik, medicinska sestra ili ljekarnik.
English: In an embryo-foetal developmental toxicity study with rabbits, decreased foetal body weight, increased abortions, increased incidence of incomplete ossification and skeletal malformations were seen at sub-clinical exposures based on AUC).
Croatian: U ispitivanju embriofetalne razvojne toksičnosti u ženki kunića primijećeni su smanjena tjelesna težina ploda, povećan broj pobačaja, povećana incidencija nepotpunog okoštavanja i koštanih malformacija pri izloženostima koje su bile manje od kliničke izloženosti na temelju AUC-a.
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.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za majku, mora se donijeti odluka hoće li se prekinuti dojenje ili obustaviti liječenje trametinibom.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Croatian: Većina je ispitanika imala LDH ≤ GGN (65%), funkcionalni status 0 (72%) prema Istočnoj suradnoj grupi za onkologiju (engl.
English: When trametinib is used in combination with dabrafenib please refer to the dabrafenib SmPC (section 4.4).
Croatian: Kada se trametinib primjenjuje u kombinaciji s dabrafenibom pogledajte Sažetak opisa svojstava lijeka za dabrafenib (dio 4.4).
English: The majority of subjects had BRAF V600E mutation-positive melanoma (89%).
Croatian: Većina je ispitanika imala melanom s pozitivnom BRAF V600E mutacijom (89%).
English: If you have any further questions on the effect of this medicine on fertility, ask your doctor, nurse or pharmacist.
Croatian: Ako imate dodatnih pitanja o učinku ovog lijeka na plodnost, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: Cut-off dates
Croatian: Završni datumi prikupljanja podataka
English: Trametinib should be permanently discontinued for patients diagnosed with treatment-related ILD or pneumonitis (see section 4.2).
Croatian: Primjenu trametiniba se mora trajno obustaviti u bolesnika kojima se dijagnosticiraju IBP ili pneumonitis povezani s liječenjem (vidjeti dio 4.2).
English: The clinical status of the patient and the adverse reaction profile should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and cognitive skills.
Croatian: Pri razmatranju bolesnikove sposobnosti izvođenja zadataka koji zahtijevaju rasuđivanje te motoričke ili kognitivne vještine, treba imati na umu klinički status bolesnika i profil nuspojava.
English: 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.
Croatian: Prijavljena su povišenja krvnog tlaka povezana s trametinibom kao monoterapijom i u kombinaciji s dabrafenibom u bolesnika koji su otprije bolovali od hipertenzije i u onih koji nisu.
English: Effect of food on trametinib
Croatian: Učinak hrane na trametinib
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava često anemija
English: 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).
Croatian: Film ovojnica: hipromeloza (E464), titanijev dioksid (E171), polietilenglikol, žuti željezov oksid (E172) (za tablete od 0,5 mg), polisorbat 80 (E433) i crveni željezov oksid (E172) (za tablete od 2 mg).
English: Trametinib in combination with dabrafenib in patients with melanoma who have progressed on a BRAF inhibitor
Croatian: Trametinib u kombinaciji s dabrafenibom u bolesnika s melanomom u kojih je došlo do progresije tijekom terapije BRAF inhibitorom
English: The recommended dose of dabrafenib, when used in combination with trametinib, is 150 mg twice daily.
Croatian: Preporučena doza dabrafeniba, kada se primjenjuje u kombinaciji s trametinibom, iznosi 150 mg dvaput na dan.