FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of 2 mg once daily, steady-state geometric mean Cmax, AUC(0-) and predose concentration were 22.2 ng/ml, 370 ng*hr/ml and 12.1 ng/ml, respectively with a low peak:trough ratio (1.8).
Croatian: Nakon primjene doze od 2 mg jedanput na dan, u stanju dinamičke ravnoteže geometrijske srednje vrijednosti Cmax, AUC(0-) i koncentracije prije primjene doze iznosile su 22,2 ng/ml, 370 ng*hr/ml odnosno 12,1 ng/ml, uz nizak omjer vršne i najniže vrijednosti (1,8).
English: Mekinist is not recommended if you have ever had a blockage of the vein draining the eye (retinal vein occlusion).
Croatian: Mekinist se ne preporučuje ako ste ikada imali začepljenje vene koja odvodi krv iz oka (okluziju mrežnične vene).
English: If possible, show them the Mekinist and dabrafenib pack with each leaflet.
Croatian: Ako je moguće, pokažite im pakiranja Mekinista i dabrafeniba s uputama o lijeku.
English: Discontinue permanently, or interrupt therapy until Grade 0 to 1 and reduce by one dose level when resuming therapy.
Croatian: Trajno obustaviti, ili prekinuti terapiju dok se ne postigne 0. ili 1. stupanj, a zatim nastaviti terapiju dozom smanjenom za jednu razinu.
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).
Croatian: Iznimke u kojima su prilagodbe doze potrebne za samo jednu od dviju terapija navedene su u nastavku za pireksiju, uveitis, zloćudne bolesti s pozitivnom RAS mutacijom koje ne zahvaćaju kožu (u prvom redu povezano s dabrafenibom), smanjenje ejekcijske frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF), okluziju mrežnične vene (engl. retinal vein occlusion, RVO), odvajanje pigmentnog epitela mrežnice (engl. retinal pigment epithelial detachment, RPED) i intersticijsku bolest pluća (IBP)/pneumonitis (u prvom redu povezano s trametinibom).
English: Patients treated with trametinib or combination with dabrafenib may develop ILD or pneumonitis.
Croatian: U bolesnika liječenih trametinibom ili kombinacijom s dabrafenibom mogu se razviti IBP ili pneumonitis.
English: Trametinib monotherapy compared to BRAF inhibitors
Croatian: Monoterapija trametinibom u usporedbi s BRAF inhibitorima
English: Side effects when Mekinist and dabrafenib are taken together
Croatian: Nuspojave kada se Mekinist i dabrafenib uzimaju zajedno
English: Trametinib is absorbed orally with median time to achieve peak concentrations of 1.5 hours post-dose.
Croatian: Trametinib se nakon peroralne primjene apsorbira s medijanom vremena do postizanja vršnih koncentracija od 1,5 sata nakon doziranja.
English: Mekinist can cause eye problems including blindness.
Croatian: Mekinist može izazvati očne tegobe, uključujući sljepoću.
English: • If you miss a dose of Mekinist or dabrafenib, take it as soon as you remember: Do not make up for missed doses and just take your next dose at your regular time: o If it is less than 12 hours to your next scheduled dose of Mekinist, which is taken once daily.
Croatian: Nemojte nadoknađivati propuštenu dozu i jednostavno uzmite svoju sljedeću dozu u redovito vrijeme: o Ako ima manje od 12 sati do Vaše sljedeće planirane doze Mekinista, koji se uzima jedanput na dan.
English: In these patients a 13% (95% CI: 5.0, 27.0) confirmed response rate was observed with a median PFS of 3.6 months (95% CI: 2, 4).
Croatian: U tih bolesnika uočena je potvrđena stopa odgovora od 13% (95% CI: 5,0, 27,0) uz medijan PFS-a od 3,6 mjeseci (95% CI: 2, 4).
English: Trametinib was found to be an in vitro inhibitor of CYP2C8, CYP2C9 and CYP2C19, an inducer of CYP3A4 and an inhibitor of the transporters OAT1, OAT3, OCT2, MATE1, OATP1B1, OATP1B3, P-gp and BCRP.
Croatian: Pokazalo se da trametinib in vitro djeluje kao inhibitor CYP2C8, CYP2C9 i CYP2C19, induktor CYP3A4 te inhibitor prijenosnika OAT1, OAT3, OCT2, MATE1, OATP1B1, OATP1B3, P-gp-a i BCRP-a.
English: If you are breast-feeding, or planning to breast-feed, you must tell your doctor.
Croatian: Ako dojite ili planirate dojiti, o tome morate obavijestiti svog liječnika.
English: Most patients (94%) enrolled in the combination-therapy-treated cohorts had an ECOG performance status of 0 or 1.
Croatian: Većina bolesnika (94%) uključenih u kohorte liječene kombiniranom terapijom imala je ECOG funkcionalni status od 0 ili 1. 26 (28%) nikada nije pušilo.
English: There are limited data in patients taking the combination of trametinib with dabrafenib who have progressed on a prior BRAF inhibitor.
Croatian: Postoje ograničeni podaci u bolesnika koji su uzimali kombinaciju trametiniba s dabrafenibom u kojih je došlo do progresije tijekom prethodne terapije BRAF inhibitorom.
English: Always take Mekinist exactly as your doctor, nurse or pharmacist has told you.
Croatian: Uvijek uzmite Mekinist točno onako kako Vam je rekao liječnik, medicinska sestra ili ljekarnik.
English: and BRF115532 (n=1,076)
Croatian: a, BRF113928, i BRF115532 (n=1076)
English: BOTTLE LABEL
Croatian: NALJEPNICA BOČICE
English: The primary endpoint of the study was to evaluate the efficacy of trametinib compared to chemotherapy with respect to PFS in patients with advanced/metastatic BRAF V600E/K mutation-positive melanoma without a prior history of brain metastases (N=273) which is considered the primary efficacy population.
Croatian: Mjera primarnog ishoda ispitivanja bila je ocijeniti djelotvornost trametiniba u usporedbi s kemoterapijom s obzirom na PFS u bolesnika s uznapredovalim/metastatskim melanomom pozitivnim na BRAF mutaciju V600E/K i bez moždanih metastaza u anamnezi (N=273), koji su se smatrali primarnom populacijom za ispitivanje djelotvornosti.
English: In a single-arm Phase II study, designed to evaluate the objective response rate, safety, and pharmacokinetics following dosing of trametinib at 2 mg once daily in patients with BRAF V600E, V600K, or V600D mutation-positive metastatic melanoma (MEK113583), two separate cohorts were enrolled: Cohort A: patients with prior treatment with a BRAF inhibitor either with or without other prior therapy, Cohort B: patients with at least 1 prior chemotherapy or immunotherapy, without prior treatment with a BRAF inhibitor.
Croatian: U ispitivanju faze II s jednom skupinom, koje je osmišljeno je kako bi se procijenile stopa objektivnog odgovora, sigurnost i farmakokinetika nakon primjene trametiniba u dozi od 2 mg jedanput na dan u bolesnika s metastatskim melanomom pozitivnim na BRAF mutaciju V600E, V600K ili V600D (MEK113583), uključene su dvije odvojene kohorte: Kohorta A: bolesnici koji su prethodno liječeni BRAF inhibitorom, samim ili u kombinaciji s drugim ranijim terapijama; Kohorta B: bolesnici koji su prethodno primili najmanje jednu kemoterapiju ili imunoterapiju, ali nisu liječeni BRAF inhibitorom.
English: Efficacy in patients with ocular or mucosal melanoma has not been assessed.
Croatian: Nije ocijenjena djelotvornost u bolesnika s melanomom oka ili sluznice.
English: The other side effects that you may see when you take Mekinist alone are as follows:
Croatian: Sljedeće nuspojave mogli biste primijetiti kada uzimate samo Mekinist:
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).
Croatian: Rezultat preživljenja bez progresije bolesti bio je konzistentan u podskupini bolesnika s melanomom pozitivnim na mutaciju V600K (HR=0,50 [95% CI: 0,18; 1,35], p=0,0788).
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III studies, MEK115306 (COMBI-d) and MEK116513 (COMBI-v), 435 were treated with the combination in the adjuvant treatment of Stage III BRAF V600 mutant melanoma after complete resection in a randomised Phase III study BRF115532 (COMBI-AD) and 82 were treated with the combination for BRAF V600 mutant NSCLC in a multi-cohort, non-randomised Phase II study BRF113928 (see section 5.1).
Croatian: Od tih je bolesnika njih 559 primalo kombiniranu terapiju za liječenje melanoma s BRAF V600 mutacijom u dva randomizirana ispitivanja faze III, MEK115306 (COMBI-d) i MEK116513 (COMBI-v), 435 je primalo kombiniranu terapiju u adjuvantnom liječenju melanoma stadija III s BRAF V600 mutacijom nakon potpune resekcije u randomiziranom ispitivanju faze III BRF115532 (COMBI-AD) i 82 je primalo kombiniranu terapiju za NSCLC s BRAF V600 mutacijom u nerandomiziranom ispitivanju faze II BRF113928 s više kohorti (vidjeti dio 5.1).
English: In juvenile rats, increased heart weight with no histopathology was observed at 0.35 mg/kg/day (approximately twice the adult human clinical exposure based on AUC).
Croatian: U mladih štakora opažena je povećana težina srca bez histopatoloških nalaza pri dozi od 0,35 mg/kg/dan (izloženost približno dvostruko veća od kliničke izloženosti u odraslih ljudi na temelju AUC-a).
English: Continue treatment and monitor as clinically indicated.
Croatian: Nastaviti s liječenjem i pratiti sukladno kliničkoj potrebi.
English: Contact your doctor immediately if you get a severe skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, or soles of your feet.
Croatian: Odmah se javite svom liječniku ako dobijete težak kožni osip praćen bilo kojim od sljedećih simptoma: mjehurićima na koži, mjehurićima ili ranicama u ustima, ljuštenjem kože, vrućicom, crvenilom ili oticanjem lica ili tabana.
English: Liver monitoring may be continued thereafter as clinically indicated (see section 4.4).
Croatian: Nakon toga se nadziranje jetrene funkcije može nastaviti sukladno kliničkoj indikaciji (vidjeti dio 4.4).
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated.
Croatian: Znakovi ili simptomi rabdomiolize moraju se odgovarajuće klinički procijeniti i liječiti kako je indicirano.
English: In patients receiving trametinib in combination with dabrafenib, pyrexia may be accompanied by severe rigors, dehydration, and hypotension which in some cases can lead to acute renal insufficiency.
Croatian: U bolesnika koji primaju trametinib u kombinaciji s dabrafenibom pireksija može biti popraćena teškom tresavicom, dehidracijom i hipotenzijom koja u nekim slučajevima može dovesti do akutne bubrežne insuficijencije.
English: Trametinib has minor influence on the ability to drive or use machines.
Croatian: Trametinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • A hole (perforation) in the stomach or intestines
Croatian: • proboj (perforacija) želuca ili crijeva
English: When trametinib is used in combination with dabrafenib and the patient's temperature is ≥38.5
Croatian: Kada se trametinib koristi u kombinaciji s dabrafenibom a bolesnikova temperatura je ≥ 38,5
English: Chemotherapy included patients on dacarbazine (DTIC) 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m every 3 weeks.
Croatian: Kemoterapija je uključivala bolesnike koji su primali dakarbazin (DTIC) u dozi od 1000 mg/m2 svaka 3 tjedna ili paklitaksel u dozi od 175 mg/m2 svaka 3 tjedna.
English: In clinical trials, central testing for BRAF V600 mutation using a BRAF mutation assay was conducted on the most recent tumour sample available.
Croatian: U kliničkim se ispitivanjima provodilo centralno testiranje na mutaciju BRAF V600 uz pomoć testa za detekciju BRAF mutacije na najnovijim dostupnim tumorskim uzorcima.
English: • Allergic reaction (hypersensitivity)
Croatian: • alergijska reakcija (preosjetljivost)
English: How should you take Mekinist in combination with dabrafenib
Croatian: Kako uzimati Mekinist u kombinaciji s dabrafenibom
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III studies and one supportive Phase I/II study.
Croatian: Djelotvornost i sigurnost preporučene doze trametiniba (2 mg jedanput na dan) u kombinaciji s dabrafenibom (150 mg dvaput na dan) za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom proučavale su se u dva ispitivanja faze III i jednom potpornom ispitivanju faze I/II.
English: Dabrafenib dose* Only when used in combination with trametinib
Croatian: Doza dabrafeniba* samo kada se primjenjuje u kombinaciji s trametinibom
English: Chemotherapy (n=108) Trametinib (n=214)
Croatian: Kemoterapija (n=108) Trametinib (n=214)
English: The efficacy and safety of trametinib in patients with BRAF unresectable or metastatic mutant melanoma (V600E and V600K) were evaluated in a randomised open-label Phase III study (MEK114267 [METRIC]).
Croatian: Djelotvornost i sigurnost trametiniba u bolesnika oboljelih od neoperabilnog ili metastatskog melanoma s BRAF mutacijom (V600E i V600K) ocijenjene su u randomiziranom otvorenom ispitivanju faze III (MEK114267 [METRIC]).
English: Mekinist 2 mg film-coated tablets EU/1/14/931/005
Croatian: Mekinist 2 mg filmom obložene tablete EU/1/14/931/005
English: If uveitis does not respond to local ocular therapy, dabrafenib should be withheld until resolution of ocular inflammation and then dabrafenib should be restarted reduced by one dose level.
Croatian: Ako uveitis ne reagira na lokalnu terapiju za oko, potrebno je uskratiti dabrafenib dok se upala oka ne riješi te zatim ponovno uvesti dabrafenib u dozi smanjenoj za jednu razinu.
English: The most common adverse reactions (incidence ≥20%) for trametinib were rash, diarrhoea, fatigue, oedema peripheral, nausea, and dermatitis acneiform.
Croatian: Najčešće nuspojave kod primjene trametiniba (incidencija ≥ 20%) bile su osip, proljev, umor, periferni edem, mučnina i akneiformni dermatitis.
English: The incidence and severity of pyrexia are increased with the combination therapy (see dabrafenib SmPC section 4.4).
Croatian: Incidencija i težina pireksije povećavaju se s kombiniranom terapijom (vidjeti Sažetak opisa svojstava lijeka za dabrafenib dio 4.4).
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Croatian: Prekinuti terapiju dok se toksičnost ne smanji na 0. ili 1. stupanj, a zatim nastaviti terapiju dozom smanjenom za jednu razinu.
English: Combination with dabrafenib
Croatian: Kombinacija s dabrafenibom
English: If a dose of dabrafenib is missed, when trametinib is given in combination with dabrafenib, the dose of dabrafenib should only be taken if it is more than 6 hours until the next scheduled dose.
Croatian: Ako bolesnik propusti dozu dabrafeniba, kada se trametinib daje u kombinaciji s dabrafenibom, smije uzeti dozu dabrafeniba samo ako do sljedeće predviđene doze ima više od 6 sati.
English: Of these patients, 211 were treated with trametinib for BRAF V600 mutant melanoma in the randomised open-label Phase III study MEK114267 (METRIC) (see section 5.1).
Croatian: Od tih je bolesnika njih 211 primalo trametinib za liječenje melanoma s BRAF V600 mutacijom u randomiziranom otvorenom ispitivanju faze III, MEK114267 (METRIC) (vidjeti dio 5.1 ).
English: Mekinist can result in the breakdown of muscle (rhabdomyolysis).
Croatian: Mekinist može uzrokovati razgradnju mišića (rabdomiolizu).
English: oC please refer to the dabrafenib SmPC (section 4.2) for dose modifications for dabrafenib.
Croatian: oC, pogledajte Sažetak opisa svojstava lijeka za dabrafenib (dio 4.2) za prilagodbe doze za dabrafenib.
English: Tell your doctor or nurse if you have any new or worsening symptoms of lung or breathing problems, including:
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako se pojave novi ili pogoršaju postojeći simptomi plućnih ili dišnih tegoba, uključujući:
English: Based on a population pharmacokinetic analysis, gender and body weight were found to influence trametinib oral clearance.
Croatian: Populacijska farmakokinetička analiza pokazala je da spol i tjelesna težina utječu na klirens trametiniba nakon peroralne primjene.
English: Pyrexia When trametinib is used in combination with dabrafenib and the patient's temperature is ≥38.5
Croatian: Pireksija Kada se trametinib primjenjuje u kombinaciji s dabrafenibom a bolesnikova temperatura je ≥ 38,5
English: The bottles also include a silica gel desiccant in a small cylinder shaped container.
Croatian: Bočice sadrže i mali cilindrični spremnik sa silikonskim gelom kao sredstvom za sušenje.
English: The pharmacokinetics of trametinib were characterised in 223 patients enrolled in clinical trials with trametinib who had mild renal impairment and 35 patients with moderate renal impairment using a population pharmacokinetic analysis.
Croatian: Farmakokinetika trametiniba okarakterizirana je temeljem populacijske farmakokinetičke analize u 223 bolesnika s blagim i 35 bolesnika s umjerenim oštećenjem bubrežne funkcije uključenih u klinička ispitivanja trametiniba.
English: • have or have ever had kidney problems.
Croatian: • imate ili ste ranije imali tegoba s bubrezima.
English: In rats decreased foetal weights and increased post-implantation loss were seen at exposures below or slightly above the clinical exposures based on AUC.
Croatian: U štakora su primijećeni smanjena težina ploda i veći broj gubitaka nakon implantacije pri izloženostima koje su bile manje ili neznatno veće od kliničke izloženosti na temelju AUC-a.
English: Alanine aminotransferase increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased a
Croatian: Pretrage vrlo često povišena alanin aminotransferaza povišena aspartat aminotransferaza često povišena alkalna fosfataza u krvi povišena gama-glutamiltransferaza povišena kreatin fosfokinaza u krvi a
English: Rash has been observed in about 60% of patients when given as monotherapy and in about 24% of patients in trametinib and dabrafenib combination studies in the integrated safety population.
Croatian: Osip je primijećen u približno 60% bolesnika kada se daje kao monoterapija te u oko 24% bolesnika u ispitivanjima kombinacije trametiniba i dabrafeniba u objedinjenoj populaciji u kojoj se ispitivala sigurnost.
English: Ask your doctor, nurse or pharmacist for advice.
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet.
English: It is not known whether trametinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se trametinib u majčino mlijeko.
English: Patients in the chemotherapy arm were allowed to cross over to the trametinib arm after independent confirmation of progression.
Croatian: Bolesnici u skupini koja je primala kemoterapiju mogli su prijeći u skupinu liječenu trametinibom nakon neovisne potvrde progresije bolesti.
English: Please refer to sections 4.4 and 4.8 of the dabrafenib SmPC.
Croatian: Pogledajte dijelove 4.4 i 4.8 Sažetka opisa svojstava lijeka za dabrafenib.
English: Heart disorder
Croatian: Srčani poremećaj
English: Table 13 Investigator-assessed RFS results for Study BRF115532 (COMBI-AD)
Croatian: Tablica 13 Rezultati RFS-a prema procjeni ispitivača za ispitivanje BRF115532 (COMBI-AD)
English: The usual dose of Mekinist either used alone or in combination with dabrafenib is one 2 mg tablet once a day.
Croatian: Uobičajena doza lijeka Mekinist bilo kad se uzima sam ili u kombinaciji s dabrafenibom je jedna tableta od 2 mg jedanput na dan.
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.
Croatian: Ako bolesnik propusti dozu trametiniba, smije je uzeti samo ako je do sljedeće predviđene doze preostalo više od 12 sati.
English: Trametinib must be permanently discontinued in patients diagnosed with treatment-related ILD or pneumonitis.
Croatian: Primjena trametiniba mora se trajno obustaviti u bolesnika kojima se dijagnosticiraju IBP ili pneumonitis povezani s liječenjem.
English: • headaches, dizziness, or feeling weak
Croatian: • glavobolje, omaglicu ili osjećaj slabosti
English: When trametinib is used in combination with dabrafenib see sections 4.4 and 4.5 of the dabrafenib SmPC for interactions.
Croatian: Kada se trametinib koristi u kombinaciji s dabrafenibom, vidjeti dijelove 4.4 i 4.5 Sažetka opisa svojstava lijeka za dabrafenib za interakcije.
English: Patients ≥65 years were more likely to experience SARs and ARs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
Croatian: ≥ 65 godina veća je bila vjerojatnost da će doživjeti ozbiljne nuspojave i nuspojave koje će dovesti do trajne obustave uzimanja lijeka, smanjenja doze i prekida doziranja nego u onih u dobi
English: Figure 2 Kaplan-Meier curves Updated OS analysis for Study MEK116513
Croatian: Slika 2 Kaplan-Meier krivulje ažurirane analize OS-a za ispitivanje MEK116513
English: Cases of cuSCC (including keratoacanthoma) have been reported in patients treated with trametinib in combination with dabrafenib.
Croatian: Slučajevi cuSCC-a (uključujući keratoakantom) prijavljeni su u bolesnika liječenih trametinibom u kombinaciji s dabrafenibom.
English: Total dose recovery was low after a 10-day collection period (<50%) following administration of a single oral dose of radiolabelled trametinib as a solution, due to the long elimination half-life.
Croatian: Nakon primjene jedne radioaktivno označene doze trametiniba u obliku otopine, pronađena je mala količina ukupne doze nakon 10-dnevnog razdoblja prikupljanja (< 50%), što je posljedica dugog poluvijeka eliminacije.
English: A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect trametinib oral clearance.
Croatian: Populacijska farmakokinetička analiza pokazala je da blago povišene razine bilirubina i/ili AST-a (prema klasifikaciji Nacionalnog instituta za rak [engl.
English: In vitro and in vivo studies demonstrated that trametinib is metabolised predominantly via deacetylation alone or in combination with mono-oxygenation.
Croatian: Ispitivanja in vitro i in vivo pokazala su da se trametinib prvenstveno metabolizira deacetilacijom, samom ili u kombinaciji uz monooksigenaciju.
English: The safety and efficacy of trametinib in non-Caucasian patients have not been established.
Croatian: Sigurnost i djelotvornost trametiniba u bolesnika koji nisu bijele rase nisu ustanovljene.
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
Croatian: Rezultati za primarnu analizu RFS-a prikazani su u tablici 13. Ispitivanje je pokazalo statistički značajnu razliku RFS-a kao primarnog ishoda između liječenih skupina, s medijanom RFS-a od 16,6 mjeseci u skupini koja je primala placebo, i nije bio dostignut za skupinu koja je primala kombinaciju (HR: 0,47; 95% interval pouzdanosti: (0,39; 0,58); p=1,53×10
English: Dose adjustment for trametinib below 1 mg once daily is not recommended, whether used as monotherapy or in combination with dabrafenib.
Croatian: Ne preporučuje se prilagodba doze za trametinib ispod 1 mg jedanput na dan, bilo da se primjenjuje kao monoterapija ili u kombinaciji s dabrafenibom.
English: If you take too many tablets of Mekinist, contact your doctor, nurse or pharmacist for advice.
Croatian: Ako uzmete previše Mekinist tableta, obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet.
English: Mekinist 0.5 mg film-coated tablets EU/1/14/931/001
Croatian: Mekinist 0,5 mg filmom obložene tablete EU/1/14/931/001
English: Tell your doctor or nurse if you have any new or worsening symptoms, including:
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako dobijete bilo koji novi simptom ili Vam se postojeći pogorša, uključujući:
English: How to take it
Croatian: Kako uzimati lijek