natgillin/translations-raw huggingface dataset:
Trametinib has a volume of distribution of approximately 1200 L determined following administration of a 5 g intravenous microdose. 
Volumen porazdelitve trametiniba je približno 1200 l, določeno po uporabi intravenskega mikroodmerka 5 g.
• Infection of the skin (cellulitis) 
• okužba kože (celulitis)
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. 
Populacijska farmakokinetična analiza kaže, da blago zvišanje bilirubina in/ali AST (po klasifikaciji NCI - National Cancer Institute) ne vpliva pomembno na peroralni očistek trametiniba.
You and your doctor will decide whether you will take Mekinist or breast-feed. 
Skupaj z zdravnikom se boste odločili, ali boste jemali zdravilo Mekinist ali boste dojili.
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. 
Mediana starost je bila 54 let (22 % je bilo starih  65 let); vsi so imeli stanje zmogljivosti 0 ali 1 po lestvici ECOG in 3 % so imeli anamnezo metastaz v možganih.
• after eating, you must wait at least 2 hours before taking Mekinist. 
• morate po jedi počakati vsaj 2 uri, preden vzamete zdravilo Mekinist.
Some people taking Mekinist develop other conditions which can be serious. 
Nekaterim bolnikom, ki so jemali zdravilo Mekinist, so se pojavila druga bolezenska stanja, ki so lahko resna.
• Lack of energy or feeling weak or tired 
• pomanjkanje energije, občutek šibkosti ali utrujenosti
Administration of a single dose of trametinib with a high-fat, high-calorie meal resulted in a 70% and 10% decrease in Cmax and AUC, respectively compared to fasted conditions (see sections 4.2 and 4.5). 
Uporaba enkratnega odmerka trametiniba z zelo mastnim, zelo kaloričnim obrokom je povzročila 70 % znižanje Cmax in 10 % znižanje AUC v primerjavi s stanjem na tešče (glejte poglavji 4.2. in 4.5).
In the Phase III study with trametinib in patients with unresectable or metastatic melanoma (n=211), 49 patients (23%) were ≥65 years of age, and 9 patients (4%) were ≥75 years of age. 
V študiji trametiniba III. faze pri bolnikih z inoperabilnim ali metastatskim melanomom (n = 211) je bilo 49 bolnikov (23 %) starih ≥ 65 let, 9 bolnikov (4 %) pa ≥ 75 let.
Grade 2-3 RPED 
RPED 2. do 3. stopnje
Therefore, before starting treatment your doctor will test for this mutation. 
Zdravnik vas bo pred zdravljenjem testiral za to mutacijo.
The dabrafenib doses should be about 12 hours apart. 
Presledek med odmerkoma dabrafeniba naj bo približno 12 ur.
Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively. 
Ocenjeno preživetje po 1 oziroma 2 letih od randomizacije je bilo v skupini s kombiniranim zdravljenjem 97 % oziroma 91 %, v skupini s placebom pa 94 % oziroma 83 %.
The mean absolute bioavailability of a single 2 mg tablet dose is 72% relative to an intravenous (IV) microdose. 
Povprečna absolutna biološka uporabnost posamičnega odmerka 2 mg v tableti je 72 % glede na intravenski mikroodmerek.
Mekinist can cause new or worsening high blood pressure (hypertension). 
Zdravilo Mekinist lahko povzroči pojav visokega krvnega tlaka ali njegovo poslabšanje (hipertenzija).
Your doctor should check your heart function before and during treatment. 
Zdravnik mora preveriti delovanje vašega srca pred začetkom in med potekom zdravljenja.
Efficacy in patients with ocular or mucosal melanoma has not been assessed. 
Učinkovitosti pri bolnikih z očesnim ali sluzničnim melanomom niso ocenili.
The other side effects that you may see when you take Mekinist alone are as follows: 
Drugi neželeni učinki, ki jih lahko opazite, če jemljete samo zdravilo Mekinist so:
Trametinib plasma IV clearance is 3.21 L/hr. 
Plazemski očistek intravensko uporabljenega trametiniba je 3,21 l/uro.
If you forget to take Mekinist 
Če ste pozabili vzeti zdravilo Mekinist
• Heart rate that is lower than the normal range and/or a decrease in heart rate 
• srčni utrip, ki je nižji od normalnih vrednosti in/ali znižanje srčnega utripa
Please read the dabrafenib Package Leaflet for details of the side effects you may get when taking this medicine. 
Preberite navodilo za uporabo za dabrafenib glede podrobnosti o neželenih učinkih, do katerih lahko pride pri jemanju tega zdravila.
In the previously-treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease. 
Med predhodno zdravljenimi bolniki je 38 bolnikov (67 %) prej prejelo eno linijo sistemskega zdravljenja proti raku za zdravljenje metastatske bolezni.
The safety of trametinib in subjects with predisposing factors for RVO, including uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes, has not been established. 
Varnost trametiniba pri osebah s predispozicijskimi dejavniki za RVO, vključno z neurejenim glavkomom ali očesno hipertenzijo, neurejeno hipertenzijo, neurejeno sladkorno boleznijo ali z anamnezo sindromov hiperviskoznosti ali hiperkoagulabilnosti ni ugotovljena.
It is not known whether trametinib is excreted in human milk. 
Ni znano, ali se trametinib izloča v materino mleko.
Mekinist is not recommended for children and adolescents since the effects of Mekinist in people younger than 18 years old are not known. 
Učinek zdravila Mekinist ni znan pri osebah, mlajših od 18 let.
• have or have ever had kidney problems. 
• če imate ali ste kdaj imeli težave z ledvicami,
The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy. 
Tveganje za krvavitve se lahko poveča v primeru sočasne uporabe antiagregacijskih ali antikoagulantnih zdravil.
• dark urine due to kidney damage 
• temnim urinom zaradi okvare ledvic
However, based on the low dose and low clinical systemic exposure relative to the in vitro potency of inhibition or induction values, trametinib is not considered to be an in vivo inhibitor or inducer of these enzymes or transporters, although transient inhibition of BCRP substrates in the gut may occur (see section 4.5). 
Toda zaradi nizkega odmerka in majhne klinične sistemske izpostavljenosti glede na in vitro moč zaviranja oziroma indukcijske vrednosti, trametinib ne velja za zaviralca ali induktorja teh encimov ali prenašalcev in vivo, lahko pa se pojavi prehodno zavrtje substratov BCRP v črevesu (glejte poglavje 4.5).
In repeat-dose studies the effects seen after trametinib exposure are found mainly in the skin, gastrointestinal tract, haematological system, bone and liver. 
V študijah ponavljajočih se odmerkov so učinke po izpostavljenosti trametinibu našli v glavnem v koži, prebavilih, hematološkem sistemu, kosteh in jetrih.
Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity. 
Predklinična in klinična preskušanja z retrospektivnimi analizami obojestranskega sekvenciranja po Sangerju so pokazala, da ta test odkrije tudi manj pogosto mutacijo BRAF V600D in mutacijo V600E/K601E z manjšo senzitivnostjo.
• If you are a woman who could become pregnant, you must use reliable birth control (contraception) while you are taking Mekinist and for at least 16 weeks after you stop taking it. 
• Če ste ženska, ki bi lahko zanosila, morate med jemanjem zdravila Mekinist in še vsaj 16 tednov po koncu njegovega jemanja uporabljati zanesljivo kontracepcijsko zaščito.
If trametinib is used during pregnancy, or if the patient becomes pregnant while taking trametinib, the patient should be informed of the potential hazard to the foetus. 
Če je trametinib uporabljen med nosečnostjo, ali če bolnica med zdravljenjem s trametinibom zanosi, jo je treba seznaniti z možno nevarnostjo za plod.
Trametinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells and micronuclei in the bone marrow of rats. 
Trametinib ni bil genotoksičen v študijah, ki so ocenjevale reverzne mutacije pri bakterijah, kromosomske aberacije v celicah sesalcev in mikrojedra v kostnem mozgu podgan.
• after taking Mekinist, you must wait at least 1 hour before eating, or 
• morate po zaužitju zdravila Mekinist počakati vsaj 1 uro, preden jeste, ali
Results for the primary analysis of RFS are presented in Table 13. 
V preglednici 13 so prikazani rezultati primarne analize RFS.
Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility. 
Jemanje zdravila Mekinist skupaj z dabrafenibom: Dabrafenib lahko pri moških trajno zmanjša plodnost.
Studies in juvenile animals have shown adverse effects of trametinib which were not observed in adult animals (see section 5.3). 
V študijah na mladih živalih so se pokazali neželeni učinki trametiniba, ki jih pri odraslih živalih niso opažali (glejte poglavje 5.3).
Continue treatment with retinal evaluation monthly until resolution. 
Nadaljujte zdravljenje in vsak mesec opravite pregled mrežnice, dokler odstop ne izgine.
Kaplan-Meier curves of investigator-assessed OS (post-hoc analysis 20 May 2013) is presented in Figure 3. 
Kaplan-Meierjeve krivulje celokupnega preživetja po oceni raziskovalcev (post-hoc analiza 20. maja 2013) so prikazane na sliki 3.
Take Mekinist once a day, on an empty stomach (at least 1 hour before a meal or 2 hours after a meal). 
Zdravilo Mekinist vzemite enkrat na dan, na prazen želodec (vsaj 1 uro pred jedjo ali 2 uri po jedi).
• have or have ever had lung or breathing problems. 
• če imate ali ste kdaj imeli težave s pljuči ali dihanjem,
It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity (see Table 2). 
Zdravljenje s trametinibom je priporočljivo nadaljevati, dokler bolniku koristi, oziroma do pojava nesprejemljivih toksičnih učinkov (glejte preglednico 2).
Resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue trametinib in patients taking trametinib 1 mg daily. 
Znova začnite uporabljati trametinib v nižjem odmerku (zmanjšan za 0,5 mg), ali ukinite trametinib pri bolnikih, ki ga jemljejo po 1 mg na dan.
• Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis) 
• razgradnja mišic, ki lahko povzroči bolečine v mišicah in okvaro ledvic (rabdomioliza)
There are no clinical data in patients with moderate or severe hepatic impairment; therefore, the potential need for starting dose adjustment cannot be determined. 
Kliničnih podatkov za bolnike z zmerno ali hudo okvaro jeter ni, zato morebitne potrebe po prilagoditvi začetnega odmerka ni mogoče opredeliti.
Very common side effects that may show up in your blood tests • Abnormal blood test results related to the liver 
Zelo pogosti neželeni učinki, ki se lahko pokažejo v izvidih krvnih preiskav • nenormalni izvidi krvnih preiskav, povezanih z jetri
• Take Mekinist and dabrafenib on an empty stomach, at least one hour before or two hours after a meal. 
• Zdravilo Mekinist in dabrafenib jemljite na prazen želodec, najmanj eno uro pred obrokom in najmanj dve uri po obroku.
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). 
Rezultat PFS se je skladal v podskupini bolnikov, ki so imeli melanom s pozitivno mutacijo V600K (razmerje ogroženosti = 0,50, [95-odstotni IZ: 0,18; 1,35], p = 0,0788).
Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction Trametinib should be interrupted in patients who have an asymptomatic, absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN) (see section 4.4). 
Znižanje iztisnega deleža levega prekata (LVEF)/disfunkcija levega prekata Zdravljenje s trametinibom je treba prekiniti pri bolnikih, ki imajo asimptomatsko, absolutno zmanjšanje LVEF za > 10 % v primerjavi z izhodiščem, iztisni delež pa je pod spodnjo normalno mejo v ustanovi (glejte poglavje 4.4).
Before you take Mekinist in combination with dabrafenib your doctor needs to know if you: 
Preden boste začeli jemati zdravilo Mekinist v kombinaciji z dabrafenibom, mora vaš zdravnik vedeti:
• Decreased red blood cells (anaemia), abnormal test related to creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle 
• zmanjšano število rdečih krvnih celic (anemija), nenormalni izvidi preiskav, povezanih s kreatin-fosfokinazo (to je encim, ki se večinoma nahaja v srcu, možganih in skeletnih mišicah)
Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS). 
Med sekundarnimi cilji opazovanja so bili celokupno preživetje (OS; ključni sekundarni cilj opazovanja), stanje brez ponovitve bolezni (FFR - freedom from relapse) in preživetje brez oddaljenih metastaz (DMFS - distant metastasis-free survival).
7.5d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing 
d a - preživetje brez napredovanja (kot ga oceni raziskovalec) b - celokupni odziv = popoln odziv + delen odziv c - trajanje odziva d - v času poročanja je večina odzivov (59 % pri dabrafenibu + trametinibu in 42 % pri vemurafenibu), kot jih je ocenil raziskovalec, še trajala
Grade 2-3 RPED that improves to Grade 0-1 within 3 weeks 
RPED 2. do 3. stopnje, ki se v 3 tednih izboljša na 1. stopnjo ali stopnjo 0
Based on in vitro and in vivo data, trametinib is unlikely to significantly affect the pharmacokinetics of other medicinal products via interaction with CYP enzymes or transporters (see section 5.2). 
Glede na podatke in vitro in in vivo ni verjetno, da bi trametinib pomembno vplival na farmakokinetiko drugih zdravil preko interakcij z encimi CYP ali prenašalci (glejte poglavje 5.2).
Most of the findings are reversible after drug-free recovery. 
Večina ugotovljenih učinkov je bila reverzibilna po obdobju brez zdravila.
The safety and efficacy of trametinib in non-Caucasian patients have not been established. 
Varnost in učinkovitost trametiniba nista ugotovljeni pri bolnikih, ki niso belci.
There are no data with trametinib in patients with severe renal impairment; therefore, the potential need for starting dose adjustment cannot be determined. 
Podatkov o trametinibu pri bolnikih s hudo okvaro ledvic ni, zato ni mogoče ugotoviti morebitne potrebe po prilagoditvi začetnega odmerka.
and BRF115532 (n=1,076) 
a, BRF113928 in BRF115532 (n = 1.076)
All of these effects were reversible following an off-treatment period and attributable to pharmacology. 
Vsi našteti učinki so po obdobju brez zdravljenja izzveneli in jih je mogoče pripisati farmakološkemu delovanju učinkovine.
Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated. 
V primeru znakov ali simptomov rabdomiolize je potrebno ustrezno klinično ovrednotenje in zdravljenje, kot je indicirano.
• Take Mekinist once daily and take dabrafenib twice daily. 
• Zdravilo Mekinist jemljite enkrat na dan, dabrafenib pa dvakrat na dan.
• Inflammation of hair follicles in the skin 
• vnetje mešičkov las/dlak v koži
Trametinib is not a substrate of CYP enzymes or of the transporters BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, and MATE1. 
Trametinib ni substrat encimov CYP ali prenašalcev BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2 in MATE1.
Number of deaths 
Zdravljenje Število smrti
The film-coated tablets are supplied in opaque white plastic bottles with threaded plastic closures. 
Filmsko obložene tablete so na voljo v motno belih plastenkah s plastično navojno zaporko.
Keep the bottle tightly closed with the dessicant inside (small cylinder shaped container). 
Plastenko shranjujte tesno zaprto, s sušilnim sredstvom (majhen cilindrično oblikovan vsebnik) v plastenki.
As it cannot be excluded that strong inhibition of hepatic P-gp may result in increased levels of trametinib, caution is advised when co-administering trametinib with medicinal products that are strong inhibitors of P-gp (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole). 
Ni mogoče izključiti možnosti, da bi močno zaviranje prenašalca P-gp v jetrih povzročilo zvišanje koncentracije trametiniba, zato je priporočena previdnost pri sočasnem odmerjanju trametiniba in zdravil, ki so močni zaviralci P-gp (na primer verapamila, ciklosporina, ritonavirja, kinidina, itrakonazola).
Mekinist is not recommended if you have ever had blockage of the vein draining the eye (retinal vein occlusion). 
Zdravila Mekinist ni priporočljivo uporabljati, če ste kdaj imeli zaporo vene, po kateri kri odteka iz očesa (zaporo mrežnične vene).
In patients who are diagnosed with RVO, treatment with trametinib should be permanently discontinued. 
Pri bolnikih, pri katerih je diagnosticirana RVO, je treba zdravljenje s trametinibom trajno končati.
Following single and repeated doses of trametinib, trametinib as parent is the main circulating component in plasma. 
Po enkratnem in večkratnih odmerkih je trametinib glavna snov, ki kroži v plazmi.
Patients ≥65 years were more likely to experience ARs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years. 
Bolniki, stari ≥ 65 let, so imeli večjo verjetnost NU, ki so povzročili trajno prenehanje uporabe zdravila, znižanje odmerka ali prekinitev odmerjanja, kot bolniki, stari < 65 let.
In the ITT population, 54% of patients were male and all were Caucasian. 
V populaciji ZNZ je bilo 54 % moških in vsi bolniki in bolnice so bili belci.
In clinical trials, the median time to first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 to 5 months. 
V kliničnih preskušanjih je bila mediana časa do prvega pojava disfunkcije levega prekata, srčnega popuščanja in zmanjšanja LVEF od 2 do 5 mesecev.
Do not change your dose or stop Mekinist or dabrafenib unless your doctor, nurse or pharmacist tells you to. 
Ne spreminjajte odmerka in ne prekinjajte zdravljenja z zdravilom Mekinist ali dabrafenibom, razen če vam tako naroči zdravnik, medicinska sestra ali farmacevt.
No initial dose adjustment is required in patients >65 years of age. 
Bolnikom, starim > 65 let, začetnega odmerka ni treba prilagoditi.
Chemotherapy (n=108) 
Kemoterapija (n = 108)
When trametinib and dabrafenib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib. 
Pri jemanju trametiniba in dabrafeniba v kombinaciji, je treba dnevni odmerek trametiniba vzeti enkrat na dan vsak dan ob istem času skupaj z bodisi jutranjim ali večernim odmerkom dabrafeniba.
• Heart pumping less efficiently, causing shortness of breath, extreme tiredness and swelling in ankles and legs (heart failure) 
• manj učinkovito črpalno delovanje srca, ki povzroča kratko sapo, skrajno utrujenost in otekanje gležnjev in nog (srčno popuščanje)
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). 
Bolniki morajo trametinib, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, vzeti vsaj eno uro pred jedjo ali vsaj dve uri po jedi, ker hrana vpliva na absorpcijo trametiniba (glejte poglavji 4.2 in
Your doctor may advise an eye examination before you take Mekinist and while you are taking it. 
Zdravnik vam lahko svetuje pregled oči pred začetkom jemanja zdravila Mekinist in med jemanjem tega zdravila.
Lung or breathing problems 
Težave s pljuči ali dihanjem
The deacetylated metabolite was further metabolised by glucuronidation. 
Deacetiliran presnovek se nadalje presnavlja z glukuronidacijo.
Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 6. 
Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 6.
No data are available in patients with moderate or severe hepatic impairment. 
Za bolnike z zmerno ali hudo okvaro jeter podatkov ni.
Mekinist can cause eye problems including blindness. 
Zdravilo Mekinist lahko povzroči težave z očmi, tudi slepoto.
Chemotherapy included patients on dacarbazine (DTIC) 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m every 3 weeks. 
Kemoterapija je vključevala bolnike na dakarbazinu (DTIC) 1000 mg/m na 3 tedne ali na paklitakselu 175 mg/m2 na 3 tedne.
What Mekinist looks like and contents of the pack 
Izgled zdravila Mekinist in vsebina pakiranja
As trametinib is metabolised predominantly via deacetylation mediated by hydrolytic enzymes (e.g. carboxyl-esterases), its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions (see section 5.2). 
Presnova trametiniba poteka predvsem z deacetilacijo, ki jo katalizirajo hidrolitični encimi (npr. karboksilesteraze), zato ni verjetno, da bi na njegovo farmakokinetiko vplivala druga zdravila preko presnovnih interakcij (glejte poglavje 5.2).
In patients with BRAF and NRAS mutation positive melanoma, administration of trametinib resulted in dose-dependent changes in tumour biomarkers including inhibition of phosphorylated ERK, inhibition of Ki67 (a marker of cell proliferation), and increases in p27 (a marker of apoptosis). 
Pri bolnikih z melanomom s pozitivno mutacijo BRAF in NRAS je trametinib povzročil od odmerka odvisne spremembe tumorskih bioloških označevalcev, vključno z zavrtjem fosforilirane ERK, zavrtjem Ki67 (označevalec celične proliferacije) in zvišanjem p27 (označevalec apoptoze).
Based on in vitro studies, trametinib is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2D6 and CYP3A4. 
Študije in vitro kažejo, da trametinib ne zavira CYP1A2, CYP2A6, CYP2B6, CYP2D6 in CYP3A4.
Patients in the chemotherapy arm were allowed to cross over to the trametinib arm after independent confirmation of progression. 
Bolnikom v skupini s kemoterapijo je bil dovoljen prehod v skupino s trametinibom, če je bilo neodvisno potrjeno napredovanje.
Female patients of reproductive potential must be advised to use effective methods of contraception during treatment with trametinib and for 16 weeks after stopping treatment. 
Ženskam v rodni dobi je treba svetovati, da morajo med zdravljenjem in še 16 tednov po prenehanju zdravljenja s trametinibom uporabljati učinkovite kontracepcijske metode.
Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 8. 
Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 8.
If the LVEF recovers, treatment with trametinib may be restarted, but the dose should be reduced by one dose level with careful monitoring (see section 4.4). 
Če se LVEF popravi, je mogoče znova uvesti trametinib, vendar je odmerek treba znižati za eno odmerno raven in potreben je skrben nadzor (glejte poglavje 4.4).
The median time to onset of the first occurrence of haemorrhagic events for the combination of trametinib and dabrafenib was 94 days in the melanoma Phase III studies and 75 days in the NSCLC study for the patients who had received prior anti-cancer therapy. 
Mediana časa do pojava prve krvavitve pri zdravljenju s kombinacijo trametiniba in dabrafeniba je bila 94 dni v študijah melanoma faze III in 75 dni v študiji nedrobnoceličnega pljučnega raka pri bolnikih, ki so že prej prejemali zdravila za zdravljenje raka.