natgillin/translations-raw huggingface dataset:
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction. 
V vseh časovnih točkah po odmerku na 8. dan so bile srednje spremembe od izhodišča v intervalu QTcF 4 -6 milisekund, s pridruženimi zgornjimi 95-odstotnimi intervali zaupanja < 7 milisekund.
Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc. 
Pri bolnikih s podaljšanim intervalom QTc oziroma bolnikih, pri katerih bi se podaljšanje intervala QTc lahko pojavilo, je potrebna previdnost pri predpisovanju dasatiniba.
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date. 
Zdravljenje z dasatinibom je v povprečju trajalo 3 mesece, pri 2% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal 
Pogosti astenija, bolečina, bolečina v prsih, generalizirani edem*k, mrzlica
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage. 
b Vključuje krvavitve v osrednjem živčevju, cerebralni hematom, cerebralno krvavitev, ekstraduralni hematom,
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib 
SPRYCEL 140 mg filmsko obložene tablete dasatinib
Other secondary endpoints included duration of MCyR, PFS, and overall survival. 
Drugi sekundarni opazovani dogodki so vključevali trajanje dobrega citogenetskega odziva, preživetje brez progresije bolezni (PFS - “progression-free survival”) in skupno preživetje.
An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy. 
Pri bolnikih s KML v obdobju limfoblastne preobrazbe ali s Ph+ ALL, ki imatiniba niso prenašali ali pa so bili na predhodno zdravljenje z imatinibom odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
Prior complete haematologic response (CHR) to imatinib was 
Popoln hematološki odziv (CHR)
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover. 
V skupini, ki je prejemala dasatinib, je bil pred prehodom v skupino z alternativnim zdravljenjem popolni hematološki odziv dosežen pri 93% bolnikov, v skupini, ki je prejemala imatinib, pa pri 82% bolnikov.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate). 
Ena filmsko obložena tableta vsebuje 140 mg dasatiniba (v obliki monohidrata).
However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2). 
Pri bolnikih z blago, zmerno ali s hudo okvaro jeter se zdravljenje lahko uvede s priporočenim začetnim odmerkom, vendar pa je pri bolnikih z okvaro jeter kljub temu potrebna previdnost pri uporabi zdravila SPRYCEL (glejte poglavje 5.2).
• spread to other parts of the body or cannot be removed by surgery. 
• se je razširila na druge dele telesa ali je ni mogoče kirurško odstraniti.
They may be taken with or without food. 
Lahko se jemljejo skupaj s hrano ali brez.
Specific inducers of these enzymes have not been studied and may result in a loss of efficacy. 
Specifični induktorji teh encimov se niso preučevali in lahko povzročijo izgubo učinkovitosti.
These data show that the efficacy of the combination would be lower in these patients. 
Ti podatki kažejo, da je učinkovitost uporabe te kombinacije pri teh bolnikih nižja.
Then continue taking your tablets at regular times as usual. 
Nato tablete jemljite redno kot običajno.
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets 
EU/1/18/1315/001 84 filmsko obloženih tablet EU/1/18/1315/002 168 filmsko obloženih tablet
PFS as assessed by investigators (investigator assessment) was a supportive analysis. 
PFS, kot so ga ocenili raziskovalci (ocenjevanje raziskovalcev), je predstavljal podporno analizo.
All events occurred in the setting of new or progressive brain metastases. 
Vsi dogodki so se zgodili v primeru novih ali napredujočih metastaz v možganih.
If necessary, your doctor may interrupt your treatment or stop it altogether. 
Po potrebi zdravnik lahko prekine zdravljenje ali ga v celoti preneha izvajati.
Confirmed overall responses 
Potrjeni skupni odzivi
Patients should be assessed at each visit for symptoms of new or worsening visual disturbances. 
Bolnike je treba ob vsakem obisku pregledati za simptome novih ali poslabšanih motenj vida.
LVEF should be evaluated every 2 weeks. 
LVEF je treba oceniti vsaka 2 tedna.
Mektovi is not recommended for children and adolescents under 18 years of age. 
Zdravilo Mektovi se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Visual impairment was generally reversible. 
Okvara vida je bila večinoma reverzibilna.
These differences were within the variability observed for these parameters in both cohorts of this study (25 % - 49 %) and the variability previously observed in patient clinical studies, hence these differences are unlikely to be clinically relevant. 
Te razlike so v obsegu variabilnosti, ki so jo opazili za te parametre pri obeh kohortah te študije (od 25 % do 49 %), in variabilnosti, ki so jo predhodno opazili pri bolnikih v kliničnih študijah, zato ni verjetno, da so te razlike klinično pomembne.
• a particular change (mutation) in a gene responsible for producing a protein called BRAF, and 
• pri kateri je prišlo do posebne spremembe (mutacije) gena, ki proizvaja protein z imenom BRAF, ter
• red or black stools that look like tar 
• rdeče ali črno blato, ki je videti kot katran,
Dose modifications recommendations in case of adverse reactions are presented below and in Tables 1 and 2. 
Priporočene spremembe odmerka v primeru neželenih učinkov so navedene spodaj in v preglednicah 1 in 2.
The safety and efficacy of binimetinib in children and adolescents have not yet been established. 
Varnost in učinkovitost zdravila binimetinib pri otrocih in mladostnikih še nista bili dokazani.
Mektovi can be taken with food or between meals. 
Zdravilo Mektovi se lahko jemlje skupaj s hrano ali med obroki.
You will also receive treatment with another medicine, encorafenib. 
Zdravili se boste še z enim zdravilom, enkorafenibom.
As a precaution, drink plenty of fluids during treatment. 
Kot previdnostni ukrep med zdravljenjem pijte veliko tekočin.
Genital examinations (for women) and anal examinations are also recommended before the initiation and at the end of your treatment. 
Pregledi spolovil (za ženske) in analni pregledi se prav tako priporočajo pred začetkom zdravljenja in na koncu zdravljenja.
Similar results were observed per Investigator assessment. 
Podobni rezultati so se pokazali tudi pri posameznih ocenah raziskovalca.
The efficacy results based on investigator assessment were consistent with the independent central assessment. 
Rezultati učinkovitosti po oceni raziskovalcev so se ujemali z rezultati neodvisnega centralnega ocenjevanja.
Each pack contains either 84 or 168 tablets. 
Eno pakiranje vsebuje 84 ali 168 tablet.
Binimetinib is more distributed in plasma than blood. 
Binimetinib je bolj porazdeljen v plazmi kot v krvi.
Table 4 and Figure 1 summarise the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee. 
preglednici 4 in na sliki 1 je povzetek vrednosti PFS in drugih rezultatov učinkovitosti glede na centralni pregled podatkov, ki ga je izvedel neodvisni slepi radiološki odbor.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
V vsaki skupini pogostnosti so neželeni učinki razvrščeni padajoče po resnosti.
• unusual vaginal bleeding 
• nenavadno vaginalno krvavenje.
What you need to know before you take Mektovi 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Mektovi 3.
Updated analysis, cut-off date: 07 November 2017 
Posodobljena analiza, končni datum: 7. november 2017
If you miss a dose of Mektovi, take it as soon as you remember. 
Če pozabite vzeti odmerek zdravila Mektovi, ga vzemite takoj, ko se spomnite.
There is no specific treatment of overdose. 
Za preveliko odmerjanje ni specifičnega zdravljenja.
Your doctor will check your skin before initiation of treatment, every 2 months during treatment, and for up to 6 months after you stop taking these medicines to look for any new skin cancer. 
Zdravnik vam bo kožo pregledal pred začetkom zdravljenja in na vsaka 2 meseca med zdravljenjem, preglede pa bo izvajal tudi do 6 mesecev po tem, ko prenehate jemati ta zdravila, da bi preveril nastanek morebitnega novega kožnega raka.
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. 
V primeru prevelikega odmerjanja moramo bolnika zdraviti s potrebnimi podpornimi ukrepi in ga ustrezno spremljati.
In urine, 6.5 % of the radioactivity was excreted as binimetinib. 
V urinu je bilo 6,5 % radioaktivnosti izločene kot binimetinib.
84 film-coated tablets 168 film-coated tablets 
84 filmsko obloženih tablet 168 filmsko obloženih tablet
New primary malignancies 
Nove primarne malignosti
Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, da bi nadomestili odmerek.
Based on its mechanism of action, encorafenib may promote malignancies associated with activation of RAS through mutation or other mechanisms. 
Na podlagi svojega mehanizma delovanja lahko enkorafenib povzroči malignosti, povezane z aktivacijo gena RAS preko mutacije ali drugih mehanizmov.
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 
4.03 (National Cancer Institute Common Terminology Criteria for Adverse Events; NCI CTCAE)
Therapy should be discontinued if the patient is not able to tolerate 30 mg orally twice daily. 
Zdravljenje je treba prekiniti, če bolnik ne prenaša 30 mg peroralno dvakrat dnevno.
Swallow the tablets whole with water. 
Cele tablete pogoltnite z vodo.
CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease. 
IZ = interval zaupanja; CR = skupni odziv; DCR = stopnja nadzora bolezni (CR + PR + SD + brez CR/brez PD; brez CR/brez PD velja samo za bolnike brez ciljne lezije, ki niso dosegli CR ali ki nimajo progresivne bolezni (PD)); HR = razmerje tveganja; NE = neovrednoteno; PFS = preživetje brez napredovanja; PR = delni odziv; SD = stabilna bolezen; Vem = vemurafenib.
Dose reduction below 30 mg twice daily is not recommended. 
Odmerek, manjši od 30 mg dvakrat dnevno, ni priporočen.
The patient should be advised to maintain an adequate fluid intake during treatment. 
Bolnikom je treba svetovati, da med zdravljenjem vzdržujejo vnos zadostne količine tekočin.
Mutations in the BRAF gene can produce proteins that cause the melanoma to grow. 
Mutacije gena BRAF lahko proizvedejo proteine, zaradi katerih melanom raste.
LVEF should be evaluated every 2 weeks until recovery. 
LVEF je treba oceniti vsaka 2 tedna do okrevanja.
Carcinogenic potential of binimetinib was not evaluated. 
Kancerogeni potencial binimetiniba ni bil ocenjen.
PVC/PVDC/Alu blister containing 12 tablets. 
Pretisni omot iz PVC/PVDC/aluminija z 12 tabletami.
Prior treatment with BRAF/MEK inhibitors was not allowed. 
Predhodno zdravljenje z zaviralci BRAF/MEK ni bilo dovoljeno.
What Mektovi is and what it is used for 2. 
Kaj je zdravilo Mektovi in za kaj ga uporabljamo 2.
Cardiac electrophysiology 
Kardiološka elektrofiziologija
In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK. 
Pri melanomu in drugih vrstah raka to pot pogosto aktivirajo mutirane oblike gena BRAF, ki aktivirajo MEK.
Enrolment in Part 2 started after all Part 1 patients were randomised. 
Sodelovanje v 2. delu se je začelo, ko so bili vsi bolniki iz 1. dela randomizirani.
The tablets are to be swallowed whole with water. 
Tablete je treba pogoltniti cele z vodo.
Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reaction that may affect their ability to drive and use machines (see sections 4.4 and 4.8). 
Bolnikom je treba svetovati, naj ne vozijo ali upravljajo strojev, če zaznajo motnje vida ali kateri koli drug neželeni učinek, ki bi lahko vplival na njihovo sposobnost vožnje in upravljanja strojev (glejte poglavji 4.4. in 4.8).
• some medicines to treat HIV such as indinavir, atazanavir 
• nekatera zdravila za zdravljenje virusa HIV, kot sta indinavir, atazanavir,
Each film-coated tablet contains 133.5 mg of lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 133,5 mg laktoze monohidrata.
The tablets also contain lactose. 
Tablete vsebujejo tudi laktozo.
There are insufficient data to evaluate potential differences in the exposure of binimetinib by race or ethnicity. 
Na voljo ni dovolj podatkov, da bi se ocenilo morebitne razlike v izpostavljenosti binimetinibu glede na rasno ali etnično pripadnost.
In the small group of patients aged ≥ 75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment. 
Pri manjši skupini bolnikov, starih 75 let in več (n = 15), je pri bolnikih pogosteje prišlo do resnih neželenih dogodkov in neželenih dogodkov, zaradi katerih se je zdravljenje prenehalo izvajati.
Special attention should be paid to patients with neuromuscular conditions associated with CK elevation and rhabdomyolysis. 
Posebno pozornost je treba nameniti bolnikom z nevromuskulatornimi stanji, ki so povezana z dvigom CK in rabdomiolizo.
In humans, the blood-to-plasma ratio is 0.718. 
Pri ljudeh je razmerje med krvjo in plazmo 0,718.
LVD was generally reversible following dose reduction or dose interruption. 
LVD je bila večinoma reverzibilna po zmanjšanju odmerka ali prekinitvi vnosa.
Usually, these skin cancers (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can continue without interruption. 
Običajno so te vrste kožnega raka (glejte tudi poglavje 2) omejene na majhna področja in jih je mogoče kirurško odstraniti, zdravljenje z zdravilom Mektovi (in enkorafenibom) pa se lahko neprekinjeno nadaljuje.
Dose re-escalation to 45 mg twice daily is not recommended if the dose reduction is due to left ventricular dysfunction (LVD) or any Grade 4 toxicity. 
Povečanje odmerka na 45 mg dvakrat dnevno ni priporočeno, če je bil odmerek zmanjšan zaradi disfunkcije levega prekata (LVD) ali katere koli toksičnosti 4. stopnje.
An evaluation of change over time in score yielded the same trend for EORTC QLQ-C30 and at all visit for FACT-M. 
Ocena spremembe rezultata skozi čas je pokazala enak trend pri vprašalniku EORTC QLQ-C30 in pri vseh obiskih za FACT-M.
If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently. 
Če pride do resnih neželenih učinkov (kot so težave s srcem, očmi ali kožo), zdravnik lahko zmanjša odmerek oz. začasno ali dokončno prekine zdravljenje.
Other medicines and Mektovi 
Druga zdravila in zdravilo Mektovi
Treatment continued until disease progression or unacceptable toxicity. 
Zdravljenje je potekalo do napredovanja bolezni ali pojava nesprejemljive toksičnosti.
Patients should be instructed to immediately inform their physicians if new skin lesions develop. 
Bolnikom je treba naročiti, naj svojega zdravnika takoj obvestijo o pojavu kakršnih koli sprememb na koži.
After oral administration, binimetinib is rapidly absorbed with a median Tmax of 1.5 hours. 
Po peroralni uporabi se binimetinib zelo hitro absorbira s srednjo vrednostjo Tmax 1,5 ure.
If the adverse reaction that resulted in a dose reduction is under effective management, dose re-escalation to 45 mg twice daily may be considered. 
Če neželeni učinek, ki je privedel do zmanjšanja odmerka, učinkovito obvladujemo, se lahko preuči možnost za povečanje odmerka na 45 mg dvakrat dnevno.
Alopecia* 
Alopecija*
The potential embryo-foetal effects of binimetinib were evaluated in rats and rabbits. 
Morebitni učinki binimetiniba na embrio in fetus so bili ocenjeni pri podganah in zajcih.
Some medicines may affect how Mektovi works, or make it more likely that you will have side effects. 
Nekatera zdravila lahko vplivajo na delovanje zdravila Mektovi ali pa je zaradi njih bolj verjetno, da pride do neželenih učinkov.
This is a precaution in case a squamous cell carcinoma develops inside your body. 
Gre za previdnostni ukrep v primeru, da bi se vam v telesu razvijal ploščatocelični karcinom.
It should be ensured that patient has adequate hydration. 
Zagotoviti je treba zadostno hidriranost bolnika.
Most of these cases were Grade 1 or 2 (14.6 %) and 3.3 % were Grade 3 or 4 events. 
Večina teh primerov je bila 1. ali 2. stopnje (14,6 %), 3,3 % primerov pa so bili 3. ali 4. stopnje.
However, if the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time. 
Če pa s pozabljenim odmerkom zamujate več kot 6 ur, ta odmerek preskočite in vzemite naslednjega ob običajnem času.
Binimetinib has phototoxic potential in vitro. 
Binimetinib ima in vitro fototoksični potencial.
Based on a population pharmacokinetic analysis, age or body weight do not have a clinically important effect on the systemic exposure of binimetinib. 
Glede na populacijsko farmakokinetično analizo starost ali telesna masa nimata klinično pomembnega vpliva na sistemsko izpostavljenost binimetinibu.
In clinical study sub-analysis, however, there was no apparent relationship observed between binimetinib exposure and UGT1A1 mutation status. 
Vendar pa pri podanalizi klinične študije ni bil opažen nikakršen očiten odnos med izpostavljenostjo binimetinibu in stanjem mutacije UGT1A1.
Dry skin* 
Suha koža*
An additional secondary endpoint included PFS of Combo 450 compared with Enco 300. 
Dodatna sekundarna končna meritev je vključevala PFS pri kombinaciji 450 v primerjavi z Enko 300.
Binimetinib is 97.2 % bound to human plasma proteins in vitro. 
Binimetinib je in vitro 97,2-odstotno vezan na proteine človeške plazme.
Number of events (progressive disease(PD)) (%) 
Število dogodkov (progresivna bolezen (PD)) (%)
The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with encorafenib 300 mg and 6.2 months in patients treated with vemurafenib. 
Mediana trajanja izpostavljenosti je bila 11,7 mesecev pri bolnikih, zdravljenih s kombinacijo 450, 7,1 mesecev pri bolnikih, zdravljenih s 300 mg enkorafeniba, in 6,2 mesecev pri bolnikih, zdravljenih z vemurafenibom.
Rhabdomyolysis/Creatine phosphokinase (CK) elevation 
Rabdomioliza/dvig kreatin fosfokinaze (CK)
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE41 
Farmakoterapevtska skupina: zdravilo z delovanjem na novotvorbe, zaviralec proteinskih kinaz, oznaka ATC: L01XE41
Most patients had metastatic disease (95 %) and were Stage IVM1c (64 %); 27 % of patients had elevated baseline serum lactate dehydrogenase (LDH), and 45% of patients had at least 3 organs with tumour involvement at baseline and 3.5 % had brain metastases. 
Večina bolnikov je imela metastatsko bolezen (95 %) in stadij IVM1c (64 %); 27 % bolnikov je imelo povišano izhodiščno vrednost serumske laktat dehidrogenaze (LDH), 45 % bolnikov je imelo vsaj 3 organe s tumorji v izhodišču in 3,5 % jih je imelo možganske metastaze.
Contents of the pack and other information What Mektovi contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Mektovi
In vitro experiments indicate that binimetinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). 
In vitro preskusi nakazujejo, da je binimetinib substrat P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (angl. Breast Cancer Resistance Protein - BCRP).
Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each) or 168 tablets (14 blisters of 12 tablets each). 
Zdravilo Mektovi je na voljo v pakiranjih po 84 tablet (7 pretisnih omotov, vsak vsebuje 12 tablet) ali 168 tablet (14 pretisnih omotov, vsak vsebuje 12 tablet).
The median (range) binimetinib terminal half-life (T1/2) was 8.66 h (8.10 to 13.6 h). 
Srednja vrednost (razpon) končne razpolovne dobe binimetiniba (T1/2) je bila 8,66 h (od 8,10 do 13,6 h).
Grade 3-4 LVEF, or absolute decrease of LVEF from baseline of ≥ 10 %, binimetinib should be discontinued and LVEF should be evaluated every 2 weeks until recovery. 
3. ali 4. stopnje ali absolutnem zmanjšanju LVEF ≥ 10 % od izhodiščne vrednosti, prenehati z uporabo binimetiniba in ocenjevati LVEF vsaka 2 tedna do okrevanja.
When Mektovi is used in combination with encorafenib (which targets the changed “BRAF” protein), the combination slows down or stops the growth of your cancer. 
Ko se zdravilo Mektovi uporabi v kombinaciji z enkorafenibom (ki deluje na spremenjeni protein »BRAF«), ta kombinacija upočasni ali zaustavi rast rakavih celic.
• Heart problems: Mektovi can make your heart work less well, or make existing heart problems worse. 
• Težave s srcem: Zdravilo Mektovi lahko poslabša delovanje srca ali poslabša obstoječe težave s srcem.
Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment. 
Druge sekundarne primerjave učinkovitosti med kombinacijo 450 in vemurafenibom ali Enko 300 so vključevale celokupno preživetje (OS), objektivno stopnjo odziva (ORR), trajanje odziva (DoR) in stopnjo nadzora bolezni (DCR), kot so jih ocenili odbor BIRC in raziskovalci.
The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy. 
Tveganje za pojav krvavitev se poveča ob sočasnem zdravljenju z antikoagulacijskimi in antitrombotičnimi zdravili.
Before starting treatment your doctor will check for BRAF mutation. 
Pred začetkom zdravljenja bo vaš zdravnik preveril, ali se je pri vas razvila mutacija gena BRAF.
The mean (CV %) apparent clearance (CL/F) of binimetinib was 28.2 L/h (17.5 %). 
Povprečni (CV %) navidezni očistek (CL/F) binimetiniba je bil 28,2 l/h (17,5 %).
The median duration of treatment was longer for Combo 300 vs. Enco 300, 52.1 weeks vs 31.5 weeks. 
Vrednost mediane trajanja zdravljenja je bila večja pri kombinaciji 300 v primerjavi z Enko 300: 52,1 tednov proti 31,5 tednov.
• a medicine used to treat breathing problems, theophylline. 
• zdravilo, ki se uporablja za zdravljenje težav z dihanjem, teofilin.
If you vomit at any time after taking Mektovi, do not take an additional dose. 
Če kadar koli po tem, ko ste vzeli zdravilo Mektovi, bruhate, ne vzemite dodatnega odmerka.
Since binimetinib is highly bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with binimetinib. 
Ker je binimetinib v veliki meri vezan na proteine v plazmi, hemodializa verjetno ne bo učinkovita pri zdravljenju prevelikega odmerjanja binimetiniba.
The effects of renal impairment on the pharmacokinetics of binimetinib in combination with encorafenib have not been evaluated clinically. 
Učinki okvare ledvic na farmakokinetiko binimetiniba v kombinaciji z enkorafenibom niso bili klinično ocenjeni.
Binimetinib has minor influence on the ability to drive or use machines. 
Binimetinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
In this patient, rhabdomyolysis was observed with concomitant symptomatic Grade 4 CK elevation. 
Pri tem bolniku je bil sočasno z rabdomiolizo opažen simptomatični dvig CK 4. stopnje.