FrancophonIA/ELRC3.0 huggingface dataset:
English: There are insufficient data to evaluate potential differences in the exposure of binimetinib by race or ethnicity.
Slovenian: Na voljo ni dovolj podatkov, da bi se ocenilo morebitne razlike v izpostavljenosti binimetinibu glede na rasno ali etnično pripadnost.
English: 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.
Slovenian: 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.
English: Special attention should be paid to patients with neuromuscular conditions associated with CK elevation and rhabdomyolysis.
Slovenian: Posebno pozornost je treba nameniti bolnikom z nevromuskulatornimi stanji, ki so povezana z dvigom CK in rabdomiolizo.
English: In humans, the blood-to-plasma ratio is 0.718.
Slovenian: Pri ljudeh je razmerje med krvjo in plazmo 0,718.
English: LVD was generally reversible following dose reduction or dose interruption.
Slovenian: LVD je bila večinoma reverzibilna po zmanjšanju odmerka ali prekinitvi vnosa.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: An evaluation of change over time in score yielded the same trend for EORTC QLQ-C30 and at all visit for FACT-M.
Slovenian: Ocena spremembe rezultata skozi čas je pokazala enak trend pri vprašalniku EORTC QLQ-C30 in pri vseh obiskih za FACT-M.
English: 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.
Slovenian: Če pride do resnih neželenih učinkov (kot so težave s srcem, očmi ali kožo), zdravnik lahko zmanjša odmerek oz. začasno ali dokončno prekine zdravljenje.
English: Other medicines and Mektovi
Slovenian: Druga zdravila in zdravilo Mektovi
English: Treatment continued until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje je potekalo do napredovanja bolezni ali pojava nesprejemljive toksičnosti.
English: Patients should be instructed to immediately inform their physicians if new skin lesions develop.
Slovenian: Bolnikom je treba naročiti, naj svojega zdravnika takoj obvestijo o pojavu kakršnih koli sprememb na koži.
English: After oral administration, binimetinib is rapidly absorbed with a median Tmax of 1.5 hours.
Slovenian: Po peroralni uporabi se binimetinib zelo hitro absorbira s srednjo vrednostjo Tmax 1,5 ure.
English: 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.
Slovenian: Če neželeni učinek, ki je privedel do zmanjšanja odmerka, učinkovito obvladujemo, se lahko preuči možnost za povečanje odmerka na 45 mg dvakrat dnevno.
English: Alopecia*
Slovenian: Alopecija*
English: The potential embryo-foetal effects of binimetinib were evaluated in rats and rabbits.
Slovenian: Morebitni učinki binimetiniba na embrio in fetus so bili ocenjeni pri podganah in zajcih.
English: Some medicines may affect how Mektovi works, or make it more likely that you will have side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila Mektovi ali pa je zaradi njih bolj verjetno, da pride do neželenih učinkov.
English: This is a precaution in case a squamous cell carcinoma develops inside your body.
Slovenian: Gre za previdnostni ukrep v primeru, da bi se vam v telesu razvijal ploščatocelični karcinom.
English: It should be ensured that patient has adequate hydration.
Slovenian: Zagotoviti je treba zadostno hidriranost bolnika.
English: Most of these cases were Grade 1 or 2 (14.6 %) and 3.3 % were Grade 3 or 4 events.
Slovenian: Večina teh primerov je bila 1. ali 2. stopnje (14,6 %), 3,3 % primerov pa so bili 3. ali 4. stopnje.
English: However, if the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time.
Slovenian: Če pa s pozabljenim odmerkom zamujate več kot 6 ur, ta odmerek preskočite in vzemite naslednjega ob običajnem času.
English: Binimetinib has phototoxic potential in vitro.
Slovenian: Binimetinib ima in vitro fototoksični potencial.
English: Based on a population pharmacokinetic analysis, age or body weight do not have a clinically important effect on the systemic exposure of binimetinib.
Slovenian: Glede na populacijsko farmakokinetično analizo starost ali telesna masa nimata klinično pomembnega vpliva na sistemsko izpostavljenost binimetinibu.
English: In clinical study sub-analysis, however, there was no apparent relationship observed between binimetinib exposure and UGT1A1 mutation status.
Slovenian: Vendar pa pri podanalizi klinične študije ni bil opažen nikakršen očiten odnos med izpostavljenostjo binimetinibu in stanjem mutacije UGT1A1.
English: Dry skin*
Slovenian: Suha koža*
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Slovenian: Dodatna sekundarna končna meritev je vključevala PFS pri kombinaciji 450 v primerjavi z Enko 300.
English: Binimetinib is 97.2 % bound to human plasma proteins in vitro.
Slovenian: Binimetinib je in vitro 97,2-odstotno vezan na proteine človeške plazme.
English: Number of events (progressive disease(PD)) (%)
Slovenian: Število dogodkov (progresivna bolezen (PD)) (%)
English: 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.
Slovenian: 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.
English: Rhabdomyolysis/Creatine phosphokinase (CK) elevation
Slovenian: Rabdomioliza/dvig kreatin fosfokinaze (CK)
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE41
Slovenian: Farmakoterapevtska skupina: zdravilo z delovanjem na novotvorbe, zaviralec proteinskih kinaz, oznaka ATC: L01XE41
English: 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.
Slovenian: 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.
English: Contents of the pack and other information What Mektovi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Mektovi
English: In vitro experiments indicate that binimetinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Slovenian: In vitro preskusi nakazujejo, da je binimetinib substrat P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (angl. Breast Cancer Resistance Protein - BCRP).
English: Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each) or 168 tablets (14 blisters of 12 tablets each).
Slovenian: 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).
English: The median (range) binimetinib terminal half-life (T1/2) was 8.66 h (8.10 to 13.6 h).
Slovenian: Srednja vrednost (razpon) končne razpolovne dobe binimetiniba (T1/2) je bila 8,66 h (od 8,10 do 13,6 h).
English: 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.
Slovenian: 3. ali 4. stopnje ali absolutnem zmanjšanju LVEF ≥ 10 % od izhodiščne vrednosti, prenehati z uporabo binimetiniba in ocenjevati LVEF vsaka 2 tedna do okrevanja.
English: 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.
Slovenian: Ko se zdravilo Mektovi uporabi v kombinaciji z enkorafenibom (ki deluje na spremenjeni protein »BRAF«), ta kombinacija upočasni ali zaustavi rast rakavih celic.
English: • Heart problems: Mektovi can make your heart work less well, or make existing heart problems worse.
Slovenian: • Težave s srcem: Zdravilo Mektovi lahko poslabša delovanje srca ali poslabša obstoječe težave s srcem.
English: 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.
Slovenian: 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.
English: The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy.
Slovenian: Tveganje za pojav krvavitev se poveča ob sočasnem zdravljenju z antikoagulacijskimi in antitrombotičnimi zdravili.
English: Before starting treatment your doctor will check for BRAF mutation.
Slovenian: Pred začetkom zdravljenja bo vaš zdravnik preveril, ali se je pri vas razvila mutacija gena BRAF.
English: The mean (CV %) apparent clearance (CL/F) of binimetinib was 28.2 L/h (17.5 %).
Slovenian: Povprečni (CV %) navidezni očistek (CL/F) binimetiniba je bil 28,2 l/h (17,5 %).
English: The median duration of treatment was longer for Combo 300 vs. Enco 300, 52.1 weeks vs 31.5 weeks.
Slovenian: Vrednost mediane trajanja zdravljenja je bila večja pri kombinaciji 300 v primerjavi z Enko 300: 52,1 tednov proti 31,5 tednov.
English: • a medicine used to treat breathing problems, theophylline.
Slovenian: • zdravilo, ki se uporablja za zdravljenje težav z dihanjem, teofilin.
English: If you vomit at any time after taking Mektovi, do not take an additional dose.
Slovenian: Če kadar koli po tem, ko ste vzeli zdravilo Mektovi, bruhate, ne vzemite dodatnega odmerka.
English: Since binimetinib is highly bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with binimetinib.
Slovenian: Ker je binimetinib v veliki meri vezan na proteine v plazmi, hemodializa verjetno ne bo učinkovita pri zdravljenju prevelikega odmerjanja binimetiniba.
English: The effects of renal impairment on the pharmacokinetics of binimetinib in combination with encorafenib have not been evaluated clinically.
Slovenian: Učinki okvare ledvic na farmakokinetiko binimetiniba v kombinaciji z enkorafenibom niso bili klinično ocenjeni.
English: Binimetinib has minor influence on the ability to drive or use machines.
Slovenian: Binimetinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: In this patient, rhabdomyolysis was observed with concomitant symptomatic Grade 4 CK elevation.
Slovenian: Pri tem bolniku je bil sočasno z rabdomiolizo opažen simptomatični dvig CK 4. stopnje.
English: How to store Mektovi 6.
Slovenian: Shranjevanje zdravila Mektovi 6.
English: The incidences of liver laboratory abnormalities reported in the pooled Combo 450 population are listed below:
Slovenian: Pojavnosti nenormalnih laboratorijskih izvidov delovanja jeter, poročanih pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450, so navedene spodaj:
English: Encorafenib + binimetinib n = 192 (Combo 450)
Slovenian: Enkorafenib + binimetinib n = 192 (Kombinacija 450)
English: Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity.
Slovenian: Trajanje zdravljenja Zdravljenje naj traja toliko časa, dokler ima bolnik od njega še koristi oziroma dokler se ne razvije nesprejemljiva toksičnost.
English: • Grade 2 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x - ≤ 5x upper limit of normal (ULN)
Slovenian: • 2. stopnja aspartat aminotransferaza (AST) ali alanin aminotransferaza (ALT) > 3kratnika-≤ 5-kratnika zgornje meje normalne vrednosti (ULN)
English: Visual impairment, including vision blurred and reduced visual acuity, occurred in 21.5 % (59/274) of patients.
Slovenian: Okvara vida, vključno z zamegljenim vidom in zmanjšano ostrino vida, se je pojavila pri 21,5 % (59/274) bolnikov.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Mektovi therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Mektovi, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Binimetinib should be permanently discontinued in patients diagnosed with treatment related pneumonitis or ILD.
Slovenian: Vnos binimetiniba je treba trajno prekiniti pri bolnikih z diagnozo z zdravljenjem povezane pljučnice ali ILD.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with binimetinib in one or more subsets of the paediatric population in melanoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z enkorafenibom za eno ali več podskupin pediatrične populacije z melanomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What you need to know before you take Mektovi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Mektovi
English: Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by standard therapy as appropriate.
Slovenian: Izmeriti je treba izhodiščni krvni tlak in ga nato spremljati med zdravljenjem ter po potrebi uvesti standardno terapijo za nadzor hipertenzije.
English: • sudden shortness of breath or trouble breathing
Slovenian: • nenadno kratko sapo ali težave z dihanjem,
English: • Lung or breathing problems: This medicine may cause lung or breathing problems including inflammation of the lungs (pneumonitis or interstitial lung disease); signs and symptoms can include: cough, shortness of breath or fatigue.
Slovenian: • Težave s pljuči ali dihanjem: To zdravilo lahko povzroči težave s pljuči ali dihanjem, vključno z vnetjem pljuč (pljučnica ali intersticijska pljučna bolezen); znaki in simptomi lahko vključujejo: kašelj, kratko sapo ali utrujenost.
English: The maximum contribution of direct glucuronidation to the clearance of binimetinib was estimated to have been 61.2 %.
Slovenian: Neposredna glukuronidacija po ocenah k očistku binimetiniba prispeva največ 61,2-odstotno.
English: Mektovi is an anti-cancer medicine that contains the active substance binimetinib.
Slovenian: Mektovi je zdravilo proti raku, ki vsebuje učinkovino binimetinib.
English: Binimetinib should be withheld for up to 2 weeks and ophthalmic monitoring should be repeated including visual acuity assessment.
Slovenian: Vnašanje binimetiniba je treba prekiniti za do 2 tedna in ponoviti oftalmološki pregled, vključno z oceno ostrine vida.
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, AR00426032 (M3) by oxidative N-desmethylation.
Slovenian: In vitro CYP1A2 in CYP2C19 katalizirata pretvorbo v aktivni presnovek AR00426032 (M3) z oksidativno N-demetilacijo.
English: The incidence of Grade 3 or 4 adverse reactions was 5.8 % (16/274).
Slovenian: Pojavnost neželenih učinkov 3. ali 4. stopnje je bila 5,8 % (16/274).
English: The proportion of patients experiencing adverse events and serious adverse events were similar in patients aged <65 years and those aged > 65 years.
Slovenian: Delež bolnikov, pri katerih je prišlo do neželenih dogodkov in resnih neželenih dogodkov, je podoben pri bolnikih, mlajših od 65 let, in bolnikih, starih 65 let in več.
English: What Mektovi is and what it is used for
Slovenian: Kaj je zdravilo Mektovi in za kaj ga uporabljamo
English: Most events were reported as retinopathy, retinal detachment, subretinal fluid, macular oedema, and chorioretinopathy and led to dose interruptions or dose modifications in 4.7 % (13/274) of patients.
Slovenian: Večino dogodkov so poročali kot retinopatijo, odstop mrežnice, subretinalno tekočino, makulozni edem in horioretinopatijo ter je povzročila prekinitev vnosa ali spremembo odmerka pri 4,7 % (13/274) bolnikov.
English: Randomisation was stratified by American Joint Committee on Cancer (AJCC) Stage (IIIB, IIIC, IVM1a or IVM1b, vs IVM1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) and prior immunotherapy for unresectable or metastatic disease (yes vs no).
Slovenian: Randomizacija je bila stratificirana po stadijih Ameriškega združenega odbora za raka (AJCC) (IIIB, IIIC, IVM1a ali IVM1b proti IVM1c) in lestvici za ocenjevanje stanja bolnikove zmogljivosti onkološke skupine za preučevanje raka (ECOG) (0 proti 1) ter predhodne imunoterapije za neresektabilno ali metastatsko bolezen (»Da« proti »Ne«).
English: For patients receiving 45 mg binimetinib twice daily, the recommended reduced dose of binimetinib is 30 mg twice daily.
Slovenian: Za bolnike, ki prejemajo 45 mg binimetiniba dvakrat dnevno, je priporočeni zmanjšani odmerek binimetiniba 30 mg dvakrat dnevno.
English: The main route of hepatic transformation of binimetinib being glucoronidation, the decision for treatement should be made by the treating physician taking into account the individual benefit-risk.
Slovenian: Glavna pot transformacije binimetiniba v jetrih je glukuronidacija, zato se mora za zdravljenje odločiti lečeči zdravnik, pri čemer mora upoštevati razmerje med koristmi in tveganji za posameznika.
English: Tell your doctor if you have ever had blockage in the vein carrying blood away from the eye (retinal vein occlusion), as Mektovi is not recommended in such cases.
Slovenian: Če ste kadar koli imeli zaporo v veni, ki odvaja kri iz očesa (zapora mrežnične vene), obvestite zdravnika, saj se zdravilo Mektovi v takih primerih ne priporoča.
English: • stomach (abdominal) pain
Slovenian: • bolečine v trebuhu (abdominalne bolečine),
English: Binimetinib dose should be maintained and it should be ensured that patient is adequately hydrated.
Slovenian: Nadaljevati je treba z enakim odmerkom binimetiniba in zagotoviti je treba zadostno hidriranost bolnika.
English: CK and creatinine levels should be monitored monthly during the first 6 months of treatment and as clinically indicated.
Slovenian: Raven CK in kreatinina je treba v prvih 6 mesecih zdravljenja spremljati enkrat na mesec in kot je klinično indicirano.
English: • medicine used to treat depression such as duloxetine
Slovenian: • zdravilo, ki se uporablja za zdravljenje depresije, kot je duloksetin,
English: Mektovi targets another protein called “MEK” that stimulates cancer cell growth.
Slovenian: Zdravilo Mektovi deluje na drug protein z imenom »MEK«, ki spodbuja rast rakavih celic.
English: Part 2 of study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Slovenian: 2. del študije CMEK162B2301 je bil zasnovan za ocenjevanje doprinosa, ki ga ima binimetinib v kombinaciji enkorafeniba in binimetiniba.
English: It is recommended that LVEF is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of binimetinib, 1 month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Slovenian: Priporočeno je, da se LVEF oceni z ehokardiografijo ali slikanjem MUGA (multi-gated acquisition scan) pred začetkom uporabe binimetiniba, 1 mesec po začetku uporabe in nato v približno 3mesečnih intervalih ali pogosteje, kakor je klinično indicirano, v času trajanja terapije.
English: An analysis of time to definitive 10 % deterioration in EORTC QLQ-C30 score provided with similar results.
Slovenian: Analiza časa do dokončnega 10-odstotnega poslabšanja po oceni z vprašalnikom EORTC QLQ-C30 je pokazala podobne rezultate.
English: Hyperkeratosis *
Slovenian: Hiperkeratoza*
English: Therefore, binimetinib should be used with caution in these patients.
Slovenian: Pri teh bolnikih je treba binimetinib uporabljati previdno.
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, which represents less than 20 % of the binimetinib exposure clinically.
Slovenian: In vitro CYP1A2 in CYP2C19 katalizirata pretvorbo v aktivni presnovek, ki predstavlja manj kot 20 % klinične izpostavljenosti binimetinibu.
English: Results from a dedicated clinical study with binimetinib only indicate similar exposures in patients with mild impairment (Child-Pugh Class A) and subjects with normal liver function.
Slovenian: Rezultati namenske klinične študije z binimetinibom kot samostojnim zdravilom nakazujejo podobno izpostavljenost pri bolnikih z blago okvaro (ChildPugh razreda A) in udeležencih z normalno jetrno funkcijo.
English: Inhibition of P-gp or BCRP is unlikely to result in a clinically important increase in binimetinib concentrations as binimetinib exhibits moderate to high passive permeability.
Slovenian: P-gp ali BCRP povzročilo klinično pomembno povečanje koncentracij binimetiniba, saj binimetinib izkazuje zmerno do visoko pasivno prepustnost.
English: Binimetinib treatment in combination with encorafenib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z binimetinibom v kombinaciji z enkorafenibom mora pričeti in nadzorovati le zdravnik, ki ima izkušnje z uporabo protirakavih zdravil.
English: The safety of binimetinib has not been established in patients with predisposing factors for RVO including uncontrolled glaucoma, ocular hypertension, uncontrolled diabetes mellitus or a history of hyperviscosity or hypercoagulability syndromes.
Slovenian: Varnost binimetiniba ni bila dokazana pri bolnikih, ki imajo faktorje tveganja za RVO, vključno z nenadzorovanim glavkomom, očesno hipertenzijo, nenadzorovano sladkorno boleznijo ali anamnezo hiperviskoznega ali hiperkoagulabilnega sindroma.
English: Standard genotixicity studies with binimetinib were negative.
Slovenian: Rezultati standardnih študij genotoksičnosti z binimetinibom so bili negativni.
English: A minimal risk for photosensitisation was shown in vivo at an oral dose providing 3.8-fold higher exposure than that achieved with the recommended dose in humans.
Slovenian: Pri preskušanjih in vivo se je pokazalo minimalno tveganje za fotosenzibilnost pri peroralnem dajanju zdravila s 3,8-krat večjo izpostavljenostjo, kot je dosežena pri priporočenem odmerku za ljudi.
English: These data indicate that there is minimal risk for phototoxicity with binimetinib at therapeutic doses in patients.
Slovenian: Ti podatki kažejo, da pri terapevtskih odmerkih binimetiniba za bolnika obstaja minimalno tveganje za fototoksičnost.
English: Women of childbearing potential must use effective contraception during treatment with binimetinib and for at least 1 month following the last dose.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z binimetinibom in vsaj še 1 mesec po zadnjem odmerku.
English: Encorafenib n = 194 (Enco 300)
Slovenian: Enkorafenib n = 194 (Enko 300)