FrancophonIA/ELRC3.0 huggingface dataset:
English: Mektovi film-coated tablets are yellow/dark yellow, unscored biconvex, oval film-coated tablets debossed with “A” on one side and “15” on the other side.
Slovenian: Filmsko obložene tablete Mektovi so rumene/temno rumene, bikonveksne in ovalne tablete brez zareze, z vtisnjeno črko »A« na eni strani tablete in številko »15« na drugi strani.
English: Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Jetrna okvara Pri bolnikih z blago jetrno okvaro prilagoditev odmerka ni potrebna (Child-Pugh A).
English: Binimetinib is metabolised by UGTs and CYP1A2 and is a substrate for Pgp.
Slovenian: Binimetinib se presnavlja z encimi UGT in CYP1A2 in je substrat za Pgp.
English: Photosensitivity*
Slovenian: Fotosenzibilnost*
English: High blood pressure: Mektovi can increase blood pressure.
Slovenian: Visok krvni tlak: Zdravilo Mektovi lahko poviša krvni tlak.
English: Cerebral haemorrhage occurred in 1.5 % (4/274) of patients with fatal outcome in 3 patients.
Slovenian: Krvavitev v možganih se je pojavila pri 1,5 % (4/274) bolnikov, s smrtnim izidom pri 3 bolnikih.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, the primary biotransformation pathways of binimetinib observed in humans include glucuronidation, Ndealkylation, amide hydrolysis, and loss of ethane-diol from the side chain.
Slovenian: Po enkratnem peroralnem odmerku 45 mg [14C] binimetiniba so pri zdravih udeležencih opazovali primarne poti biotransformacije, ki pri ljudeh vključujejo glukuronidacijo, N-dealkilacijo, hidrolizo amidov in odcep etandiola iz stranske verige.
English: Binimetinib and encorafenib (a BRAF inhibitor, see section 5.1 of encorafenib SmPC) both inhibit the MAPK pathway resulting in higher anti-tumour activity.
Slovenian: Binimetinib in enkorafenib (zaviralec BRAF, glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila enkorafeniba) oba zavirata pot MAPK, kar privede do večje protitumorske aktivnosti.
English: The mean LVEF value dropped by 5.9 % in the pooled Combo 450 population, from a mean of 63.9 % at baseline to 58.1 %.
Slovenian: Srednja vrednost LVEF se je znižala za 5,9 % pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 s srednje vrednosti 63,9 % pri izhodišču na 58,1 %.
English: • Skin changes: Mektovi, when taken with encorafenib, may cause other types of skin cancer such as cutaneous squamous cell carcinoma.
Slovenian: • Spremembe na koži: Ko zdravilo Mektovi jemljete z enkorafenibom, lahko povzroči druge vrste kožnega raka, kot je ploščatocelični karcinom kože.
English: In a gastric irritation study in rats, an increased incidence of superficial mucosal lesions and of hemorrhagic ulcers were observed.
Slovenian: Pri študijah draženja želodca pri podganah se je opazila povečana incidenca površinskih lezij na sluznici in krvavečih ulkusov.
English: Lipase increased
Slovenian: Zvišana vrednost lipaze
English: Overall response rate, n (%) (95 % CI)
Slovenian: Stopnja skupnega odziva, n (%) (95 % IZ)
English: Exceptions where dose reductions are necessary for encorafenib only (adverse reactions primarily related to encorafenib) are: palmar-plantar erythrodysaesthesia syndrome (PPES), uveitis including iritis and iridocyclitis and QTc prolongation.
Slovenian: V naslednjih izjemnih primerih je treba zmanjšati le odmerek enkorafeniba (neželeni učinki, povezani predvsem z enkorafenibom): sindrom roka-noga (PPES), vnetje uvee, vključno z iritisom in iridociklitisom, ter podaljšanje intervala QTc.
English: Binimetinib in combination with encorafenib in patients with brain metastases
Slovenian: Binimetinib v kombinaciji z enkorafenibom pri bolnikih z metastazami v možganih
English: Effect of CYP enzymes on binimetinib
Slovenian: Učinek encimov CYP na binimetinib
English: Preliminary Part 2 data at a cut-off date of 9 November 2016 demonstrated the contribution of binimetinib with an improved median PFS estimate of 12.9 months (95 % CI: 10.1, 14.0) for Combo 300 compared to 9.2 months (95 % CI: 7.4, 11.0) for Enco 300 (Parts 1 and 2) per independent central review (BIRC).
Slovenian: Predhodni podatki iz 2. dela študije s končnim datumom 9. novembra 2016 so potrdili doprinos binimetiniba z izboljšano oceno mediane vrednosti PFS pri 12,9 mesecih (95-odstotni IZ: 10,1, 14,0) za kombinacijo 300 v primerjavi z 9,2 meseci (95-odstotni IZ: 7,4, 11,0) za Enko 300 (1. in 2. del) na posamezni neodvisni centralni pregled (BIRC).
English: Dermatitis acneiform*
Slovenian: Akneiformni dermatitis*
English: If binimetinib is temporarily interrupted, encorafenib should be reduced to 300 mg once daily during the time of binimetinib dose interruption (see Tables 1 and 2) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.
Slovenian: Če je vnos binimetiniba začasno prekinjen, je treba odmerek enkorafeniba zmanjšati na 300 mg enkrat dnevno za obdobje trajanja prekinitve vnosa binimetiniba (glejte preglednici 1 in 2), saj bolniki enkorafeniba kot samostojnega zdravila v odmerku 450 mg ne prenašajo dobro.
English: Dose interruption or dose modification was reported in 0.4 % (1/274) of patients.
Slovenian: O prekinitvi vnosa ali spremembi odmerka so poročali pri 0,4 % (1/274) bolnikov.
English: The most frequent haemorrhagic events were haematuria in 3.3 % (9/274) of patients, rectal haemorrhage in 2.9 % (8/274) and haematochezia in 2.9 % (8/274) of patients.
Slovenian: Najpogostejši hemoragični dogodki so bili hematurija pri 3,3 % (9/274) bolnikov, rektalna krvavitev pri 2,9 % (8/274) in hematohezija pri 2,9 % (8/274) bolnikov.
English: Table 3: Adverse reactions occurring in patients receiving binimetinib in combination with encorafenib at the recommended dose (n = 274) System Organ Class
Slovenian: Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z binimetinibom v kombinaciji z enkorafenibom v priporočenem odmerku (n = 274)
English: Your doctor will check that your heart is working properly before and during your treatment with this medicine.
Slovenian: Vaš zdravnik bo pred zdravljenjem s tem zdravilom in med njim preveril, ali vaše srce deluje pravilno.
English: The efficacy and safety of binimetinib in combination with encorafenib have been established only in patients with tumours expressing BRAF V600E and V600K mutations.
Slovenian: Varnost in učinkovitost binimetiniba v kombinaciji z enkorafenibom sta bili dokazani samo pri bolnikih s tumorji, ki so posledica mutacij V600E in V600K gena BRAF.
English: What Mektovi looks like and contents of the pack
Slovenian: Izgled zdravila Mektovi in vsebina pakiranja
English: No effects were observed at 3times the human therapeutic exposure.
Slovenian: Pri 3kratni izpostavljenosti kot pri človeškem terapevtskem odmerku učinki niso bili opaženi.
English: A drug interaction study in healthy subjects indicated that the extent of binimetinib exposure is not altered in the presence of a gastric pH-altering agent (rabeprazole).
Slovenian: Študija medsebojnega delovanja z drugimi zdravili pri zdravih udeležencih je nakazala, da na obseg izpostavljenosti binimetinibu prisotnost učinkovine, ki spreminja pH v želodcu (rabeprazol), ne vpliva.
English: Effects of binimetinib on other medicinal products
Slovenian: Učinki binimetiniba na druga zdravila
English: This increase expends to three fold in both moderate and severe hepatic impairment when considering unbound binimetinib exposure (see section 4.2).
Slovenian: To povečanje je trikratno pri bolnikih z zmerno in hudo okvaro jeter, ko se upošteva izpostavljenost nevezanemu binimetinibu (glejte poglavje 4.2).
English: The pharmacokinetics of binimetinib were studied in healthy subjects and patients with solid tumours and advanced and unresectable or metastatic cutaneous melanoma.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetične lastnosti binimetiniba so preučevali pri zdravih udeležencih in bolnikih s čvrstimi tumorji ter napredovanim in neresektabilnim ali metastatskim kožnim melanomom.
English: Before taking binimetinib in combination with encorafenib, patients must have BRAF V600 mutation confirmed by validated test.
Slovenian: Pred začetkom jemanja binimetiniba v kombinaciji z enkorafenibom mora biti pri bolnikih z validiranim testom potrjena mutacija V600 gena BRAF.
English: • muscle pain, cramps, stiffness or spasm
Slovenian: • bolečine v mišicah, krče, togost ali spazme,
English: • a medicine for carcinoma treatment called sorafenib
Slovenian: • zdravilo za zdravljenje raka sorafenib,
English: • Eye problems: Mektovi can cause serious eye problems.
Slovenian: • Težave z očmi: Zdravilo Mektovi lahko povzroči resne težave z očmi.
English: Besides the serious side effects mentioned above, people taking Mektovi and encorafenib together may also get the following side effects.
Slovenian: Poleg zgoraj navedenih resnih neželenih učinkov se lahko pri bolnikih, ki jemljejo zdravilo Mektovi skupaj z enkorafenibom, pojavijo še naslednji neželeni učinki.
English: The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg) twice daily, taken about 12 hours apart (corresponding to a daily dose of 90 mg).
Slovenian: Priporočeni odmerek zdravila Mektovi je 45 mg (3 tablete po 15 mg) dvakrat dnevno v razmiku približno 12 ur (kar ustreza dnevnemu odmerku 90 mg).
English: For additional information on warnings and precautions associated with encorafenib treatment, see section 4.4 of encorafenib SmPC.
Slovenian: Za dodatne informacije o posebnih opozorilih in previdnostnih ukrepih, povezanih z zdravljenjem z enkorafenibom, glejte poglavje 4.4
English: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review)
Slovenian: Preglednica 4: Študija CMEK162B2301, 1. del: Preživetje brez napredovanja in potrjeni rezultati skupnega odziva (neodvisni centralni pregled)
English: It is unknown whether binimetinib or its metabolite are excreted in human milk.
Slovenian: Ni znano, ali se binimetinib/presnovki izločajo v materino mleko.
English: RPED was Grade 1 (asymptomatic) in 21.2 % (58/274) of patients, Grade 2 in 6.6 % (18/274) of patients and Grade 3 in 1.8 % (5/274) of patients.
Slovenian: RPED je bil 1. stopnje (asimptomatični) pri 21,2 % (58/274) bolnikov, 2. stopnje pri 6,6 % (18/274) bolnikov in 3. stopnje pri 1,8 % (5/274) bolnikov.
English: QTc prolongation of > 60 ms compared to pre-treatment values was observed in 4.9 % (13/268) patients in the encorafenib plus binimetinib group, and in 3.4 % (7/204) in the encorafenib single agent group (see section 5.1 of encorafenib SmPC).
Slovenian: Podaljšanje intervala QTc za > 60 ms v primerjavi z vrednostmi pred zdravljenjem je bilo opaženo pri 4,9 % (13/268) bolnikov v skupini z enkorafenibom in binimetinibom ter pri 3,4 % (7/204) bolnikov v skupini z enkorafenibom kot samostojnim zdravilom (glejte poglavje 5.1 v Povzetku glavnih značilnosti enkorafeniba).
English: Most events were mild, with Grade 3 or 4 events reported in 0.7 % (2/274) of patients.
Slovenian: V večini primerov je šlo za blag dogodek, o dogodkih 3. ali 4. stopnje pa so poročali pri 0,7 % (2/274) bolnikov.
English: The confirmed ORR per BIRC was 65.9 % (95 % CI: 59.8, 71.7) for Combo 300, and 50.4 % (95 % CI 44.3, 56.4) for Enco 300 (Parts 1 and 2).
Slovenian: Potrjene vrednosti ORR na posamezni pregled BIRC so znašale 65,9 % (95-odstotni IZ: 59,8, 71,7) za kombinacijo 300 in 50,4 % (95-odstotni IZ: 44,3, 56,4) za Enko 300 (1. in 2. del).
English: Each film-coated tablet contains 15 mg binimetinib.
Slovenian: Ena filmsko obložena tableta vsebuje 15 mg binimetiniba.
English: A similar proportion of patients in each treatment arm received subsequent treatment with checkpoint inhibitors, mainly pembrolizumab, nivolumab and ipilimumab (34.4 % Combo 450 arm, 36.1 % encorafenib arm, 39.8 % vemurafenib arm).
Slovenian: Podobno razmerje bolnikov pri posamezni veji zdravljenja je prejelo nadaljnjo imunoterapijo, v glavnem pembrolizumab, nivolumab in ipilimumab (34,4 % pri kombinaciji 450, 36,1 % pri zdravljenju z enkorafenibom in 39,8 % pri zdravljenju z vemurafenibom).
English: Effect of UGT1A1 inducers or inhibitors on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Slovenian: Učinek induktorjev ali zaviralcev UGT1A1 na binimetinib Binimetinib se primarno presnavlja z glukuronidacijo preko UGT1A1.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, the apparent volume of distribution (Vz/F) of binimetinib is 374 L.
Slovenian: Po enkratnem peroralnem odmerku 45 mg [14C] binimetiniba pri zdravih udeležencih je navidezni volumen porazdelitve (Vz/F) binimetiniba 374 l.
English: The recommended dose of binimetinib is 45 mg (three 15 mg tablets) twice daily, corresponding to a total daily dose of 90 mg approximately 12 hours apart.
Slovenian: Priporočeni odmerek binimetiniba je 45 mg (tri 15 mg tablete) dvakrat dnevno, kar ustreza skupnemu dnevnemu odmerku 90 mg, v razmiku približno 12 ur.
English: A definitive 10% deterioration in FACT-M and in EORTC QLQ-C30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Slovenian: Dokončno 10-odstotno poslabšanje po oceni FACT-M in vprašalniku EORTC QLQ-C30 je bilo glede na druga zdravljenja bistveno zakasnjeno pri bolnikih,
English: Basal cell carcinoma*
Slovenian: Bazalnocelični karcinom*
English: Serious side effects Mektovi may cause serious side effects.
Slovenian: Zdravilo Mektovi lahko povzroči resne neželene učinke.
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Slovenian: Ledvična okvara Za bolnike z ledvično okvaro prilagoditev odmerka ni priporočena (glejte poglavje 5.2).
English: Other side effects when Mektovi and encorafenib are taken together:
Slovenian: Drugi neželeni učinki, ko se zdravilo Mektovi in enkorafenib jemljeta skupaj:
English: • blurred vision, loss of vision, or other vision changes (such as coloured dots in your vision)
Slovenian: • zamegljenega vida, izgube vida ali drugih sprememb vida (vidite na primer barvaste pikice), • kolobarja (vidite zamegljen obris okrog predmetov),
English: In rats, lower gestational body weight gain and fetal body weights and a decreased number of ossified fetal sternebrae were noted.
Slovenian: Pri podganah so bili zabeleženi nižje pridobivanje telesne teže med nosečnostjo in nižja telesna teža ploda ter zmanjšano število okostenelih prsnih kosti fetusa.
English: There are limited efficacy data with the combination of binimetinib and encorafenib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Slovenian: Na voljo so omejeni podatki o učinkovitosti kombinacije binimetiniba in enkorafeniba pri bolnikih z melanomom z mutacijo V600 gena BRAF, ki imajo metastaze v možganih (glejte poglavje 5.1).
English: Binimetinib is a weak inhibitor of OAT3, and caution should be taken when it is used with sensitive substrates (such as pravastatin or ciprofloxacin).
Slovenian: Binimetinib je šibek zaviralec prenašalca OAT3, zato je pri sočasni uporabi z občutljivimi substrati (npr. pravastatinom in ciprofloksacinom) potrebna previdnost.
English: As binimetinib is primarily metabolised and eliminated via the liver, patients with moderate to severe hepatic impairment may have increased exposure.
Slovenian: Jetrna okvara Ker se binimetinib primarno presnavlja in izloča preko jeter, lahko pri bolnikih z zmerno do hudo okvaro jeter pride do povečane izpostavljenosti.
English: Lactose monohydrate Cellulose microcrystalline (E460i) Silica colloidal anhydrous (E551) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460i) brezvodni koloidni silicijev dioksid (E551) premrežen natrijev karmelozat (E468) magnezijev stearat (E470b)
English: Binimetinib is a weak inhibitor of OAT3.
Slovenian: Učinek binimetiniba na prenašalce Binimetinib je šibek zaviralec prenašalca OAT3.
English: • First occurrence of Grade 4 (AST or ALT > 20 ULN)
Slovenian: • Prvi pojav 4. stopnje (AST ali ALT > 20-kratnika ULN)
English: Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so spodaj navedeni po razvrstitvi organov po sistemu MedDRA in so razvrščeni po pogostnosti po naslednjem ključu: zelo pogosti (≥ 1/10), pogosti ( ≥ 1/100 do < 1/10), občasni
English: • Tablet core: lactose monohydrate, cellulose microcrystalline (E460i), silica colloidal anhydrous (E551), croscarmellose sodium (E468) and magnesium stearate (E470b).
Slovenian: • Jedro tablete: laktoza monohidrat, mikrokristalna celuloza (E460i), brezvodni koloidni silicijev dioksid (E551), premrežen natrijev karmelozat (E468) in magnezijev stearat (E470b).
English: Avoid driving or using machines if you have any problems with your vision or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Mektovi.
Slovenian: Če imate med jemanjem zdravila Mektovi težave z vidom ali kakšne koli druge neželene učinke, ki lahko vplivajo na vaše sposobnosti upravljanja vozil in strojev (glejte poglavje 4), ne upravljajte vozil in strojev.
English: Mektovi 15 mg tablets binimetinib
Slovenian: Mektovi 15 mg tablete binimetinib
English: As encorafenib is not recommended in patients with moderate (Child Pugh B) and severe hepatic impairment (Child Pugh C), administration of binimetinib is not recommended in these patients (see sections 4.2 and 5.2).
Slovenian: Ker uporaba enkorafeniba ni priporočljiva pri bolnikih z zmerno (Child-Pugh B) in hudo jetrno okvaro (Child-Pugh C), dajanje binimetiniba tem bolnikom ni priporočljivo (glejte poglavji 4.2. in 5.2).
English: Binimetinib should be resumed at a reduced dose if all of the following are present within 4 weeks: o LVEF is at or above the LLN o Absolute decrease from baseline is 10 % or less.
Slovenian: Treba je nadaljevati z zmanjšanim odmerkom binimetiniba, če v obdobju 4 tednov velja vse od spodaj naštetega: o vrednost LVEF je enaka ali nad LLN;
English: There are limited data for use of the combination of binimetinib with encorafenib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Slovenian: Na voljo so omejeni podatki o uporabi kombinacije binimetiniba z enkorafenibom pri bolnikih, pri katerih je, ob predhodnem jemanju zaviralca BRAF za zdravljenje neresektabilnega ali metastatskega melanoma z mutacijo BRAF V600, bolezen napredovala.
English: • Retinal vein occlusion (RVO) Binimetinib should be permanently discontinued.
Slovenian: • Zapora mrežnične vene (RVO) Vnašanje binimetiniba je treba trajno prekiniti.
English: Most events were Grade 1-2, with Grade 3 reported in 0.4 % (1/274) of patients and no event led to discontinuation.
Slovenian: V večini primerov je šlo za 1.-2. stopnjo, o 3. stopnji so poročali pri 0,4 % (1/274) bolnikov, v nobenem primeru pa ni prišlo do prenehanja zdravljenja.
English: • Grade 3 or Grade 4
Slovenian: • 3. ali 4. stopnja
English: Your doctor will examine your eyes for any problems with your sight while you are taking Mektovi.
Slovenian: Zdravnik vam bo med jemanjem zdravila Mektovi pregledal oči za kakšne koli težave z vidom.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, a mean of 62.3 % of the radioactivity was eliminated in the feces while 31.4 % was eliminated in the urine.
Slovenian: Po enkratnem peroralnem odmerku 45 mg [14C] binimetiniba se je pri zdravih udeležencih v povprečju 62,3 % radioaktivnosti izločilo v blatu, 31,4 % pa v urinu.
English: Grade 3 events occurred in 1.1 % (3/274) of patients.
Slovenian: Dogodek 3. stopnje je bil poročan pri 1,1 % (3/274) bolnikov.
English: Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:
Slovenian: Krvni strdki: Zdravilo Mektovi lahko povzroči nastanek krvnih strdkov (venski tromboembolizem, vključno s pljučno embolijo); znaki in simptomi lahko vključujejo:
English: In case of vomiting after administration of binimetinib, the patient should not re-take the dose and should take the next scheduled dose.
Slovenian: Če bolnik po vnosu binimetiniba bruha, bolnik ne sme vzeti novega odmerka, ampak mora naslednji odmerek vzeti po običajnem urniku.
English: The median age of patients was 56 years (range 20-89), 58 % were male, 90 % were Caucasian, and 72 % of patients had baseline ECOG performance status of 0.
Slovenian: Mediana starosti bolnikov je bila 56 let (od 20 do 89), 58 % bolnikov je bilo moških, 90 % belcev in
English: If encorafenib is temporarily interrupted (see section 4.2 of encorafenib SmPC), binimetinib should be interrupted.
Slovenian: Če je vnos enkorafeniba začasno prekinjen (glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila enkorafenib), je treba prekiniti vnos binimetiniba.
English: Talk to your doctor immediately if you get chest pain, sudden shortness of breath, trouble breathing, pain in your legs with or without swelling, swelling in your arms and legs, or a cool, pale arm or leg.
Slovenian: V primeru bolečin v prsih, nenadne kratke sape, težav z dihanjem, bolečin v nogah z otekanjem ali brez, otekanja rok in nog oz. hladne,
English: DCR, n (%) (95 % CI)
Slovenian: DCR, n (%) (95 % IZ)
English: Hypertension*
Slovenian: Hipertenzija*
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E533b) Iron oxide yellow (E172) Iron oxide black (E172)
Slovenian: Filmska obloga polivinil alkohol (E1203) makrogol 3350 (E1521) titanov dioksid (E171) smukec (E533b)
English: The PFS for encorafenib 300 mg orally daily used in combination with binimetinib 45 mg orally twice daily (Combo 300, n = 258) was compared to the PFS for Enco 300 (n = 280, including 194 patients from Part 1 and 86 patients from Part 2).
Slovenian: Vrednost PFS pri dnevnem peroralnem vnosu 300 mg enkorafeniba v kombinaciji z vnosom 45 mg binimetiniba peroralno dvakrat dnevno (kombinacija 300, n = 258) se je primerjala z vrednostjo PFS pri Enko 300 (n = 280, vključno s 194 bolniki iz 1. dela in 86 bolniki iz 2. dela).
English: No patients discontinued treatment due to anaemia, 1.5 % (4/274) required dose interruption or dose modification.
Slovenian: Zaradi anemije noben bolnik ni prenehal z zdravljenjem, pri 1,5 % (4/274) bolnikov se je dajanje odmerkov moralo prekiniti ali se je odmerek moral spremenil.
English: Venous thromboembolism
Slovenian: Venski tromboembolizemf
English: Blood creatinine increased*
Slovenian: Zvišana vrednost kreatinina v krvi*
English: Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up of blood, blood clots, vomit containing blood or that looks like “coffee grounds”, red or black stools that look like tar, passing blood in the urine, stomach (abdominal) pain, unusual vaginal bleeding.
Slovenian: Če imate kakršne koli simptome krvavitev, kot so kašljanje krvi ali krvnih strdkov, kri v bruhanju ali bruhanje, ki je videti kot »kavna usedlina«, rdeče ali črno blato, ki je videti kot katran, kri v urinu,
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, at least 50 % of the binimetinib dose was absorbed.
Slovenian: Po enkratnem peroralnem odmerku 45 mg [14C] binimetiniba pri zdravih udeležencih se je absorbiralo vsaj 50 % odmerka binimetiniba.
English: Liver laboratory values should be monitored before initiation of binimetinib and encorafenib and at least monthly during the 6 first months of treatment, and then as clinically indicated.
Slovenian: Pred uvedbo zdravljenja z binimetinibom in enkorafenibom je treba spremljati laboratorijske vrednosti delovanja jeter in jih v prvih 6 mesecih zdravljenja preveriti najmanj enkrat na mesec, nato pa kot je klinično indicirano.