FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving binimetinib in combination with encorafenib should undergo a head and neck examination, chest/abdomen computerised tomography (CT) scan, anal and pelvic examinations (for women) and complete blood cell counts prior to initiation, during and at the end of treatment as clinically appropriate.
Croatian: Bolesnici koji se liječe binimetinibom u kombinaciji s enkorafenibom moraju se podvrgnuti pregledu glave i vrata, kompjuteriziranoj tomografiji (CT) prsnog koša/abdomena, pregledu anusa i zdjelice (u žena) te kompletne krvne slike prije, tijekom i po završetku liječenja ili kada se smatra da je klinički indicirano.
English: Cut-off date: 19 May 2016
Croatian: Datum prestanka prikupljanja podataka: 19. svibnja 2016.
English: Binimetinib is metabolised by UGTs and CYP1A2 and is a substrate for Pgp.
Croatian: Binimetinib se metabolizira preko UGT-a i CYP1A2 i predstavlja supstrat za P-gp.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Mektovi Lijek čuvajte izvan pogleda i dohvata djece.
English: No patients discontinued treatment due to anaemia, 1.5 % (4/274) required dose interruption or dose modification.
Croatian: Nijednom bolesniku nije zbog anemije trajno obustavljeno liječenje; 1,5% (4/274) je zahtijevalo privremeni prekid liječenja ili prilagodbu doze.
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.
Croatian: Nakon jednokratne doze od 45 mg [14C] binimetiniba u zdravih ispitanika, primarni putovi biotransformacije binimetiniba primijećeni u ljudi uključuju glukuronidaciju, N-dealkilaciju, hidrolizu amida, i gubitak etan-diola s bočnog lanca.
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8 %) were < 65 years old, 65 patients (23.7 %) were 65 -74 years old and 15 patients (5.5 %) were aged > 75.
Croatian: U bolesnika liječenih kombiniranom terapijom 450 (n=274), 194 bolesnika (70,8%) bili su dobi < 65 godina, 65 bolesnika (23,7%) bilo je dobi 65-74 godina i 15 bolesnika (5,5%) bilo je dobi
English: Overall response rate, n (%) (95 % CI)
Croatian: Stopa ukupnog odgovora, n (%) (95% CI)
English: An increased litter incidence of foetal ventricular septal defects and pulmonary trunk alterations was noted at the highest doses.
Croatian: Primijećena je povećana pojava ventrikularnih septalnih defekata kod fetusa te promjene plućnog aterijskog stabla u slučaju primjene najvećih doza.
English: Encorafenib n = 194 (Enco 300)
Croatian: Encorafenib n = 194 (enkorafenib 300)
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: Sindrom palmarno-plantarne eritrodizestezije
English: Mektovi can affect your ability to drive or use machines.
Croatian: Lijek Mektovi može utjecati na vašu sposobnost upravljanja vozilima ili strojevima.
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 %.
Croatian: Srednja vrijednost LVEF pala je za 5,9 u ukupnoj populaciji kombinirane terapije 450 sa srednje vrijednosti od 63,9% na početku do 58,1%.
English: Tell your doctor immediately if you detect any skin changes during and after the treatment including: new wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakve promjene na koži tijekom i nakon liječenja, uključujući i sljedeće: nova bradavica, rana na koži ili crvenkasta kvržica koja krvari ili ne prolazi ili promjena veličine ili boje madeža.
English: In patients treated with Combo 450, dermatitis acneiform occurred in 4.4 % (12/274) of patients, was Grade 1 and 2 and no event led to treatment discontinuation.
Croatian: U bolesnika liječenih kombiniranom terapijom 450, akneiformni dermatitis pojavio se u 4,4% (12/274) bolesnika, bio je stupnja 1 i 2 i nijedan slučaj nije doveo do trajne obustave liječenja.
English: Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2.
Croatian: Binimetinib je ATP-nekompetitivni, reverzibilni inhibitor kinazne aktivnosti MEK1 i MEK2 (mitogen-activated extracellular signal regulated kinase).
English: If necessary, your doctor may interrupt your treatment or stop it altogether.
Croatian: Ako je potrebno, liječnik može prekinuti liječenje privremeno ili trajno.
English: In rabbits, mortality, maternal physical signs of toxicity, lower gestational body weight and abortion were noted.
Croatian: Kod kunića su primijećeni mortalitet, fizički znakovi toksičnosti kod majki, manja gestacijska težina i pobačaji.
English: In cynomolgus monkeys, oral administration of binimetinib was associated with gastro-intestinal intolerance, moderate clinical pathology changes, bone marrow hypercellularity and microscopic findings of gastrointestinal inflammation, reversible at the lowest doses which were below human therapeutic exposures.
Croatian: Kod makaki majmuna, peroralna primjena binimetiniba povezuje se sa želučano-crijevnom netolerancijom, umjerenim kliničkim patološkim promjenama, hipercelularnosti koštane srži i mikroskopskim nalazima želučano-crijevne upale, reverzibilne pri najmanjim dozama koje su ispod razina izloženosti pri terapijskim dozama u ljudi.
English: Few patients requiring dose interruptions or dose reductions (0.7 % or 2/274).
Croatian: U malog broja bolesnika bilo je neophodno privremeno prekinuti ili smanjiti dozu (0,7% ili 2/274).
English: Neuropathy peripheral*
Croatian: Poremećaji živčanog sustava periferna neuropatija*
English: Your doctor will run blood tests to check for muscle problems before and during treatment.
Croatian: Vaš će liječnik provesti krvne pretrage kako bi provjerio pojavu problema s mišićima prije i tijekom liječenja.
English: Permanent discontinuation of binimetinib and encorafenib should be considered in patients who develops RAS mutation-positive non-cutaneous malignancies.
Croatian: Mora se razmotriti trajno obustavljanje binimetiniba i enkorafeniba u bolesnika koji razviju zloćudne promjene koje nisu na koži s pozitivnom RAS mutacijom.
English: • Liver problems: Mektovi can cause abnormal blood tests related to your liver (raised levels of liver enzymes).
Croatian: • Problemi s jetrom: lijek Mektovi može prouzročiti abnormalne krvne pretrage u svezi s funkcijom jetre (povećane razine jetrenih enzima).
English: Talk to your doctor, pharmacist or nurse before taking Mektovi about all of your medical conditions, particularly if you have any of the following:
Croatian: Prije nego uzmete lijek Mektovi obratite se svom liječniku, ljekarniku ili medicinskoj sestri vezano uz sva Vaša medicinska stanja, pogotovo ako imate bilo što od sljedećeg:
English: As encorafenib is not recommended in patients with moderate (Child Pugh B) or severe hepatic impairment (Child-Pugh C), administration of binimetinib is not recommended in these patients.
Croatian: Kako se ne preporučuje davanje enkorafeniba bolesnicima s umjerenim (Child-Pugh B) i teškim oštećenjem jetre (Child- Pugh C), ne preporučuje se ni davanje binimetiniba u ovih bolesnika
English: Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Croatian: Binimetinib u kombinaciji s enkorafenibom indiciran je za liječenje odraslih bolesnika s neresektabilnim ili metastatskim melanomom s BRAF V600 mutacijom (vidjeti dijelove 4.4 i 5.1).
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.
Croatian: Potrebno je provjeriti vrijednosti laboratorijskih pretraga jetrene funkcije prije započinjanja liječenja binimetinibom i enkorafenibom i pratiti ih najmanje jedanput mjesečno tijekom prvih 6 mjeseci liječenja, potom kako je klinički indicirano.
English: Other skin cancers: When Mektovi is taken with encorafenib, the patient may develop different types of skin cancer such as cutaneous squamous cell carcinoma.
Croatian: Druge vrste raka kože: Ako se lijek Mektovi uzima s enkorafenibom, bolesnik može razviti druge vrste raka kože, kao što je planocelularni karcinom.
English: In case of vomiting after administration of binimetinib, the patient should not re-take the dose and should take the next scheduled dose.
Croatian: U slučaju povraćanja nakon primjene binimetiniba, bolesnik ne smije uzeti još jednu dozu nego treba uzeti sljedeću dozu prema uobičajenom rasporedu.
English: Uveitis including iridocyclitis and iritis have been reported in patients treated with binimetinib in combination with encorafenib (see section 4.8).
Croatian: Uveitis, uključujući iridociklitis i iritis, prijavljeni su u bolesnika liječenih binimetinibom u kombinaciji s enkorafenibom (vidjeti dio 4.8).
English: At the recommended dose (n = 274) in patients with unresectable or metastatic melanoma, the most common adverse reactions (> 25 %) occurring in patients treated with binimetinib administered with encorafenib were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia.
Croatian: Pri preporučenoj dozi (n = 274) u bolesnika s neoperabilnim ili metastatskim melanomom, najčešće nuspojave (> 25%) koje su se javljale tijekom liječenja binimetinibom primijenjenim s enkorafenibom bile su umor, mučnina, proljev, povraćanje, odvajanje mrežnice, bol u trbuhu, artralgija, povećanje kreatin kinaze u krvi i mijalgija.
English: Results from a dedicated clinical study showed that patients with severe renal impairment (eGFR ≤ 29 mL/min/1.73 m2), had a 29 % increase in exposure (AUCinf), a 21 % increase in Cmax, and a 22 % decrease in CL/F compared to matching healthy subjects.
Croatian: Rezultati iz posebnog kliničkog ispitivanja pokazali su da je kod bolesnika s teškim oštećenjem bubrežne funkcije (eGFR ≤ 29 mL/min/1,73 m2) došlo do 29% povećanja u izloženosti (AUCinf), povećanja od 21% za
English: High blood pressure: Mektovi can increase blood pressure.
Croatian: Visok krvni tlak: lijek Mektovi može povećati krvni tlak.
English: If encorafenib is temporarily interrupted (see section 4.2 of encorafenib SmPC), binimetinib should be interrupted.
Croatian: Ako je enkorafenib privremeno prekinut (vidjeti dio 4.2 sažetka opisa svojstava lijeka za enkorafenib), mora se privremeno prekinuti i binimetinib.
English: The median relative dose intensity (RDI) for Combo 450 was 99.6 % for binimetinib and 100 % for encorafenib the median RDI was 86.2 % for Enco 300 and 94.5 % for vemurafenib.
Croatian: Medijan relativnog intenziteta doze (engl. relative dose intensity, RDI) u skupine liječene kombiniranom terapijom 450 bio je 99,6% za binimetinib i 100% za enkorafenib; medijan RDI-ja je bio 86,2% za skupinu liječenih enkorafenibom 300 i 94,5% za skupinu liječenu vemurafenibom.
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).
Croatian: Potvrđeni ORR prema BIRC-u iznosio je 65,9% (95% CI: 59,8; 71,7) za kombiniranu terapiju 300 i 50,4% (95% CI: 44,3; 56,4) za enkorafenib 300 (dijelovi 1 i 2).
English: Talk to your doctor immediately if you get blurred vision, loss of vision or other vision changes (such as coloured dots in your vision), halo (seeing blurred outline around objects).
Croatian: Odmah obavijestite svog liječnika ako primijetite zamućenje vida, sljepilo ili druge poremećaje vida (npr. obojene točkice u vidnom polju) ili halo (viđenje nejasnih aureola oko objekata).
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.
Croatian: Odmah obavijestite liječnika budete li imali bol u prsnom košu, iznenadni nedostatak zraka, poteškoće pri disanju, bol u nogama s ili bez oticanja, oticanje ruku i nogu ili hladne, blijede ruke ili noge.
English: Talk to your doctor immediately if you get muscle pain, cramps, stiffness, spasm, dark urine.
Croatian: Odmah obavijestite svog liječnika budete li imali bolove u mišićima, grčeve, ukočenost, spazam, tamnu mokraću.
English: Table 3: Adverse reactions occurring in patients receiving binimetinib in combination with encorafenib at the recommended dose (n = 274) System Organ Class
Croatian: Tablica 3: Nuspojave koje se pojavljuju u bolesnika koji primjenjuju binimetinib u kombinaciji s enkorafenibom u preporučenoj dozi (n = 274)
English: Most events were mild, with Grade 3 or 4 events reported in 0.7 % (2/274) of patients.
Croatian: Većina događaja bila je blaga, sa stupnjem 3 ili 4 prijavljenim u 0,7% (2/274) bolesnika.
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib is co-administered with encorafenib (see section 5.2).
Croatian: Iako je enkorafenib relativno potentan reverzibilni inhibitor UGT1A1, nisu klinički zapažene nikakve promjene u izloženosti lijeku binimetinibu pri istodobnoj primjeni s enkorafenibom (vidjeti dio 5.2).
English: Binimetinib undergoes minimal renal elimination.
Croatian: Binimetinib podliježe minimalnoj eliminaciji putem bubrega.
English: • passing blood in the urine
Croatian: • pojava krvi u mokraći
English: Binimetinib should be withheld for up to 4 weeks.
Croatian: Treba prekinuti binimetinib u razdoblju do 4 tjedna.
English: • Eye problems: Mektovi can cause serious eye problems.
Croatian: • Problemi s očima: lijek Mektovi može prouzročiti ozbiljne očne probleme.
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with binimetinib when used in combination with encorafenib.
Croatian: Zloćudne bolesti na koži poput planocelularnog karcinoma, uključujući i keratoakantom, primijećene su u bolesnika liječenih binimetinibom u kombinaciji s enkorafenibom.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES)
Croatian: često palmarno-plantarna eritrodizestezija (PPES)
English: • Grade 4 (CK > 10x ULN) asymptomatic
Croatian: • Stupanj 4 (CPK > 10x GGN) asimptomatsko
English: Part 1 of study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Croatian: Dio 1 ispitivanja CMEK162B2301 dokazuje statistički značajno poboljšanje u PFS-u skupine liječene kombiniranom terapijom 450 u usporedbi sa skupinom liječenom vemurafenibom.
English: • an herbal treatment for depression: St. John's wort
Croatian: • biljni lijekovi protiv depresije: gospina trava
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).
Croatian: Preporučena doza lijeka Mektovi je 45 mg (3 tablete od 15 mg) dvaput na dan približno svakih 12 sati (što odgovara ukupnoj dnevnoj dozi od 90 mg).
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).
Croatian: Preliminarno, dio 2 na datum prestanka prikupljanja podataka, 9. studenoga 2016., pokazao je doprinos lijeka binimetiniba, s poboljšanjem medijana PFS-a procijenjenim na 12,9 mjeseci (95% CI: 10,1; 14,0) za kombiniranu terapiju 300 u usporedbi s 9,2 mjeseca (95% CI: 7,4; 11,0) za enkorafenib 300 (dijelovi 1 i 2) prema neovisnoj središnjoj procjeni (BIRC).
English: • Skin changes: Mektovi, when taken with encorafenib, may cause other types of skin cancer such as cutaneous squamous cell carcinoma.
Croatian: • Promjene na koži: lijek Mektovi može, ako se uzima zajedno s enkorafenibom, prouzročiti druge vrste raka kože, kao što je planocelularni karcinom.
English: Ocular toxicities including RPED and RVO can occur when binimetinib is administered.
Croatian: Do okularne toksičnosti, uključujući RPED i RVO, može doći kod primjene binimetiniba.
English: See the end of section 4 for how to report side effects.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte kraj dijela 4.
English: Dermatitis acneiform*
Croatian: često akneiformni dermatitis*
English: Cerebral haemorrhage occurred in 1.5 % (4/274) of patients with fatal outcome in 3 patients.
Croatian: Krvarenje u mozgu pojavilo se u 1,5% (4/274) bolesnika, sa smrtnim ishodom u 3 bolesnika.
English: Therefore, binimetinib should be used with caution in these patients.
Croatian: Stoga se u ovih bolesnika binimetinib mora primjenjivati s oprezom.
English: Mektovi 15 mg tablets binimetinib
Croatian: Mektovi 15 mg tablete binimetinib
English: The median time to definitive 10 % deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95 % CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95 % CI: 0.29, 0.72).
Croatian: Medijan vremena do jasnog 10% pogoršanja vrijednosti prema FACT-M rezultatu nije dostignuto u skupini kombinirane terapije 450, a bio je 22,1 mjeseca (95% CI: 15,2; NP) u skupini liječenih vemurafenibom s HR za razliku od 0,46 (95% CI: 0,29; 0,72).
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.
Croatian: RPED je bio stupnja 1 (asimptomatski) u 21,2% (58/274) bolesnika; stupnja 2 u 6,6% (18/274) bolesnika i stupnja 3 u 1,8% (5/274) bolesnika.
English: Very common (may affect more than 1 in 10 people) - reduced red blood cell count (anaemia) - problem with the nerves resulting in pain, loss of sensation or tingling in hands and feet - headache - dizziness - bleeding at various sites in the body - problems with your vision (visual impairment) - stomach pain - diarrhoea - being sick (vomiting) - feeling sick (nausea) - constipation
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - smanjen broj crvenih krvnih stanica (anemija) - problem sa živcima koji može uzrokovati bol, gubitak osjeta ili trnce u šakama i stopalima - glavobolja - omaglica - krvarenja s raznih mjesta u tijelu
English: • Grade 3 (CK > 5 - 10x upper limit of normal (ULN)) asymptomatic
Croatian: • Stupanj 3 (CPK > 5 - 10x gornje granica normale (GGN)) asimptomatsko
English: Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:
Croatian: Krvni ugrušci: lijek Mektovi može prouzročiti krvne ugruške (vensku tromboemboliju uključujući i plućnu emboliju); znakovi i simptomi mogu uključivati sljedeće:
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.
Croatian: Preporučena doza binimetiniba je 45 mg (tri tablete od 15 mg) dvaput na dan (što odgovara ukupnoj dnevnoj dozi od 90 mg) približno svakih 12 sati.
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.
Croatian: I binimetinib i enkorafenib (BRAF inhibitor, vidjeti dio 5.1 sažetka opisa svojstava lijeka za enkorafenib) inhibiraju MAPK signalni put, što rezultira većom antitumorskom aktivnošću.
English: No effects were noted at 14-times the human therapeutic exposure .
Croatian: Nisu primijećeni nikakvi učinci kod izloženosti 14 puta veće od one u ljudi pri terapijskim dozama.
English: This increase expends to three fold in both moderate and severe hepatic impairment when considering unbound binimetinib exposure (see section 4.2).
Croatian: Povećanje postaje trostruko u bolesnika s umjerenim i teškim oštećenjem jetrene funkcije ako se uzme u obzir izloženost nevezanom binimetinibu (vidjeti dio 4.2).
English: LVD led to treatment discontinuation in 0.4% (1/274) of patients and led to dose interruptions or dose reductions in 6.6 % (18/274) of patients.
Croatian: LVD je doveo do trajnog prekida liječenja u 0,4% (1/274) bolesnika i doveo do privremenog obustavljanja ili smanjenja doze u 6,6% (18/274) bolesnika.
English: • muscle pain, cramps, stiffness or spasm
Croatian: • bol u mišićima, grčeve, ukočenost ili spazam
English: Binimetinib is not recommended in patients with a history of RVO.
Croatian: Binimetinib se ne preporučuje u bolesnika s anamnezom RVO-a.
English: Depending on the severity of symptoms, degree of CK elevation or creatinine elevation, dose reduction, dose interruption or permanent discontinuation of binimetinib may be required (see Table 1 in section 4.2).
Croatian: Ovisno o težini simptoma, stupnju povišenja kreatin kinaze ili povišenja kreatinina, može biti potrebno smanjiti dozu, prekinuti dozu ili trajno obustaviti binimetinib (vidjeti Tablicu 1 u dijelu 4.2).
English: If one of these toxicities occurs, see section 4.2. of encorafenib Summary of Product Characteristics (SmPC) for dose modification instructions for encorafenib.
Croatian: Ako dođe do jedne od ovih toksičnosti, vidjeti dio 4.2 sažetka opisa svojstava lijeka za enkorafenib za upute o prilagodbi doze enkorafeniba.
English: Most events were Grade 1-2, with Grade 3 reported in 0.4 % (1/274) of patients and no event led to discontinuation.
Croatian: Većina je nuspojava bila stupnja 1-2, dok je stupanj 3 zabilježen u 0,4% (1/274) bolesnika i nijedan slučaj nije doveo do trajne obustave liječenja.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of treatment resistance in BRAF V600E mutant human melanoma xenografts in vivo.
Croatian: Također, kombinacija enkorafeniba i binimetiniba sprečava pojavu rezistencije na liječenje u ljudskih ksenografta melanoma s BRAF V600E mutacijom in vivo.
English: Constipation occurred in 24.1 % (66/274) of patients and was Grade 1 or 2.
Croatian: Konstipacija se javila u 24,1% (66/274) bolesnika i bila je stupnja 1 ili 2.
English: Muscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:
Croatian: Problemi s mišićima: Lijek Mektovi može uzrokovati razgradnju mišića (rabdomioliza) koja može prouzročiti oštećenje bubrega koje može uzrokovati smrt ; znakovi i simptomi mogu uključivati:
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E533b) Iron oxide yellow (E172) Iron oxide black (E172)
Croatian: Film-ovojnica poli(vinilni alkohol) (E1203) makrogol 3350 (E1521) titanijev dioksid (E171) talk (E533b) željezov oksid, žuti (E172) željezov oksid, crni (E172)
English: • some medicines typically used to treat epilepsy such as phenobarbital, phenytoin,
Croatian: • lijekovi koji se koriste za liječenje epilepsije kao što su fenobarbital, fenitoin, karbamazepin
English: Gamma-glutamyl transferase increased*
Croatian: Povišenje gama-glutamil transferaze* vrlo često povišenje kreatinina u krvi*
English: Grade 3 events occurred in 1.1 % (3/274) of patients.
Croatian: Događaji stupnja 3 javili su se u 1,1% (3/274) bolesnika.
English: Dry skin*
Croatian: vrlo često suha koža*
English: Binimetinib in combination with encorafenib in patients with brain metastases
Croatian: Binimetinib u kombinaciji s enkorafenibom u bolesnika s metastazama u mozgu
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).
Croatian: Ograničeni su podaci o djelotvornosti kombinacije binimetiniba i enkorafeniba u bolesnika s melanomom s BRAF V600 mutacijom koji je metastazirao u mozak (vidjeti dio 5.1).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva hiperkeratoza*
English: Effects of binimetinib on other medicinal products
Croatian: Učinak binimetiniba na druge lijekove