FrancophonIA/ELRC3.0 huggingface dataset:
English: The occurrence of LVEF decrease can be managed with treatment interruption, dose reduction or with treatment discontinuation (see section 4.2).
Croatian: Pojava smanjenja LVEF-a može se zbrinuti privremenim prekidom liječenja, smanjenjem doze ili trajnom obustavom liječenja (vidjeti dio 4.2).
English: In the pooled Combo 450 population, VTE was reported as Grade 1 or 2 in 3.6 % (10/274) of patients and Grade 3 or 4 in 1.1 % (3/274) of patients.
Croatian: ukupnoj populaciji kombinirane terapije 450, VTE je prijavljen kao stupanj 1 ili 2 u 3,6% (10/274) bolesnika i kao stupanj 3 ili 4 u 1,1% (3/274) bolesnika.
English: • Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Croatian: • Ponovna pojava stupnja 3 (AST ili ALT > 5x GGN i bilirubin u krvi > 2x GGN)
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date 19 May 2016)
Croatian: Slika 1: Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje preživljenja bez progresije prema neovisnoj središnjoj procjeni (datum prestanka prikupljanja podataka: 19. svibnja 2016.)
English: Your doctor will check that your heart is working properly before and during your treatment with this medicine.
Croatian: Vaš će liječnik prije i tijekom liječenja ovim lijekom provjeriti radi li vaše srce ispravno.
English: Talk to your doctor immediately if you have any symptoms of heart problems such as feeling dizzy, tired, lightheaded, if you have shortness of breath, if you feel like your heart is pounding, racing, beating irregularly or if you have swelling in the legs.
Croatian: Odmah obavijestite svog liječnika ako imate bilo kakve simptome srčanih tegoba, kao što su osjećaj omaglice, umora, ošamućenosti, nedostatak zraka, osjećaj lupanja srca, ubrzan puls, preskakanje srca ili ako su vam noge otečene.
English: If during treatment patient develops VTE or pulmonary embolism, it should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Croatian: Ako se tijekom liječenja u bolesnika pojavi VTE ili plućna embolija, potrebno ju je zbrinuti prekidom doze, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
English: Table 2: Recommended dose modifications for binimetinib (used in combination with encorafenib) for other adverse reactions
Croatian: Tablica 2: Preporučeno prilagođavanje doze za binimetinib (kada se primjenjuje u kombinaciji s enkorafenibom) za druge nuspojave Težina nuspojava
English: Alopecia*
Croatian: vrlo često alopecija*
English: Asymptomatic CK elevations are seen in patients treated with binimetinib (see section 4.8), and, rhabdomyolysis was uncommonly reported.
Croatian: Asimptomatsko povišenje kreatin kinaze primijećeno je u bolesnika liječenih binimetinibom (vidjeti dio 4.8), a rjeđe je primijećena rabdomioliza.
English: Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Croatian: Proljev je zapažen u 28,4% (73/257) bolesnika, a stupanj 3 prijavljen je kod 1,6% (4/257) bolesnika.
English: Haemorrhagic events were observed in 17.9 % (49/274) of patients in the pooled Combo 450 population.
Croatian: Krvarenje je zapaženo u 17,9% (49/274) bolesnika iz ukupne populacije kombinirane terapije 450.
English: • If not resolved within 4 weeks, binimetinib should be permanently discontinued.
Croatian: • Ako se ne riješi unutar 4 tjedna, treba trajno obustaviti binimetinib.
English: Blood alkaline phosphatase increased Common Amylase increased
Croatian: često povišenje alkalne fosfataze u krvi često povišenje amilaze često povišenje lipaze često
English: • If not improved to Grade 2, binimetinib should be permanently discontinued.
Croatian: • Ako nije došlo do poboljšanja na stupanj 2, treba trajno obustaviti binimetinib.
English: Immune system disorders Hypersensitivityb
Croatian: Poremećaji imunološkog sustava preosjetljivostb često
English: Mektovi 15 mg film-coated tablets
Croatian: Mektovi 15 mg filmom obložene tablete
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Croatian: • Ponovna pojava stupnja 4 (AST ili ALT > 20x GGN )
English: Survival at 12 months (95% CI)
Croatian: Preživljenje nakon 12 mjeseci (95% CI)
English: In the pooled Combo 450 population, rash occurred in 19.7 % (54/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450, osip se pojavio u 19,7% (54/274) bolesnika.
English: Nausea occurred in 41.6 % (114/274) with Grade 3 or 4 observed in 2.6 % (7/274) of patients.
Croatian: Mučnina se javila u 41,6% (114/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,6% (7/274)
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).
Croatian: Kako se ne preporučuje uporaba enkorafeniba u bolesnika s umjerenim (Child-Pugh B) ili teškim oštećenjem jetrene funkcije (Child-Pugh C), u ovih bolesnika se ne preporučuje ni primjena binimetiniba (vidjeti dio 4.2 sažetka opisa svojstava lijeka za enkorafenib).
English: It should be considered to permanently discontinue binimetinib.
Croatian: Treba razmotriti trajno obustavljanje binimetiniba.
English: If binimetinib is permanently discontinued, encorafenib should be discontinued.
Croatian: Ako je binimetinib trajno obustavljen, onda se mora obustaviti i enkorafenib.
English: Binimetinib should be withheld until improved to Grade 0 or 1.
Croatian: Treba prekinuti dozu binimetiniba dok se ne dosegne poboljšanje na stupanj 0 ili 1.
English: In the pooled Combo 450 population, headache occurred in 21.5% (59/274) of patients including Grade 3 in 1.5% (4/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450, glavobolja se javila u 21,5% (59/274) bolesnika uključujući i nuspojave stupnja 3 u 1,5% (4/274) bolesnika.
English: Rash led to treatment discontinuation in 0.4 % (1/274) of patients and to dose interruption or dose modification in 1.1 % (3/274) of patients.
Croatian: Osip je doveo do trajne obustave liječenja u 0,4% (1/274) bolesnika i privremenog prekida ili prilagodbe doze u 1,1% (3/274) bolesnika.
English: • medicine used to treat depression such as duloxetine
Croatian: • lijekovi koji se koriste za liječenje depresije, kao što je duloksetin • lijekovi kojima se obično liječi visok kolesterol, kao što je pravastatin
English: Effect of binimetinib on transporters
Croatian: Učinak binimetiniba na transportne proteine
English: The occurrence of Grade ≥ 3 haemorrhagic events should be managed with dose interruption, reduction or treatment discontinuation (see Table 2 in section 4.2) and as clinically indicated.
Croatian: Pojava krvarenja stupnja ≥ 3 mora se zbrinuti prekidom doze, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 2, dio 4.2) i postupiti kao što je klinički indicirano.
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Effect of transporters on binimetinib
Croatian: Učinak transportnih proteina na binimetinib
English: Effects of other medicinal products on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Croatian: Binimetinib se pretežno metabolizira glukuronidacijom putem UGT1A1.
English: • dark urine
Croatian: • tamno obojena mokraća
English: If during treatment patient develops uveitis, see section 4.2 of encorafenib SmPC for guidance.
Croatian: Ako tijekom liječenja bolesnik razvije uveitis, za smjernice vidjeti dio 4.2 sažetka opisa svojstava lijeka za enkorafenib.
English: In the pooled Combo 450 population, diarrhoea was observed in 38 % (104/274) of patients and was Grade 3 or 4 in 3.3 % (9/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450 proljev je primijećen u 38% (104/274) bolesnika i bio je stupnja 3 ili 4 u 3,3% (9/274) bolesnika.
English: HRa (95% CI) (vs Enco 300)
Croatian: HRa (95% CI) (naspram enkorafeniba 300)
English: Package leaflet: Information for the patient Mektovi 15 mg film-coated tablets binimetinib This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Mektovi 15 mg filmom obložene tablete binimetinib
English: In cell free system, binimetinib inhibits MEK1 and MEK2 with the half maximal inhibitory concentration (IC50)'s in the 12-46 nM. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation.
Croatian: U bezstaničnom sustavu binimetinib inhibira MEK1 i MEK2 uz IC50 (koncentracija pri kojoj dolazi do 50% inhibicije) u rasponu12-46 nM.
English: Combination with encorafenib
Croatian: Kombinirana primjena s enkorafenibom
English: Mektovi 15 mg film-coated tablets binimetinib
Croatian: Mektovi 15 mg filmom obložene tablete binimetinib
English: Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) and inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.
Croatian: Pgp prijenosa (kao što je gospina trava i fenitoin) mogu smanjiti izloženost binimetinibu, što može rezultirati smanjenom djelotvornošću lijeka.
English: • halo (seeing blurred outline around objects)
Croatian: • halo (viđenje nejasnih aura oko objekata) • bol u oku, oticanje ili crvenilo
English: Common
Croatian: National
English: Mektovi contains lactose.
Croatian: Lijek Mektovi sadrži laktozu.
English: If no improvement within 2 weeks, binimetinib should be withheld until improved to Grade 0 or 1 or to baseline levels, and then resumed at the same dose.
Croatian: • Ako nema poboljšanja unutar 2 tjedna, treba prekinuti binimetinib dok se ne postigne poboljšanje na stupanj 0 ili 1
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see below, Table 1 and Table 2).
Croatian: Zbog zbrinjavanja nuspojava će možda biti potrebno smanjiti dozu, privremeno prekinuti liječenje ili trajno obustaviti liječenje (vidjeti u nastavku Tablicu 1 i Tablicu 2).
English: Or, binimetinib should be permanently discontinued.
Croatian: Ili, treba trajno obustaviti binimetinib.
English: Bleeding problems: Mektovi can cause serious bleeding problems.
Croatian: Krvarenja: lijek Mektovi može prouzročiti ozbiljna krvarenja.
English: Vemurafenib
Croatian: Nuspojave
English: VTE can occur when binimetinib is administered (see section 4.8).
Croatian: Prilikom primjene binimetiniba može se pojaviti VTE (vidjeti dio 4.8).
English: Abdominal pain*
Croatian: Poremećaji probavnog sustava bol u abdomenu*
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, anaemia was observed in 9.7% (25/257) of patients with Grade 3-4 reported in 2.7% (7/257) patients.
Croatian: U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, anemija je zapažena u 9,7% (25/257) bolesnika sa stupnjem 3-4 prijavljenim u 2,7% (7/257) bolesnika.
English: The occurrence of symptomatic RPED can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Croatian: Pojava simptomatskog RPED-a može se zbrinuti privremenim prekidom liječenja, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija*
English: Mektovi contains lactose
Croatian: Lijek Mektovi sadrži laktozu
English: In urine, 6.5 % of the radioactivity was excreted as binimetinib.
Croatian: Na količinu nepromijenjenog binimetiniba izlučenog putem mokraće otpadalo je 6,5% radioaktivnosti.
English: • If improved to Grade 2, binimetinib should be resumed at a lower dose.
Croatian: • Ako je došlo do poboljšanja na stupanj 2, treba nastaviti sa smanjenom dozom binimetiniba.
English: Haemorrhages, including major haemorrhagic events, can occur when binimetinib is administered (see section 4.8).
Croatian: Do krvarenja, uključujući događaje obilnog krvarenja, može doći kod primjene binimetiniba (vidjeti dio 4.8).
English: Mektovi is for oral use.
Croatian: Lijek Mektovi je namijenjen za peroralnu primjenu.
English: HRa (95 % CI) (vs. Vem) Nominal p-value
Croatian: HRa (95% CI) (naspram vemurafeniba) Nominalna p-vrijednost HRa (95% CI) (naspram vemurafeniba) Nominalna p-vrijednost
English: HRa (95 % CI) (vs Vem)
Croatian: HRa (95% CI) (naspram vemurafeniba)
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).
Croatian: uglavnom pembrolizumabom, nivolumabom i ipilimumabom (34,4% skupina liječena kombiniranom terapijom 450, 36,1% skupina liječena enkorafenibom, 39,8% skupina liječena vemurafenibom).
English: Blood creatine phosphokinase increased
Croatian: Pretrage povišenje kreatin fosfokinaze u krvi vrlo često porast transaminaza*
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).
Croatian: PFS za enkorafenib 300 mg peroralno jednom dnevno u kombinaciji s binimetinibom 45 mg peroralno dvaput dnevno (komb. 300, n = 258) bio je uspoređen s PFS-om za enkorafenib 300 (n = 280,
English: • If improved to Grade 0 or 1, binimetinib should be resumed at same dose.
Croatian: • Ako je došlo do poboljšanja na stupanj 0 ili 1, treba nastaviti s istom dozom binimetiniba.
English: Blood creatinine elevation and renal failure occurred when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Croatian: Povišenje kreatinina u krvi i zatajenje bubrega zabilježeni su pri primjeni binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
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.
Croatian: prije početka primjene binimetiniba, 1 mjesec nakon početka primjene te približno svaka 3 mjeseca ili češće ako je klinički indicirano tijekom trajanja liječenja.
English: Vomiting occurred in 28.1 % (77/274) of patients with Grade 3 or 4 reported in 2.2 % (6/274) of patients.
Croatian: Povraćanje se javilo u 28,1% (77/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,2%
English: • Binimetinib should be permanently discontinued.
Croatian: • Treba trajno obustaviti binimetinib.
English: • headaches, dizziness or weakness
Croatian: • glavobolje, omaglicu ili slabost • iskašljavanje krvi ili krvnih ugrušaka
English: The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma, based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1) (hereafter referred to as the pooled Combo 450 population).
Croatian: 274 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom mutacijom BRAF V600, na temelju dva ispitivanja faze II (CMEK162X2110 i CLGX818X2109) te jednog ispitivanja faze III (CMEK162B2301, dio 1) (u daljnjem tekstu: ukupna populacija kombinirane terapije 450).
English: Haemorrhagic events led to discontinuation of treatment in 1.1 % (3/274) of patients.
Croatian: Događaji krvarenja koji su doveli do trajne obustave liječenja javili su se u 1,1% (3/274) bolesnika.
English: The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC).
Croatian: Progression-Free Survival) u skupini bolesnika liječenih kombiniranom terapijom 450 u usporedbi sa skupinom bolesnika liječenih vemurafenibom, kako je procijenjeno od strane zaslijepljenog,
English: Mektovi is not recommended while breast-feeding.
Croatian: Lijek Mektovi ne preporučuje se tijekom dojenja.
English: The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically relevant (see section 5.2); however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Croatian: Nije vjerojatno da bi razmjer interakcija lijekova posredovanih s UGT1A1 bio klinički relevantan (vidjeti dio 5.2); međutim, budući da to nije procijenjeno u službenom kliničkom ispitivanju, potreban je oprez kod istodobne primjene s
English: Heart problems: Mektovi can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include:
Croatian: Vaše srce radi (smanjenje ejekcijske frakcije lijeve klijetke); znakovi i simptomi mogu uključivati:
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.
Croatian: Treba nastaviti sa smanjenom dozom binimetiniba ako je sve u nastavku prisutno unutar 4 tjedna:
English: Binimetinib should be permanently discontinued.
Croatian: Treba trajno obustaviti binimetinib.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
Croatian: U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, mučnina je zapažena u 27,2% (70/257) bolesnika i bila je stupnja 3 u 1,6% (4/257) bolesnika.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, haemorrhagic events were observed in 6.6% (17/257) of patients and were Grade 3-4 in 1.6% (4/257) of patients.
Croatian: U ispitivanju CMEK162B2301-dio 2, u skupini kombinirane terapije 300, događaji krvarenja zapaženi su u 6,6% (17/257) bolesnika i bili su stupnja 3-4 u 1,6% (4/257) bolesnika.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, RPED was observed in 12.5% (32/257) of patients with 0.4% (1/257) Grade 4 event.
Croatian: U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, RPED je zapažen u 12,5% (32/257) bolesnika s 0,4% (1/257) za nuspojave stupnja 4.
English: Pruritus*
Croatian: vrlo često pruritus*
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.
Croatian: Druga sekundarna usporedba djelotvornosti između skupine liječene kombiniranom terapijom 450 i skupine liječene vemurafenibom ili enkorafenibom 300 uključivala je ukupno preživljenje (engl.
English: Uveitis was also reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Croatian: Uveitis je također prijavljen kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
English: (see section 4.2 of encorafenib SmPC).
Croatian: (vidjeti dijelove 4.2 i 5.2).
English: HRa (95 % CI) (vs Enco 300) p value (stratified log-rank)b
Croatian: HRa (95% CI) (naspram vemurafeniba) p-vrijednost (stratificirani lograng)b
English: Pneumonitis/ILD can occur with binimetinib.
Croatian: Prilikom primjene binimetiniba može se pojaviti pneumonitis/ILD (engl.
English: Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Croatian: Odstupanja od normalnih vrijednosti pretraga jetrene funkcije potrebno je zbrinuti prekidom doze, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Croatian: Tablica 5: Ispitivanje CMEK162B2301, dio 1: Interim rezultati ukupnog preživljenja (datum prestanka prikupljanja podataka: 7. studenoga 2017.) Encorafenib + binimetinib n = 192 (kombinirana terapija
English: • If improved to Grade 0 or 1 or baseline level, binimetinib should be resumed at reduced dose, or
Croatian: • Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne razine, treba nastaviti sa smanjenom dozom binimetiniba, ili
English: Binimetinib should be withheld.
Croatian: Treba prekinuti binimetinib.
English: The safety of binimetinib in combination with encorafenib has not been established in patients with a baseline LVEF that is either below 50 % or below the institutional LLN.
Croatian: LVEF-om koji je ispod 50% ili ispod DGN ustanove.
English: • First occurrence of Grade 3 adverse reactions
Croatian: • Prva pojava nuspojava stupnja 3
English: Effect of UGT1A1 inducers or inhibitors on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Croatian: Učinak UGT1A1 induktora ili inhibitora na binimetinib
English: • Retinal vein occlusion (RVO) Binimetinib should be permanently discontinued.
Croatian: • Ponovljene nuspojave stupnja 4 • Treba trajno obustaviti binimetinib.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, fatigue was observed in 33.5% (86/257) of patients with 1.6% (4/257) Grade 3-4 events.
Croatian: U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, umor je zapažen u 33,5% (86/257) bolesnika i bio je stupnja 3-4 u 1,6% (4/257) bolesnika.
English: In patients treated with Combo 450, VTE occurred in 4.7 % (13/274) of patients, including 2.2 % (6/274) of patients who developed pulmonary embolism.
Croatian: uključujući 2,2% (6/274) bolesnika koji su razvili plućnu emboliju.
English: Facial paresis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Croatian: Facijalna pareza bila je zabilježena kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
English: Non-cutaneous malignancies
Croatian: Zloćudne bolesti koje nisu na koži
English: • If improved to Grade 0 or 1, binimetinib should be resumed at reduced dose, or
Croatian: • Ako je došlo do poboljšanja na stupanj 0 ili 1, treba nastaviti sa smanjenom dozom binimetiniba, ili
English: LVD defined as symptomatic or asymptomatic decreases in ejection fraction can occur when binimetinib is administered.
Croatian: Kod primjene binimetiniba može doći do disfunkcije lijevog ventrikula definirane kao simptomatsko ili asimptomatsko smanjenje ejekcijske frakcije.
English: PPES can occur when binimetinib is used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Croatian: Sindrom palmarno-plantarne eritrodizestezije (PPES) može se pojaviti kad se binimetinib primjenjuje u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
English: - itching - dry skin - hair loss or thinning (alopecia) - skin rash of various types - thickening of the outer layers of the skin - joint pain (arthralgia) - muscle pain, weakness or spasm - back pain - pain in the extremities - fever - swelling of the hands or feet (peripheral oedema), localised swelling - fatigue - abnormal blood test results for liver function - abnormal blood test result related to blood creatine kinase, indicating damage to heart and muscle
Croatian: - crvenilo, ispucala ili oštećena koža - upala masnog potkožnog sloja, simptomi uključuju osjetljive kožne kvržice - osip na koži koji može biti u obliku područja promijenjene boje, u razini kože ili u obliku uzdignutih čvorića poput akni (dermatitis s aknama)
English: Pancreatitis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Croatian: Pankreatitis je također prijavljen kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).