FrancophonIA/ELRC3.0 huggingface dataset:
English: If encorafenib is temporarily interrupted (see Table 2), binimetinib should be interrupted.
Croatian: Ako je enkorafenib privremeno prekinut (vidjeti Tablicu 2), treba prekinuti s doziranjem binimetiniba.
English: In the pooled Combo 450 population, mild, mostly Grade 1, asymptomatic blood creatinine elevation was noted in 6.2% (17/274) of patients treated with the Combo 450 mg.
Croatian: U ukupnoj populaciji kombinirane terapije 450, blag, uglavnom stupnja 1, asimptomatski porast kreatinina u krvi primijećen je u 6,2% (17/274) bolesnika liječenih kombiniranom terapijom 450 mg.
English: Concomitant use with agents that are substrates of CYP3A4 (e.g., hormonal contraceptives) may result in increased toxicity or loss of efficacy of these agents.
Croatian: CYP3A4 enzima (npr. hormonski kontraceptivi) može prouzročiti povećanje toksičnosti ili smanjenje djelotvornosti ovih lijekova.
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: Slični udio bolesnika u svakoj skupini liječenja primio je sljedeće liječenje checkpoint inhibitorima, poglavito pembrolizumabom, nivolumabom i ipilimumabom (34,4% skupina liječena kombiniranom terapijom 450, 36,1% skupina liječena enkorafenibom, 39,8% skupina liječena vemurafenibom).
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).
Croatian: American Joint Committee on Cancer) (IIIB, IIIC, IVM1a ili IVM1b, naspram IVM1c) i funkcionalnim statusima Istočne kooperativne onkološke skupine ECOG (engl.
English: The median relative dose intensity (RDI) for Combo 450 was 100% for encorafenib and 99.6% for binimetinib; the median RDI was 86.2% for Enco 300 and 94.5% for vemurafenib.
Croatian: Medijan relativnog intenziteta doze (RDI) u skupine liječene kombiniranim liječenjem 450 bio je 100% za enkorafenib i 99,6% za binimetinib; medijan RDI bio je 86,2% za skupinu liječenu enkorafenibom i 94,5% za skupinu liječenu vemurafenibom.
English: - Kidney problems: Braftovi can alter your kidney activity (often abnormal blood tests, more rarely dehydration and vomiting).
Croatian: - Problemi s bubrezima: Lijek Braftovi može promijeniti aktivnost Vaših bubrega (često uzrokovati odstupanja u rezultatima krvnih pretraga, a rjeđe dehidraciju i povraćanje).
English: Effect of encorafenib on binimetinib
Croatian: Učinak enkorafeniba na binimetinib
English: Supraventricular tachycardiad
Croatian: Često supraventrikularna tahikardijad
English: Effect of CYP enzymes on encorafenib
Croatian: Učinak CYP enzima na enkorafenib
English: Co-administration of encorafenib with a CYP3A4 inducer was not assessed in a clinical study; however, a reduction in encorafenib exposure is likely and may result in compromised efficacy.
Croatian: Istodobna primjena enkorafeniba s lijekovima koji induciraju CYP3A4 nije procijenjena kliničkim ispitivanjem, ali smanjenje izloženosti enkorafenibu vjerojatno je i može rezultirati smanjenjem djelotvornosti lijeka.
English: The occurrence of QTc prolongation can be managed with dose reduction, interruption or discontinuation with correction of abnormal electrolytes and control of risk factors (see section 4.2).
Croatian: Pojava produljenja QTc intervala može se zbrinuti smanjenjem doze, privremenim prekidom liječenja ili trajnom obustavom liječenja uz korigiranje poremećaja elektrolita i kontroliranje čimbenika rizika (vidjeti dio 4.2).
English: Other skin cancers: Treatment with Braftovi may result in a different type of skin cancer such as cutaneous squamous cell carcinoma.
Croatian: Drugi karcinomi kože: Liječenje lijekom Braftovi može prouzročiti drugačiji tip raka kože, kao što je planocelularni karcinom.
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), not known (cannot be estimated from the available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidence of liver laboratory abnormalities was:
Croatian: U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, incidencija odstupanja laboratorijskih vrijednosti jetrenih funkcija bila je:
English: PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Croatian: Preživljenje bez progresije (PFS) je prema ocjeni ispitivača bila potporna analiza djelotvornosti.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of resistance in BRAFV600E mutant human melanoma xenografts in vivo.
Croatian: Također, kombinacija enkorafeniba i binimetiniba sprečava pojavu rezistencije u ksenografta ljudskog melanoma s BRAFV600E mutacijom in vivo.
English: In the 4-week and 13-week monkey toxicity study, isolated/sporadic episodes of emesis and diarrhoea as well as ophthalmic lesions were observed at slightly above human therapeutic exposures.
Croatian: U ispitivanjima toksičnosti u majmuna u trajanju od 4 tjedna i 13 tjedana, primijećene su izolirane/sporadične epizode povraćanja i proljeva kao i oftalmičke lezije na nešto većim razinama u odnosu na terapijsku razinu izloženosti lijeku u ljudi.
English: Pancreatitis*
Croatian: pankreatitis*
English: Encorafenib should be withheld, supportive measures such as topical therapy should be instituted, and the patient should be reassessed weekly.
Croatian: Treba prekinuti s enkorafenibom i poduzeti potporne mjere kao što je topikalna terapija te procijeniti stanje bolesnika jednom tjedno.
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, at least 86% of the encorafenib dose was absorbed.
Croatian: Nakon jednokratne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, apsorbiralo se najmanje 86% doze enkorafeniba.
English: The recommended dose of Braftovi is 6 capsules of 75 mg once daily (corresponding to a daily dose of 450 mg).
Croatian: Preporučena doza lijeka Braftovi je 6 kapsula od 75 mg jednom dnevno (što odgovara dnevnoj dozi od
English: Dry skin* Pruritus* Alopecia*
Croatian: hiperkeratoza* osip* suha koža* pruritus* alopecija*
English: The efficacy and safety of encorafenib have been established only in patients with tumours expressing BRAF V600E and V600K mutations.
Croatian: Djelotvornost i sigurnost primjene enkorafeniba su utvrđene samo u bolesnika koji imaju tumor s izraženim mutacijama BRAF V600E i
English: A thorough QT study to evaluate the QT prolongation potential of encorafenib has not been conducted.
Croatian: Nije provedeno temeljito ispitivanje QT radi utvrđivanja potencijala produljenja QT intervala pri primjeni enkorafeniba.
English: Encorafenib in combination with binimetinib 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: Enkorafenib u kombinaciji s binimetinibom indiciran je za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom (vidjeti dijelove 4.4 i 5.1).
English: - Skin changes: Braftovi may cause other types of skin cancer such as cutaneous squamous cell carcinoma.
Croatian: - Promjene na koži: Lijek Braftovi može prouzročiti druge vrste raka kože kao što je planocelularni karcinom.
English: In the event of an overdose, encorafenib treatment should be interrupted and renal function must be monitored as well as adverse reactions.
Croatian: slučaju predoziranja mora se prekinuti liječenje enkorafenibom i pratiti bubrežnu funkciju, kao i nuspojave.
English: Heart problems: Braftovi when taken with binimetinib can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include: - feeling dizzy, tired or lightheaded - shortness of breath - feeling like your heart is pounding, racing or beating irregularly - swelling in the legs
Croatian: Srčani problemi: Lijek Braftovi, kad se uzima s binimetinibom, može utjecati na to koliko dobro srce radi (smanjenje ejekcijske frakcije lijeve klijetke); znakovi i simptomi mogu uključivati: - osjećaj omaglice, umora ili ošamućenosti - nedostatak zraka - osjećaj kao da Vam srce lupa, ubrzano kuca ili kuca nepravilno - oticanje nogu
English: Renal failure events, including acute kidney injury and renal impairment, were reported in 3.3% (9/274) patients treated with encorafenib and binimetinib with Grade 3 or 4 events in 2.2% (6/274) of patients.
Croatian: Slučajevi zatajenja bubrega, uključujući i akutno oštećenje bubrega i poremećaj funkcije bubrega, prijavljeni su u 3,3% (9/274) bolesnika liječenih enkorafenibom i binimetinibom s događajima stupnja 3 ili 4 u 2,2% (6/274) bolesnika.
English: Encorafenib single agent 300 mg (n = 217)
Croatian: Enkorafenib kao monoterapija 300 mg (n = 217)
English: Encorafenib should be permanently discontinued (see monitoring in section 4.4).
Croatian: Treba trajno obustaviti liječenje enkorafenibom (vidjeti praćenje u dijelu 4.4).
English: Based on a population pharmacokinetic analysis, body weight was found to be a significant model covariate on clearance and volume of distribution.
Croatian: Na temelju populacijske farmakokinetičke analize, utvrđeno je da tjelesna težina predstavlja značajnu kovarijatu u modelu klirensa i volumena distribucije.
English: In the sub-acute 28-day and sub-chronic 13-week rat toxicology studies, encorafenib treatment at 20 mg/kg/d (dose level approximately 8 times the human exposure at the recommended dose) resulted in decreased testes and epididymis weights with tubular degeneration and oligospermia.
Croatian: U subakutnim 28-dnevnim i subkroničnim 13-tjednim toksikološkim ispitivanjima u štakora, liječenje enkorafenibom pri dozi od 20 mg/kg/dan (razina doze približno 8 puta veća od ljudske izloženosti lijeku pri preporučenoj dozi)
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 PFS-a u skupine liječene kombiniranim liječenjem 450 u usporedbi sa skupinom liječenom vemurafenibom.
English: Exceptions where dose modifications are necessary for binimetinib only (adverse reactions primarily related to binimetinib) are: retinal pigment epithelial detachment (RPED), retinal vein occlusion (RVO), interstitial lung disease/pneumonitis, cardiac dysfunction, creatine phosphokinase (CK) elevation and rhabdomyolysis, and venous thromboembolism (VTE).
Croatian: Iznimke u kojima su prilagodbe doze potrebne samo za binimetinib (nuspojave povezane u prvom redu s binimetinibom) su: odvajanje pigmentnog epitela mrežnice (engl. retinal pigment epithelial detachment, RPED), okluzija mrežničnih vena (engl. retinal vein occlusion, RVO), intersticijska bolest pluća/pneumonitis, srčani poremećaji, povišenje razine kreatin fosfokinaze i rabdomioliza i venska tromboembolija (VTE).
English: Amylase and lipase elevations were reported in 3.3% (9/274) and 5.1% (14/274) of patients, respectively.
Croatian: Povišene vrijednosti amilaza i lipaza prijavljene su u 3,3% (9/274) odnosno 5,1% (14/274) bolesnika.
English: Few patients required dose interruptions or dose reductions (0.7% or 2/274).
Croatian: U malog broja bolesnika bilo je neophodno obustavljanje ili smanjenje doze (0,7% ili 2/274).
English: Braftovi is for oral use.
Croatian: Lijek Braftovi je namijenjen za peroralnu primjenu.
English: Therefore, the potential need for dose adjustment cannot be determined.
Croatian: Stoga nije moguće dati preporuku o prilagodbi doziranja.
English: CK elevation and rhabdomyolysis
Croatian: Povišenje kreatin kinaze i rabdomioliza
English: The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Croatian: Najčešće nuspojave (≥ 25%) u bolesnika liječenih enkorafenibom 300 mg u kombinaciji s binimetinibom bile su umor, mučnina i proljev.
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, metabolism was found to be the major clearance pathway for encorafenib (approximately 88% of the recovered radioactive dose).
Croatian: Nakon jedne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, metabolizam se pokazao kao glavni put uklanjanja enkorafeniba (približno 88% radioaktivno označenog lijeka).
English: As encorafenib is primarily metabolised and eliminated via the liver, patients with mild to severe hepatic impairment may have increased encorafenib exposure over the range of inter-subject variability exposure (see section 5.2).
Croatian: Kako se enkorafenib primarno metabolizira i eliminira putem jetre, u bolesnika s blagim do teškim oštećenjem jetrene funkcije izloženost enkorafenibu može biti povećana u odnosu na normalnu interindividualnu varijabilnost izloženosti (vidjeti dio 5.2).
English: In the pooled encorafenib 300 population, PPES was reported in 51.6% (112/217) of patients.
Croatian: U ukupnoj populaciji enkorafeniba 300, PPES je prijavljen u 51,6% (112/217) bolesnika.
English: Most events were mild, with Grade 3 or 4 events reported in 4.6% (10/217) of patients.
Croatian: Većina događaja bila je blaga, sa stupnjem 3 ili 4 prijavljenim u 4,6% (10/217) bolesnika.
English: RPED occurred in 29.6% (81/274) of patients, most of them had Grade 1-2 and 1.8% (5/274) had Grade 3 events.
Croatian: RPED je prijavljen u 29,6% (81/274) bolesnika, od kojih je većina imala stupanj 1-2, a 1,8% (5/274) bolesnika je imalo događaje stupnja 3.
English: The pharmacokinetics of encorafenib have been shown to be approximatively dose linear after single and multiples doses.
Croatian: Ispitivanje je pokazalo da enkorafenib pokazuje linearnu farmakokinetiku proporcionalnu dozi nakon jednokratne primjene i višestrukih doza.
English: Alternative agents with no or minimal CYP3A induction potential should be considered.
Croatian: Treba razmotriti zamjenske lijekove koji nisu uopće ili su minimalni induktori CYP3A.
English: Package leaflet: Information for the patient Braftovi 50 mg hard capsules
Croatian: Uputa o lijeku: Informacije za bolesnika Braftovi 50 mg tvrde kapsule
English: If you take more capsules than you should, contact your doctor, pharmacist or nurse straightaway.
Croatian: Ako uzmete više kapsula nego što ste trebali, odmah se obratite svom liječniku, ljekarniku ili medicinskoj sestri.
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 skali FACT-M nije dosegnut u skupini liječenoj kombiniranom terapijom 450, a bio je 22,1 mjeseca (95% CI: 15,2; NE) u skupini liječenoj vemurafenibom s omjerom hazarda razlike 0,46 (95% CI: 0,29; 0,72).
English: How to take Braftovi
Croatian: Kako uzimati lijek Braftovi
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: Potvrđena stopa objektivnog odgovora (ORR) prema BIRC-u iznosila 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: Closer monitoring of encorafenib related toxicities in patients with mild hepatic impairment is recommended, including clinical examination and liver function tests, with assessment of ECGs as clinically appropriate during treatment.
Croatian: Preporučuje se pomniji nadzor toksičnosti povezanih s enkorafenibom u bolesnika s blagim oštećenjem funkcije jetre, uključujući i klinički pregled i pretrage jetrene funkcije, s procjenom
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when encorafenib is administered (see section 4.8).
Croatian: Nove primarne zloćudne bolesti, kožne i one koje nisu kožne, zabilježene su u bolesnika liječenih BRAF inhibitorima i mogu se javiti tijekom primjene enkorafeniba (vidjeti dio 4.8).
English: After oral administration, encorafenib is rapidly absorbed with a median Tmax of 1.5 to 2 hours.
Croatian: Enkorafenib se brzo apsorbira uz medijan Tmax od približno 1,5 do 2 sata nakon peroralne primjene u bolesnika.
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 daha, osjećaj lupanja srca, ubrzan puls, preskakanje srca ili ako su Vam noge otečene.
English: The median time to onset of the first event of cuSCC (all grades) was 6.5 months (range 1.0 to 22.8 months).
Croatian: Medijan vremena do prvog pojavljivanja planocelularnog karcinoma (za sve stupnjeve) iznosilo je 6,5 mjeseci (u rasponu od 1,0 do 22,8 mjeseci).
English: Specifically, encorafenib inhibits in vitro and in vivo BRAFV600E, D and K mutant melanoma cell growth.
Croatian: Enkorafenib selektivno inhibira in vitro i in vivo rast stanica s mutiranim BRAFV600E, D i K u melanoma.
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 encorafenib administered with binimetinib 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 u bolesnika liječenih enkorafenibom primijenjenim s binimetinibom bile su umor, mučnina, proljev, povraćanje, odvajanje mrežnice, bol u abdomenu, artralgija, povećanje kreatin kinaze u krvi i mijalgija.
English: Gamma-glutamyl transferase (GGT) increased*
Croatian: Vrlo često povišenje gama-glutamil transferaze (GGT)*
English: Constipation occurred in 24.1% (66/274) of patients and was Grade 1 or 2.
Croatian: Konstipacija se javila kod 24,1% (66/274) bolesnika i bila je stupnja 1 ili 2.
English: Table 5 and Figure 1 summarize the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
Croatian: sadrže sažetak PFS-a i drugih rezultata djelotvornosti temeljenih na središnjoj analizi podataka procijenjenih od strane zaslijepljenog neovisnog povjerenstva za procjenu.
English: • QTcF>500 ms and increased by >60 ms from pre-treatment values
Croatian: na > 500 ms i povećanje za > 60 ms u odnosu na vrijednosti prije liječenja
English: Additionally, in the 13-week rat toxicity study, reversible clinical pathology changes were noted at doses ≥ 100 mg/kg/d.
Croatian: Dodatno, u 13-tjednom ispitivanju toksičnosti u štakora, reverzibilne kliničke patološke promjene zabilježene su pri dozama
English: Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal anhydrous (E551) Magnesium stearate (E470b)
Croatian: Mikrokristalična celuloza (E460i) Sukcinatna kiselina (E363) Krospovidon (E1202) Bezvodni koloidni silicijev dioksid (E551) Magnezijev stearat (E470b)
English: Your doctor will check that your heart is working properly before and during your treatment with these medicines.
Croatian: Vaš će liječnik prije i tijekom liječenja ovim lijekovima provjeriti radi li vaše srce ispravno.
English: These melanomas are usually removed by surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Croatian: Ti melanomi se obično uklanjaju kirurškim zahvatom, a liječenje lijekom Braftovi (i binimetinibom)
English: Examples of moderate or strong CYP3A4 inducers include, but are not limited to carbamazepine, rifampicin, phenytoin and St. John's Wort.
Croatian: Primjeri umjerenih ili snažnih induktora CYP3A4 uključuju, ali nisu ograničeni na karbamazepin, rifampicin, fenitoin i gospinu travu.
English: Dermatitis acneiform* Skin exfoliationf Photosensitivity*
Croatian: Često akneiformni dermatitis* eksfolijacija kožef fotoosjetljivost*
English: Dose interruption or modification was reported in 3.7% (8/217) and symptomatic treatment including corticosteroids was reported in 5.1% (11/217) of patients.
Croatian: (8/217), a simptomatsko liječenje, uključujući i kortikosteroide, zabilježeno je u 5,1% (11/217)
English: When encorafenib was used at a dose of 300 mg once daily in combination with binimetinib 45 mg twice daily (Combo 300) in study CMEK162B2301-Part 2, the frequency category was lower compared to the pooled Combo 450 population for the following adverse reactions: anemia, peripheral neuropathy, haemorrhage, hypertension, pruritus (common); and colitis, increased amylase and increased lipase (uncommon).
Croatian: Kad se enkorafenib primjenjivao u dozi od 300 mg jednom dnevno u kombinaciji s binimetinibom 45 mg dvaput dnevno (kombinirane terapije 300) u ispitivanju CMEK162B2301 - dio 2, kategorija učestalosti sljedećih nuspojava bila je niža u odnosu na ukupnu kombiniranu populaciju 450: anemija, periferna neuropatija, krvarenje, hipertenzija, pruritus (često); kolitis, povišenje amilaze i povišenje lipaze (manje često).
English: Women of childbearing potential / Contraception in females Women of childbearing potential must use effective contraception during treatment with encorafenib and for at least 1 month following the last dose.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja enkorafenibom i najmanje 1 mjesec nakon uzimanja posljednje doze lijeka.
English: No dosing recommendation can be made in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Croatian: Ne može se preporučiti doza u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 4.4).
English: Liver laboratory values should be monitored before initiation of encorafenib and binimetinib and monitored at least monthly during the 6 first months of treatment, then as clinically indicated.
Croatian: Potrebno je pratiti rezultate laboratorijskih pretraga jetrene funkcije prije započinjanja liječenja enkorafenibom i binimetinibom i najmanje jedanput mjesečno tijekom prvih 6 mjeseci liječenja, a potom kako je klinički indicirano.
English: • Capsule contents: copovidone (E1208), poloxamer 188, cellulose microcrystalline (E460i), succinic acid (E363), crospovidone (E1202), silica colloidal anhydrous (E551), magnesium stearate (E470b)
Croatian: • Kapsula sadrži: kopovidon (E1208), poloksamer 188, mikrokristaličnu celulozu (E460i), sukcinatnu kiselinu (E363), krospovidon (E1202), bezvodni koloidni silicijev dioksid (E551), magnezijev stearat (E470b)
English: Non-cutaneous malignancies Based on its mechanism of action, encorafenib may promote malignancies associated with activation of RAS through mutation or other mechanisms.
Croatian: S obzirom na mehanizam djelovanja, enkorafenib može prouzročiti progresiju zloćudnih bolesti povezanih s aktivacijom RAS gena mutacijom ili drugim mehanizmima djelovanja.
English: PPES led to discontinuation in 4.1% (9/217) of patients and to dose interruption or dose modification in 23.0% (50/217) of patients.
Croatian: PPES je doveo do obustave liječenja u 4,1% (9/217) bolesnika i privremenog prekida ili prilagodbe doze liječenja u 23,0% (50/217) bolesnika.
English: • Increased GGT: 14.6% (40/274) overall - Grade 3-4: 8.4% (23/274)
Croatian: • Povišenje GGT: 14,6% (40/274) ukupno - stupanj 3-4: 8,4% (23/274)
English: Dermatologic reactions
Croatian: Dermatološke reakcije Osip