natgillin/translations-raw huggingface dataset:
The safety of encorafenib (450 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the pooled Combo 450 population), based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1). 
Sigurnost enkorafeniba (450 mg peroralno jednom dnevno) u kombinaciji s binimetinibom (45 mg peroralno dvaput dnevno) procijenjena je na 274 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom mutacijom BRAF V600 (u daljnjem tekstu: ukupna populacija kombinirane terapije 450), na temelju dva ispitivanja faze II (CMEK162X2110 i CLGX818X2109) te jednog ispitivanja faze III (CMEK162B2301, dio 1).
The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors. 
(OCT1, OATP1B1, OATP1B3 i OATPB1) ispitivana je in vitro korištenjem specifičnih inhibitora transportera.
Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients. 
Povraćanje se javilo kod 15,2% (39/257) bolesnika i to stupnja 3 prijavljenog u 0,4% (1/257) bolesnika.
Encorafenib should not be used in patients with wild type BRAF malignant melanoma. 
V600K. Enkorafenib se ne smije primjenjivati u bolesnika koji imaju maligni melanom s divljim tipom BRAF gena.
Keep this medicine out of the sight and reach of children. 
Kako čuvati lijek Braftovi Lijek čuvajte izvan pogleda i dohvata djece.
Before taking encorafenib in combination with binimetinib, patients must have BRAF V600 mutation confirmed by a validated test. 
Prije primjene enkorafeniba u kombinaciji s binimetinibom, u bolesnika se validiranim testom mora potvrditi da je tumor pozitivan na mutaciju BRAF V600.
In Part 1, patients in the study were randomised to receive encorafenib 450 mg orally daily and binimetinib 45 mg orally twice daily (Combo 450, n = 192), encorafenib 300 mg orally daily (Enco 300, n = 194), or vemurafenib 960 mg orally twice daily (hereafter referred to as Vem, n = 191). 
U dijelu 1, bolesnici su u ispitivanju randomizirani na liječenje enkorafenibom 450 mg peroralno jednom dnevno i binimetinibom 45 mg peroralno dvaput dnevno (kombinirana terapija 450, n = 192), enkorafenibom 300 mg peroralno jednom dnevno (enkorafenib 300, n = 194), ili vemurafenibom
In the pooled Combo 450 population, anaemia was reported in 19.7% (54/274) of patients; 4.7% (13/274) patients had a Grade 3 or 4. 
U ukupnoj populaciji kombinirane terapije 450, anemija je prijavljena u 19,7% (54/274) bolesnika; 4,7% (13/274) bolesnika je imalo nuspojave stupnja 3 ili 4.
In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients. 
U ukupnoj populaciji enkorafeniba 300, fotoosjetljivost je zabilježena u 4,1% (9/217) bolesnika.
erythromycin, penicillin) - medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine) - medicines typically used to treat cancer (such as methotrexate, imatinib) - medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin) - an herbal treatment for depression: St. John's wort - some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir, dolutegravir - birth control medicines containing hormones - medicines typically used to treat high blood pressure (such as diltiazem, bosentan, furosemide) - a medicine used to treat an uneven heartbeat: amiodarone. 
karbamazepin) - lijekovi koji se obično koriste za liječenje raka (kao što su metotreksat, imatinib) - lijekovi kojima se obično liječi visok kolesterol (kao što su rosuvastatin, atorvastatin) - biljni lijekovi protiv depresije: gospina trava - neki lijekovi za liječenje HIV infekcije, kao što su ritonavir, amprenavir, raltegravir,
Encorafenib should be maintained. 
Treba održavati dozu enkorafeniba.
Talk to your doctor immediately if you get blurred vision, loss of vision, or other vision changes (e.g. coloured dots in your vision), halo (seeing blurred outline around objects). 
Odmah obavijestite svog liječnika ako primijetite zamućenje vida, gubitak vida ili druge poremećaje vida (npr. obojene točkice u vidnom polju) ili halo (viđenje nejasnog obrisa oko objekata).
Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, radioactivity was eliminated equally in both the faeces and urine (mean of 47.2%). 
Nakon jedne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, eliminacija radioaktivno označene doze lijeka bila je podjednaka putem stolice i putem mokraće (srednja vrijednost od 47,2%).
Neuropathy peripheral* Dizziness* 
periferna neuropatija* omaglica* glavobolja*
Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient. 
Krvarenje iz čira na želucu sa smrtnim ishodom uslijed otkazivanja brojnih organa prijavljeno je kod jednog bolesnika.
Survival at 24 months (95% CI) 
Preživljenje 24 mjeseca (95 % CI)
Based on a population pharmacokinetic analysis gender was not found to be a significant model covariate on clearance or volume of distribution. 
Populacijske farmakokinetičke analize pokazale su da spol ne predstavlja značajnu kovarijatu u modelu klirensa ili volumena distribucije enkorafeniba.
Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016) 
Slika 1 Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje preživljenja bez progresije prema neovisnom središnjem pregledu (krajnji rok: 19. svibnja 2016.)
Most events were mild, with Grade 3 or 4 events reported in 0.7% (2/274) of patients. 
Većina događaja bila je blaga, sa stupnjem 3 ili 4 prijavljenim u 0,7% (2/274) bolesnika.
• Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172) 
• Ovojnica kapsule: želatina (E441), titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172)
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. 
Medijan dobi bolesnika bio je 56 godina (raspon 20 - 89), 58% ispitivane populacije bili su muškarci,
If not improved despite supportive therapy within 2 weeks, encorafenib should be withheld until improved to Grade 0 or 1 and treatment should be resumed at same dose level or at a reduced dose. 
Ako se ne postigne poboljšanje unutar dva tjedna usprkos potpornoj terapiji, treba prekinuti s enkorafenibom dok se ne postigne poboljšanje na stupanj 0 ili 1 te nastaviti liječenje s istom razinom doze ili smanjenom dozom.
A decision must be made whether to discontinue breast-feeding or to discontinue encorafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother. 
Uzimajući u obzir korist dojenja za dijete i dobrobit terapije za majku, nužno je donijeti odluku o tome hoće li se prekinuti dojenje ili obustaviti terapiju enkorafenibom.
BRAF V600 Mutant Unresectable or Metastatic Melanoma The safety and efficacy of encorafenib in combination with binimetinib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicentre study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay. 
Neoperabilni ili metastatski melanom s mutacijom BRAF V600 Sigurnost i djelotvornost enkorafeniba u kombinaciji s binimetinibom procijenjena je u dvodijelnom randomiziranom (1:1:1), aktivno kontroliranom, otvorenom, multicentričnom ispitivanju faze III u bolesnika s neoperabilnim ili metastatskim melanomom s mutacijom BRAF V600 E ili K
It is used in adults in combination with another medicine containing binimetinib to treat a type of skin cancer called melanoma when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body, or cannot be removed by surgery 
- koji ima određenu promjenu (mutaciju) gena pod nazivom BRAF, odgovornog za stvaranje proteina, i - koji se proširio na druge dijelove tijela ili se ne može ukloniti kirurškim zahvatom
LVD defined as symptomatic or asymptomatic decreases in ejection fraction has been reported when encorafenib is used in combination with binimetinib. 
Disfunkcija lijeve klijetke (engl. left ventricular dysfunction, LVD) LVD karakteriziran simptomatskim ili asimptomatskim smanjenjem ejekcijske frakcije zabilježen je pri primjeni enkorafeniba u kombinaciji s binimetinibom.
In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients. 
U ukupnoj populaciji enkorafeniba 300, osip je prijavljen u 43,3% (94/217) bolesnika.
Serious side effects Braftovi may cause serious side effects. 
Ozbiljne nuspojave Lijek Braftovi može izazvati ozbiljne nuspojave.
Braftovi is not recommended while breast-feeding. 
Lijek Braftovi se ne preporučuje tijekom dojenja.
Abdominal pain was reported in 27.4% (75/274) of patients and was Grade 3 in 2.6% (7/274) patients. 
Bol u abdomenu prijavljena je u 27,4% (75/274) bolesnika i bila je stupnja 3 u 2,6% (7/274) bolesnika.
• Recurrent Grade 4 (AST or ALT > 20 ULN) 
• Ponovni nastup stupnja 4 (AST ili ALT > 20x GGN)
Or, encorafenib should be permanently discontinued. 
Ili, treba trajno obustaviti enkorafenib.
Amylase increased *composite terms which included more than one preferred term a includes keratoacanthoma, squamous cell carcinoma, lip squamous cell carcinoma and squamous cell carcinoma of skin b includes angioedema, drug hypersensitivity, hypersensitivity, hypersensitivity vasculitis and urticaria c includes facial nerve disorder, facial paralysis, facial paresis d includes extrasystoles, sinus tachycardia, supraventricular extrasystoles, tachyarrhythmia, tachycardia e includes erythema, generalised erythema, plantar erythema f includes dermatitis exfoliative, skin exfoliation, exfoliative rash g includes myalgia, muscle fatigue, muscle injury, muscle spasm, muscle weakness h includes left ventricular dysfunction, ejection fraction decreased, cardiac failure and ejection fraction abnormal i includes haemorrhage at various sites including cerebral haemorrhage j includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, thrombophlebitis superficial and thrombosis k includes colitis, colitis ulcerative, enterocolitis and proctitis l includes myalgia, muscular weakness, muscle spasm, muscle injury, myopathy, myositis m includes fluid retention, peripheral oedema, localised oedema 
tahikardiju e uključujući eritem, generalizirani eritem, plantarni eritem f uključujući eksfolijativni dermatitis, eksfolijaciju kože, eksfolijativni osip g uključujući mijalgiju, umor mišića, oštećenje mišića, grčenje mišića, slabost mišića h uključujući disfunkciju lijeve klijetke, smanjenje ejekcijske frakcije, zatajenje srca i poremećaj ejekcijske frakcije i uključujući krvarenje u bilo kojem dijelu tijela, uključujući i krvarenje u mozgu j uključujući plućnu emboliju, trombozu dubokih vena, emboliju, tromboflebitis, površinski tromboflebitis i trombozu k uključujući kolitis, ulcerozni kolitis, enterokolitis i proktitis l uključujući mijalgiju, slabost mišića, oštećenje mišića, grčenje mišića, miopatiju, miozitis m uključujući zadržavanje tekućine, periferni edem, lokalizirani edem
The most common adverse drug reactions (ADRs) (>25%) reported with encorafenib 300 were hyperkeratosis, alopecia, PPES, fatigue, rash, arthralgia, dry skin, nausea, myalgia, headache, vomiting and pruritus. 
Najčešće nuspojave (≥ 25%) prijavljene kod liječenja enkorafenibom od 300 mg su hiperkeratoza, alopecija, sindrom palmarno plantarne eritrodizestezije, umor, osip, artralgija, suha koža, mučnina, mijalgija, glavobolja, povraćanje i pruritus.
Encorafenib N=194 (Enco300) 
Enkorafenib n = 194 (enkorafenib 300)
If rash worsens or does not improve within 2 weeks with treatment, encorafenib should be withheld until Grade 0 or 1 and then resumed at the same dose. 
Ako se osip pogorša ili se ne poboljša unutar 2 tjedna uz liječenje, treba prekinuti s enkorafenibom dok se ne poboljša do stupnja 0 ili 1, a potom nastaviti s istom dozom.
Due to the potential risk for QT prolongation, it is recommended that serum electrolytes abnormalities, including magnesium and potassium, are corrected and risk factors for QT prolongation controlled (e.g. congestive heart failure, bradyarrhythmias) before treatment initiation and during treatment. 
Uslijed potencijalnog rizika od produljenja QT intervala, preporučuje se korigiranje poremećaja serumskih elektrolita, uključujući magnezij i kalij, te kontroliranje čimbenika rizika za produljenje QT
For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC. 
Za dodatne informacije o upozorenjima i mjerama opreza tijekom liječenja binimetinibom, vidjeti dio 4.4 sažetka opisa svojstava lijeka za binimetinib.
If binimetinib is permanently discontinued, encorafenib should be discontinued. 
Ako je binimetinib trajno obustavljen, treba obustaviti i enkorafenib.
Basal cell carcinoma 
Manje često bazocelularni karcinom
Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017) 
Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje interim ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
Encorafenib in combination with binimetinib in patients who have progressed on a BRAF inhibitor There are limited data for the use of the combination of encorafenib with binimetinib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation. 
Ograničeni su podaci o uporabi enkorafeniba u kombinaciji s binimetinibom u bolesnika koji su imali progresiju pri primjeni prethodnog BRAF inhibitora korištenog za liječenje neoperabilnog ili metastatskog melanoma s BRAF V600 mutacijom.
Effect of encorafenib on transporters 
Učinak enkorafeniba na transportne proteine
If uveitis is Grade 2 or 3 and it improves to Grade 0 or 1, then treatment should be resumed at a reduced dose. 
Ako nastupi uveitis stupnja 2 ili 3 i poboljša se do stupnja 0 ili 1, treba nastaviti sa smanjenom dozom.
Pancreatitis was reported in 0.7% (2/274) of patients. 
Upala gušterače prijavljena je u 0,7% (2/274) bolesnika.
In the pooled Combo 450 population, rash occurred in 19.7% (54/274) of patients. 
U ukupnoj populaciji kombinirane terapije 450, osip se pojavio u 19,7% (54/274) bolesnika.
In case of vomiting after administration of encorafenib, the patient should not take an additional dose and should take the next scheduled dose. 
Ako bolesnik povrati nakon primjene enkorafeniba, ne smije uzeti dodatnu dozu lijeka, već liječenje mora nastaviti prema uobičajenom rasporedu.
Encorafenib should be permanently discontinued. 
Treba trajno obustaviti enkorafenib.
New melanomas may also occur while taking Braftovi. 
Novi melanomi mogu se također pojaviti tijekom uzimanja lijeka
Survival at 12 months (95% CI) 
Preživljenje 12 mjeseci (95 % CI)
Encorafenib N=194 (Enco 300) 
Enkorafenib N = 194 (enkorafenib 300)
This could affect the ability to father a child. Talk to your doctor if this is a concern for you. 
To bi moglo utjecati na sposobnost da imate dijete.
Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. 
4.2 Doziranje i način primjene Liječenje enkorafenibom u kombinaciji s binimetinibom mora započeti i nadzirati liječnik s iskustvom u primjeni antitumorskih lijekova.
• Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257) 
• Povišenje transaminaza: 13,2% (34/257) ukupno - stupanj 3-4: 5,4% (14/257)
- Bleeding problems: Braftovi may cause serious bleeding problems. 
- Krvarenje: Lijek Braftovi može prouzročiti ozbiljne probleme s krvarenjem.
Blood creatinine should be monitored as clinically indicated and creatinine elevation managed with dose modification or discontinuation (see Table 3 in section 4.2). 
Potrebno je pratiti kreatinin u krvi kako je klinički indicirano i zbrinuti povećanje kreatinina pomoću prilagodbe doze ili obustave liječenja (vidjeti
Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8). 
Odstupanja od normalnih vrijednosti pretraga jetrene funkcije, uključujući porast ALT i AST, prijavljena su pri liječenju enkorafenibom (vidjeti dio 4.8).
Examples of strong CYP3A4 inhibitors include, but are not limited to, ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole and grapefruit juice. 
Primjeri snažnih inhibitora CYP3A4 uključuju, ali nisu ograničeni na ritonavir, itrakonazol, klaritromicin,
In the Combo 300 arm in Part 2 of the pivotal study, PPES was observed in 3.9% (10/257) of patients with Grade 3 reported in 0.4% (1/257) of patients. 
U skupini kombinirane terapije 300 dijela 2 pivotalnog ispitivanja, PPES je zapažen u 3,9% (10/257) bolesnika sa stupnjem 3 prijavljenim u 0,4% (1/257) bolesnika.
Effect of transporters on encorafenib 
Učinak transportera na enkorafenib
In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274). 
U ukupnoj populaciji kombinirane terapije 450, uveitis je prijavljen u 4,4% (12/274) bolesnika, i to kao stupanj 1 u 0,4% (1/274), stupanj 2 u 3,6% (10/274) i stupanj 3 u 0,4% (1/274) bolesnika.
Gamma-glutamyl transferase (GGT) increased* Transaminase increased* 
povišenje kreatin fosfokinaze u krvi povišenje gama-glutamil transferaze (GGT)* povišenje transaminaza*
Encorafenib should be used with caution in patients with severe renal impairment. 
Enkorafenib se mora s oprezom davati bolesnicima s teškim oštećenjem bubrežne funkcije.
Combination with binimetinib 
Kombinirana primjena s binimetinibom
Administration of encorafenib at a dose of 450 mg once daily as a single agent is not recommended. 
Ne preporučuje se primjena enkorafeniba u dozi od 450 mg jednom dnevno kao monoterapija.
The encorafenib single agent (300 mg orally once daily) safety profile is based on data from 217 patients with unresectable or metastatic BRAF V600-mutant melanoma (hereafter referred to as the pooled encorafenib 300 population). 
Sigurnosni profil enkorafeniba kao monoterapije (300 mg peroralno jednom dnevno) temelji se na podacima 217 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom BRAF V600 mutacijom (u daljnjem tekstu ukupna populacija 300 enkorafeniba).
The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2). 
Sigurnost enkorafeniba (300 mg peroralno, jednom dnevno) u kombinaciji s binimetinibom (45 mg peroralno, dvaput dnevno) procijenjena je na 257 bolesnika s pozitivnom mutacijom BRAF V600 s neoperabilnim ili metastatskim melanomom (u daljnjem tekstu: kombinirana 300 populacija), na temelju ispitivanja faze III (CMEK162B2301, dio 2).
The pharmacokinetics of encorafenib have not been studied in patients with severe renal impairment. 
Farmakokinetika enkorafeniba nije ispitivana u bolesnika s teškim oštećenjem bubrežne funkcije.
Bleeding problems: Braftovi can cause serious bleeding problems. 
Krvarenja: lijek Braftovi može prouzročiti ozbiljna krvarenja.
Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay. 
Enkorafenib je pokazao fototoksičnost u in vitro testu 3T3 Neutral Red Uptake.
Nausea occurred in 41.6% (114/274) with Grade 3 or 4 observed in 2.6% (7/274) of patients. 
Mučnina se javila u 41,6% (114/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,6% (7/274) bolesnika.
If no improvement within 4 weeks, encorafenib should be withheld until improved to Grade 0 or 1 or to pretreatment/baseline levels and then resumed at the same dose. 
Ako nema poboljšanja unutar 4 tjedna, treba prekinuti enkorafenib dok se ne postigne poboljšanje na stupanj 0 ili 1 ili na početne vrijednosti, a potom nastaviti s istom dozom.
Dilatation of the aortic arc was observed in some foetuses. 
U nekih fetusa zapaženo je proširenje luka aorte.
In the pooled Combo 450 population, diarrhoea was observed in 38% (104/274) of patients and was Grade 3-4 in 3.3% (9/274) patients. 
U ukupnoj populaciji kombinirane terapije 450, proljev je primijećen u 38% (104/274) bolesnika i bio je stupnja 3-4 u 3,3% (9/274) bolesnika.
Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients. 
Proljev je zapažen u 28,4% (73/257) bolesnika i to stupnja 3 prijavljenog u 1,6% (4/257) bolesnika.
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. 
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.
No dose adjustment is required for patients with mild or moderate renal impairment based on a population pharmacokinetics (PK) analysis. 
Oštećenje bubrežne funkcije Nije potrebno posebno prilagođavati dozu bolesnicima s blagim do umjerenim oštećenjem bubrežne funkcije na temelju populacijske farmakokinetičke analize.
For information on the posology and recommended dose modifications of binimetinib, see section 4.2 of binimetinib SmPC. 
Za informacije o doziranju i preporučenoj prilagodbi doze binimetiniba, vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
• If improved to Grade 0 or 1 or to baseline levels, it should be resumed at a reduced dose. 
• Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom dozom.
Vomiting* Constipation Abdominal pain* Diarrhoea* 
konstipacija bol u abdomenu* proljev*
Each hard capsule contains 50 mg encorafenib. 
Jedna tvrda kapsula sadrži 50 mg enkorafeniba.
In the pooled Combo 450 population, cuSCC including keratoacanthomas was observed in 3.3% (9/274) of patients. 
U ukupnoj populaciji kombinirane terapije 450, planocelularni karcinom kože, uključujući keratoakantom, zapažen je u 3,3% (9/274) bolesnika.
Each hard capsule contains 75 mg encorafenib. 
Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
• Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520) 
• Boja za označavanje: šelak (E904), željezov oksid, crni (E172), propilenglikol (E1520)
Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017) 
Tablica 6: Ispitivanje CMEK162B2301, dio 1: Interim rezultati ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
Encorafenib in combination with binimetinib in patients with brain metastases There are limited efficacy data with the combination of encorafenib and binimetinib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1). 
Ograničeni su podaci o djelotvornosti kombinacije enkorafeniba i binimetiniba u bolesnika s melanomom s BRAF V600 mutacijom koji je metastazirao u mozak (vidjeti dio 5.1).
If uveitis is Grade 1 and it improves to Grade 0, then treatment should be resumed at the same dose. 
Ako nastupi uveitis stupnja 1 i poboljša se do stupnja 0, treba nastaviti s istom dozom.
Vomiting occurred in 28.1% (77/274) of patients with Grade 3 or 4 reported in 2.2% (6/274) of patients. 
Povraćanje se javilo u 28,1% (77/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,2% (6/274) bolesnika.
Haemorrhagic events were observed in 17.9% (49/274) of patients in the pooled Combo 450 population. 
Krvarenje je zapaženo u 17,9% (49/274) bolesnika iz ukupne populacije kombinirane terapije 450.
HRa (95% CI) (vs Enco 300) 
HRa (95 % CI) (naspram enkorafeniba 300)