FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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
English: 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
Croatian: - 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
English: LVD defined as symptomatic or asymptomatic decreases in ejection fraction has been reported when encorafenib is used in combination with binimetinib.
Croatian: 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.
English: In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients.
Croatian: U ukupnoj populaciji enkorafeniba 300, osip je prijavljen u 43,3% (94/217) bolesnika.
English: Serious side effects Braftovi may cause serious side effects.
Croatian: Ozbiljne nuspojave Lijek Braftovi može izazvati ozbiljne nuspojave.
English: Braftovi is not recommended while breast-feeding.
Croatian: Lijek Braftovi se ne preporučuje tijekom dojenja.
English: Abdominal pain was reported in 27.4% (75/274) of patients and was Grade 3 in 2.6% (7/274) patients.
Croatian: Bol u abdomenu prijavljena je u 27,4% (75/274) bolesnika i bila je stupnja 3 u 2,6% (7/274) bolesnika.
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Croatian: • Ponovni nastup stupnja 4 (AST ili ALT > 20x GGN)
English: Or, encorafenib should be permanently discontinued.
Croatian: Ili, treba trajno obustaviti enkorafenib.
English: 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
Croatian: 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
English: 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.
Croatian: 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.
English: Encorafenib N=194 (Enco300)
Croatian: Enkorafenib n = 194 (enkorafenib 300)
English: 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.
Croatian: 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.
English: 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.
Croatian: Uslijed potencijalnog rizika od produljenja QT intervala, preporučuje se korigiranje poremećaja serumskih elektrolita, uključujući magnezij i kalij, te kontroliranje čimbenika rizika za produljenje QT
English: For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC.
Croatian: Za dodatne informacije o upozorenjima i mjerama opreza tijekom liječenja binimetinibom, vidjeti dio 4.4 sažetka opisa svojstava lijeka za binimetinib.
English: If binimetinib is permanently discontinued, encorafenib should be discontinued.
Croatian: Ako je binimetinib trajno obustavljen, treba obustaviti i enkorafenib.
English: Basal cell carcinoma
Croatian: Manje često bazocelularni karcinom
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Croatian: Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje interim ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
English: 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.
Croatian: 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.
English: Effect of encorafenib on transporters
Croatian: Učinak enkorafeniba na transportne proteine
English: If uveitis is Grade 2 or 3 and it improves to Grade 0 or 1, then treatment should be resumed at a reduced dose.
Croatian: Ako nastupi uveitis stupnja 2 ili 3 i poboljša se do stupnja 0 ili 1, treba nastaviti sa smanjenom dozom.
English: Pancreatitis was reported in 0.7% (2/274) of patients.
Croatian: Upala gušterače prijavljena je u 0,7% (2/274) bolesnika.
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: In case of vomiting after administration of encorafenib, the patient should not take an additional dose and should take the next scheduled dose.
Croatian: Ako bolesnik povrati nakon primjene enkorafeniba, ne smije uzeti dodatnu dozu lijeka, već liječenje mora nastaviti prema uobičajenom rasporedu.
English: Encorafenib should be permanently discontinued.
Croatian: Treba trajno obustaviti enkorafenib.
English: New melanomas may also occur while taking Braftovi.
Croatian: Novi melanomi mogu se također pojaviti tijekom uzimanja lijeka
English: Survival at 12 months (95% CI)
Croatian: Preživljenje 12 mjeseci (95 % CI)
English: Encorafenib N=194 (Enco 300)
Croatian: Enkorafenib N = 194 (enkorafenib 300)
English: This could affect the ability to father a child. Talk to your doctor if this is a concern for you.
Croatian: To bi moglo utjecati na sposobnost da imate dijete.
English: 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.
Croatian: 4.2 Doziranje i način primjene Liječenje enkorafenibom u kombinaciji s binimetinibom mora započeti i nadzirati liječnik s iskustvom u primjeni antitumorskih lijekova.
English: • Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
Croatian: • Povišenje transaminaza: 13,2% (34/257) ukupno - stupanj 3-4: 5,4% (14/257)
English: - Bleeding problems: Braftovi may cause serious bleeding problems.
Croatian: - Krvarenje: Lijek Braftovi može prouzročiti ozbiljne probleme s krvarenjem.
English: Blood creatinine should be monitored as clinically indicated and creatinine elevation managed with dose modification or discontinuation (see Table 3 in section 4.2).
Croatian: Potrebno je pratiti kreatinin u krvi kako je klinički indicirano i zbrinuti povećanje kreatinina pomoću prilagodbe doze ili obustave liječenja (vidjeti
English: Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8).
Croatian: Odstupanja od normalnih vrijednosti pretraga jetrene funkcije, uključujući porast ALT i AST, prijavljena su pri liječenju enkorafenibom (vidjeti dio 4.8).
English: Examples of strong CYP3A4 inhibitors include, but are not limited to, ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole and grapefruit juice.
Croatian: Primjeri snažnih inhibitora CYP3A4 uključuju, ali nisu ograničeni na ritonavir, itrakonazol, klaritromicin,
English: 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.
Croatian: 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.
English: Effect of transporters on encorafenib
Croatian: Učinak transportera na enkorafenib
English: 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).
Croatian: 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.
English: Gamma-glutamyl transferase (GGT) increased* Transaminase increased*
Croatian: povišenje kreatin fosfokinaze u krvi povišenje gama-glutamil transferaze (GGT)* povišenje transaminaza*
English: Encorafenib should be used with caution in patients with severe renal impairment.
Croatian: Enkorafenib se mora s oprezom davati bolesnicima s teškim oštećenjem bubrežne funkcije.
English: Combination with binimetinib
Croatian: Kombinirana primjena s binimetinibom
English: Administration of encorafenib at a dose of 450 mg once daily as a single agent is not recommended.
Croatian: Ne preporučuje se primjena enkorafeniba u dozi od 450 mg jednom dnevno kao monoterapija.
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: The pharmacokinetics of encorafenib have not been studied in patients with severe renal impairment.
Croatian: Farmakokinetika enkorafeniba nije ispitivana u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Bleeding problems: Braftovi can cause serious bleeding problems.
Croatian: Krvarenja: lijek Braftovi može prouzročiti ozbiljna krvarenja.
English: Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay.
Croatian: Enkorafenib je pokazao fototoksičnost u in vitro testu 3T3 Neutral Red Uptake.
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) bolesnika.
English: 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.
Croatian: 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.
English: Dilatation of the aortic arc was observed in some foetuses.
Croatian: U nekih fetusa zapaženo je proširenje luka aorte.
English: 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.
Croatian: 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.
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 i to stupnja 3 prijavljenog u 1,6% (4/257) bolesnika.
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: No dose adjustment is required for patients with mild or moderate renal impairment based on a population pharmacokinetics (PK) analysis.
Croatian: Oštećenje bubrežne funkcije Nije potrebno posebno prilagođavati dozu bolesnicima s blagim do umjerenim oštećenjem bubrežne funkcije na temelju populacijske farmakokinetičke analize.
English: For information on the posology and recommended dose modifications of binimetinib, see section 4.2 of binimetinib SmPC.
Croatian: Za informacije o doziranju i preporučenoj prilagodbi doze binimetiniba, vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
English: • If improved to Grade 0 or 1 or to baseline levels, it should be resumed at a reduced dose.
Croatian: • Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom dozom.
English: Vomiting* Constipation Abdominal pain* Diarrhoea*
Croatian: konstipacija bol u abdomenu* proljev*
English: Each hard capsule contains 50 mg encorafenib.
Croatian: Jedna tvrda kapsula sadrži 50 mg enkorafeniba.
English: In the pooled Combo 450 population, cuSCC including keratoacanthomas was observed in 3.3% (9/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450, planocelularni karcinom kože, uključujući keratoakantom, zapažen je u 3,3% (9/274) bolesnika.
English: Each hard capsule contains 75 mg encorafenib.
Croatian: Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
English: • Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
Croatian: • Boja za označavanje: šelak (E904), željezov oksid, crni (E172), propilenglikol (E1520)
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Croatian: Tablica 6: Ispitivanje CMEK162B2301, dio 1: Interim rezultati ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
English: 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).
Croatian: 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).
English: If uveitis is Grade 1 and it improves to Grade 0, then treatment should be resumed at the same dose.
Croatian: Ako nastupi uveitis stupnja 1 i poboljša se do stupnja 0, treba nastaviti s istom dozom.
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% (6/274) 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: HRa (95% CI) (vs Enco 300)
Croatian: HRa (95 % CI) (naspram enkorafeniba 300)
English: Uncommon (may affect up to 1 in 100 people) - type of skin cancer such as basal cell carcinoma - inflammation of the eye (uveitis) - inflammation of the pancreas (pancreatitis) causing severe abdominal pain - abnormal blood test result for pancreas function (amylase)
Croatian: Manje često (može se javiti u do 1 na 100 osoba) - vrsta raka kože, kao što je bazocelularni karcinom - upala oka (uveitis) - upala gušterače (pankreatitis) koja izaziva jaku bol u abdomenu
English: • If improved to Grade 0 or 1 or to baseline levels, then it should be resumed at a reduced dose level.
Croatian: • Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom razinom doze.
English: In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450, umor se javio u 43,8% (120/274) bolesnika, uključujući i stupanj 3 u 2,9% (8/274) bolesnika.
English: Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520)
Croatian: Željezov oksid, crni (E172) Propilenglikol (E1520)
English: If during treatment LVD occurs, see section 4.2 of binimetinib SmPC.
Croatian: Ako se tijekom liječenja pojavi disfunkcija lijeve klijetke (LVD), vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
English: Caution should be exercised if a moderate CYP3A inhibitor is co-administered with encorafenib.
Croatian: Nužan je oprez pri istodobnoj primjeni umjereno jakih inhibitora CYP3A s enkorafenibom.
English: In the pooled encorafenib 300 population, facial paresis was observed in 7.4% (16/217) of patients.
Croatian: U ukupnoj populaciji enkorafeniba 300, facijalna pareza se javila u 7,4% (16/217) bolesnika.
English: Encorafenib dose when used in combination with binimetinib
Croatian: Doziranje enkorafeniba kad se primjenjuje u kombinaciji s binimetinibom
English: Nausea Vomiting* Constipation
Croatian: konstipacija mučnina povraćanje*
English: The embryo-foetal development study in rats indicated that encorafenib induced foetal toxicity with lower foetal weights and delays in skeletal development.
Croatian: Ispitivanje embriofetalnog razvoja kod štakora pokazalo je da enkorafenib izaziva toksičnost u fetusa,
English: Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine
Croatian: (rabdomioliza) koje može prouzročiti oštećenje bubrega i može biti opasno po život; znakovi i simptomi mogu uključivati: - bol u mišićima, grčeve, ukočenost ili spazam - tamno obojena mokraća
English: The hard capsule (capsule) has a flesh coloured opaque cap and white opaque body, with a stylised “A” printed on the cap and “LGX 75mg” printed on the body.
Croatian: Tvrda kapsula (kapsula) ima neprozirnu kapicu boje mesa i neprozirno tijelo bijele boje, sa stiliziranim „A” tiskanim na kapici i „LGX 75mg” na tijelu kapsule.
English: Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients.
Croatian: Osip je doveo do obustavljanja liječenja u 0,4% (1/274) bolesnika i privremenog prekida ili prilagodbe doze u 1,1%
English: Uncommon (may affect up to 1 in 100 people) - weakness and paralysis of face muscles - inflammation of the pancreas (pancreatitis) causing severe abdominal pain
Croatian: Manje često (može se javiti u do 1 na 100 osoba) - slabost ili paraliza mišića lica
English: Dose interruption or dose modification occurred in 1.1% (3/274) of patients.
Croatian: Do privremenog prekida ili prilagodbe doze došlo je u 1,1% (3/274) bolesnika.
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Croatian: Dodatna sekundarna mjera ishoda uključuje preživljenje bez progresije (PFS) u skupini bolesnika liječenih kombiniranom 450 terapijom u usporedbi sa skupinom liječenom enkorafenibom 300.
English: Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Croatian: Lijekovi koji su supstrati UGT1A1 (npr. raltegravir, atorvastatin,
English: HRa (95% CI) (vs Vem)
Croatian: HRa (95 % CI) (naspram vemurafeniba)
English: Overall response rate, n (%)
Croatian: Stopa ukupnog odgovora, n (%) (95 % CI)
English: Common cuSCC a New Primary Melanoma*
Croatian: Često planocelularni karcinom kožea novi primarni melanom*
English: Side effects when Braftovi and binimetinib are taken together
Croatian: Nuspojave pri istodobnoj primjeni lijeka Braftovi i binimetiniba
English: Encorafenib should be withheld (see monitoring in section
Croatian: Treba prekinuti enkorafenib (vidjeti praćenje u dijelu 4.4).
English: Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib.
Croatian: Braftovi 75 mg: Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
English: Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients.
Croatian: Osip je doveo do obustavljanja liječenja u 0,5% (1/217) bolesnika i privremenog prekida ili prilagodbe doze u 7,4%
English: Decreased appetite
Croatian: - tamnjenje kože - gubitak apetita
English: Encorafenib has minor influence on the ability to drive or use machines.
Croatian: Enkorafenib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The hard capsule (capsule) has an orange opaque cap and flesh opaque body, with a stylised “A” printed on the cap and “LGX 50mg” printed on the body.
Croatian: Tvrda kapsula (kapsula) ima narančastu neprozirnu kapicu i neprozirno tijelo boje mesa, sa stiliziranim „A” tiskanim na kapici i „LGX 50mg” na tijelu kapsule.
English: Dose interruption or dose modification was reported in 0.4% (1/274) of patients.
Croatian: Privremeni prekid ili prilagodba doze zabilježeni su u 0,4% (1/274) bolesnika.