FrancophonIA/ELRC3.0 huggingface dataset:
English: How to take Braftovi How much to take
Croatian: Kako uzimati lijek Braftovi Koliko lijeka uzeti
English: Ask your doctor, pharmacist or nurse for advice.
Croatian: Za savjet pitajte svog liječnika, ljekarnika ili medicinsku sestru.
English: Each pack contains either 42 or 168 hard capsules.
Croatian: Jedno pakiranje sadrži 42 ili 168 tvrdih kapsula.
English: The incidence of Grade 3 or 4 elevation was 0.7% (2/274).
Croatian: Incidencija porasta stupnja 3 ili 4 bila je 0,7% (2/274).
English: The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with Enco 300 and 6.2 months in patients treated with vemurafenib.
Croatian: Medijan duljine izloženosti bio je 11,7 mjeseci u bolesnika skupine liječene kombiniranim liječenjem 450, 7,1 mjeseci u skupine liječene enkorafenibom 300 i 6,2 mjeseca u skupine liječene vemurafenibom.
English: In the 4-week and 13-week rat toxicity studies, clinical signs, reduced body weight reduced epididymides and prostate weights and microscopic findings in testes, epididymides, stomach and skin were noted.
Croatian: U ispitivanjima toksičnosti u štakora u trajanju od 4 tjedna i 13 tjedana, zabilježeni su klinički znakovi kao što su smanjena tjelesna težina, smanjenje epididimisa i težine prostate, te su primijećene mikroskopske promjene na testisima, epididimisima, trbuhu i koži.
English: Each pack contains either 28 or 112 hard capsules.
Croatian: Jedno pakiranje sadrži 28 ili 112 tvrdih kapsula.
English: Encorafenib potentially inhibits a number of transporters.
Croatian: Enkorafenib potencijalno može inhibirati neke transportne proteine.
English: No dosing recommendation can be made in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Croatian: Ne mogu se dati preporuke o doziranju u bolesnika s umjerenim (Child-Pugh stupanj B) ili teškim (Child-Pugh stupanj C) oštećenjem funkcije jetre.
English: Therefore, in these patients, binimetinib should be used with caution and for any symptomatic left ventricular dysfunction, Grade 3-4 LVEF or for absolute decrease of LVEF from baseline of ≥ 10%, binimetinib and encorafenib should be discontinued and LVEF should be evaluated every 2 weeks until recovery.
Croatian: Takve se bolesnike mora pomno nadzirati tijekom primjene binimetiniba i kod bilo kakve simptomatske disfunkcije lijeve klijetke, smanjenja LVEF-a stupnja 3-4 ili apsolutnog smanjenja LVEF-a ≥ 10% u odnosu na početnu vrijednost, prekinuti s binimetinibom i enkorafenibom, a LVEF se mora procijeniti svaka dva tjedna do oporavka.
English: Encorafenib should be withheld for up to 4 weeks.
Croatian: Treba prekinuti enkorafenib u razdoblju do 4 tjedna.
English: EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Croatian: EU/1/18/1314/002 42 tvrde kapsule EU/1/18/1314/004 168 tvrde kapsule
English: Braftovi 50 mg hard capsules EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules Braftovi 75 mg hard capsules EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Croatian: Braftovi 50 mg tvrde kapsule EU/1/18/1314/001 28 tvrdih kapsula EU/1/18/1314/003 112 tvrdih kapsula Braftovi 75 mg tvrde kapsule EU/1/18/1314/002 42 tvrde kapsule EU/1/18/1314/004 168 tvrdih kapsula
English: Patients should ensure adequate fluid intake during treatment.
Croatian: Bolesnici moraju tijekom liječenja unositi dovoljno tekućine.
English: QT Prolongation has been observed in patients treated with BRAF-inhibitors.
Croatian: Opaženo je produljenje QT intervala u bolesnika liječenih BRAF inhibitorima.
English: Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration.
Croatian: Zapaženi slučajevi zatajenja bubrega, uključujući akutno oštećenje bubrega i oštećenje bubrežne funkcije, uglavnom su povezani s povraćanjem i dehidracijom.
English: Suspicious skin lesions should be managed with dermatological excision and dermatopathologic evaluation.
Croatian: Svaku je sumnjivu kožnu leziju potrebno kirurški odstraniti i poslati na dermatopatološku analizu.
English: There are insufficient data to exclude a clinically significant exposure dependent QT prolongation.
Croatian: Nema dovoljno podataka da bi se isključilo klinički značajno produljenje QT intervala ovisno o izloženosti.
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with BRAF-inhibitors including encorafenib.
Croatian: Zloćudne bolesti na koži poput planocelularnog karcinoma, uključujući i keratoakantom, primijećene su u bolesnika liječenih BRAF inhibitorima, uključujući i enkorafenib.
English: Facial paresis was generally reversible and led to treatment discontinuation in 0.9% (2/217).
Croatian: Facijalna pareza općenito je bila reverzibilna i dovela do prekida u liječenju u 0,9% (2/217) bolesnika.
English: Study CMEK162B2301, Part 1
Croatian: Ispitivanje CMEK162B2301, dio 1
English: Left ventricular dysfunction (LVD)
Croatian: Disfunkcija lijeve klijetke (LVD)
English: Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems such as fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal epithelial pigmental detachment).
Croatian: Problemi s očima: Lijek Braftovi, kada se uzima s binimetinibom, može prouzročiti ozbiljne probleme u vezi s očima kao što je propuštanje tekućine ispod mrežnice u oku što rezultira odvajanjem njenih različitih slojeva u oku (odvajanjem pigmentnog epitela mrežnice).
English: Study CMEK162B2301, Part 2:
Croatian: Ispitivanje CMEK162B2301, dio 2:
English: Encorafenib should be maintained and supportive measures such as topical therapy should be instituted.
Croatian: Treba održavati dozu enkorafeniba i poduzeti potporne mjere kao što je topikalna terapija.
English: Braftovi is an anti-cancer medicine that contains the active substance encorafenib.
Croatian: Lijek Braftovi je lijek protiv raka koji sadrži djelatnu tvar enkorafenib.
English: If a dose of encorafenib is missed, the patient should only take the missed dose if it is more than 12 hours until the next scheduled dose.
Croatian: Ako bolesnik propusti dozu enkorafeniba, smije ju uzeti samo ako do sljedeće doze po rasporedu ima više od 12 sati.
English: Based on findings in animals, the use of encorafenib may impact fertility in males of reproductive potential (see section 5.3).
Croatian: Na osnovu ispitivanja na životinjama, primjena enkorafeniba može utjecati na plodnost mužjaka u reproduktivnoj dobi (vidjeti dio 5.3).
English: The median time to onset of the first event of facial paresis was 0.3 months (range 0.1 to 12.1 months).
Croatian: Medijan vremena do prvog pojavljivanja facijalne pareze bio je 0,3 mjeseca (u rasponu od 0,1 do 12,1 mjeseci).
English: • Grade 1-3
Croatian: • Stupanj 1 - 3
English: Agents that are substrates of renal transporters OAT1, OAT3, OCT2 (such as furosemide, penicillin) or agents that are substrates of the hepatic transporters OATP1B1, OATP1B3, OCT1 (such as atorvastatin, bosentan) or substrates of BCRP (such as methotrexate, rosuvastatin) or substrates of P-gp (e.g. posaconazole) may have increased exposure and should be therefore co-administered with caution.
Croatian: Lijekovi koji su supstrati bubrežnih transportnih proteina OAT1, OAT3, OCT2 (npr. furosemid i penicillin) ili lijekovi koji su supstrati jetrenih transportnih proteina OATP1B1, OATP1B3, OCT1 (npr. atorvastatin i bosentan) ili supstrati BCRP-a (npr. metotreksat, rosuvastatin) ili supstrati P-gp-a (npr. posakonazol) mogu imati povećanu izloženost i stoga se moraju s oprezom primjenjivati istodobno s enkorafenibom.
English: Additionally, no differences in exposure have been observed clinically when binimetinib is co-administered with encorafenib.
Croatian: Dodatno, nikakve razlike u izloženosti lijeku nisu klinički zabilježene kada je binimetinib primijenjen istodobno s enkorafenibom.
English: The mean (CV%) apparent clearance (CL/F) of encorafenib was 27.9 L/h (9.15%).
Croatian: Srednja vrijednost (CV %) prividnog klirensa (CL/F) enkorafeniba bila je 27,9 litara/sat (9,15%).
English: - Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems.
Croatian: - Problemi s očima: Lijek Braftovi, kada se uzima s binimetinibom, može prouzročiti ozbiljne očne probleme.
English: As Braftovi is to be used in combination with binimetinib, read the binimetinib leaflet carefully as well as this leaflet.
Croatian: Budući da se lijek Braftovi koristi u kombinaciji s binimetinibom, pažljivo pročitajte uputu o lijeku za binimetinib, kao i ovu uputu.
English: In vitro, CYP3A4 was predicted to be the major enzyme contributing to total oxidative clearance of encorafenib in human liver microsomes (~83.3%), followed by CYP2C19 and CYP2D6 (~16.0% and 0.71%, respectively).
Croatian: CYP3A4 glavni enzim koji doprinosi ukupnom oksidativnom klirensu enkorafeniba u mikrosomima ljudske jetre (~ 83,3%), a zatim CYP2C19 i CYP2D6 (~ 16,0% i 0,71%, redom).
English: Pancreatic enzyme elevation, mostly asymptomatic, was reported in the pooled Combo 450 population.
Croatian: Povišenje enzima gušterače, uglavnom asimptomatsko, prijavljeno je kod ukupne populacije kombinirane terapije 450.
English: Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded.
Croatian: Bolesnici su imali histološki potvrđen kožni melanom ili melanom nepoznata primarnog sijela, ali su bili isključeni oni s uvealnim ili mukoznim melanomom.
English: - The active substance is encorafenib.
Croatian: - Djelatna tvar je enkorafenib.
English: There are no data from the use of encorafenib in pregnant women.
Croatian: Nema podataka o primjeni enkorafeniba u trudnica.
English: Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors with single doses of encorafenib in healthy volunteers resulted in a 2 and 3-fold increase in the area under the concentration-time curve (AUC), respectively and in 44.6% and 68.3% increase in maximum encorafenib concentration (Cmax) respectively.
Croatian: Istodobna primjena umjerenih (diltiazem) i snažnih (posakonazol) inhibitora CYP3A4 s jednom dozom enkorafeniba u zdravih dobrovoljaca rezultiralo je dvostrukim, odnosno trostrukim povećanjem površine ispod krivulje plazmatske koncentracije u vremenu (AUC), i za 44,6%, odnosno 68,3% većom maksimalnom koncentracijom enkorafeniba (Cmax).
English: Updated analysis, cut-off date: 07 November 2017 PFS
Croatian: Ažurirane analize, krajnji rok: 7. studenoga 2017.
English: Encorafenib is both an inhibitor and inducer of CYP3A4.
Croatian: Enkorafenib je i inhibitor i induktor CYP3A4.
English: In the absence of clinical data, encorafenib is not recommended in patients with moderate or severe hepatic impairment.
Croatian: S obzirom na odsustvo kliničkih podataka, ne preporučuje se primjena enkorafeniba u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
English: • Grade 4
Croatian: • Stupanj 4
English: • If not improved, encorafenib should be permanently discontinued.
Croatian: • Ako nema poboljšanja, treba trajno obustaviti enkorafenib.
English: Braftovi 50 mg is available in packs of 28 capsules (7 blisters of 4 capsules each) or 112 capsules (28 blisters of 4 capsules each).
Croatian: Lijek Braftovi 50 mg dostupan je u pakiranjima od 28 kapsule (7 blistera od po 4 kapsule) ili 112 kapsule (28 blistera od po 4 kapsule).
English: The half maximal inhibitory concentration (IC50) of encorafenib against BRAFV600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively.
Croatian: Inhibitorna koncentracija enkorafeniba koja postiže 50% maksimalnog učinka (IC50) na staničnim linijama s mutacijom BRAFV600E, BRAF i CRAF kretala se u rasponu od 0,35, 0,47 i 0,30 nM, redom.
English: Your doctor will run blood tests to monitor your kidneys before and during treatment.
Croatian: Vaš će liječnik provoditi krvne pretrage kako bi nadzirao funkciju bubrega prije i tijekom liječenja.
English: As encorafenib is primarily metabolised and eliminated via the liver, based on PBPK modelling, patients with moderate to severe hepatic impairment may have greater increases in exposure than patients with mild hepatic impairment.
Croatian: Kako se enkorafenib primarno metabolizira i eliminira putem jetre, na temelju PBPK modeliranja u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije može doći do značajnijeg povećanja izloženosti nego u bolesnika s blagim oštećenjem jetrene funkcije.
English: Most events were Grade 1-2, with Grade 3 reported in 0.4% (1/274) of patients and no event led to discontinuation.
Croatian: Većina događaja bila je stupnja 1 - 2, dok je stupanj 3 zabilježen u 0,4 % (1/274) bolesnika i nijedan događaj nije doveo do prekida liječenja.
English: Ocular events
Croatian: Okularni događaji
English: EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules
Croatian: EU/1/18/1314/001 28 tvrdih kapsula EU/1/18/1314/003 112 tvrdih kapsula
English: Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Croatian: Dio 2 ispitivanja CMEK162B2301 osmišljen je za procjenu doprinosa binimetiniba u kombiniranom liječenju enkorafenibom i binimetinibom.
English: Ophthalmic lesions were partially reversible and consisted of a separation or detachment in the retina between the outer rods and cones layer and retinal pigmented epithelium at the central macula at the fovea.
Croatian: Oftalmičke su lezije bile djelomično reverzibilne i sastoje se od odvajanja ili separacije u mrežnici, sloja vanjskih štapića i čunjića i pigmentiranog epitela mrežnice na središnjoj makuli očnog dna.
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, the mean (SD) blood-to-plasma concentration ratio is 0.58 (0.02) and the mean (CV%) apparent volume of distribution (Vz/F) of encorafenib is 226 L (32.7%).
Croatian: Nakon jedne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, srednja vrijednost omjera koncentracija u krvi i plazmi (SD) bio je 0,58 (0,02), a srednja vrijednost (CV %) prividnog volumena raspodjele (Vz/F) za enkorafenib bila je 226 L (32,7%).
English: Cutaneous reactions • Grade 2
Croatian: Kožne reakcije • Stupanj 2
English: Table 5: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review)
Croatian: Tablica 5: Ispitivanje CMEK162B2301, dio 1: Preživljenje bez progresije i potvrđeni rezultati ukupnog odgovora (neovisni središnji pregled)
English: The embryo-foetal development study in rabbits indicated that encorafenib induced foetal toxicity with lower foetal weights and transitory changes in skeletal development.
Croatian: Ispitivanje embriofetalnog razvoja kod kunića pokazalo je da enkorafenib izaziva toksičnost u fetusa, niže težine fetusa i prolazne promjene u koštanom razvoju.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) PPES was reported in 6.2% (17/274) of patients in the pooled Combo 450 population.
Croatian: Sindrom palmarno-plantarne eritrodizestezije (PPES) PPES je prijavljen u 6,2% (17/274) bolesnika u ukupnoj populaciji kombinirane terapije 450.
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: Primarna mjera ishoda djelotvornosti u ispitivanju bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) u skupini bolesnika liječenih kombiniranom 450 terapijom u usporedbi sa skupinom bolesnika liječenih vemurafenibom, kako je procijenjeno od strane zaslijepljenog neovisnog povjerenstva za procjenu (engl. blinded independent review committee, BIRC).
English: If you forget to take Braftovi
Croatian: Ako ste zaboravili uzeti lijek Braftovi
English: Based on in vitro studies, there is potential for encorafenib to inhibit renal transporters OCT2, OAT1, OAT3 and hepatic transporters OATP1B1 and OATP1B3 at clinical concentrations.
Croatian: Na temelju in vitro ispitivanja, postoji mogućnost da enkorafenib inhibira bubrežne transportere OCT2, OAT1 i OAT3 te jetrene transportere OATP1B1 i OATP1B3 pri kliničkim koncentracijama.
English: No patients discontinued treatment due to anaemia, 1.5% (4/274) required dose interruption or dose modification.
Croatian: Nijednom bolesniku nije zbog anemije trajno obustavljeno liječenje; 1,5% (4/274) je zahtijevalo privremeni prekid liječenja ili prilagodbu doze.
English: Dose modifications in case of adverse reactions are provided below and in Table 2.
Croatian: Preporuke za prilagodbu doza u slučaju nuspojava navedene su u nastavku i u Tablici 2.
English: The proportions of patients experiencing adverse events (AE) and serious adverse events (SAE) were similar in patients aged <65 years and those aged ≥65 years.
Croatian: Udio bolesnika koji su doživjeli nuspojave i ozbiljne nuspojave bio je približno jednak u bolesnika dobi < 65 godina i bolesnika dobi ≥ 65 godina.
English: If you stop taking Braftovi
Croatian: Ako prestanete uzimati lijek Braftovi
English: Talk to your doctor immediately if you have any symptoms of bleeding problems such as coughing up of blood, blood clots, vomit containing blood or that looks like “coffee grounds”, red or black stools that look like tar, passing blood in the urine, stomach (abdominal) pain, unusual vaginal bleeding.
Croatian: Odmah obavijestite svog liječnika ako imate bilo kakve simptome krvarenja, kao što su iskašljavanje krvi, krvni ugrušci, povraćanje koje sadrži krv ili izgleda poput „taloga kave”, crvene ili crne stolice koje izgledaju poput katrana, krv u mokraći, bol u trbuhu ili neobična vaginalna krvarenja.
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8%) were <65 years old, 65 patients (23.7%) were 65 -74 years old and 15 patients (5.5%) were aged > 75.
Croatian: U bolesnika liječenih kombiniranim liječenjem 450 (n = 274), 194 bolesnika (70,8%) bili su dobi < 65 godina, 65 bolesnika (23,7%) bilo je dobi 65-74 godina i 15 bolesnika (5,5%) bilo je dobi
English: Encorafenib is moderately (86.1%) bound to human plasma proteins in vitro.
Croatian: Enkorafenib se umjereno veže za proteine u ljudskoj plazmi (86,1%) in vitro.
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see Tables 1 and 2).
Croatian: Zbog zbrinjavanja nuspojava će možda biti potrebno smanjiti dozu, privremeno ili trajno prekinuti liječenje (vidjeti Tablice 1 i 2).
English: If binimetinib is temporarily interrupted, encorafenib should be reduced at 300 mg once daily during the time of binimetinib dose interruption (see section 4.2 of binimetinib Summary of Product Characteristics [SmPC]) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.
Croatian: Ako je binimetinib privremeno prekinut, treba smanjiti enkorafenib na 300 mg jednom dnevno tijekom privremenog prekida doze binimetiniba (vidjeti sažetak opisa svojstava lijeka za binimetinib, dio 4.2) jer enkorafenib nije dobro podnošljiv u dozi od 450 mg kao monoterapija.
English: The safety of encorafenib in combination with binimetinib has not been established in patients with a baseline LVEF that is either below 50% or below the institutional lower limits of normal.
Croatian: Sigurnost primjene enkorafeniba u kombinaciji s binimetinibom nije utvrđena u bolesnika s početnom vrijednosti ejekcijske frakcije lijeve klijetke (LVEF) koja je 50% ili manja u odnosu na određene donje granice normale.
English: Encorafenib is to be given in combination with binimetinib.
Croatian: Enkorafenib se treba davati u kombinaciji s binimetinibom.
English: Encorafenib undergoes minimal renal elimination.
Croatian: Enkorafenib podliježe minimalnoj eliminaciji putem bubrega.
English: Tell your doctor immediately if you detect skin changes during and after treatment including: new wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole.
Croatian: Obavijestite svog liječnika odmah ako primijetite promjene na koži tijekom i nakon liječenja, uključujući i sljedeće: nova bradavica, ranica na koži ili crvenkasta kvržica koja krvari ili ne prolazi ili promjena veličine ili boje madeža.
English: Permanent discontinuation of encorafenib should be considered.
Croatian: Treba razmotriti trajno obustavljanje enkorafeniba.
English: If concomitant use with a strong CYP3A inhibitor is necessary, patients should be carefully monitored for safety (see section 4.5).
Croatian: Ako je neophodna istodobna primjena snažnih inhibitora CYP3A, bolesnike je radi sigurnosti potrebno pomno nadzirati (vidjeti dio 4.5).
English: Braftovi may reduce sperm count in males.
Croatian: Plodnost Lijek Braftovi može smanjiti broj spermatozoida u muškaraca.
English: Encorafenib 450 mg in combination with binimetinib (n = 274)
Croatian: Enkorafenib 450 mg u kombinaciji s binimetinibom (n = 274)
English: Tell your doctor, pharmacist or nurse immediately if you get the following while you are taking this medicine: - Heart problems: Braftovi when taken with binimetinib can make your heart work less well, alter the electrical activity of your heart called “QT interval prolongation” or make existing heart problems worse.
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako tijekom uzimanja ovog lijeka primijetite sljedeće: - Srčani problemi: Lijek Braftovi, kada se uzima s binimetinibom, može učiniti da Vaše srce slabije radi, prouzročiti promjenu električne aktivnosti srca koja se naziva „produljenje QT
English: Encorafenib is metabolised by CYP3A4, CYP2C19 and CYP2D6.
Croatian: Enkorafenib se metabolizira pomoću CYP3A4, CYP2C19 i CYP2D6.
English: Encorafenib and binimetinib (a MEK inhibitor, see section 5.1 of binimetinib SmPC) both inhibit the MAPK pathway, resulting in higher anti-tumour activity.
Croatian: Enkorafenib i binimetinib (MEK inhibitor, vidjeti dio 5.1 sažetka opisa svojstava lijeka za binimetinib) oba inhibiraju MAPK signalni put, što rezultira većom antitumorskom aktivnošću.
English: • First occurrence of any Grade 4 adverse reaction
Croatian: • Prvi nastup bilo kojih nuspojava stupnja 4
English: Across pooled combination studies of encorafenib and binimetinib at the recommended doses and a single-agent encorafenib study, results suggest that encorafenib has the potential to result in small increases in QTc interval (see section 5.1).
Croatian: U objedinjenim ispitivanjima kombinacije enkorafeniba i binimetiniba u preporučenim dozama i ispitivanju primjene enkorafeniba kao monoterapije, dobiveni rezultati ukazuju da enkorafenib ima potencijal prouzročiti blago produljenje QTc intervala (vidjeti dio 5.1).
English: Patients receiving encorafenib should undergo a head and neck examination, chest/abdomen computerised tomography (CT) scan, anal and pelvic examinations (for women) and complete blood cell counts prior to initiation, during and at the end of treatment as clinically appropriate.
Croatian: Bolesnicima koji primaju enkorafenib potrebno je napraviti pregled glave i vrata, kompjuteriziranu tomografiju (CT) prsnog koša/abdomena, pregled anusa i zdjelice (u žena) te kompletnu krvnu sliku prije, tijekom i po završetku liječenja ili kada se smatra da je klinički indicirano.
English: Preliminary Part 2 data, at a cut-off date of 9 November 2016, demonstrated the contribution of binimetinib with an improved median PFS estimate of 12.9 months (95% CI: 10.1, 14.0) for Combo 300 compared to 9.2 months (95% CI: 7.4, 11.0) for Enco 300 (Parts 1 and 2) per independent central review (BIRC).
Croatian: Preliminarni podaci za dio 2, na krajnjem roku 9. studenoga 2016., pokazali su doprinos binimetiniba poboljšanjem medijana PFS-a procijenjenog na 12,9 mjeseci (95% CI: 10,1; 14,0) za kombiniranu terapiju 300 u usporedbi s 9,2 mjeseca (95% CI: 7,4; 11,0) za enkorafenib 300 (dijelovi 1 i 2) prema neovisnom središnjem pregledu (BIRC).
English: Copovidone (E1208) Poloxamer 188
Croatian: Kopovidon (E1208)