natgillin/translations-raw huggingface dataset:
Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration.
Zapaženi slučajevi zatajenja bubrega, uključujući akutno oštećenje bubrega i oštećenje bubrežne funkcije, uglavnom su povezani s povraćanjem i dehidracijom.
Suspicious skin lesions should be managed with dermatological excision and dermatopathologic evaluation.
Svaku je sumnjivu kožnu leziju potrebno kirurški odstraniti i poslati na dermatopatološku analizu.
There are insufficient data to exclude a clinically significant exposure dependent QT prolongation.
Nema dovoljno podataka da bi se isključilo klinički značajno produljenje QT intervala ovisno o izloženosti.
Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with BRAF-inhibitors including encorafenib.
Zloćudne bolesti na koži poput planocelularnog karcinoma, uključujući i keratoakantom, primijećene su u bolesnika liječenih BRAF inhibitorima, uključujući i enkorafenib.
Facial paresis was generally reversible and led to treatment discontinuation in 0.9% (2/217).
Facijalna pareza općenito je bila reverzibilna i dovela do prekida u liječenju u 0,9% (2/217) bolesnika.
Study CMEK162B2301, Part 1
Ispitivanje CMEK162B2301, dio 1
Left ventricular dysfunction (LVD)
Disfunkcija lijeve klijetke (LVD)
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).
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).
Study CMEK162B2301, Part 2:
Ispitivanje CMEK162B2301, dio 2:
Encorafenib should be maintained and supportive measures such as topical therapy should be instituted.
Treba održavati dozu enkorafeniba i poduzeti potporne mjere kao što je topikalna terapija.
Braftovi is an anti-cancer medicine that contains the active substance encorafenib.
Lijek Braftovi je lijek protiv raka koji sadrži djelatnu tvar enkorafenib.
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.
Ako bolesnik propusti dozu enkorafeniba, smije ju uzeti samo ako do sljedeće doze po rasporedu ima više od 12 sati.
Based on findings in animals, the use of encorafenib may impact fertility in males of reproductive potential (see section 5.3).
Na osnovu ispitivanja na životinjama, primjena enkorafeniba može utjecati na plodnost mužjaka u reproduktivnoj dobi (vidjeti dio 5.3).
The median time to onset of the first event of facial paresis was 0.3 months (range 0.1 to 12.1 months).
Medijan vremena do prvog pojavljivanja facijalne pareze bio je 0,3 mjeseca (u rasponu od 0,1 do 12,1 mjeseci).
• Grade 1-3
• Stupanj 1 - 3
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.
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.
Additionally, no differences in exposure have been observed clinically when binimetinib is co-administered with encorafenib.
Dodatno, nikakve razlike u izloženosti lijeku nisu klinički zabilježene kada je binimetinib primijenjen istodobno s enkorafenibom.
The mean (CV%) apparent clearance (CL/F) of encorafenib was 27.9 L/h (9.15%).
Srednja vrijednost (CV %) prividnog klirensa (CL/F) enkorafeniba bila je 27,9 litara/sat (9,15%).
- Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems.
- Problemi s očima: Lijek Braftovi, kada se uzima s binimetinibom, može prouzročiti ozbiljne očne probleme.
As Braftovi is to be used in combination with binimetinib, read the binimetinib leaflet carefully as well as this leaflet.
Budući da se lijek Braftovi koristi u kombinaciji s binimetinibom, pažljivo pročitajte uputu o lijeku za binimetinib, kao i ovu uputu.
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).
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).
Pancreatic enzyme elevation, mostly asymptomatic, was reported in the pooled Combo 450 population.
Povišenje enzima gušterače, uglavnom asimptomatsko, prijavljeno je kod ukupne populacije kombinirane terapije 450.
Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded.
Bolesnici su imali histološki potvrđen kožni melanom ili melanom nepoznata primarnog sijela, ali su bili isključeni oni s uvealnim ili mukoznim melanomom.
- The active substance is encorafenib.
- Djelatna tvar je enkorafenib.
There are no data from the use of encorafenib in pregnant women.
Nema podataka o primjeni enkorafeniba u trudnica.
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.
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).
Updated analysis, cut-off date: 07 November 2017 PFS
Ažurirane analize, krajnji rok: 7. studenoga 2017.
Encorafenib is both an inhibitor and inducer of CYP3A4.
Enkorafenib je i inhibitor i induktor CYP3A4.
In the absence of clinical data, encorafenib is not recommended in patients with moderate or severe hepatic impairment.
S obzirom na odsustvo kliničkih podataka, ne preporučuje se primjena enkorafeniba u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
• Grade 4
• Stupanj 4
• If not improved, encorafenib should be permanently discontinued.
• Ako nema poboljšanja, treba trajno obustaviti enkorafenib.
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).
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).
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.
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.
Your doctor will run blood tests to monitor your kidneys before and during treatment.
Vaš će liječnik provoditi krvne pretrage kako bi nadzirao funkciju bubrega prije i tijekom liječenja.
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.
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.
Most events were Grade 1-2, with Grade 3 reported in 0.4% (1/274) of patients and no event led to discontinuation.
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.
Ocular events
Okularni događaji
EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules
EU/1/18/1314/001 28 tvrdih kapsula EU/1/18/1314/003 112 tvrdih kapsula
Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Dio 2 ispitivanja CMEK162B2301 osmišljen je za procjenu doprinosa binimetiniba u kombiniranom liječenju enkorafenibom i binimetinibom.
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.
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.
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%).
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%).
Cutaneous reactions • Grade 2
Kožne reakcije • Stupanj 2
Table 5: Study CMEK162B2301, Part 1: Progression-free survival and confirmed overall response results (independent central review)
Tablica 5: Ispitivanje CMEK162B2301, dio 1: Preživljenje bez progresije i potvrđeni rezultati ukupnog odgovora (neovisni središnji pregled)
The embryo-foetal development study in rabbits indicated that encorafenib induced foetal toxicity with lower foetal weights and transitory changes in skeletal development.
Ispitivanje embriofetalnog razvoja kod kunića pokazalo je da enkorafenib izaziva toksičnost u fetusa, niže težine fetusa i prolazne promjene u koštanom razvoju.
Palmar-plantar erythrodysaesthesia syndrome (PPES) PPES was reported in 6.2% (17/274) of patients in the pooled Combo 450 population.
Sindrom palmarno-plantarne eritrodizestezije (PPES) PPES je prijavljen u 6,2% (17/274) bolesnika u ukupnoj populaciji kombinirane terapije 450.
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).
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).
If you forget to take Braftovi
Ako ste zaboravili uzeti lijek Braftovi
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.
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.
No patients discontinued treatment due to anaemia, 1.5% (4/274) required dose interruption or dose modification.
Nijednom bolesniku nije zbog anemije trajno obustavljeno liječenje; 1,5% (4/274) je zahtijevalo privremeni prekid liječenja ili prilagodbu doze.
Dose modifications in case of adverse reactions are provided below and in Table 2.
Preporuke za prilagodbu doza u slučaju nuspojava navedene su u nastavku i u Tablici 2.
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.
Udio bolesnika koji su doživjeli nuspojave i ozbiljne nuspojave bio je približno jednak u bolesnika dobi < 65 godina i bolesnika dobi ≥ 65 godina.
If you stop taking Braftovi
Ako prestanete uzimati lijek Braftovi
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.
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.
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.
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
Encorafenib is moderately (86.1%) bound to human plasma proteins in vitro.
Enkorafenib se umjereno veže za proteine u ljudskoj plazmi (86,1%) in vitro.
The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see Tables 1 and 2).
Zbog zbrinjavanja nuspojava će možda biti potrebno smanjiti dozu, privremeno ili trajno prekinuti liječenje (vidjeti Tablice 1 i 2).
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.
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.
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.
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.
Encorafenib is to be given in combination with binimetinib.
Enkorafenib se treba davati u kombinaciji s binimetinibom.
Encorafenib undergoes minimal renal elimination.
Enkorafenib podliježe minimalnoj eliminaciji putem bubrega.
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.
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.
Permanent discontinuation of encorafenib should be considered.
Treba razmotriti trajno obustavljanje enkorafeniba.
If concomitant use with a strong CYP3A inhibitor is necessary, patients should be carefully monitored for safety (see section 4.5).
Ako je neophodna istodobna primjena snažnih inhibitora CYP3A, bolesnike je radi sigurnosti potrebno pomno nadzirati (vidjeti dio 4.5).
Braftovi may reduce sperm count in males.
Plodnost Lijek Braftovi može smanjiti broj spermatozoida u muškaraca.
Encorafenib 450 mg in combination with binimetinib (n = 274)
Enkorafenib 450 mg u kombinaciji s binimetinibom (n = 274)
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.
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
Encorafenib is metabolised by CYP3A4, CYP2C19 and CYP2D6.
Enkorafenib se metabolizira pomoću CYP3A4, CYP2C19 i CYP2D6.
Encorafenib and binimetinib (a MEK inhibitor, see section 5.1 of binimetinib SmPC) both inhibit the MAPK pathway, resulting in higher anti-tumour activity.
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.
• First occurrence of any Grade 4 adverse reaction
• Prvi nastup bilo kojih nuspojava stupnja 4
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).
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).
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.
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.
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).
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).
Copovidone (E1208) Poloxamer 188
Kopovidon (E1208)
If encorafenib is temporarily interrupted (see Table 2), binimetinib should be interrupted.
Ako je enkorafenib privremeno prekinut (vidjeti Tablicu 2), treba prekinuti s doziranjem binimetiniba.
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.
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.
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.
CYP3A4 enzima (npr. hormonski kontraceptivi) može prouzročiti povećanje toksičnosti ili smanjenje djelotvornosti ovih lijekova.
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).
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).
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).
American Joint Committee on Cancer) (IIIB, IIIC, IVM1a ili IVM1b, naspram IVM1c) i funkcionalnim statusima Istočne kooperativne onkološke skupine ECOG (engl.
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.
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.
- Kidney problems: Braftovi can alter your kidney activity (often abnormal blood tests, more rarely dehydration and vomiting).
- Problemi s bubrezima: Lijek Braftovi može promijeniti aktivnost Vaših bubrega (često uzrokovati odstupanja u rezultatima krvnih pretraga, a rjeđe dehidraciju i povraćanje).
Effect of encorafenib on binimetinib
Učinak enkorafeniba na binimetinib
Supraventricular tachycardiad
Često supraventrikularna tahikardijad
Effect of CYP enzymes on encorafenib
Učinak CYP enzima na enkorafenib
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.
Istodobna primjena enkorafeniba s lijekovima koji induciraju CYP3A4 nije procijenjena kliničkim ispitivanjem, ali smanjenje izloženosti enkorafenibu vjerojatno je i može rezultirati smanjenjem djelotvornosti lijeka.
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).
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).
Other skin cancers: Treatment with Braftovi may result in a different type of skin cancer such as cutaneous squamous cell carcinoma.
Drugi karcinomi kože: Liječenje lijekom Braftovi može prouzročiti drugačiji tip raka kože, kao što je planocelularni karcinom.
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).
< 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidence of liver laboratory abnormalities was:
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, incidencija odstupanja laboratorijskih vrijednosti jetrenih funkcija bila je:
PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Preživljenje bez progresije (PFS) je prema ocjeni ispitivača bila potporna analiza djelotvornosti.
Additionally, the combination of encorafenib and binimetinib prevented the emergence of resistance in BRAFV600E mutant human melanoma xenografts in vivo.
Također, kombinacija enkorafeniba i binimetiniba sprečava pojavu rezistencije u ksenografta ljudskog melanoma s BRAFV600E mutacijom in vivo.