FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on exposure, relative potency, and pharmacokinetic properties, both hydroxy- and desmethyl-dabrafenib are likely to contribute to the clinical activity of dabrafenib while the activity of carboxy-dabrafenib is not likely to be significant.
Slovenian: Na podlagi izpostavljenosti, relativne jakosti in farmakokinetičnih lastnosti verjetno h kliničnemu delovanju prispevata tako hidroksi- kot dezmetildabrafenib, medtem ko za delovanje karboksidabrafeniba ni verjetno, da bi bilo pomembno.
English: Following administration of 150 mg twice daily, geometric mean Cmax, AUC(0-) and predose concentration (C) were 1478 ng/ml, 4341 ng*hr/ml and 26 ng/ml, respectively.
Slovenian: Po uporabi 150 mg dvakrat na dan so bila geometrična povprečja Cmax 1478 ng/mL, AUC(0-) 4341 ng*h/mL in koncentracije pred odmerkom (C) 26 ng/mL.
English: Groups of medicinal products that can be affected include, but are not limited to:
Slovenian: To lahko velja za, vendar ni omejeno na, spodaj naštete skupine zdravil:
English: separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) and swelling around the eyes
Slovenian: odstop membrane, ki je občutljiva za svetlobo in leži na očesnem ozadju (mrežnice) od spodaj ležeče plasti (odstop mrežnice) in oteklina okrog oči
English: In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥0.2 times adult human clinical exposure based on AUC).
Slovenian: V študijah juvenilne toksičnosti pri podganah so opažali učinke na rast (krajša dolžina dolgih kosti), ledvično toksičnost (tubularni depoziti, večja incidenca kortikalnih cist in tubularna bazofilija ter reverzibilno zvišanje koncentracije sečnine in/ali kreatinina) in testikularno toksičnost (degeneracija in dilatacija tubulov) (≥ 0,2-kratna klinična izpostavljenost pri odraslem človeku na podlagi AUC).
English: Therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5ºC (please refer to Table 2 for dose modification guidance).
Slovenian: Zdravljenje z dabrafenibom je treba prekiniti, če je bolnikova telesna temperatura ≥ 38,5 °C (za navodila za prilagajanje odmerka glejte preglednico 2).
English: Tafinlar is for oral use.
Slovenian: Zdravilo Tafinlar je namenjeno peroralni uporabi.
English: N=5 3.1 (2.8, NR)
Slovenian: N = 5 3,1 (2,8; ND)
English: • halo (seeing a blurred outline around objects)
Slovenian: • odsevi (zamegljeni obrisi okoli predmetov)
English: Worst-case QTc prolongation of >60 millisecond (msec) was observed in 3% of dabrafenib-treated subjects (one >500 msec in the integrated safety population).
Slovenian: Največje podaljšanje intervala QTc za > 60 milisekund (ms) so opazili pri 3 % oseb, ki so se zdravile z dabrafenibom (en primer podaljšanja na > 500 ms v združeni populaciji za oceno varnosti).
English: For dabrafenib monotherapy in study MEK115306, cutaneous squamous cell carcinomas (including those classified as keratoacanthoma or mixed keratoacanthoma subtype) occurred in 10% of patients and approximately 70% of the events occurred within the first 12 weeks of treatment with a median time to onset of 8 weeks.
Slovenian: Pri uporabi dabrafeniba v monoterapiji v študiji MEK115306 so se ploščatocelični karcinomi kože (vključno s spremembami, prepoznanimi kot keratoakantom ali mešani keratoakantomski podtip) pojavili pri 10 % bolnikov, pri čemer se je približno 70 % dogodkov pojavilo v prvih 12 tednih zdravljenja, mediana časa nastanka je bila 8 tednov.
English: Dabrafenib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay and in vivo at doses ≥100 mg/kg (>44 times clinical exposure based on Cmax) in an oral phototoxicity study in hairless mice.
Slovenian: Dabrafenib je bil fototoksičen za mišje fibroblaste v in vitro preskusu fototoksičnosti 3T3 NRU (Neutral Red Uptake) in in vivo pri odmerkih ≥ 100 mg/kg (> 44-kratna klinična izpostavljenost na podlagi Cmax) v peroralni študiji fototoksičnosti pri brezdlakavih miših.
English: Efficacy of dabrafenib in subjects previously treated with a protein kinase inhibitor has not been investigated.
Slovenian: Učinkovitost dabrafeniba še ni raziskana pri bolnikih, predhodno zdravljenih s kakšnim zaviralcem proteinske kinaze.
English: • High blood pressure (hypertension)
Slovenian: • zvišan krvni tlak (hipertenzija)
English: Taking Tafinlar in combination with trametinib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Slovenian: Jemanje zdravila Tafinlar v kombinaciji s trametinibom lahko povzroči resno krvavitev, med drugim krvavitev v možganih, v prebavilih (npr. v želodcu, danki ali črevesju), v pljučih in drugih organih, bolnik lahko zaradi krvavitve tudi umre.
English: If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time.
Slovenian: Če je zamuda z izpuščenim odmerkom daljša od 6 ur, preskočite izpuščeni odmerek in vzemite naslednji odmerek ob običajnem času.
English: • after taking Tafinlar, you must wait at least 1 hour before eating, or
Slovenian: • morate po jemanju zdravila Tafinlar počakati vsaj 1 uro, preden jeste, ali
English: Primary analysis (data cut-off: 26-Aug-2013)
Slovenian: Primarna analiza (konec zbiranja podatkov: 26-avg-2013)
English: The IUO is an allele-specific polymerase chain reaction (PCR) assay performed on DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumour tissue.
Slovenian: IUO je alelsko specifičen test z verižno reakcijo s polimerazo (PCR), ki se opravi na DNA, pridobljeni iz tumorskega tkiva, fiksiranega s formalinom in vklopljenega v parafin (FFPEformalin-fixed paraffin-embedded).
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Slovenian: Beljakovine MEK so del poti ERK (ERK - z zunajceličnim signalom povezana kinaza).
English: Tafinlar can have side effects that may affect your ability to drive or use machines.
Slovenian: Zdravilo Tafinlar ima lahko neželene učinke, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev.
English: N Events Median, months (95% CI) NA (46.9, NA)
Slovenian: N dogodki mediana, meseci (95% IZ) NA (46,9; NA)
English: (7.5, NR) a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (≥59%) of investigator-assessed responses were still ongoing e - ORR difference calculated based on the ORR result not rounded f - Updated analysis was not pre-planned and the p-value was not adjusted for multiple testing NR = Not reached
Slovenian: a - PFS: preživetje brez napredovanja bolezni (angl. Progression Free Survival) (po oceni raziskovalca) b - ORR: stopnja celokupnega odziva (angl. Overall Response Rate) = popolni odziv + delni odziv c - DoR: trajanje odziva (angl. duration of response) d - v času poročanja je večina (≥ 59 %) odzivov po oceni raziskovalca še trajala e - razlika v stopnji celokupnega odziva (ORR) je izračunana iz nezaokroženih vrednosti posameznih ORR f - posodobljena analiza ni bila vnaprej načrtovana, vrednost p pa se ni prilagodila za večkratno testiranje.
English: The safety profile from MEK116513 is generally similar to that of MEK115306 with the following exceptions: 1) The following adverse reactions have a higher frequency category as compared to MEK115306: muscle spasm (very common); renal failure and lymphoedema (common); acute renal failure (uncommon); 2) The following adverse reactions have occurred in MEK116513 but not in MEK115306: cardiac failure, left ventricular dysfunction, interstitial lung disease (uncommon).
Slovenian: Varnostni profil v študiji MEK116513 je bil večinoma podoben kot v študiji MEK115306 z naslednjimi izjemami: 1. naslednji neželeni učinki so razvrščeni v višjo kategorijo pogostnosti kot v študiji MEK115306: mišični krči (zelo pogosti); odpoved ledvic in limfedem (pogosti); akutna odpoved ledvic (občasni); 2. naslednji neželeni učinki so se pojavljali v študiji MEK116513, niso pa se pojavljali v študiji MEK115306: srčno popuščanje, disfunkcija levega prekata, intersticijska bolezen pljuč (občasni).
English: Carboxy-dabrafenib is excreted in bile and urine.
Slovenian: Karboksidabrafenib se izloča v žolču in urinu.
English: No clinically relevant effect of dabrafenib or its metabolites on the QTc interval was observed.
Slovenian: Klinično pomembnih učinkov dabrafeniba ali njegovih presnovkov na podaljšanje intervala QTc niso opazili.
English: • Allergic reactions (hypersensitivity)
Slovenian: • alergijske reakcije (preobčutljivost)
English: • have heart problems such as heart failure or problems with the way your heart beats.
Slovenian: • če imate težave s srcem, kot je srčno popuščanje ali težave z nepravilnim bitjem srca,
English: Table 3 Adverse reactions reported in the integrated safety population of dabrafenib monotherapy in the studies BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680 (n=578)
Slovenian: Preglednica 3 Neželeni učinki, o katerih so poročali pri skupini za vrednotenje varnosti zdravila, zdravljeni z dabrafenibom v monoterapiji v študijah BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220 in BRF112680 (n=578)
English: Tell your doctor immediately if it feels like your heart is pounding, racing, or beating irregularly, or if you experience dizziness, tiredness, light-headedness, shortness of breath or swelling in the legs.
Slovenian: Zdravniku morate takoj povedati, če čutite razbijanje srca, hitro ali neredno bitje srca, omotico, utrujenost, vrtoglavost, kratko sapo ali otekanje nog.
English: Hydroxy-dabrafenib terminal half-life parallels that of parent with a half-life of 10 hrs while the carboxy- and desmethyl-metabolites exhibited longer half-lives (21-22 hours).
Slovenian: Terminalni razpolovni čas hidroksidabrafeniba je podoben razpolovnemu času matične učinkovine in znaša 10 ur, razpolovna časa karboksi- in dezmetilnega presnovka pa sta daljša (21 do 22 ur).
English: • Inflammation of the heart muscle (myocarditis) which can result in breathlessness, fever,
Slovenian: • vnetje srčne mišice (miokarditis), ki lahko povzroči zadihanost, zvišano telesno temperaturo,
English: Figure 2 Kaplan-Meier overall survival curves for Study MEK116513
Slovenian: Slika 2 Kaplan-Meierjevi krivulji celokupnega preživetja v študiji MEK116513
English: There is no specific treatment for an overdose of dabrafenib.
Slovenian: Za preveliko odmerjanje dabrafeniba ni specifičnega zdravljenja.
English: MEK115306 (COMBI-d):
Slovenian: Študija MEK115306 (COMBI-d):
English: Granulomatous nephritis has been reported (see section 4.8).
Slovenian: Poročali so o granulomatoznem nefritisu (glejte poglavje 4.8).
English: Ask your doctor, pharmacist or nurse for advice.
Slovenian: Za nasvet prosite zdravnika, farmacevta ali medicinsko sestro.
English: Following co-administration of a single dose of rosuvastatin (OATP1B1, OATP1B3 and BCRP substrate) with repeat-dose dabrafenib 150 mg twice daily in 16 patients, Cmax of rosuvastatin increased 2.6-fold whereas the AUC was only minimally changed (7% increase).
Slovenian: Pri sočasni uporabi enkratnega odmerka rosuvastatina (substrata OATP1B1, OATP1B3 in BCRP) s ponavljajočimi odmerki dabrafeniba 150 mg dvakrat dnevno pri 16 bolnikih, se je Cmax rosuvastatina povečala za 2,6-krat, medtem ko se je AUC spremenila le minimalno (7% povečanje).
English: Of the total number of patients in the integrated safety population of dabrafenib monotherapy (n=578), 22% were 65 years of age and older, and 6% were 75 years of age and older.
Slovenian: Od celotnega števila bolnikov v skupini za vrednotenje varnosti zdravila pri uporabi dabrafeniba v monoterapiji (n = 578) je bilo 22 % starih 65 let ali več in 6 % 75 let ali več.
English: Dabrafenib exposure (Cmax and AUC) increased in a dose proportional manner between 12 and 300 mg following single-dose administration, but the increase was less than dose-proportional after repeat twice daily dosing.
Slovenian: Izpostavljenost dabrafenibu (Cmax in AUC) se je po uporabi enkratnega odmerka v razponu od 12 do 300 mg povečevala sorazmerno odmerku, po ponavljajočem se odmerjanju dvakrat na dan pa je bil porast manj kot sorazmeren odmerku.
English: If fever is associated with other severe signs or symptoms, dabrafenib should be restarted at a reduced dose once fever resolves and as clinically appropriate (see section 4.2).
Slovenian: Če je zvišana telesna temperatura povezana z drugimi hudimi znaki ali simptomi, je treba zdravljenje z dabrafenibom znova začeti z nižjim odmerkom, ko zvišana telesna temperatura mine in kot je klinično primerno (glejte poglavje 4.2).
English: Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see section 4.4).
Slovenian: Prilagoditve odmerka ali prekinitve zdravljenja niso priporočljive v primeru neželenih učinkov ploščatoceličnega karcinoma kože ali novega primarnega melanoma (glejte poglavje 4.4).
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second line or higher patients and 68 years in the first line patients.
Slovenian: Med skupno 93 bolniki, ki so bili vključeni v kohorti B in C s kombiniranim zdravljenjem, je bila večina belcev (> 90 %), žensk je bilo približno toliko kot moških (54 % žensk in 46 % moških), mediana starost bolnikov, ki so prejemali že najmanj drugo linijo zdravljenja, je bila 64 let, pri bolnikih, ki so prejemali prvo linijo zdravljenja, pa je bila mediana starosti 68 let.
English: Dabrafenib can be restarted once the fever resolves with appropriate prophylaxis using non-steroidal anti-inflammatory medicinal products or paracetamol.
Slovenian: Ko zvišana telesna temperatura mine, je mogoče zdravljenje z dabrafenibom znova začeti ob ustrezni profilaksi z uporabo nesteroidnih protivnetnih zdravil ali paracetamola.
English: Your doctor may advise an eye examination before you take Tafinlar in combination with trametinib and while you are taking it.
Slovenian: Zdravnik vam lahko svetuje pregled oči pred začetkom jemanja zdravila Tafinlar v kombinaciji s trametinibom in med zdravljenjem s to kombinacijo.
English: When you take Tafinlar and trametinib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).
Slovenian: V času jemanja zdravila Tafinlar skupaj s trametinibom se lahko pojavi katerikoli od zgoraj naštetih neželenih učinkov, vendar je pogostnost pojavljanja lahko drugačna (večja ali manjša).
English: Changes in your skin Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib (frequency not known).
Slovenian: Spremembe na koži Pri bolnikih, ki so jemali zdravilo Tafinlar v kombinaciji s trametinibom, so poročali o resnih kožnih reakcijah (pogostnost ni znana).
English: Dabrafenib in combination with trametinib in patients with brain metastases
Slovenian: Dabrafenib v kombinaciji s trametinibom pri bolnikih z metastazami v možganih
English: If you are breast-feeding, or planning to breast-feed, you must tell your doctor.
Slovenian: Če dojite ali nameravate dojiti, morate to povedati zdravniku.
English: Non-small cell lung cancer (NSCLC)
Slovenian: Nedrobnocelični pljučni rak (NDCPR)
English: MEK116513 (COMBI-v):
Slovenian: Študija MEK116513 (COMBI-v):
English: • Flu-like illness
Slovenian: • gripi podobna bolezen
English: Prior to initiation of treatment patients should undergo a head and neck examination with minimally visual inspection of oral mucosa and lymph node palpation, as well as chest/abdomen computerised tomography (CT) scan.
Slovenian: Bolnikom je treba pred uvedbo zdravljenja pregledati glavo in vrat (pregled mora obsegati najmanj ogled ustne sluznice in palpacijo bezgavk) in opraviti morajo računalniško tomografsko slikanje (CT) prsnega koša/trebuha.
English: • skin sore or reddish bump that bleeds or does not heal
Slovenian: • razjedo na koži ali rdečkasto bulo, ki krvavi in se ne celi
English: What Tafinlar contains - The active substance is dabrafenib.
Slovenian: Kaj vsebuje zdravilo Tafinlar - Učinkovina je dabrafenib.
English: (22.6, NR)
Slovenian: (22,6; ND)
English: Primary analysis (Data cut-off: 17Apr-2014)
Slovenian: Primarna analiza (konec zbiranja podatkov: 17-apr-2014)
English: • Low blood pressure (hypotension)
Slovenian: • nizek krvni tlak (hipotenzija)
English: RAS-associated malignancies have been reported in clinical trials, both with another BRAF inhibitor (chronic myelomonocytic leukaemia and non-cutaneous SCC of the head and neck) as well as with dabrafenib monotherapy (pancreatic adenocarcinoma, bile duct adenocarcinoma) and with dabrafenib in combination with the MEK inhibitor, trametinib (colorectal cancer, pancreatic cancer).
Slovenian: V kliničnih študijah so bili opisani malignomi povezani z RAS, in sicer tako z drugim zaviralcem BRAF (kronična mielomonocitna levkemija in nekožni ploščatocelični karcinom glave in vratu), kot z dabrafenibom v monoterapiji (adenokarcinom pankreasa, adenokarcinom žolčnih vodov) in dabrafenibom v kombinaciji z zaviralcem MEK, trametinibom (kolorektalni rak, rak pankreasa).
English: In the integrated safety population for dabrafenib in combination with trametinib, 2% of patients developed cuSCC and the events occurred later than with dabrafenib monotherapy with a median time to onset of 18-31 weeks.
Slovenian: V skupini za vrednotenje varnosti zdravila pri bolnikih, ki so prejemali dabrafenib v kombinaciji s trametinibom, so se ploščatocelični karcinomi kože razvili v 2 %, tovrstni dogodki pa so se pojavili kasneje kot pri uporabi dabrafeniba v monoterapiji z mediano časa do nastanka 18-31 tednov.
English: In combined female fertility, early embryonic and embryo-foetal development studies in rats numbers of ovarian corpora lutea were reduced in pregnant females at 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), but there were no effects on oestrous cycle, mating or fertility indices.
Slovenian: V kombiniranih študijah plodnosti samic, zgodnjega embrionalnega ter embriofetalnega razvoja pri podganah se je število rumenih telesc v jajčniku pri brejih podganah ob odmerku 300 mg/kg/dan (to je približno 3-kratna klinična izpostavljenost pri človeku na podlagi AUC) zmanjšalo, ni pa bilo vplivov na estrusni ciklus, parjenje ali indekse plodnosti.
English: Patients were randomised 1:1 to receive either combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily) or two placebos for a period of 12 months.
Slovenian: Bolnike so randomizirali v razmerju 1:1 tako, da so prejemali bodisi kombinirano zdravljenje (dabrafenib 150 mg dvakrat na dan in trametinib 2 mg enkrat na dan) ali dva placeba v obdobju 12 mesecev.
English: Monitoring for skin lesions should occur as described for cuSCC.
Slovenian: Nadzor nad kožnimi spremembami je treba izvajati, kot je opisano za ploščatocelični karcinom kože.
English: Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.
Slovenian: Dabrafenib je dokazano zaviral navzdolnji farmakodinamski biološki označevalec (fosforilirano ERK) in zavrl celično rast melanomskih celičnih linij z mutacijo BRAF V600 in vitro in v živalskih modelih.
English: Please see trametinib SmPC (see section 4.6) when used in combination with trametinib.
Slovenian: Prosimo glejte povzetek glavnih značilnosti trametiniba (glejte poglavje 4.6) pri uporabi v kombinaciji s trametinibom.
English: N=99 5.6 (4.8, NR)
Slovenian: N = 99 5,6 (4,8; ND)
English: Tell your doctor immediately if you get eye redness and irritation, blurred vision, eye pain or other vision changes during your treatment (see also section 4).
Slovenian: Zdravniku morate nemudoma povedati, če se vam med zdravljenjem pojavijo pordelost ali draženje oči, zamegljen vid, bolečine v očesu ali kakšna druga sprememba vida (glejte tudi poglavje 4).
English: ORR, DoR and PFS were also assessed by an Independent Review Committee (IRC) as a sensitivity analysis.
Slovenian: Stopnjo celokupnega odziva, trajanje odziva in preživetje brez napredovanja bolezni je ocenila tudi neodvisna ocenjevalna komisija (angl. Independent Review Committee, IRC) z analizo občutljivosti.
English: • If you take too much Tafinlar or trametinib, immediately contact your doctor, nurse or pharmacist.
Slovenian: • Če ste vzeli preveč zdravila Tafinlar ali trametiniba, takoj obvestite zdravnika, medicinsko sestro ali farmacevta.
English: Patients with melanoma driven by BRAF mutations other than V600E were excluded.
Slovenian: Bolniki z melanomom, ki ga vodijo druge mutacije BRAF, in ne V600E, so bili izključeni.
English: Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose.
Slovenian: Dabrafenib se absorbira peroralno in mediani čas do najvišje koncentracije v plazmi je 2 uri po odmerku.
English: Tafinlar 50 mg and 75 mg hard capsules are available in packs containing 28 or 120 capsules.
Slovenian: Tafinlar 50 mg trde kapsule in Tafinlar 75 mg trde kapsule so na voljo v pakiranjih po 28 ali 120 kapsul.
English: In studies of up to 13 weeks, decreases in reticulocyte counts and/or red cell mass were observed in dogs and rats (≥10 and 1.4 times clinical exposure, respectively).
Slovenian: V študijah, ki so trajale do 13 tednov, so pri psih in podganah opažali zmanjšanje števila retikulocitov in/ali mase eritrocitov (pri psih ob ≥ 10-kratni in pri podganah ob 1,4-kratni klinični izpostavljenosti).
English: • Cardiac glycosides (e.g. digoxin, see section 4.4)
Slovenian: • srčni glikozidi (npr. digoksin, glejte poglavje 4.4)
English: P < 0.001
Slovenian: b p < 0,001
English: Tafinlar in combination with trametinib is also used to prevent melanoma from coming back after it has been removed by surgery.
Slovenian: Zdravilo Tafinlar v kombinaciji s trametinibom uporabljamo tudi pri preprečevanju ponovitve bolezni po kirurški odstranitvi melanoma.
English: • Analgesics (e.g. fentanyl, methadone)
Slovenian: • analgetiki (npr. fentanil, metadon)
English: Hole in the stomach or intestine (perforation)
Slovenian: Predrtje stene želodca ali črevesa (perforacija)
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III trials and one supportive Phase I/II study.
Slovenian: Učinkovitost in varnost priporočenega odmerka trametiniba (2 mg enkrat na dan) v kombinaciji z dabrafenibom (150 mg dvakrat na dan) za zdravljenje odraslih bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 so proučevali v dveh študijah faze III in eni potrditveni študiji faze I/II.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Slovenian: Večina preiskovancev je imela ob izhodišču vrednost LDH ≤ ZMN (65 %), stanje zmogljivosti 0 po lestvici Eastern Cooperative Oncology Group (ECOG) (72 %) in zasevke v visceralnih organih (73 %).
English: There are no clinical data in subjects with moderate to severe hepatic impairment and the potential need for dose adjustment cannot be determined (see section 5.2).
Slovenian: Kliničnih podatkov za bolnike z zmerno do hudo okvaro jeter ni in morebitne potrebe po prilagoditvi odmerka ni mogoče opredeliti (glejte poglavje 5.2).
English: • Blurred vision, eyesight problems, inflammation of the eye (uveitis)
Slovenian: • zamegljen vid, težave z vidom, vnetje v očesu (uveitis)