FrancophonIA/ELRC3.0 huggingface dataset:
English: At the pre-specified analysis with a 19 December 2011 data cut, a significant improvement in the primary endpoint of PFS (HR=0.30; 95% Cl 0.18, 0.51; p < 0.0001) was achieved.
Croatian: U prethodno određenoj analizi s podacima zaključenim 19. prosinca 2011., dosegnuto je značajno poboljšanje primarnog ishoda PFS (HR=0,30; 95% CI 0,18; 0,51; p < 0,0001).
English: Tafinlar 50 mg and 75 mg hard capsules are available in packs containing 28 or 120 capsules.
Croatian: Tafinlar 50 mg i 75 mg tvrde kapsule dostupne su u pakiranjima od 28 ili 120 kapsula.
English: The most commonly observed BRAF mutation is V600E which accounts for approximately 90% of the BRAF mutations that are seen in melanoma.
Croatian: Najčešća BRAF mutacija je V600E, koja predstavlja oko 90% BRAF mutacija koje nalazimo u melanomima.
English: Two of these patients had a QTcB Grade 3 increase (>500 msec) that was also an increase >60 msec from baseline.
Croatian: Dvoje od tih bolesnika imalo je povećanje QTcB 3. stupnja (> 500 ms) koje je ujedno bilo i povećanje > 60 ms od početne vrijednosti.
English: Dabrafenib related material is excreted primarily in faeces, with 71% of an oral dose recovered in faeces; 23% of the dose was recovered in urine in the form of metabolites only.
Croatian: Spojevi koji potječu od dabrafeniba se primarno izlučuju u stolicu, 71% oralne doze pronađeno je u stolici; 23% doze pronađeno je u urinu samo u obliku metabolita.
English: Tafinlar is a medicine that contains the active substance dabrafenib.
Croatian: Tafinlar je lijek koji sadrži djelatnu tvar dabrafenib.
English: Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care (see sections 4.2 and 4.4).
Croatian: Bolesnici u kojih se javila ozbiljna neinfektivna vrućica dobro su reagirali na prekid doziranja i/ili smanjenje doze i suportivnu njegu (vidjeti dijelove 4.2 i 4.4).
English: Women of childbearing potential must use effective methods of contraception during therapy and for 2 weeks following discontinuation of dabrafenib and 16 weeks following the last dose of trametinib when given in combination with dabrafenib.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom terapije dabrafenibom te još 2 tjedna nakon prekida terapije dabrafenibom, odnosno još 16 tjedana nakon posljednje doze trametiniba kada se daje u kombinaciji s dabrafenibom.
English: LVEF reduction/Left ventricular dysfunction
Croatian: Smanjenje LVEF/disfunkcija lijeve klijetke
English: In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastrointestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone.
Croatian: U ispitivanju na psima u kojem su se trametinib i dabrafenib davali u kombinaciji tijekom 4 tjedna, bili su uočeni znakovi gastrointestinalne toksičnosti i smanjena celularnost limfnog tkiva timusa pri nižim izloženostima nego u pasa kojima se davao samo trametinib.
English: • eye redness and irritation
Croatian: • crvenilo oka i iritaciju
English: 24.6 (11.7, NE)
Croatian: 24,6 (11,7; NO)
English: Dabrafenib has minor influence on the ability to drive and use machines.
Croatian: Dabrafenib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively).
Croatian: Procjene preživljavanja u 1. i 2. godini od randomizacije bile su 97% i 91% u skupini koja je primala kombinaciju, odnosno 94% i 83% u skupini koja je primala placebo.
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.
Croatian: Nakon primjene 150 mg dva puta dnevno, geometrijska sredina Cmax, AUC(0-) i koncentracije prije doze (C) bile su 1478 ng/ml, 4341 ng*hr/ml i 26 ng/ml.
English: Red iron oxide (E172) Titanium dioxide (E171) Hypromellose (E464)
Croatian: Ovojnica kapsule željezov oksid, crveni (E172) titanijev dioksid (E171) hipromeloza (E464)
English: Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.
Croatian: Trametinib je reverzibilan, visoko selektivan, alosterički inhibitor aktivacije mitogenom aktivirane kinaze 1 regulirane izvanstaničnim signalima (engl. mitogen-activated extracellular signal regulated kinase 1, MEK1) i MEK2 te inhibitor aktivnosti MEK kinaze.
English: • have any liver problems.
Croatian: • imate bilo kakvu bolest jetre
English: Based on the population pharmacokinetic analysis, gender and weight were found to influence dabrafenib oral clearance; weight also impacted oral volume of distribution and distributional clearance.
Croatian: Na temelju analize populacijske farmakokinetike spol i tjelesna težina su utjecale na klirens dabrafeniba nakon peroralne primjene; težina je također utjecala na volumen distribucije i distribucijski klirens.
English: Before starting treatment, tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Prije početka liječenja, obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Tell your doctor, pharmacist or nurse if you are taking any of these (or if you are not sure).
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate bilo koji od ovih lijekova (ili ako niste sigurni).
English: • Antipsychotics (e.g. haloperidol)
Croatian: • Antipsihotike (npr. haloperidol)
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Croatian: Slijed terapija nakon progresije tijekom terapije BRAF inhibitorom nije ustanovljen.
English: BRF115532 (n=1076)
Croatian: BRF113928, i BRF115532 (n=1076)
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.
Croatian: Temeljeno na izloženosti, relativnoj potentnosti i farmakokinetičkim svojstvima, oba spoja, hidroksi- i desmetildabrafenib vjerojatno pridonose kliničkoj aktivnosti dabrafeniba, dok je za aktivnost karboksidabrafeniba malo vjerojatno da će biti značajna.
English: Efficacy of dabrafenib in subjects previously treated with a protein kinase inhibitor has not been investigated.
Croatian: Djelotvornost dabrafeniba u bolesnika koji su ranije liječeni inhibitorima protein kinaze nije bila ispitivana.
English: Keep a list of the medicines you take, so you can show it to your doctor, pharmacist or nurse.
Croatian: Vodite popis svih lijekova koje uzimate kako biste ga mogli pokazati svom liječniku, ljekarniku ili medicinskoj sestri.
English: • loss of vision
Croatian: • gubitak vida
English: Based on updated data with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), the RFS benefit was maintained with an estimated HR of 0.49 [95% CI: (0.40, 0.59)] (Figure 4).
Croatian: Temeljem ažuriranih podataka s dodatnih 10 mjeseci praćenja u usporedbi s primarnom analizom (minimalni period praćenja od 40 mjeseci), održana je korist u RFS-u s utvrđenim HR od 0,49 [95% CI: (0,40; 0,59)] (slika 4).
English: * The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events (CTC-AE) v4.0
Croatian: Common Terminology Criteria for Adverse Events (CTC-AE) v4.0)
English: • Inflamed, flaky skin (exfoliative dermatitis)
Croatian: • upaljena koža koja se ljušti (eksfolijativni dermatitis)
English: What Tafinlar contains - The active substance is dabrafenib.
Croatian: Što Tafinlar sadrži - Djelatna tvar je dabrafenib.
English: Talk to your doctor if you get a skin rash while taking Tafinlar in combination with trametinib.
Croatian: Porazgovarajte s Vašim liječnikom ako dobijete kožni osip tijekom uzimanja Tafinlara u kombinaciji s trametinibom.
English: Eye problems
Croatian: Problemi s očima
English: Patients with a history of prior malignancy, if disease-free for at least 5 years, were eligible.
Croatian: Bolesnici s prethodnim zloćudnim bolestima u anamnezi, ako su bili bez bolesti najmanje 5 godina, mogli su sudjelovati u ispitivanju.
English: Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Croatian: Neklinička i klinička ispitivanja s retrospektivnom dvosmjernom Sanger sekvencionirajućom analizom pokazala su da test s manjom osjetljivosti također otkriva manje česte BRAF V600D mutacije i V600E/K601E mutacije.
English: • Hypnotics (e.g. diazepam, midazolam, zolpidem)
Croatian: • Hipnotike (npr. diazepam, midazolam, zolpidem)
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.
Croatian: Prije početka liječenja bolesnici moraju biti podvrgnuti pregledu glave i vrata minimalno s inspekcijom sluznice usne šupljine i palpacijom limfnih čvorova, kao i snimanju prsnog koša/abdomena kompjuteriziranom tomografijom (CT).
English: d 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 dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing NR = Not reached
Croatian: d a - Preživljenje bez progresije (procjena ispitivača) b - Ukupna stopa odgovora = kompletan odgovor + djelomični odgovor c - Trajanje odgovora d - U vrijeme izvješćivanja većina (59% za dabrafenib+trametinib i 42% za vemurafenib) odgovora koje je procijenio ispitivač bila je još u tijeku
English: Patients should be made aware of the potential for fatigue and eye problems to affect these activities.
Croatian: Bolesnike treba obavijestiti o mogućem umoru i poteškoćama s očima koji mogu utjecati na navedene aktivnosti.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018
Croatian: Datum posljednje obnove odobrenja: 08. svibnja 2018.
English: How to take it Swallow the capsules whole with water, one after the other.
Croatian: Kapsule progutajte cijele s vodom, jednu po jednu.
English: Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl-dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, and dabrafenib and its desmethyl metabolite were found to be inhibitors of organic cation transporter 2 (OCT2) in vitro, the risk of a drug-drug interaction at these transporters is minimal based on clinical exposure of dabrafenib and its metabolites.
Croatian: Iako su dabrafenib i njegovi metaboliti, hidroksidabrafenib, karboksidabrafenib i desmetildabrafenib, bili inhibitori humanih transportera organskih aniona (OAT) 1 i OAT3 in vitro, i dabrafenib i njegov desmetil metabolit su inhibitori transportera organskih kationa 2 (OCT2) in vitro, temeljem kliničke izloženosti dabrafenibu i njegovim metabolitima rizik od interakcije lijeka s drugim lijekom na tim transporterima je minimalan.
English: Some medicines may affect how Tafinlar works, or make it more likely that you will have side effects.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Tafinlar, ili mogu povećati vjerojatnost pojave nuspojava.
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
Croatian: (korioretinopatija), odvajanje membrane osjetljive na svjetlost u pozadini oka (mrežnice) od potpornih slojeva (odignuće mrežnice) i oticanje oko očiju
English: The onset of these serious non-infectious febrile events was typically within the first month of therapy.
Croatian: Navedeni događaji ozbiljne neinfektivne vrućice obično su se javljali unutar prvog mjeseca liječenja.
English: • Inflammation of the fatty layer under the skin (panniculitis)
Croatian: • upala masnog sloja ispod kože (panikulitis)
English: The potential effect of dabrafenib on QT prolongation was assessed in a dedicated multiple dose QT study.
Croatian: Potencijalni učinak dabrafeniba na produljenje QT intervala procjenjivan je u ciljanom QT ispitivanju s višestrukim dozama.
English: Potent inducers of these enzymes should be avoided when possible as these agents may decrease the efficacy of dabrafenib (see section 4.5).
Croatian: Kada je to moguće, potrebno je izbjegavati snažne induktore tih enzima budući da mogu umanjiti djelotvornost dabrafeniba (vidjeti dio 4.5).
English: These changes in dabrafenib AUC and Cmax are considered not clinically meaningful.
Croatian: Te promjene AUC-a i Cmax-a za dabrafenib ne smatraju se klinički značajnima.
English: Signs that your liver may not be working properly may include: - loss of appetite - feeling sick (nausea) - being sick (vomiting) - pain in your stomach (abdomen) - yellowing of your skin or the whites of your eyes (jaundice) - dark-coloured urine - itching of your skin
Croatian: Znakovi da Vaša jetra možda ne radi kako treba mogu uključivati: - gubitak apetita - mučninu - povraćanje - bol u trbuhu (abdomenu) - žutilo kože ili bjeloočnica (žutica) - tamnu mokraću - svrbež na koži
English: There is no specific treatment for an overdose of dabrafenib.
Croatian: Ne postoji specifična terapija za slučaj predoziranja dabrafenibom.
English: Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations.
Croatian: Lijekovi koji su snažni inhibitori ili induktori CYP2C8 ili CYP3A4 vjerojatno će stoga povisiti ili sniziti koncentracije dabrafeniba.
English: The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Croatian: Test je dizajniran za detekciju BRAF V600E i V600K mutacija s visokom osjetljivosti (manje od 5% V600E i V600K sekvenci u pozadini sekvenci divljeg tipa koristeći DNK izoliranu iz FFPE tkiva).
English: Tafinlar in combination with trametinib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Croatian: Tafinlar u kombinaciji s trametinibom koristi se i za liječenje vrste raka pluća koji se zove rak pluća nemalih stanica (NSCLC).
English: In clinical trials in unresectable or metastatic melanoma,these cases were identified within the first 5 months of dabrafenib as monotherapy.
Croatian: U kliničkim ispitivanjima neoperabilnog ili metastatskog melanoma, ti slučajevi identificirani su unutar prvih 5 mjeseci monoterapije dabrafenibom.
English: A small decrease in trametinib bioavailability, corresponding to a decrease in AUC of 12%, was estimated when trametinib is administered in combination with dabrafenib, a CYP3A4 inducer, using a population pharmacokinetic analysis.
Croatian: Malo smanjenje u bioraspoloživosti trametiniba, koje odgovara smanjenju AUC-a od 12%, bilo je procijenjeno kada je trametinib bio primijenjen u kombinaciji s dabrafenibom, CYP3A4 induktorom, koristeći analizu populacijske farmakokinetike.
English: Check with your doctor if you think any of these may apply to you.
Croatian: Porazgovarajte sa svojim liječnikom ako mislite da se bilo što od ovog odnosi na Vas.
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 2).
Croatian: Čini se da se Kaplan-Meierova krivulja OS-a stabilizira od 3. do 5. godine (vidjeti sliku 2).
English: Therapy should be interrupted if the patient's temperature is ≥38.5ºC.
Croatian: Terapija se mora prekinuti u slučaju povišenja tjelesne temperature bolesnika na ≥ 38,5ºC.
English: The majority of subjects had Stage IVM1c disease (67%).
Croatian: Većina ispitanika imala je bolest stadija IVM1c (67%).
English: • Joint pain, muscle pain, or pain in the hands or feet
Croatian: • bolovi u zglobovima, bolovi u mišićima ili bolovi u šakama i stopalima
English: It should be noted that approximately half of these occurrences with dabrafenib monotherapy (4%) and 1% with dabrafenib in combination with trametinib were Grade 3 in severity.
Croatian: Treba napomenuti da je oko polovine od tih slučajeva s dabrafenibom kao monoterapijom (4%) i 1% s dabrafenibom u kombinaciji s trametinibom bilo 3. stupnja težine.
English: No clinically relevant effect of dabrafenib or its metabolites on the QTc interval was observed.
Croatian: Nije uočen klinički značajan učinak dabrafeniba ili njegovih metabolita na QTc interval.
English: • Birth control medicines containing hormones (such as pills, injections or patches) may not work as well while you are taking Tafinlar or combination treatment (Tafinlar as well as trametinib).
Croatian: • Lijekovi za sprječavanje trudnoće koji sadrže hormone (poput pilula, injekcija ili flastera) mogu imati oslabljeno djelovanje tijekom uzimanja lijeka Tafinlar ili kombinirane terapije (i Tafinlar i trametinib).
English: If possible, show them the Tafinlar pack with this leaflet.
Croatian: Ako je moguće, pokažite im pakiranje lijeka Tafinlar te ovu uputu o lijeku.
English: A supratherapeutic dose of 300 mg dabrafenib twice daily was administered in 32 subjects with BRAF V600 mutation-positive tumours.
Croatian: Supraterapijska doza od 300 mg dabrafeniba dva puta dnevno primjenjivana je u 32 ispitanika s tumorima pozitivnim na BRAF V600 mutaciju.
English: The ORR results assessed by IRC were consistent with the investigator assessment.
Croatian: Rezultati za ORR koje je procijenio neovisni odbor za procjenu bili su u skladu s procjenom ispitivača.
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.
Croatian: Izloženost dabrafenibu (Cmax i AUC) povećavala se proporcionalno dozi između 12 i 300 mg nakon primjene u jednoj dozi, ali je povećanje bilo manje proporcionalno dozi nakon dva puta dnevno ponovljene doze.
English: For additional information on warnings and precautions associated with trametinib treatment, please refer to the trametinib SmPC.
Croatian: Za dodatne informacije o upozorenjima i mjerama opreza povezanima s liječenjem trametinibom, pogledajte sažetak opisa svojstava lijeka za trametinib.
English: Table 4 Adverse reactions reported in the integrated safety population of dabrafenib in combination with trametinib in the studies MEK115306, MEK116513
Croatian: Tablica 4 Nuspojave zabilježene u objedinjenoj populaciji u kojoj se ispitivala sigurnost za dabrafenib u kombinaciji s trametinibom u ispitivanjima MEK115306, MEK116513
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 1).
Croatian: Čini se da se Kaplan-Meierova krivulja OS-a stabilizira od 3. do 5. godine (vidjeti sliku 1).
English: • Infection of the urinary system
Croatian: • infekcija mokraćnog sustava
English: Therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5ºC (please refer to Table 2 for dose modification guidance).
Croatian: Terapija dabrafenibom mora se prekinuti u slučaju porasta tjelesne temperature bolesnika na ≥ 38,5ºC (pogledajte tablicu 2 za smjernice o prilagodbi doze).
English: If the fever is severe, your doctor may recommend that you stop taking Tafinlar while they treat the fever with other medicines.
Croatian: Ako je vrućica izrazita, liječnik Vam može predložiti prekid terapije lijekom Tafinlar dok traje liječenje vrućice drugim lijekovima.
English: Skin peeling.
Croatian: Ljuštenje kože.
English: As of 25 June 2012 cut-off, thirty five subjects (55.6%) of the 63 randomised to DTIC had crossed over to dabrafenib and 63% of subjects randomised to dabrafenib and 79% of subjects randomised to DTIC had progressed or died.
Croatian: Prema podacima od 25. lipnja 2012., 35 ispitanika (55,6%) od 63 randomiziranih na DTIC je prešlo na dabrafenib, te je 63% ispitanika randomiziranih na dabrafenib i 79% ispitanika randomiziranih na DTIC imalo progresiju bolesti ili je umrlo.
English: b This study was designed to support or reject the null hypothesis of OIRR ≤10% (based on historical results) in favour of the alternative hypothesis of OIRR ≥ 30% in BRAF V600E mutation positive subjects.
Croatian: b Ovo je ispitivanje dizajnirano za potvrdu ili odbacivanje nulte hipoteze OIRR ≤ 10% (temeljeno na ranijim podacima) u prilog alternativne hipoteze OIRR ≥ 30% u ispitanika s BRAF V600E
English: • reddish patches on the trunk that are circular or target-shaped, with central blisters.
Croatian: • crvenkaste mrlje na trupu koje su kružnog oblika ili u obliku mete, s mjehurićima u sredini.
English: Prior BRAF inhibitor therapy
Croatian: Prethodna terapija BRAF inhibitorom
English: Patients taking Tafinlar may commonly (may affect up to 1 in 10 people) develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Croatian: Bolesnici koji uzimaju Tafinlar mogu često (može se javiti u do 1 na 10 osoba) razviti drugačiju vrstu kožnog raka koji se naziva planocelularni karcinom kože.
English: The median time to onset of the first occurrence of cuSCC in the combination arm of the adjuvant treatment study was approximately 18 weeks and was 33 weeks in the placebo arm.
Croatian: Medijan vremena do prve pojave cuSCC-a bio je otprilike 18 tjedana u skupini koja je primala kombinaciju u ispitivanju adjuvantnog liječenja i 33 tjedna u skupini koja je primala placebo.
English: Sixty percent of patients were male and 99.6% were Caucasian; the median age was 52 years with 21% of patients being ≥65 years, 98.4% had ECOG status of 0 or 1, and 97% of patients had metastatic disease.
Croatian: Šezdeset posto bolesnika su bili muškarci i 99,6% bijele rase; medijan dobi je bio 52 godine s 21% bolesnika ≥ 65 godina, 98,4% je imalo ECOG status 0 ili 1, a 97% bolesnika je imalo metastatsku bolest.
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.
Croatian: Od ukupno 93 bolesnika koliko ih je bilo uključeno u kohorte B i C koje su primale kombiniranu terapiju, većina su bili bijelci (>90%), sa sličnim omjerom žena u odnosu na muškarce (54% naspram 46%), uz medijan dobi od 64 godine u bolesnika na drugoj ili višoj liniji terapije te 68 godina u bolesnika na prvoj liniji.
English: Activation of MAP-kinase signalling in BRAF wild type cells which are exposed to BRAF inhibitors may lead to increased risk of non-cutaneous malignancies, including those with RAS mutations (see section 4.4).
Croatian: Aktivacija signalnog puta MAP-kinaze u stanicama s divljim tipom BRAF gena koje su izložene BRAF inhibitorima može dovesti do povećanog rizika od zloćudnih bolesti koje neće zahvatiti kožu, uključujući onih s RAS mutacijama (vidjeti dio 4.4).
English: Effect of food on dabrafenib
Croatian: Učinak hrane na dabrafenib
English: OS data from a further post-hoc analysis based on the 18 December 2012 data cut demonstrated a 12-month OS rate of 63% and 70% for DTIC and dabrafenib treatments, respectively.
Croatian: Podaci o OS-u iz daljnje post-hoc analize temeljene na podacima sa zaključno 18. prosinca 2012. pokazali su da dvanaestomjesečni OS iznosi 63% za DTIC i 70% za dabrafenib.