natgillin/translations-raw huggingface dataset:
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). 
Sigurnosni profil iz MEK116513 je općenito sličan onome iz MEK115306 sa sljedećim iznimkama: 1) Sljedeće nuspojave imaju veću učestalost u usporedbi s MEK115306: spazam mišića (vrlo često); zatajenje bubrega i limfedem (često); akutno zatajenje bubrega (manje često); 2) Sljedeće nuspojave su se pojavile u MEK116513, ali ne u MEK 115306: zatajenje srca, disfunkcija lijeve klijetke, intersticijska bolest pluća (manje često).
Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old. 
Dob iznad 75 godina bila je značajan prediktor koncentracije karboksi- i desmetildabrafeniba u plazmi s 40% jačom izloženosti u ispitanika
• some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin 
• neke lijekove koji smanjuju razinu kolesterola, poput atorvastatina i simvastatina
Patients ≥65 years were more likely to experience SAEs and AEs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years. 
≥ 65 godina veća je bila vjerojatnost da će doživjeti ozbiljne štetne događaje i štetne događaje koji će dovesti do trajne obustave uzimanja lijeka, smanjenja doze i prekida doziranja nego u onih u dobi
How to take Tafinlar 
Kako uzimati Tafinlar
Administration of dabrafenib with food reduced the bioavailability (Cmax and AUC decreased by 51% and 31% respectively) and delayed absorption of dabrafenib capsules when compared to the fasted state. 
Primjena dabrafeniba uz hranu smanjila je bioraspoloživost (Cmax i AUC smanjeni za 51% odnosno 31%) i odgodila je apsorpciju kapsula dabrafeniba u usporedbi s primjenom natašte.
Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively). 
Istovremena primjena rezultirala je porastom AUC-a hidroksi- i desmetildabrafeniba (porast od 82% odnosno 68%).
Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2-receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib. 
Ne očekuje se da lijekovi koji mijenjaju pH u gornjem dijelu probavnog sustava (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) smanjuju bioraspoloživost dabrafeniba.
Tell your doctor as soon as possible if you have severe abdominal pain. 
Obratite se svom liječniku čim prije ako imate jaku bol u trbuhu.
• Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4) 
• Antikoagulanse (npr. acenokumarol, varfarin, vidjeti dio 4.4)
For the primary endpoint of investigator-assessed ORR, the ORR in the first line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously treated population was 66.7% (95% CI, 52.9%, 78.6%). 
Za ORR kao primarnu mjeru ishoda prema procjeni ispitivača, ORR u populaciji na prvoj liniji terapije bio je 61,1% (95% CI, 43,5%, 76,9%), a u prethodno liječenoj populaciji bio je 66,7% (95% CI, 52,9%, 78,6%).
Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively. 
Srednji AUC omjeri metabolita i roditeljskog spoja nakon primjene ponovljenih doza bile su 0,9, 11 i 0,7 za hidroksi-, karboksi-, i desmetildabrafenib.
When dabrafenib and trametinib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib. 
Kada se dabrafenib i trametinib uzimaju u kombinaciji potrebno je uzeti dozu trametiniba jedanput na dan u isto vrijeme svakoga dana bilo s jutarnjom ili s večernjom dozom dabrafeniba.
At 1 year 
Na 1 godinu
Worst-case QTc prolongation of >60 millisecond (msec) was observed in 3% of dabrafenib-treated subjects (one >500 msec in the integrated safety population). 
Najteži slučaj produljenja QTc od > 60 milisekundi (ms) zabilježen je u 3% ispitanika liječenih dabrafenibom (jedan > 500 ms u objedinjenoj populaciji u kojoj se ispitivala sigurnost).
Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K). 
Ispitanici su bili stratificirani prema razini laktat dehidrogenaze (LDH) (> gornje granice normale (GGN) naspram  GGN) i BRAF mutaciji (V600E naspram V600K).
Please also read the trametinib package leaflet for details of the side effects you may get with trametinib. 
Pročitajte i uputu o lijeku za trametinib za pojedinosti o nuspojavama koje biste mogli dobiti uz trametinib.
Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics). 
Poluvrijeme dabrafeniba nakon jedne oralne doze je 8 sati zahvaljujući eliminaciji koja je nakon peroralne primjene, limitirana apsorpcijom (flip-flop farmakokinetika).
• If you are a woman who could become pregnant you must use a reliable birth control method while you are taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks following the last dose of trametinib when given in combination with Tafinlar. 
• Ako ste žena koja može ostati trudna, tada tijekom uzimanja lijeka Tafinlar i još najmanje 2 tjedna nakon prestanka njegovog uzimanja, te još najmanje 16 tjedana nakon posljednje doze trametiniba kada se daje u kombinaciji s Tafinlarom, morate koristiti pouzdana sredstva za sprječavanje trudnoće.
Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose. 
Dabrafenib se apsorbira oralno pri čemu je medijan vremena postizanja vršne koncentracije u plazmi 2 sata nakon primjene doze.
Dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN) therefore caution should be used in this setting (see section 5.2). 
Dabrafenib nije ispitivan u bolesnika s bubrežnom insuficijencijom (definirana kao kreatinin > 1,5 x GGN), te je stoga potreban oprez u ovakvim slučajevima (vidjeti dio 5.2).
Adjuvant treatment of Stage III melanoma 
Adjuvantno liječenje melanoma stadija III
Tafinlar can affect how well your heart pumps blood when taken in combination with trametinib. 
Tafinlar može utjecati na to koliko će dobro srce izbacivati krv kada se uzima u kombinaciji s trametinibom.
• Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot), 
• smanjenje broja crvenih krvnih stanica (anemija), trombocita u krvi (stanice koje pomažu u zgrušavanju krvi), i vrste bijelih krvnih stanica (leukopenija)
Cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with dabrafenib/trametinib combination therapy. 
Slučajevi teških kožnih nuspojava (engl. severe cutaneous adverse reactions, SCAR), uključujući Stevens-Johnsonov sindrom i reakciju na lijek s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne, prijavljeni su tijekom liječenja kombiniranom terapijom dabrafenibom/trametinibom.
NR = Not reached, NA = Not applicable 
ND = Nije dostignuto, NP = Nije primjenjivo
A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect dabrafenib oral clearance. 
Analiza populacijske farmakokinetike ukazala je na to da blago povišene razine bilirubina i/ili AST (temeljem klasifikacije Nacionalnog instituta za tumore [NCI]) ne utječu značajno na klirens dabrafeniba nakon peroralne primjene.
Deep vein thrombosis/Pulmonary embolism 
Duboka venska tromboza/plućna embolija
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). 
U ispitivanjima trajanja do 13 tjedana, kod pasa i štakora je nađeno smanjenje broja retikulocita i/ili crvenih krvnih stanica (≥ 10 odnosno 1,4 puta kliničke izloženosti).
Do not change your dose or stop Tafinlar or trametinib unless your doctor, nurse or pharmacist tells you to. 
Ne mijenjajte dozu i ne prekidajte uzimanje Tafinlara ili trametiniba ako Vam to ne kažu Vaš liječnik, medicinska sestra ili ljekarnik.
There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib. 
Zabilježen je porast AUC-a karboksidabrafeniba od 73% i smanjenje AUC-a desmetildabrafeniba od 30%.
Common side effects that may show up in your blood tests 
Česte nuspojave koje se mogu vidjeti na krvnim pretragama
(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 
- Preživljenje bez progresije (procjena ispitivača) b - Ukupna stopa odgovora = kompletan odgovor + djelomični odgovor c - Trajanje odgovora d - U vrijeme izvješćivanja većina (≥ 59%) odgovora koje je procijenio ispitivač bila je još u tijeku e - Razlika u ORR-u izračunata na temelju rezultata za ORR koji nije bio zaokružen f - Ažurirana analiza nije unaprijed planirana i p-vrijednost nije bila prilagođena za višestruko ispitivanje ND = Nije dostignuto
Your doctor will also check your head, your neck, your mouth, your lymph glands and you will have scans of your chest and stomach area (called CT scans) regularly. 
Liječnik će Vas također redovito upućivati na pregled glave, vrata, usta, limfnih žlijezda te na CT pretragu prsišta i područja trbuha.
When dabrafenib is used in combination with trametinib refer to the guidance for medicinal product interactions found in sections 4.4 and 4.5 of dabrafenib and trametinib SmPC. 
Kada se dabrafenib koristi u kombinaciji s trametinibom, pogledajte informacije o interakcijama lijekova u dijelovima 4.4 i 4.5 sažetka opisa svojstava lijeka dabrafeniba i trametiniba.
Tell your doctor, pharmacist or nurse immediately if you get a fever (temperature 38.5ºC or above) while you are taking this medicine. 
Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako za vrijeme uzimanja ovog lijeka dobijete vrućicu (temperatura 38,5ºC ili viša).
Dabrafenib can be restarted once the fever resolves with appropriate prophylaxis using non-steroidal anti-inflammatory medicinal products or paracetamol. 
Nakon što se vrućica povuče dabrafenib se može ponovno uvesti uz odgovarajuću profilaksu nesteroidnim protuupalnim lijekovima ili paracetamolom.
Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at Baseline. 
Većina ispitanika imala je LDH ≤ GGN (67%), funkcionalni status ECOG 0 (70%) i visceralnu bolest (78%) na početku.
• birth control medicines (contraceptives) containing hormones, such as pills, injections, or patches 
• lijekove za sprječavanje trudnoće (kontraceptive) koji sadrže hormone, poput pilula, injekcija ili flastera
Based on 153 events (60 [14%] in the combination arm and 93 [22%] in the placebo arm) corresponding to a 26% information fraction of the total target of 597 OS events, the estimated hazard ratio for OS was 0.57 (95% CI: 0.42, 0.79; p=0.0006). 
Temeljem 153 događaja (60 [14%] u skupini koja je primala kombinaciju i 93 [22%] u skupini koja je primala placebo) koji odgovaraju 26%-tnom dijelu informacija od ukupno 597 događaja OS-a, procijenjeni omjer hazarda za OS bio je 0,57 (95% CI: 0,42; 0,79; p=0,0006).
If treatment-related toxicities occur when dabrafenib is used in combination with trametinib, then both treatments should be simultaneously dose reduced, interrupted or discontinued. 
Ako se pojave toksičnosti povezane s terapijom kada se dabrafenib primjenjuje u kombinaciji s trametinibom, u obje je terapije istovremeno potrebno smanjiti dozu, privremeno je prekinuti ili trajno obustaviti.
In vitro experiments have demonstrated paradoxical activation of mitogen-activated protein kinase (MAP kinase) signalling in BRAF wild-type cells with RAS mutations when exposed to BRAF inhibitors. 
In vitro ispitivanja su pokazala paradoksalnu aktivaciju signalnog puta mitogen-aktivirane protein kinaze (MAP kinaza) u staničnim linijama divljeg BRAF tipa s RAS mutacijama nakon izlaganja BRAF inhibitorima.
Tafinlar in combination with trametinib can result in the breakdown of muscle (rhabdomyolysis). 
Tafinlar u kombinaciji s trametinibom može imati za posljedicu razgradnju mišića (rabdomioliza).
Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care. 
Bolesnici u kojih se javila ozbiljna neinfektivna vrućica dobro su reagirali na prekid doziranja i/ili smanjenje doze i suportivnu njegu.
• have or have had any gastrointestinal problems such as diverticulitis (inflamed pouches in the colon) or metastases to the gastrointestinal tract. 
- ako imate ili ste imali probleme s probavnim sustavom kao što je divertikulitis (upaljene vrećice u kolonu) ili metastaze u probavnom sustavu.
The assay was specifically designed to differentiate between the V600E and V600K mutations. 
Test je posebno osmišljen kako bi razlikovao V600E i V600K mutacije.
Tell your doctor as soon as possible if you get any of these symptoms. 
Obavijestite svog liječnika čim prije ako dobijete bilo koji od ovih simptoma.
The study showed a statistically significant difference for the primary outcome of RFS between treatment arms, with a median RFS of 16.6 months for the placebo arm and not yet reached for the combination arm (HR: 0.47; 95% confidence interval: (0.39, 0.58); p=1.53×10 
Ispitivanje je pokazalo statistički značajnu razliku RFS-a kao primarnog ishoda između liječenih skupina, s medijanom RFS-a od 16,6 mjeseci u skupini koja je primala placebo, i nije bio dostignut za skupinu koja je primala kombinaciju (HR: 0,47; 95% interval pouzdanosti: (0,39; 0,58); p=1,53×10
All patients receiving dabrafenib as monotherapy or in combination with trametinib who developed cuSCC continued on treatment without dose modification. 
Svi bolesnici koji su primali dabrafenib kao monoterapiju ili u kombinaciji s trametinibom i u kojih se razvio cuSCC nastavlili su liječenje bez prilagodbe doze.
If necessary, your doctor may decide to interrupt your treatment or to stop it altogether. 
Ako bude potrebno, Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje.
Based on the population pharmacokinetic analysis, age had no significant effect on dabrafenib pharmacokinetics. 
Na temelju analize populacijske farmakokinetike dob nije imala značajan učinak na farmakokinetiku dabrafeniba.
Endpoints/ assessment 
Mjere ishoda/ procjena
Upon discontinuation of dabrafenib offset of induction is gradual, concentrations of sensitive CYP3A4, CYP2B6, CYP2C8, CYP2C9 and CYP2C19, UDP glucuronosyl transferase (UGT) and transporter substrates (e.g. Pgp or MRP-2) may increase and patients should be monitored for toxicity and dose of these agents may need to be adjusted. 
Nakon prekida terapije dabrafenibom, smanjenje indukcije nastupa postupno, koncentracije osjetljivih supstrata CYP3A4, CYP2B6, CYP2C8, CYP2C9 i CYP2C19, UDP glukuronozil transferaze (UGT) i transportera (npr. Pgp ili MRP-2) mogu se povećati, te je bolesnike potrebno pratiti zbog toksičnosti, a doze navedenih lijekova možda treba prilagoditi.
No data are available in patients with moderate to severe hepatic impairment. 
Nisu dostupni podaci za bolesnike s umjerenim i teškim oštećenjem jetre.
Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes). 
Enzimi koji mogu biti inducirani uključuju CYP3A u jetri i crijevima, CYP2B6, CYP2C8, CYP2C9, CYP2C19, i UGT enzime (enzimi koji konjugiraju glukuronid).
Renal failure due to pyrexia-associated pre-renal azotaemia or granulomatous nephritis was uncommon; however dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN). 
Zatajenja bubrega zbog prerenalne azotemije povezane s pireksijom ili granulomatoznog nefritisa, bila su manje česta; međutim, dabrafenib nije ispitivan u bolesnika s inicijalnom bubrežnom insuficijencijom (definirana kao kreatinin > 1,5 x GGN).
Table 5 Kinase inhibitory activity of dabrafenib against RAF kinases 
Tablica 5 Inhibitorna aktivnost koju dabrafenib pokazuje prema RAF kinazama
• some medicines used for pain relief, such as fentanyl and methadone 
• neke lijekove koji se koriste za smanjivanje boli, poput fentanila i metadona
However, in repeat dose studies, testicular degeneration/depletion was seen in rats and dogs (≥0.2 times the human clinical exposure based on AUC). 
Međutim, u ispitivanjima s ponovljenim dozama, u štakora i pasa je uočena testikularna degeneracija/deplecija (≥ 0,2 puta kliničke izloženosti u ljudi temeljeno na AUC-u).
Carboxy-dabrafenib is excreted in bile and urine. 
Karboksidabrafenib se izlučuje u žuč i urin.
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. 
Odmah obavijestite svog liječnika ako osjetite: lupanje srca te ubrzane ili nepravilne otkucaje srca ili ako se pojave omaglica, umor, ošamućenost, nedostatak zraka ili oticanje nogu.
(11.0, NR) 
(11,0; ND)
• some medicines to lower fat (lipids) in the blood stream, such as gemfibrozil 
• neke lijekove koji snizuju masnoće (lipide) u krvi, poput gemfibrozila
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. 
Dabrafenib je bio fototoksičan u in vitro testu na mišjim fibroblastima 3T3 Neutral Red Uptake (NRU) i in vivo pri dozama ≥ 100 mg/kg (> 44 puta kliničke izloženosti temeljeno na Cmax) u ispitivanju fototoksičnosti nakon peroralne primjene kod bezdlakih miševa.
• Low blood pressure (hypotension) 
• niski krvni tlak (hipotenzija)
Treatment with dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. 
Liječenje dabrafenibom treba propisati i nadzirati kvalificirani liječnik koji ima iskustva s primjenom protutumorskih lijekova.
Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see section 4.4). 
Prilagođavanje doze ili privremeni prekid terapije ne preporučuju se kod nuspojava u obliku planocelularnog karcinoma kože (engl. cutaneous squamous cell carcinoma (cuSCC)) ili novonastalog primarnog melanoma (vidjeti dio 4.4).
Take your morning and evening doses of Tafinlar at the same times every day. 
Dnevne i večernje doze lijeka Tafinlar uzimajte svaki dan u isto vrijeme.
N=5 3.1 (2.8, NR) 
N=5 3,1 (2,8; ND)
No data is available in patients with melanoma harbouring BRAF V600 mutations others than V600E and V600K. 
Nema raspoloživih podataka o bolesnicima s melanomom koji nose BRAF V600 mutacije osim onih s V600E i V600K.
Concomitant administration of dabrafenib with digoxin may result in decreased digoxin exposure. 
Istodobna primjena dabrafeniba s digoksinom može rezultirati smanjenom izloženošću digoksinu.
No dose modifications are required as long as effective local therapies can control ocular inflammation. 
Nije potrebna prilagodba doze kod uveitisa sve dok učinkovita lokalna terapija može kontrolirati upalu oka.
Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib. 
Do početka indukcije vjerojatno dolazi nakon 3 dana ponavljajućih doza dabrafeniba.
When an individual's adverse reactions are under effective management, dose re-escalation following the same dosing steps as de-escalation may be considered. 
Ako se nuspojave bolesnika uspješno liječe, može se razmotriti povećanje doze prema istim koracima za doziranje kao i kod smanjenja.
Tafinlar when given in combination with trametinib can cause eye problems including blindness. 
Tafinlar kada se daje u kombinaciji s trametinobom može izazvati očne tegobe, uključujući sljepoću.
• Eye changes including swelling in the eye caused by fluid leakage (chorioretinopathy), 
• promjene na očima uključujući oticanje u oku uzrokovano curenjem tekućine
Avoid co-administration of dabrafenib with potent inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St John's wort (Hypericum perforatum)) of CYP2C8 or CYP3A4. 
Izbjegavajte istovremenu primjenu dabrafeniba i snažnih induktora (npr. rifampicin, fenitoin, karbamazepin, fenobarbital ili gospina trava (Hypericum perforatum)) enzima CYP2C8 ili CYP3A4.
No relevant change in AUC was noted for hydroxy-dabrafenib. 
Nije primijećena značajna promjena AUC-a hidroksidabrafeniba.
If a dose of trametinib is missed, when dabrafenib is given in combination with trametinib, the dose of trametinib should only be taken if it is more than 12 hours until the next scheduled dose. 
Ako bolesnik propusti dozu trametiniba, kada se dabrafenib daje u kombinaciji s trametinibom, smije uzeti dozu trametiniba samo ako do sljedeće doze po rasporedu ima više od 12 sati.
Patients should be evaluated for signs and symptoms of infection (see section 4.4). 
Bolesnike je potrebno pregledati, tražeći znakove i simptome infekcije (vidjeti dio 4.4).
At 5 years 
Na 5 godina
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). 
Nakon istodobne primjene jedne doze rosuvastatina (OATP1B1, OATP1B3 i BCRP supstrat) pri ponavljanom doziranju dabrafeniba od 150 mg dvaput dnevno u 16 bolesnika, Cmax rosuvastatina se povećao 2,6 puta dok se AUC samo minimalno promijenio (povećanje od 7%).
• Skin effects including cutaneous squamous cell carcinoma (a type of skin cancer), wart-like growths, skin tags, uncontrolled skin growths or lesions (basal cell carcinoma), dry skin, itching or redness of skin, patches of thick, scaly, or crusty skin (actinic keratosis), skin lesions, skin reddening, increased sensitivity of the skin to sun 
• kožne nuspojave uključujući planocelularni karcinom kože (vrsta raka kože), bradavičaste izrasline, kožne privjeske, nekontrolirani rast kože ili lezija (karcinom bazalnih stanica), pojavu suhe kože, svrbeža ili crvenila kože, debeli ljuskasti ili korasti dijelovi kože (aktinička keratoza), kožne lezije, crvenilo kože, povećana osjetljivost kože na sunce
Dabrafenib is an enzyme inducer and increases the synthesis of drug-metabolising enzymes including CYP3A4, CYP2Cs and CYP2B6 and may increase the synthesis of transporters. 
Dabrafenib inducira enzime i povećava sintezu enzima za metaboliziranje lijekova uključujući CYP3A4, CYP2Cs i CYP2B6 i može povećati sintezu transportera.
There are limited data in patients taking the combination of dabrafenib with trametinib who have progressed on a prior BRAF inhibitor. 
Postoje ograničeni podaci u bolesnika koji su uzimali kombinaciju dabrafeniba s trametinibom u kojih je došlo do progresije tijekom prethodne terapije BRAF inhibitorom.