FrancophonIA/ELRC3.0 huggingface dataset:
English: Tafinlar in combination with trametinib can cause problems with your liver which may develop into serious conditions such as hepatitis and liver failure, which may be fatal.
Croatian: Tafinlar u kombinaciji s trametinibom može uzrokovati tegobe s jetrom koji se mogu razviti u ozbiljne bolesti kao što su hepatitis i zatajenje jetre, koje mogu biti smrtonosne.
English: All patients received study medicinal product as first-line treatment for metastatic disease.
Croatian: Svi su bolesnici primali ispitivani lijek kao prvu liniju terapije za mestastatsku bolest.
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Croatian: MEK proteini su sastavni dijelovi signalnog puta kinaze regulirane izvanstaničnim signalima (engl. extracellular signal-regulated kinase, ERK).
English: Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Croatian: Također se preporučuje pregled zdjelice (za žene) kao i analni pregled prije i na kraju liječenja.
English: If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time.
Croatian: Ako s propuštenom dozom kasnite više od 6 sati, propustite tu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
English: Included in these clinical trials were in total 402 subjects with BRAF V600E and 49 subjects with BRAF V600K mutation.
Croatian: U ova klinička ispitivanja je ukupno uključeno 402 ispitanika s BRAF V600E i 49 ispitanika s BRAF V600K mutacijom.
English: You may also get additional side effects due to taking trametinib at the same time as Tafinlar.
Croatian: Mogli biste dobiti i dodatne nuspojave zbog uzimanja trametiniba istodobno s Tafinlarom.
English: (actinic keratosis), chapping or cracking of the skin
Croatian: (aktinička keratoza), isušena ili ispucala koža
English: If dabrafenib is being used in combination with trametinib then therapy with dabrafenib may be continued at the same dose.
Croatian: Ako se dabrafenib koristi u kombinaciji s trametinibom, terapija dabrafenibom može se nastaviti u istoj dozi.
English: When dabrafenib is used alone and in combination with trametinib, therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5
Croatian: Kada se dabrafenib primjenjuje sam i u kombinaciji s trametinibom, terapiju dabrafenibom treba privremeno prekinuti ako je tjelesna temperatura bolesnika ≥ 38,5
English: • Blurred vision, eyesight problems, inflammation of the eye (uveitis)
Croatian: • zamagljeni vid, problemi s vidom, upala oka (uveitis)
English: The response was durable with median DoR in the previously treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Croatian: Odgovor je bio dugotrajan uz medijan DoR-a u prethodno liječenoj populaciji od 9,8 mjeseci (95% CI, 6,9; 16,0) prema procjeni ispitivača.
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).
Croatian: 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).
English: 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.
Croatian: Dob iznad 75 godina bila je značajan prediktor koncentracije karboksi- i desmetildabrafeniba u plazmi s 40% jačom izloženosti u ispitanika
English: • some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin
Croatian: • neke lijekove koji smanjuju razinu kolesterola, poput atorvastatina i simvastatina
English: 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.
Croatian: ≥ 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
English: How to take Tafinlar
Croatian: Kako uzimati Tafinlar
English: 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.
Croatian: 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.
English: Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively).
Croatian: Istovremena primjena rezultirala je porastom AUC-a hidroksi- i desmetildabrafeniba (porast od 82% odnosno 68%).
English: 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.
Croatian: Ne očekuje se da lijekovi koji mijenjaju pH u gornjem dijelu probavnog sustava (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) smanjuju bioraspoloživost dabrafeniba.
English: Tell your doctor as soon as possible if you have severe abdominal pain.
Croatian: Obratite se svom liječniku čim prije ako imate jaku bol u trbuhu.
English: • Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4)
Croatian: • Antikoagulanse (npr. acenokumarol, varfarin, vidjeti dio 4.4)
English: 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%).
Croatian: 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%).
English: Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively.
Croatian: Srednji AUC omjeri metabolita i roditeljskog spoja nakon primjene ponovljenih doza bile su 0,9, 11 i 0,7 za hidroksi-, karboksi-, i desmetildabrafenib.
English: 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.
Croatian: 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.
English: At 1 year
Croatian: Na 1 godinu
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).
Croatian: 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).
English: Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K).
Croatian: Ispitanici su bili stratificirani prema razini laktat dehidrogenaze (LDH) (> gornje granice normale (GGN) naspram  GGN) i BRAF mutaciji (V600E naspram V600K).
English: Please also read the trametinib package leaflet for details of the side effects you may get with trametinib.
Croatian: Pročitajte i uputu o lijeku za trametinib za pojedinosti o nuspojavama koje biste mogli dobiti uz trametinib.
English: Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics).
Croatian: Poluvrijeme dabrafeniba nakon jedne oralne doze je 8 sati zahvaljujući eliminaciji koja je nakon peroralne primjene, limitirana apsorpcijom (flip-flop farmakokinetika).
English: • 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.
Croatian: • 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.
English: Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose.
Croatian: Dabrafenib se apsorbira oralno pri čemu je medijan vremena postizanja vršne koncentracije u plazmi 2 sata nakon primjene doze.
English: 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).
Croatian: 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).
English: Adjuvant treatment of Stage III melanoma
Croatian: Adjuvantno liječenje melanoma stadija III
English: Tafinlar can affect how well your heart pumps blood when taken in combination with trametinib.
Croatian: Tafinlar može utjecati na to koliko će dobro srce izbacivati krv kada se uzima u kombinaciji s trametinibom.
English: • Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot),
Croatian: • smanjenje broja crvenih krvnih stanica (anemija), trombocita u krvi (stanice koje pomažu u zgrušavanju krvi), i vrste bijelih krvnih stanica (leukopenija)
English: 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.
Croatian: 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.
English: NR = Not reached, NA = Not applicable
Croatian: ND = Nije dostignuto, NP = Nije primjenjivo
English: 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.
Croatian: 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.
English: Deep vein thrombosis/Pulmonary embolism
Croatian: Duboka venska tromboza/plućna embolija
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).
Croatian: 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).
English: Do not change your dose or stop Tafinlar or trametinib unless your doctor, nurse or pharmacist tells you to.
Croatian: Ne mijenjajte dozu i ne prekidajte uzimanje Tafinlara ili trametiniba ako Vam to ne kažu Vaš liječnik, medicinska sestra ili ljekarnik.
English: There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib.
Croatian: Zabilježen je porast AUC-a karboksidabrafeniba od 73% i smanjenje AUC-a desmetildabrafeniba od 30%.
English: Common side effects that may show up in your blood tests
Croatian: Česte nuspojave koje se mogu vidjeti na krvnim pretragama
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
Croatian: - 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
English: 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.
Croatian: Liječnik će Vas također redovito upućivati na pregled glave, vrata, usta, limfnih žlijezda te na CT pretragu prsišta i područja trbuha.
English: 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.
Croatian: 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.
English: Tell your doctor, pharmacist or nurse immediately if you get a fever (temperature 38.5ºC or above) while you are taking this medicine.
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako za vrijeme uzimanja ovog lijeka dobijete vrućicu (temperatura 38,5ºC ili viša).
English: Dabrafenib can be restarted once the fever resolves with appropriate prophylaxis using non-steroidal anti-inflammatory medicinal products or paracetamol.
Croatian: Nakon što se vrućica povuče dabrafenib se može ponovno uvesti uz odgovarajuću profilaksu nesteroidnim protuupalnim lijekovima ili paracetamolom.
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at Baseline.
Croatian: Većina ispitanika imala je LDH ≤ GGN (67%), funkcionalni status ECOG 0 (70%) i visceralnu bolest (78%) na početku.
English: • birth control medicines (contraceptives) containing hormones, such as pills, injections, or patches
Croatian: • lijekove za sprječavanje trudnoće (kontraceptive) koji sadrže hormone, poput pilula, injekcija ili flastera
English: 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).
Croatian: 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).
English: If treatment-related toxicities occur when dabrafenib is used in combination with trametinib, then both treatments should be simultaneously dose reduced, interrupted or discontinued.
Croatian: 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.
English: 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.
Croatian: 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.
English: Tafinlar in combination with trametinib can result in the breakdown of muscle (rhabdomyolysis).
Croatian: Tafinlar u kombinaciji s trametinibom može imati za posljedicu razgradnju mišića (rabdomioliza).
English: Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care.
Croatian: Bolesnici u kojih se javila ozbiljna neinfektivna vrućica dobro su reagirali na prekid doziranja i/ili smanjenje doze i suportivnu njegu.
English: • have or have had any gastrointestinal problems such as diverticulitis (inflamed pouches in the colon) or metastases to the gastrointestinal tract.
Croatian: - ako imate ili ste imali probleme s probavnim sustavom kao što je divertikulitis (upaljene vrećice u kolonu) ili metastaze u probavnom sustavu.
English: The assay was specifically designed to differentiate between the V600E and V600K mutations.
Croatian: Test je posebno osmišljen kako bi razlikovao V600E i V600K mutacije.
English: Tell your doctor as soon as possible if you get any of these symptoms.
Croatian: Obavijestite svog liječnika čim prije ako dobijete bilo koji od ovih simptoma.
English: 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
Croatian: 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
English: All patients receiving dabrafenib as monotherapy or in combination with trametinib who developed cuSCC continued on treatment without dose modification.
Croatian: 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.
English: If necessary, your doctor may decide to interrupt your treatment or to stop it altogether.
Croatian: Ako bude potrebno, Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje.
English: Based on the population pharmacokinetic analysis, age had no significant effect on dabrafenib pharmacokinetics.
Croatian: Na temelju analize populacijske farmakokinetike dob nije imala značajan učinak na farmakokinetiku dabrafeniba.
English: Endpoints/ assessment
Croatian: Mjere ishoda/ procjena
English: 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.
Croatian: 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.
English: No data are available in patients with moderate to severe hepatic impairment.
Croatian: Nisu dostupni podaci za bolesnike s umjerenim i teškim oštećenjem jetre.
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes).
Croatian: Enzimi koji mogu biti inducirani uključuju CYP3A u jetri i crijevima, CYP2B6, CYP2C8, CYP2C9, CYP2C19, i UGT enzime (enzimi koji konjugiraju glukuronid).
English: 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).
Croatian: 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).
English: Table 5 Kinase inhibitory activity of dabrafenib against RAF kinases
Croatian: Tablica 5 Inhibitorna aktivnost koju dabrafenib pokazuje prema RAF kinazama
English: • some medicines used for pain relief, such as fentanyl and methadone
Croatian: • neke lijekove koji se koriste za smanjivanje boli, poput fentanila i metadona
English: However, in repeat dose studies, testicular degeneration/depletion was seen in rats and dogs (≥0.2 times the human clinical exposure based on AUC).
Croatian: 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).
English: Carboxy-dabrafenib is excreted in bile and urine.
Croatian: Karboksidabrafenib se izlučuje u žuč i urin.
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.
Croatian: 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.
English: (11.0, NR)
Croatian: (11,0; ND)
English: • some medicines to lower fat (lipids) in the blood stream, such as gemfibrozil
Croatian: • neke lijekove koji snizuju masnoće (lipide) u krvi, poput gemfibrozila
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.
Croatian: 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.
English: • Low blood pressure (hypotension)
Croatian: • niski krvni tlak (hipotenzija)
English: Treatment with dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje dabrafenibom treba propisati i nadzirati kvalificirani liječnik koji ima iskustva s primjenom protutumorskih lijekova.
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).
Croatian: 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).
English: Take your morning and evening doses of Tafinlar at the same times every day.
Croatian: Dnevne i večernje doze lijeka Tafinlar uzimajte svaki dan u isto vrijeme.
English: N=5 3.1 (2.8, NR)
Croatian: N=5 3,1 (2,8; ND)
English: No data is available in patients with melanoma harbouring BRAF V600 mutations others than V600E and V600K.
Croatian: Nema raspoloživih podataka o bolesnicima s melanomom koji nose BRAF V600 mutacije osim onih s V600E i V600K.