FrancophonIA/ELRC3.0 huggingface dataset:
English: In 1% of patients receiving dabrafenib as monotherapy in the integrated safety population, serious non-infectious febrile events were identified as fever accompanied by severe rigors, dehydration, hypotension and/or acute renal insufficiency or pre-renal origin in subjects with normal baseline renal function.
Croatian: U 1% bolesnika koji su primali dabrafenib kao monoterapiju u objedinjenoj populaciji u kojoj se ispitivala sigurnost, identificirani su događaji ozbiljne neinfektivne vrućice koji su bili definirani kao vrućica praćena jakom tresavicom, dehidracijom, hipotenzijom i/ili akutnom bubrežnom insuficijencijom prerenalnog podrijetla u bolesnika čije su početne vrijednosti bubrežne funkcije bile normalne.
English: If signs and symptoms suggestive of SCARs appear, dabrafenib and trametinib should be withdrawn.
Croatian: Ako se pojave znakovi i simptomi koji upućuju na SCAR, potrebno je prekinuti liječenje dabrafenibom i trametinibom.
English: • Antiepileptic (e.g. carbamazepine, phenytoin, primidone, valproic acid)
Croatian: • Antiepileptike (npr. karbamazepin, fenitoin, primidon, valproična kiselina)
English: Concomitant administration of dabrafenib with warfarin results in decreased warfarin exposure.
Croatian: Istodobna primjena dabrafeniba s varfarinom rezultira smanjenom izloženošću varfarinu.
English: • Take Tafinlar in combination with trametinib exactly as your doctor, nurse or pharmacist tells you.
Croatian: • Uzimajte Tafinlar u kombinaciji s trametinibom točno onako kako Vam Vaš liječnik, medicinska sestra ili ljekarnik kažu.
English: Cohort B N=65
Croatian: Kohorta B N=65
English: Dabrafenib is a substrate of CYP2C8 and CYP3A4.
Croatian: Dabrafenib je supstrat enzima CYP2C8 i CYP3A4.
English: The efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC therefore dabrafenib should not be used in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC (see sections 4.2 and 5.1).
Croatian: Djelotvornost i sigurnost dabrafeniba nisu ustanovljene u bolesnika s melanomom divljeg tipa BRAF gena ili NSCLC-om divljeg tipa BRAF gena, te se stoga dabrafenib ne smije koristiti u bolesnika s melanomom divljeg tipa BRAF gena ili NSCLC-om divljeg tipa BRAF gena (vidjeti dijelove 4.2 i 5.1).
English: The combination of dabrafenib with trametinib has shown anti-tumour activity in BRAF V600 mutation positive melanoma cell lines in vitro and delays the emergence of resistance in vivo in BRAF V600 mutation positive melanoma xenografts.
Croatian: Kombinacija dabrafeniba s trametinibom je pokazala antitumorsku aktivnost u staničnim linijama melanoma pozitivnog na mutaciju BRAF V600 in vitro i odgađa pojavu rezistencije u ksenograftima s melanomom pozitivnim na mutaciju BRAF V600 in vivo.
English: The primary endpoint of the study was OS with a key secondary endpoint of PFS.
Croatian: Mjera primarnog ishoda u ispitivanju bio je OS uz PFS kao ključnu mjeru sekundarnog ishoda.
English: • some immunosuppressants, such as cyclosporin, tacrolimus and sirolimus
Croatian: • neke imunosupresive, poput ciklosporina, takrolimusa i sirolimusa
English: In the Phase II study BRF113928 in patients with advanced NSCLC the incidence and severity of pyrexia were increased slightly when dabrafenib was used in combination with trametinib (48%, 3% Grade 3) as compared to dabrafenib monotherapy (39%, 2% Grade 3).
Croatian: U ispitivanju faze II BRF113928 u bolesnika s uznapredovalim NSCLC-om, incidencija i težina pireksije bile su neznatno povećane kada se dabrafenib koristio u kombinaciji s trametinibom (48%, od čega je 3% bilo 3. stupnja) u usporedbi s monoterapijom dabrafenibom (39%, od čega je 2% bilo 3. stupnja).
English: Cardiovascular effects, including coronary arterial degeneration/necrosis and/or haemorrhage, cardiac atrioventricular valve hypertrophy/haemorrhage and atrial fibrovascular proliferation were seen in dogs (≥2 times clinical exposure based on AUC).
Croatian: Učinci na kardiovaskularni sustav, uključujući degeneraciju/nekrozu koronarne arterije i/ili krvarenje, hipertrofiju/krvarenje atrioventrikularnog srčanog zaliska, te fibrovaskularnu proliferaciju atrija uočeni su kod pasa (≥ 2 puta kliničke izloženosti temeljeno na AUC-u).
English: The most common adverse reactions (incidence 15%) reported with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash, and vomiting.
Croatian: Najčešće nuspojave (incidencija  15%) prijavljene pri uporabi dabrafeniba bile su hiperkeratoza, glavobolja, pireksija, artralgija, umor, mučnina, papilom, alopecija, osip i povraćanje.
English: The investigator assessed confirmed response rate in patients with BRAF V600E metastatic melanoma (n=76) was 59% (95% CI: 48.2, 70.3) and the median DoR was 5.2 months (95% CI: 3.9, not calculable) based on a median follow-up time of 6.5 months.
Croatian: Potvrđena stopa odgovora prema procjeni ispitivača u bolesnika s BRAF V600E metastatskim melanomom (n=76) iznosila je 59% (95% CI: 48,2; 70,3), a medijan DoR-a 5,2 mjeseca (95% CI: 3,9; nije bilo moguće izračunati) temeljem medijana vremena praćenja od 6,5 mjeseci.
English: The recommended dose of trametinib, when used in combination with dabrafenib, is 2 mg once daily.
Croatian: Preporučena doza trametiniba, kada se primjenjuje u kombinaciji s dabrafenibom, iznosi 2 mg jedanput na dan.
English: • If you take too much Tafinlar or trametinib, immediately contact your doctor, nurse or pharmacist.
Croatian: • Ako uzmete previše Tafinlara ili trametiniba, odmah se obratite svom liječniku, medicinskoj sestri ili ljekarniku.
English: Discontinue permanently, or interrupt therapy until Grade 0 to 1 and reduce by one dose level when resuming therapy.
Croatian: Trajno ili privremeno prekinuti terapiju dok se razina toksičnosti ne smanji na 0. ili 1. stupanj te pri nastavljanju terapije dozu smanjiti za jednu razinu.
English: The metabolism of dabrafenib is primarily mediated by CYP2C8 and CYP3A4 to form hydroxy-dabrafenib, which is further oxidised via CYP3A4 to form carboxy-dabrafenib.
Croatian: Metabolizam dabrafeniba je primarno posredovan s CYP2C8 i CYP3A4 kako bi nastao hidroksidabrafenib, koji se dalje oksidira putem CYP3A4 i stvara karboksidabrafenib.
English: Cohort A N=15
Croatian: Kohorta A N=15
English: The efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC.
Croatian: Djelotvornost i sigurnost dabrafeniba nisu ustanovljene u bolesnika s melanomom divljeg tipa BRAF gena ili NSCLC-om divljeg tipa BRAF gena.
English: • feeling like your heart is pounding, racing, or beating irregularly
Croatian: • osjećaj lupanja srca te ubrzane ili nepravilne otkucaje
English: If a dose of dabrafenib is missed, it should not be taken if it is less than 6 hours until the next scheduled dose.
Croatian: Ako bolesnik propusti dozu dabrafeniba, ne smije ju uzeti ako do sljedeće doze po rasporedu ima manje od 6 sati.
English: Bleeding problems
Croatian: Tegobe s krvarenjem
English: No new primary melanoma was reported from the Phase II NSCLC study (BRF113928).
Croatian: U ispitivanju faze II za NSCLC (BRF113928) nisu zabilježeni slučajevi pojave novih primarnih melanoma.
English: At 2 years
Croatian: Na 2 godine
English: • medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole
Croatian: • lijekove za terapiju gljivičnih infekcija, poput ketokonazola, itrakonazola, vorikonazola i posakonazola
English: Improvements for the secondary endpoint of PFS were sustained over a 5 year timeframe in the combination arm compared to vemurafenib monotherapy.
Croatian: Poboljšanja za mjeru sekundarnog ishoda PFS bila su održana tijekom 5-godišnjeg vremenskog okvira u skupini koja je primala kombinaciju u usporedbi s monoterapijom vemurafenibom.
English: If you take too many capsules of Tafinlar, contact your doctor, pharmacist or nurse for advice.
Croatian: Ako uzmete previše kapsula lijeka Tafinlar, za savjet se obratite svom liječniku, ljekarniku ili medicinskoj sestri.
English: The recommended dose of trametinib, when used in combination with Tafinlar, is 2 mg once a day.
Croatian: Preporučena doza trametiniba, kada se uzima u kombinaciji s Tafinlarom, iznosi 2 mg jednput na dan.
English: Dose adjustment for trametinib below 1 mg once daily is not recommended, when used in combination with dabrafenib.
Croatian: Ne preporučuje se prilagodba doze za trametinib ispod 1 mg jedanput na dan, kada se primjenjuje u kombinaciji s dabrafenibom.
English: Tafinlar can cause eye problems when taken in combination with trametinib.
Croatian: Tafinlar može uzrokovati očne tegobe kada se uzima u kombinaciji s trametinibom.
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a
Croatian: Pretrage vrlo često povišena alanin aminotransferaza povišena aspartat aminotransferaza često povišena alkalna fosfataza u krvi povišena gama-glutamiltransferaza povišena kreatin fosfokinaza u krvi a
English: Patients should take dabrafenib as monotherapy or in combination with trametinib at least one hour prior to or two hours after a meal due to the effect of food on dabrafenib absorption (see section 5.2).
Croatian: Zbog djelovanja hrane na apsorpciju dabrafeniba, bolesnici moraju uzimati dabrafenib kao monoterapiju ili u kombinaciji s trametinibom barem jedan sat prije ili dva sata nakon obroka (vidjeti dio 5.2).
English: Improvements for the primary endpoint of PFS were sustained over a 5 year timeframe in the combination arm compared to dabrafenib monotherapy.
Croatian: Poboljšanja za mjeru primarnog ishoda PFS bila su održana tijekom 5-godišnjeg vremenskog okvira u skupini koja je primala kombinaciju u usporedbi s monoterapijom dabrafenibom.
English: In the Phase III study MEK115306 no patients treated with trametinib in combination with dabrafenib had worst-case QTcB prolongation to >500 msec; QTcB was increased more than 60 msec from baseline in 1% (3/209) of patients.
Croatian: U ispitivanju faze III MEK115306 niti jedan bolesnik liječen trametinibom u kombinaciji s dabrafenibom nije imao najteži slučaj produljenja QTcB > 500 ms; u 1% (3/209) bolesnika QTcB bio je povećan za više od 60 ms u odnosu na početnu vrijednost.
English: Overall survival, median, months (95% CI) Median, months
Croatian: Ukupno preživljenje, medijan, mjeseci (95% CI) Medijan, mjeseci
English: Patients with melanoma driven by BRAF mutations other than V600E were excluded from the confirmatory trial and with respect to patients with the V600K mutation in single arm clinical trials the activity appears lower than in V600E tumours.
Croatian: Bolesnici s melanomom s drugim BRAF mutacijama, izuzev mutacije V600E, bili su isključeni iz ispitivanja djelotvornosti, a klinička ispitivanja s jednom skupinom pokazala su manju aktivnost kod tumora s mutacijom V600K nego kod onih s mutacijom V600E.
English: N Events Median, months (95% CI) NA (46.9, NA)
Croatian: N Događaji Medijan, mjeseci (95% CI) NP (46,9; NP)
English: Cohort D N=17
Croatian: Kohorta D N=17
English: The safety of dabrafenib in combination with trametinib has been evaluated in the integrated safety population of 1076 patients with BRAF V600 mutant unresectable or metastatic melanoma, Stage III BRAF V600 mutant melanoma following complete resection (adjuvant treatment) and advanced NSCLC treated with dabrafenib 150 mg twice daily and trametinib 2 mg once daily.
Croatian: Sigurnost dabrafeniba u kombinaciji s trametinibom procijenjena je u objedinjenoj populaciji u kojoj se ispitivala sigurnost, koju je činilo 1076 bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom, melanomom stadija III s BRAF V600 mutacijom nakon potpune resekcije (adjuvantno liječenje) i uznapredovalim NSCLC-om s BRAF V600 mutacijom liječenih dabrafenibom u dozi od 150 mg dvaput na dan i trametinibom u dozi od 2 mg jedanput na dan.
English: New primary melanomas have been reported in clinical trials in patients treated with dabrafenib.
Croatian: U kliničkim ispitivanjima zabilježeni su slučajevi novih primarnih melanoma u bolesnika liječenih dabrafenibom.
English: Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 substrates.
Croatian: Dabrafenib je supstrat za metaboličke enzime CYP2C8 i CYP3A4, dok su aktivni metaboliti, hidroksidabrafenib i desmetildabrafenib supstrati CYP3A4.
English: Microcrystalline cellulose Magnesium stearate Colloidal silicone dioxide
Croatian: 6.1 Popis pomoćnih tvari Sadržaj kapsule celuloza, mikrokristalična magnezijev stearat silicijev dioksid, koloidni
English: Administration of dabrafenib 150 mg twice daily and warfarin resulted in a decrease in AUC of S- and R- warfarin of 37% and 33%, respectively, compared to administration of warfarin alone.
Croatian: Primjena dabrafeniba od 150 mg dvaput dnevno i varfarina rezultirala je smanjenjem AUC-a S- i R-varfarina od 37% odnosno 33% u usporedbi s primjenom samog varfarina.
English: In the Phase III clinical trials MEK115306 and MEK116513 in patients with unresectable or metastatic melanoma, cuSCC occurred in 10% (22/211) of patients receiving dabrafenib as a monotherapy and in 18% (63/349) of patients receiving vemurafenib as a monotherapy, respectively.
Croatian: U kliničkim ispitivanjima faze III MEK115306 i MEK116513 u bolesnika s neoperabilnim ili metastatskim melanomom, cuSCC se pojavio u 10% (22/211) bolesnika koji su primali dabrafenib kao monoterapiju i u 18% (63/349) bolesnika koji su primali vemurafenib kao monoterapiju.
English: 2nd dose reduction
Croatian: 2. smanjenje doze
English: • Thickening of the outer layers of the skin
Croatian: • zadebljanje površinskih slojeva kože
English: Others may develop a type of skin cancer called basal cell carcinoma (BCC).
Croatian: Drugi mogu razviti tip raka kože koji se naziva karcinom bazalnih stanica.
English: Subsequently, all patient samples were re-tested using the bioMerieux (bMx) THxID BRAF validated assay, which has CE marking.
Croatian: Naknadno, uzorci svih bolesnika su ponovo testirani koristeći bioMerieux (bMx) THxID BRAF validirani test koji ima CE oznaku. bMx THxID BRAF test je alel specifični PCR koji se provodi na DNK izoliranoj iz FFPE tumorskog tkiva.
English: Renal failure has been identified in <1% of patients treated with dabrafenib alone and in ≤1% of patients treated with dabrafenib in combination with trametinib.
Croatian: Zatajenje bubrega je utvrđeno u < 1% bolesnika liječenih samo dabrafenibom i u ≤ 1% bolesnika liječenih dabrafenibom u kombinaciji s trametinibom.
English: • some antibiotics, such as clarithromycin, doxycyline and telithromycin
Croatian: • neke antibiotike, poput klaritromicina, doksiciklina i telitromicina
English: Hepatic metabolism and biliary secretion are the primary routes of elimination of dabrafenib and its metabolites and patients with moderate to severe hepatic impairment may have increased exposure.
Croatian: Primarni putevi eliminacije dabrafeniba i njegovih metabolita su jetreni metabolizam i izlučivanje putem žuči, pa bolesnici s umjerenim do teškim oštećenjem jetre mogu imati povećanu izloženost lijeku.
English: At 4 years
Croatian: Na 4 godine
English: NA = Not applicable
Croatian: NP = Nije primjenjivo
English: Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction If dabrafenib is being used in combination with trametinib and absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN), please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Croatian: Kada se dabrafenib primjenjuje u kombinaciji s trametinibom i postoji apsolutno smanjenje ejekcijske frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF) za > 10% u odnosu na početnu vrijednost te je vrijednost ejekcijske frakcije ispod donje granice normale (DGN) za određenu ustanovu, pogledajte sažetak opisa svojstava lijeka za trametinib (dio 4.2) za upute za prilagodbu doze trametiniba.
English: Hepatic effects, including hepatocellular necrosis and inflammation, were observed in mice (≥0.6 times clinical exposure).
Croatian: U miševa su primijećeni učinci na jetru, uključujući hepatocelularnu nekrozu i upalu (pri izloženosti ≥ 0,6 puta kliničke izloženosti).
English: Trametinib dose* Only when used in combination with dabrafenib
Croatian: Doza trametiniba* samo kada se primjenjuje u kombinaciji s dabrafenibom
English: The side effects that you may see when you take Tafinlar in combination with trametinib are as follows:
Croatian: Sljedeće nuspojave mogli biste primijetiti kada uzimate Tafinlar u kombinaciji s trametinibom:
English: Desmethyl-dabrafenib is metabolised by CYP3A4 to oxidative metabolites.
Croatian: CYP3A4 metabolizira desmetildabrafenib u oksidativne metabolite.
English: The bottles also include a silica gel desiccant in a small cylinder shaped container.
Croatian: U bocama se također u malom cilindričnom spremniku nalazi silika gel kao sredstvo za sušenje.
English: In these patients a 13% (95 CI: 5.0, 27.0) confirmed response rate was observed with a median PFS of 3.6 months (95% CI: 2, 4).
Croatian: U tih bolesnika uočena je potvrđena stopa odgovora od 13% (95% CI: 5,0, 27,0) uz medijan PFS-a od 3,6 mjeseci (95% CI: 2, 4).
English: Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Croatian: Dabrafenib u kombinaciji s trametinibom indiciran je za adjuvantno liječenje odraslih bolesnika s melanomom stadija III s BRAF V600 mutacijom, nakon potpune resekcije.
English: Co-administration of repeat dosing of trametinib 2 mg once daily and dabrafenib 150 mg twice daily resulted in no clinically meaningful changes in trametinib or dabrafenib Cmax and AUC with increases of 16 and 23%, respectively, in dabrafenib Cmax and AUC.
Croatian: Istodobna primjena ponovljenih doza trametiniba 2 mg jedanput na dan i dabrafeniba 150 mg dvaput na dan nije rezultirala klinički značajnim promjenama u Cmax i AUC-u trametiniba niti dabrafeniba uz porast od 16% u Cmax, odnosno 23% u AUC-u dabrafeniba.
English: 7.6 (5.9, NR)
Croatian: 7,6 (5,9; ND)
English: • some medicines to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine,
Croatian: • neke lijekove za liječenje HIV infekcije, poput ritonavira, amprenavira, indinavira, darunavira,
English: When dabrafenib is given in combination with trametinib, the SmPC of trametinib must be consulted prior to intiation of combination treatment.
Croatian: Kada se dabrafenib daje u kombinaciji s trametinibom, mora se pročitati sažetak opisa svojstava lijeka za trametinib prije započinjanja liječenja.
English: Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking dabrafenib in combination with trametinib (see section 4.8).
Croatian: Kolitis i gastrointestinalna perforacija, uključujući smrtonosni ishod, prijavljeni su u bolesnika koji su uzimali dabrafenib u kombinaciji s trametinibom (vidjeti dio 4.8).
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).
Croatian: Ako je vrućica povezana s drugim teškim znacima ili simptomima, nakon njenog povlačenja i prema kliničkoj indikaciji, dabrafenib se može ponovno početi davati u smanjenoj dozi (vidjeti dio 4.2).
English: Patients with brain metastases (results from the Phase II study (BREAK-MB) BREAK-MB was a multicentre, open-label, two-cohort, Phase II study designed to evaluate the intracranial response of dabrafenib in subjects with histologically confirmed (Stage IV) BRAF-mutation positive (V600E or V600K) melanoma metastatic to the brain.
Croatian: Bolesnici s metastazama u mozgu (Rezultati iz ispitivanja faze II (BREAK-MB) BREAK-MB je bilo multicentrično otvoreno ispitivanje faze II, u dvije kohorte dizajnirano za procjenu intrakranijalnog odgovora na dabrafenib u ispitanika s histološki potvrđenim melanomom s metastazama u mozgu (stadij IV) i pozitivnim na BRAF mutaciju (V600E ili V600K).
English: The safety of dabrafenib monotherapy is based on the integrated safety population from five clinical trials, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680, which included 578 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with dabrafenib 150 mg twice daily.
Croatian: Sigurnost monoterapije dabrafenibom temelji se na ispitivanju sigurnosti u objedinjenoj populaciji iz pet kliničkih ispitivanja, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220 i BRF112680, u kojima je bilo uključeno 578 bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom liječenih dabrafenibom u dozi od 150 mg dvaput dnevno.
English: Overall responsea % (95% CI) Duration of response Median, months (95% CI)
Croatian: % (95% CI) Trajanje odgovora Medijan, mjeseci (95% CI)
English: The most common adverse reactions (incidence 20%) for dabrafenib in combination with trametinib were: pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.
Croatian: Najčešće nuspojave (incidencija ≥ 20%) za dabrafenib u kombinaciji s trametinibom bile su: pireksija, umor, mučnina, zimica, glavobolja, proljev, povraćanje, artralgija i osip.
English: Most subjects were Caucasian (>96%) and male (55%), with a median age of 55 years (24% were ≥65 years).
Croatian: Ispitanici su većinom bili bijele rase (> 96%) i muškarci (55%), uz medijan starosti od 55 godina (24% imalo je ≥ 65 godina).
English: Limited safety and efficacy data have been collected on dabrafenib in non-Caucasian patients.
Croatian: Prikupljeni su ograničeni podaci o sigurnosti i djelotvornosti dabrafeniba u bolesnika drugih rasnih skupina osim bijelaca.
English: Therefore, transient inhibition of CYP3A4 may be observed during the first few days of treatment.
Croatian: Stoga se tijekom prvih nekoliko dana terapije može zamijetiti prolazna inhibicija CYP3A4.
English: Tafinlar is not recommended while breast-feeding.
Croatian: Tafinlar se ne preporučuje za vrijeme dojenja.
English: • Inflammation of the heart muscle (myocarditis) which can result in breathlessness, fever,
Croatian: • upala srčanog mišića (miokarditis) koja može uzrokovati nedostatak zraka, vrućicu, osjećaj lupanja srca i bol u prsnom košu.
English: Duration of intracranial response, median, months (95% CI)
Croatian: Trajanje intrakranijalnog odgovora, medijan, mjeseci (95% CI)
English: Dabrafenib in combination with trametinib in patients with melanoma who have progressed on a BRAF inhibitor
Croatian: Dabrafenib u kombinaciji s trametinibom u bolesnika s melanomom u kojih je došlo do progresije tijekom terapije BRAF inhibitorom
English: Before taking dabrafenib or combination with trametinib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Croatian: Prije uzimanja dabrafeniba ili kombinacije s trametinibom, bolesnici moraju imati validiranim testom potvrđenu BRAF V600 mutaciju tumora.
English: Cohort A N=74
Croatian: Kohorta A N=74
English: Influenza-like illness
Croatian: • bolest nalik gripi
English: Talk to your doctor, before taking Tafinlar.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Tafinlar.
English: A decrease of 16% in AUC was noted for carboxy-dabrafenib.
Croatian: Uočeno je smanjenje AUC-a karboksidabrafeniba od 16%.
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Croatian: Ispitanici su većinom bili bijele rase (> 99%) i muškarci (53%), medijana starosti od 56 godina (28% je imalo ≥ 65 years).
English: Black iron oxide (E172) Shellac
Croatian: Tinta za označavanje željezov oksid, crni (E172) šelak propilenglikol