FrancophonIA/ELRC3.0 huggingface dataset:
English: If a patient vomits after taking dabrafenib, the patient should not retake the dose and should take the next scheduled dose.
Croatian: Ako bolesnik povrati nakon uzimanja dabrafeniba, ne smije uzeti još jednu dozu nego treba uzeti sljedeću dozu prema uobičajenom rasporedu.
English: 1.5 mg once daily
Croatian: 1,5 mg jedanput na dan
English: Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
Croatian: Prije uzimanja dabrafeniba bolesnici moraju imati validiranim testom potvrđenu BRAF V600 tumorsku mutaciju.
English: Overall confirmed response n (%) (95% CI)
Croatian: Ukupni potvrđeni odgovor n (%) (95% CI)
English: RPED and RVO may occur with dabrafenib in combination with trametinib.
Croatian: Moguća je pojava RPED-a i RVO-a u kombinaciji dabrafeniba s trametinibom.
English: Previously untreated patients (results from the Phase III study [BREAK-3]) The efficacy and safety of dabrafenib were evaluated in a Phase III randomised, open-label study [BREAK 3] comparing dabrafenib to dacarbazine (DTIC) in previously untreated patients with BRAF V600E mutation positive advanced (unresectable Stage III) or metastatic (Stage IV) melanoma.
Croatian: Bolesnici koji nisu ranije liječeni (rezultati faze III ispitivanja [BREAK-3]) Djelotvornost i sigurnost dabrafeniba procijenjene su u randomiziranom, otvorenom ispitivanju faze III [BREAK 3] gdje je uspoređivan dabrafenib s dakarbazinom (DTIC) kod ranije neliječenih bolesnika s uznapredovalim (neoperabilnim, stadij III) ili metastatskim (stadij IV) melanomom pozitivnim na BRAF V600E mutaciju.
English: Tafinlar 75 mg hard capsules are opaque dark pink and imprinted with “GS LHF” and “75 mg”.
Croatian: Tafinlar 75 mg tvrde kapsule su neprozirne tamnoroze s otisnutim "GS LHF" i "75 mg".
English: Take the doses of Tafinlar and trametinib exactly as your doctor, nurse or pharmacist tells you.
Croatian: Uzimajte doze Tafinlara i trametiniba točno onako kako Vam kažu Vaš liječnik, medicinska sestra ili ljekarnik.
English: In the Phase III study BRF115532 (COMBI-AD) in the adjuvant treatment of melanoma, 1% (6/435) of patients receiving dabrafenib in combination with trametinib as compared to 1% (5/432) of patients receiving placebo developed cuSCC.
Croatian: U ispitivanju faze III BRF115532 (COMBI-AD) u adjuvantnom liječenju melanoma, 1% (6/435) bolesnika koji su primali dabrafenib u kombinaciji s trametinibom razvio je cuSCC, u usporedbi s 1% (5/432) bolesnika koji su primali placebo.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Please see trametinib SmPC (see section 4.6) when used in combination with trametinib.
Croatian: Vidjeti sažetak opisa svojstava lijeka za trametinib (dio 4.6) kada se primjenjuje u kombinaciji s trametinibom.
English: Frequency (all grades) Adverse reactions
Croatian: Učestalost (svi stupnjevi) Nuspojave
English: In the Phase III study BRF115532 in the adjuvant treatment of melanoma, the incidence and severity of pyrexia were higher in the dabrafenib in combination with trametinib arm (67%; 6% Grade 3/4) as compared to the placebo arm (15%; <1% Grade 3).
Croatian: U ispitivanju faze III BRF115532 u adjuvantnom liječenju melanoma, incidencija i težina pireksije bile su više u skupini koja je primala dabrafenib u kombinaciji s trametinibom (67%; 6% 3./4. stupnja) u usporedbi sa skupinom koja je primala placebo (15%; <1% 3. stupnja).
English: By Investigator By IRC
Croatian: Ispitivačeva Neovisnog odbora za procjenu
English: No data are available in subjects with severe renal impairment (see section 4.2).
Croatian: Podaci za osobe s teškim oštećenjem bubrega nisu dostupni (vidjeti dio 4.2).
English: No studies have been conducted to investigate the pharmacokinetics of dabrafenib in paediatric patients.
Croatian: Pedijatrijska populacija Nije provedeno niti jedno ispitivanje farmakokinetike dabrafeniba u pedijatrijskih bolesnika.
English: A population pharmacokinetic analysis suggests that mild renal impairment does not affect oral clearance of dabrafenib.
Croatian: Analiza populacijske farmakokinetike ukazala je na to da umjereno oštećenje bubrega ne utječe na klirens dabrafeniba nakon peroralne primjene.
English: N=1 2.9 (NR, NR)
Croatian: N=1 2,9 (ND; ND)
English: • Increase in blood sugar level (hyperglycaemia)
Croatian: • povećanje razine šećera (hiperglikemija) u krvi
English: (19.2, NR)
Croatian: (19,2; ND)
English: • Corticosteroids (e.g. dexamethasone, methylprednisolone)
Croatian: • Kortikosteroide (npr. deksametazon, metilprednizolon)
English: Administration of ketoconazole (a CYP3A4 inhibitor) 400 mg once daily, with dabrafenib 75 mg twice daily, resulted in a 71% increase in dabrafenib AUC and a 33% increase in dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone.
Croatian: Primjena ketokonazola (inhibitor CYP3A4) od 400 mg jednom dnevno s dabrafenibom od 75 mg dvaput dnevno, rezultirala je porastom AUC-a dabrafeniba od 71% i porastom Cmax-a dabrafeniba od 33% u odnosu na primjenu samog dabrafeniba od 75 mg dvaput dnevno.
English: In the combination therapy arm of study MEK115306 in patients with unresectable or metastatic melanoma, pyrexia was reported in 57% (119/209) of patients with 7% Grade 3, as compared to the dabrafenib monotherapy arm with 33% (69/211) of patients reporting pyrexia, 2% Grade 3.
Croatian: U skupini koja je primala kombiniranu terapiju u ispitivanju MEK115306 u bolesnika s neoperabilnim ili metastatskim melanomom, pireksija je prijavljena u 57% (119/209) bolesnika od čega je 7% bilo 3. stupnja, a u skupini koja je primala dabrafenib kao monoterapiju pireksija je prijavljena u 33% (69/211) bolesnika od čega je 2% bilo 3. stupnja.
English: • some anti-inflammatory medicines, such as dexamethasone and methylprednisolone
Croatian: • neke protuupalne lijekove, poput deksametazona i metilprednizolona
English: Cohort A N=76
Croatian: Kohorta A N=76
English: Please refer to the trametinib SmPC for additional information (see section 4.4).
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib za dodatne informacije (vidjeti dio 4.4).
English: The majority of subjects had BRAF V600E mutation-positive melanoma (89%).
Croatian: Većina je ispitanika imala melanom pozitivan na BRAF V600E mutaciju (89%).
English: • Cohort B: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 59 patients enrolled.
Croatian: • Kohorta B: kombinirana terapija (dabrafenib 150 mg dvaput na dan i trametinib 2 mg jedanput na dan), uključeno 59 bolesnika.
English: • Cohort C: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 34 patients.
Croatian: • Kohorta C: kombinirana terapija (dabrafenib 150 mg dvaput na dan i trametinib 2 mg jedanput na dan), 34 bolesnika.
English: Please refer to trametinib SmPC for information on method of administration when given in combination with dabrafenib.
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib za informacije o načinu primjene kada se daje u kombinaciji s dabrafenibom.
English: • Low levels of phosphate (hypophosphataemia) in the blood
Croatian: • niska razina fosfata (hipofosfatemija) u krvi
English: In the integrated safety population of dabrafenib in combination with trametinib (n=1076), 265 patients (25%) were ≥65 years of age, 62 patients (6%) were ≥75 years of age.
Croatian: U objedinjenoj populaciji u kojoj se ispitivala sigurnost dabrafeniba u kombinaciji s trametinibom (n=1076), 265 bolesnika (25%) bilo je u dobi
English: New malignancies, cutaneous and non-cutaneous, can occur when dabrafenib is used as monotherapy or in combination with trametinib.
Croatian: Nove zloćudne bolesti, kožne i koje ne zahvaćaju kožu, mogu se pojaviti kada se dabrafenib primjenjuje kao monoterapija i u kombinaciji s trametinibom.
English: Administration of gemfibrozil (a CYP2C8 inhibitor) 600 mg twice daily, with dabrafenib 75 mg twice daily, resulted in a 47% increase in dabrafenib AUC but did not alter dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone.
Croatian: Primjena gemfibrozila (inhibitor CYP2C8) od 600 mg dvaput dnevno s dabrafenibom od 75 mg dvaput dnevno, rezultirala je porastom AUC-a dabrafeniba od 47%, no nije utjecala na Cmax samog dabrafeniba od 75 mg dvaput dnevno.
English: Elevations in blood pressure have been reported in association with dabrafenib in combination with trametinib, in patients with or without pre-existing hypertension.
Croatian: Prijavljena su povišenja krvnog tlaka povezana s dabrafenibom u kombinaciji s trametinibom u bolesnika koji su otprije bolovali od hipertenzije i u onih koji nisu.
English: • If you do become pregnant while you are taking this medicine, tell your doctor immediately.
Croatian: • Odmah obavijestite liječnika ako zatrudnite za vrijeme uzimanja ovog lijeka.
English: The 5-year overall survival rate was 40% (95% CI: 31.2, 48.4) in the combination arm versus 33% (95% CI: 25.0, 41.0) in the dabrafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 8.4, 26.0) in the combination arm versus 14% (95% CI: 6.8, 23.1) in the dabrafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Croatian: Za bolesnike koji su imali normalnu razinu laktat dehidrogenaze na početku, 5-godišnja stopa ukupnog preživljenja bila je 40% (95% CI: 31,2; 48,4) u skupini koja je primala kombinaciju naspram 33% (95% CI: 25,0; 41,0) u skupini koja je primala monoterapiju dabrafenibom, a za bolesnike koji su imali povišenu razinu laktat dehidrogenaze na početku, 5-godišnja stopa ukupnog preživljenja bila je 16% (95% CI: 8,4; 26,0) u skupini koja je primala kombinaciju naspram 14% (95% CI: 6,8; 23,1) u skupini koja je primala monoterapiju dabrafenibom.
English: Rash has been observed in about 24% of patients in clinical trials when dabrafenib is used in combination with trametinib (see section 4.8).
Croatian: Osip je primijećen u približno 24% bolesnika u kliničkim ispitivanjima kada je dabrafenib primijenjen u kombinaciji s trametinibom (vidjeti dio 4.8).
English: Please refer to the trametinib SmPC (see section 4.4) for additional information.
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib (vidjeti dio 4.4) za dodatne informacije.
English: • Immunosuppressants (e.g. cyclosporin, tacrolimus, sirolimus)
Croatian: • Imunosupresive (npr. ciklosporin, takrolimus, sirolimus)
English: Permanently discontinue trametinib and dabrafenib for life-threatening pulmonary embolism.
Croatian: Potrebno je trajno obustaviti liječenje trametinibom i dabrafenibom kod plućne embolije opasne po život.
English: Administration of rifampin (a CYP3A4/CYP2C8 inducer) 600 mg once daily with dabrafenib 150 mg twice daily resulted in a decrease in repeat dose dabrafenib Cmax (27%) and AUC (34%).
Croatian: Primjena rifampicina (induktor CYP3A4/CYP2C8) od 600 mg jednom dnevno s dabrafenibom od 150 mg dvaput dnevno, rezultirala je smanjenjem Cmax-a (27%) i AUC-a (34%) u ponovljenoj dozi dabrafeniba.
English: The efficacy and safety of dabrafenib in combination with trametinib were studied in a Phase III, multicentre, randomised, double-blind, placebo-controlled study in patients with Stage III (Stage IIIA [lymph node metastasis >1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection.
Croatian: Djelotvornost i sigurnost dabrafeniba u kombinaciji s trametinibom ispitivane su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III u bolesnika s melanomom stadija III (stadij IIIA [metastaze u limfnim čvorovima >1 mm], IIIB, ili IIIC) s mutacijom BRAF V600 E/K, nakon potpune resekcije.
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis (see section 4.4).
Croatian: Nakon epizode pankreatitisa, bolesnike je potrebno pozorno nadzirati pri ponovnom uvođenju dabrafeniba (vidjeti dio 4.4).
English: Primary analysis (Data cut-off: 17Apr-2014)
Croatian: Primarna analiza (završni datum za podatke: 17. travnja
English: • Dabrafenib monotherapy
Croatian: • Monoterapija dabrafenibom
English: Your doctor may take blood samples to monitor your liver and kidney function while you are taking Tafinlar.
Croatian: Vaše jetrene i bubrežne funkcije dok uzimate Tafinlar.
English: Alternative agents should be considered during administration with dabrafenib when possible.
Croatian: Kada je to moguće, tijekom primjene dabrafeniba treba razmotriti alternativne tvari.
English: 1 mg once daily
Croatian: 1 mg jedanput na dan
English: 75 mg twice daily
Croatian: 75 mg dvaput na dan
English: MEK115306 was a Phase III, randomised, double-blinded study comparing the combination of dabrafenib and trametinib to dabrafenib and placebo in first-line therapy for subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.
Croatian: MEK115306 bilo je randomizirano, dvostruko slijepo ispitivanje faze III u kojem se uspoređivala kombinacija dabrafeniba i trametiniba s dabrafenibom i placebom u prvoj liniji liječenja za ispitanike s neoperabilnim (stadij IIIC) ili metastatskim (stadij IV) melanomom kože pozitivnim na BRAF V600E/K mutaciju.
English: Primary analysis (data cut-off: 26-Aug-2013)
Croatian: Primarna analiza (završni datum za podatke: 26. kolovoza 2013.)
English: Dabrafenib dose Used as monotherapy or in combination with trametinib
Croatian: Doza dabrafeniba koji se primjenjuje kao monoterapija ili u kombinaciji s trametinibom
English: Kinase
Croatian: Kinaze
English: Efficacy results from the primary analysis and a post-hoc analysis with 6-months additional follow up are summarised in Table 11.
Croatian: Rezultati djelotvornosti iz primarne analize i post-hoc analize s dodanim podacima o praćenju tijekom 6 mjeseci, sažeto su prikazani u tablici 11. Podaci o OS-u iz daljnje post-hoc analize temeljene na podacima sa zaključnim datumom 18. prosinca 2012. prikazani su na slici 3.
English: Cohort B N=18
Croatian: Kohorta B N=18
English: At 3 years
Croatian: Na 3 godine
English: Dose modification
Croatian: Kožne promjene
English: In vitro, dabrafenib produced dose-dependent increases in CYP2B6 and CYP3A4.
Croatian: In vitro, dabrafenib je uzrokovao povećanja CYP2B6 i CYP3A4 ovisna o dozi.
English: 1st dose reduction
Croatian: 1. smanjenje doze
English: What Tafinlar looks like and contents of the pack Tafinlar 50 mg hard capsules are opaque dark red and imprinted with “GS TEW” and “50 mg”.
Croatian: Tafinlar 50 mg tvrde kapsule su neprozirne tamnocrvene s otisnutim "GS TEW" i "50 mg".
English: Cohort C N=16
Croatian: Kohorta C N=16
English: If uveitis does not respond to local ocular therapy, withhold dabrafenib until resolution of ocular inflammation and then restart dabrafenib reduced by one dose level (see section 4.4).
Croatian: Ako uveitis ne reagira na lokalnu okularnu terapiju, treba prekinuti primjenu dabrafeniba do povlačenja upale oka i tada ponovno započeti primjenu dabrafeniba u dozi smanjenoj za jednu razinu (vidjeti dio 4.4).
English: A drug utilisation review (DUR) is therefore essential when initiating dabrafenib treatment.
Croatian: Pri započinjanju terapije dabrafenibom nužno je provjeriti pregled iskorištenosti lijeka (DUR).
English: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”.
Croatian: Neprozirne tamnocrvene kapsule, približno 18 mm duge, s otisnutim ‘GS TEW' i '50 mg' na ovojnici kapsule.
English: N=4 3.8 (NR, NR)
Croatian: N=4 3,8 (ND; ND)
English: Dabrafenib in combination with trametinib has been reported to decrease LVEF (see section 4.8).
Croatian: Prijavljeno je da dabrafenib u kombinaciji s trametinibom smanjuje LVEF (vidjeti dio 4.8).
English: Co-administration of repeat doses of dabrafenib 150 mg twice daily and the pH-elevating agent rabeprazole 40 mg once daily resulted in a 3% increase in AUC and a 12% decrease in dabrafenib Cmax.
Croatian: Istovremena primjena ponovljenih doza dabrafeniba od 150 mg dvaput dnevno i lijeka koji povisuje pH, rabeprazola od 40 mg jednom dnevno rezultirala je povećanjem AUC-a od 3% i smanjenjem Cmax-a od 12% za dabrafenib.
English: 2 mg once daily
Croatian: 2 mg jedanput na dan
English: Please refer to the trametinib SmPC section 4.4 for additional information.
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib, dio 4.4 za dodatne informacije.
English: Effect of other medicinal products on dabrafenib
Croatian: Učinak drugih lijekova na dabrafenib
English: OS analysis data cut-off: 13-Mar-2015)
Croatian: Analiza OS-a (završni datum za podatke: 13. ožujka 2015.)
English: Rhabdomyolysis has been reported in patients taking dabrafenib in combination with trametinib (see section 4.8).
Croatian: Rabdomioliza je prijavljena u bolesnika koji su uzimali dabrafenib u kombinaciji s trametinibom (vidjeti dio 4.8).
English: • have any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue.
Croatian: ili oticanje u oku koje može biti uzrokovano blokadom tekućine (korioretinopatija). - ako imate tegobe s plućima ili disanjem, uključujući teškoće u disanju često udružene sa suhim kašljem, nedostatkom zraka i umorom.
English: Monitoring should continue for 6 months following discontinuation of dabrafenib or until initiation of another anti-neoplastic therapy.
Croatian: Praćenje nakon prekidanja terapije dabrafenibom treba nastaviti tijekom 6 mjeseci ili do započinjanja terapije drugim protutumorskim lijekom.
English: There are no data in humans for dabrafenib as monotherapy or in combination with trametinib.
Croatian: Nema podataka o utjecaju dabrafeniba kao monoterapije ili u kombinaciji s trametinibom na ljude.
English: Please refer to the trametinib SmPC for additional information.
Croatian: Pogledajte sažetak opisa svojstava lijeka za trametinib za dodatne informacije.
English: indinavir, lopinavir, nelfinavir, saquinavir, tipranavir)
Croatian: fosamprenavir, indinavir, lopinavir, nelfinavir, sakvinavir, tipranavir)
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Croatian: Eastern Cooperative Oncology Group, ECOG) 0 (72%) i visceralnu bolest (73%) na početku.
English: Table 8 Overall Survival results for Study MEK116513 (COMBI-v)
Croatian: Tablica 8 Rezultati ukupnog preživljenja za ispitivanje MEK116513 (COMBI-v)
English: Monitoring for skin lesions should occur as described for cuSCC.
Croatian: Praćenje kožnih lezija potrebno je provoditi prema uputama navedenim za planocelularni karcinom kože.
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis.
Croatian: Nakon epizode pankreatitisa, bolesnike je potrebno pozorno nadzirati pri ponovnom uvođenju dabrafeniba.
English: Pancreatitis has been reported in dabrafenib monotherapy and in combination with trametinib.
Croatian: Pankreatitis je zabilježen kod monoterapije dabrafenibom i u kombinaciji s trametinibom.
English: Combination with trametinib
Croatian: Kombinacija s trametinibom
English: Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive unresectable or metastatic melanoma.
Croatian: Ispitivanje MEK116513 bilo je randomizirano, otvoreno ispitivanje faze III s 2 skupine u kojem se uspoređivala kombinirana terapija dabrafenibom i trametinibom s monoterapijom vemurafenibom kod neoperabilnog ili metastatskog melanoma pozitivnog na BRAF V600 mutaciju.
English: Cases of RAS-driven malignancies have been seen with dabrafenib as monotherapy and in combination with trametinib.
Croatian: Zamijećeni su slučajevi RAS-om potaknutih zloćudnih bolesti pri primjeni dabrafeniba kao monoterapije i u kombinaciji s trametinibom.
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring is recommended when dabrafenib is used concomitantly with warfarin and at discontinuation of dabrafenib (see section 4.5).
Croatian: Potreban je oprez kod istovremene primjene dabrafeniba i varfarina, te se preporučuju dodatne kontrole INR-a (International Normalised Ratio), kao i nakon prekida primjene dabrafeniba (vidjeti dio 4.5).
English: Dabrafenib should be used with caution in patients with severe renal impairment when administered as monotherapy or in combination with trametinib.
Croatian: Potreban je oprez pri uporabi dabrafeniba u bolesnika s teškim oštećenjem bubrega kada se primjenjuje kao monoterapija ili u kombinaciji s trametinibom.
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Croatian: Ako imate dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: Changes in your skin which may indicate new skin cancer Your doctor will check your skin before you start taking this medicine and regularly while you are taking it. Tell your doctor immediately if you notice any changes to your skin while taking this medicine or after treatment (see also section 4).
Croatian: Promjene na koži koje mogu ukazivati na novi rak kože Prije početka liječenja ovim lijekom i redovito tijekom njegovog uzimanja
English: The efficacy and safety of dabrafenib in combination with trametinib was studied in a Phase II, three-cohort, multicentre, non-randomised and open-label study in which patients with stage IV BRAF V600E mutant NSCLC were enrolled.
Croatian: Djelotvornost i sigurnost dabrafeniba u kombinaciji s trametinibom ispitivane su u multicentričnom, nerandomiziranom, otvorenom ispitivanju faze II s tri kohorte, u koje su bili uključeni bolesnici s NSCLC-om stadija IV s BRAF V600E mutacijom.
English: The proportion of patients experiencing AEs was similar in those aged <65 years and those aged ≥65 years in all clinical trials.
Croatian: ≥ 65 godina u svim kliničkim ispitivanjima.
English: No dose modification of dabrafenib is required when taken in combination with trametinib for cases of ILD or pneumonitis.
Croatian: Nije potrebna prilagodba doze dabrafeniba kada se uzima u kombinaciji s trametinibom za slučajeve IBP-a ili pneumonitisa.
English: Table 6 Overall Survival results for Study MEK115306 (COMBI-d)
Croatian: Tablica 6 Rezultati ukupnog preživljenja za ispitivanje MEK115306 (COMBI-d)
English: Changes in your skin Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib (frequency not known).
Croatian: U ljudi koji su uzimali Tafinlar u kombinaciji s trametinibom prijavljene su ozbiljne kožne reakcije (čija je učestalost nepoznata).
English: Fever has been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib (see section 4.8).
Croatian: Vrućica je zabilježena u kliničkim ispitivanjima s dabrafenibom kao monoterapijom i u kombinaciji s trametinibom (vidjeti dio 4.8).
English: The clinical status of the patient and the adverse reaction profile of dabrafenib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Croatian: Pri razmatranju mogućnosti bolesnika za izvođenje zadataka pri kojima je potrebno rasuđivanje, motorne ili kognitivne vještine treba imati na umu klinički status bolesnika kao i profil nuspojava dabrafeniba.
English: 5-year OS analysis (data cut-off: 10-Dec-2018)
Croatian: 5-godišnja analiza (završni datum za podatke: 10. prosinca 2018.)
English: Overall survival estimate, % (95% CI)
Croatian: Procjena ukupnog preživljenja, % (95% CI)