FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of dabrafenib with digoxin may result in decreased digoxin exposure.
Croatian: Istodobna primjena dabrafeniba s digoksinom može rezultirati smanjenom izloženošću digoksinu.
English: No dose modifications are required as long as effective local therapies can control ocular inflammation.
Croatian: Nije potrebna prilagodba doze kod uveitisa sve dok učinkovita lokalna terapija može kontrolirati upalu oka.
English: Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib.
Croatian: Do početka indukcije vjerojatno dolazi nakon 3 dana ponavljajućih doza dabrafeniba.
English: When an individual's adverse reactions are under effective management, dose re-escalation following the same dosing steps as de-escalation may be considered.
Croatian: Ako se nuspojave bolesnika uspješno liječe, može se razmotriti povećanje doze prema istim koracima za doziranje kao i kod smanjenja.
English: Tafinlar when given in combination with trametinib can cause eye problems including blindness.
Croatian: Tafinlar kada se daje u kombinaciji s trametinobom može izazvati očne tegobe, uključujući sljepoću.
English: • Eye changes including swelling in the eye caused by fluid leakage (chorioretinopathy),
Croatian: • promjene na očima uključujući oticanje u oku uzrokovano curenjem tekućine
English: 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.
Croatian: Izbjegavajte istovremenu primjenu dabrafeniba i snažnih induktora (npr. rifampicin, fenitoin, karbamazepin, fenobarbital ili gospina trava (Hypericum perforatum)) enzima CYP2C8 ili CYP3A4.
English: No relevant change in AUC was noted for hydroxy-dabrafenib.
Croatian: Nije primijećena značajna promjena AUC-a hidroksidabrafeniba.
English: 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.
Croatian: 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.
English: Patients should be evaluated for signs and symptoms of infection (see section 4.4).
Croatian: Bolesnike je potrebno pregledati, tražeći znakove i simptome infekcije (vidjeti dio 4.4).
English: At 5 years
Croatian: Na 5 godina
English: 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).
Croatian: 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%).
English: • 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
Croatian: • 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
English: 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.
Croatian: Dabrafenib inducira enzime i povećava sintezu enzima za metaboliziranje lijekova uključujući CYP3A4, CYP2Cs i CYP2B6 i može povećati sintezu transportera.
English: There are limited data in patients taking the combination of dabrafenib with trametinib who have progressed on a prior BRAF inhibitor.
Croatian: Postoje ograničeni podaci u bolesnika koji su uzimali kombinaciju dabrafeniba s trametinibom u kojih je došlo do progresije tijekom prethodne terapije BRAF inhibitorom.
English: Of the total number of patients in the integrated safety population of dabrafenib monotherapy (n=578), 22% were 65 years of age and older, and 6% were 75 years of age and older.
Croatian: Od ukupnog broja ispitanika u objedinjenoj populaciji u kojoj se ispitivala sigurnost monoterapije dabrafenibom (n=578), 22% je imalo 65 i više godina, a 6% imalo je 75 godina i više.
English: • Cardiac glycosides (e.g. digoxin, see section 4.4)
Croatian: • Glikozide digitalisa (npr. digoksin, vidjeti dio 4.4)
English: P-value is obtained from the two-sided stratified logrank test (stratification factors were disease stage - IIIA vs. IIIB vs. IIIC - and BRAF V600 mutation type - V600E vs. V600K) NE = not estimable
Croatian: P-vrijednost je dobivena iz dvostranog stratificiranog logrank testa (faktori stratifikacije bili su stadij bolesti - IIIA naspram IIIB naspram IIIC - i tip BRAF V600 mutacije - V600E naspram V600K)
English: Effects of dabrafenib on substance transport systems
Croatian: Učinci dabrafeniba na sustave prijenosa tvari
English: Dabrafenib in combination with trametinib should be used with caution in patients with conditions that could impair left ventricular function.
Croatian: Dabrafenib u kombinaciji s trametinibom treba primjenjivati s oprezom u bolesnika sa stanjima koja mogu oštetiti funkciju lijevog ventrikula.
English: In a clinical drug interaction study, Cmax and AUC of oral midazolam (a CYP3A4 substrate) decreased by 47% and 65%, respectively with co-administration of repeat-dose dabrafenib.
Croatian: U kliničkom ispitivanju interakcija lijekova, snizile su se vrijednosti Cmax i AUC za oralni midazolam (supstrat CYP3A4) za 47% i 65%, pri istodobnom ponavljanom doziranju dabrafeniba.
English: (22.6, NR)
Croatian: (22,6; ND)
English: Pancreatitis has been reported in <1% of patients treated with dabrafenib as monotherapy and in combination with trametinib in unresectable or metastatic melanoma clinical trials and about 4% of patients treated with dabrafenib in combination with trametinib in the NSCLC clinical trial.
Croatian: Pankreatitis je zabilježen u < 1% bolesnika koji su primali dabrafenib kao monoterapiju i u kombinaciji s trametinibom u kliničkim ispitivanjima neoperabilnog ili metastatskog melanoma i u oko 4% bolesnika koji su primali dabrafenib u kombinaciji s trametinibom u kliničkom ispitivanju NSCLC-a.
English: Patients with brain metastases
Croatian: Bolesnici s metastazama u mozgu
English: • Analgesics (e.g. fentanyl, methadone)
Croatian: • Analgetike (npr. fentanil, metadon)
English: Granulomatous nephritis has been reported (see section 4.8).
Croatian: Prijavljen je granulomatozni nefritis (vidjeti dio 4.8).
English: Figure 4 Kaplan-Meier RFS curves for Study BRF115532 (ITT population, updated results)
Croatian: Slika 4 Kaplan-Meier RFS krivulje za ispitivanje BRF115532 (ITT populacija, ažurirani rezultati)
English: If possible, show them the Tafinlar and trametinib pack with each leaflet.
Croatian: Ako je moguće, pokažite im pakiranja Tafinlara i trametiniba s uputama o lijeku.
English: Neither dabrafenib nor its 3 main metabolites were demonstrated to be inhibitors of Pgp in vitro.
Croatian: In vitro nije dokazano da su dabrafenib i njegova 3 glavna metabolita inhibitori Pgp-a.
English: In the integrated safety population for dabrafenib in combination with trametinib, 2% of patients developed cuSCC and the events occurred later than with dabrafenib monotherapy with a median time to onset of 18-31 weeks.
Croatian: U objedinjenoj populaciji u kojoj se ispitivala sigurnost dabrafeniba u kombinaciji s trametinibom, u 2% bolesnika razvio se cuSCC, a do događaja je došlo kasnije nego uz monoterapiju dabrafenibom, s medijanom vremena do prve pojave od 18-31 tjedan.
English: How should you take Tafinlar in combination with trametinib
Croatian: Kako uzimati Tafinlar u kombinaciji s trametinibom
English: The population pharmacokinetic analysis showed no significant differences in the pharmacokinetics of dabrafenib between Asian and Caucasian patients.
Croatian: Analiza populacijske farmakokinetike nije pokazala značajne razlike u farmakokinetici dabrafeniba između bolesnika azijskog podrijetla i bijelaca.
English: Most patients (94%) enrolled in the combination therapy treated cohorts had an ECOG performance status of 0 or 1.
Croatian: Većina bolesnika (94%) uključenih u kohorte liječene kombiniranom terapijom imala je ECOG funkcionalni status 0 ili 1. 26 (28%) nikada nije pušilo.
English: Tell your doctor immediately if you get eye redness and irritation, blurred vision, eye pain or other vision changes during your treatment (see also section 4).
Croatian: Odmah obavijestite svog liječnika ako za vrijeme uzimanja ovog lijeka imate crvenilo očiju i iritaciju, zamagljen vid, bol u oku ili druge promjene vida (također pogledajte dio 4).
English: • Reddening and swelling of the palms, fingers and soles of the feet (see “Changes in your skin”
Croatian: • crvenilo i otekline dlanova, prstiju ruke i tabana (pogledajte "Kožne promjene" ranije u dijelu 4)
English: • coughing up of blood or blood clots
Croatian: • iskašljavanje krvi ili krvnih ugrušaka
English: Skin reactions (rash) can happen while taking Tafinlar in combination with trametinib.
Croatian: Kožne reakcije (osip) se mogu pojaviti tijekom uzimanja Tafinlara u kombinaciji s trametinibom.
English: Preclinical data generated in biochemical assays demonstrated that dabrafenib inhibits BRAF kinases with activating codon 600 mutations (Table 5).
Croatian: Pretklinički podaci dobiveni u biokemijskim ispitivanjima pokazali su da dabrafenib inhibira BRAF kinaze s aktiviranom mutacijom kodona 600 (tablica 5).
English: Bronchoalveolar inflammation of the lungs was observed in several dogs at ≥20 mg/kg/day (≥9 times human clinical exposure based on AUC) and was associated with shallow and/or laboured breathing.
Croatian: Kod nekoliko pasa je nađena bronhoalveolarna upala pluća pri dozama ≥ 20 mg/kg/dan (≥ 9 puta kliničke izloženosti u ljudi temeljeno na AUC-u) te je bila povezana s plitkim i/ili teškim disanjem.
English: • Skin tags
Croatian: • kožni privjesci
English: Liver monitoring may be continued thereafter as clinically indicated.
Croatian: Nakon toga se nadziranje jetrene funkcije može nastaviti sukladno kliničkoj indikaciji.
English: Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.
Croatian: Dabrafenib je pokazao supresiju nizvodnih farmakodinamičkih biomarkera (fosforilirani ERK) i inhibiciju staničnog rasta u BRAF V600 mutiranim staničnim linijama melanoma, in vitro kao i u modelima na životinjama.
English: Abnormal findings should be managed according to clinical practices.
Croatian: Patološki nalazi se moraju zbrinuti u skladu s važećim kliničkim smjernicama.
English: In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥0.2 times adult human clinical exposure based on AUC).
Croatian: U ispitivanjima juvenilne toksičnosti na štakorima, uočeni su učinci na rast (skraćena duga nožna kost), bubrežna toksičnost (tubularni depoziti, povećana incidencija kortikalnih cisti, tubularna bazofilija te reverzibilna povećanja koncentracije ureje i/ili kreatinina) i testikularna toksičnost (degeneracija i dilatacija kanalića) (≥ 0,2 puta kliničke izloženosti u odraslih ljudi temeljeno na AUC-u).
English: Dabrafenib is a substrate of human P-glycoprotein (Pgp) and human BCRP in vitro.
Croatian: Dabrafenib je in vitro supstrat humanog P-glikoproteina (Pgp) i humanog BCRP-a.
English: Always take Tafinlar exactly as your doctor, pharmacist or nurse has told you to.
Croatian: Uvijek uzmite Tafinlar točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: In combined female fertility, early embryonic and embryo-foetal development studies in rats numbers of ovarian corpora lutea were reduced in pregnant females at 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), but there were no effects on oestrous cycle, mating or fertility indices.
Croatian: U kombiniranom ispitivanju plodnosti ženki, ranog embrionalnog i embriofetalnog razvoja u štakora, broj ovarijskih žutih tijela se u skotnih ženki smanjio na 300 mg/kg/dan (približno 3 puta kliničke izloženosti u ljudi temeljeno na AUC-u), ali nije bilo učinka na reproduktivni ciklus, parenje ili plodnost.
English: BRF113710 (BREAK-2) was a multicentre, single-arm study that enrolled 92 subjects with metastatic melanoma (Stage IV) with confirmed BRAF V600E or V600K mutation-positive melanoma.
Croatian: BRF113710 (BREAK-2) je bilo multicentrično ispitivanje s jednom skupinom u koju je bilo uključeno 92 ispitanika s metastatskim melanomom (stadij IV) s potvrđenom BRAF V600E ili V600K mutacijom melanoma.
English: It is recommended that patients receiving treatment with dabrafenib in combination with trametinib have liver function monitored every four weeks for 6 months after treatment initiation with trametinib.
Croatian: U bolesnika koji se liječe dabrafenibom u kombinaciji s trametinibom preporučuje se nadzirati jetrenu funkciju svaka četiri tjedna tijekom 6 mjeseci nakon početka liječenja trametinibom.
English: Similar results were seen in the 45 patients who crossed over from dabrafenib monotherapy to the trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination in Part C of this study.
Croatian: Slični su rezultati bili uočeni u 45 bolesnika koji su prešli s monoterapije dabrafenibom na kombinaciju trametinib 2 mg jedanput na dan i dabrafenib 150 mg dvaput na dan u Dijelu C ovog ispitivanja.
English: Patients should be routinely monitored for serum creatinine while on therapy.
Croatian: Tijekom liječenja bolesnicima je potrebno redovito kontrolirati kreatinin u serumu.
English: • HIV antivirals (e.g. amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir,
Croatian: • HIV antivirusne lijekove (npr. amprenavir, atazanavir, darunavir, delavirdin, efavirenz,
English: Improvements were also observed for overall response rate (ORR) and a longer duration of response (DoR) was observed in the combination arm compared to dabrafenib monotherapy (Table 7).
Croatian: Poboljšanja su također uočena za stopu ukupnog odgovora (engl. overall response rate, ORR) i dulje trajanje odgovora (engl. duration of response, DoR) bilo je uočeno u skupini koja je primala kombinaciju u usporedbi s monoterapijom dabrafenibom (tablica 7).
English: N=99 5.6 (4.8, NR)
Croatian: N=99 5,6 (4,8; ND)
English: If the patient becomes pregnant while taking dabrafenib, the patient should be informed of the potential hazard to the foetus.
Croatian: Ako bolesnica ostane trudna tijekom primanja terapije dabrafenibom, treba ju obavijestiti o mogućim štetnim djelovanjima na fetus.
English: Developmental toxicity including embryo-lethality and ventricular septal defects and variation in thymic shape were seen at 300 mg/kg/day, and delayed skeletal development and reduced foetal body weight at ≥20 mg/kg/day (≥0.5 times human clinical exposure based on AUC).
Croatian: Razvojna toksičnost, uključujući smrtnost embrija i defekte ventrikularnog septuma i variranje oblika timusa, nađena je pri 300 kg/kg/dan, uz odgođen razvoj skeleta te smanjenje fetalne tjelesne težine na ≥ 20 mg/kg/dan (≥ 0,5 puta kliničke izloženosti u ljudi temeljeno na AUC-u).
English: Following discontinuation of dabrafenib, monitoring for non-cutaneous secondary/recurrent malignancies should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Croatian: Nakon prekida primjene dabrafeniba, potrebno je nastaviti s praćenjem sekundarnih/rekurentnih zloćudnih bolesti koje ne zahvaćaju kožu u razdoblju do 6 mjeseci ili do početka druge protutumorske terapije.
English: After an oral dose, the major route of elimination of dabrafenib is metabolism, mediated via CYP3A4 and CYP2C8.
Croatian: Nakon oralne doze, glavni put eliminacije je metabolizam, posredovan s CYP3A4 i CYP2C8.
English: The trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination demonstrated limited clinical activity in patients who had progressed on a BRAF inhibitor.
Croatian: Kombinacija trametiniba 2 mg jedanput na dan i dabrafeniba 150 mg dvaput na dan pokazala je ograničenu kliničku aktivnost u bolesnika u kojih je došlo do progresije tijekom terapije BRAF inhibitorom.
English: The investigator-assessed confirmed response rate was 15% (95% CI: 4.4, 34.9) and the median PFS was 3.6 months (95% CI: 1.9, 5.2).
Croatian: Potvrđena stopa odgovora prema procjeni ispitivača bila je 15% (95% CI: 4,4, 34,9), a medijan PFS-a bio je 3,6 mjeseci (95% CI: 1,9, 5,2).
English: The median time to diagnosis of the first occurrence of cuSCC in study MEK115306 was 223 days (range 56 to 510 days) in the combination therapy arm and 60 days (range 9 to 653 days) in the dabrafenib monotherapy arm.
Croatian: Medijan vremena do dijagnosticiranja prve pojave cuSCC-a u ispitivanju MEK115306 je bio 223 dana (raspon od 56 do 510 dana) u skupini koja je primala kombiniranu terapiju i 60 dana (raspon od 9 do 653 dana) u skupini koja je primala dabrafenib kao monoterapiju.
English: The primary endpoint of the study was progression-free survival (PFS), with a key secondary endpoint of overall survival (OS).
Croatian: Mjera primarnog ishoda u ispitivanju bila je preživljenje bez progresije (engl. progression-free survival, PFS), a ključna mjera sekundarnog ishoda ukupno preživljenje (engl. overall survival, OS).
English: Duration of response, median, months (95% CI) N=28 5.1 (3.7, NR)
Croatian: Trajanje odgovora, medijan, mjeseci (95% CI) N=28 5,1 (3,7; ND)
English: • halo (seeing a blurred outline around objects)
Croatian: • svjetlosne krugove (mutni rubovi oko predmeta)
English: Figure 2 Kaplan-Meier overall survival curves for Study MEK116513
Croatian: Slika 2 Kaplan-Meier krivulje ukupnog preživljenja za ispitivanje MEK116513
English: In vitro, dabrafenib is a mechanism based inhibitor of CYP3A4.
Croatian: In vitro, dabrafenib je inhibitor s djelovanjem na mehanizam CYP3A4.
English: • Thickening of the outer layer of the skin (hyperkeratosis), patches of thick, scaly, or crusty skin
Croatian: • zadebljanje vanjskog sloja kože (hiperkeratoza), debeli ljuskasti ili korasti dijelovi kože
English: Hypophosphataemia has been reported commonly in the integrated safety population of dabrafenib monotherapy (7%) and of dabrafenib in combination with trametinib (4%).
Croatian: Hipofosfatemija je prijavljivana često u objedinjenoj populaciji u kojoj se ispitivala sigurnost monoterapije dabrafenibom (7%) i dabrafeniba u kombinaciji s trametinibom (4%).
English: Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Croatian: Dabrafenib kao monoterapija ili u kombinaciji s trametinibom indiciran je u liječenju odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom (vidjeti dijelove 4.4 i 5.1).
English: Use caution if strong inhibitors (e.g. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) are co-administered with dabrafenib.
Croatian: Potreban je oprez pri istovremenoj primjeni snažnih inhibitora (npr. ketokonazol, gemfibrozil, nefazodon, klaritromicin, ritonavir, sakvinavir, telitromicin, itrakonazol, vorikonazol, posakonazol, atazanavir) s dabrafenibom.
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Croatian: • Antibiotike (npr. klaritromicin, doksiciklin)
English: • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
Croatian: • Blokatore kalcijevih kanala (npr. diltiazem, felodipin, nikardipin, nifedipin, verapamil)
English: The usual dose of Tafinlar either used alone or in combination with trametinib is two 75 mg capsules twice a day (corresponding to a daily dose of 300 mg).
Croatian: Uobičajena doza lijeka Tafinlar bilo kad se uzima sam ili u kombinaciji s trametinibom su dvije kapsule od 75 mg dva puta dnevno (odgovara dnevnoj dozi od 300 mg).
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III trials and one supportive Phase I/II study.
Croatian: Djelotvornost i sigurnost preporučene doze trametiniba (2 mg jedanput na dan) u kombinaciji s dabrafenibom (150 mg dvaput na dan) za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom proučavale su se u dva ispitivanja faze III i jednom potpornom ispitivanju faze I/II.
English: Decreased LVEF has been reported in 6% (65/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Croatian: Smanjenje LVEF prijavljeno je u 6% (65/1076) bolesnika u objedinjenoj populaciji u kojoj se ispitivala sigurnost dabrafeniba u kombinaciji s trametinibom.
English: Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.
Croatian: Potrebno je obavijestiti liječnika čim prije ako dobijete bilo koji od tih simptoma, bilo po prvi put ili ako se pogoršaju.
English: 12.6 (5.8, NE)
Croatian: 12,6 (5,8; NO)
English: Table 3 Adverse reactions reported in the integrated safety population of dabrafenib monotherapy in the studies BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680 (n=578)
Croatian: Tablica 3 Nuspojave zabilježene u objedinjenoj populaciji u kojoj se ispitivala sigurnost monoterapije dabrafenibom u ispitivanjima BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220 i BRF112680 (n=578)
English: Arthralgia was reported very commonly in the integrated safety population of dabrafenib monotherapy (25%) and dabrafenib in combination with trametinib (25%) although these were mainly Grade 1 and 2 in severity with Grade 3 occurring uncommonly (<1%) and no Grade 4 occurrences being reported.
Croatian: Artralgija je prijavljivana vrlo često u objedinjenoj populaciji u kojoj se ispitivala sigurnost monoterapije dabrafenibom (25%) i dabrafeniba u kombinaciji s trametinibom (25%) i većinom se radilo o 1. i 2. stupnju težine dok je 3. stupanj zamijećen manje često (< 1%), a događaji 4. stupnja nisu bili zabilježeni.
English: • Inflammation of the pancreas (causing strong abdominal pain)
Croatian: • upala gušterače (uzrokuje jaku bol u trbuhu)
English: In the integrated safety population of patients with melanoma and advanced NSCLC, cuSCC occurred in 2% (19/1076) of patients receiving dabrafenib in combination with trametinib.
Croatian: U objedinjenoj populaciji u kojoj se ispitivala sigurnost bolesnika s melanomom i uznapredovalim NSCLC-om, cuSCC se pojavio u 2% (19/1076) bolesnika koji su primali dabrafenib u kombinaciji s trametinibom.
English: Pulmonary embolism or deep vein thrombosis can occur when dabrafenib is used in combination with trametinib.
Croatian: Plućna embolija ili duboka venska tromboza mogu se javiti kada se dabrafenib koristi u kombinaciji s trametinibom.
English: Dose adjustment for dabrafenib below 50 mg twice daily is not recommended, whether used as monotherapy or in combination with trametinib.
Croatian: Ne preporučuje se prilagodba doze za dabrafenib ispod 50 mg dvaput na dan, bilo da se primjenjuje kao monoterapija ili u kombinaciji s trametinibom.