FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that skin examination be performed prior to initiation of therapy with dabrafenib and monthly throughout treatment and for up to six months after treatment for cuSCC.
Slovenian: Pred uvedbo zdravljenja z dabrafenibom je priporočljivo opraviti pregled kože ter pregled ponavljati vsak mesec med zdravljenjem in še do šest mesecev po zdravljenju ploščatoceličnega karcinoma kože.
English: • Unusual hair loss or thinning
Slovenian: • neobičajno izpadanje ali tanjšanje las
English: • Low levels of sodium (hyponatraemia) or phosphate (hypophosphataemia) in the blood
Slovenian: • znižana vrednost natrija (hiponatriemija) ali fosfatov v krvi (hipofosfatemija)
English: No dabrafenib dose adjustment is needed in Asian patients.
Slovenian: Pri bolnikih azijske rase ni potrebno prilagajati odmerkov.
English: Cohort B N=65
Slovenian: Kohorta B N = 65
English: Tafinlar should only be used to treat melanomas and NSCLC with the BRAF mutation.
Slovenian: Zdravilo Tafinlar se sme uporabljati le za zdravljenje melanoma in nedrobnoceličnega pljučnega raka, ki ima spremenjen gen BRAF.
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.
Slovenian: Odpoved ledvic so ugotovili pri < 1 % bolnikov, ki so prejemali samo dabrafenib, in pri ≤ 1 % bolnikov, ki so prejemali dabrafenib v kombinaciji s trametinibom.
English: In the Phase II and III clinical trials, screening for eligibility required central testing for BRAF V600 mutation using a BRAF mutation assay conducted on the most recent tumour sample available.
Slovenian: in III. faze je presejanje za primernost zahtevalo centralno izvedeno testiranje glede mutacije BRAF V600 z uporabo testa za mutacijo BRAF na najnovejšem vzorcu tumorja, ki je bil na voljo.
English: Hypophosphataemia has been reported commonly in the integrated safety population of dabrafenib monotherapy (7%) and of dabrafenib in combination with trametinib (4%).
Slovenian: Hipofosfatemija je bila zabeležena pogosto v skupini za vrednotenje varnosti zdravila pri uporabi dabrafeniba v monoterapiji (7 %) in pri uporabi dabrafeniba v kombinaciji s trametinibom (4 %).
English: Cohort A N=15
Slovenian: Kohorta A N = 15
English: Cohort A N=74
Slovenian: Kohorta A N = 74
English: Group
Slovenian: komisija
English: In addition, men who are taking Tafinlar may have a reduced sperm count and their sperm count may not return to normal levels after they stop taking this medicine.
Slovenian: Mogoče je, da se število semenčic po koncu jemanja tega zdravila ne vrne na normalno raven.
English: Cases of cuSCC should be managed by dermatological excision and dabrafenib treatment or, if taken in combination, dabrafenib and trametinib should be continued without any dose adjustment.
Slovenian: Primere ploščatoceličnega karcinoma kože je treba zdraviti z dermatološko ekscizijo, zdravljenje z dabrafenibom oziroma z obema zdraviloma pri zdravljenju s kombinacijo dabrafeniba in trametiniba pa je treba nadaljevati brez prilagoditve odmerka.
English: • Cohort A: Monotherapy (dabrafenib 150 mg twice daily), 84 patients enrolled.
Slovenian: • kohorta A: monoterapija (dabrafenib 150 mg dvakrat na dan), vključenih je bilo 84 bolnikov.
English: ORRb % (95% CI) ORR difference (95% CI)
Slovenian: ORRb % (95-odstotni IZ) razlika ORR (95-odstotni IZ)
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.
Slovenian: V skupni varnostni populaciji bolnikov z melanomom ali napredovalim nedrobnoceličnim pljučnim rakom je do ploščatoceličnega karcinoma kože prišlo pri 2 % (19/1076) bolnikov, ki so prejemali dabrafenib v kombinaciji s trametinibom.
English: At the pre-specified analysis with a 19 December 2011 data cut, a significant improvement in the primary endpoint of PFS (HR=0.30; 95% Cl 0.18, 0.51; p < 0.0001) was achieved.
Slovenian: Vnaprej opredeljena analiza s podatki do presečnega datuma 19. decembra 2011 je pokazala značilno izboljšanje primarnega opazovanega dogodka, preživetja brez napredovanja bolezni (razmerje ogroženost = 0,30; 95-odstotni IZ: od 0,18 do 0,51; p < 0,0001).
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.
Slovenian: Znižanje iztisnega deleža levega prekata (LVEF)/disfunkcija levega prekata Če bolnik jemlje dabrafenib v kombinaciji s trametinibom in pri njem pride do absolutnega zmanjšanja LVEF za > 10 % v primerjavi z izhodiščem, iztisni delež pa je pod spodnjo normalno mejo v ustanovi, za prilagajanje odmerka trametiniba glejte povzetek glavnih značilnosti zdravila za trametinib (poglavje 4.2).
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.
Slovenian: Če pri uporabi dabrafeniba v kombinaciji s trametinibom pride do toksičnih učinkov zdravljenja, je treba sočasno znižati odmerek obeh zdravil oz. sočasno začasno prekiniti ali dokončno ukiniti obe zdravljenji.
English: As hepatic metabolism and biliary secretion are the primary routes of elimination of dabrafenib and its metabolites, administration of dabrafenib should be undertaken with caution in patients with moderate to severe hepatic impairment (see section 4.2).
Slovenian: Ker sta presnova v jetrih in izločanje v žolču glavni poti odstranjevanja dabrafeniba in njegovih presnovkov, je treba dabrafenib le previdno uporabljati pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavje 4.2).
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.
Slovenian: faze [BREAK-2]) Študija BRF113710 (BREAK-2) je bila multicentrična študija z enim samim krakom, ki je zajela 92 bolnikov z metastatskim melanomom (stadij IV) s potrjeno mutacijo BRAF V600E ali V600K.
English: Effect of other medicinal products on dabrafenib
Slovenian: Vpliv drugih zdravil na dabrafenib
English: Discontinue permanently, or interrupt therapy until Grade 0 to 1 and reduce by one dose level when resuming therapy.
Slovenian: Trajno prenehajte zdravljenje ali ga prekinite, dokler niso toksični učinki 0 ali 1. stopnje; ko znova uvedete zdravljenje, odmerek zmanjšajte za eno odmerno raven.
English: Preclinical data generated in biochemical assays demonstrated that dabrafenib inhibits BRAF kinases with activating codon 600 mutations (Table 5).
Slovenian: Predklinični podatki iz biokemičnih preizkusov kažejo, da dabrafenib zavira BRAF-kinaze z aktivacijskimi mutacijami kodona 600 (preglednica 5).
English: After an oral dose, the major route of elimination of dabrafenib is metabolism, mediated via CYP3A4 and CYP2C8.
Slovenian: Po peroralnem odmerku je glavna pot izločanja dabrafeniba presnova, ki poteka preko CYP3A4 in CYP2C8.
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.
Slovenian: Potrjeni delež odziva po raziskovalčevi presoji je bil pri bolnikih z metastatskim melanomom z BRAF V600E (n = 76) 59 % (95-odstotni IZ: 48,2; 70,3) in mediano trajanja odziva 5,2 meseca (95-odstotni IZ: 3,9; neizračunljivo) na podlagi mediane 6,5-mesečnega spremljanja.
English: • Birth control medicines containing hormones (such as pills, injections or patches) may not work as well while you are taking Tafinlar or combination treatment (Tafinlar as well as trametinib).
Slovenian: • Med jemanjem zdravila Tafinlar ali kombiniranega zdravljenja (jemanja zdravila Tafinlar in trametiniba) se lahko zgodi, da hormonska kontracepcijska sredstva (npr. kontracepcijske tablete, injekcije ali obliži) ne delujejo enako dobro.
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.
Slovenian: Presnova v jetrih in izločanje v žolču sta glavni poti izločanja dabrafeniba in njegovih presnovkov, zato je lahko izpostavljenost zdravilu večja pri bolnikih z zmerno do hudo okvaro jeter.
English: Subsequently, all patient samples were re-tested using the bioMerieux (bMx) THxID BRAF validated assay, which has CE marking.
Slovenian: Vzorce vseh bolnikov so nato ponovno testirali z validiranim testom bioMerieux (bMx) THxID BRAF, ki ima oznako CE. Test bMx THxID BRAF je alelsko specifična PCR, opravljena na DNA, pridobljeni iz tumorskega tkiva FFPE.
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.
Slovenian: Najpogostejši neželeni učinki (s pogostnostjo ≥ 20 %) zdravljenja z dabrafenibom v kombinaciji s trametinibom so bili: zvišana telesna temperatura, utrujenost, navzea, mrzlica, glavobol, diareja, bruhanje, artralgija in izpuščaj.
English: Do not stop unless your doctor, pharmacist or nurse advises you to.
Slovenian: Ne nehajte jemati zdravila, dokler vam tega ne svetuje zdravnik, farmacevt ali medicinska sestra.
English: At 4 years
Slovenian: Po 4 letih
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
Slovenian: Rezultati študije kažejo statistično značilno razliko med obema skupinama za primarni cilj opazovanja RFS z medianim RFS 16,6 meseca v skupini s placebom, v skupini s kombiniranim zdravljenjem pa mediana še ni bila dosežena (razmerje ogroženosti: 0,47; 95-odstotni interval zaupanja: (0,39; 0,58); p = 1,53×10 Izboljšanje RFS so enotno dokazali v vseh podskupinah bolnikov glede na starost, spol in rasno pripadnost.
English: In patients with BRAF V600K mutation positive metastatic melanoma (n=16) the response rate was 13% (95% CI: 0.0, 28.7) with a median DoR of 5.3 months (95% CI: 3.7, 6.8).
Slovenian: Pri bolnikih z metastatskim melanomom z mutacijo BRAF V600K (n = 16) je bil delež odziva 13 % (95-odstotni IZ: 0,0; 28,7) in mediano trajanja odziva 5,3 meseca (95-odstotni IZ: 3,7; 6,8).
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).
Slovenian: Učinkovitost in varnost dabrafeniba nista ugotovljeni pri bolnikih z melanomom z divjim tipom BRAF in pri bolnikih z nedrobnoceličnim pljučnim rakom z divjim tipom BRAF (BRAF NDCPR), zato se dabrafeniba pri bolnikih z melanomom z divjim tipom BRAF in pri bolnikih z nedrobnoceličnim pljučnim rakom z divjim tipom BRAF ne sme uporabljati (glejte poglavji 4.2 in 5.1).
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.
Slovenian: Pri bolnikih, ki so bili stari najmanj 65 let, je obstajala nekoliko večja verjetnost za resne neželene dogodke in tiste neželene dogodke, zaradi katerih so jim morali dokončno ukiniti zdravilo, znižati odmerjanje ali začasno prekiniti zdravljenje v primerjavi s tistimi, ki so imeli manj kot 65 let.
English: Cohort D N=17
Slovenian: kohorta D N = 17
English: Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 substrates.
Slovenian: Dabrafenib je substrat presnovnih encimov CYP2C8 in CYP3A4, aktivna presnovka hidroksidabrafenib in dezmetildabrafenib pa sta substrata CYP3A4.
English: This may occur commonly (may affect up to 1 in 10 people) in patients taking Tafinlar in combination with trametinib.
Slovenian: Če uveitis ni zdravljen, lahko okvari vid. Do tega prihaja pogosto (pri največ 1 od 10 ljudi) pri bolnikih, ki jemljejo zdravilo Tafinlar v kombinaciji s trametinibom.
English: In vitro, dabrafenib is a mechanism based inhibitor of CYP3A4.
Slovenian: In vitro je dabrafenib na mehanizmu temelječ zaviralec CYP3A4.
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.
Slovenian: Uporaba kombinacije trametiniba 2 mg enkrat na dan in dabrafeniba 150 mg dvakrat na dan je izkazala določeno omejeno klinično aktivnost pri bolnikih, pri katerih je bolezen napredovala med predhodnim zdravljenjem z zaviralcem BRAF.
English: Tafinlar in combination with trametinib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Slovenian: Zdravilo Tafinlar v kombinaciji s trametinibom uporabljamo tudi pri zdravljenju vrste pljučnega raka, ki ga imenujemo nedrobnocelični pljučni rak.
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.
Slovenian: V študiji MEK115306 je bila mediana časa do diagnoze prvega pojava ploščatoceličnega karcinoma kože v skupini s kombiniranim zdravljenjem 223 dni (od 56 do 510 dni), v skupini z dabrafenibom v monoterapiji pa 60 dni (od 9 do 653 dni).
English: Duration of intracranial response, median, months (95% CI)
Slovenian: trajanje intrakranialnega odziva, mediana, meseci (95 % IZ)
English: Effect of dabrafenib on other medicinal products
Slovenian: Vpliv dabrafeniba na druga zdravila
English: • Inflammation of the pancreas (causing strong abdominal pain)
Slovenian: • vnetje trebušne slinavke (povzroči hude bolečine v trebuhu)
English: Subjects at Risk
Slovenian: razmerje ogroženosti
English: • Dabrafenib in combination with trametinib
Slovenian: • Dabrafenib v kombinaciji s trametinibom
English: At 2 years
Slovenian: Po 2 letih
English: The efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC.
Slovenian: Učinkovitost in varnost dabrafeniba nista ugotovljeni pri bolnikih z melanomom z divjim tipom BRAF in pri bolnikih z nedrobnoceličnim pljučnim rakom z divjim tipom BRAF (BRAF NDCPR).
English: These met the statistical significance to reject the null hypothesis that the ORR of dabrafenib in combination with trametinib for this NSCLC population was less than or equal to 30%.
Slovenian: Navedene stopnje so dosegale statistično značilnost, ki je omogočala zavrnitev ničelne hipoteze z domnevo, da je v navedeni populaciji bolnikov z nedrobnoceličnim pljučnim rakom stopnja celokupnega odziva pri zdravljenju z dabrafenibom v kombinaciji s trametinibom manjša ali enaka 30 %.
English: New primary melanomas have been reported in clinical trials in patients treated with dabrafenib.
Slovenian: V kliničnih preskušanjih so bili pri bolnikih, ki so prejemali dabrafenib, opisani novi primarni melanomi.
English: Non-cutaneous malignancies were reported in 1% (6/586) of patients in the integrated safety population of dabrafenib monotherapy, and <1% (8/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Slovenian: O nekožnih malignomih so poročali pri 1 % (6/586) bolnikov v skupini za vrednotenje varnosti zdravila, ki je prejemala dabrafenib v monoterapiji, in pri manj kot 1 % (8/1076) bolnikov v skupini za vrednotenje varnosti zdravila, ki je prejemala dabrafenib v kombinaciji s trametinibom.
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.
Slovenian: Kombinacija dabrafeniba in trametiniba je pokazala protitumorsko aktivnost pri melanomskih celičnih linijah z mutacijo BRAF V600 in vitro, in vivo pa zakasni nastanek rezistence pri heterolognih melanomskih presadkih z mutacijo BRAF V600.
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.
Slovenian: V skupini za vrednotenje varnosti zdravila so pri 1 % bolnikov, ki so prejemali dabrafenib v monoterapiji, ugotovili resne neinfekcijske febrilne pojave, opredeljene kot zvišana telesna temperatura s hudo mrzlico, dehidracijo, hipotenzijo in/ali akutno ledvično insuficienco predledvičnega izvora pri bolnikih z normalnim delovanjem ledvic ob izhodišču.
English: In vitro, dabrafenib produced dose-dependent increases in CYP2B6 and CYP3A4.
Slovenian: In vitro je dabrafenib povzročil od odmerka odvisen porast CYP2B6 in CYP3A4.
English: Patients taking Tafinlar alone can uncommonly (may affect up to 1 in 100 people) develop an eye problem called uveitis, which could damage your vision if it is not treated.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Tafinlar samostojno, se občasno (pri največ 1 od 100 ljudi) lahko pojavi očesna težava, ki jo imenujemo uveitis.
English: The efficacy and safety of dabrafenib in combination with trametinib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Slovenian: Bolniki z metastazami v možganih Učinkovitost in varnost dabrafeniba v kombinaciji s trametinibom pri bolnikih z melanomom z mutacijo BRAF, ki je metastaziral v možgane, so proučevali v nerandomizirani, odprti, multicentrični študiji faze II (študiji COMBI-MB).
English: No studies have been conducted to investigate the pharmacokinetics of dabrafenib in paediatric patients.
Slovenian: Pediatrična populacija Študij za preučitev farmakokinetike dabrafeniba pri pediatričnih bolnikih niso izvedli.
English: Tafinlar 75 mg hard capsules are opaque dark pink and imprinted with “GS LHF” and “75 mg”.
Slovenian: Tafinlar 75 mg trde kapsule so neprozorne temnorožnate in imajo natisnjeni oznaki "GS LHF" in "75 mg".
English: For patients with unresectable or metastatic melanoma who received dabrafenib in combination with trametinib and developed pyrexia, approximately half of the first occurrences of pyrexia happened within the first month of therapy and approximately one-third of the patients had 3 or more events.
Slovenian: Pri bolnikih z inoperabilnim ali metastatskim melanomom, ki so prejemali dabrafenib v kombinaciji s trametinibom in pri katerih je prišlo do zvišane telesne temperature, je v približno polovici primerov do prvega pojava zvišanja telesne temperature prišlo v prvem mesecu zdravljenja, pri približno eni tretjini bolnikov pa je prišlo do 3 ali več tovrstnih dogodkov.
English: % (95% CI) ORR difference (95% CI)
Slovenian: % (95-odstotni IZ) razlika ORR (95-odstotni IZ)
English: Your doctor will check your skin before you start taking Tafinlar, then check it again every month while you are taking this medicine and for 6 months after you stop taking it.
Slovenian: Pregled kože bo ponavljal vsak mesec med jemanjem tega zdravila in ga bo opravljal še 6 mesecev po koncu jemanja zdravila.
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.
Slovenian: Pri več psih so ob odmerkih ≥ 20 mg/kg/dan (≥ 9-kratna klinična izpostavljenost pri človeku na podlagi AUC) opažali bronhoalveolarno vnetje pljuč, ki ga je spremljalo plitvo in/ali oteženo dihanje.
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).
Slovenian: Stopnja potrjenega odziva po oceni raziskovalcev je bila 15 % (95-odstotni IZ: 4,4; 34,9), mediano trajanje preživetja brez napredovanja bolezni pa je bilo 3,6 meseca (95-odstotni IZ: 1,9; 5,2).
English: Dose adjustment for trametinib below 1 mg once daily is not recommended, when used in combination with dabrafenib.
Slovenian: Znižanje odmerka trametiniba pod 1 mg enkrat na dan pri uporabi v kombinaciji z dabrafenibom ni priporočeno.
English: The ORR results assessed by IRC were consistent with the investigator assessment.
Slovenian: Ocena stopnje celokupnega odziva, ki jo je opravila neodvisna ocenjevalna komisija, se je ujemala z oceno raziskovalcev.
English: A population pharmacokinetic analysis suggests that mild renal impairment does not affect oral clearance of dabrafenib.
Slovenian: Populacijska farmakokinetična analiza kaže, da blaga okvara ledvic ne vpliva na peroralni očistek dabrafeniba.
English: Improvements for the secondary endpoint of PFS were sustained over a 5 year timeframe in the combination arm compared to vemurafenib monotherapy.
Slovenian: Izboljšanje pri sekundarnem cilju opazovanja preživetja brez napredovanja bolezni (PFS) se je vzdrževalo v 5-letnem obdobju v skupini s kombinacijo v primerjavi z monoterapijo z vemurafenibom.
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 7 months longer than for dabrafenib monotherapy (25.8 months versus 18.7 months) with 5-year survival rates of 32% for the combination versus 27% for dabrafenib monotherapy (Table 6, Figure 1).
Slovenian: Glede na analizo OS po 5 letih je bila mediana OS v skupini s kombinacijo približno 7 mesecev daljša kot pri monoterapiji z dabrafenibom (25,8 meseca v primerjavi z 18,7 meseca), pri čemer je bil delež 5-letnega preživetja 32-odstoten pri kombinaciji ter 27-odstoten pri monoterapiji z dabrafenibom (preglednica 6, slika 1).
English: • have eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid leakage (chorioretinopathy).
Slovenian: • če imate težave z očmi, med katere sodi zapora vene, ki odvaja kri iz očesa (zapora mrežnične vene) ali otekanje očesa zaradi zastajanja tekočine (horioretinopatija).
English: Overall survival, median, months (95% CI) Median, months
Slovenian: Celokupno preživetje, mediana, meseci (95-odstotni IZ) Mediana, meseci
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).
Slovenian: V študiji faze II BRF113928 pri bolnikih z napredovalim nedrobnoceličnim pljučnim rakom sta bili pogostnost in izraženost zvišane telesne temperature nekoliko večji pri uporabi dabrafeniba v kombinaciji s trametinibom (48 %, pri 3 % s 3. stopnjo izraženosti) v primerjavi z uporabo dabrafeniba v monoterapiji (39 %, pri 2 % s 3. stopnjo izraženosti).
English: Hypertension Haemorrhage f
Slovenian: Zelo pogosti hipertenzija krvavitev f
English: How should you take Tafinlar in combination with trametinib
Slovenian: Kako je treba jemati zdravilo Tafinlar v kombinaciji s trametinibom
English: In the Phase III study MEK116513 four patients (1%) treated with trametinib in combination with dabrafenib had a QTcB Grade 3 increase (>500 msec).
Slovenian: V študiji III. faze MEK116513 je pri štirih bolnikih (1 %), ki so zdravili s trametinibom v kombinaciji z dabrafenibom, prišlo do podaljšanja intervala QTcB stopnje 3 (na > 500 ms).
English: 7.2 (5.9, NR)
Slovenian: 7,2 (5,9; ND)
English: • some anti-inflammatory medicines, such as dexamethasone and methylprednisolone
Slovenian: • nekatera protivnetna zdravila, npr. deksametazon in metilprednizolon