FrancophonIA/ELRC3.0 huggingface dataset:
English: Tafinlar when given in combination with trametinib can cause eye problems including blindness.
Slovenian: Zdravilo Tafinlar lahko pri jemanju v kombinaciji s trametinibom povzroči težave z očmi, tudi slepoto.
English: • headaches, dizziness, or feeling weak
Slovenian: • glavobol, omotico ali občutek šibkosti,
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 8 months longer than the median OS for vemurafenib monotherapy (26.0 months versus 17.8 months) with 5-year survival rates of 36% for the combination versus 23% for vemurafenib monotherapy (Table 8, Figure 2).
Slovenian: Glede na analizo OS po 5 letih je bila mediana OS v skupini s kombinacijo približno 8 mesecev daljša kot pri monoterapiji z vemurafenibom (26,0 meseca v primerjavi s 17,8 meseca), pri čemer je bil delež 5-letnega preživetja 36-odstoten pri kombinaciji ter 23-odstoten pri monoterapiji z vemurafenibom (preglednica 8, slika 2).
English: Overall confirmed response n (%) (95% CI)
Slovenian: celokupni potrjeni odziv n (%) (95-odstotni IZ)
English: If the patient becomes pregnant while taking dabrafenib, the patient should be informed of the potential hazard to the foetus.
Slovenian: Če bolnica med zdravljenjem z dabrafenibom zanosi, jo je treba seznaniti z možnimi nevarnostmi za plod.
English: The majority of subjects had a BRAF V600E mutation (85%).
Slovenian: Večina bolnikov je imela mutacijo BRAF V600E (85 %).
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.
Slovenian: Uporaba dabrafeniba v odmerku 150 mg dvakrat dnevno skupaj z varfarinom je povzročila zmanjšanje AUC S-varfarina za 37 % in R-varfarina za 33 % v primerjavi z uporabo samega varfarina.
English: Male fertility studies with dabrafenib have not been conducted.
Slovenian: Študij plodnosti samcev z dabrafenibom niso izvedli.
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).
Slovenian: Med temi bolniki so opažali 13-odstotno (95-odstotni IZ: 5,0; 27,0) stopnjo potrjenega odziva z medianim trajanjem preživetja brez napredovanja bolezni 3,6 meseca (95-odstotni IZ: 2; 4).
English: Concomitant administration of dabrafenib with warfarin results in decreased warfarin exposure.
Slovenian: Sočasna uporaba dabrafeniba in varfarina zmanjša izpostavljenost varfarinu.
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb)
English: • some immunosuppressants, such as cyclosporin, tacrolimus and sirolimus
Slovenian: • nekateri imunosupresivi, npr. ciklosporin, takrolimus in sirolimus
English: Induction of OATP1B1/1B3 and BCRP is not likely based on the observations from a clinical study with rosuvastatin.
Slovenian: Glede na opažanja v klinični študiji z rosuvastatinom indukcija OATP1B1/1B3 in BCRP ni verjetna.
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis (see section 4.4).
Slovenian: Ob ponovnem začetku uporabe dabrafeniba po pankreatitisu je treba bolnike skrbno nadzorovati (glejte poglavje 4.4).
English: If dabrafenib is being used in combination with trametinib then therapy with dabrafenib may be continued at the same dose.
Slovenian: Če bolnik uporablja dabrafenib v kombinaciji s trametinibom, je mogoče zdravljenje z dabrafenibom nadaljevati z nespremenjenim odmerkom.
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.
Slovenian: V kliničnih študijah faze III MEK115306 in MEK116513 je pri bolnikih z inoperabilnim ali metastatskim melanomom do ploščatoceličnega karcinoma kože prišlo pri 10 % (22/211) bolnikov, ki so prejemali dabrafenib v monoterapiji, in pri 18 % (63/349) bolnikov, ki so prejemali vemurafenib v monoterapiji.
English: Opaque white high density polyethylene (HDPE) bottle with polypropylene screw cap and a silica gel desiccant.
Slovenian: Plastenka iz motno belega polietilena velike gostote (HDPE) s polipropilensko navojno zaporko in sušilom s silicijevim dioksidom.
English: • Dabrafenib monotherapy
Slovenian: • Dabrafenib v monoterapiji
English: Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Slovenian: Dabrafenib je v kombinaciji s trametinibom indiciran za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim pljučnim rakom z mutacijo BRAF V600.
English: Figure 1 Kaplan-Meier overall survival curves for Study MEK115306 (ITT population)
Slovenian: Slika 1 Kaplan-Meierjevi krivulji celokupnega preživetja v študiji MEK115306 (populacija z namenom zdravljenja - ITT)
English: In subjects with BRAF V600 mutation positive melanoma, administration of dabrafenib resulted in inhibition of tumour phosphorylated ERK relative to baseline.
Slovenian: Pri bolnikih z melanomom s pozitivno mutacijo BRAF V600 je dabrafenib zavrl tumorsko fosforilirano ERK v primerjavi z izhodiščem.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 oseb)
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%).
Slovenian: Uporaba rifampicina (induktorja CYP3A4/CYP2C8) v odmerku 600 mg enkrat dnevno z dabrafenibom v odmerku 150 mg dvakrat dnevno je povzročila zmanjšanje Cmax (27 %) in AUC (34 %) dabrafeniba pri ponavljajočih odmerkih.
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.
Slovenian: V študiji faze III BRF115532 (COMBI-AD) adjuvantnega zdravljenja melanoma je do ploščatoceličnega karcinoma kože prišlo pri 1 % bolnikov (6/435), ki so prejemali dabrafenib v kombinaciji s trametinibom, in pri 1 % bolnikov (5/432), ki so prejemali placebo.
English: Possible side effects when Tafinlar and trametinib are taken together
Slovenian: Možni neželeni učinki pri uporabi zdravila Tafinlar skupaj s trametinibom
English: Very common
Slovenian: Zelo pogosti kašelj
English: Dabrafenib should therefore not be used in patients with wild-type BRAF melanoma or wild-type BRAF NSCLC (see sections 4.4 and 5.1).
Slovenian: Dabrafeniba se pri bolnikih z melanomom z divjim tipom BRAF in pri bolnikih z nedrobnoceličnim pljučnim rakom z divjim tipom BRAF torej ne sme uporabljati (glejte poglavji 4.4 in 5.1).
English: Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively.
Slovenian: Povprečna razmerja AUC presnovka in izhodne učinkovine po večkratnem odmerjanju so bila: 0,9 za hidroksidabrafenib, 11 za karboksidabrafenib in 0,7 za dezmetildabrafenib.
English: • Fever (see “Fever” earlier in section 4)
Slovenian: • zvišana telesna temperatura (glejte "Zvišana telesna temperatura" zgoraj v 4. poglavju)
English: When dabrafenib is used in combination with trametinib refer to the guidance for medicinal product interactions found in sections 4.4 and 4.5 of dabrafenib and trametinib SmPC.
Slovenian: Za interakcije z zdravili pri uporabi dabrafeniba v kombinaciji s trametinibom glejte poglavji 4.4 in 4.5 v povzetku glavnih značilnosti zdravila za dabrafenib oziroma trametinib.
English: If a patient vomits after taking dabrafenib, the patient should not retake the dose and should take the next scheduled dose.
Slovenian: Če bolnik po zaužitju dabrafeniba bruha, odmerka ne sme vzeti ponovno, temveč mora vzeti naslednji odmerek ob običajnem času.
English: N=1 2.9 (NR, NR)
Slovenian: N = 1 2,9 (ND; ND)
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Slovenian: Preiskovanci so bili večinoma belci (> 99 %) in moškega spola (53 %), mediana starost pa je bila 56 let (28 % jih je bilo starih najmanj 65 let.).
English: Proportion alive and relapse free
Slovenian: Delež živih brez ponovitve skupina
English: OS analysis data cut-off: 13-Mar-2015)
Slovenian: Analiza OS (konec zbiranja podatkov: 13-mar-2015)
English: Take the doses of Tafinlar and trametinib exactly as your doctor, nurse or pharmacist tells you.
Slovenian: Zdravilo Tafinlar in trametinib jemljite v natanko takšnih odmerkih, kot vam naroči zdravnik, medicinska sestra ali farmacevt.
English: Most subjects were Caucasian (>96%) and male (55%), with a median age of 55 years (24% were ≥65 years).
Slovenian: Preiskovanci so bili večinoma belci (> 96 %) in moškega spola (55 %), njihova mediana starost pa je bila 55 let (24 % jih je bilo starih najmanj 65 let).
English: indinavir, lopinavir, nelfinavir, saquinavir, tipranavir)
Slovenian: fosamprenavir, indinavir, lopinavir, nelfinavir, sakvinavir, tipranavir)
English: Use caution if strong inhibitors (e.g. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) are co-administered with dabrafenib.
Slovenian: V primeru uporabe dabrafeniba z močnimi zaviralci (npr. ketokonazolom, gemfibrozilom, nefazodonom, klaritromicinom, ritonavirjem, sakvinavirjem, telitromicinom, itrakonazolom, vorikonazolom, posakonazolom, atazanavirjem) je potrebna previdnost.
English: Hepatic effects, including hepatocellular necrosis and inflammation, were observed in mice (≥0.6 times clinical exposure).
Slovenian: Pri miših so opažali jetrne učinke, vključno z nekrozo in vnetjem jetrnih celic (≥ 0,6-kratna klinična izpostavljenost).
English: Updated analysis (data cut-off: 12-Jan-2015)
Slovenian: Posodobljena analiza (konec zbiranja podatkov: 12-jan-2015)
English: • Corticosteroids (e.g. dexamethasone, methylprednisolone)
Slovenian: • kortikosteroidi (npr. deksametazon, metilprednizolon)
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).
Slovenian: Dabrafenib je v monoterapiji ali v kombinaciji s trametinibom indiciran za zdravljenje odraslih bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 (glejte poglavji 4.4 in
English: They should not be chewed or opened and should not be mixed with food or liquids due to chemical instability of dabrafenib.
Slovenian: Zaradi kemične nestabilnosti dabrafeniba se jih ne sme zmešati s hrano ali tekočinami.
English: Cutaneous squamous cell carcinoma Seborrhoeic keratosis Acrochordon (skin tags) Basal cell carcinoma
Slovenian: Pogosti ploščatocelični karcinom kože seboroična keratoza akrohordon (kožni izrastki) bazalnocelični karcinom
English: • birth control medicines (contraceptives) containing hormones, such as pills, injections, or patches
Slovenian: • hormonska zdravila, ki preprečujejo zanositev (kontraceptivi), npr. kontracepcijske tablete,
English: • Immunosuppressants (e.g. cyclosporin, tacrolimus, sirolimus)
Slovenian: • imunosupresivi (npr. ciklosporin, takrolimus, sirolimus)
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Slovenian: V kakšnem zaporedju bi morali uporabljati zdravila po tem, ko je bolezen napredovala ob zdravljenju z zaviralcem BRAF, ni ugotovljeno.
English: Your doctor may take blood samples to monitor your liver and kidney function while you are taking Tafinlar.
Slovenian: Zdravnik vam bo med zdravljenjem z zdravilom Tafinlar, morda jemal vzorce krvi, da bo preverjal delovanje jeter in ledvic.
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.
Slovenian: Presnova dabrafeniba poteka predvsem preko CYP2C8 in CYP3A4; nastane hidroksidabrafenib, ki se s CYP3A4 naprej oksidira, s čimer nastane karboksidabrafenib.
English: Myocarditis
Slovenian: Neznana miokarditis
English: Take Tafinlar capsules and trametinib tablets with you when possible.
Slovenian: Če je mogoče, vzemite kapsule zdravila Tafinlar in tablete trametiniba s seboj in, če je možno, pokažite pakiranji zdravila Tafinlar in trametiniba ter priloženi navodili za uporabo.
English: IV plasma clearance is 12 l/hr.
Slovenian: aplikaciji je 12 l/uro.
English: 7.6 (5.9, NR)
Slovenian: 7,6 (5,9; ND)
English: Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Slovenian: Pred zdravljenjem in na koncu zdravljenja sta priporočljiva tudi ginekološki pregled (za ženske) in analni pregled (pregled zadnjika).
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.
Slovenian: MEK115306 je bila randomizirana, dvojno slepa študija faze III, v kateri so primerjali uporabo kombinacije dabrafeniba in trametiniba z uporabo dabrafeniba in placeba pri prvem zdravljenju bolnikov z inoperabilnim (stadij IIIC) ali metastatskim (stadij IV) kožnim melanomom s pozitivnim statusom mutacije BRAF V600E/K.
English: Renal failure Nephritis
Slovenian: Občasni odpoved ledvic nefritis
English: Trametinib dose* Only when used in combination with dabrafenib
Slovenian: Odmerek trametiniba* samo pri uporabi v kombinaciji z dabrafenibom začetni odmerek
English: Caution should be exercised and additional monitoring of digoxin is recommended when digoxin (a transporter substrate) is used concomitantly with dabrafenib and at discontinuation of dabrafenib (see section 4.5).
Slovenian: Med sočasno uporabo digoksina (ki je substrat prenašalca) in dabrafeniba ter v primeru prekinitve dabrafeniba je priporočljivo dodatno spremljanje koncentracije digoksina (glejte poglavje 4.5).
English: RAS-mutation-positive non-cutaneous malignancies The benefits and risks should be considered before continuing treatment with dabrafenib in patients with a non-cutaneous malignancy that has a RAS mutation.
Slovenian: Pri bolnikih z nekožnim malignomom z mutacijo RAS je treba pred odločitvijo za nadaljevanje zdravljenja z dabrafenibom pretehtati koristi in tveganja takega zdravljenja.
English: Headache Dizziness
Slovenian: Nekožni malignomi
English: Secondary endpoints included DoR, PFS, OS, safety and population pharmacokinetics.
Slovenian: Sekundarni cilji opazovanja so bili trajanje odziva (DoR), preživetje brez napredovanja bolezni (PFS), celokupno preživetje (OS) ter varnostni in populacijski farmakokinetični parametri.
English: The safety and efficacy of the combination of dabrafenib and trametinib have been evaluated in a multi-cohort, open-label, Phase II study in patients with BRAF V600 mutant melanoma with brain metastases.
Slovenian: Varnost in učinkovitost kombinacije dabrafeniba in trametiniba so ocenili v odprti študiji faze II z več kohortami pri bolnikih z melanomom z mutacijo BRAF V600, ki je metastaziral v možgane.
English: Improvements for the primary endpoint of PFS were sustained over a 5 year timeframe in the combination arm compared to dabrafenib monotherapy.
Slovenian: Izboljšanje pri primarnem cilju opazovanja, preživetju brez napredovanja bolezni, se je vzdrževalo v 5-letnem obdobju v skupini s kombinacijo v primerjavi z monoterapijo z dabrafenibom.
English: Number of events, n (%) Recurrence Relapsed with distant metastasis
Slovenian: število dogodkov, n (%) ponovitev bolezni ponovitev z oddaljenimi metastazami smrt mediana (meseci) (95-odstotni IZ)
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.
Slovenian: Dabrafenib je v kombinaciji s trametinibom indiciran za adjuvantno zdravljenje odraslih bolnikov po totalni resekciji melanoma stadija III z mutacijo BRAF V600.
English: Tell your doctor immediately if you notice any changes to your skin (see section 4 for symptoms to be aware of).
Slovenian: Če opazite kakršnekoli spremembe na koži (za simptome, na katere morate biti pozorni, glejte poglavje 4), takoj obvestite zdravnika.
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.
Slovenian: Pri bolnikih, ki so imeli normalno raven laktat dehidrogenaze ob izhodišču, je bil delež 5-letnega celokupnega preživetja 40-odstoten (95-% IZ: 31,2; 48,4) v skupini s kombinacijo in 33-odstoten (95-% IZ: 25,0; 41,0) pri monoterapiji z dabrafenibom, pri bolnikih s povišano ravnjo laktat dehidrogenaze ob izhodišču pa 16odstoten (95-% IZ: 8,4; 26,0) pri kombinaciji in 14-odstoten (95-% IZ: 6,8; 23,1) pri monoterapiji z dabrafenibom.
English: When dabrafenib is given in combination with trametinib, the SmPC of trametinib must be consulted prior to intiation of combination treatment.
Slovenian: Pri dajanju dabrafeniba v kombinaciji s trametinibom je treba pred začetkom zdravljenja pregledati povzetek glavnih značilnosti zdravila za trametinib.
English: 75 mg twice daily
Slovenian: 75 mg dvakrat na dan
English: Table 8 Overall Survival results for Study MEK116513 (COMBI-v)
Slovenian: Preglednica 8 Rezultati za celokupno preživetje v študiji MEK116513 (COMBI-v)
English: Skin and subcutaneous disorders
Slovenian: Bolezni kože in podkožja
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.
Slovenian: Uporaba ketokonazola (zaviralec CYP3A4) v odmerku 400 mg enkrat dnevno skupaj z dabrafenibom v odmerku 75 mg dvakrat dnevno je povzročila 71 % povečanje AUC dabrafeniba in 33 % povečanje Cmax dabrafeniba v primerjavi z uporabo samega dabrafeniba v odmerku 75 mg dvakrat dnevno.
English: Cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with dabrafenib/trametinib combination therapy.
Slovenian: Pri bolnikih so v času zdravljenja s kombinacijo dabrafeniba in trametiniba poročali o pojavljanju primerov hudih kožnih neželenih reakcij (SCARs - severe cutaneous adverse reactions), med drugim o Stevens-Johnsonovem sindromu in reakciji na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - drug reaction with eosinophilia and systemic symptoms), ki so lahko življenjsko nevarni oziroma smrtni.
English: For patients 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, 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: The median DoR and PFS were not yet estimable (Table 15).
Slovenian: Mediane vrednosti trajanja odziva in preživetja brez napredovanja bolezni še ni bilo mogoče ovrednotiti (preglednica 15).
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.
Slovenian: Učinkovitost in varnost dabrafeniba v kombinaciji s trametinibom so proučevali v multicentrični randomizirani, dvojno slepi, s placebom kontrolirani študiji faze III pri bolnikih po totalni resekciji kožnega melanoma z mutacijo BRAF V600 E/K v stadiju III (stadij IIIA [metastaze bezgavk > 1 mm], IIIB ali IIIC).
English: Therefore, other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Slovenian: Pri tej skupini bolnikov, ki so bili predhodno zdravljeni z zaviralcem BRAF, je zato pred zdravljenjem z navedeno kombinacijo treba razmisliti tudi o drugih možnostih zdravljenja.
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.
Slovenian: V študiji MEK115306 pri bolnikih z inoperabilnim ali metastatskim melanomom so v skupini bolnikov, ki je prejemala kombinirano zdravljenje, o zvišanju telesne temperature poročali pri 57 % (119/209) bolnikov, pri 7 % bolnikov je šlo za 3. stopnjo izraženosti, v primerjavi s skupino bolnikov, ki je prejemala dabrafenib v monoterapiji, pri kateri so o zvišanju telesne temperature poročali pri 33 % (69/211) bolnikov, pri čemer so o 3. stopnji izraženosti poročali pri 2 % bolnikov.
English: • Take Tafinlar in combination with trametinib exactly as your doctor, nurse or pharmacist tells you.
Slovenian: • Zdravilo Tafinlar v kombinaciji s trametinibom jemljite natančno po navodilih zdravnika, medicinske sestre ali farmacevta.
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.
Slovenian: Uporaba gemfibrozila (zaviralec CYP2C8) v odmerku 600 mg dvakrat dnevno skupaj z dabrafenibom v odmerku 75 mg dvakrat dnevno je povzročila 47 % povečanje AUC dabrafeniba, vendar ni povzročila spremembe Cmax dabrafeniba v primerjavi z uporabo samega dabrafeniba v odmerku 75 mg dvakrat dnevno.
English: Cohort B N=18
Slovenian: Kohorta B N = 18
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Slovenian: Prekinite zdravljenje, dokler niso toksični učinki 0 ali 1. stopnje; ko znova uvedete zdravljenje, odmerek zmanjšajte za eno odmerno raven.
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).
Slovenian: V skupini s kombinacijo so v primerjavi z monoterapijo z dabrafenibom opazili tudi izboljšanje stopnje celokupnega odziva (overall response rate, ORR) in daljše trajanje odziva (duration of response, DoR) (preglednica 7).
English: New primary melanomas have been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib in melanoma studies.
Slovenian: V kliničnih preskušanjih pri melanomu z uporabo dabrafeniba v monoterapiji in v kombinaciji s trametinibom so bili opisani novi primarni melanomi.
English: You should have your eyes examined by your doctor while you are taking this medicine.
Slovenian: Med jemanjem tega zdravila morate opraviti pregled oči pri svojem zdravniku.