FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase III study MEK115306 no patients treated with trametinib in combination with dabrafenib had worst-case QTcB prolongation to >500 msec; QTcB was increased more than 60 msec from baseline in 1% (3/209) of patients.
Slovenian: V študiji III. faze MEK115306 ni pri nobenem od bolnikov, ki so se zdravili s trametinibom v kombinaciji z dabrafenibom, prišlo do največjega podaljšanja QTcB na > 500 ms, QTcB pa je bil podaljšan za več kot 60 ms od izhodiščne vrednosti pri 1 % (3/209) bolnikov.
English: The use of oral corticosteroids should be considered in those instances in which anti-pyretics are insufficient.
Slovenian: V primerih, ko antipiretiki ne zadoščajo, je treba razmisliti o uporabi peroralnih kortikosteroidov.
English: For the primary endpoint of investigator-assessed ORR, the ORR in the first line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously treated population was 66.7% (95% CI, 52.9%, 78.6%).
Slovenian: Pri primarnem cilju opazovanja stopnje celokupnega odziva (ORR) po oceni raziskovalcev je bila v skupini bolnikov, ki so prejemali prvo linijo zdravljenja, stopnja celokupnega odziva 61,1 % (95-odstotni IZ: 43,5 %; 76,9 %), v skupini predhodno zdravljenih bolnikov pa 66,7 % (95-odstotni IZ: 52,9 %; 78,6 %).
English: The majority of patients had a BRAF V600E mutation (91%).
Slovenian: Večina bolnikov je imela mutacijo BRAF V600E (91 %).
English: 12.6 (5.8, NE)
Slovenian: 12,6 (5,8; NO)
English: • some medicines used for pain relief, such as fentanyl and methadone
Slovenian: • nekatera zdravila proti bolečinam, npr. fentanil in metadon
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).
Slovenian: Spremembe na koži, ki lahko pomenijo pojav novega kožnega raka Zdravnik vam bo pregledal kožo, preden začnete jemati to zdravilo, in jo bo redno pregledoval, medtem ko boste to zdravilo jemali.
English: • some medicines to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine,
Slovenian: • nekatera zdravila za zdravljenje HIV, npr. ritonavir, amprenavir, indinavir, darunavir,
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.
Slovenian: Bolnikom, ki prejemajo dabrafenib v kombinaciji s trametinibom, je prvih 6 mesecev po začetku zdravljenja s trametinibom delovanje jeter priporočljivo kontrolirati na štiri tedne.
English: • vomit containing blood or that looks like “coffee grounds”
Slovenian: • bruhanje krvi ali izbruhana vsebina, ki je videti kot kavna usedlina
English: Hypophosphataemia
Slovenian: Hipofosfatemija
English: • medicines to treat cancer, such as cabazitaxel
Slovenian: • zdravila za zdravljenje raka, npr. kabazitaksel
English: The population pharmacokinetic analysis showed no significant differences in the pharmacokinetics of dabrafenib between Asian and Caucasian patients.
Slovenian: Rezultati populacijske farmakokinetične analize niso pokazali statistično značilnih razlik v farmakokinetiki dabrafeniba med bolniki azijske rase in belci.
English: • Increase in blood sugar level (hyperglycaemia)
Slovenian: • zvišana vrednost sladkorja v krvi (hiperglikemija)
English: Trametinib when given in combination with Tafinlar should be taken with either the morning dose of Tafinlar or the evening dose of Tafinlar.
Slovenian: Trametinib, ki ga jemljete v kombinaciji z zdravilom Tafinlar, lahko vzamete bodisi z jutranjim ali z večernim odmerkom zdravila Tafinlar.
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at Baseline.
Slovenian: Večina preiskovancev je imela ob izhodišču vrednost LDH ≤ZMN (67 %), stanje zmogljivosti 0 po lestvici ECOG (70 %) in zasevke v visceralnih organih (78 %).
English: Duration of response, median, months (95% CI) N=28 5.1 (3.7, NR)
Slovenian: Trajanje odziva, mediana, meseci (95-odstotni IZ) N = 28 5,1 (3,7; ND)
English: Actinic keratosis Skin lesion Erythema Photosensitivity
Slovenian: Pogosti suha koža srbenje aktinična keratoza kožne lezije eritem fotosenzitivnost
English: In the adjuvant treatment of melanoma trial, pancreatitis was reported in <1% (1/435) of patients receiving dabrafenib in combination with trametinib, and no patients receiving placebo.
Slovenian: V preskušanju adjuvantnega zdravljenja melanoma so o pankreatitisu poročali pri < 1% bolnikov (1/435), ki so prejemali dabrafenib v kombinaciji s trametinibom in pri nobenem bolniku, ki je prejemal placebo.
English: efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir and atazanavir
Slovenian: delavirdin, efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, sakinavir in atazanavir
English: No dose modifications are required as long as effective local therapies can control ocular inflammation.
Slovenian: Prilagajanje odmerka ni potrebno, dokler je očesno vnetje mogoče obvladati z učinkovitimi lokalnimi zdravili.
English: • Inflammation of the lung (pneumonitis)
Slovenian: • vnetje pljuč (pnevmonitis)
English: Dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN) therefore caution should be used in this setting (see section 5.2).
Slovenian: Uporabe dabrafeniba niso preučili pri bolnikih z insuficienco ledvic (opredeljeno z vrednostjo kreatinina, ki presega 1,5-kratnik zgornje meje normalnih vrednosti), zato ga je treba v takšnih okoliščinah uporabljati previdno (glejte poglavje 5.2).
English: • Eye changes including swelling in the eye caused by fluid leakage (chorioretinopathy),
Slovenian: • spremembe v očesu, med drugim otekanje očesa zaradi prepuščanja tekočine (horioretinopatija),
English: • Thickening of the outer layers of the skin
Slovenian: • zadebelitev zunanjih plasti kože
English: The recommended dose of trametinib, when used in combination with dabrafenib, is 2 mg once daily.
Slovenian: Priporočeni odmerek trametiniba, kadar se uporablja v kombinaciji z dabrafenibom, je 2 mg enkrat na dan.
English: Dabrafenib in combination with trametinib should be used with caution in patients with conditions that could impair left ventricular function.
Slovenian: Dabrafenib v kombinaciji s trametinibom je treba uporabljati previdno pri bolnikih z motnjami, ki bi lahko poslabšale delovanje levega prekata.
English: No relevant change in AUC was noted for hydroxy-dabrafenib.
Slovenian: Pomembnejših sprememb AUC hidroksidabrafeniba niso opazili.
English: Patients with melanoma driven by BRAF mutations other than V600E were excluded from the confirmatory trial and with respect to patients with the V600K mutation in single arm clinical trials the activity appears lower than in V600E tumours.
Slovenian: Bolniki z melanomom, ki ga vodijo druge mutacije BRAF, in ne V600E, so bili izključeni iz potrditvenega preskušanja in klinične študije z enim krakom so pri bolnikih z mutacijo V600K pokazale manjšo aktivnost kot pri tumorjih V600E.
English: Black iron oxide (E172) Shellac
Slovenian: Črnilo črni železov oksid (E172) šelak propilenglikol
English: No data are available in patients with moderate to severe hepatic impairment.
Slovenian: Podatkov o bolnikih z zmerno do hudo okvaro jeter ni.
English: Take whole with a full glass of water.
Slovenian: Kapsule in tablete zaužijte cele s polnim kozarcem vode.
English: All patients receiving dabrafenib as monotherapy or in combination with trametinib who developed cuSCC continued on treatment without dose modification.
Slovenian: Vsi bolniki, ki so prejemali dabrafenib v monoterapiji ali v kombinaciji s trametinibom in ki se jim je pojavil ploščatocelični karcinom kože, so nadaljevali zdravljenje brez prilagoditve odmerka.
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.
Slovenian: Podobne rezultate so opažali pri 45 bolnikih, ki so v tej študiji v delu C prešli z jemanja dabrafeniba v monoterapiji na uporabo kombinacije trametiniba 2 mg enkrat na dan in dabrafeniba 150 mg dvakrat na dan.
English: Tell your doctor immediately if you get a temperature above 38.5ºC while you are taking this medicine.
Slovenian: Če se vam v času jemanja tega zdravila telesna temperatura zviša nad 38,5 ºC, takoj obvestite zdravnika.
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a
Slovenian: Pogosti zvišana vrednost alkalne fosfataze v krvi zvišana vrednost gama-glutamiltransferaze zvišana vrednost kreatin-fosfokinaze v krvi a
English: • headaches, dizziness, or weakness
Slovenian: • glavobol, omotica ali šibkost
English: No data are available in subjects with severe renal impairment (see section 4.2).
Slovenian: Podatkov za bolnike s hudo okvaro ledvic ni (glejte poglavje 4.2).
English: Dabrafenib is a substrate of CYP2C8 and CYP3A4.
Slovenian: Dabrafenib je substrat CYP2C8 in CYP3A4.
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
Slovenian: • spremembe na koži, med njimi ploščatocelični karcinom na koži (vrsta kožnega raka), bradavicam podobni izrastki, pecljati fibromi, kožne spremembe z nekontrolirano rastjo (bazalnocelični karcinom), suha koža, srbenje ali rdečina kože, predeli kože, ki je zadebeljena, se lušči ali jo pokrivajo kraste (aktinična keratoza), kožne spremembe, rdečina kože, povečana občutljivost kože na sonce
English: Duration of intracranial response, median, months (95% CI) N=29 4.6 (2.8, NR)
Slovenian: Trajanje intrakranialnega odziva, mediana, meseci (95-odstotni IZ) N = 29 4,6 (2,8; ND)
English: Heart disorder
Slovenian: Srčne motnje
English: For additional information on warnings and precautions associated with trametinib treatment, please refer to the trametinib SmPC.
Slovenian: Za dodatne informacije o posebnih opozorilih in previdnostnih ukrepih pri zdravljenju s trametinibom glejte povzetek glavnih značilnosti zdravila za trametinib.
English: Tafinlar in combination with trametinib can result in the breakdown of muscle (rhabdomyolysis).
Slovenian: Zdravilo Tafinlar lahko v kombinaciji s trametinibom povzroči razgradnjo mišic (rabdomiolizo).
English: • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
Slovenian: • zaviralci kalcijevih kanalčkov (npr. diltiazem, felodipin, nikardipin, nifedipin, verapamil)
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.
Slovenian: Pankreatitis je bil opisan pri < 1 % bolnikov, zdravljenih z dabrafenibom bodisi v monoterapiji ali v kombinaciji s trametinibom v kliničnih študijah z inoperabilnim ali metastatskim melanomom in pri približno 4 % bolnikov, ki so bili zdravljeni z dabrafenibom v kombinaciji s trametinibom v klinični študiji z nedrobnoceličnim pljučnim rakom.
English: Monitoring should continue for 6 months following discontinuation of dabrafenib or until initiation of another anti-neoplastic therapy.
Slovenian: Spremljanje bolnika se mora nadaljevati še 6 mesecev po prenehanju zdravljenja z dabrafenibom ali do uvedbe drugega antineoplastičnega zdravljenja.
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.
Slovenian: Če bolnik pozabi vzeti odmerek trametiniba in se zdravi z dabrafenibom v kombinaciji s trametinibom, naj ta odmerek trametiniba vzame samo, če je do naslednjega rednega odmerka več kot 12 ur.
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.
Slovenian: O artralgiji so zelo pogosto poročali v skupini za vrednotenje varnosti zdravila pri uporabi dabrafeniba v monoterapiji (25 %) oziroma pri uporabi dabrafeniba v kombinaciji s trametinibom (25 %), a izrazitost je bila v glavnem 1. in 2. stopnje; izrazitost 3. stopnje se je pojavila občasno (< 1 %), 4. stopnje pa niso zabeležili.
English: Most patients (94%) enrolled in the combination therapy treated cohorts had an ECOG performance status of 0 or 1.
Slovenian: Večina bolnikov (94 %), vključenih v kohorti s kombiniranim zdravljenjem, je imela stanje zmogljivosti po lestvici ECOG 0 ali 1. 26 bolnikov (28 %) ni nikoli kadilo.
English: There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib.
Slovenian: Povečal pa se je AUC karboksidabrafeniba in sicer za 73 % in zmanjšal AUC dezmetildabrafeniba za 30 %.
English: Two of these patients had a QTcB Grade 3 increase (>500 msec) that was also an increase >60 msec from baseline.
Slovenian: Pri dveh od teh bolnikov je bilo podaljšanje intervala QTcB stopnje 3 (na > 500 ms) hkrati tudi podaljšanje za > 60 ms od izhodiščne vrednosti.
English: Patients were stratified by BRAF mutation status (V600E versus V600K) and stage of disease prior to surgery using the American Joint Committee on Cancer (AJCC) 7th edition Melanoma Staging System (by Stage III sub-stage, indicating different levels of lymph node involvement and primary tumour size and ulceration).
Slovenian: Bolnike so stratificirali glede na status mutacije BRAF (V600E oziroma V600K) in na stadij bolezni pred kirurško odstranitvijo v skladu s 7. izdajo klasifikacije za določanje stadija melanoma AJCC (American Joint Committee on Cancer) (na podstadije stadija III glede na različno zajetost bezgavk, velikost primarnega tumorja in prisotnost ulceracije).
English: • HIV antivirals (e.g. amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir,
Slovenian: • protivirusna zdravila proti HIV (npr. amprenavir, atazanavir, darunavir, delavirdin, efavirenz,
English: The efficacy of dabrafenib in the treatment of adult patients with BRAF V600 mutation positive unresectable or metastatic melanoma has been evaluated in 3 clinical trials (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], and BRF113710 [BREAK-2]) including patients with BRAF V600E and/or V600K mutations.
Slovenian: Učinkovitost dabrafeniba za zdravljenje odraslih bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 so ocenili v treh kliničnih študijah (BRF113683 [BREAK-3], BRF113929 [BREAK-MB] in BRF113710 [BREAK-2]), ki so vključevale bolnike, ki so imeli mutacije BRAF V600E in/ali V600K.
English: The proportion of patients experiencing AEs was similar in those aged <65 years and those aged ≥65 years in all clinical trials.
Slovenian: Deleži bolnikov z neželenimi dogodki so bili v vseh kliničnih študijah pri tistih, ki so bili stari manj kot 65 let, približno enaki kot pri tistih, ki so bili stari najmanj 65 let.
English: Limited safety and efficacy data have been collected on dabrafenib in non-Caucasian patients.
Slovenian: O varnosti in učinkovitosti dabrafeniba pri bolnikih, ki niso belci, je zbrano malo podatkov.
English: • Rash, dry skin, itching, skin reddening
Slovenian: • izpuščaj, suha koža, srbenje, rdečina kože
English: The primary endpoint of the study was progression-free survival (PFS), with a key secondary endpoint of overall survival (OS).
Slovenian: Primarni cilj opazovanja je bilo preživetje brez napredovanja bolezni (progression free survival, PFS), ključni sekundarni cilj opazovanja pa je bilo celokupno preživetje (overall survival, OS).
English: Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Slovenian: Izjeme, pri katerih je treba odmerek prilagajati samo pri enem od obeh zdravil, so navedene v nadaljevanju za primere pojava zvišane telesne temperature, uveitisa, nekožnih malignomov z mutacijo RAS (zlasti v povezavi z dabrafenibom), zmanjšanja iztisnega deleža levega prekata (LVEF), zapore mrežnične vene, odstopa mrežničnega pigmentnega epitelija in intersticijske bolezni pljuč (IBP)/pnevmonitisa (zlasti v povezavi s trametinibom).
English: Based on the population pharmacokinetic analysis, age had no significant effect on dabrafenib pharmacokinetics.
Slovenian: Na podlagi populacijske farmakokinetične analize starost ne vpliva pomembno na farmakokinetiko dabrafeniba.
English: Focal arterial/perivascular inflammation in various tissues was observed in mice and an increased incidence of hepatic arterial degeneration and spontaneous cardiomyocyte degeneration with inflammation (spontaneous cardiomyopathy) was observed in rats (≥0.5 and 0.6 times clinical exposure for rats and mice respectively).
Slovenian: Pri miših so opažali fokalno arterijsko/perivaskularno vnetje v raznih tkivih, pri podganah pa večjo incidenco jetrne arterijske degeneracije in spontane degeneracije kardiomiocitov z vnetjem (spontana kardiomiopatija) (≥ 0,5-kratna klinična izpostavljenost pri podganah in 0,6-kratna klinična izpostavljenost pri miših).
English: The response was durable with median DoR in the previously treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Slovenian: Odziv je bil dolgotrajen, saj je mediana trajanja odziva po oceni raziskovalcev pri predhodno zdravljenih bolnikih dosegla 9,8 meseca (95-odstotni IZ: 6,9; 16,0).
English: BRAF V600 testing
Slovenian: Testiranje na mutacijo BRAF V600
English: Dehydration Hyponatraemia Hypophosphataemia Hyperglycaemia
Slovenian: Pogosti dehidracija hiponatriemija hipofosfatemija hiperglikemija
English: The recommended dose of trametinib, when used in combination with Tafinlar, is 2 mg once a day.
Slovenian: Priporočeni odmerek trametiniba pri uporabi v kombinaciji z zdravilom Tafinlar je 2 mg enkrat na dan.
English: The onset of these serious non-infectious febrile events was typically within the first month of dabrafenib as monotherapy.
Slovenian: Ti resni neinfekcijski febrilni pojavi so se praviloma začeli v prvem mesecu zdravljenja z dabrafenibom v monoterapiji.
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).
Slovenian: Običajni odmerek zdravila Tafinlar, bodisi pri samostojni uporabi ali pri uporabi v kombinaciji s trametinibom, sta dve 75-mg kapsuli dvakrat na dan (to ustreza dnevnemu odmerku 300 mg).
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
Slovenian: Vrednost P je izračunana na osnovi dvostranskega stratificiranega logrank testa (stratifikacijski dejavniki so bili stadij bolezni - IIIA oziroma IIIB oziroma IIIC - in vrsta mutacije BRAF V600V600E oziroma V600K)
English: There are insufficient data to evaluate the potential effect of other races on dabrafenib pharmacokinetics.
Slovenian: Za ovrednotenje morebitnega vpliva pripadnosti drugim rasam na farmakokinetiko dabrafeniba ni dovolj podatkov.
English: • some antibiotics, such as clarithromycin, doxycyline and telithromycin
Slovenian: • nekateri antibiotiki, npr. klaritromicin, doksiciklin in telitromicin
English: Dose adjustment for dabrafenib below 50 mg twice daily is not recommended, whether used as monotherapy or in combination with trametinib.
Slovenian: Znižanje odmerka dabrafeniba pod 50 mg dvakrat na dan, bodisi pri uporabi v monoterapiji ali v kombinaciji s trametinibom, ni priporočeno.
English: In 1% of patients in clinical trials with dabrafenib monotherapy, serious non-infectious febrile events were identified defined as fever accompanied by severe rigors, dehydration, hypotension and/or acute renal insufficiency of pre-renal origin in subjects with normal baseline renal function (see section 4.8).
Slovenian: V kliničnih študijah z dabrafenibom v monoterapiji, so pri 1 % bolnikov 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 (glejte poglavje 4.8).
English: • Antiepileptic (e.g. carbamazepine, phenytoin, primidone, valproic acid)
Slovenian: • antiepileptiki (npr. karbamazepin, fenitoin, primidon, valprojska kislina)
English: The recommended dose of dabrafenib, either used as monotherapy or in combination with trametinib, is 150 mg (two 75 mg capsules) twice daily (corresponding to a total daily dose of 300 mg).
Slovenian: Priporočeni odmerek dabrafeniba, bodisi v monoterapiji ali v kombinaciji s trametinibom, je 150 mg (dve 75 mg kapsuli) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg).
English: Most patients were Caucasian (99%) and male (55%), with a median age of 51 years (18% were ≥65 years).
Slovenian: Večina bolnikov je bila belcev (99 %) in moškega spola (55 %), mediana starost je bila 51 let (18 % jih je bilo starih najmanj 65 let).
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.
Slovenian: V skupini za vrednotenje varnosti zdravila je bilo pri bolnikih, zdravljenih z dabrafenibom v kombinaciji s trametinibom (n=1076) 265 bolnikov (25 %) starih najmanj 65 let; 62 bolnikov (6 %) pa je bilo starih najmanj 75 let.
English: N=12 NR (5.0, NR)
Slovenian: N = 12 ND (5,0; ND)
English: Microcrystalline cellulose Magnesium stearate Colloidal silicone dioxide
Slovenian: 6.1 Seznam pomožnih snovi Vsebina kapsule mikrokristalna celuloza magnezijev stearat koloidni silicijev dioksid
English: • medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole
Slovenian: • zdravila za zdravljenje glivičnih okužb, npr. ketokonazol, itrakonazol, vorikonazol in posakonazol
English: Figure 4 Kaplan-Meier RFS curves for Study BRF115532 (ITT population, updated results)
Slovenian: Slika 4 Kaplan-Meierjeve krivulje preživetja brez ponovitve bolezni (RFS) v študiji BRF115532 (populacija z namenom zdravljenja - ITT, posodobljeni rezultati)
English: The steady-state volume of distribution following intravenous microdose administration is 46 L.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je po intravenski uporabi mikroodmerka 46 L. Biotransformacija
English: Body weight and gender
Slovenian: Telesna masa in spol
English: If a dose of dabrafenib is missed, it should not be taken if it is less than 6 hours until the next scheduled dose.
Slovenian: Če bolnik pozabi vzeti odmerek dabrafeniba, pozabljenega odmerka ne sme vzeti, če je do naslednjega odmerka po razporedu manj kot šest ur.
English: No dose modification of trametinib is required when taken in combination with dabrafenib (see section 4.4).
Slovenian: Odmerka trametiniba ni treba prilagajati, če ga bolnik jemlje v kombinaciji z dabrafenibom (glejte poglavje 4.4).