FrancophonIA/ELRC3.0 huggingface dataset:
English: If RPED is diagnosed, the dose modification schedule in Table 3 should be followed (see section 4.2); if uveitis is diagnosed, please refer to dabrafenib SmPC section 4.4.
Slovenian: Če je diagnosticiran RPED, je treba upoštevati shemo prilagoditve odmerka v preglednici 3 (glejte poglavje 4.2), če pa je postavljena diagnoza uveitisa, glejte poglavje 4.4 v povzetku glavnih značilnosti zdravila za dabrafenib.
English: • Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
Slovenian: • bolezni nohtov, na primer spremembe nohtne posteljice, bolečine v predelu nohtov, okužba in oteklost kožice ob nohtih
English: Taking Mekinist or the combination of Mekinist and dabrafenib may increase the risk of developing holes in the gut wall.
Slovenian: Jemanje zdravila Mekinist ali kombinacije zdravila Mekinist in dabrafeniba lahko poveča tveganje za nastanek lukenj v steni črevesa.
English: ORR, DoR and PFS were also assessed by an Independent Review Committee (IRC) as a sensitivity analysis.
Slovenian: Stopnjo celokupnega odziva, trajanje odziva in preživetje brez napredovanja bolezni je ocenila tudi neodvisna ocenjevalna komisija (IRC - Independent Review Committee) z analizo občutljivosti.
English: If haemorrhage occurs, patients should be treated as clinically indicated.
Slovenian: Če pride do krvavitve, je treba bolnika zdraviti v skladu s kliničnimi indikacijami.
English: Mekinist can have side effects that may affect your ability to drive or use machines.
Slovenian: Zdravilo Mekinist ima lahko neželene učinke, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev.
English: In more severe cases hospitalisation, interruption or permanent discontinuation of trametinib or trametinib and dabrafenib combination was required.
Slovenian: V hujših primerih je bil potreben sprejem v bolnišnico oziroma začasna prekinitev ali dokončna ukinitev zdravljenja s trametinibom ali s kombinacijo trametiniba in dabrafeniba.
English: • have heart problems such as heart failure (which can cause shortness of breath, difficulty in breathing when lying down, swelling of the feet or legs) or problems with the way your heart beats.
Slovenian: • če imate težave s srcem, kot je srčno popuščanje (ki lahko povzroča zadihanost, oteženo dihanje v ležečem položaju, otekanje stopal ali nog) ali težave z nepravilnim bitjem srca.
English: Additionally, in juvenile rats given trametinib, decreased ovarian weights, slight delays in hallmarks of female sexual maturation (vaginal opening and increased incidence of prominent terminal end buds within the mammary gland) and slight hypertrophy of the surface epithelium of the uterus were observed.
Slovenian: Poleg tega so pri mladih podganah, ki so jim dajali trametinib, opažali zmanjšano maso ovarijev in manjše zaostanke pri pojavljanju znakov spolnega dozorevanja pri samicah (odpiranja nožnice in povečanega pojavljanja izrazitih terminalnih brstov v mlečni žlezi) ter blago hipertrofijo krovnega epitelija maternice.
English: • If you do become pregnant while you are taking Mekinist, tell your doctor immediately.
Slovenian: • Če med jemanjem zdravila Mekinist zanosite, o tem takoj obvestite zdravnika.
English: Rash has been observed in about 60% of patients when given as monotherapy and in about 24% of patients in trametinib and dabrafenib combination studies in the integrated safety population.
Slovenian: Izpuščaj so opažali pri približno 60 % bolnikov, zdravljenih z monoterapijo, in pri približno 24 % bolnikov v študijah s kombiniranim zdravljenjem s trametinibom in dabrafenibom v skupini za vrednotenje varnosti zdravila.
English: In clinical trials, central testing for BRAF V600 mutation using a BRAF mutation assay was conducted on the most recent tumour sample available.
Slovenian: V kliničnih preskušanjih so centralno testiranje mutacije BRAF V600 opravili s testom za mutacijo BRAF na najnovejšem vzorcu tumorja, ki je bil na voljo.
English: Based on cross-study comparisons, overall survival and progression-free survival data appear to show similar effectiveness between trametinib and BRAF inhibitors; however, overall response rates were lower in patients treated with trametinib than those reported in patients treated with BRAF inhibitors.
Slovenian: Primerjave med študijami kažejo, da je trametinib glede celokupnega preživetja in preživetja brez napredovanja podobno učinkovit kot zaviralci BRAF, a deleži odziva so bili pri prejemnikih trametiniba manjši kot med prejemniki zaviralcev BRAF.
English: No studies have been conducted to investigate the pharmacokinetics of trametinib in paediatric patients.
Slovenian: Študij farmakokinetike trametiniba pri pediatričnih bolnikih niso izvedli.
English: Trametinib may result in transient inhibition of BCRP substrates (e.g. pitavastatin) in the gut, which may be minimised with staggered dosing (2 hours apart) of these agents and trametinib.
Slovenian: Trametinib lahko povzroči prehodno zavrtje substratov BCRP (npr. pitavastatina) v črevesu; to je mogoče omejiti na najmanjšo mero tako, da se ta zdravila in trametinib uporablja z medsebojnim zamikom (zamik 2 ur).
English: Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by standard therapy as appropriate (see section 4.4).
Slovenian: Krvni tlak je treba izmeriti izhodiščno in ga kontrolirati med zdravljenjem; hipertenzijo je treba obvladovati s standardnim zdravljenjem, kot je ustrezno (glejte poglavje 4.4).
English: LVEF reduction/Left ventricular dysfunction
Slovenian: Zmanjšanje iztisnega deleža levega prekata (LVEF)/disfunkcija levega prekata
English: Following administration of 2 mg once daily, steady-state geometric mean Cmax, AUC(0-) and predose concentration were 22.2 ng/ml, 370 ng*hr/ml and 12.1 ng/ml, respectively with a low peak:trough ratio (1.8).
Slovenian: Po uporabi 2 mg enkrat na dan so bila v stanju dinamičnega ravnovesja geometrična povprečja Cmax 22,2 ng/ml, AUC(0-) 370 ng*hr/ml in koncentracije pred odmerkom 12,1 ng/ml; razmerje med najvišjo in najnižjo vrednostjo je bilo nizko (1,8).
English: In embryo-foetal developmental toxicity studies in rats and rabbits, trametinib induced maternal and developmental toxicity.
Slovenian: V študijah toksičnosti za embriofetalni razvoj na podganah in kunčjih samicah je trametinib povzročil toksične učinke pri samicah materah in razvojne toksične učinke.
English: Combination with dabrafenib
Slovenian: Kombinacija z dabrafenibom
English: The pharmacokinetics of trametinib were characterised in 223 patients enrolled in clinical trials with trametinib who had mild renal impairment and 35 patients with moderate renal impairment using a population pharmacokinetic analysis.
Slovenian: Farmakokinetiko trametiniba so s populacijsko farmakokinetično analizo preučili pri 223 bolnikih, vključenih v klinična preskušanja trametiniba, ki so imeli blago okvaro ledvic, in pri 35 bolnikih, ki so imeli zmerno okvaro ledvic.
English: Percent survival at 12 months (95% CI)
Slovenian: Odstotek preživetja po 12 mesecih (95-odstotni IZ)
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second-line or higher patients and 68 years in the first-line patients.
Slovenian: Med skupno 93 bolniki, ki so bili vključeni v kohorti B in C s kombiniranim zdravljenjem, je bila večina belcev (> 90 %), žensk je bilo približno toliko kot moških (54 % žensk in 46 % moških), mediana starost bolnikov, ki so prejemali že najmanj drugo linijo zdravljenja, je bila 64 let, pri bolnikih, ki so prejemali prvo linijo zdravljenja, pa je bila mediana starosti 68 let.
English: Use with dabrafenib may render hormonal contraceptives less effective and therefore an alternative method of contraception, such as a barrier method, should be used when trametinib is used in combination with dabrafenib.
Slovenian: Uporaba skupaj z dabrafenibom lahko zmanjša učinkovitost hormonskih kontraceptivov, zato je v času uporabe trametiniba v kombinaciji z dabrafenibom treba uporabljati drug način kontracepcije, na primer pregradne metode.
English: If uveitis does not respond to local ocular therapy, dabrafenib should be withheld until resolution of ocular inflammation and then dabrafenib should be restarted reduced by one dose level.
Slovenian: Če se uveitis ne odziva na lokalna očesna zdravila, je treba zdravljenje z dabrafenibom prekiniti, dokler očesno vnetje ni odpravljeno, nato pa je treba dabrafenib ponovno uvesti v odmerku, ki je nižji za eno odmerno raven.
English: In a single-arm Phase II study, designed to evaluate the objective response rate, safety, and pharmacokinetics following dosing of trametinib at 2 mg once daily in patients with BRAF V600E, V600K, or V600D mutation-positive metastatic melanoma (MEK113583), two separate cohorts were enrolled: Cohort A: patients with prior treatment with a BRAF inhibitor either with or without other prior therapy, Cohort B: patients with at least 1 prior chemotherapy or immunotherapy, without prior treatment with a BRAF inhibitor.
Slovenian: faze z enim krakom, ki je bila namenjena oceni objektivnega deleža odziva, varnosti in farmakokinetike po uporabi 2 mg trametiniba enkrat na dan pri bolnikih z metastatskim melanomom s pozitivno mutacijo BRAF V600E, V600K ali V600D (MEK113583), sta bili vključeni dve ločeni kohorti: kohorta A: bolniki, predhodno zdravljeni z zaviralcem BRAF, bodisi z drugim predhodnim zdravljenjem bodisi brez njega; kohorta B: bolniki z vsaj 1 predhodno kemoterapijo ali imunoterapijo in brez predhodnega zdravljenja z zaviralcem BRAF.
English: Taking Mekinist or the combination of Mekinist and dabrafenib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Slovenian: Jemanje zdravila Mekinist ali kombinacije zdravila Mekinist in dabrafeniba lahko povzroči resno krvavitev, med drugim krvavitev v možganih, v prebavilih (npr. v želodcu, danki ali črevesju), v pljučih in drugih organih, bolnik lahko zaradi krvavitve tudi umre.
English: Most patients (87%) in the ITT population had BRAF V600E mutation and 12% of patients had BRAF V600K.
Slovenian: Večina oseb (87 %) v populaciji ZNZ je imela mutacijo BRAF V600E, 12 % pa je imelo mutacijo BRAF V600K.
English: Please refer to sections 4.4 and 4.8 of the dabrafenib SmPC.
Slovenian: Glejte poglavji 4.4 in 4.8 v povzetku glavnih značilnosti zdravila za dabrafenib.
English: If your doctor decides that you will receive treatment with the combination of Mekinist and dabrafenib, read the dabrafenib leaflet carefully as well as this leaflet.
Slovenian: Če se zdravnik odloči, da vas bo zdravil s kombinacijo zdravila Mekinist in dabrafeniba, pozorno preberite navodilo za uporabo za dabrafenib in to navodilo za uporabo.
English: Trametinib was found to be an in vitro inhibitor of CYP2C8, CYP2C9 and CYP2C19, an inducer of CYP3A4 and an inhibitor of the transporters OAT1, OAT3, OCT2, MATE1, OATP1B1, OATP1B3, P-gp and BCRP.
Slovenian: Ugotovljeno je, da trametinib in vitro zavira CYP2C8, CYP2C9 in CYP2C19, inducira CYP3A4 ter zavira prenašalce OAT1, OAT3, OCT2, MATE1, OATP1B1, OATP1B3, Pgp in BCRP.
English: 7 tablets 30 tablets
Slovenian: 30 tablet
English: The efficacy and safety of trametinib have not been evaluated in patients whose melanoma tested negative for the BRAF V600 mutation.
Slovenian: Učinkovitost in varnost trametiniba nista ocenjeni pri bolnikih, ki so imeli negativen izvid testiranja melanoma za mutacijo BRAF V600.
English: - The active substance is trametinib.
Slovenian: - Učinkovina je trametinib.
English: How to take Mekinist
Slovenian: Kako jemati zdravilo Mekinist
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.
Slovenian: Ko so neželeni učinki učinkovito obvladani, pride v poštev ponovno zvišanje odmerka; pri tem je treba zvišanje opraviti po enakih stopnjah, kot je bilo opravljeno znižanje.
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 primary endpoint of the study was to evaluate the efficacy of trametinib compared to chemotherapy with respect to PFS in patients with advanced/metastatic BRAF V600E/K mutation-positive melanoma without a prior history of brain metastases (N=273) which is considered the primary efficacy population.
Slovenian: Primarni opazovani dogodek študije je bila ocena učinkovitosti trametiniba v primerjavi s kemoterapijo, kar zadeva preživetje brez napredovanja bolezni (PFS- progression-free survival) pri bolnikih z napredovalim/metastatskim melanomom s pozitivno mutacijo BRAF V600E/K in brez anamneze metastaz v možganih (n = 273), ki veljajo za primarno populacijo učinkovitosti.
English: Tell your doctor or nurse if you have any new or worsening symptoms, including:
Slovenian: Povejte zdravniku ali medicinski sestri, če se pojavijo novi simptomi ali se poslabšajo že prisotni simptomi, vključno z:
English: In juvenile rats, increased heart weight with no histopathology was observed at 0.35 mg/kg/day (approximately twice the adult human clinical exposure based on AUC).
Slovenian: Pri mladih podganah so opažali povečanje mase srca brez histopatoloških sprememb pri odmerku 0,35 mg/kg/dan (kar je na podlagi AUC približno 2-kratnik klinične izpostavljenosti pri človeku).
English: In vitro and in vivo studies demonstrated that trametinib is metabolised predominantly via deacetylation alone or in combination with mono-oxygenation.
Slovenian: Študije in vitro in in vivo so pokazale, da se trametinib presnovi predvsem z deacetilacijo samo ali v kombinaciji z monooksigenacijo.
English: Male patients taking trametinib in combination with dabrafenib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible.
Slovenian: Moške bolnike, ki jemljejo trametinib v kombinaciji z dabrafenibom, je treba seznaniti z možnim tveganjem za motnje sprematogeneze, ki so lahko ireverzibilne.
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI) P value Overall Response Rate (%)
Slovenian: Mediano PFS (meseci) (95-odstotni IZ) Razmerje ogroženosti (95-odstotni IZ) Vrednost p Celokupni delež odziva (%)
English: • Blurred vision, eyesight problems, inflammation of the eye (uveitis)
Slovenian: • zamegljen vid, težave z vidom, vnetje očesa (uveitis)
English: Usually, these skin changes remain local and can be removed with surgery and treatment with Mekinist and dabrafenib can be continued without interruption.
Slovenian: Te kožne spremembe običajno ostanejo omejene in jih je mogoče odstraniti s kirurškim posegom, bolnik pa lahko brez prekinitve nadaljuje zdravljenje z zdravilom Mekinist in dabrafenibom.
English: Left ventricular dysfunction Ejection fraction decreased Bradycardia
Slovenian: Pogosti disfunkcija levega prekata zmanjšanje iztisnega deleža bradikardija
English: It is recommended that you do not breast-feed while you are taking Mekinist.
Slovenian: Priporočljivo je, da med jemanjem zdravila Mekinist ne dojite.
English: • Eyesight problems (see also “Eye (vision) problems” earlier in section 4)
Slovenian: • težave z vidom (glejte tudi "Težave z očmi (težave z vidom)" zgoraj v poglavju 4)
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 studies and one supportive Phase I/II study.
Slovenian: Učinkovitost in varnost priporočenega odmerka trametiniba (2 mg enkrat na dan) v kombinaciji z dabrafenibom (150 mg dvakrat na dan) za zdravljenje odraslih bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 so proučevali v dveh študijah faze III in eni potrditveni študiji faze I/II.
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated (see section 4.4).
Slovenian: V primeru znakov ali simptomov rabdomiolize je potrebno ustrezno klinično ovrednotenje in zdravljenje, kot je indicirano (glejte poglavje 4.4).
English: Of these patients, 211 were treated with trametinib for BRAF V600 mutant melanoma in the randomised open-label Phase III study MEK114267 (METRIC) (see section 5.1).
Slovenian: Od teh bolnikov jih je bilo 211 zdravljenih s trametinibom zaradi melanoma z mutacijo BRAF V600 v randomizirani odprti študiji III. faze z oznako MEK114267 (METRIC) (glejte poglavje 5.1).
English: Trametinib is absorbed orally with median time to achieve peak concentrations of 1.5 hours post-dose.
Slovenian: Trametinib se absorbira peroralno in mediani čas do najvišje koncentracije je 1,5 ure po odmerku.
English: Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4).
Slovenian: Jemanje zdravila Mekinist ali kombinacije zdravila Mekinist in dabrafeniba lahko povzroči zvišanje telesne temperature, pri čemer je verjetnost za to večja pri jemanju navedene kombinacije zdravil (glejte tudi poglavje 4).
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 (see section 4.4).
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 (glejte poglavje 4.4).
English: In patients receiving trametinib in combination with dabrafenib, pyrexia may be accompanied by severe rigors, dehydration, and hypotension which in some cases can lead to acute renal insufficiency.
Slovenian: Pri bolnikih, ki prejemajo trametinib v kombinaciji z dabrafenibom, zvišano telesno temperaturo lahko spremljajo huda okorelost, dehidracija in hipotenzija, kar v nekaterih primerih lahko povzroči akutno ledvično insuficienco.
English: Progression-Free Survival
Slovenian: Preživetje brez napredovanja (PFS)
English: Effects of trametinib on drug-metabolising enzymes and transporters: In vitro and in vivo data suggest that trametinib is unlikely to affect the pharmacokinetics of other medicinal products.
Slovenian: Vplivi trametiniba na encime, ki presnavljajo zdravila, in prenašalce: Glede na podatke in vitro in in vivo ni verjetno, da bi trametinib vplival na farmakokinetiko drugih zdravil.
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: Chemotherapy (n=108) Trametinib (n=214)
Slovenian: Kemoterapija (n = 108) Trametinib (n = 214)
English: Measurement of patients' BRAF V600 mutation status was required.
Slovenian: Zahtevano je bilo merjenje bolnikovega stanja za mutacijo BRAF V600.
English: Mekinist should be taken with either the morning dose of dabrafenib or the evening dose of dabrafenib.
Slovenian: Zdravilo Mekinist lahko vzamete bodisi z jutranjim ali z večernim odmerkom dabrafeniba.
English: Patients (N=322) who were treatment naïve or may have received one prior chemotherapy treatment in the metastatic setting [Intent to Treat (ITT) population] were randomised 2:1 to receive trametinib 2 mg once daily or chemotherapy (dacarbazine 1000 mg/m every 3 weeks or paclitaxel 175 mg/m every 3 weeks).
Slovenian: Bolnike (n = 322), ki še niso bili zdravljeni ali so v okviru metastatske bolezni prejeli eno predhodno kemoterapijo [populacija z-namenom-zdravljenja (ZNZ)], so v razmerju 2:1 randomizirali na prejemanje 2 mg trametiniba enkrat na dan ali kemoterapije (dakarbazin 1000 mg/m na 3 tedne ali paklitaksel 175 mg/m na 3 tedne).
English: Mekinist can result in the breakdown of muscle (rhabdomyolysis).
Slovenian: Zdravilo Mekinist lahko povzroči razgradnjo mišic (rabdomiolizo).
English: Table 3 Recommended dose modifications for trametinib for RPED
Slovenian: Preglednica 3 Priporočene prilagoditve odmerka trametiniba v primeru RPED RPED 1. stopnje
English: The proportion of subjects experiencing adverse reactions (AR) and serious adverse reactions (SAR) was similar in the subjects aged <65 years and those aged ≥65 years.
Slovenian: Delež bolnikov, ki so se jim pojavili neželeni učinki (NU) ali resni neželeni učinki (RNU), je bil pri preiskovancih v starosti < 65 let in ≥ 65 let podoben.
English: The safety of trametinib monotherapy has been evaluated in the integrated safety population of 329 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with trametinib 2 mg once daily in studies MEK114267, MEK113583, and MEK111054.
Slovenian: Varnost trametiniba v monoterapiji so ocenili v skupini bolnikov za vrednotenje varnosti zdravila pri 329 bolnikih z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600, zdravljenih z 2 mg trametiniba enkrat na dan v študijah MEK114267, MEK113583 in MEK111054.
English: Dose modifications are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see dabrafenib SmPC for further details).
Slovenian: Prilagoditve odmerka niso priporočljive v primeru neželenih učinkov ploščatoceličnega karcinoma kože ali novega primarnega melanoma (za več podatkov glejte povzetek glavnih značilnosti zdravila za dabrafenib).
English: The efficacy and safety of trametinib in patients with BRAF unresectable or metastatic mutant melanoma (V600E and V600K) were evaluated in a randomised open-label Phase III study (MEK114267 [METRIC]).
Slovenian: Učinkovitost in varnost trametiniba pri bolnikih z inoperabilnim ali metastatskim melanomom z mutacijo BRAF (V600E in V600K) so ocenili v randomizirani odprti študiji faze III (MEK114267 [METRIC]).
English: In the integrated safety population of trametinib in combination with dabrafenib (n=1,076) 265 patients (25%) were ≥65 years of age; 62 patients (6%) were ≥75 years of age.
Slovenian: V skupini za vrednotenje varnosti zdravila, zdravljeni s trametinibom v kombinaciji z dabrafenibom, (n = 1076) je bilo 265 bolnikov (25 %) starih najmanj 65 let; 62 bolnikov (6 %) pa je bilo starih najmanj 75 let.
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: Mekinist 2 mg film-coated tablets EU/1/14/931/005
Slovenian: Mekinist 2 mg filmsko obložene tablete EU/1/14/931/005
English: Skin peeling.
Slovenian: • srbenje kože.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Slovenian: Večina preiskovancev je imela ob izhodišču vrednost LDH ≤ ZMN (65 %), stanje zmogljivosti 0 po lestvici ECOG (Eastern Cooperative Oncology Group) (72 %) in zasevke v visceralnih organih (73 %).
English: Tell your doctor or nurse as soon as possible if you get any skin rash, or if you have a rash that gets worse.
Slovenian: Zdravniku ali medicinski sestri morate čimprej povedati, če se vam pojavi kakšen izpuščaj na koži, ali če se vam izpuščaj poslabša.