FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2).
Slovenian: Nemudoma obvestite zdravnika, če imate katerega od naslednjih resnih neželenih učinkov - če do njih pride prvič ali če se stanje poslabša
English: If you forget to take Mektovi
Slovenian: Če ste pozabili vzeti zdravilo Mektovi
English: Yellow to dark yellow, unscored biconvex, ovaloid film-coated tablets approximately 12 mm in length and 5 mm in width, with the “A” logo debossed on one side of the tablet and “15” on the other side.
Slovenian: Rumene do temno rumene, bikonveksne, ovalne filmsko obložene tablete brez zareze, dolge približno 12 mm in široke 5 mm, z vtisnjenim logotipom »A« na eni strani tablete in številko »15« na drugi strani.
English: See section 2 “Mektovi contains lactose”.
Slovenian: Glejte poglavje 2 »Zdravilo Mektovi vsebuje laktozo«.
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Slovenian: Z nestratificiranimi analizami podskupin so se pokazale ocenjene vrednosti v korist kombinaciji 450, vključno z izhodiščno vrednostjo encima LDH, s stanjem zmogljivosti ECOG in stadijem po AJCC.
English: Binimetinib should be permanently discontinued with the occurrence of RVO (see Table 1 in section 4.2).
Slovenian: Vnos binimetiniba je treba trajno prekiniti ob pojavu RVO (glejte preglednico 1 v poglavju 4.2).
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with binimetinib when used in combination with encorafenib.
Slovenian: Kožne malignosti, kot je ploščatocelični karcinom kože (cuSCC), vključno s keratoakantomom, so opazili pri bolnikih, zdravljenih z binimetinibom v kombinaciji z enkorafenibom.
English: It is not known if Mektovi passes into breast milk.
Slovenian: Ni znano, ali zdravilo Mektovi prehaja v materino mleko.
English: Do not take Mektovi if you are allergic to binimetinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na binimetinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: How to take Mektovi How much to take
Slovenian: Kako jemati zdravilo Mektovi Koliko zdravila Mektovi vzeti
English: There are no data from the use of binimetinb in pregnant women.
Slovenian: Podatkov o uporabi binimetiniba pri nosečnicah ni.
English: The number of viable foetuses and foetal body weights were reduced and post-implantation loss and resorptions were increased.
Slovenian: Število fetusov, sposobnih za razvoj, in telesna teža fetusa sta se zmanjšala, povečala pa sta se izguba po implantaciji in resorpcija.
English: Mektovi is not recommended during pregnancy.
Slovenian: Zdravilo Mektovi se ne priporoča med nosečnostjo.
English: • Symptomatic retinal pigment epithelial detachments (RPED) (Grade 2 or 3)
Slovenian: • Simptomatični odstop mrežničnega pigmentnega epitelija (RPED) (2. ali 3. stopnja)
English: Treatment with binimetinib should be withheld in patients with suspected pneumonitis or ILD, including patients presenting new or progressive pulmonary symptoms or findings such as cough, dyspnoea, hypoxia, reticular opacities or pulmonary infiltrates (see Table 1 in section 4.2).
Slovenian: Zdravljenje z binimetinibom je treba prekiniti pri bolnikih, pri katerih sumimo na pljučnico ali ILD, vključno z bolniki, ki kažejo nove ali razvite simptome pljučnih stanj, kot so kašelj, dispneja, hipoksija, retikularna zasenčenja ali pljučna infiltracija (glejte preglednico 1 v poglavju 4.2).
English: In case of severe hypertension, temporary interruption of binimetinib is recommended until hypertension is controlled (see Table 2 in section 4.2).
Slovenian: V primeru hude hipertenzije se priporoča začasna prekinitev vnosa binimetiniba, dokler hipertenzija ni spet pod nadzorom (glejte razpredelnico 2 v poglavju 4.2).
English: In rabbits, mortality, maternal physical signs of toxicity, lower gestational body weight and abortion were noted.
Slovenian: Pri kuncih so bili zabeleženi umrljivost, fizični znaki toksičnosti pri materi, nižja telesna teža med nosečnostjo in splav.
English: Results from a dedicated clinical study showed that patients with severe renal impairment (eGFR ≤ 29 mL/min/1.73 m2), had a 29 % increase in exposure (AUCinf), a 21 % increase in Cmax, and a 22 % decrease in CL/F compared to matching healthy subjects.
Slovenian: Rezultati namenske klinične študije so pokazali, da je v primerjavi z zdravimi udeleženci pri bolnikih s hudo ledvično okvaro (oGF ≤ 29 ml/min/1,73 m2) prišlo do 29-odstotnega povečanja izpostavljenosti (AUCinf), 21-odstotnega povečanja Cmax in 22
English: • heart problems
Slovenian: • težave s srcem,
English: • pain in your legs with or without swelling
Slovenian: • bolečine v nogah z otekanjem ali brez,
English: Neuropathy peripheral*
Slovenian: Periferna nevropatija*
English: Eye problems: Mektovi can cause fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal pigment epithelial detachment) which could lead to:
Slovenian: Težave z očmi: Zaradi zdravila Mektovi lahko pride do iztekanja tekočine pod mrežnico v očesu, kar povzroči odstop različnih plasti v očesu (odstop retinalnega pigmentnega epitelija) in lahko privede do:
English: Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded.
Slovenian: Bolniki so imeli histološko potrjen kožni ali neznani primarni melanom, bolniki z uvealnim ali mukoznim melanomom pa so bili izključeni.
English: Part 1 of study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Slovenian: 1. del študije CMEK162B2301 je pokazal statistično pomembno izboljšanje vrednosti PFS pri bolnikih, zdravljenih s kombinacijo 450, v primerjavi z bolniki, zdravljenimi z vemurafenibom.
English: Therefore, in these patients, binimetinib should be used with caution and for any symptomatic left ventricular dysfunction,
Slovenian: Zato je pri teh bolnikih binimetinib treba uporabljati previdno in v primeru simptomatične disfunkcije levega prekata, LVEF
English: The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Slovenian: Med najpogostejšimi neželenimi učinki (> 25 %), ki so se pojavili pri bolnikih, zdravljenih z odmerkom 300 mg enkorafeniba, skupaj z binimetinibom, so bili utrujenost, slabost in driska.
English: Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2.
Slovenian: Mehanizem delovanja Binimetinib je z ATP nekompetitivni, reverzibilni zaviralec kinazne aktivnosti z mitogenom aktivirane in zunajceličnim signalom regulirane kinaze 1 in 2 (MEK1 in MEK2).
English: It is used in adults in combination with another medicine containing encorafenib to treat a type of skin cancer called melanoma when it has
Slovenian: ki vsebuje enkorafenib, se uporablja pri odraslih za zdravljenje vrste kožnega raka, ki se imenuje melanom,
English: If you stop taking Mektovi
Slovenian: Če ste prenehali jemati zdravilo Mektovi
English: Elderly patients No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Slovenian: Za bolnike, stare 65 let ali več, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: If a dose of binimetinib is missed, it should not be taken if it is less than 6 hours until the next dose is due.
Slovenian: Če bolnik pozabi vzeti odmerek binimetiniba, zdravila ne sme vzeti, če je do naslednjega odmerka manj kot 6 ur.
English: • coughing up of blood or blood clots
Slovenian: • izkašljevanje krvi ali krvnih strdkov,
English: New onset elevated blood pressure or worsening of pre-existing hypertension were reported in 11.7 % (32/274) of patients treated with the Combo 450.
Slovenian: O pojavu novega nastanka zvišanega krvnega tlaka ali o poslabšanju obstoječe hipertenzije so poročali pri 11,7 % (32/274) bolnikov iz združene populacije bolnikov v okviru zdravljenja s kombinacijo 450.
English: Skin papilloma*
Slovenian: Kožni papilom*
English: Talk to your doctor, pharmacist or nurse before taking Mektovi about all of your medical conditions, particularly if you have any of the following:
Slovenian: Pred začetkom jemanja zdravila Mektovi se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro o svojem zdravstvenem stanju, zlasti če imate katero koli od naslednjih stanj:
English: Based on a population pharmacokinetic (PK) analysis, the PK of binimetinib were similar in males as compared with females.
Slovenian: Glede na populacijsko farmakokinetično (FK) analizo je FK binimetiniba podobna pri moških in ženskah.
English: 27 patients (5 %) had received prior checkpoint inhibitors (antiPD1/PDL1 or ipilimumab) (8 patients in Combo 450 arm (4 %); 7 patients in vemurafenib arm (4 %); 12 patients in Enco 300 arm (6 %) including 22 patients in the metastatic setting (6 patients in Combo 450 arm; 5 patients in vemurafenib arm; 11 patients in Enco 300 arm) and 5 patients in the adjuvant setting (2 patients in Combo 450 arm; 2 patients in vemurafenib arm; 1 patient in Enco 300 arm.
Slovenian: 27 bolnikov (5 %) je predhodno prejelo predhodno imunoterapijo (antiPD1/PDL1 ali ipilimumab) (8 bolnikov pri kombinaciji 450 (4 %); 7 bolnikov pri vemurafenibu (4 %); 12 bolnikov pri Enko 300 (6 %), vključno z 22 bolniki z metastatsko boleznijo (6 bolnikov pri kombinaciji 450, 5 bolnikov pri vemurafenibu, 11 bolnikov pri Enko 300) in 5 bolniki v okviru adjuvantnega zdravljenja (2 bolnika pri kombinaciji 450, 2 bolnika pri vemurafenibu, 1 bolnik pri Enko 300).
English: Binimetinib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila binimetinib ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8 %) were < 65 years old, 65 patients (23.7 %) were 65 -74 years old and 15 patients (5.5 %) were aged > 75.
Slovenian: Pri bolnikih v okviru zdravljenja s kombinacijo 450 (n = 274) je bilo 194 bolnikov (70,8 %) mlajših od 65 let, 65 bolnikov (23,7 %) je bilo starih med 65 in 74 let, 15 bolnikov (5,5 %) pa je bilo starejših od 75 let.
English: Liver metabolism mainly via glucuronidation is the primary route of elimination of binimetinib (see section 5.2).
Slovenian: Presnova v jetrih, zlasti glukuronidacija, je primarna pot izločanja binimetiniba (glejte poglavje 5.2).
English: Study CMEK162B2301, Part 2
Slovenian: Študija CMEK162B2301, 2.del
English: The most common adverse events reported with a higher incidence in patients aged ≥ 65 years compared to patients aged < 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation.
Slovenian: Najpogostejši neželeni dogodki, o katerih so pogosteje poročali pri bolnikih, starih 65 let in več, v primerjavi z bolniki, mlajšimi od 65 let, so vključevali drisko, srbenje, zvišano vrednost GGT in zvišano vrednost alkalne fosfataze v krvi.
English: Tell your doctor immediately if you detect any skin changes during and after the treatment including: new wart, skin sore or reddish bump that bleeds or does not heal, or a change in size or colour of a mole.
Slovenian: Zdravnika nemudoma obvestite, če med zdravljenjem ali po njem opazite kakršne koli spremembe na koži, vključno z novim izrastkom, rano na koži ali rdečkasto buško, iz katere krvavite ali ki se ne zaceli, ali spremembo velikosti ali barve materinega znamenja.
English: • headaches, dizziness or weakness
Slovenian: • glavoboli, vrtoglavica ali oslabelost,
English: If binimetinib is used during pregnancy, or if the patient becomes pregnant while taking binimetinib, the patient should be informed of the potential hazard to the foetus.
Slovenian: Če bolnica jemlje binimetinib med nosečnostjo ali med jemanjem binimetiniba zanosi, jo je treba opozoriti o možni nevarnosti za plod.
English: Venous thromboembolism (VTE)
Slovenian: Venski tromboembolizem (VTE)
English: Binimetinib and encorafenib should be continued without any dose modifications.
Slovenian: Jemanje binimetiniba in enkorafeniba je treba nadaljevati z nespremenjenim odmerkom.
English: Hypertension events were reported as Grade 3 in 5.5 % (15/274) of patients, including hypertensive crisis (0.4 % (1/274)).
Slovenian: Hipertenzija je bila poročana kot dogodek 3. stopnje pri 5,5 % (15/274) bolnikov, vključno s hipertenzivno krizo (0,4 % (1/274)).
English: Tell your doctor if you have had a different type of cancer than melanoma, as binimetinib when taken with encorafenib may worsen certain other types of cancers.
Slovenian: Če ste že imeli vrsto raka, ki ni melanom, obvestite zdravnika, saj jemanje binimetiniba z enkorafenibom lahko poslabša stanje nekaterih drugih vrst raka.
English: In addition, simulations to investigate the effect of 400 mg atazanavir (UGT1A1 inhibitor) on the exposure of 45 mg binimetinib predicted similar binimetinib Cmax in the presence or absence of atazanavir.
Slovenian: Poleg tega so s pomočjo simulacij za raziskavo učinka 400 mg atazanavira (zaviralec UGT1A1) na izpostavljenost 45 mg binimetiniba napovedali podobno najvišjo koncentracijo Cmax binimetiniba, ne glede na prisotnost oziroma odsotnost atazanivira.
English: Binimetinib is to be given in combination with encorafenib.
Slovenian: Binimetinib je treba jemati v kombinaciji z enkorafenibom.
English: Binimetinib should be withheld for up to 4 weeks.
Slovenian: Vnašanje binimetiniba je treba prekiniti za do 4 tedne.
English: • vomit containing blood or that looks like “coffee grounds”
Slovenian: • kri v bruhanju ali bruhanje, ki je videti kot »kavna usedlina«,
English: The median relative dose intensity (RDI) for Combo 450 was 99.6 % for binimetinib and 100 % for encorafenib the median RDI was 86.2 % for Enco 300 and 94.5 % for vemurafenib.
Slovenian: Mediana relativne jakosti odmerka (RDI) za kombinacijo 450 je bila 99,6 % za binimetinib in 100 % za enkorafenib, mediana RDI za Enko 300 je bila 86,2 %, za vemurafenib pa
English: Dermatologic reactions Dermatologic reactions may occur when binimetinib is used in combination with encorafenib.
Slovenian: Kožne reakcije Do kožnih reakcij lahko pride, ko se binimetinib uporablja v kombinaciji z enkorafenibom.
English: • a cool, pale arm or leg
Slovenian: • otekanje rok in nog, • hladno, bledo roko ali nogo.
English: If you are a woman who could become pregnant, you must use reliable contraception while you are taking Mektovi, and you must continue to use reliable contraception at least 1 month after taking your last dose.
Slovenian: Če ste ženska z možnostjo zanositve, morate med jemanjem zdravila Mektovi in še vsaj 1 mesec po tem, ko vzamete zadnji odmerek, uporabljati zanesljivo kontracepcijo.
English: It may cause permanent harm or birth defects to an unborn baby.
Slovenian: Nerojenemu otroku lahko povzroči trajne poškodbe ali razvoj prirojenih motenj.
English: In cynomolgus monkeys, oral administration of binimetinib was associated with gastro-intestinal intolerance, moderate clinical pathology changes, bone marrow hypercellularity and microscopic findings of gastrointestinal inflammation, reversible at the lowest doses which were below human therapeutic exposures.
Slovenian: Pri javanskih makakih je bilo peroralno dajanje binimetiniba povezano z gastrointestinalno intoleranco, zmernimi kliničnimi patološkimi spremembami, hipercelularnostjo kostnega mozga in mikroskopskimi odkritji gastrointestinalnega vnetja, reverzibilnimi pri najmanjših odmerkih, ki so bili manjši od človeškega terapevtskega odmerka.
English: • Muscle problems: Mektovi can cause breakdown of muscle (rhabdomyolysis).
Slovenian: • Težave z mišicami: Zdravilo Mektovi lahko povzroči razkroj mišic (rabdomioliza).
English: • some medicines typically used to treat epilepsy such as phenobarbital, phenytoin,
Slovenian: • nekatera zdravila, ki se običajno uporabljajo za zdravljenje epilepsije, kot so fenobarbital,
English: Other skin cancers: When Mektovi is taken with encorafenib, the patient may develop different types of skin cancer such as cutaneous squamous cell carcinoma.
Slovenian: Druge vrste kožnega raka: Ko se zdravilo Mektovi jemlje z enkorafenibom, se pri bolniku lahko razvijejo različne vrste kožnega raka, kot je ploščatocelični karcinom kože.
English: Binimetinib has not been evaluated in patients with Gilbert's disease.
Slovenian: Gilbertov sindrom Binimetinib se ni ocenil pri bolnikih z Gilbertovim sindromom.
English: The median time to onset of the first event of RPED (all grades) was 1.5 month (range 0.03 to 17.5 months).
Slovenian: Mediana časa do prvega pojava RPED (za vse stopnje) je bila 1,5 meseca (v razponu od 0,03 do 17,5 meseca).
English: Binimetinib is a potential inducer of CYP1A2, and caution should be taken when it is used with sensitive substrates (such as duloxetine or theophylline).
Slovenian: Binimetinib je potencialni induktor encima CYP1A2, zato je pri sočasni uporabi z občutljivimi substrati (npr. duloksetinom in teofilinom) potrebna previdnost.
English: Few patients requiring dose interruptions or dose reductions (0.7 % or 2/274).
Slovenian: Pri redkih bolnikih je bilo treba prekiniti vnos ali zmanjšati odmerek (0,7 % ali 2/274).
English: Tell your doctor right away if you have any unusual bleeding or signs of bleeding, including:
Slovenian: V primeru kakršne koli nenavadne krvavitve ali znakov krvavenja nemudoma obvestite zdravnika, npr.:
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib is co-administered with encorafenib (see section 5.2).
Slovenian: Čeprav je enkorafenib relativno močen reverzibilni zaviralec UGT1A1, niso bile klinično opažene nobene razlike v izpostavljenosti binimetinibu, ko je bil binimetinib uporabljen skupaj z enkorafenibom (glejte poglavje 5.2).
English: Binimetinib pharmacokinetics have been shown to be approximately dose-linear.
Slovenian: Farmakokinetične lastnosti binimetiniba so približno linearne glede na odmerek.
English: No clinicallly significant drug-drug interactions caused by binimetinib on other transporters is expected.
Slovenian: Ne pričakuje se nikakršna klinično pomembna interakcija med zdravili, do katere bi prišlo zaradi delovanja binimetiniba na druge prenašalce.
English: There are no data on the effect on fertility in humans for binimetinib.
Slovenian: Ni podatkov o učinkih binimetiniba na plodnost pri ljudeh.
English: In repeat-dose toxicity studies, no concern in terms of fertility was raised from pathological examination of reproductive organs in rats and monkeys.
Slovenian: Pri študijah toksičnosti večkratnih odmerkov po patoloških preiskavah reproduktivnih organov podgan in opic ni bilo vzbujenih pomislekov glede plodnosti.
English: Additionally, your doctor needs to check for squamous cell carcinoma on your head, neck, mouth and lymph glands, and you will have CT scans regularly.
Slovenian: Poleg tega vam mora zdravnik pregledati glavo, vrat, usta in bezgavke, redno pa boste slikani z računalniško tomografijo, s čimer se preveri obstoj ploščatoceličnega karcinoma.
English: Binimetinib in combination with encorafenib 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: Binimetinib je v kombinaciji z enkorafenibom indiciran za zdravljenje odraslih bolnikov z neresektabilnim ali metastatskim melanomom z mutacijo BRAF V600 (glejte poglavji 4.4 in 5.1).
English: • Liver problems: Mektovi can cause abnormal blood tests related to your liver (raised levels of liver enzymes).
Slovenian: • Težave z jetri: Zdravilo Mektovi lahko povzroči nenormalne rezultate preiskav krvi, povezanih z delovanjem jeter (povečane ravni jetrnih encimov).
English: As Mektovi is to be used in combination with encorafenib, read the encorafenib leaflet carefully as well as this leaflet.
Slovenian: Zdravilo Mektovi se mora uporabljati v kombinaciji z enkorafenibom, zato pozorno preberite to navodilo in navodilo za enkorafenib.
English: • Grade 3 or 4 LVEF decrease or symptomatic left ventricular dysfunction (LVD)
Slovenian: 3. ali 4. stopnje ali simptomatična disfunkcija levega prekata (LVD)
English: Binimetinib inhibits growth of BRAF V600 mutant melanoma cell lines and demonstrates anti-tumour effects in BRAF V600 mutant melanoma animal models.
Slovenian: Binimetinib zavira rast celičnih linij melanoma z mutacijo V600 gena BRAF in kaže protitumorske učinke na živalskih modelih melanoma z mutacijo V600 gena BRAF.
English: • Uncomplicated deep vein thrombosis (DVT) or pulmonary embolism (PE) ≤ Grade 3
Slovenian: Venski tromboembolizem (VTE) • Nezapletena globoka venska tromboza (DVT) ali pljučna embolija (PE) ≤ 3. stopnji
English: Dermatologic evaluations should be performed prior to initiation of therapy with binimetinib in combination with encorafenib, every 2 months while on therapy and for up to 6 months following discontinuation of the combination.
Slovenian: Opraviti je treba dermatološki pregled pred uvedbo zdravljenja z binimetinibom v kombinaciji z enkorafenibom in nato še vsaka 2 meseca med zdravljenjem ter do 6 mesecev po prenehanju zdravljenja.
English: If treatment-related toxicities occur when binimetinib is used in combination with encorafenib, then both treatments should be simultaneously dose reduced, interrupted or discontinued.
Slovenian: Če se med jemanjem binimetiniba v kombinaciji z enkorafenibom pojavijo toksični učinki, povezani z zdravljenjem, je treba hkrati zmanjšati odmerek obeh zdravil oziroma začasno ali dokončno prekiniti zdravljenje.
English: The safety of binimetinib in combination with encorafenib has not been established in patients with a baseline LVEF that is either below 50 % or below the institutional LLN.
Slovenian: Varnosti binimetiniba v kombinaciji z enkorafenibom niso ocenjevali pri bolnikih, ki imajo izhodiščno vrednost LVEF pod 50 % ali pod spodnjo mejo normalne vrednosti (LLN).
English: Repeated oral administration of binimetinib in rats for up to 6 months was associated with soft tissue mineralisation, gastric mucosal lesions and reversible minimal to mild clinical pathology changes at 7 to 12.5 times human therapeutic exposures.
Slovenian: Z binimetinibom, ki se je do 6 mesecev ponavljajoče peroralno dajal podganam, so bile povezane mineralizacija v mehkem tkivu, lezije na želodčni sluznici in reverzibilne minimalne do blage klinične patološke spremembe, pri čemer je bila izpostavljenost binimetinibu 7- do 12,5-krat večja kot pri človeškem terapevtskem odmerku.
English: Package leaflet: Information for the patient Mektovi 15 mg film-coated tablets binimetinib This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Mektovi 15 mg filmsko obložene tablete binimetinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: No effects were noted at 14-times the human therapeutic exposure .
Slovenian: Pri 14-kratni izpostavljenosti kot pri človeškem terapevtskem odmerku se učinki niso zabeležili.
English: If one of these toxicities occurs, see section 4.2. of encorafenib Summary of Product Characteristics (SmPC) for dose modification instructions for encorafenib.
Slovenian: Če se pojavi eden od teh toksičnih učinkov, glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila enkorafenib, kjer so navedena navodila za spreminjanje odmerka enkorafeniba.
English: • lung or breathing problems
Slovenian: • težave s pljuči ali dihanjem,
English: Ocular toxicities
Slovenian: Očesne toksičnosti
English: • Symptomatic RPED (Grade 4) associated with reduced visual acuity (Grade 4)
Slovenian: (4. stopnja), povezan z zmanjšano ostrino vida (4. stopnja)
English: Binimetinib should be withheld until improved to Grade 0 or 1.
Slovenian: Vnašanje binimetiniba je treba prekiniti, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje.