FrancophonIA/ELRC3.0 huggingface dataset:
English: Median time to initial onset of serous retinopathy events was 1 month (range 0-9 months).
Slovenian: Mediana časa do začetnega pojava serozne retinopatije je bila 1 mesec (razpon: od 0 do 9 mesecev).
English: General dose modifications
Slovenian: Splošne prilagoditve odmerka
English: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A substrate) and dextromethorphan (a sensitive CYP2D6 substrate) were not altered in the presence of cobimetinib.
Slovenian: Klinična študija medsebojnega delovanja zdravil pri onkoloških bolnikih je pokazala, da se koncentraciji midazolama (občutljiv substrat CYP3A) in dekstrometorfana (občutljiv substrat CYP2D6) v plazmi v prisotnosti kobimetiniba nista spremenili.
English: For management of haemorrhage please see section 4.2.
Slovenian: Za obvladovanje krvavitev glejte poglavje 4.2.
English: Cotellic is for oral use.
Slovenian: Zdravilo Cotellic je za peroralno uporabo.
English: Tél: +33 (0) 1 47 61 40 00
Slovenian: Roche Tél: +33 (0)1 47 61 40 00
English: The pharmacokinetics of cobimetinib were evaluated in 6 subjects with mild hepatic impairment (Child Pugh A), 6 subjects with moderate hepatic impairment (Child Pugh B), 6 subjects with severe hepatic impairment (Child Pugh C) and 10 healthy subjects.
Slovenian: Farmakokinetiko kobimetiniba so ocenili pri 6 bolnikih z blago okvaro jeter (stopnje A po Child Pughovi lestvici), 6 bolnikih z zmerno okvaro jeter (stopnje B po Child Pughovi lestvici), 6 bolnikih s hudo okvaro jeter (stopnje C po Child Pughovi lestvici) in 10 zdravih preiskovancih.
English: Concomitant administration of P-gp inhibitors such as ciclosporin and verapamil may have the potential to increase plasma concentrations of cobimetinib.
Slovenian: Sočasna uporaba zaviralcev P-gp, npr. ciklosporina in verapamila, lahko zveča koncentracijo kobimetiniba v plazmi.
English: Cotellic contain lactose
Slovenian: Zdravilo Cotellic vsebuje laktozo
English: Rhabdomyolysis***
Slovenian: keratoakantom**
English: < 10% absolute decrease from baseline
Slovenian: < 10 % absolutno zmanjšanje od izhodišča
English: Diarrhoea should be managed with anti-diarrhoeal agents and supportive care.
Slovenian: Drisko je treba obvladati z antidiaroiki in podpornim zdravljenjem.
English: nefadozone for depression amiodarone for an uneven heartbeat diltiazem, verapamil for high blood pressure imatinib for cancer carbamazepine, phenytoin for fits (seizures)
Slovenian: nefadozon proti depresiji amiodaron proti neenakomernemu bitju srca diltiazem, verapamil proti visokemu krvnemu tlaku imatinib proti raku karbamazepin, fenitoin proti epileptičnim krčem (konvulzijam)
English: Grade ≤2 (tolerable) photosensitivity should be managed with supportive care.
Slovenian: Fotosenzibilnost stopnje ≤ 2 (znosno) je treba obvladovati s podpornim zdravljenjem.
English: · Eye problems
Slovenian: • Težave z očmi
English: · If you get side effects, your doctor may decide to lower your dose, stop treatment temporarily or permanently.
Slovenian: • Če se vam pojavijo neželeni učinki, vam lahko zdravnik zmanjša odmerek tega zdravila ali pa začasno ali trajno prekine zdravljenje z njim.
English: The objective response rate (ORR) in the Cotellic plus vemurafenib arm was 67.6% vs 44.8% in the placebo plus vemurafenib arm.
Slovenian: Delež objektivnega odziva (ORR) je bil v skupini z zdravilom Cotellic in vemurafenibom 67,6 % v primerjavi s 44,8 % v skupini s placebom in vemurafenibom.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Slovenian: Mikrokristalna celuloza (E460) Premreženi natrijev karmelozat (E468)
English: Permanent discontinuation
Slovenian: Trajno prenehanje
English: There is no specific antidote for overdosage with cobimetinib.
Slovenian: Specifičnega antidota za preveliko odmerjanje kobimetiniba ni.
English: Therefore, cobimetinib blocks the cell proliferation induced by the MAPK pathway through inhibition of the MEK1/2 signalling node.
Slovenian: Zato kobimetinib blokira proliferacijo celic, ki jo inducira pot MAPK, z zavrtjem signalnega vozlišča MEK1/2.
English: This can be a sign of muscle damage (rhabdomyolysis) (see also “Muscle problems” in Section 4).
Slovenian: To je lahko znak poškodbe mišic (rabdomiolize) (glejte tudi "Težave z mišicami" v poglavju 4).
English: ADR frequencies are based upon the safety analysis of patients treated with cobimetinib plus vemurafenib with a median follow up of 11.2 months (data cut-off date of 19 September 2014).
Slovenian: Pogostnosti neželenih učinkov temeljijo na varnostni analizi pri bolnikih, zdravljenih s kobimetinibom in vemurafenibom; mediana spremljanja je bila 11,2 meseca (presečni datum zbiranja podatkov: 19. september 2014).
English: The recommended dose is 3 tablets (a total of 60 mg) once a day.
Slovenian: Priporočeni odmerek je 3 tablete (skupaj 60 mg) enkrat na dan.
English: The safety profile of Study NO25395 was consistent with that observed in Study GO28141.
Slovenian: Varnostne značilnosti v študiji NO25395 so se skladale z varnostnimi značilnostmi, ugotovljenimi v študiji GO28141.
English: (or ≥ 10% absolute decrease from baseline)
Slovenian: (ali ≥ 10 % absolutno zmanjšanje od izhodišča)
English: If you are sick (vomit) after taking Cotellic, do not take an extra dose of Cotellic on that day.
Slovenian: Če po zaužitju zdravila Cotellic bruhate, tisti dan ne vzemite dodatnega odmerka zdravila Cotellic.
English: The majority of events were reported as chorioretinopathy or retinal detachment.
Slovenian: Večina primerov je bila opisana kot horioretinopatija ali odstop mrežnice.
English: In Study GO28141, the most common adverse reactions (>20%) observed with a higher frequency in the Cotellic plus vemurafenib arm were diarrhoea, rash, nausea, pyrexia, photosensitivity reaction, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatine phosphokinase, and vomiting.
Slovenian: V študiji GO28141 so bili najbolj pogosti neželeni učinki (> 20 %), opaženi z večjo pogostnostjo v skupini, zdravljeni z zdravilom Cotellic in vemurafenibom, driska, izpuščaj, navzea, zvišana telesna temperatura, fotosenzibilnostna reakcija, zvišanje alanin-aminotransferaze, zvišanje aspartat aminotransferaze, zvišanje kreatin-fosfokinaze v krvi in bruhanje.
English: Cardiovascular safety of cobimetinib in combination with vemurafenib has not been evaluated in vivo.
Slovenian: Kardiovaskularne varnosti kobimetiniba v kombinaciji z vemurafenibom niso ocenili in vivo.
English: Systemic total cobimetinib exposures after a single dose were similar in subjects with mild or moderate hepatic impairment compared to healthy subjects, while subjects with severe hepatic impairment had lower total cobimetinib exposures (AUC0-∞ geometric mean ratio of 0.69 compared to healthy subjects) which is not considered to be clinically significant.
Slovenian: Sistemska izpostavljenost celokupnemu kobimetinibu po enkratnem odmerku je bila pri bolnikih z blago ali zmerno okvaro jeter podobna kot pri zdravih preiskovancih, pri bolnikih s hudo okvaro jeter pa je bila izpostavljenost celokupnemu kobimetinibu manjša (razmerje geometrijskih povprečnih vrednosti AUC0-∞ je bilo pri njih v primerjavi z zdravimi preiskovanci 0,69), kar se ne smatra za klinično pomembno.
English: Grade 3 events: Cotellic treatment should be interrupted during evaluation to avoid any potential contribution to the event.
Slovenian: Neželeni dogodki stopnje 3: zdravljenje z zdravilom Cotellic je treba med obravnavo dogodka prekiniti, da se izognemo morebitnemu poslabšanju le-tega.
English: Co-administration of cobimetinib with a strong CYP3A inducer was not assessed in a clinical study, however, a reduction in cobimetinib exposure is likely.
Slovenian: Sočasne uporabe kobimetiniba z močnim induktorjem CYP3A v klinični študiji niso ocenili, a verjetno se izpostavljenost kobimetinibu zmanjša.
English: This study treated 129 patients with Cotellic and vemurafenib: 63 were BRAF inhibitor (BRAFi) therapy naïve and 66 patients had previously progressed on prior vemurafenib therapy.
Slovenian: V tej študiji so 129 bolnikov zdravili s kombinacijo zdravila Cotellic in vemurafeniba: 63 bolnikov predhodno še ni dobivalo zaviralca BRAF (BRAFi; BRAF inhibitor), 66 bolnikom pa je bolezen med predhodnim zdravljenjem z vemurafenibom napredovala.
English: Effects of cobimetinib on drug transport systems
Slovenian: Vpliv kobimetiniba na transportne sisteme zdravil
English: The median estimate for investigator-assessed PFS was 9.9 months for the Cotellic plus vemurafenib arm vs. 6.2 months for the placebo plus vemurafenib arm.
Slovenian: Mediana ocene za PFS po oceni raziskovalca je bila 9,9 meseca za skupino z zdravilom Cotellic in vemurafenibom v primerjavi s 6,2 meseca za skupino s placebom in vemurafenibom.
English: Based on a population pharmacokinetic analysis, gender, race, ethnicity, baseline ECOG, mild and moderate renal impairment did not affect the pharmacokinetic of cobimetinib.
Slovenian: Na podlagi populacijske farmakokinetične analize so ugotovili, da spol, rasa, etnična pripadnost, izhodiščna ocena ECOG ter blaga in zmerna okvara ledvic niso vplivali na farmakokinetiko kobimetiniba.
English: Cobimetinib is a substrate of P-glycoprotein (P-gp).
Slovenian: Kobimetinib je substrat P-glikoproteina (P-gp).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cotellic in one or more subsets of the paediatric population in malignant solid tumours (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila (EMA) je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Cotellic za vse skupine pediatrične populacije za maligne parenhimske tumorje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Dose modification advice for rhabdomyolysis and Creatine phosphokinase (CPK) elevations Rhabdomyolysis or symptomatic CPK elevations
Slovenian: Nasvet za prilagoditev odmerka pri rabdomiolizi in zvišanjih kreatin-fosfokinaze (CPK) Rabdomioliza ali simptomatska zvišanja CPK:
English: Progression-Free Survival (PFS) Median (months) (95 % CI)
Slovenian: Preživetje brez napredovanja bolezni (PFS) Mediana (meseci) (95-% interval zaupanja)
English: Most events observed in clinical trials were resolved, or improved to asymptomatic Grade 1, following dose interruption or reduction.
Slovenian: Večina dogodkov, opaženih v kliničnih preskušanjih, je po prekinitvi ali zmanjšanju odmerka izzvenela ali se izboljšala na nesimptomatsko stopnjo 1.
English: The mean accumulation ratio at steady state was approximately 2.4-fold.
Slovenian: Povprečni delež kopičenja je bil v stanju dinamičnega ravnovesja približno 2,4-kraten.
English: The safety of Cotellic in combination with vemurafenib has also been evaluated in 129 patients with advanced BRAF V600 mutated melanoma in Study NO25395.
Slovenian: Varnost zdravila Cotellic v kombinaciji z vemurafenibom so ocenili tudi pri 129 bolnikih z napredovalim melanomom z mutacijo BRAF V600 v študiji NO25395.
English: Based on preclinical data and the human mass balance study, cobimetinib is mainly metabolised, with minimal renal elimination.
Slovenian: Na podlagi predkliničnih podatkov in študije masnega ravnovesja pri človeku se kobimetinib večinoma presnovi in se le minimalno izloča skozi ledvice.
English: What Cotellic is and what it is used for
Slovenian: Kaj je zdravilo Cotellic in za kaj ga uporabljamo
English: Effects of cobimetinib on other medicinal products
Slovenian: Učinki kobimetiniba na druga zdravila
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Slovenian: Zaporedje zdravljenj po napredovanju med zdravljenjem z zaviralcem BRAF ni bilo določeno.
English: Tell your doctor straight away if you get diarrhoea.
Slovenian: Zdravnika morate takoj obvestiti, če se vam pojavi driska.
English: If you get side effects your doctor may decide to lower your dose, stop treatment temporarily or permanently.
Slovenian: Če se vam pojavijo neželeni učinki, vam lahko zdravnik zmanjša odmerek tega zdravila, ali začasno ali trajno prekine zdravljenje z njim.
English: Cotellic treatment and vemurafenib treatment should be interrupted.
Slovenian: Zdravljenje z zdravilom Cotellic in zdravljenje z vemurafenibom je treba prekiniti.
English: LVEF should be evaluated before initiation of treatment to establish baseline values, then after the first month of treatment and at least every 3 months or as clinically indicated until treatment discontinuation.
Slovenian: LVEF je treba izmeriti pred začetkom zdravljenja za določitev izhodiščne vrednosti, nato pa ga kontrolirati po prvem mesecu zdravljenja ter vsaj na 3 mesece oziroma kot je klinično indicirano, do prenehanja zdravljenja.
English: What Cotellic is Cotellic is an anti-cancer medicine that contains the active substance cobimetinib.
Slovenian: Kaj je zdravilo Cotellic Zdravilo Cotellic je zdravilo proti raku, ki vsebuje zdravilno učinkovino kobimetinib.
English: Talk to your doctor before taking Cotellic if you are taking: Medicine or active substance
Slovenian: Preden vzamete zdravilo Cotellic, se posvetujte z zdravnikom, če jemljete: Zdravilo ali zdravilna učinkovina
English: St John's Wort a herbal medicine, used to treat depression.
Slovenian: šentjanževka zeliščno zdravilo, ki se uporablja za zdravljenje depresije.
English: Increased AST
Slovenian: Zvišanje AST
English: Dose modification of Cotellic is independent of vemurafenib dose modification.
Slovenian: Prilagoditev odmerka zdravila Cotellic je neodvisna od prilagoditve odmerka vemurafeniba.
English: If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety.
Slovenian: Če se sočasni uporabi močnega zaviralca CYP3A ni mogoče izogniti, je treba bolnike skrbno nadzirati glede varnosti.
English: Taking the medicine · Swallow the tablets whole with water.
Slovenian: Jemanje zdravila • Tablete zaužijte cele in z vodo.
English: The recommended dose of Cotellic is 60 mg (3 tablets of 20 mg) once daily.
Slovenian: Priporočeni odmerek zdravila Cotellic je 60 mg (3 tablete po 20 mg) enkrat na dan.
English: Table 5 Efficacy results from Study GO28141 (coBRIM)
Slovenian: Rezultati učinkovitosti v študiji GO28141 (coBRIM)
English: There are no data on the safety or efficacy of Cotellic in combination with vemurafenib in patients with central nervous system metastasis or in patients with non-cutaneous malignant melanoma.
Slovenian: Podatkov o varnosti in učinkovitost zdravila Cotellic v kombinaciji z vemurafenibom pri bolnikih z metastazami v osrednjem živčevju ali pri bolnikih z malignim melanomom, ki se ne nahaja na koži, ni.
English: Very common ≥ 1/10
Slovenian: Zelo pogosti ≥ 1/10
English: Cobimetinib has linear pharmacokinetics in the dose range of ~3.5 mg to 100 mg.
Slovenian: Farmakokinetika kobimetiniba je v razponu odmerkov od ~ 3,5 mg do 100 mg linearna.
English: 2nd Appearance
Slovenian: 2. pojav
English: Cotellic can increase the amount of some liver enzymes in your blood during treatment.
Slovenian: • Težave z jetri Zdravilo Cotellic lahko med zdravljenjem zviša količino nekaterih jetrnih encimov v krvi.
English: Cotellic + vemurafenib N=247
Slovenian: Zdravilo Cotellic + vemurafenib n = 247
English: Following intravenous administration of a 2 mg dose of cobimetinib, the mean plasma clearance (CL) was 10.7 L/hr.
Slovenian: Po uporabi intravenskega odmerka 2 mg kobimetiniba je bil povprečni plazemski očistek 10,7 l/uro.
English: It is not known whether cobimetinib is excreted in human breast milk.
Slovenian: Ni znano, ali se kobimetinib pri človeku izloča v materino mleko.
English: Primary Endpoint a, f
Slovenian: Primarni opazovani dogodeka, f
English: If haemorrhage occurs, treat as clinically indicated (see section 4.2 and 4.4).
Slovenian: Če se pojavi krvavitev, ukrepajte, kot je klinično indicirano (glejte poglavji 4.2 in 4.4).
English: If rhabdomyolysis or symptomatic CPK elevations do not improve within 4 weeks, Cotellic treatment should be permanently discontinued.
Slovenian: Če se rabdomioliza ali simptomatska zvišanja CPK ne izboljšajo v 4 tednih, je potrebno trajno prenehanje zdravljenja z zdravilom Cotellic.
English: Figure 2: Forest plot for hazard ratios of final overall survival subgroup analyses - Intent to treat population (cut-off date: 28 August 2015)
Slovenian: Drevesni diagram razmerij ogroženosti za končno celokupno preživetje v analizah podskupin - populacija z-namenom-zdravljenja (presečni datum 28. avgust 2015)
English: Maintain Cotellic at a dose of 60 mg once daily (3 tablets)
Slovenian: Ohranite odmerek zdravila Cotellic 60 mg enkrat na dan (3 tablete).
English: Table 3 lists adverse reactions considered associated with the use of Cotellic.
Slovenian: Preglednica 3 prikazuje neželene učinke, ki veljajo za povezane z uporabo zdravila Cotellic.
English: Tell your doctor straight away if you have any unusual bleeding or any of these symptoms: headaches, dizziness, feeling weak, blood in the stools or black stools and vomiting blood.
Slovenian: Takoj obvestite zdravnika, če imate neobičajno krvavitev ali katerega koli od navedenih simptomov: glavobol, omotico, občutek šibkosti, kri v blatu ali črno blato in bruhanje krvi.
English: In patients who were naive to BRAF inhibitor therapy, the median overall survival was 28.5 months (95% CI 23.3-34.6).
Slovenian: Med bolniki, ki predhodno niso bili zdravljeni z zaviralcem BRAF, je bila mediana celokupnega preživetja 28,5 mesecev (95-% interval zaupanja: 23,3-34,6).
English: Heart problems (common: may affect up to 1 in 10 people) Cotellic can lower the amount of blood pumped by your heart.
Slovenian: Težave s srcem (pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov) Zdravilo Cotellic lahko zmanjša količino krvi, ki jo črpa srce.
English: Rhabdomyolysis and CPK elevations
Slovenian: Rabdomioliza in zvišanja CPK
English: In vitro, cobimetinib produced moderate hERG ion channel inhibition (IC50= 0.5 µM [266 ng/mL]), which is approximately 18 fold higher than peak plasma concentrations (Cmax) at the 60 mg to be marketed dose (unbound Cmax=14 ng/mL [0.03 µM]).
Slovenian: In vitro je kobimetinib povzročil zmerno zavrtje ionskih kanalčkov hERG (IC50 ꞊ 0,5 µM [266 ng/ml]); to je približno 18-krat več od največje koncentracije v plazmi (Cmax) med uporabo odmerka 60 mg, ki bo na trgu (nevezani Cmax ꞊ 14 ng/ml [0,03 µM]).
English: Increased blood bilirubin Other laboratory abnormalities Increased blood CPK
Slovenian: Zvišanje bilirubina v krvi Druga laboratorijska odstopanja Zvišanje CPK v krvi
English: The median estimate for independent review of PFS was 11.3 months for the Cotellic plus vemurafenib arm vs. 6.0 months for the placebo plus vemurafenib arm (HR 0.60 (0.45; 0.79); p-value = 0.0003).
Slovenian: Mediana ocene za PFS po oceni neodvisnega revizijskega telesa je bila 11,3 meseca za skupino z zdravilom Cotellic in vemurafenibom v primerjavi s 6,0 meseca za skupino s placebom in vemurafenibom (razmerje ogroženosti 0,60 (0,45; 0,79); vrednost p = 0,0003).
English: In toxicology studies, degenerative changes were observed in reproductive tissues including increased apoptosis/necrosis of corpora lutea and seminal vesicle, epididymal and vaginal epithelial cells in rats, and epididymal epithelial cells in dogs.
Slovenian: V študijah toksičnosti so opažali degenerativne spremembe reproduktivnih tkiv, vključno z večjo apoptozo/nekrozo corpora lutea in seminalnih vezikul ter epididimalnih in nožničnih epitelijskih celic pri podganah in epididimalnih epitelijskih celic pri psih.
English: Clinical judgment should be applied when considering restarting Cotellic treatment.
Slovenian: Pri odločanju o ponovni uvedbi zdravljenja z zdravilom Cotellic je potrebna klinična presoja.
English: For patients reporting new or worsening visual disturbances, an ophthalmologic examination is recommended.
Slovenian: Za bolnike, ki navajajo nove motnje vida ali poslabšanje obstoječih, je priporočljiv oftalmološki pregled.
English: Significant improvement in the primary endpoint, investigator-assessed PFS, was observed in patients assigned to the Cotellic plus vemurafenib arm compared to the placebo plus vemurafenib arm (HR 0.51 (0.39; 0.68); p-value < 0.0001).
Slovenian: Pomembno izboljšanje v primarnem opazovanem dogodku, PFS po oceni raziskovalca, so opazili pri bolnikih, dodeljenih v skupino, ki je prejemala zdravilo Cotellic in vemurafenib, v primerjavi s skupino, ki je prejemala placebo in vemurafenib (razmerje ogroženosti 0,51 (0,39; 0,68); vrednost p < 0,0001).
English: Cobimetinib is metabolized by CYP3A and cobimetinib AUC increased approximately 7 fold in the presence of a strong CYP3A inhibitor (itraconazole) in healthy subjects.
Slovenian: Kobimetinib se presnavlja s CYP3A in v prisotnosti močnega zaviralca CYP3A (itrakonazola) se je pri zdravih osebah AUC kobimetiniba povečala približno 7-krat.
English: Table 1 below gives general Cotellic dose modification guidance.
Slovenian: Preglednica 1 spodaj prikazuje splošne smernice za prilagoditev odmerka zdravila Cotellic.
English: Cobimetinib is a reversible, selective, allosteric, oral inhibitor that blocks the mitogen-activated protein kinase (MAPK) pathway by targeting the mitogen-activated extracellular signal-regulated kinase (MEK) 1 and MEK 2 which results in inhibition of phosphorylation of the extracellular signalregulated kinase (ERK) 1 and ERK 2.
Slovenian: Kobimetinib je reverzibilen, selektiven, alosteričen peroralni zaviralec, ki blokira pot mitogeno aktivirane proteinske kinaze (MAPK), in sicer z vplivom na mitogeno aktivirano, z zunajceličnim signalom regulirano kinazo (MEK) 1 in MEK 2.
English: Cotellic can cause eye problems (see also “Eye (vision) problems” in Section 4).
Slovenian: Zdravilo Cotellic lahko povzroči težave z očmi (glejte tudi "Težave z očmi (težave z vidom)" v poglavju 4).
English: Serum CPK and creatinine levels should be measured before initiation of treatment, to establish baseline values, and then monitored monthly during treatment, or as clinically indicated.
Slovenian: Serumske koncentracije CPK in kreatinina je treba za določitev izhodiščne vrednosti izmeriti pred začetkom zdravljenja in nato med zdravljenjem spremljati mesečno ali kot je klinično indicirano.
English: · Heart problems
Slovenian: • težave s srcem,
English: In patients who had progressed on BRAF inhibitor therapy, the median overall survival was 8.4 months (95% CI 6.7-11.1).
Slovenian: Med bolniki, ki jim je bolezen med predhodnim zdravljenjem z zaviralcem BRAF napredovala, je bila mediana celokupnega preživetja 8,4 mesece (95-% interval zaupanja: 6,7-11,1).
English: Each film-coated tablet contains 36 mg lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 36 mg laktoze monohidrata.
English: Studies in animals have shown embryolethality and foetal malformations of the great vessels and skull (see section 5.3).
Slovenian: Študije na živalih so pokazale smrtnost zarodkov in malformacije velikih žil in lobanje pri plodovih (glejte poglavje 5.3).
English: If serous retinopathy is diagnosed, Cotellic treatment should be withheld until visual symptoms improve to Grade ≤1.
Slovenian: Če je ugotovljena serozna retinopatija, je treba zdravljenje z zdravilom Cotellic prekiniti, dokler se simptomi vida ne izboljšajo na stopnjo ≤ 1.
English: Cotellic treatment should be interrupted.
Slovenian: Zdravljenje z zdravilom Cotellic je treba prekiniti.
English: Grade 4 events or cerebral haemorrhage: Cotellic treatment should be interrupted.
Slovenian: Neželeni dogodki stopnje 4 ali možganska krvavitev: zdravljenje z zdravilom Cotellic je treba prekiniti.
English: If symptoms of new or worsening visual disturbances are identified, an ophthalmologic examination is recommended.
Slovenian: V primeru simptomov novih motenj vida ali poslabšanju obstoječih je priporočljiv oftalmološki pregled.
English: Grade ≤2 (tolerable) rash should be managed with supportive care.
Slovenian: Izpuščaj stopnje ≤ 2 (znosen) je treba obvladovati s podpornim zdravljenjem.