FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, cobimetinib is a potential inducer of CYP1A2 and may therefore reduce the exposure of substrates of this enzyme e.g., theophylline.
Slovenian: In vitro je kobimetinib potencialen induktor CYP1A2 in lahko zato zmanjša izpostavljenost substratom tega encima, npr. teofilinu.
English: Cobimetinib is 94.8% bound to human plasma proteins in vitro.
Slovenian: Kobimetinib je in vitro 94,8-% vezan na beljakovine v človeški plazmi.
English: Grade 1 or Grade 2 (tolerable)
Slovenian: Stopnja 1 ali 2 (znosni)
English: When Cotellic is used in combination with vemurafenib (which targets the changed “BRAF” protein), it further slows down or stops the growth of your cancer.
Slovenian: Če je zdravilo Cotellic uporabljeno v kombinaciji z vemurafenibom (ki je usmerjen na spremenjeno beljakovino "BRAF"), dodatno upočasni ali ustavi rast raka.
English: Diarrhoea (very common: may affect more than 1 in 10 people) Tell your doctor straight away if you get diarrhoea and follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Slovenian: Driska (zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov) Zdravnika morate takoj obvestiti, če se vam pojavi driska, in upoštevati morate zdravnikova navodila, kako ukrepati, da boste pomagali preprečiti ali zdraviti drisko.
English: · Cotellic can be taken with or without food.
Slovenian: • Zdravilo Cotellic lahko vzamete s hrano ali brez nje.
English: g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Slovenian: Presečni datum zbiranja podatkov za končno analizo celokupnega preživetja je bil 28. avgust 2015; mediana spremljanja je bila 18,5 meseca.
English: Changes in reported laboratory data
Slovenian: Spremembe v zabeleženih rezultatih laboratorijskih preiskav
English: *** Please refer to the paragraph Rhabdomyolysis in the “Description of selected adverse reactions” section.
Slovenian: *** Glejte odstavek Rabdomioliza v poglavju "Opis izbranih neželenih učinkov".
English: Since food does not alter the pharmacokinetics of cobimetinib, it can be administered with or without food.
Slovenian: Ker hrana ne vpliva na farmakokinetiko kobimetiniba, ga je mogoče jemati s hrano ali brez nje.
English: Among the 63 BRAFi naïve patients, 20 patients had received prior systemic therapy for advanced melanoma with the majority (80%) being immunotherapy.
Slovenian: Od 63 bolnikov, ki predhodno še niso dobivali BRAFi, je bilo 20 bolnikov predhodno sistemsko zdravljenih zaradi napredovalega melanoma, večina (80 %) z imunoterapijo.
English: Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase for all Grades and Grades 3-4.
Slovenian: Preglednica 4 prikazuje pogostnost izmerjenih jetrnih laboratorijskih odstopanj in zvišanje kreatin-fosfokinaze za vse stopnje in za stopnjo 3-4.
English: The median time to first occurrence of Grade 3 or 4 CPK elevations was 16 days (range: 11 days to 10 months); the median time to complete resolution was 16 days (range: 2 days to 15 months).
Slovenian: Mediana časa do prvega pojava zvišanja CPK stopnje 3 ali 4 je bila 16 dni (razpon: od 11 dni do 10 mesecev); mediana časa do dokončnega izboljšanja je bila 16 dni (razpon: od 2 dni do 15 mesecev).
English: This is because Cotellic can affect the way some other medicines work.
Slovenian: Zdravilo Cotellic namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John's Wort) should be avoided.
Slovenian: Zato se je treba izogibati sočasni uporabi z zmernimi in močnimi induktorji CYP3A (npr. s karbamazepinom, rifampicinom, fenitoinom ali šentjanževko).
English: Also, some other medicines can affect the way Cotellic works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila Cotellic.
English: The fraction absorbed was ~88% indicating high absorption and first pass metabolism.
Slovenian: Absorbirani delež je bil ~ 88 %: to kaže veliko absorpcijo in presnovo prvega prehoda.
English: There are no data from the use of Cotellic in pregnant women.
Slovenian: O uporabi zdravila Cotellic pri nosečnicah ni podatkov.
English: Additionally, for:
Slovenian: Dodatno:
English: In Study GO28141, there were 89 patients (18.1%) aged 65-74, 38 patients (7.7%) aged 75-84 and 5 patients (1.0%) aged 85 years and older.
Slovenian: V študiji GO28141 je bilo 89 bolnikov (18,1 %) starih od 65 do 74 let, 38 bolnikov (7,7 %) od 75 do 84 let in 5 bolnikov (1,0 %) starih 85 let ali več.
English: If serum CPK is elevated, check for signs and symptoms of rhabdomyolysis or other causes.
Slovenian: Če je serumska CPK zvišana, preverite pisotnost znakov in simptomov rabdomiolize ali drugih vzrokov.
English: There are minimal data for Cotellic in patients with severe renal impairment, therefore an effect cannot be excluded.
Slovenian: Podatkov o zdravilu Cotellic za bolnike s hudo okvaro ledvic je zelo malo, zato vpliva ni mogoče izključiti.
English: Therefore other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Slovenian: Zato je treba razmisliti o drugih možnostih zdravljenja pred uvedbo kombinacije pri tej populaciji bolnikov, ki so se predhodno zdravili z zaviralcem BRAF.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da ste noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: The tablets should be swallowed whole with water.
Slovenian: Tablete je treba zaužiti cele, z vodo.
English: · If you become pregnant during treatment with Cotellic or in the 3 months after your last dose, tell your doctor straight away.
Slovenian: • Če med zdravljenjem z zdravilom Cotellic ali v 3 mesecih po zadnjem odmerku tega zdravila zanosite, morate o tem takoj obvestiti zdravnika.
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Slovenian: Bolnike je treba na vsakem pregledu oceniti glede simptomov novih motenj vida ali poslabšanja obstoječih motenj vida.
English: The clinical relevance of these findings has not been investigated.
Slovenian: Klinični pomen teh izsledkov ni raziskan.
English: · Cotellic is not recommended during pregnancy - although the effects of Cotellic have not been studied in pregnant women, it may cause permanent harm or birth defects to an unborn baby.
Slovenian: • Zdravilo Cotellic ni priporočljivo med nosečnostjo: učinki zdravila Cotellic pri nosečnicah sicer niso raziskani, vendar je mogoče, da zdravilo povzroči trajno okvaro ali prirojene hibe pri še nerojenem otroku.
English: Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.
Slovenian: Zdravilo Cotellic je usmerjeno na beljakovino, imenovano "MEK", ki je pomembna za nadzor rasti rakavih celic.
English: Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break).
Slovenian: Vsak odmerek obsega tri 20-mg tablete (60 mg) in ga je treba vzeti enkrat na dan 21 dni zapored (obdobje zdravljenja od 1. do 21. dne), temu sledi 7-dnevni premor (premor zdravljenja od 22. do 28. dne).
English: Using Clopper-Pearson method d Using Hauck-Anderson method e
Slovenian: Z uporabo Hauck-Andersonove metode.
English: The tablets contain lactose (a type of sugar).
Slovenian: Tablete vsebujejo laktozo (vrsto sladkorja).
English: Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Cotellic v kombinaciji z vemurafenibom sme uvesti in nadzorovati le usposobljen zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: All patients restarting treatment with a dose reduction of Cotellic should have LVEF measurements taken after approximately 2 weeks, 4 weeks, 10 weeks and 16 weeks, and then as clinically indicated.
Slovenian: Vsem bolnikom, ki znova začnejo zdravljenje z zmanjšanim odmerkom zdravila Cotellic, je treba LVEF izmeriti po približno 2, 4, 10 in 16 tednih, potem pa kot je klinično indicirano.
English: Grade 2 (intolerable) or Grade 3/4 1st Appearance
Slovenian: Stopnja 2 (neznosni) ali stopnja 3/4
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XE38
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XE38
English: Among patients who had progressed on vemurafenib (n=66), the objective response rate was 15%.
Slovenian: Med bolniki, ki jim je bolezen med uporabo vemurafeniba napredovala (n = 66), je bil delež objektivnega odziva 15 %.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: No preferential binding to human red blood cells was observed (blood to plasma ratio 0.93).
Slovenian: Prednostne vezave na človeške eritrocite niso opazili (razmerje med krvjo in plazmo 0,93).
English: The median follow up was 14.2 months.
Slovenian: Mediana spremljanja je bila 14,2 meseca.
English: Other medicines and Cotellic
Slovenian: Druga zdravila in zdravilo Cotellic
English: During this 7 day break in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
Slovenian: Med tem 7-dnevnim premorom v jemanju zdravila Cotellic morate še naprej jemati vemurafenib, kot vam je naročil zdravnik.
English: Your doctor should do tests before and during your treatment with Cotellic to check how well your heart can pump blood.
Slovenian: Zdravnik mora pred zdravljenjem z zdravilom Cotellic in med zdravljenjem opraviti preiskave, s katerimi preveri, kako dobro vaše srce črpa kri.
English: It is important to keep taking Cotellic for as long as your doctor prescribes it.
Slovenian: Pomembno je, da zdravilo Cotellic jemljete toliko časa, kot vam je predpisal zdravnik.
English: Each subsequent Cotellic treatment cycle should start after the 7-day treatment break has elapsed.
Slovenian: Vsak nadaljnji cikel zdravljenja z zdravilom Cotellic se mora začeti po preteku 7-dnevnega premora.
English: In animals, no fertility studies have been performed, but adverse effects were seen on reproductive organs (see section 5.3).
Slovenian: Pri živalih niso izvedli študij plodnosti, opažali pa so neželene učinke na reproduktivne organe (glejte poglavje 5.3).
English: Grade 3: Cotellic should be continued at the prescribed dose.
Slovenian: Stopnja 3: Zdravilo Cotellic je treba nadaljevati v predpisanem odmerku.
English: · This medicine does not require any special storage conditions.
Slovenian: • Za shranjevanje zdravila niso potrebna posebna navodila.
English: The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Slovenian: Tveganje za krvavitve se lahko poveča pri sočasni uporabi antitrombotične ali antikoagulantne terapije.
English: Cotellic treatment and vemurafenib treatment should be discontinued if liver laboratory abnormalities do not resolve to Grade ≤1 within 4 weeks or if Grade 4 liver laboratory abnormalities recur after initial improvement.
Slovenian: Zdravljenje z zdravilom Cotellic in zdravljenje z vemurafenibom je treba prenehati, če se jetrna laboratorijska odstopanja v 4 tednih ne zmanjšajo na stopnjo ≤ 1, ali če se jetrna laboratorijska odstopanja stopnje 4 po začetnem izboljšanju ponovijo.
English: A population pharmacokinetic analysis using data from 151 patients with mild renal impairment (creatinine clearance (CRCL) 60 to less than 90 mL/min), 48 patients with moderate renal impairment (CRCL 30 to less than 60 mL/min), and 286 patients with normal renal function (CRCL greater than or equal to 90 mL/min), showed that CRCL had no meaningful influence on exposure of cobimetinib.
Slovenian: Populacijska farmakokinetična analiza s podatki 151 bolnikov z blago okvaro ledvic (očistek kreatinina od 60 do manj kot 90 ml/min), 48 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do manj kot 60 ml/min) in 286 bolnikov z normalnim delovanjem ledvic (očistek kreatinina večji ali enak 90 ml/min) je pokazala, da očistek kreatinina ne vpliva pomembno na izpostavljenost kobimetinibu.
English: Cobimetinib and its metabolites were characterised in a mass balance study in healthy subjects.
Slovenian: Kobimetinib in njegove presnovke so opredelili v študiji masnega ravnovesja pri zdravih osebah.
English: If you stop taking Cotellic
Slovenian: Če ste prenehali jemati zdravilo Cotellic
English: Most events resolved with no change in Cotellic dose.
Slovenian: Večina dogodkov se je izboljšala brez spremembe odmerka zdravila Cotellic.
English: Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should consult with their physician and discuss whether the benefits outweigh the risks on an individual basis.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko pomanjkanja laktaze ali malabsorpcijo glukoze/galaktoze se morajo posvetovati z zdravnikom in se z njim pogovoriti, ali zanje koristi zdravljenja odtehtajo tveganje.
English: Scores for all functioning domains and most symptoms (appetite loss, constipation, nausea and vomiting, dyspnoea, pain, fatigue) showed that the mean change from baseline was similar between the two treatment arms and did not demonstrate a clinically meaningful change (all scores were ≤ 10 point change from baseline).
Slovenian: Rezultati za vsa funkcijska področja in večino simptomov (izgubo apetita, zaprtost, navzeo in bruhanje, dispnejo, bolečine, utrujenost) so pokazali, da je bila povprečna sprememba od izhodišča med zdravljenima skupinama podobna in se ni klinično pomembno spremenila (vsi rezultati so se od izhodiščne vrednosti razlikovali za ≤ 10 točk).
English: N/A
Slovenian: N/P
English: Film coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Slovenian: Titanov dioksid (E171) Makrogol 3350
English: · Do not take a double dose to make up for a missed dose.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: If concomitant use with a strong or moderate CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety and dose modifications applied if clinically indicated (see Table 1 in section 4.2).
Slovenian: Če se sočasni uporabi močnega ali zmernega zaviralca CYP3A ni mogoče izogniti, je treba bolnike skrbno nadzirati glede varnosti in odmerek prilagoditi, če je to klinično indicirano (glejte preglednico 1 v poglavju 4.2).
English: The dose of vemurafenib may be reduced as clinically appropriate.
Slovenian: Odmerek vemurafeniba je mogoče zmanjšati, kot je klinično primerno.
English: Cotellic can cause severe bleeding, especially in your brain or stomach (see also “Severe bleeding” in Section 4).
Slovenian: Zdravilo Cotellic lahko povzroči hudo krvavitev, zlasti v možganih ali trebuhu (glejte tudi "Huda krvavitev" v poglavju 4).
English: Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain.
Slovenian: Zdravilo Cotellic lahko povzroči zvečane koncentracije kreatin-fosfokinaze, encima, ki se nahaja predvsem v mišicah, srcu in možganih.
English: In case of vomiting after administration of Cotellic, the patient should not take an additional dose on that day and treatment should be continued as prescribed the following day.
Slovenian: Če bolnik po uporabi zdravila Cotellic bruha, tisti dan ne sme vzeti dodatnega odmerka, temveč mora zdravljenje nadaljevati naslednji dan, kot je predpisano.
English: Please also refer to the Package Leaflet for vemurafenib, which is used in combination with Cotellic.
Slovenian: Glejte tudi navodilo za uporabo vemurafeniba, ki se uporablja v kombinaciji z zdravilom Cotellic.
English: Median time to initial onset of events was 4 months (1-13 months).
Slovenian: Mediana časa do začetnega pojava je bila 4 mesece (od 1 do 13 mesecev).
English: White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side.
Slovenian: Bele, okrogle, filmsko obložene tablete s premerom približno 6,6 mm in vtisnjeno oznako "COB" na eni strani.
English: Objective response rate (ORR) (95% CI) for ORR
Slovenian: Delež objektivnega odziva (ORR) 95-% interval zaupanja za ORR
English: Consider permanent discontinuation *The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Slovenian: *Izrazitost kliničnih neželenih dogodkov je ocenjena po CTC-AE (Common Terminology Criteria for Adverse Events) v 4.0
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported according to NCICTCAE v 4.0 (common toxicity criteria) for assessment of toxicity in Study GO28141.
Slovenian: Znotraj posamezne skupine pogostnosti so neželeni učinki navedeni po padajoči izrazitosti in navedeni v skladu z NCI-CTCAE v 4.0 (skupna merila toksičnosti) za oceno toksičnosti v študiji GO28141.
English: In a repeat dose toxicity study in juvenile rats, cobimetinib systemic exposures were 2 to11 fold higher on post natal day 10 than on post natal day 38 when exposures were similar to those in adult rats.
Slovenian: V študiji toksičnosti ponavljajočih odmerkov pri mladih podganah je bila sistemska izpostavljenost kobimetinibu 10. dan po skotitvi od 2- do 11-krat večja kot 38. dan po skotitvi, ko je bila podobna kot pri odraslih podganah.
English: In the Phase III study with Cotellic in combination with vemurafenib in patients with unresectable or metastatic melanoma (n=247), 183 patients (74%) were <65 years of age, and 44 patients (18%) were 65-74 years of age, 16 (6%) were 75-84 years of age, and 4 patients (2%) were aged ³85 years.
Slovenian: V študiji faze III z zdravilom Cotellic v kombinaciji z vemurafenibom je bilo med bolniki z neoperabilnim ali metastatskim melanomom (n = 247) 183 bolnikov (74 %), mlajših od 65 let, 44 (18 %) je bilo starih od 65 do 74 let, 16 (6 %) od 75 do 84 let in 4 bolniki (2 %) so bili stari 85 let ali več.
English: The transport across the blood brain barrier is unknown.
Slovenian: Prenos preko krvno-možganske pregrade ni znan.
English: The absolute bioavailability of cobimetinib was 45.9% (90% CI: 39.7%, 53.1%) in healthy subjects.
Slovenian: Absolutna biološka uporabnost kobimetiniba je bila pri zdravih osebah 45,9 % (90-% interval zaupanja: 39,7 %, 53,1 %).
English: Blood creatine phosphokinase increase
Slovenian: Zvišanje kreatin-fosfokinaze v krvi
English: The dose of Cotellic and/or vemurafenib may be either temporarily interrupted and/or reduced as clinically indicated.
Slovenian: Odmerek zdravila Cotellic in/ali vemurafeniba je mogoče začasno prekiniti in/ali zmanjšati, kot je klinično primerno.
English: Very rare < 1/10,000
Slovenian: Zelo redki < 1/10.000
English: Treatment should be taken for 21 consecutive days followed by a 7-day break
Slovenian: Zdravilo je treba jemati 21 dni zapored, temu pa mora slediti 7-dnevni premor
English: Other anti-cancer agents
Slovenian: Druga zdravila proti raku
English: Standard genotoxicity studies with cobimetinib were negative.
Slovenian: Običajne študije genotoksičnosti s kobimetinibom so bile negativne.
English: In vitro studies show that cobimetinib is not a substrate of the liver uptake transporters OATP1B1, OATP1B3 and OCT1, however, it weakly inhibits these transporters.
Slovenian: Študije in vitro kažejo, da kobimetinib ni substrat jetrnih privzemnih prenašalcev OATP1B1, OATP1B3 in OCT1, vendar pa jih rahlo zavira.
English: The mean steady-state Cmax and AUC0-24 were 273 ng/mL and 4340 ng.h/mL respectively.
Slovenian: Povprečna Cmax v stanju dinamičnega ravnovesja je bila 273 ng/ml in povprečna AUC0-24 4340 ng.h/ml.
English: If you are sick
Slovenian: Če bruhate
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Slovenian: Neželeni učinki, zabeleženi pri bolnikih z melanomom, so prikazani spodaj po organskih sistemih MedDRA, pogostnosti in stopnji izrazitosti.
English: Eye (vision) problems (very common: may affect more than 1 in 10 people) Cotellic can cause eye problems.
Slovenian: Težave z očmi (težave z vidom) (zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov) Zdravilo Cotellic lahko povzroči težave z očmi.
English: The mean elimination half-life following oral dosing of cobimetinib was 43.6 hours (range: 23.1 to 69.6 hours).
Slovenian: Povprečni eliminacijski razpolovni čas po peroralni uporabi kobimetiniba je bil 43,6 ure (razpon: od 23,1 do 69,6 ure).
English: The median PFS for patients who had progressed on vemurafenib was 2.8 months, with median follow-up time of 8.1 months.
Slovenian: Mediana PFS pri bolnikih, ki jim je bolezen med uporabo vemurafeniba napredovala, je bila 2,8 meseca; mediana spremljanja je bila 8,1 meseca.
English: CYP3A and CYP2D6 substrates
Slovenian: Substrati CYP3A in CYP2D6
English: Cobimetinib is a substrate of P-gp in vitro.
Slovenian: Kobimetinib je substrat P-gp in vitro.
English: Cotellic has minor influence on the ability to drive or use machines.
Slovenian: Zdravilo Cotellic ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Treatment can be restarted with no change in Cotellic dose.
Slovenian: Zdravljenje je mogoče znova začeti brez spremembe odmerka zdravila Cotellic.
English: N/A = Not Applicable
Slovenian: N/P = ne pride v poštev
English: Severe bleeding (common: may affect up to 1 in 10 people) Cotellic can cause severe bleeding, especially in your brain or stomach.
Slovenian: Huda krvavitev (pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov) Zdravilo Cotellic lahko povzroči hudo krvavitev, zlasti v možganih ali trebuhu.
English: Figure 1 Kaplan-Meier curves of final overall survival - Intent to treat population (cut-off date: 28 August 2015)
Slovenian: Kaplan-Meierjevi krivulji končnega celokupnega preživetja - populacija z-namenom-zdravljenja (presečni datum 28. avgust 2015)
English: No oxidative metabolites greater than 10% of total circulating radioactivity or human specific metabolites were observed in plasma.
Slovenian: V plazmi niso opazili oksidativnih presnovkov, ki bi presegali 10 % celotne radioaktivnosti v obtoku; prav tako niso opazili za človeka specifičnih presnovkov.
English: The final OS analysis for Study GO28141 was conducted with a data-cut off date of 28 August 2015.
Slovenian: Končna analiza celokupnega preživetja za študijo GO28141 je bila izvedena s podatki s presečnim datumom 28. avgust 2015.
English: · If it is less than 12 hours before your next dose, skip the missed dose.
Slovenian: • Če je do naslednjega odmerka manj kot 12 ur, pozabljeni odmerek izpustite.
English: No dose modification of Cotellic is required when taken in combination with vemurafenib.
Slovenian: Sprememba odmerkov zdravila Cotellic ni potrebna, kadar se ta uporablja v kombinaciji z vemurafenibom.
English: Your doctor will do blood tests to monitor for this.
Slovenian: Za spremljanje tega bo zdravnik opravil preiskave krvi.
English: In vitro data indicate cobimetinib is not an inhibitor of OAT1, OAT3 or OCT2.
Slovenian: In vitro podatki nakazujejo, da kobimetinib ni zaviralec OAT1, OAT3 ali OCT2.
English: The median duration of response was 14.3 months.
Slovenian: Mediana trajanja odziva je bila 14,3 meseca.
English: The most common adverse reactions (>20%) observed with a higher frequency in the placebo plus vemurafenib arm were arthralgia, alopecia, and hyperkeratosis.
Slovenian: Najbolj pogosti neželeni učinki (> 20 %), opaženi z večjo pogostnostjo v skupini, ki je prejemala placebo in vemurafenib, so bili artralgija, alopecija in hiperkeratoza.