FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U ispitivanju toksičnosti ponovljenih doza na juvenilnim štakorima, razine sistemske izloženosti kobimetinibu bile su 2 - 11 puta veće 10. dana nakon okota nego 38. dana nakon okota, kada su razine izloženosti bile slične onima u odraslih štakora.
English: If a dose is missed, it can be taken up to 12 hours prior to the next dose to maintain the once-daily regimen.
Croatian: Ako se doza propusti, može se uzeti do 12 sati prije vremena predviđenog za sljedeću dozu kako bi se održao raspored uzimanja jedanput na dan.
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.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, posavjetujte se sa svojim liječnikom prije uzimanja ovog lijeka.
English: Film coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Film ovojnica poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk (E553b)
English: The median duration of response was 6.8 months.
Croatian: Medijan trajanja odgovora iznosio je 6, 8 mjeseci.
English: Among the 63 BRAFi naïve patients, 20 patients had received prior systemic therapy for advanced melanoma with the majority (80%) being immunotherapy.
Croatian: BRAF inhibitorom, njih 20 je prethodno primalo sistemsku terapiju za uznapredovali melanom, koja je u većini slučajeva (80%) bila imunoterapija.
English: In vitro, cobimetinib is a potential inducer of CYP1A2 and may therefore reduce the exposure of substrates of this enzyme e.g., theophylline.
Croatian: Budući da je kobimetinib potencijalni induktor CYP1A2 in vitro, može smanjiti izloženost supstratima ovoga enzima, npr. teofilinu.
English: Avoid driving or using machines if you have problems with your vision or other problems that might affect your ability e.g. if you feel dizzy or tired.
Croatian: Izbjegavajte upravljanje vozilima ili rad sa strojevima ako imate tegoba s vidom ili nekih drugih tegoba koje bi Vam mogle umanjiti sposobnost, npr. ako osjećate omaglicu ili umor.
English: Continue to take Cotellic as normal, the next day.
Croatian: Nastavite uzimati Cotellic sutradan, prema uobičajenom rasporedu.
English: The fraction absorbed was ~88% indicating high absorption and first pass metabolism.
Croatian: Udio apsorbiranog lijeka iznosio je ~88%, što ukazuje na visoku stopu apsorpcije i metabolizma prvog prolaza.
English: · Start your next Cotellic 21 day treatment period after the 7 day break.
Croatian: · Započnite sljedeće 21-dnevno razdoblje liječenja lijekom Cotellic nakon 7-dnevne pauze.
English: Patients with severe hepatic impairment may have increased plasma concentrations of unbound cobimetinib compared to patients with normal hepatic function (see section 5.2).
Croatian: Bolesnici s teškim oštećenjem jetrene funkcije mogu imati povećane koncentracije nevezanog kobimetiniba u plazmi u usporedbi s bolesnicima s normalnom funkcijom jetre (vidjeti dio 5.2).
English: · If it is less than 12 hours before your next dose, skip the missed dose.
Croatian: · Ako je do sljedeće doze preostalo manje od 12 sati, preskočite propuštenu dozu.
English: Cobimetinib and its metabolites were characterised in a mass balance study in healthy subjects.
Croatian: Eliminacija Kobimetinib i njegovi metaboliti okarakterizirani su u ispitivanju masene bilance u zdravih ispitanika.
English: (or 40-49% and < 10% absolute decrease from baseline)
Croatian: (ili 40 - 49% i apsolutno smanjenje za < 10% u odnosu na početnu vrijednost)
English: The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Croatian: Rizik od krvarenja može biti povećan kod istodobne primjene antitrombocitnih lijekova ili antikoagulansa.
English: The mean elimination half-life following oral dosing of cobimetinib was 43.6 hours (range: 23.1 to 69.6 hours).
Croatian: Srednja vrijednost poluvijeka eliminacije nakon peroralne primjene kobimetiniba iznosila je 43,6 sati (raspon: 23,1 - 69,6 sati).
English: No dose modification of Cotellic is required when taken in combination with vemurafenib.
Croatian: Nije potrebno prilagođavati dozu lijeka Cotellic kada se uzima u kombinaciji s vemurafenibom.
English: Table 4 Liver function and other laboratory tests observed in the Phase III Study GO28141
Croatian: Tablica 4 Nalazi pretraga jetrene funkcije i drugih laboratorijskih pretraga u ispitivanju faze III GO28141
English: Unchanged medicinal product in faeces and urine accounted for 6.6% and 1.6% of the administered dose, respectively, indicating that cobimetinib is primarily metabolised with minimal renal elimination.
Croatian: Lijek u neizmijenjenu obliku izlučen fecesom i urinom činio je 6,6% odnosno 1,6% primijenjene doze, što ukazuje na to da se kobimetinib prvenstveno metabolizira, uz minimalnu eliminaciju putem bubrega.
English: How Cotellic works
Croatian: Kako Cotellic djeluje
English: The volume of distribution was 1050 L in healthy subjects given an intravenous dose of 2 mg.
Croatian: Volumen distribucije u zdravih ispitanika koji su primili intravensku dozu od 2 mg iznosio je 1050 l.
English: Tell your doctor straight away if you notice any of the side effects listed below or if these get worse during treatment.
Croatian: Odmah obavijestite svog liječnika ako tijekom liječenja primijetite bilo koju od nuspojava navedenih u nastavku ili ako se one pogoršaju.
English: Based on a population pharmacokinetic analysis, gender, race, ethnicity, baseline ECOG, mild and moderate renal impairment did not affect the pharmacokinetic of cobimetinib.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, spol, dob, rasa, etničko podrijetlo, početni ECOG status te blago i umjereno oštećenje bubrežne funkcije nisu utjecali na farmakokinetiku kobimetiniba.
English: Cobimetinib was extensively metabolised and eliminated in faeces.
Croatian: Kobimetinib se opsežno metabolizirao i eliminirao fecesom.
English: Please also refer to the Package Leaflet for vemurafenib, which is used in combination with Cotellic.
Croatian: Pročitajte i uputu o lijeku za vemurafenib, koji se koristi u kombinaciji s lijekom Cotellic.
English: This can be a sign of muscle damage (rhabdomyolysis) (see also “Muscle problems” in Section 4).
Croatian: To može biti znak oštećenja mišića (rabdomiolize) (pogledajte i odlomak 'Mišićne tegobe' u dijelu 4.).
English: The clinical relevance of these findings has not been investigated.
Croatian: Nije istražen klinički značaj tih nalaza.
English: Cobimetinib is 94.8% bound to human plasma proteins in vitro.
Croatian: Vezivanje kobimetiniba za proteine u ljudskoj plazmi in vitro iznosi 94,8%.
English: Tell your doctor straight away if you get diarrhoea.
Croatian: · Proljev Odmah obavijestite svog liječnika ako dobijete proljev.
English: Women of childbearing potential should use two effective methods of contraception, such as a condom or other barrier method (with spermicide, if available) during treatment and for at least 3 months after treatment has finished.
Croatian: Žene reproduktivne dobi moraju koristiti dvije učinkovite metode kontracepcije, poput prezervativa ili neke druge mehaničke metode (po mogućnosti sa spermicidom) tijekom liječenja i još najmanje tri mjeseca po njegovu završetku.
English: The objective response rate (ORR) in the Cotellic plus vemurafenib arm was 67.6% vs 44.8% in the placebo plus vemurafenib arm.
Croatian: Stopa objektivnog odgovora (ORR) u skupini liječenoj lijekom Cotellic plus vemurafenibom iznosila je 67,6%, u odnosu na 44,8% u skupini koja je primala placebo plus vemurafenib.
English: The recommended dose is 3 tablets (a total of 60 mg) once a day.
Croatian: Preporučena doza je 3 tablete (ukupno 60 mg) jedanput na dan.
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Croatian: Nuspojave prijavljene u bolesnika s melanomom navedene su prema MedDRA klasifikaciji organskih sustava, učestalosti i stupnju težine.
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).
Croatian: Učestalost nuspojava određena je na temelju analize sigurnosti primjene u bolesnika liječenih kobimetinibom plus vemurafenibom, uz medijan trajanja praćenja od 11,2 mjeseca (podaci prikupljeni do 19. rujna 2014.).
English: Given that cobimetinib concentrations are likely to be significantly reduced when co-administered with moderate to strong CYP3A inducers, patient's efficacy may be compromised.
Croatian: obzirom da će koncentracije kobimetiniba vjerojatno biti značajno smanjene pri istodobnoj primjeni s umjerenim do snažnim induktorima CYP3A, moguće je da će njegova djelotvornost kod bolesnika biti smanjena.
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.
Croatian: U tom je ispitivanju 129 bolesnika liječeno lijekom Cotellic i vemurafenibom: 63 bolesnika prethodno nisu primala terapiju BRAF inhibitorom, dok je 66 bolesnika doživjelo progresiju bolesti tijekom prethodne terapije vemurafenibom.
English: CYP3A and CYP2D6 substrates
Croatian: Supstrati CYP3A i CYP2D6
English: Tell your doctor straight away if you get the following symptoms: blurred vision, distorted vision, partly missing vision, or any other changes to your sight during treatment.
Croatian: Odmah obavijestite svog liječnika ako primijetite sljedeće simptome: zamagljen vid, iskrivljen vid, djelomičan gubitak vida ili bilo koju drugu promjenu vida koja nastupi tijekom liječenja.
English: Cobimetinib is the predominant moiety in plasma.
Croatian: Kobimetinib je predominantni oblik u plazmi.
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.
Croatian: Liječenje lijekom Cotellic i vemurafenibom mora se trajno obustaviti ako se odstupanja u laboratorijskim vrijednostima ne poboljšaju do ≤ 1. stupnja unutar 4 tjedna ili ako nakon početnog poboljšanja ponovno dođe do odstupanja 4. stupnja.
English: There is no evidence of any clinically significant drug-drug interaction between cobimetinib and vemurafenib in unresectable or metastatic melanoma patients and therefore no dose adjustments is recommended.
Croatian: Nema dokaza klinički značajne interakcije između kobimetiniba i vemurafeniba u bolesnika s neoperabilnim ili metastatskim melanomom i stoga se ne preporučuje prilagođavati dozu.
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.
Croatian: Sistemske ukupne izloženosti kobimetinibu nakon jedne doze bile su slične u ispitanika s blagim ili umjerenim oštećenjem jetrene funkcije u odnosu na zdrave ispitanike, dok su ispitanici s teškim oštećenjem jetrene funkcije imali niže ukupne izloženosti kobimetinibu (omjer geometrijskih srednjih vrijednosti AUC0-∞ u odnosu na zdrave ispitanike iznosila je 0,69), što se ne smatra klinički značajnim.
English: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: · na zahtjev Europske agencije za lijekove; · prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Croatian: Redoslijed liječenja nakon progresije tijekom terapije BRAF inhibitorom nije ustanovljen.
English: The most common adverse reactions (>20%) observed with a higher frequency in the placebo plus vemurafenib arm were arthralgia, alopecia, and hyperkeratosis.
Croatian: Najčešće nuspojave (> 20%) primijećene s većom učestalošću u skupini koja je primala placebo plus vemurafenib bile su artralgija, alopecija i hiperkeratoza.
English: Therefore, cobimetinib blocks the cell proliferation induced by the MAPK pathway through inhibition of the MEK1/2 signalling node.
Croatian: Dakle, kobimetinib blokira proliferaciju stanica koju inducira signalni put MAPK tako što inhibira signalni čvor MEK 1/2.
English: 1st occurrence: 40 mg nd occurrence: 20 mg rd occurrence: permanent discontinuation
Croatian: Prvi nastup: 40 mg Drugi nas tup: 20 mg
English: A human mass balance study was conducted in healthy subjects, and showed that cobimetinib was extensively metabolised and eliminated in faeces.
Croatian: Ispitivanje masene bilance provedeno u zdravih ispitanika pokazalo je da se kobimetinib opsežno metabolizira i eliminira fecesom.
English: Cardiovascular safety of cobimetinib in combination with vemurafenib has not been evaluated in vivo.
Croatian: Kardiovaskularna sigurnost kobimetiniba u kombinaciji s vemurafenibom nije se ispitivala in vivo.
English: If rhabdomyolysis or symptomatic CPK elevations do not improve within 4 weeks, Cotellic treatment should be permanently discontinued.
Croatian: Ako se rabdomioliza ili simptomatsko povišenje vrijednosti CPK-a ne poboljšaju unutar 4 tjedna, liječenje lijekom Cotellic treba trajno obustaviti.
English: No studies have been conducted to investigate the pharmacokinetics of cobimetinib in paediatric patients.
Croatian: Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika kobimetiniba u pedijatrijskih bolesnika.
English: Diarrhoea should be managed with anti-diarrhoeal agents and supportive care.
Croatian: Proljev treba zbrinuti antidijaroicima i potpornim liječenjem.
English: This is because Cotellic can affect the way some other medicines work.
Croatian: Naime, Cotellic može utjecati na način djelovanja nekih drugih lijekova.
English: Grade ≤3: After rhabdomyolysis has been ruled out, Cotellic dosing does not need to be modified.
Croatian: ≤ 3. stupnja: Nakon što se isključi rabdomioliza, nije potrebno prilagođavati dozu lijeka Cotellic.
English: Following oral dosing of 60 mg in cancer patients, cobimetinib showed a moderate rate of absorption with a median Tmax of 2.4 hours.
Croatian: Nakon peroralne primjene doze od 60 mg u bolesnika oboljelih od raka, kobimetinib je pokazao umjerenu brzinu apsorpcije, uz medijan Tmax od 2,4 sata.
English: Key Secondary Endpointsa, f,
Croatian: Ključne sekundarne mjere ishoda a,f
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).
Croatian: Medijan vremena do prvog nastupa povišenja vrijednosti CPK-a 3. ili 4. stupnja iznosio je 16. dana (raspon: 11 dana do 10 mjeseci); medijan vremena do potpunog povlačenja bio je
English: Your doctor will discuss with you the benefits and risks of taking Cotellic, if you are breast-feeding.
Croatian: Vama o koristima i rizicima uzimanja lijeka Cotellic.
English: Cobimetinib is a substrate of P-glycoprotein (P-gp).
Croatian: Kobimetinib je supstrat P-glikoproteina (P-gp).
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.
Croatian: Budući da se kobimetinib metabolizira putem CYP3A, njegov se AUC povećao približno 7 puta kod primjene snažnog inhibitora CYP3A (itrakonazola) u zdravih ispitanika.
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.
Croatian: Ako bolesnik povrati nakon primjene lijeka Cotellic, ne smije uzeti dodatnu dozu toga dana, već treba nastaviti liječenje sutradan, prema uobičajenom rasporedu.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Croatian: karmelozanatrij, umrežena (E468) magnezijev stearat (E470b)
English: The majority of events were Grades 1 or 2, with Grade ≥3 events occurring in 4% of patients in the Cotellic plus vemurafenib arm vs 0% in the placebo plus vemurafenib arm.
Croatian: Većina događaja bila je 1. ili 2. stupnja težine, dok su se događaji ≥ 3. stupnja javili u 4% bolesnika u skupini koja je primala Cotellic plus vemurafenib naspram 0% bolesnika u skupini koja je primala placebo plus vemurafenib.
English: Grade 3: Cotellic should be continued at the prescribed dose.
Croatian: 3. stupanj: Liječenje lijekom Cotellic treba nastaviti propisanom dozom.
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.
Croatian: Nema podataka o sigurnosti ni djelotvornosti lijeka Cotellic u kombinaciji s vemurafenibom u bolesnika s metastazama u središnjem živčanom sustavu niti u bolesnika sa zloćudnim melanomom koji ne zahvaća kožu.
English: Difference in ORR % (95% CI)
Croatian: Razlika u % ORR-a (95% CI)
English: Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase for all Grades and Grades 3-4.
Croatian: Tablica 4 prikazuje učestalost izmjerenih odstupanja u laboratorijskim vrijednostima jetrenih parametara i povišenih vrijednosti kreatin fosfokinaze za sve stupnjeve te za 3. - 4. stupanj.
English: In patients who had progressed on BRAF inhibitor therapy, the median overall survival was 8.4 months (95% CI 6.7-11.1).
Croatian: Medijan ukupnog preživljenja bolesnika koji su doživjeli progresiju bolesti za vrijeme terapije BRAF inhibitorom iznosio je 8,4 mjeseca (95% CI: 6,7 - 11,1).
English: Asymptomatic and < 10% absolute decrease from baseline
Croatian: Asimptomatsko stanje i apsolutno smanjenje za < 10% u odnosu na početnu vrijednost
English: · If you get side effects, your doctor may decide to lower your dose, stop treatment temporarily or permanently.
Croatian: · Ako se razviju nuspojave, Vaš će liječnik možda odlučiti smanjiti dozu, privremeno prekinuti primjenu lijeka ili trajno obustaviti liječenje.
English: There is no data on the effectiveness of Cotellic dose modification for haemorrhage events.
Croatian: Nema podataka o učinkovitosti prilagođavanja doze lijeka Cotelllic u slučaju događaja krvarenja.
English: Symptomatic
Croatian: Simptomatski
English: Cotellic can lower the amount of blood pumped by your heart (see also “Heart problems” in Section 4).
Croatian: Cotellic može smanjiti količinu krvi koju srce pumpa (pogledajte i odlomak 'Srčane tegobe' u dijelu 4.).
English: No clinical DDI studies have been conducted to assess this finding, and clinically relevant inhibition of intestinal BCRP cannot be ruled out.
Croatian: Nisu provedena klinička ispitivanja interakcija između lijekova kojima bi se ocijenio taj nalaz te se ne može isključiti klinički značajna inhibicija BCRP-a u crijevima.
English: If symptoms of new or worsening visual disturbances are identified, an ophthalmologic examination is recommended.
Croatian: Ako se utvrde simptomi novih ili pogoršanje postojećih poremećaja vida, preporučuje se oftalmološki pregled.
English: Rare ≥ 1/10,000 to < 1/1,000
Croatian: često ≥ 1/100 i < 1/10 manje često ≥ 1/1000 i < 1/100 rijetko ≥ 1/10 000 i < 1/1000 vrlo rijetko < 1/10 000
English: General dose modifications
Croatian: Općenite prilagodbe doze
English: Cotellic can cause severe bleeding, especially in your brain or stomach (see also “Severe bleeding” in Section 4).
Croatian: · Krvarenje Cotellic može uzrokovati teško krvarenje, osobito u mozgu ili trbuhu (pogledajte i odlomak 'Teško krvarenje' u dijelu 4.).
English: For strong CYP3A inhibitors used short-term (7 days or less), consider interrupting cobimetinib therapy during the duration of inhibitor use.
Croatian: Ako se inhibitori CYP3A primjenjuju kratkotrajno (7 dana ili manje), treba razmotriti privremeni prekid liječenja kobimetinibom tijekom primjene inhibitora.
English: The 1-year (75 %) and 2-year (48 %) OS estimates for the Cotellic plus vemurafenib arm were greater than those for placebo plus vemurafenib arm (64 % and 38 % respectively).
Croatian: Procijenjene stope 1-godišnjeg (75 %) i 2godišnjeg (48 %) ukupnog preživljenja za skupinu koja je primala Cotellic plus vemurafenib bile su veće nego za skupinu koja je primala placebo plus vemurafenib (64 % odnosno 38 %).
English: Grade 4 events or cerebral haemorrhage: Cotellic treatment should be interrupted.
Croatian: Događaji 4. stupnja ili cerebralno krvarenje: Liječenje lijekom Cotellic treba privremeno prekinuti.
English: The final OS analysis for Study GO28141 was conducted with a data-cut off date of 28 August 2015.
Croatian: Konačna analiza ukupnog preživljenja u ispitivanju GO28141 provedena je s podacima prikupljenima do 28. kolovoza 2015.
English: P-glycoprotein inhibitors
Croatian: Inhibitori P-glikoproteina
English: Symptomatic regardless of LVEF Permanent discontinuation
Croatian: Simptomatsko stanje neovisno o LVEF-u
English: The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
Croatian: Bolesnici koji se prethodno nisu liječili BRAF inhibitorom (n = 63) ostvarili su stopu objektivnog odgovora od 87%, a 16% njih ostvarilo je potpun odgovor.
English: Cotellic has minor influence on the ability to drive or use machines.
Croatian: Cotellic malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The recommended dose of Cotellic is 60 mg (3 tablets of 20 mg) once daily.
Croatian: Preporučena doza lijeka Cotellic je 60 mg (3 tablete od 20 mg) jedanput na dan.
English: The mean accumulation ratio at steady state was approximately 2.4-fold.
Croatian: Srednja vrijednost omjera kumulacije u stanju dinamičke ravnoteže iznosila je približno 2,4 puta.
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.
Croatian: Sigurnost lijeka Cotellic u kombinaciji s vemurafenibom ocjenjivala se i u 129 bolesnika s uznapredovalim melanomom s mutacijom BRAF V600 u ispitivanju NO25395.
English: What Cotellic contains · The active substance is cobimetinib.
Croatian: Što Cotellic sadrži · Djelatna tvar je kobimetinib.
English: Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Croatian: Cotellic je indiciran za primjenu u kombinaciji s vemurafenibom za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s mutacijom BRAF V600 (vidjeti dijelove 4.4 i 5.1).
English: Rhabdomyolysis has been reported in the post-marketing setting.
Croatian: Prijavljena je rabdomioliza u razdoblju nakon stavljanja lijeka u promet.
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.
Croatian: Kliničko ispitivanje interakcija između lijekova u bolesnika oboljelih od raka pokazalo je da prisutnost kobimetiniba ne mijenja plazmatske koncentracije midazolama (osjetljiva supstrata CYP3A) ni dekstrometorfana (osjetljiva supstrata CYP2D6).