FrancophonIA/ELRC3.0 huggingface dataset:
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]).
Croatian: In vitro je kobimetinib uzrokovao umjerenu inhibiciju hERG ionskih kanala (IC50 = 0,5 µM [266 ng/ml]), pri koncentraciji koja je približno 18 puta veća od vršnih plazmatskih koncentracija (Cmax) postignutih nakon primjene doze od 60 mg, koja će se nalaziti na tržištu (Cmax nevezanog lijeka = 14 ng/ml [0,03 µM]).
English: When administered to pregnant rats, cobimetinib caused embryolethality and foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.
Croatian: Kada se primjenjivao skotnim ženkama štakora, kobimetinib je uzrokovao embrioletalnost te malformacije velikih krvnih žila i lubanje ploda pri sistemskim izloženostima sličnima onima koje se postižu u ljudi kod primjene preporučene doze.
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.
Croatian: Istodobna primjena kobimetiniba sa snažnim induktorima CYP3A nije se ocjenjivala u kliničkom ispitivanju, ali vjerojatno bi dovela do smanjene izloženosti kobimetinibu.
English: · The other ingredients are: · lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate in the tablet core; and · polyvinyl alcohol, titanium dioxide, macrogol and talc in the film-coating.
Croatian: · laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij i magnezijev stearat u jezgri tablete; te · poli(vinilni) alkohol, titanijev dioksid, makrogol i talk u film ovojnici
English: ▼This medicine is subject to additional monitoring.
Croatian: ▼Ovaj je lijek pod dodatnim praćenjem.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Cotellic.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Cotellic.
English: How to take Cotellic
Croatian: Kako uzimati Cotellic
English: Based on preclinical data and the human mass balance study, cobimetinib is mainly metabolised, with minimal renal elimination.
Croatian: Prema pretkliničkim podacima i ispitivanju masene bilance u ljudi, kobimetinib se prvenstveno metabolizira, uz minimalnu eliminaciju kroz bubrege.
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.
Croatian: (Child-Pugh stadij A), 6 ispitanika s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B), 6 ispitanika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) i 10 zdravih ispitanika.
English: Fatigue was observed at similar frequencies in both arms.
Croatian: Umor je u obje skupine primijećen sa sličnom učestalošću.
English: The dose of Cotellic and/or vemurafenib may be either temporarily interrupted and/or reduced as clinically indicated.
Croatian: Cotellic i/ili vemurafeniba može se privremeno prekinuti i/ili se njihova doza može smanjiti, sukladno kliničkoj indikaciji.
English: For patients reporting new or worsening visual disturbances, an ophthalmologic examination is recommended.
Croatian: U bolesnika koji prijave razvoj nove ili pogoršanje postojećih poremećaja vida preporučuje se oftalmološki pregled.
English: Purpose of the medicine itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole for some fungal and bacterial infections ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir for HIV infection telaprevir for hepatitis C
Croatian: Namjena lijeka itrakonazol, klaritromicin, eritromicin, telitromicin, vorikonazol, rifampicin, posakonazol, flukonazol, mikonazol liječenje nekih gljivičnih i bakterijskih infekcija ritonavir, kobicistat, lopinavir, delavirdin, amprenavir, fosamprenavir liječenje HIV infekcije telaprevir liječenje hepatitisa C
English: Baseline age and baseline body weight were identified as statistically significant covariates on cobimetinib clearance and volume of distribution respectively.
Croatian: Početna dob i početna tjelesna težina identificirani su kao statistički značajne kovarijante koje utječu na klirens odnosno volumen distribucije kobimetiniba.
English: Interrupt treatment until Grade ≤ 1, restart treatment at 20 mg once daily (1 tablet)
Croatian: Privremeno prekinuti liječenje dok se ne postigne ≤ 1. stupanj, a zatim ponovno započeti liječenje dozom od 20 mg jedanput na dan (1 tableta)
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.
Croatian: Vrijednosti CPK-a i kreatinina u serumu treba izmjeriti prije započinjanja liječenja, kako bi se utvrdile početne vrijednosti, a zatim pratiti jednom mjesečno tijekom liječenja ili sukladno kliničkoj indikaciji.
English: Other anti-cancer agents
Croatian: Ostali lijekovi za liječenje raka
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.
Croatian: Medijan procijenjene vrijednosti PFS-a prema ocjeni ispitivača iznosio je 9,9 mjeseci za skupinu koja je primala Cotellic plus vemurafenib, u odnosu na 6,2 mjeseca za skupinu koja je primala placebo plus vemurafenib.
English: Signs or symptoms of rhabdomyolysis warrant an appropriate clinical evaluation and treatment as indicated, along with Cotellic dose modification or discontinuation according to the severity of the adverse reaction (see section 4.2 and 4.4).
Croatian: Znakovi ili simptomi rabdomiolize nalažu odgovarajuću kliničku procjenu i liječenje sukladno indikaciji, uz prilagodbu doze lijeka Cotellic ili obustavu liječenja sukladno težini nuspojave (vidjeti dijelove 4.2 i 4.4).
English: (or ≥ 10% absolute decrease from baseline)
Croatian: (ili apsolutno smanjenje za ≥ 10% u odnosu na početnu vrijednost)
English: Effects of cobimetinib on drug transport systems
Croatian: Učinci kobimetiniba na sustave prijenosa lijekova
English: Maintain Cotellic at a dose of 60 mg once daily (3 tablets)
Croatian: Održavati dozu lijeka Cotellic od 60 mg jedanput na dan (3 tablete).
English: The mean apparent CL following oral dosing of 60 mg in cancer patients was 13.8 L/hr.
Croatian: Srednja vrijednost prividnog klirensa nakon peroralne primjene doze od 60 mg u bolesnika oboljelih od raka iznosila je 13,8 l/h.
English: Secondary efficacy endpoints included overall survival (OS), objective response rate, duration of response (DoR) as assessed by INV and PFS as assessed by an independent review facility (IRF).
Croatian: (engl. overall survival, OS), stopu objektivnog odgovora (engl. objective response rate, ORR), trajanje odgovora prema ocjeni ispitivača i PFS prema ocjeni neovisnog ocjenjivačkog tijela.
English: Studies in animals have shown embryolethality and foetal malformations of the great vessels and skull (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na embrioletalnost te malformacije velikih krvnih žila i lubanje ploda (vidjeti dio 5.3).
English: Grade 2 (intolerable) or Grade ≥3 acneiform rash: General dose modification recommendations in Table 1 for Cotellic should be followed.
Croatian: Akneiformni osip 2. stupnja (nepodnošljiv) ili ≥ 3. stupnja: Treba se pridržavati općenitih preporuka za prilagođavanje doze lijeka Cotellic navedenih u Tablici 1.
English: Following intravenous administration of a 2 mg dose of cobimetinib, the mean plasma clearance (CL) was 10.7 L/hr.
Croatian: Nakon intravenske primjene doze kobimetiniba od 2 mg, srednja vrijednost plazmatskog klirensa iznosila je 10,7 l/h.
English: Cotellic in combination with vemurafenib in patients with brain metastases The safety and efficacy of the combination of Cotellic and vemurafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Croatian: Cotellic u kombinaciji s vemurafenibom u bolesnika s moždanim metastazama Sigurnost i djelotvornost kombinacije lijeka Cotellic i vemurafeniba nisu se ocjenjivale u bolesnika s melanomom pozitivnim na mutaciju BRAF V600 koji je metastazirao u mozak.
English: Dose limiting toxicities included skin ulcerations, surface exudates, and acanthosis in the rat and chronic active inflammation and degeneration of the oesophagus associated with varying degrees of gastroenteropathy in dogs.
Croatian: Toksičnosti koje su ograničavale dozu uključivale su kožne ulceracije, površinske eksudate i akantozu u štakora te kroničnu aktivnu upalu i degeneraciju jednjaka povezanu s različitim stupnjevima gastroenteropatije u pasa.
English: Asymptomatic CPK elevations
Croatian: Asimptomatsko povišenje vrijednosti CPK-a:
English: In the preclinical models, the combination of cobimetinib and vemurafenib showed that by simultaneously targeting mutated BRAF V600 proteins and MEK proteins in melanoma cells, the combination of the two products inhibits MAPK pathway reactivation through MEK1/2, resulting in a stronger inhibition of intracellular signalling and decreased tumour cell proliferation
Croatian: Pretklinički su modeli pokazali da simultano ciljano djelovanje kombinacije kobimetiniba i vemurafeniba na proteine s mutacijom BRAF V600 i MEK proteine u stanicama melanoma inhibira reaktivaciju signalnog puta MAPK putem MEK 1/2, što dovodi do snažnije inhibicije unutarstanične signalizacije i smanjene proliferacije tumorskih stanica.
English: Before starting this treatment, patients must have BRAF V600 mutation-positive melanoma tumour status confirmed by a validated test (see sections 4.4 and 5.1).
Croatian: Prije početka ovoga liječenja, u bolesnika se validiranim testom mora potvrditi da je melanomski tumor pozitivan na mutaciju BRAF V600 (vidjeti dijelove 4.4 i 5.1).
English: There is no specific antidote for overdosage with cobimetinib.
Croatian: Nema specifičnog protulijeka za predoziranje kobimetinibom.
English: Grade ≤2 (tolerable) photosensitivity should be managed with supportive care.
Croatian: Fotoosjetljivost ≤ 2. stupnja (podnošljivu) treba zbrinuti potpornom njegom.
English: If serous retinopathy is diagnosed, Cotellic treatment should be withheld until visual symptoms improve to Grade ≤1.
Croatian: Ako se dijagnosticira serozna retinopatija, liječenje lijekom Cotellic treba odgoditi dok se vidni simptomi ne poboljšaju do ≤ 1. stupnja.
English: What Cotellic is used for
Croatian: Za što se Cotellic koristi
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: Liver laboratory tests should be monitored before initiation of combination treatment and monthly during treatment, or more frequently if clinically indicated (see section 4.2).
Croatian: Laboratorijske vrijednosti jetrenih parametara treba kontrolirati prije početka kombiniranog liječenja te jednom mjesečno tijekom liječenja ili češće, ako je to klinički indicirano (vidjeti dio 4.2).
English: Median time to initial onset of serous retinopathy events was 1 month (range 0-9 months).
Croatian: Medijan vremena do prvog nastupa događaja serozne retinopatije iznosio je 1 mjesec (raspon:
English: Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1.
Croatian: Fotoosjetljivost 2. stupnja (nepodnošljiva) ili ≥ 3. stupnja: Primjenu lijeka Cotellic i vemurafeniba treba prekinuti dok se fotoosjetljivost ne ublaži do ≤ 1. stupnja.
English: 495 previously untreated patients with unresectable locally advanced or metastatic melanoma were randomised to receive either: · Placebo once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28, or · Cotellic 60 mg once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28
Croatian: Nakon potvrde prisutnosti mutacije BRAF V600 uz pomoć testa cobas® 4800 BRAF V600 Mutation Test, 495 prethodno neliječenih bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim melanomom bilo je randomizirano u skupine koje su primale: · placebo jedanput na dan od 1. do 21. dana svakog 28-dnevnog ciklusa liječenja i 960 mg vemurafeniba dvaput na dan od 1. do 28. dana ciklusa, ili · Cotellic u dozi od 60 mg jedanput na dan od 1. do 21. dana svakog 28-dnevnog ciklusa liječenja i 960 mg vemurafeniba dvaput na dan od 1. do 28. dana ciklusa
English: The median PFS for patients who had progressed on vemurafenib was 2.8 months, with median follow-up time of 8.1 months.
Croatian: PFS-a u bolesnika koji su doživjeli progresiju bolesti tijekom liječenja vemurafenibom iznosio je 2,8 mjeseci uz medijan praćenja od 8,1 mjesec.
English: The majority of events were reported as chorioretinopathy or retinal detachment.
Croatian: Većina događaja prijavljena je kao korioretinopatija ili odvajanje mrežnice.
English: Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis
Croatian: Planocelularni karcinom kože, keratoakantom i hiperkeratoza
English: If Grade ≥3 diarrhoea recurs, the dose of Cotellic and vemurafenib should be reduced (see section 4.2).
Croatian: Ako se proljev ≥ 3. stupnja ponovno pojavi, potrebno je smanjiti doze lijeka Cotellic i vemurafeniba (vidjeti dio 4.2).
English: Cotellic is for oral use.
Croatian: Cotellic je namijenjen za peroralnu primjenu.
English: Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Croatian: Blagi inhibitori CYP3A: Kobimetinib se može primjenjivati istodobno s blagim inhibitorima CYP3A bez prilagodbe doze.
English: Cotellic treatment should be permanently discontinued for haemorrhage events attributed to Cotellic.
Croatian: Liječenje lijekom Cotellic treba trajno obustaviti kod događaja krvarenja koji se pripišu lijeku Cotellic.
English: The efficacy of Cotellic was evaluated in Phase Ib Study, NO25395, which was designed to assess the safety, tolerability, pharmacokinetics and efficacy of Cotellic when added to vemurafenib for the treatment of patients with BRAFV600 mutation-positive (as detected by the cobas® 4800 BRAF V600
Croatian: Djelotvornost lijeka Cotellic ocjenjivala se u ispitivanju faze Ib NO25395, koje je bilo dizajnirano da ocijeni sigurnost, podnošljivost, farmakokinetiku i djelotvornost lijeka Cotellic kao dodatka vemurafenibu u liječenju bolesnika s neoperabilnim ili metastatskim melanomom pozitivnim na mutaciju BRAF V600 (koja je potvrđena testom cobas® 4800 BRAF V600 Mutation Test).
English: If severity is improved by at least one grade within 4 weeks, Cotellic could be restarted at a dose reduced by 20 mg, if clinically indicated.
Croatian: Ako se težina smanji za najmanje jedan stupanj unutar 4 tjedna, Cotellic se može ponovno uvesti u dozi smanjenoj za 20 mg, ako je to klinički indicirano.
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).
Croatian: Medijan procijenjene vrijednosti PFS-a prema ocjeni neovisnog ocjenjivačkog tijela iznosio je 11,3 mjeseca za skupinu liječenu lijekom Cotellic plus vemurafenibom, u odnosu na 6,0 mjeseci za skupinu koja je primala placebo plus vemurafenib (HR: 0,60 [0,45; 0,79]; p-vrijednost = 0,0003).
English: Consider permanent discontinuation *The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Croatian: Razmotriti trajnu obustavu liječenja * Intenzitet kliničkih nuspojava ocijenjena prema verziji 4.0 Zajedničkih terminoloških kriterija za nuspojave
English: No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC (section 4.2) for dose modifications for vemurafenib.
Croatian: Ako se tijekom liječenja QTc interval produlji na više od 500 ms, vidjeti Sažetak opisa svojstava lijeka za vemurafenib (dio 4.2) za informacije o prilagodbi doze vemurafeniba.
English: Signs include yellowing of the skin or eyes · inflammation of the lungs that may cause difficulty breathing, and can be life-threatening (called “pneumonitis”).
Croatian: · upala pluća koja može uzrokovati otežano disanje i ugroziti život (zvana "pneumonitis").
English: If CPK elevations do not improve to Grade ≤3 within 4 weeks following dose interruption, Cotellic treatment should be permanently discontinued.
Croatian: Ako se povišene vrijednosti CPK-a ne poboljšaju do ≤ 3. stupnja unutar 4 tjedna od privremenog prekida, liječenje lijekom Cotellic treba trajno obustaviti.
English: Tell your doctor straight away if you get any of these symptoms: muscle aches, muscle spasms, weakness, or dark- or redcoloured urine.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od ovih simptoma: bolove u mišićima, mišićne grčeve, slabost ili tamnu ili crvenu boju mokraće.
English: Effects of cobimetinib on other medicinal products
Croatian: Učinci kobimetiniba na druge lijekove
English: * Please refer to the paragraph Haemorrhage in the “Description of selected adverse reactions” section ** Please refer to the paragraph Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis in the “Description of selected adverse reactions” section.
Croatian: * Vidjeti odlomak Krvarenje u dijelu "Opis odabranih nuspojava" ** Vidjeti odlomak Planocelularni k arcinom kože, k eratoakantom i hiperkeratoza u dijelu "Opis odabranih nuspojava" *** Vidjeti odlomak Rabdomioliza u dijelu "Opis odabranih nuspojava"
English: What Cotellic is Cotellic is an anti-cancer medicine that contains the active substance cobimetinib.
Croatian: Cotellic je lijek za liječenje raka koji sadrži djelatnu tvar kobimetinib.
English: If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety.
Croatian: Ako se istodobna primjena snažnog inhibitora CYP3A ne može izbjeći, bolesnike je potrebno pažljivo nadzirati zbog mogućih nuspojava.
English: Alternative agents with no or minimal CYP3A induction should be considered.
Croatian: Treba razmotriti druge lijekove koji ne induciraju ili minimalno induciraju CYP3A.
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.
Croatian: Odmah obavijestite svog liječnika ako imate neuobičajeno krvarenje ili bilo koji od sljedećih simptoma: glavobolju, omaglicu, slabost, krv u stolici ili crnu boju stolice te povraćanje krvi.
English: Tell your doctor straight away if it feels like your heart is pounding, racing or beating unevenly, or if you experience dizziness, lightheadedness, shortness of breath, tiredness, or swelling in the legs.
Croatian: Odmah obavijestite svog liječnika ako osjetite lupanje srca te ubrzane ili nepravilne otkucaje ili ako primijetite omaglicu, ošamućenost, nedostatak zraka, umor ili oticanje nogu.
English: LIST OF EXCIPIENTS The tablets also contain lactose.
Croatian: POPIS POMOĆNIH TVARI Tablete sadrže i laktozu.
English: cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin, posaconazole, nefazodone and grapefruit juice.
Croatian: ritonavir, kobicistat, telaprevir, lopinavir, itrakonazol, vorikonazol, klaritromicin, telitromicin, posakonazol, nefazodon i sok od grejpa.
English: What Cotellic is and what it is used for
Croatian: Što je Cotellic i za što se koristi Što je Cotellic
English: Cotellic treatment and vemurafenib treatment should be interrupted.
Croatian: Liječenje lijekom Cotellic i vemurafenibom treba se privremeno prekinuti.
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).
Croatian: Ako se istodobna primjena snažnog ili umjerenog inhibitora CYP3A ne može izbjeći, bolesnike je potrebno pažljivo nadzirati zbog mogućih nuspojava te prilagoditi dozu ako je to klinički indicirano (vidjeti
English: If you are sick
Croatian: Ako povratite
English: Cotellic can cause eye problems (see also “Eye (vision) problems” in Section 4).
Croatian: Cotellic može uzrokovati očne tegobe (pogledajte i odlomak 'Očne (vidne) tegobe' u dijelu 4.).
English: Basal cell carcinoma, Cutaneous squamous cell carcinoma**, Keratoacanthoma**
Croatian: karcinom bazalnih stanica, planocelularni karcinom kože**, keratoakantom**
English: For Grade 1 and 2 liver laboratory abnormalities, Cotellic and vemurafenib should be continued at the prescribed dose.
Croatian: U slučaju odstupanja u laboratorijskim vrijednostima jetrenih parametara 1. i 2. stupnja, liječenje lijekom Cotellic i vemurafenibom treba nastaviti propisanom dozom.
English: Unbound cobimetinib exposures were similar between subjects with mild and moderate hepatic impairment compared to subjects with normal hepatic function while subjects with severe hepatic impairment had approximately 2-fold higher exposures (see section 4.2).
Croatian: Izloženosti nevezanom kobimetinibu bile su slične u ispitanika s blagim i umjerenim oštećenjem jetrene funkcije u odnosu na ispitanike s normalnom funkcijom jetre, dok su ispitanici s teškim oštećenjem jetrene funkcije imali približno 2 puta veće izloženosti (vidjeti dio 4.2).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: Patients with a baseline LVEF either below institutional lower limit of normal (LLN) or below 50% have not been studied.
Croatian: Bolesnici s početnim LVEF-om ispod donje granice normale (DGN) koju propisuje ustanova ili ispod
English: · If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: · Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Rhabdomyolysis and CPK elevations
Croatian: Rabdomioliza i povišenje vrijednosti CPK-a
English: Grade 3 liver laboratory abnormalities should be managed with vemurafenib treatment interruption or dose reduction.
Croatian: Odstupanja u laboratorijskim vrijednostima jetrenih parametara 3. stupnja treba zbrinuti privremenim prekidom liječenja vemurafenibom ili smanjenjem njegove doze.
English: Table 2 Recommended dose modifications for Cotellic in patients with left ventricular ejection fraction (LVEF) decrease from baseline
Croatian: Tablica 2 Prilagodbe preporučene doze lijeka Cotellic u bolesnika sa smanjenom ejekcijskom frakcijom lijeve klijetke (engl. left ventricular ejection fraction, LVEF) u odnosu na početnu vrijednost
English: If you forget to take Cotellic · If it is more than 12 hours before your next dose, take the missed dose as soon as you remember.
Croatian: · Ako je do sljedeće doze preostalo više od 12 sati, uzmite propuštenu dozu čim se sjetite.
English: If CPK improves to Grade ≤3 within 4 weeks, Cotellic could be restarted, if clinically indicated, at a dose reduced by 20 mg and the patient should be closely monitored.
Croatian: Ako se CPK poboljša do ≤ 3. stupnja unutar 4 tjedna, Cotellic se može ponovno uvesti ako je to klinički indicirano, u dozi smanjenoj za 20 mg i bolesnika treba pomno nadzirati.
English: Cotellic should be used with caution in patients with severe renal impairment.
Croatian: Cotellic treba primjenjivati uz oprez u bolesnika s teškim oštećenjem bubrežne funkcije.