FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important to keep taking Cotellic for as long as your doctor prescribes it.
Croatian: Važno je da nastavite uzimati Cotellic onoliko dugo koliko Vam ga liječnik propisuje.
English: Once the dose has been reduced, it should not be increased at a later time.
Croatian: Nakon što se doza jednom smanji, naknadno se više ne smije povećavati.
English: The tablets should be swallowed whole with water.
Croatian: Tablete treba progutati cijele, s vodom.
English: Efficacy results are summarized in Table 5.
Croatian: Rezultati za djelotvornost sažeto su prikazani u Tablici 5.
English: If you take more Cotellic than you should, talk to a doctor straight away.
Croatian: Ako uzmete više lijeka Cotellic nego što ste trebali, odmah se obratite liječniku.
English: The decision on whether to reduce the dose for either or both treatments should be based on the prescriber's assessment of individual patient safety or tolerability.
Croatian: Odluka o smanjenju doze jednoga ili obaju lijekova treba se temeljiti na propisivačevoj procjeni sigurnosti ili podnošljivosti u pojedinoga bolesnika.
English: g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Croatian: g Završni datum prikupljanja podataka za konačnu analizu OS-a bio je 28. kolovoza 2015., a medijan trajanja praćenja iznosio je 18,5 mjeseci.
English: Take the medicine package and this leaflet with you.
Croatian: Ponesite pakiranje lijeka i ovu uputu sa sobom.
English: Severe diarrhoea can cause loss of body fluid (dehydration).
Croatian: Težak proljev može uzrokovati gubitak tekućine iz tijela (dehidraciju).
English: If you take more Cotellic than you should
Croatian: Ako uzmete više lijeka Cotellic nego što ste trebali
English: Your doctor will do blood tests to monitor for this.
Croatian: Vaš će liječnik provoditi krvne pretrage kako bi to pratio.
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.
Croatian: · Ne preporučuje se primjena lijeka Cotellic tijekom trudnoće - iako se učinci lijeka Cotellic nisu ispitivali u trudnica, on može uzrokovati trajno oštećenje ili prirođene mane u nerođena djeteta.
English: The intracranial activity of cobimetinib is currently unknown (see sections 5.1 and 5.2).
Croatian: Intrakranijsko djelovanje kobimetiniba trenutno nije poznato (vidjeti dijelove 5.1 i 5.2).
English: · It is used in combination with another anti-cancer medicine called vemurafenib.
Croatian: · Koristi se u kombinaciji s još jednim lijekom za liječenje raka, koji se zove vemurafenib.
English: Since food does not alter the pharmacokinetics of cobimetinib, it can be administered with or without food.
Croatian: Budući da hrana ne mijenja farmakokinetiku kobimetiniba, on se može primjenjivati s hranom ili bez nje.
English: There were no apparent trends in the time of onset of Grade ≥3 events.
Croatian: Nisu primijećeni nikakvi trendovi s obzirom na vrijeme nastupa događaja ≥ 3. stupnja.
English: ^ Data cut-off date of 19 September 2014
Croatian: Podaci prikupljeni do 19. rujna 2014.
English: Cotellic contain lactose
Croatian: Cotellic sadrži laktozu
English: · It can only be used in patients whose cancer has a change (mutation) in a protein called “BRAF”.
Croatian: · Smije se koristiti samo u bolesnika čiji rak ima promjenu (mutaciju) u proteinu pod nazivom
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse effects that may affect their ability.
Croatian: Bolesnicima treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako primijete poremećaje vida ili bilo koje druge štetne učinke koji bi mogli utjecati na njihovu sposobnost.
English: A decision should be made whether to discontinue breast-feeding or discontinue Cotellic therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje lijekom Cotellic uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Grade 3 events: Cotellic treatment should be interrupted during evaluation to avoid any potential contribution to the event.
Croatian: Događaji 3. stupnja: Liječenje lijekom Cotellic treba privremeno prekinuti tijekom evaluacije događaja kako bi se izbjegao eventualni doprinos tom događaju.
English: However, sensitivity analysis suggests neither of these covariates had clinically significant impact on steady state exposure.
Croatian: Međutim, analiza osjetljivosti ukazuje na to da nijedna od tih kovarijanti nije klinički značajno utjecala na izloženost u stanju dinamičke ravnoteže.
English: Cotellic can increase the amount of some liver enzymes in your blood during treatment.
Croatian: Cotellic može povećati količinu nekih jetrenih enzima u krvi tijekom liječenja.
English: Cotellic is used to treat adult patients with a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery.
Croatian: Cotellic se koristi za liječenje odraslih bolesnika s jednom vrstom raka kože koji se naziva melanomom i koji se proširio u druge dijelove tijela ili se ne može kirurški odstraniti.
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.
Croatian: Kada se Cotellic koristi u kombinaciji s vemurafenibom (koji ciljano djeluje na izmijenjeni protein "BRAF"), dodatno usporava ili zaustavlja rast raka.
English: Follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Croatian: Slijedite upute svog liječnika o tome kako spriječiti ili liječiti proljev.
English: Each pack contains 63 tablets.
Croatian: Jedno pakiranje sadrži 63 tablete.
English: Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain.
Croatian: Cotellic može uzrokovati povećanje vrijednosti kreatin fosfokinaze, enzima koji se uglavnom nalazi u mišićima, srcu i mozgu.
English: Other medicines and Cotellic
Croatian: Drugi lijekovi i Cotellic
English: One pack size is available: 63 tablets (3 blisters of 21 tablets).
Croatian: Dostupna je jedna veličina pakiranja: 63 tablete (3 blistera s 21 tabletom).
English: Malta (see Ireland)
Croatian: Malta (vidjeti United Kingdom)
English: The absolute bioavailability of cobimetinib was 45.9% (90% CI: 39.7%, 53.1%) in healthy subjects.
Croatian: Apsolutna bioraspoloživost kobimetiniba iznosila je 45,9% (90% CI: 39,7%; 53,1%) u zdravih ispitanika.
English: Your doctor should do tests before and during your treatment with Cotellic to check how well your heart can pump blood.
Croatian: Vaš bi liječnik prije i tijekom liječenja lijekom Cotellic trebao napraviti pretrage kako bi utvrdio koliko Vam dobro srce pumpa krv.
English: No oxidative metabolites greater than 10% of total circulating radioactivity or human specific metabolites were observed in plasma.
Croatian: U plazmi nije pronađen udio oksidiranih metabolita veći od 10% ukupne cirkulirajuće radioaktivnosti, kao ni metaboliti specifični za ljude.
English: Best Overall Response (BOR) Complete Response Partial Response
Croatian: Najbolji ukupan odgovor Potpun odgovor
English: Therefore, it may take up to 2 weeks following treatment cessation for cobimetinib to be completely removed from systemic circulation.
Croatian: Dakle, možda će biti potrebno do 2 tjedna nakon prekida liječenja da se kobimetinib potpuno izluči iz sistemske cirkulacije.
English: Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity (see Table 1 below).
Croatian: Liječenje lijekom Cotellic treba nastaviti sve dok bolesnik više ne bude imao koristi od njega ili dok se ne razvije neprihvatljiva toksičnost (vidjeti Tablicu 1 u nastavku).
English: The tablets contain lactose (a type of sugar).
Croatian: Ove tablete sadrže laktozu (jednu vrst šećera).
English: Some of these eye problems may be a result of “serous retinopathy” (a build-up of fluid under the retina in the eye).
Croatian: Neke od tih očnih tegoba mogu biti posljedica "serozne retinopatije" (nakupljanja tekućine ispod mrežnice u oku).
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.
Croatian: Proljev (vrlo često: može se javiti u više od 1 na 10 osoba) Odmah obavijestite svog liječnika ako dobijete proljev te slijedite njegove upute o tome kako spriječiti ili liječiti proljev.
English: PHARMACEUTICAL FORM AND CONTENTS 63 film-coated tablets
Croatian: OBLIK I SADRŽAJ 63 filmom obložene tablete
English: No preferential binding to human red blood cells was observed (blood to plasma ratio 0.93).
Croatian: Nije primijećeno preferencijalno vezivanje za crvene krvne stanice u ljudi (omjer krvi i plazme: 0,93).
English: Always take Cotellic exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite Cotellic točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: Your doctor will do blood tests to check these amounts and monitor how well your liver is working.
Croatian: Vaš će liječnik provoditi krvne pretrage kako bi odredio tu količinu i kontrolirao radi li Vam jetra pravilno.
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XE38
Croatian: Farmakoterapijska skupina: Antineoplastici, ATK oznaka: L01XE38 Mehanizam djelovanja
English: Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John's Wort) should be avoided.
Croatian: Stoga treba izbjegavati istodobnu primjenu umjerenih i snažnih induktora CYP3A (npr. karbamazepina, rifampicina, fenitoina i gospine trave).
English: Grade 4:
Croatian: 4. stupanj:
English: In vitro data indicate cobimetinib is not an inhibitor of OAT1, OAT3 or OCT2.
Croatian: In vitro podaci ukazuju na to da kobimetinib nije inhibitor prijenosnika OAT1, OAT3 ni OCT2.
English: Also, some other medicines can affect the way Cotellic works.
Croatian: Isto tako, neki drugi lijekovi mogu utjecati na način djelovanja lijeka Cotellic.
English: No dose adjustment is required in patients aged ≥65 years old.
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥ 65 godina.
English: Global health status / health-related quality of life by patient-report were measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30).
Croatian: Opći zdravstveni status / kvaliteta života vezana uz zdravlje koje su prijavljivali bolesnici određivali su se na temelju upitnika za ocjenu kvalitete života EORTC - Core 30 (QLQ-C30).
English: LVEF value
Croatian: Vrijednost LVEF-a
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).
Croatian: Svaka se doza sastoji od tri tablete od 20 mg (60 mg), a uzima se jedanput na dan tijekom 21 uzastopnog dana (od 1. do 21. dana ciklusa liječenja), nakon čega slijedi 7-dnevna pauza (od 22. do 28. dana ciklusa).
English: Severe bleeding (common: may affect up to 1 in 10 people) Cotellic can cause severe bleeding, especially in your brain or stomach.
Croatian: Teško krvarenje (često: može se javiti u do 1 na 10 osoba) Cotellic može uzrokovati teško krvarenje, osobito u mozgu ili trbuhu.
English: Most events resolved with no change in Cotellic dose.
Croatian: Većina događaja povukla se bez promjene doze lijeka Cotellic.
English: Caution should be used in patients with additional risk factors for bleeding, such as brain metastases, and/or in patients that use concomitant medications that increase the risk of bleeding (including antiplatelet or anticoagulant therapy).
Croatian: Potreban je oprez u bolesnika s dodatnim rizičnim čimbenicima za krvarenje, kao što su moždane metastaze, i/ili u bolesnika koji istodobno uzimaju lijekove koji povećavaju rizik od krvarenja (uključujući antitrombocitne lijekove ili antikoagulanse).
English: Figure 1 Kaplan-Meier curves of final overall survival - Intent to treat population (cut-off date: 28 August 2015)
Croatian: Slika 1 Kaplan-Meierove krivulje konačnog ukupnog preživljenja - populacija koju se namjeravalo liječiti (podaci prikupljeni do 28. kolovoza 2015.)
English: Continue at current dose
Croatian: Nastaviti liječenje trenutnom dozom
English: Most events observed in clinical trials were resolved, or improved to asymptomatic Grade 1, following dose interruption or reduction.
Croatian: Većina događaja primijećenih u kliničkim ispitivanjima povukla se ili poboljšala do asimptomatskog 1. stupnja nakon privremenog prekida primjene ili smanjenja doze.
English: Each film-coated tablet contains 36 mg lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 36 mg laktoze hidrata.
English: In animals, no fertility studies have been performed, but adverse effects were seen on reproductive organs (see section 5.3).
Croatian: Nisu provedena ispitivanja plodnosti na životinjama, ali primijećeni su štetni učinci na reproduktivne organe (vidjeti dio 5.3).
English: Among patients who had progressed on vemurafenib (n=66), the objective response rate was 15%.
Croatian: Među bolesnicima koji su doživjeli progresiju bolesti tijekom liječenja vemurafenibom (n = 66), stopa objektivnog odgovora iznosila je 15%.
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Croatian: Bolesnike je potrebno pregledati pri svakom posjetu kako bi se utvrdili mogući simptomi novih ili pogoršanje postojećih poremećaja vida.
English: Table 5 Efficacy results from Study GO28141 (coBRIM)
Croatian: Tablica 5 Rezultati za djelotvornost iz ispitivanja GO28141 (coBRIM)
English: Taking the medicine · Swallow the tablets whole with water.
Croatian: Uzimanje lijeka · Tablete progutajte cijele s vodom.
English: Each subsequent Cotellic treatment cycle should start after the 7-day treatment break has elapsed.
Croatian: Svaki sljedeći ciklus liječenja lijekom Cotellic treba započeti nakon što prođe 7-dnevna pauza u liječenju.
English: The proportion of patients experiencing adverse events (AE) was similar in the patients aged <65 years and those aged ³65 years.
Croatian: Udio bolesnika u kojih su nastupile nuspojave bio je sličan u bolesnika u dobi od < 65 godina i onih u dobi od ³ 65 godina.
English: The primary analysis for Study GO28141 was conducted with a data cut-off date of 09 May 2014.
Croatian: Primarna analiza ispitivanja GO28141 provedena je s podacima prikupljenima do 9. svibnja 2014.
English: Standard genotoxicity studies with cobimetinib were negative.
Croatian: Standardna ispitivanja genotoksičnosti kobimetiniba bila su negativna.
English: · Do not take this medicine after the expiry date which is stated on the blister and the carton after EXP.
Croatian: · Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "EXP" ili "Rok valjanosti".
English: White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side.
Croatian: Bijele, okrugle, filmom obložene tablete promjera približno 6,6 mm, s utisnutom oznakom "COB" na jednoj strani.
English: What Cotellic looks like and contents of the pack Cotellic film-coated tablets are white, round with “COB” debossed on one side.
Croatian: Kako Cotellic izgleda i sadržaj pakiranja Cotellic filmom obložene tablete su bijele okrugle tablete s utisnutom oznakom "COB" na jednoj strani.
English: Additionally, for:
Croatian: Uz to:
English: Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.
Croatian: Cotellic ciljano djeluje na protein koji se zove "MEK", a koji je važan za kontrolu rasta stanica raka.
English: Oxidation by CYP3A and glucuronidation by UGT2B7 appear to be the major pathways of cobimetinib metabolism.
Croatian: Čini se da su oksidacija putem CYP3A i glukuronidacija putem UGT2B7 glavni putovi metabolizma kobimetiniba.
English: Cobimetinib has linear pharmacokinetics in the dose range of ~3.5 mg to 100 mg.
Croatian: Kobimetinib ima linearnu farmakokinetiku u rasponu doza od ~3,5 mg do 100 mg.
English: There is no experience with overdose in human clinical trials.
Croatian: Nema iskustva s predoziranjem iz kliničkih ispitivanja provedenih u ljudi.
English: Grade 2 (intolerable) or Grade 3/4 1st Appearance
Croatian: 2. stupanj (nepodnošljivo) ili 3./4. stupanj
English: Concomitant administration of P-gp inhibitors such as ciclosporin and verapamil may have the potential to increase plasma concentrations of cobimetinib.
Croatian: Istodobna primjena inhibitora P-gp-a, poput ciklosporina i verapamila, može povećati plazmatske koncentracije kobimetiniba.
English: LVEF value following treatment break
Croatian: Vrijednost LVEF-a nakon privremenog prekida liječenja
English: Median time to initial onset of events was 4 months (1-13 months).
Croatian: Medijan vremena do prvog nastupa događaja iznosio je 4 mjeseca (raspon: 1 - 13 mjeseci).
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.
Croatian: U ispitivanju GO28141 sudjelovalo je 89 bolesnika (18,1%) u dobi od 65 - 74 godine, 38 bolesnika (7,7%) u dobi od 75 - 84 godine te 5 bolesnika (1,0%) u dobi od 85 ili više godina.
English: The median follow up was 14.2 months.
Croatian: Medijan trajanja praćenja iznosio je 14,2 mjeseca.
English: During this 7 day break in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
Croatian: Tijekom te 7-dnevne pauze u liječenju lijekom Cotellic nastavite uzimati vemurafenib prema uputama liječnika.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Cotellic.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Cotellic.
English: If you are sick (vomit) after taking Cotellic, do not take an extra dose of Cotellic on that day.
Croatian: Ako povratite nakon što uzmete Cotellic, nemojte uzeti dodatnu dozu lijeka Cotellic toga dana.
English: There are no data from the use of Cotellic in pregnant women.
Croatian: Nema podataka o primjeni lijeka Cotellic u trudnica.
English: Cotellic should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Croatian: Cotellic se u trudnoći smije primjenjivati samo kada je to neophodno, nakon pažljive procjene majčinih potreba i rizika za plod.
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).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Cotellic u jednoj ili više podskupina pedijatrijske populacije u zloćudnim solidnim tumorima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Objective response rate (ORR) (95% CI) for ORR
Croatian: Stopa objektivnog odgovora (ORR) 95% CI za ORR
English: Patients with ECOG performance status 2 or higher were excluded from the study.
Croatian: Bolesnici s ECOG funkcionalnim statusom 2 ili više nisu bili uključeni u ispitivanje.
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.
Croatian: Liječenje lijekom Cotellic u kombinaciji s vemurafenibom mora započeti i nadzirati isključivo kvalificiran liječnik s iskustvom u primjeni lijekova za liječenje raka.
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.
Croatian: LVEF je potrebno procijeniti prije početka liječenja radi utvrđivanja početnih vrijednosti, potom nakon prvog mjeseca liječenja, a zatim najmanje svaka 3 mjeseca ili sukladno kliničkoj indikaciji do prekida liječenja.
English: Table 3 lists adverse reactions considered associated with the use of Cotellic.
Croatian: Tablici 3 navode se nuspojave koje se smatraju povezanima s primjenom lijeka Cotellic.
English: The median duration of response was 14.3 months.
Croatian: Medijan trajanja odgovora iznosio je 14,3 mjeseca.
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).
Croatian: Rezultati za sve domene funkcioniranja i većinu simptoma (gubitak teka, konstipaciju, mučninu i povraćanje, dispneju, bol, umor) pokazali su da je srednja vrijednost promjene od početnih vrijednosti bila slična u obje liječene skupine te nisu pokazali klinički značajnu promjenu (kod svih je rezultata razlika u odnosu na početnu vrijednost bila ≤ 10 bodova).
English: If serum CPK is elevated, check for signs and symptoms of rhabdomyolysis or other causes.
Croatian: Ako su vrijednosti CPK u serumu povišene, treba provjeriti postoje li znakovi i simptomi rabdmiolize ili drugih uzroka.
English: · It is not known if Cotellic passes into breast milk.
Croatian: · Nije poznato izlučuje li se Cotellic u majčino mlijeko.
English: Cotellic can affect your ability to drive or use machines.
Croatian: Cotellic može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: · Periodic safety update reports
Croatian: · Periodička izvješća o neškodljivosti
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.
Croatian: Populacijska farmakokinetička analiza podataka prikupljenih u 151 bolesnika s blagim oštećenjem bubrežne funkcije (klirens kreatinina [CrCl] od 60 do manje od 90 ml/min), 48 bolesnika s umjerenim oštećenjem bubrežne funkcije (CrCl od 30 do manje od 60 ml/min) i 286 bolesnika s normalnom bubrežnom funkcijom (CrCl od 90 ml/min ili više) pokazala je da CrCl nema značajnog utjecaja na izloženost kobimetinibu.
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.
Croatian: U ispitivanju faze III lijeka Cotellic u kombinaciji s vemurafenibom u bolesnika s neoperabilnim ili metastatskim melanomom (n = 247), 183 bolesnika (74%) imalo je < 65 godina, 44 bolesnika (18%) bilo je u dobi od 65 - 74 godine, njih 16 (6%) bilo je u dobi od 75 - 84 godine, dok su 4 bolesnika (2%) bila u dobi od ³ 85 godina.
English: The safety profile of Study NO25395 was consistent with that observed in Study GO28141.
Croatian: Sigurnosni profil u ispitivanju NO25395 bio je u skladu s onim primijećenim u ispitivanju GO28141.
English: The mean steady-state Cmax and AUC0-24 were 273 ng/mL and 4340 ng.h/mL respectively.
Croatian: Srednja vrijednost Cmax i AUC0-24 u stanju dinamičke ravnoteže iznosila je 273 ng/ml odnosno 4340 ng.h/ml.