FrancophonIA/ELRC3.0 huggingface dataset:
English: Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Croatian: Alecensa je kao monoterapija indicirana za liječenje odraslih bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om koji su prethodno bili liječeni krizotinibom.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grapefruit or Seville oranges).
Croatian: Preporučuje se odgovarajući nadzor bolesnika koji istodobno uzimaju snažne inhibitore CYP3A (uključujući, između ostalih, ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol, nefazodon, grejp ili gorke naranče).
English: Tell your doctor straight away if you get any of the following signs: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih znakova: žutu boju kože ili bjeloočnica, bol na desnoj strani trbuha, tamnu mokraću, svrbež kože, manji osjećaj gladi nego inače, mučninu ili povraćanje, umor, pojačanu sklonost krvarenju ili nastanku modrica.
English: ● The recommended dose is 4 capsules (600 mg) twice a day.
Croatian: Preporučena doza je 4 kapsule (600 mg) dvaput na dan.
English: Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.
Croatian: Alektinib je visokoselektivan i potentan inhibitor tirozin kinaza ALK i RET.
English: Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa.
Croatian: Bolesnice reproduktivne dobi koje primaju lijek Alecensa moraju koristiti visoko učinkovite kontracepcijske metode tijekom liječenja i još najmanje 3 mjeseca nakon posljednje doze lijeka Alecensa.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Croatian: Bolesnike treba uputiti da prijave bilo kakvu neobjašnjivu bol u mišićima, osjetljivost mišića na dodir ili mišićnu slabost.
English: ● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
Croatian: Ako je Alecensa zapakirana u blistere, čuvati u originalnom pakiranju radi zaštite od vlage.
English: Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Croatian: Abnormalna morfologija eritrocita primijećena je pri razinama izloženosti koje su bile najmanje 10 - 60% veće od izloženosti u ljudi nakon primjene preporučene doze (na temelju AUC-a).
English: Cause-specific HR [95% CI]
Croatian: HR specifičan za uzrok [95% CI]
English: Based on population pharmacokinetic analysis, the geometric mean (coefficient of variation %) steady-state Cmax, Cmin and AUC0-12hr for alectinib were approximately 665 ng/mL (44.3%), 572 ng/mL (47.8%) and 7430 ng*h/mL (45.7%), respectively.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, geometrijske srednje vrijednosti (koeficijent varijacije %) Cmax, Cmin i AUC0-12h alektiniba u stanju dinamičke ravnoteže iznosile su približno 665 ng/ml (44,3%), 572 ng/ml (47,8%) odnosno 7430 ng*h/ml (45,7%).
English: Thereafter, monitoring should be performed periodically, since events may occur later than 3 months, with more frequent testing in patients who develop aminotransferase and bilirubin elevations.
Croatian: Testiranje je potrebno provoditi i češće u bolesnika koji razviju povišene vrijednosti aminotransferaza i bilirubina.
English: Crizotinib N=151
Croatian: Krizotinib N=151
English: Within each system organ class, undesirable effects are presented in order of decreasing frequency.
Croatian: Unutar svakog organskog sustava nuspojave su prikazane u padajućem nizu prema učestalosti.
English: If you stop taking Alecensa
Croatian: Ako prestanete uzimati lijek Alecensa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1169/002
English: ● severe muscle pain, tenderness, and weakness (myalgia).
Croatian: ● jaku bol u mišićima, osjetljivost mišića na dodir i mišićnu slabost (mialgija).
English: Following a single oral administration of 600 mg with a high-fat, high-calorie meal, alectinib and M4 exposure was increased by around 3-fold relative to fasted conditions (see section 4.2).
Croatian: Nakon jednokratne peroralne primjene doze od 600 mg uz visokokaloričan obrok s visokim udjelom masti, izloženost alektinibu i njegovu metabolitu M4 povećala se približno trostruko u odnosu na primjenu natašte (vidjeti dio 4.2).
English: If you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time.
Croatian: Ako povratite nakon uzimanja doze lijeka Alecensa, nemojte uzeti dodatnu dozu, nego uzmite sljedeću dozu u uobičajeno vrijeme.
English: Dose modification is not required in case of asymptomatic bradycardia (see section 4.2).
Croatian: U slučaju asimptomatske bradikardije, nije potrebno prilagođavati dozu (vidjeti dio 4.2).
English: Pack size: 224 (4 packs of 56) hard capsules.
Croatian: Veličina pakiranja: 224 (4 pakiranja od 56) tvrdih kapsula.
English: Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer' (‘NSCLC').
Croatian: Alecensa se koristi za liječenje odraslih osoba oboljelih od jedne vrste raka pluća koji se zove „rak pluća nemalih stanica“.
English: The ECOG performance status at baseline was 0 or 1 in 89.7% of patients and 2 in 10.3% of patients.
Croatian: Funkcionalni ECOG status na početku ispitivanja iznosio je 0 ili 1 u 89,7% bolesnika te 2 u 10,3% bolesnika.
English: ● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Croatian: Tinta za označavanje: crveni željezov oksid (E172), žuti željezov oksid (E172), boja indigo carmine aluminium lake (E132), karnauba vosak, bijeli šelak i glicerilmonooleat.
English: NE [17.7; NE]
Croatian: NP [17,7; NP]
English: What Alecensa is used for
Croatian: Za što se Alecensa koristi
English: Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Roche Pharma AG
English: Permanently discontinue Alecensa.
Croatian: Trajno obustaviti liječenje lijekom Alecensa.
English: ORR (INV)*, *** Responders n (%) [95% CI]
Croatian: ORR (ispitivač)*, *** Bolesnici s odgovorom, n (%) [95% CI]
English: No case of bradycardia led to withdrawal from Alecensa treatment.
Croatian: Niti u jednom slučaju bradikardija nije dovela do prekida liječenja lijekom Alecensa.
English: If you vomit after taking Alecensa
Croatian: Ako povratite nakon uzimanja lijeka Alecensa
English: A total of 303 patients were included in the Phase III trial, 151 patients randomised to the crizotinib arm and 152 patients randomised to the Alecensa arm receiving Alecensa orally, at the recommended dose of 600 mg twice daily.
Croatian: Ukupno su 303 bolesnika uključena u ispitivanje faze III, od čega je 151 bolesnik randomiziran za primanje krizotiniba, a 152 bolesnika za peroralnu primjenu lijeka Alecensa u preporučenoj dozi od 600 mg dvaput na dan.
English: If you forget to take Alecensa
Croatian: Ako ste zaboravili uzeti lijek Alecensa
English: ● rapid loss of kidney function (kidney problems).
Croatian: ● brz gubitak bubrežne funkcije (bubrežne tegobe)
English: CNS-CR n (%)
Croatian: CR u SŽS-u, n (%)
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije.
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of BCRP.
Croatian: Stoga bi alektinib i M4 mogli povećati plazmatske koncentracije istodobno primijenjenih supstrata BCRP-a.
English: ● Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
Croatian: ● žuta boja kože ili bjeloočnica, bol na desnoj strani trbuha, tamna mokraća, svrbež kože, manji osjećaj gladi nego inače, mučnina ili povraćanje, umor, pojačana sklonost krvarenju ili nastanku modrica (mogući znakovi jetrenih tegoba).
English: Elimination Following administration of a single dose of 14C-labeled alectinib administered orally to healthy subjects the majority of radioactivity was excreted in faeces (mean recovery 97.8%) with minimal excretion in urine (mean recovery 0.46%).
Croatian: C-označene doze alektiniba u zdravih ispitanika, većina se radioaktivnosti izlučila kroz feces (srednja vrijednost pronađene radioaktivnosti: 97,8%), uz minimalno izlučivanje mokraćom (srednja vrijednost pronađene radioaktivnosti: 0,46%).
English: Based on a population pharmacokinetic analysis alectinib and M4 exposures were similar in patients with mild and moderate renal impairment and normal renal function.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, izloženost alektinibu i metabolitu M4 bila je slična u bolesnika s blagim i umjerenim oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom.
English: The majority of these events were of Grade 1 and 2 intensity, and events of Grade ≥ 3 were reported in 3.7% and 3.7% of the patients, respectively.
Croatian: Većina tih događaja bila je intenziteta stupnja 1 i 2, dok su događaji stupnja ≥ 3 prijavljeni u 3,7% odnosno 3,7% bolesnika.
English: Tell your doctor straight away if you get new or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Croatian: Odmah obavijestite svog liječnika ako se pojave novi ili pogoršaju postojeći znakovi mišićnih tegoba, uključujući neobjašnjivu bol u mišićima ili bol u mišićima koja ne prolazi, osjetljivost na dodir ili slabost.
English: Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Croatian: Odmah obavijestite svog liječnika ako primijetite pojavu novih ili pogoršanje postojećih znakova, uključujući otežano disanje, nedostatak zraka, produktivan ili suhi kašalj ili vrućicu.
English: Temporarily withhold until recovery to baseline or ≤ Grade 1 (≤ 3 times ULN), then resume at reduced dose (see Table 1).
Croatian: Privremeno odgoditi primjenu lijeka do oporavka na početnu vrijednost ili stupnja ≤ 1 (≤ 3 puta iznad GGN-a), a zatim nastaviti liječenje smanjenom dozom (vidjeti Tablicu 1).
English: Study NP28761
Croatian: Ispitivanje NP28761
English: Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
Croatian: Ovisno o težini povišenja vrijednosti CPK-a, potrebno je privremeno odgoditi primjenu lijeka Alecensa, a zatim nastaviti liječenje istom ili smanjenom dozom (vidjeti dio 4.2).
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Croatian: Stoga bi alektinib i M4 mogli povećati plazmatske koncentracije istodobno primijenjenih supstrata P-gp-a.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Croatian: Preporučuje se odgovarajući nadzor bolesnika koji istodobno uzimaju snažne induktore CYP3A (uključujući, između ostalih, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum)).
English: The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALK-positive NSCLC patients who were treatment naïve.
Croatian: Sigurnost i djelotvornost lijeka Alecensa ocjenjivale su se u globalnom, randomiziranom, otvorenom, kliničkom ispitivanju faze III (BO28984, ALEX) u prethodno neliječenih bolesnika s ALK-pozitivnim NSCLC-om.
English: In pregnant rats, alectinib caused total embryo-foetal loss (miscarriage) at exposures 4.5-fold of the human AUC exposure and small foetuses with retarded ossification and minor abnormalities of the organs at exposures 2.7-fold of the human AUC exposure.
Croatian: U skotnih ženki štakora, alektinib je uzrokovao potpuni gubitak embrija/fetusa (pobačaj) pri razinama izloženosti koje su bile 4,5 puta veće od izloženosti u ljudi (na temelju AUC-a), te malu veličinu fetusa uz zakašnjelu osifikaciju i manje abnormalnosti organa pri razinama izloženosti koje su bile 2,7 puta veće od izloženosti u ljudi (na temelju AUC-a).
English: If you have severe liver problems before starting your treatment with Alecensa:
Croatian: Ako ste prije početka liječenja lijekom Alecensa imali teške jetrene tegobe:
English: In the pivotal Alecensa clinical trials it was reported that three patients with Grade 3-4 AST/ALT elevations had drug induced liver injury.
Croatian: U pivotalnim kliničkim ispitivanjima lijeka Alecensa, u tri je bolesnika s povišenim vrijednostima AST-a/ALT-a stupnja 3-4 prijavljeno oštećenje jetre inducirano djelovanjem lijeka.
English: In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
Croatian: U skotnih ženki kunića, alektinib je uzrokovao gubitak embrija/fetusa, malu veličinu fetusa i povećanu incidenciju skeletnih varijacija pri razinama izloženosti koje su bile 2,9 puta veće od izloženosti u ljudi (na temelju AUC-a) nakon primjene preporučene doze.
English: CPK elevation > 10 times ULN or second occurrence of CPK elevation of > 5 times ULN
Croatian: Povišene vrijednosti CPK-a > 10 puta iznad GGN-a ili ponovni nastup povišenja vrijednosti CPK-a > 5 puta iznad GGN-a
English: ● mitoxantrone, a medicine used to treat certain types of cancer or autoimmune diseases (e.g.
Croatian: ● mitoksantron, lijek koji se koristi za liječenje određenih vrsta raka ili autoimunih bolesti (npr.
English: ● New or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness (potential signs of muscle problems).
Croatian: ● novi znakovi ili pogoršanje postojećih znakova mišićnih tegoba, uključujući neobjašnjivu bol u mišićima ili bol u mišićima koja ne prolazi, osjetljivost na dodir ili slabost (mogući znakovi mišićnih tegoba).
English: Increased hepatic alkaline phosphatase (ALP) and direct bilirubin as well as vacuolation/degeneration/necrosis of bile duct epithelium and enlargement/focal necrosis of hepatocytes was observed in rats and/or monkeys at exposures equal to or greater than 20-30% of the human exposure by AUC at the recommended dose.
Croatian: U štakora i/ili majmuna primijećene su povišene vrijednosti jetrene alkalne fosfataze (ALP) i direktnog bilirubina, ali i vakuolizacija/degeneracija/nekroza epitela žučovoda te povećanje/fokalna nekroza hepatocita, pri razinama izloženosti koje su bile najmanje 20 - 30% veće od izloženosti u ljudi nakon primjene preporučene doze (na temelju AUC-a).
English: ● If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
Croatian: Ako je Alecensa zapakirana u boce, čuvati u originalnom pakiranju i držati bocu čvrsto zatvorenom radi zaštite od vlage.
English: Table 5 Efficacy results from studies NP28673 and NP28761
Croatian: Tablica 5 Rezultati djelotvornosti iz ispitivanja NP28673 i NP28761
English: Based on the severity of the adverse drug reaction, Alecensa should be withheld and resumed at a reduced dose, or permanently discontinued as described in Table 2 (see section 4.2).
Croatian: Ovisno o težini nuspojave lijeka, potrebno je odgoditi primjenu lijeka Alecensa i zatim nastaviti liječenje smanjenom dozom ili trajno obustaviti liječenje na način opisan u Tablici 2 (vidjeti dio 4.2).
English: CPK elevation > 5 times ULN
Croatian: Povišene vrijednosti CPK-a > 5 puta iznad GGN-a
English: The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
Croatian: Mjera primarnog ishoda bila je ocijeniti djelotvornost lijeka Alecensa na temelju stope objektivnog odgovora (ORR) prema ocjeni središnjeg neovisnog ocjenjivačkog povjerenstva (IRC) temeljenoj na verziji 1.1 RECIST kriterija u cjelokupnoj populaciji (prethodno izloženoj i prethodno neizloženoj citotoksičnoj kemoterapiji).
English: Negligible amounts of alectinib and the active metabolite M4 are excreted unchanged in urine (< 0.2%
Croatian: Mokraćom se u neizmijenjenom obliku izlučuju zanemarive količine alektiniba i njegova aktivnog metabolita M4 (< 0,2% doze).
English: Target organs in both rat and monkey at clinically relevant exposures in the repeat-dose toxicology studies included, but were not limited to the erythroid system, gastrointestinal tract, and hepatobiliary system.
Croatian: U ispitivanjima toksičnosti ponovljenih doza ciljni organi i kod štakora i kod majmuna pri klinički značajnim razinama izloženosti uključivali su, između ostaloga, eritroidni sustav, probavni sustav i sustav jetre i žuči.
English: Alecensa is for oral use.
Croatian: Alecensa se primjenjuje peroralno.
English: Elevations of CPK occurred in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Croatian: U pivotalnim ispitivanjima lijeka Alecensa nastupila su povišenja vrijednosti CPK-a, uključujući događaje stupnja 3 (vidjeti dio 4.8).
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies.
Croatian: U ispitivanjima opće toksičnosti nisu primijećeni štetni učinci na reproduktivne organe mužjaka i ženki
English: [7.6, NE]
Croatian: [7,6; NP]
English: This is to check you do not have any liver or muscle problems while taking Alecensa.
Croatian: Na taj će način provjeriti imate li jetrenih ili mišićnih tegoba tijekom liječenja lijekom Alecensa.
English: ● abnormal results of blood tests to check kidney function (high level of creatinine)
Croatian: ● odstupanja u nalazima krvnih testova kojima se provjerava bubrežna funkcija (visoka razina kreatinina)
English: In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
Croatian: U kliničkom ispitivanju faze III BO28984, mučnina stupnja 4 zabilježena je u jednog bolesnika (0,2%) u skupini liječenoj lijekom Alecensa, dok je incidencija mučnine, povraćanja i proljeva stupnja 3 i 4 u skupini koja je primala krizotinib iznosila 3,3%, 3,3% odnosno 2,0%.
English: Alecensa 150 mg hard capsules alectinib
Croatian: Alecensa 150 mg tvrde kapsule alektinib
English: In 5.2% of patients, bilirubin elevations led to dose modifications and in 1.5% of patients, bilirubin elevations led to withdrawal from Alecensa treatment.
Croatian: Povišene vrijednosti bilirubina su u 5,2% bolesnika dovele do prilagodbe doze, dok su u 1,5% bolesnika dovele do prekida liječenja lijekom Alecensa.
English: If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Croatian: U slučaju povraćanja nakon uzimanja doze lijeka Alecensa bolesnici trebaju uzeti sljedeću dozu prema uobičajenom rasporedu.
English: There were no fatal cases of ILD in any of the clinical trials.
Croatian: Ni u jednom od kliničkih ispitivanja nije zabilježen nijedan slučaj IBP-a sa smrtnim ishodom.
English: Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay but induced a slight increase in numerical aberrations in the in vitro cytogenetic assay using Chinese Hamster Lung (CHL) cells with metabolic activation, and micronuclei in a rat bone marrow micronucleus test.
Croatian: Alektinib nije bio mutagen u in vitro testu reverzne mutacije bakterija (Amesov test), ali je inducirao blago povećanje numeričkih aberacija u in vitro citogenetskom testu na stanicama pluća kineskog hrčka (engl.
English: Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana anti-ALK (D5F3) immunohistochemistry (IHC) was required before randomisation into the study.
Croatian: Prije randomiziranog uključivanja u ispitivanje bilo je obvezno provesti testiranje uzoraka tkiva svih bolesnika u središnjem laboratoriju radi utvrđivanja prisutnosti ekspresije proteina ALK imunohistokemijskim testom Ventana anti-ALK (D5F3).
English: The safety and efficacy of Alecensa in ALK-positive NSCLC patients pre-treated with crizotinib were studied in two Phase I/II clinical trials (NP28673 and NP28761).
Croatian: Sigurnost i djelotvornost lijeka Alecensa u bolesnika s ALK-pozitivnim NSCLC-om prethodno liječenih krizotinibom ispitivane su u dvama kliničkim ispitivanjima faze I/II (NP28673 i NP28761).
English: Bottles: Store in the original package and keep the bottle tightly closed in order to protect from moisture.
Croatian: Boce: Čuvati u originalnom pakiranju i držati bocu čvrsto zatvorenom radi zaštite od vlage.
English: See ‘Side effects' in section 4 for more information.
Croatian: Za više informacija pogledajte dio 4. „Nuspojave“.
English: ● abnormal results of blood tests to check for muscle damage (high level of creatine phosphokinase)
Croatian: ● odstupanja u nalazima krvnih pretraga kojima se utvrđuje oštećenje mišića (visoka razina kreatin fosfokinaze)
English: ● nilotinib, a medicine used to treat certain types of cancer
Croatian: ● nilotinib, lijek koji se koristi za liječenje određenih vrsta raka
English: Alecensa has not been studied in patients with severe renal impairment.
Croatian: Alecensa nije ispitivana u bolesnika s teškim oštećenjem bubrežne funkcije.
English: The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax and AUCinf by 4% and 18%, respectively.
Croatian: M4 bio je malen, uz smanjenje Cmax i AUCinf za 4% odnosno 18%.
English: Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment.
Croatian: ● upalu pluća (pneumonitis) - Alecensa može uzrokovati teško ili po život opasno oticanje (upalu) pluća tijekom liječenja.
English: Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
Croatian: Istodobna primjena višestrukih oralnih doza rifampicina, snažnog induktora CYP3A, od 600 mg jedanput na dan s jednokratnom oralnom dozom alektiniba od 600 mg smanjila je Cmax i AUCinf alektiniba za 51% odnosno 73% te povećala Cmax i AUCinf metabolita M4 2,20 odnosno 1,79 puta.
English: The ECOG (Eastern Cooperative Oncology Group) performance status at baseline was 0 or 1 in 90.6% of patients and 2 in 9.4% of patients.
Croatian: Funkcionalni ECOG status na početku ispitivanja iznosio je 0 ili 1 u 90,6% bolesnika te 2 u 9,4% bolesnika.
English: ● methotrexate, a medicine used to treat certain types of cancer or to treat autoimmune diseases (e.g.
Croatian: ● metotreksat, lijek koji se koristi za liječenje određenih vrsta raka ili za liječenje autoimunih bolesti (npr. reumatoidnog artritisa)