FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for liver function including ALT, AST, and total bilirubin as outlined in section 4.4 and managed as recommended in section 4.2.
Croatian: Potrebno je pratiti jetrenu funkciju bolesnika, uključujući ALT, AST i ukupni bilirubin, kako je opisano u dijelu 4.4 te ih treba zbrinuti na način preporučen u dijelu 4.2.
English: Based on a population PK analysis, the apparent clearance (CL/F) of alectinib was 81.9 L/hour.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, prividni klirens (CL/F) alektiniba iznosio je 81,9 l/h.
English: White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
Croatian: Bijela tvrda kapsula duljine 19,2 mm, s oznakom „ALE“ otisnutom crnom tintom na kapici kapsule i oznakom „150 mg“ otisnutom crnom tintom na tijelu kapsule.
English: 240 hard capsules
Croatian: 240 tvrdih kapsula
English: When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Croatian: Kada se Alecensa primjenjuje istodobno sa supstratima BCRP-a (npr. metotreksatom, mitoksantronom, topotekanom i lapatinibom), preporučuje se odgovarajući nadzor.
English: Permanently discontinue in case of recurrence.
Croatian: U slučaju ponovnog nastupa, trajno obustaviti liječenje.
English: This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Croatian: Ovaj lijek sadrži 48 mg natrija (glavni sastojak kuhinjske soli) po preporučenoj dnevnoj dozi (1200 mg).
English: What you need to know before you take Alecensa
Croatian: Što morate znati prije nego počnete uzimati lijek Alecensa
English: In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations.
Croatian: Ispitivanja in vitro pokazuju da ni alektinib ni njegov glavni metabolit (M4) ne inhibiraju CYP1A2, CYP2B6, CYP2C9, CYP2C19 ni CYP2D6 pri klinički značajnim koncentracijama.
English: Table 4 Summary of efficacy results from study BO28984 (ALEX)
Croatian: Tablica 4 Sažetak rezultata djelotvornosti iz ispitivanja BO28984 (ALEX)
English: Alectinib demonstrated in vitro and in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.
Croatian: Alektinib je in vitro i in vivo pokazao aktivnost protiv mutiranih oblika enzima ALK, uključujući mutacije odgovorne za rezistenciju na krizotinib.
English: 12-month cumulative incidence of CNS progression (IRC) [95% CI]
Croatian: 12-mjesečna kumulativna incidencija progresije u SŽS-u (IRC) [95% CI]
English: ● everolimus, a medicine used to treat certain types of cancer or used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Croatian: ● everolimus, lijek koji se koristi za liječenje određenih vrsta raka ili sprječavanje imunološkog sustava tijela da odbaci presađen bubreg, srce ili jetru
English: ● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
Croatian: ● lijekovi koji se koriste za liječenje AIDS-a/HIV infekcije (npr. ritonavir, sakvinavir)
English: Female patients, who become pregnant while taking Alecensa or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the foetus.
Croatian: Bolesnice koje zatrudne tijekom liječenja lijekom Alecensa ili unutar 3 mjeseca nakon posljednje doze lijeka Alecensa moraju se obratiti svom liječniku te ih je potrebno upozoriti na moguće štetne učinke za plod.
English: The major metabolite of alectinib (M4) has shown similar in vitro potency and activity.
Croatian: Glavni metabolit alektiniba (M4) pokazao je sličnu potentnost i aktivnost in vitro.
English: Patients should be advised to avoid prolonged sun exposure while taking Alecensa, and for at least 7 days after discontinuation of treatment.
Croatian: Bolesnicima treba savjetovati da izbjegavaju dugotrajno izlaganje suncu tijekom liječenja lijekom Alecensa i još najmanje 7 dana po završetku liječenja.
English: The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
Croatian: Korist u smislu PFS-a bila je dosljedna za bolesnike s metastazama u SŽS-u na početku ispitivanja (HR = 0,40; 95% CI: 0,25-0,64, medijan PFS-a za lijek Alecensa = NP, 95% CI: 9,2-NP; medijan PFS-a za krizotinib = 7,4 mjeseca, 95% CI: 6,6-9,6) i za one bez metastaza u SŽS-u na početku ispitivanja (HR = 0,51; 95% CI: 0,33-0,80; medijan PFS-a za lijek Alecensa = NP, 95% CI: NP, NP; medijan PFS-a za krizotinib = 14,8 mjeseci, 95% CI:10,8-20,3), što ukazuje na prednost lijeka Alecensa pred krizotinibom u obje podskupine.
English: Your doctor will take blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
Croatian: Liječnik će provoditi krvne pretrage prije početka liječenja i zatim svaka 2 tjedna tijekom prva 3 mjeseca liječenja, a nakon toga nešto rjeđe.
English: As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
Croatian: Budući da alektinib inhibira P-gp, ne očekuje se da će istodobna primjena s inhibitorima P-gp-a značajno utjecati na izloženost metabolitu
English: Population PK analysis supports dose proportionality for alectinib across the dose range of 300 to 900 mg under fed conditions.
Croatian: Populacijska farmakokinetička analiza potvrđuje da je apsorpcija alektiniba proporcionalna dozi u rasponu doza od 300 do 900 mg uz primjenu nakon obroka.
English: A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
Croatian: U majmuna je primijećen blag hipotenzivni učinak pri razinama izloženosti koje su bile približno jednake klinički značajnoj izloženosti.
English: If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours.
Croatian: Ako propusti uzeti planiranu dozu lijeka Alecensa, bolesnik je može nadoknaditi, osim ako je do sljedeće doze preostalo manje od 6 sati.
English: 1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Croatian: 5) uključuje slučajeve stomatitisa i ulceracije u ustima uključuje slučajeve povišenih vrijednosti bilirubina u krvi, hiperbilirubinemije i povišenih vrijednosti konjugiranog bilirubina uključuje dva bolesnika s prijavljenim MedDRA pojmom oštećenja jetre induciranog djelovanjem lijeka, kao i jednog bolesnika s prijavljenim povišenim vrijednostima AST-a i ALT-a stupnja 4 koji je imao dokumentirano oštećenje jetre inducirano djelovanjem lijeka, potvrđeno biopsijom jetre 8) uključuje slučajeve osipa, makulo-papularnog osipa, akneiformnog dermatitisa, eritema, generaliziranog osipa, papularnog osipa, pruritičkog osipa, makularnog osipa i eksfolijacijskog osipa 9) uključuje slučajeve mialgije i mišićno-koštane boli uključuje slučajeve perifernog edema, edema, generaliziranog edema, edema vjeđa, periorbitalnog edema, edema lica i lokaliziranog edema
English: The absolute bioavailability of alectinib capsules was 36.9% (90% CI: 33.9%, 40.3%) under fed conditions in healthy subjects.
Croatian: Apsolutna bioraspoloživost kapsula alektiniba uz primjenu nakon obroka u zdravih ispitanika iznosila je 36,9% (90% CI: 33,9%, 40,3%).
English: However, since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see section 5.2).
Croatian: Međutim, budući da je izlučivanje alektiniba bubrezima zanemarivo, nije potrebno prilagođavati dozu u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Dose modifications for elevation of CPK occurred in 3.2% of patients; withdrawal from Alecensa treatment did not occur due to CPK elevations.
Croatian: Prilagodba doze zbog povišenih vrijednosti CPK-a provedena je u 3,2% bolesnika; nije došlo do prekida liječenja lijekom Alecensa zbog povišenja vrijednosti CPK-a.
English: Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Croatian: Stoga nije potrebno prilagođavati dozu kada se Alecensa primjenjuje istodobno s inhibitorima protonske pumpe ili drugim lijekovima koji povisuju želučani pH (npr. antagonistima
English: ● New or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever - the signs may be similar to those from your lung cancer (potential signs of lung inflammation - pneumonitis).
Croatian: ● novi znakovi ili pogoršanje postojećih znakova, uključujući otežano disanje, nedostatak zraka, produktivan ili suhi kašalj ili vrućicu - ti znakovi mogu biti slični onima koje uzrokuje rak pluća (mogući znakovi upale pluća - pneumonitisa).
English: Description of selected adverse drug reactions
Croatian: Opis odabranih nuspojava lijeka
English: ● is ‘ALK-positive' - this means your cancer cells have a fault in a gene that makes an enzyme called
Croatian: ● „ALK-pozitivan“ - to znači da stanice raka imaju grešku u genu koji je odgovoran za stvaranje enzima koji se zove ALK („kinaza anaplastičnog limfoma“).
English: There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
Croatian: U 66 od 365 bolesnika (18%) liječenih lijekom Alecensa vrijednosti srčane frekvencije nakon primjene doze bile su ispod 50 otkucaja u minuti.
English: The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects.
Croatian: Farmakokinetički parametri alektiniba i njegova glavnog aktivnog metabolita (M4) određeni su u bolesnika s ALK-pozitivnim NSCLC-om i zdravih ispitanika.
English: The mean in vitro human blood-to-plasma concentration ratios of alectinib and M4 are 2.64 and 2.50, respectively, at clinically relevant concentrations.
Croatian: u krvi u odnosu na plazmu u ljudi in vitro iznosi 2,64 odnosno 2,50 pri klinički značajnim koncentracijama.
English: When you take Alecensa your doctor will do blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
Croatian: Dok budete uzimali lijek Alecensa, liječnik će provoditi krvne pretrage prije početka liječenja i zatim svaka 2 tjedna tijekom prva 3 mjeseca liječenja, a nakon toga nešto rjeđe.
English: ● If it is less than 6 hours until your next dose, skip the missed dose.
Croatian: Ako je do sljedeće doze preostalo manje od 6 sati, preskočite propuštenu dozu.
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:
Croatian: Liječnik će Vam možda smanjiti dozu, privremeno prekinuti primjenu lijeka ili posve obustaviti liječenje:
English: Blood and lymphatic system disorders Anaemia
Croatian: Poremećaji krvi i limfnog sustava anemija vrlo često
English: ● vomiting - 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: ● povraćanje - ako povratite nakon uzimanja doze lijeka Alecensa, nemojte uzeti dodatnu dozu, nego uzmite sljedeću dozu u uobičajeno vrijeme
English: ● The active substance is alectinib.
Croatian: Djelatna tvar je alektinib.
English: Alecensa contains lactose
Croatian: Alecensa sadrži laktozu
English: Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
Croatian: Sadržaj kapsule laktoza hidrat hidroksipropilceluloza natrijev laurilsulfat magnezijev stearat karmelozakalcij
English: ● Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose'), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium'), magnesium stearate and carmellose calcium
Croatian: ● Sadržaj kapsule: laktoza hidrat (pogledajte odlomak „Alecensa sadrži laktozu“ u dijelu 2.), hidroksipropilceluloza, natrijev laurilsulfat (pogledajte odlomak „Alecensa sadrži natrij“ u dijelu 2.), magnezijev stearat i karmelozakalcij
English: This medicinal product contains 48 mg sodium per daily dose (1200 mg), equivalent to 2.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 48 mg natrija po dnevnoj dozi (1200 mg), što odgovara 2,4% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije (SZO) za odraslu osobu.
English: Effects of other medicinal products on alectinib
Croatian: Učinci drugih lijekova na alektinib
English: Based on its mechanism of action, Alecensa may cause foetal harm when administered to a pregnant woman.
Croatian: S obzirom na mehanizam djelovanja, Alecensa može imati štetne učinke na plod kada se primjenjuje u trudnica.
English: Table 2 Dose modification advice for specified Adverse Drug Reactions (see sections 4.4 and 4.8) CTCAE grade
Croatian: Tablica 2 Preporuke za prilagodbu doze kod specifičnih nuspojava lijeka (vidjeti dijelove 4.4 i 4.8)
English: Patients should also be advised to use a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sun screen and lip balm (SPF ≥50) to help protect against potential sunburn.
Croatian: Bolesnicima treba savjetovati i da koriste kreme koje štite od širokog spektra ultraljubičastih zraka (UVA/UVB) te balzam za usne (sa zaštitnim faktorom ≥ 50), kako bi se zaštitili od mogućih sunčevih opeklina.
English: If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and Alecensa treatment should be adjusted as described in Table 2 (see sections 4.2 and 4.5, ‘P-gp substrates' and ‘BCRP substrates').
Croatian: Ako u bolesnika nastupi simptomatska bradikardija ili po život opasni događaji, potrebno je procijeniti istodobno primijenjene lijekove za koje se zna da uzrokuju bradikardiju, kao i antihipertenzivne lijekove , te prilagoditi liječenje lijekom Alecensa na način opisan u Tablici 2 (vidjeti dio 4.2 i odlomak 'Supstrati P-gp-a' i 'Supstrati BCRP-a' u dijelu 4.5).
English: Immediately interrupt and permanently discontinue Alecensa if no other potential causes of ILD/pneumonitis have been identified.
Croatian: Odmah prekinuti primjenu i trajno obustaviti liječenje lijekom Alecensa ako se ne identificiraju drugi mogući uzroci IBP-a/pneumonitisa.
English: (range 1 - 30)
Croatian: (raspon: 1 - 30)
English: Women of childbearing potential must be advised to avoid pregnancy while on Alecensa.
Croatian: Žene reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću tijekom liječenja lijekom Alecensa.
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
Croatian: Bolesnici s podležećim teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) trebaju primati početnu dozu od 450 mg dvaput na dan (ukupna dnevna doza od 900 mg) (vidjeti dio 5.2).
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension) or vision disorders while taking Alecensa (see section 4.8).
Croatian: Potreban je oprez pri upravljanju vozilima ili radu sa strojevima jer bolesnici mogu doživjeti simptomatsku bradikardiju (npr. sinkopu, omaglicu, hipotenziju) ili poremećaje vida tijekom liječenja lijekom Alecensa (vidjeti dio 4.8).
English: HDPE bottle with a child-resistant closure and an integrated desiccant.
Croatian: HDPE boca sa zatvaračem sigurnim za djecu i ugrađenim sredstvom za sušenje.
English: Pack size: 240 hard capsules.
Croatian: Veličina pakiranja: 240 tvrdih kapsula.
English: In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
Croatian: In vitro, alektinib i M4 inhibiraju efluksni prijenosnik zvan protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
English: Following oral administration of 600 mg twice daily under fed conditions in ALK-positive NSCLC patients, alectinib was absorbed reaching Tmax after approximately 4 to 6 hours.
Croatian: Nakon peroralne primjene doze od 600 mg dvaput na dan nakon obroka u bolesnika s ALK-pozitivnim NSCLC-om, alektinib se apsorbirao i postigao Tmax nakon približno 4 - 6 sati.
English: ● The recommended dose is 3 capsules (450 mg) twice a day.
Croatian: Preporučena doza je 3 kapsule (450 mg) dvaput na dan.
English: In vitro, alectinib and M4 show weak time-dependent inhibition of CYP3A4, and alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations.
Croatian: In vitro, alektinib i M4 pokazuju slabu inhibiciju CYP3A4 ovisnu o vremenu, dok alektinib u kliničkim koncentracijama pokazuje slab potencijal za indukciju CYP3A4 i CYP2B6.
English: M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Croatian: Cmax i AUCinf metabolita M4 bili su 39% odnosno 34% niži, zbog čega je kombinirana izloženost alektinibu i njegovu metabolitu M4 (AUCinf) bila 1,8 puta viša u bolesnika s teškim oštećenjem jetrene funkcije u usporedbi s uparenim zdravim ispitanicima.
English: Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
Croatian: Nakon primjene jedne peroralne doze od 300 mg alektiniba u ispitanika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C), Cmax alektiniba bio je isti, dok je AUCinf bio 2,2 puta viši u usporedbi s istim parametrima u uparenih zdravih ispitanika.
English: No fertility studies in animals have been performed to evaluate the effect of Alecensa.
Croatian: Nisu provedena ispitivanja na životinjama kojima bi se ocijenio učinak lijeka Alecensa na plodnost.
English: ● digoxin, a medicine used to treat heart problems
Croatian: ● digoksin, lijek koji se koristi za liječenje srčanih tegoba
English: ● Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: At the time of entry in the study, 99% of patients had stage IV disease, 61% had brain metastases and in 96% of patients tumours were classified as adenocarcinoma.
Croatian: U trenutku uključivanja u ispitivanje, 99% bolesnika imalo je bolest stadija IV, njih 61% imalo je metastaze u mozgu, a u 96% bolesnika tumor je klasificiran kao adenokarcinom.
English: When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Croatian: Kada se Alecensa primjenjuje istodobno sa supstratima P-gp-a (npr. digoksinom, dabigatraneteksilatom, topotekanom, sirolimusom, everolimusom, nilotinibom i lapatinibom), preporučuje se odgovarajući nadzor.
English: Effects of alectinib on other medicinal products
Croatian: Učinci alektiniba na druge lijekove
English: (range 1 - 29)
Croatian: (raspon: 1 - 29)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1169/001
English: Figure 1: Kaplan Meier Plot of INV Assessed PFS in BO28984 (ALEX)
Croatian: Slika 1: Kaplan-Meierova krivulja PFS-a prema ocjeni ispitivača u ispitivanju BO28984 (ALEX)
English: The majority of the events were of Grade 1 and 2 intensity; Grade 3 events were reported in 3.2% of the patients.
Croatian: Većina događaja bila je intenziteta stupnja 1 i 2 ; događaji stupnja 3 prijavljeni su u 3,2% bolesnika.
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 (see sections 4.6 and 5.3).
Croatian: Bolesnice reproduktivne dobi koje se liječe lijekom Alecensa moraju koristiti visoko učinkovite kontracepcijske metode tijekom liječenja i još najmanje 3 mjeseca nakon posljednje doze lijeka Alecensa (vidjeti dijelove 4.6 i
English: Alecensa 600 mg twice daily
Croatian: Alecensa 600 mg dvaput na dan
English: The geometric mean steady-state Cmax, Cmin and AUC0-12hr for M4 were approximately 246 ng/mL (45.4%), 222 ng/mL (46.6%) and 2810 ng*h/mL (45.9%), respectively.
Croatian: Geometrijske srednje vrijednosti Cmax, Cmin i AUC0-12h metabolita M4 u stanju dinamičke ravnoteže iznosile su približno 246 ng/ml (45,4%), 222 ng/ml (46,6%) odnosno 2810 ng*h/ml (45,9%).
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; ORR = objective response rate; NE = not estimable
Croatian: CI = interval pouzdanosti; DOR = trajanje odgovora; IRC = neovisno ocjenjivačko povjerenstvo; ORR = stopa objektivnog odgovora; NP = ne može se procijeniti
English: Alecensa may cause foetal harm when administered to a pregnant woman.
Croatian: Alecensa može uzrokovati oštećenje ploda kada se primjenjuje trudnicama.
English: The hepatic impairment study also included a group with moderate (Child-Pugh B) hepatic impairment, and a modestly higher alectinib exposure was observed in this group compared with matched healthy subjects.
Croatian: Ispitivanje provedeno u bolesnika s oštećenjem jetrene funkcije uključivalo je i skupinu s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B) i u toj je skupini opaženo blago povećanje izloženosti alektinibu u usporedbi s uparenim zdravim ispitanicima.
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily with food (total daily dose of 900 mg).
Croatian: Bolesnici s podležećim teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) trebaju primati početnu dozu od 450 mg dvaput na dan s hranom (ukupna dnevna doza od 900 mg).
English: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Croatian: Alecensa je kao monoterapija indicirana za prvu liniju liječenja odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) pozitivnim na kinazu anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK).
English: At the time of entry in the study, 99% of patients had stage IV disease, 60% had brain metastases and in 94% of patients tumours were classified as adenocarcinoma.
Croatian: U trenutku uključivanja u ispitivanje, 99% bolesnika imalo je bolest stadija IV, 60% bolesnika imalo je metastaze u mozgu, a u 94% bolesnika tumor je klasificiran kao adenokarcinom.