FrancophonIA/ELRC3.0 huggingface dataset:
English: The demographic characteristics of the overall study population were 67% Caucasian, 26% Asian, 56% females, and the median age was 52 years.
Slovenian: Demografske značilnosti celotne študijske populacije so bile: 67 % belcev, 26 % Azijcev, 56 % žensk, mediana starost 52 let.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate oz. ne prebavljate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: CPK levels should be assessed every two weeks for the first month of treatment and as clinically indicated in patients reporting symptoms.
Slovenian: Koncentracije CPK je treba določiti vsaka dva tedna v prvem mesecu zdravljenja, pri bolnikih, ki poročajo o simptomih, pa kot je klinično indicirano.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri do 1 od 10 bolnikov):
English: A risk for induction of CYP2B6 and PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Slovenian: Tveganja za indukcijo encimov CYP2B6 in drugih encimov, reguliranih s PXR, razen encima CYP3A4, ni mogoče povsem izključiti.
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis.
Slovenian: Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na pnevmonitis.
English: The limited data on the safety and efficacy of Alecensa in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Omejeni podatki glede varnosti in učinkovitosti zdravila Alecensa pri bolnikih, starih 65 let ali več, ne kažejo, da bi bilo treba starejšim bolnikom odmerek prilagoditi (glejte poglavje 5.2).
English: The events declined in frequency after the first month of treatment.
Slovenian: Pogostnost učinkov se je po prvem mesecu zdravljenja zmanjšala.
English: The demographic characteristics of the overall study population were 84% Caucasian, 8% Asian, 55% females.
Slovenian: Demografske značilnosti celotne študijske populacije so bile: 84 % belcev, 8 % Azijcev, 55 % žensk.
English: You should use caution when drinking grapefruit juice or eating grapefruit or Seville oranges while on treatment with Alecensa as they may change the amount of Alecensa in your body.
Slovenian: Bodite previdni, če med zdravljenjem z zdravilom Alecensa pijete grenivkin sok ali jeste grenivke ali grenke pomaranče, saj lahko spremenijo količino zdravila Alecensa v vašem telesu.
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Slovenian: Ocenite sočasna zdravila, za katera je znano, da povzročajo bradikardijo, in antihipertenzivna zdravila.
English: Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, prirojeno pomanjkanje laktaze ali malabsorbcija glukoze-galaktoze, ne smejo jemati tega zdravila.
English: ● liver injury (hepatotoxicity).
Slovenian: ● poškodba jeter (hepatotoksičnost).
English: Stratified log-rank p-value p <0.0001
Slovenian: Stratificirana log-rang p-vrednost p < 0,0001
English: ● blurred vision, loss of sight, black dots or white spots in your vision, and seeing double (problems with your eyes)
Slovenian: ● zamegljen vid, izguba vida, črne ali bele pike v vidnem polju ali dvojni vid (težave z očmi);
English: Management of adverse events may require dose reduction, temporary interruption, or discontinuation of treatment with Alecensa.
Slovenian: Obvladovanje neželenih učinkov lahko obsega zmanjšanje odmerka, začasno prekinitev uporabe ali ukinitev zdravljenja z zdravilom Alecensa.
English: These patients were treated with the recommended dose of 600 mg twice daily.
Slovenian: Ti bolniki so bili zdravljeni s priporočenim odmerkom 600 mg dvakrat na dan.
English: The safety and efficacy of Alecensa in children and adolescents below 18 years of age have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Alecensa pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: Liver function, including ALT, AST, and total bilirubin should be monitored at baseline and then every 2 weeks during the first 3 months of treatment.
Slovenian: Delovanje jeter, vključno z ALT, AST in celokupnim bilirubinom, je treba kontrolirati izhodiščno in nato na 2 tedna prve 3 mesece zdravljenja.
English: Age, body weight, race and gender had no clinically meaningful effect on the systemic exposure of alectinib and M4.
Slovenian: Starost, telesna masa, rasa in spol niso klinično pomembno vplivali na sistemsko izpostavljenost alektinibu in M4.
English: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
Slovenian: Vsaka trda kapsula vsebuje 33,7 mg laktoze (v obliki monohidrata) in 6 mg natrija (v obliki natrijevega lavrilsulfata).
English: ALK (‘anaplastic lymphoma kinase'), see ‘How Alecensa works', below
Slovenian: imenovan ALK (anaplastična limfomska kinaza); glejte "Kako deluje zdravilo Alecensa", spodaj;
English: Based on a population PK analysis, the apparent clearance (CL/F) of alectinib was 81.9 L/hour.
Slovenian: Na podlagi populacijske farmakokinetične analize je navidezni očistek (CL/F) alektiniba 81,9 l/uro.
English: What Alecensa is and what it is used for 2.
Slovenian: Kaj je zdravilo Alecensa in za kaj ga uporabljamo 2.
English: This is because it is not known if Alecensa can pass over into breast milk and could therefore harm your baby.
Slovenian: Ni namreč znano, ali zdravilo Alecensa prehaja v materino mleko in bi tako lahko škodovalo otroku.
English: ● If you become pregnant when taking the medicine or during the 3 months after taking your last dose, tell your doctor straight away.
Slovenian: ● Če med jemanjem tega zdravila ali v 3 mesecih po zadnjem odmerku tega zdravila zanosite, morate nemudoma obvestiti zdravnika.
English: M4 has shown similar in vitro potency and activity against ALK.
Slovenian: M4 je in vitro pokazal podobno moč in aktivnost proti ALK.
English: Grades 3-4
Slovenian: Stopnja 3 do 4*
English: Metabolite M1b was detected as a minor metabolite from in vitro and in human plasma in healthy subjects.
Slovenian: Presnovek M1b so določili kot manj pogost presnovek in vitro in v človeški plazmi pri zdravih osebah.
English: Severe myalgia and CPK elevations
Slovenian: Huda mialgija in zvišanja CPK
English: The European Medicines Agency has waived the obligation to submit the results of studies with Alecensa in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Alecensa za vse podskupine pediatrične populacije pri karcinomu pljuč (drobnoceličnem in nedrobnoceličnem karcinomu) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: For all patients with hepatic impairment, appropriate monitoring (e.g. markers of liver function) is advised, see section 4.4.
Slovenian: Za vse bolnike z okvaro jeter je priporočeno ustrezno spremljanje (npr. spremljanje označevalcev delovanja jeter); glejte poglavje 4.4.
English: Also some other medicines can affect the way Alecensa works.
Slovenian: Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Alecensa.
English: The geometric mean Metabolite/Parent ratio at steady state is 0.399.
Slovenian: Geometrična sredina razmerja presnovek/matična snov je v stanju dinamičnega ravnovesja 0,399.
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.
Slovenian: Izhodiščno stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) je bilo 0 ali 1 pri 90,6 % bolnikov in 2 pri 9,4 % bolnikov.
English: Alectinib and its major metabolite M4 are highly bound to human plasma proteins (>99%), independent of active substance concentration.
Slovenian: Alektinib in njegov glavni presnovek M4 sta v veliki meri vezana na beljakovine v človeški plazmi (> 99 %) ne glede na koncentracijo učinkovine.
English: Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate.
Slovenian: Večkratni 600-mg odmerki alektiniba niso vplivali na izpostavljenost midazolamu (2 mg), ki je občutljiv substrat CYP3A.
English: Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
Slovenian: Bolnike, ki se jim pojavi simptomatska bradikardija, je treba obravnavati, kot je priporočeno v poglavjih 4.2 in 4.4.
English: ● medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
Slovenian: ● zdravila za zdravljenje tuberkuloze (npr. rifampicin, rifabutin),
English: The events generally occurred during the first 3 months of treatment, were usually transient and resolved upon temporary interruption of Alecensa treatment (reported for 1.5% and 3.0% of the patients, respectively) or dose reduction (2.2% and 1.2%, respectively).
Slovenian: Takšno zvišanje se je običajno pojavilo v prvih 3 mesecih zdravljenja, po navadi je bilo prehodno in je minilo po začasni prekinitvi jemanja zdravila Alecensa (pri 1,5 % oziroma 3,0 % bolnikov) ali po zmanjšanju odmerka (pri 2,2 % oziroma 1,2 % bolnikov).
English: ● This means you take a total of 8 capsules (1200 mg) each day.
Slovenian: ● To pomeni, da vsak dan vzamete 8 kapsul (1200 mg).
English: Results from the human mass balance study demonstrated that alectinib and M4 were the main circulating moieties in plasma with 76% of the total radioactivity in plasma.
Slovenian: Rezultati študije masnega ravnovesja pri človeku so pokazali, da sta alektinib in M4 glavni snovi v obtoku v plazmi (76 % celotne radioaktivnosti).
English: If you are able to become pregnant, you must use highly effective contraception while on treatment and for at least 3 months after stopping treatment.
Slovenian: Če bi lahko zanosili, morate med zdravljenjem in vsaj še 3 mesece po koncu zdravljenja uporabljati visoko učinkovito kontracepcijsko zaščito.
English: In addition, one patient experienced a Grade 4 adverse event of drug-induced liver injury.
Slovenian: Poleg tega je imel en bolnik neželeni učinek stopnje 4, z zdravilom povzročeno poškodbo jeter.
English: ● dabigatran etexilate, a medicine used to treat blood clots
Slovenian: ● dabigatran eteksilat, zdravilo za zdravljenje krvnih strdkov,
English: In addition to crizotinib, patients may have received previous treatment with chemotherapy.
Slovenian: Poleg krizotiniba so lahko bolniki predhodno prejemali kemoterapijo.
English: Alecensa has not been studied in children or adolescents.
Slovenian: Zdravila Alecensa niso preizkušali pri otrocih in mladostnikih.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vplivi drugih zdravil na alektinib
English: The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56).
Slovenian: Kapsule so pakirane v pretisne omote in so na voljo v škatli, ki vsebuje 224 trdih kapsul (4 pakiranja po 56 trdih kapsul).
English: It is unknown whether alectinib and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se alektinib in njegovi presnovki pri človeku izločajo v materino mleko.
English: In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
Slovenian: V predkliničnih študijah je zavrtje ALK-tirozin-kinaze povzročilo blokado nadaljnjih signalnih poti, vključno s STAT 3 in PI3K/AKT, in je izzvalo smrt tumorskih celic (apoptozo).
English: (range 0.5 - 29.0)
Slovenian: (razpon 0,5-29,0)
English: This is because Alecensa can affect the way some other medicines work.
Slovenian: Zdravilo Alecensa namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: Based on in vitro data, alectinib is not a substrate of P-gp.
Slovenian: Glede na podatke in vitro alektinib ni substrat P-gp.
English: Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.
Slovenian: Alektinib je visoko selektiven in močan zaviralec ALK- in RET-tirozin-kinaze.
English: CPK elevation > 10 times ULN or second occurrence of CPK elevation of > 5 times ULN
Slovenian: Zvišanje CPK > 10-kratna ZMN ali drugi pojav zvišanja CPK > 5-kratna ZMN
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin)
Slovenian: Ta vključujejo zdravila za zdravljenje glivičnih okužb (protiglivična zdravila, kot so ketokonazol, itrakonazol, vorikonazol, posakonazol) in zdravila za zdravljenje določenih vrst bakterijskih okužb (antibiotiki, kot je telitromicin),
English: Hypersensitivity to alectinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za alektinib ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: ● medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
Slovenian: ● zdravila, ki se uporabljajo za preprečevanje epileptičnih napadov ali krčev (antiepileptiki, kot so fenitoin, karbamazepin in fenobarbital),
English: Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell.
Slovenian: Včasih vam lahko zdravnik zmanjša odmerek, zdravljenje za krajši čas prekine ali zdravljenje ukine, če se ne počutite dobro.
English: (range 0.3 - 27.0)
Slovenian: (razpon 0,3-27,0)
English: Alecensa contains lactose (a type of sugar).
Slovenian: Zdravilo Alecensa vsebuje laktozo (vrsto sladkorja).
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.
Slovenian: Medtem, ko boste jemali zdravilo Alecensa, vam bo zdravnik opravil preiskave krvi pred začetkom zdravljenja, potem na 2 tedna prve 3 mesece zdravljenja, pozneje pa manj pogosto.
English: Formation of metabolite M1b and its minor isomer M1a is likely to be catalyzed by a combination of CYP isozymes (including isozymes other than CYP3A) and aldehyde dehydrogenase (ALDH) enzymes.
Slovenian: Nastanek presnovka M1b in njegovega manj pogostega izomera M1a verjetno katalizira kombinacija izoencimov CYP (vključno z izoencimi, ki niso CYP3A) in encimov aldehid dehidrogenaze (ALDH).
English: ● swelling caused by fluid build-up in the body (oedema)
Slovenian: ● otekanje zaradi zastajanja tekočine v telesu (edemi);
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.
Slovenian: Bolnikom je treba kontrolirati delovanje jeter, vključno z ALT, AST in celokupnim bilirubinom, kot je opisano v poglavju 4.4, in postopati, kot je priporočeno v poglavju 4.2.
English: Based on preclinical data, alectinib is not a substrate of p-glycoprotein or BCRP, which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system.
Slovenian: Glede na predklinične podatke alektinib ni substrat p-glikoproteina ali BCRP (ki sta izločevalna prenašalca v krvno-možganski pregradi), zato se lahko porazdeli in zadrži v osrednjem živčevju.
English: Multiple doses of esomeprazole, a proton pump inhibitor, 40 mg once daily, demonstrated no clinically relevant effect on the combined exposure of alectinib and M4.
Slovenian: Večkratni odmerki esomeprazola, zaviralca protonske črpalke, 40 mg enkrat na dan, niso imeli klinično pomembnega vpliva na skupno izpostavljenost alektinibu in M4.
English: 240 hard capsules
Slovenian: 240 trdih kapsul
English: The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability.
Slovenian: Odmerek zdravila Alecensa je treba zmanjševati v korakih po 150 mg dvakrat na dan, upoštevaje prenašanje.
English: It is used if your lung cancer:
Slovenian: Uporablja se za zdravljenje raka pljuč, ki:
English: ● This means you take a total of 6 capsules (900 mg) each day.
Slovenian: ● To pomeni, da vsak dan vzamete 6 kapsul (900 mg).
English: The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg).
Slovenian: Priporočeni odmerek zdravila Alecensa je 600 mg (štiri 150-mg kapsule) dvakrat na dan s hrano (celoten dnevni odmerek 1200 mg).
English: Alecensa may slow down or stop the growth of your cancer.
Slovenian: Zdravilo Alecensa lahko upočasni ali ustavi rast raka, ki ga imate, lahko pa ga pomaga tudi zmanjšati.
English: Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.
Slovenian: Zdravljenje z zdravilom Alecensa je treba ukiniti, če bolnik ne prenese odmerka 300 mg dvakrat na dan.
English: The ECOG performance status at baseline was 0 or 1 in 89.7% of patients and 2 in 10.3% of patients.
Slovenian: Izhodiščno stanje zmogljivosti po ECOG je bilo 0 ali 1 pri 89,7 % bolnikov in 2 pri 10,3 % bolnikov.
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.
Slovenian: V ključnih kliničnih preskušanjih z zdravilom Alecensa so poročali, da so imeli trije bolniki z zvišano AST/ALT stopnje 3 do 4 z zdravilom povzročeno poškodbo jeter.
English: Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib'.
Slovenian: Zdravilo Alencensa vam lahko predpišejo tudi za prvo zdravljenje raka pljuč ali če ste se predhodno že zdravili z zdravilom, ki vsebuje krizotinib.
English: ● If it is less than 6 hours until your next dose, skip the missed dose.
Slovenian: ● Če je do naslednjega odmerka manj kot 6 ur, pozabljeni odmerek izpustite.
English: The subjects in the Child Pugh B group however did in general not suffer from abnormal bilirubin, albumin or prothrombin time, indicating that they may not be fully representative of moderately hepatically impaired subjects with decreased metabolic capacity.
Slovenian: Preskušanci v skupini z okvaro jeter razreda B po ChildPughovi lestvici na splošno niso imeli nenormalnih vrednosti bilirubina, albumina ali protrombinskega časa, kar lahko pomeni, da niso bili najboljši predstavniki oseb z zmerno okvaro jeter in zmanjšano presnovno sposobnostjo.
English: * Includes one Grade 5 event ** Increased alkaline phosphatase was reported in the post-marketing period and in pivotal phase II and phase III clinical trials.
Slovenian: ** O zvišani alkalni fosfatazi so poročali v obdobju trženja zdravila ter v ključnih kliničnih preskušanjih faze II
English: The range of body weights for patients enrolled in clinical studies is 36.9-123 kg.
Slovenian: Razpon telesne mase pri bolnikih, vključenih v klinične študije, je bil 36,9 do
English: What Alecensa is Alecensa is a cancer medicine that contains the active substance alectinib.
Slovenian: Kaj je zdravilo Alecensa Zdravilo Alecensa je zdravilo za zdravljenje raka, ki vsebuje učinkovino alektinib.
English: Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of Alecensa.
Slovenian: Študij kancerogenosti za ugotavljanje kancerogenosti zdravila Alecensa niso izvedli.
English: This is to check you do not have any liver or muscle problems while taking Alecensa.
Slovenian: Namen tega je preveriti, da med jemanjem zdravila Alecensa nimate težav z jetri ali mišicami.
English: ● nefazodone, a medicine used to treat depression
Slovenian: ● nefazodon, zdravilo za zdravljenje depresije.
English: Efficacy data are summarised in Table 4 and the Kaplan-Meier curve for investigator assessed PFS is shown in Figure 1.
Slovenian: Podatki o učinkovitosti so povzeti v preglednici 4, Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni raziskovalca pa je prikazana na sliki 1.
English: (range 1 - 30)
Slovenian: (razpon: 1-30)
English: 224 (4 packs of 56) hard capsules
Slovenian: 224 (4 pakiranja po 56) trdih kapsul
English: CYP substrates
Slovenian: Substrati CYP
English: The geometric mean volume of distribution at steady state (Vss) of alectinib following IV administration was 475 L, indicating extensive distribution into tissues.
Slovenian: Geometrična sredina volumna porazdelitve v stanju dinamičnega ravnovesja (Vss) alektiniba je bila po intravenski uporabi 475 l; to kaže na izdatno porazdelitev v tkiva.
English: See ‘Side effects' in section 4 for more information.
Slovenian: Za več informacij glejte "Neželeni učinki" v poglavju 4.
English: ● slow heart beat (bradycardia).
Slovenian: ● počasen srčni utrip (bradikardija);
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
Slovenian: Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na pnevmonitis (glejte poglavji 4.2 in
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.
Slovenian: To zdravilo vsebuje 48 mg natrija na dnevni odmerek (1200 mg), kar je enako 2,4 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: ● The recommended dose is 4 capsules (600 mg) twice a day.
Slovenian: ● Priporočeni odmerek je 4 kapsule (600 mg) dvakrat na dan.
English: Baseline demographic and disease characteristics for Alecensa were median age 58 years (54 years for crizotinib), 55% female (58% for crizotinib), 55% non-Asian (54% for crizotinib), 61% with no smoking history (65% for crizotinib), 93% ECOG PS of 0 or 1 (93% for crizotinib), 97% Stage IV disease (96% for crizotinib), 90% adenocarcinoma histology (94% for crizotinib), 40% CNS metastases at baseline (38% for crizotinib) and 17% having received prior CNS radiation (14% for crizotinib).
Slovenian: (54 let za krizotinib), 55 % žensk (58 % za krizotinib), 55 % neazijske rase (54 % za krizotinib), 61 % brez anamneze kajenja (65 % za krizotinib), 93 % stanje zmogljivosti po ECOG 0 ali 1 (93 % za krizotinib), 97 % bolezen stopnje IV (96 % za krizotinib), 90 % histologijo adenokarcinomov (94 % za krizotinib), 40 % metastaze v osrednjem živčevju v izhodišču (38 % za krizotinib) in 17 % bolnikov,
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.
Slovenian: In vitro alektinib ni bil mutagen v preizkusu bakterijskih reverznih mutacij (Ames), je pa in vitro povzročil rahlo povečanje numeričnih aberacij v citogenetskem preizkusu z uporabo celic pljuč kitajskega hrčka (CHL) s presnovno aktivacijo ter mikrojeder v mikrojedrnem testu na kostnem mozgu podgan.
English: If you take more Alecensa than you should, talk to a doctor or go to hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Alecensa, kot bi smeli Če vzamete več zdravila Alecensa, kot bi smeli, se morate takoj posvetovati z zdravnikom ali iti v bolnišnico.
English: There is no specific antidote for overdose with Alecensa.
Slovenian: Specifičnega antidota za preveliko odmerjanje zdravila Alecensa ni.
English: CPK elevation > 5 times ULN
Slovenian: Zvišanje CPK > 5-kratna ZMN