FrancophonIA/ELRC3.0 huggingface dataset:
English: Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).
Slovenian: Bolnikom, pri katerih je diagnosticirana IBP/pnevmonitis, je treba zdravljenje z zdravilom Alecensa nemudoma prekiniti; če ni mogoče ugotoviti drugih možnih vzrokov za IBP/pnevmonitis, je treba zdravljenje ukiniti (glejte poglavje 4.2).
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).
Slovenian: Bolniki z obstoječo hudo okvaro jeter (razreda C po Child-Pughovi lestvici) naj prejmejo začetni odmerek 450 mg dvakrat na dan s hrano (celoten dnevni odmerek 900 mg).
English: Dose reduction schedule
Slovenian: Shema zmanjševanja odmerka
English: Crizotinib N=151
Slovenian: krizotinib n = 151
English: General disorders and administration site conditions Oedema10)
Slovenian: Splošne težave in spremembe na mestu aplikacije edemi10)
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.
Slovenian: Za M4 pa so bile v stanju dinamičnega ravnovesja geometrične sredine Cmax, Cmin in AUC0-12 približno 246 ng/ml (45,4 %), 222 ng/ml (46,6 %) in 2810 ng·h/ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1169/001
English: ALK positive non-small cell lung cancer
Slovenian: Klinična učinkovitost in varnost ALK-pozitivni nedrobnocelični rak pljuč
English: Hepatobiliary disorders Increased bilirubin6)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišan bilirubin6)
English: Permanently discontinue in case of recurrence.
Slovenian: V primeru ponovitve ukinite zdravljenje.
English: Alecensa contains lactose
Slovenian: Zdravilo Alecensa vsebuje laktozo
English: Symptomatic bradycardia can occur with Alecensa (see section 4.8).
Slovenian: Med uporabo zdravila Alecensa se lahko pojavi simptomatska bradikardija (glejte poglavje 4.8).
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.
Slovenian: V preskušanje faze III so skupno vključili 303 bolnike; 151 bolnikov so randomizirali v skupino s krizotinibom in 152 bolnikov v skupino z zdravilom Alecensa, kjer so prejemali zdravilo Alecensa peroralno v priporočenem odmerku 600 mg dvakrat na dan.
English: ORR (INV)*, *** Responders n (%) [95% CI]
Slovenian: ORR (raziskovalec)*, *** Odzivni bolniki n (%) [95-% IZ]
English: Alectinib steady-state is reached within 7 days with continuous 600 mg twice daily dosing.
Slovenian: Stanje dinamičnega ravnovesja alektiniba je med stalno uporabo 600 mg dvakrat na dan doseženo v 7 dneh.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1169/002
English: Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer' (‘NSCLC').
Slovenian: Zdravilo Alecensa uporabljamo za zdravljenje odraslih bolnikov s podtipom raka pljuč, imenovanim "nedrobnocelični rak pljuč".
English: In faeces, 84% and 5.8% of the dose was excreted as unchanged alectinib or M4, respectively.
Slovenian: V blatu se je 84 % odmerka izločilo v obliki nespremenjenega alektiniba in 5,8 % v obliki M4.
English: Hard capsule.
Slovenian: Ovojnica kapsule
English: No fertility studies in animals have been performed to evaluate the effect of Alecensa.
Slovenian: Specifičnih študij za ugotavljanje vpliva zdravila Alecensa na plodnost pri živalih niso izvedli.
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.
Slovenian: Če bolnica zanosi med zdravljenjem z zdravilom Alecensa ali v 3 mesecih po zadnjem odmerku tega zdravila, mora obvestiti zdravnika, ta pa jo mora seznaniti z možno nevarnostjo za plod.
English: ● Do not take Alecensa if you are pregnant.
Slovenian: ● Med nosečnostjo ne jemljite zdravila Alecensa, ker lahko škoduje vašemu otroku.
English: CYP3A inducers
Slovenian: Zaviralci CYP3A4
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).
Slovenian: Glede na izrazitost neželenega učinka je treba uporabo zdravila Alecensa začasno prekiniti in zdravilo znova uvesti v manjšem odmerku, ali pa ga je treba ukiniti, kot je opisano v preglednici 2 (glejte poglavje 4.2).
English: Effect of transporters on alectinib disposition
Slovenian: Vpliv prenašalcev na odstranjevanje alektiniba
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; ORR = objective response rate; NE = not estimable
Slovenian: IZ = interval zaupanja; DOR = trajanje odziva (duration of response); IRC = odbor za neodvisni pregled (independent review committee); NO = ni ocenljivo; ORR = delež objektivnega odziva (objective response rate);
English: [14.8, NE]
Slovenian: [14,8; NO]
English: Temporarily withhold until recovery to baseline or ≤ Grade 1 (≤ 3 times ULN), then resume at reduced dose (see Table 1).
Slovenian: Začasno prekinite uporabo zdravila, dokler se vrednosti ne normalizirajo ali znižajo na stopnjo ≤ 1 (≤ 3-kratno ZMN), nato znova začnite zdravljenje z manjšim odmerkom (glejte preglednico 1).
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.
Slovenian: Takoj obvestite zdravnika, če se vam med zdravljenjem pojavijo kakšni novi bolezenski znaki ali poslabšanje znakov mišičnih težav, kot so nepojasnjena mišična bolečina ali mišična bolečina, ki ne preneha, občutljivost ali šibkost.
English: Alecensa is for oral use.
Slovenian: Zdravilo Alecensa je namenjeno peroralni uporabi.
English: The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
Slovenian: Farmakokinetika alektiniba pri bolnikih s hudo okvaro ledvic ni raziskana.
English: ● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
Slovenian: ● zdravila za zdravljenje AIDSa/okužbe z virusom HIV (npr. ritonavir, sakvinavir), ● zdravila za zdravljenje okužb.
English: Red iron oxide (E172) Yellow iron oxide (E172) Indigo carmine aluminum lake (E132) Carnauba wax
Slovenian: Rdeči železov oksid (E172) Rumeni železov oksid (E172) Indigotin (E132) Karnauba vosek
English: Pack size: 224 (4 packs of 56) hard capsules.
Slovenian: velikost pakiranja: 224 (4 pakiranja po 56) trdih kapsul
English: CTCAE grade
Slovenian: Stopnja po CTCAE
English: In BO28984 (ALEX; N=152) the median duration of exposure to Alecensa was 17.9 months, whereas the median duration of exposure to crizotinib was 10.7 months.
Slovenian: n = 152) je bilo mediano trajanje izpostavljenosti zdravilu Alecensa 17,9 mesecev, mediano trajanje izpostavljenosti krizotinibu pa 10,7 mesecev.
English: The co-primary endpoint was to evaluate the ORR as per central IRC assessment using RECIST 1.1 in patients with prior exposure of cytotoxic chemotherapy treatments.
Slovenian: Soprimarni opazovani dogodek je bilo ovrednotenje ORR, kot ga je ocenil centralni IRC na podlagi meril RECIST 1.1 pri bolnikih, ki so predhodno prejemali citotoksično kemoterapijo.
English: Alecensa 150 mg hard capsules alectinib
Slovenian: Alecensa 150 mg trde kapsule alektinib
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.
Slovenian: Pri klinično pomembni izpostavljenosti so bili v študijah toksičnosti ponavljajočih odmerkov med ciljnimi organi pri podganah in opicah eritroidni sistem, prebavila in hepatobiliarni sistem, a ne le ti.
English: ● Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
Slovenian: ● Ovojnica kapsule: hipromeloza, karagenan, kalijev klorid, titanov dioksid (E171), koruzni škrob in karnauba vosek.
English: HR [95% CI]
Slovenian: HR [95-% IZ]
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of BCRP.
Slovenian: Zato lahko alektinib in M4 zvečata koncentracijo sočasno uporabljenih substratov BCRP v plazmi.
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).
Slovenian: Varnost in učinkovitost zdravila Alecensa so pri bolnikih z ALK-pozitivnim nedrobnoceličnim rakom pljuč, predhodno zdravljenih s krizotinibom, raziskovali v dveh kliničnih preskušanjih faze I/II (NP28673 in NP28761).
English: Among patients included in the study, 20% of the patients had previously progressed on crizotinib treatment only, and 80% had previously progressed on crizotinib and at least one chemotherapy treatment.
Slovenian: Med bolniki, vključenimi v študijo, je bilo 20 % takšnih, ki jim je bolezen pred tem napredovala med zdravljenjem s samim krizotinibom, pri 80 % pa je pred tem napredovala med zdravljenjem s krizotinibom in vsaj še eno kemoterapijo.
English: ● nilotinib, a medicine used to treat certain types of cancer
Slovenian: ● nilotinib, zdravilo za zdravljenje nekaterih vrst raka,
English: In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
Slovenian: Substrati BCRP Alektinib in M4 in vitro zavirata izločevalni prenašalec BCRP (Breast Cancer Resistance Protein).
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.
Slovenian: Če po zaužitju odmerka zdravila Alecensa bruhate, ne vzemite dodatnega odmerka, temveč le naslednji odmerek ob običajnem času.
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.
Slovenian: Zaradi zvišanega bilirubina so 5,2 % bolnikom prilagodili odmerek, 1,5 % bolnikom pa ukinili zdravljenje z zdravilom Alecensa.
English: ● sensitivity to sunlight - do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Slovenian: ● občutljivost za sončno svetlobo - med jemanjem zdravila Alecensa in še 7 dni po prenehanju jemanja se izogibajte dolgotrajnejšemu izpostavljanju soncu.
English: Stomatitis 5)
Slovenian: Preglednica 5.
English: The primary endpoint was to evaluate the efficacy of Alecensa by ORR as per central IRC assessment using RECIST version 1.1.
Slovenian: Primarni opazovani dogodek je bila ocena učinkovitosti zdravila Alecensa na podlagi ORR, kot ga je ocenil IRC na podlagi meril RECIST (različica 1.1).
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.
Slovenian: Pri brejih podganah je alektinib pri izpostavljenosti, ki je bila (glede na AUC) 4,5-krat večja od izpostavljenosti pri človeku, povzročil embrio-fetalno izgubo (splave) in pri izpostavljenosti, ki je bila (glede na AUC) 2,7-krat večja od izpostavljenosti pri človeku, majhne plodove z zapoznelo osifikacijo in manjšimi nepravilnostmi organov.
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies.
Slovenian: V splošnih toksikoloških študijah niso ugotovili neugodnih vplivov na reproduktivne organe samcev in samic.
English: ● abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase)
Slovenian: ● nenormalni izvidi preiskav krvi, ki odražajo bolezen jeter ali bolezni kosti (velika koncentracija alkalne fosfataze);
English: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the ULN as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alecensa (see section 4.8).
Slovenian: Pri bolnikih v ključnih kliničnih preskušanjih z zdravilom Alecensa so se pojavila zvišanja alaninaminotransferaze (ALT) in aspartat-aminotransferaze (AST) na več kot 5-kratno ZMN in zvišanja bilirubina na več kot 3-kratno ZMN (glejte poglavje 4.8).
English: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
Slovenian: ALT = alanin-aminotransferaza, AST = aspartat-aminotransferaza, CPK = kreatin-fosfokinaza,
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%).
Slovenian: C označenega alektiniba pri zdravih osebah se je večina radioaktivnosti izločila v blatu (povprečno se je v blatu pojavilo 97,8 %), izločanje v urinu pa je bilo minimalno (povprečno se je v urinu pojavilo 0,46 %).
English: Alecensa may cause foetal harm when administered to a pregnant woman.
Slovenian: Zdravilo Alecensa lahko škoduje plodu, če je uporabljeno med nosečnostjo.
English: White shellac
Slovenian: Beli šelak
English: Mothers should be advised against breast-feeding while receiving Alecensa.
Slovenian: Materam se priporoča, naj med jemanjem zdravila Alecensa ne dojijo.
English: What Alecensa looks like and contents of the pack Alecensa hard capsule are white, with ‘ALE' printed in black ink on the cap and ‘150 mg' printed in black ink on the body.
Slovenian: Trde kapsule zdravila Alecensa so bele barve ter imajo na pokrovčku s črno barvo izpisano "ALE", na telesu pa prav tako s črno barvo "150 mg".
English: The data described below reflect exposure to Alecensa in 405 patients with ALK-positive advanced NSCLC who participated in one randomised Phase III clinical trial (BO28984) and in two single-arm phase II clinical trials (NP28761, NP28673).
Slovenian: Podatki, opisani v nadaljevanju, odsevajo izpostavljenost zdravilu Alecensa pri 405 bolnikih z ALKpozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki so sodelovali v enem randomiziranem kliničnem preskušanju faze III (BO28984) in v dveh kliničnih preskušanjih z eno skupino faze II (NP28761, NP28673).
English: INFORMATION IN BRAILLE alecensa
Slovenian: PODATKI V BRAILLOVI PISAVI
English: ● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Slovenian: ● Barva za napis: rdeči železov oksid (E172), rumeni železov oksid (E172), indigotin (E132), karnauba vosek, bel šelak in glicerilmonooleat.
English: Based on a population pharmacokinetic analysis, alectinib and M4 exposures were similar in patients with mild hepatic impairment and normal hepatic function.
Slovenian: Na podlagi populacijske farmakokinetične analize sta bili izpostavljenosti alektinibu in M4 pri bolnikih z blago okvaro jeter in bolnikih z normalnim delovanjem jeter podobni.
English: Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Slovenian: Na podlagi podatkov in vitro je CYP3A4 glavni encim v presnovi alektiniba in njegovega glavnega aktivnega presnovka M4; CYP3A katalizira od 40 do 50 % vse presnove v jetrih.
English: Elevations of CPK occurred in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Slovenian: V ključnih preskušanjih z zdravilom Alecensa so se pojavila zvišanja CPK, vključno z dogodki stopnje 3 (glejte poglavje 4.8).
English: How to take Alecensa
Slovenian: Kako jemati zdravilo Alecensa
English: Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at the same dose.
Slovenian: Začasno prekinite uporabo zdravila, dokler se vrednosti ne normalizirajo ali znižajo na ≤ 2,5kratno ZMN, nato znova začnite zdravljenje z enakim odmerkom.
English: ● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
Slovenian: ● Če je zdravilo Alecensa v pretisnih omotih, ga shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Dose modifications of Alecensa treatment due to these adverse events were only required for two patients (0.5%); Alecensa treatment was not withdrawn due to these events of myalgia.
Slovenian: Prilagoditev zdravljenja z zdravilom Alecensa je bila zaradi teh učinkov potrebna le pri dveh bolnikih (0,5 %).
English: ADRs (MedDRA)
Slovenian: Neželeni učinek (MedDRA)
English: Time to CNS progression (IRC)*, ** Number of patients with event n (%)
Slovenian: (IRC)*, ** Število bolnikov z dogodkom n (%)
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.
Slovenian: In vitro je bilo ob klinično pomembnih koncentracijah povprečno razmerje koncentracije alektiniba med človeško krvjo in plazmo 2,64, M4 pa 2,50.
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.
Slovenian: Pri bolnikih z ALK-pozitivnim nedrobnoceličnim rakom pljuč se je alektinib po peroralni uporabi 600 mg dvakrat na dan na poln želodec absorbiral in je dosegel tmax po približno 4 do 6 urah.
English: CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Slovenian: Osrednje živčevje - ORR pri bolnikih z merljivimi in nemerljivimi metastazami v osrednjem živčevju v izhodišču (IRC)
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.
Slovenian: Na podlagi populacijske farmakokinetične analize je bila izpostavljenost alektinibu in M4 pri bolnikih z blago in zmerno okvaro ledvic podobna kot pri tistih z normalnim delovanjem ledvic.
English: Across clinical trials (NP28761, NP28673, BO28984) two patients with Grade 3-4 AST/ALT elevations had documented drug induced liver injury by liver biopsy.
Slovenian: V kliničnih preskušanjih (NP28761, NP28673, BO28984) sta imela dva bolnika z zvišanjem AST/ALT stopnje 3 do 4 zabeleženo z zdravilom povzročeno poškodbo jeter, potrjeno z jetrno biopsijo.
English: How Alecensa works
Slovenian: Kako deluje zdravilo Alecensa
English: Photosensitivity to sunlight has been reported with Alecensa administration (see section 4.8).
Slovenian: Med uporabo zdravila Alecensa je bila opisana fotosenzibilnost na sončno svetlobo (glejte poglavje 4.8).
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
Slovenian: IME ZDRAVILA Alecensa 150 mg trde kapsule
English: If you vomit after taking Alecensa
Slovenian: Če po zaužitju zdravila Alecensa bruhate
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.
Slovenian: Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja od 20 do 30 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so pri podganah in/ali opicah opažali zvišanje jetrne alkalne fosfataze (ALP) in direktnega bilirubina, vakuolacijo/degeneracijo/nekrozo epitelija žolčnih vodov in povečanje/fokalno nekrozo hepatocitov.
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.
Slovenian: Takoj obvestite zdravnika, če se vam pojavijo kakšni novi bolezenski znaki ali poslabšanje bolezenskih znakov, na primer težko dihanje, kratka sapa, kašelj (z izkašljevanjem sluzi ali brez) ali zvišana telesna temperatura;
English: In the phase III clinical trial BO28984, Grade 3 or 4 bilirubin elevations occurred in 3.3% of patients receiving Alecensa versus no patient receiving crizotinib.
Slovenian: V kliničnem preskušanju faze III BO28984 se je zvišan bilirubin stopnje 3 ali 4 pojavil pri 3,3 % bolnikov, ki so prejemali zdravilo Alecensa, in pri nobenem od bolnikov, ki so prejemali krizotinib.
English: This event led to withdrawal from Alecensa treatment.
Slovenian: Ta dogodek je povzročil ukinitev zdravljenja z zdravilom Alecensa.
English: ● inflammation of the mucous membrane of the mouth
Slovenian: ● vnetje sluznice ust;
English: Table 3 ADRs reported in Alecensa clinical trials (NP28761, NP28673, BO28984; N=405) and during post-marketing
Slovenian: Neželeni učinki, poročani pri zdravilu Alecensa v kliničnih preskušanjih (NP28761, NP28673, BO28984; n = 405) in med obdobjem trženja
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Slovenian: Zato lahko alektinib in M4 zvečata koncentracijo sočasno uporabljenih substratov prenašalca P-gp v plazmi.
English: Study NP28761 was a Phase I/II single arm multicentre study conducted in patients with ALK positive advanced NSCLC who have previously progressed on crizotinib treatment.
Slovenian: Študija NP28761 je bila multicentrična študija faze I/II z eno samo skupino, opravljena pri bolnikih z ALK-pozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki jim je bolezen pred tem napredovala med zdravljenjem s krizotinibom.
English: Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
Slovenian: Glede na izrazitost zvišanja CPK je treba uporabo zdravila Alecensa začasno prekiniti in zdravilo znova uvesti v manjšem odmerku (glejte poglavje 4.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
English: A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Slovenian: V delu študije, ki je bil faze II, je bilo skupaj vključenih 87 bolnikov, ki so prejemali zdravilo Alecensa peroralno v priporočenem odmerku 600 mg dvakrat na dan.
English: ● If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
Slovenian: ● Če je zdravilo Alecensa v plastenkah, ga shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago.
English: ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Slovenian: Stratifikacijski dejavniki za randomizacijo so bili stanje zmogljivosti po ECOG (0/1 v primerjavi z 2), rasa (azijska v primerjavi z neazijsko) ter prisotnost metastaz v osrednjem živčevju v izhodišču (da v primerjavi z ne).
English: If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Slovenian: Če bolnik po uporabi odmerka zdravila Alecensa bruha, naj vzame naslednji odmerek ob predvidenem času.
English: Interstitial lung disease (ILD)/pneumonitis
Slovenian: Intersticijska bolezen pljuč (IBP)/pnevmonitis
English: What Alecensa contains
Slovenian: Kaj vsebuje zdravilo Alecensa