FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=89) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions' below)
Slovenian: Pogostnosti navedenih izbranih gastrointestinalnih neželenih učinkov (diareje, navzee in bruhanja) izhajajo iz podatkov bolnikov, ki so prejemali priporočeni odmerek ceritiniba 450 mg skupaj s hrano (N=89) v študiji A2112 (ASCEND-8) (glejte podpoglavje "Gastrointestinalni neželeni učinki" spodaj)
English: Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo.
Slovenian: Ceritinib je peroralen visoko selektiven in močan zaviralec ALK. Ceritinib zavira avtofosforilacijo ALK, z ALK posredovano fosforilacijo proteinov nadaljnje signalne poti in proliferacijo od ALK odvisnih tumorskih celic tako in vitro kot in vivo.
English: 1% of patients required permanent discontinuation of treatment in clinical studies with ceritinib (see sections 4.2 and 4.4).
Slovenian: V kliničnih študijah s ceritinibom je bilo treba zdravljenje dokončno ukiniti pri 1 % bolnikov (glejte poglavji 4.2 in 4.4).
English: These medicines should be used with care or may need to be avoided during your treatment with Zykadia.
Slovenian: Navedena zdravila je treba v času zdravljenja z zdravilom Zykadia uporabljati previdno ali pa se jim je treba izogibati.
English: Efficacy results from ASCEND-8 are summarised in Table 5 below.
Slovenian: V preglednici 5 spodaj so prikazani rezultati za oceno učinkovitosti iz študije ASCEND-8.
English: Particular caution should be exercised when treating patients with severe hepatic impairment, and the dose should be adjusted (see section 4.2).
Slovenian: Pri zdravljenju bolnikov s hudo okvaro jeter je potrebna posebna previdnost in prilagoditev odmerka (glejte poglavje 4.2).
English: If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Zykadia, kot bi smeli Če pomotoma vzamete preveč tablet ali če kdo drug pomotoma vzame vaše zdravilo, takoj obvestite zdravnika ali pokličite v bolnišnico.
English: Respiratory, thoracic and mediastinal disorders Pneumonitis d
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pnevmonitis d pogosti
English: 40 hard capsules 90 hard capsules
Slovenian: 40 trdih kapsul 90 trdih kapsul
English: The majority of patients were Caucasian (60.0%) or Asian (37.9%).
Slovenian: Bolniki so bili večinoma belci (60,0 %) ali predstavniki rumene rase (37,9 %).
English: - If your next dose is in less than 12 hours, skip the missed tablets.
Slovenian: Če je do naslednjega odmerka manj kot 12 ur, izpustite pozabljene tablete.
English: It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Slovenian: Uporabljamo ga za zdravljenje odraslih v napredovali fazi vrste pljučnega raka, ki jo imenujemo nedrobnocelični pljučni rak.
English: If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Zykadia, kot bi smeli Če pomotoma vzamete preveč kapsul ali če kdo drug pomotoma vzame vaše zdravilo, takoj obvestite zdravnika ali pokličite v bolnišnico.
English: Limited information is available in ALK-positive NSCLC patients with non-adenocarcinoma histology.
Slovenian: Na voljo je le malo podatkov o bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom drugih histoloških oblik, ki niso adenokarcinom.
English: Withhold Zykadia until recovery to asymptomatic (grade ≤1) bradycardia or to a heart rate of 60 beats per minute (bpm) or above.
Slovenian: Prekinite odmerjanje zdravila Zykadia, dokler simptomi bradikardije ne izzvenijo (do stopnje ≤1) ali do zvišanja srčne frekvence na 60 utripov na minuto ali več.
English: An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Slovenian: Za določanje bolnikov z ALK-pozitivnim nedrobnoceličnim pljučnim rakom je potrebna natančna in validirana testna metoda za določanje ALK (glejte poglavje 5.1).
English: P-gp inhibitors
Slovenian: Zaviralci P-gp
English: Therefore, ceritinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as class I (e.g. quinidine, procainamide, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) anti-arrhythmics or other medicinal products that may lead to QT prolongation such as domperidone, droperidol, chloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride and moxifloxacin.
Slovenian: Previdnost je zato potrebna pri uporabi ceritiniba pri bolnikih, ki že imajo podaljšan interval QT ali lahko pri njih pride do podaljšanja intervala QT, vključno z bolniki, ki jemljejo antiaritmična zdravila, kot so antiaritmiki razreda I (npr. kinidin, prokainamid, dizopiramid) ali razreda III (npr. amiodaron, sotalol, dofetilid in ibutilid) ali druga zdravila, ki lahko povzročijo podaljšanje intervala QT, kot so domperidon, droperidol, klorokin, halofantrin, klaritromicin, haloperidol, metadon, cisaprid in moksifloksacin.
English: Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Slovenian: Ovojnica kapsule: želatina, indigotin (E132) in titanov dioksid (E171).
English: Diarrhoea, nausea, or vomiting occurred in 74.2% of 89 patients treated with Zykadia at the recommended dose of 450 mg taken with food in a dose optimisation study and were mainly grade 1 events (49.4%).
Slovenian: Do diareje, navzee ali bruhanja je prišlo pri 74,2 % od 89 bolnikov, ki so prejemali zdravilo Zykadia v priporočenem odmerku 450 mg skupaj s hrano v študiji za optimizacijo odmerka.
English: In vitro data show that the IC50 for the inhibitory effect of ceritinib on the hERG potassium channel was 0.4 micromolar.
Slovenian: Po podatkih in vitro je srednja inhibitorna koncentracija (IC50) ceritiniba za zaviranje hERG kalijevih kanalčkov 0,4 μmol/l.
English: new or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath.
Slovenian: novonastali kašelj ali poslabšanje že prej prisotnega kašlja z izmečkom ali brez izmečka, zvišana telesna temperatura, bolečine v prsih, oteženo dihanje ali zadihanost.
English: Increasing the frequency of international normalised ratio (INR) monitoring may be considered if co-administration with warfarin is unavoidable.
Slovenian: Če se sočasnemu odmerjanju z varfarinom ni mogoče izogniti, je treba razmisliti o povečanju pogostnosti merjenja internacionalnega normaliziranega razmerja (INR).
English: The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Slovenian: Mediana starost bolnikov je bila 54,0 let (od 28 do 84 let); 77,1 % bolnikov je bilo starih manj kot 65 let.
English: In clinical studies, QT prolongation was observed with ceritinib.
Slovenian: V kliničnih študijah so pri uporabi ceritiniba opažali podaljšanje intervala QT.
English: Dose interruption and dose reduction should be employed as necessary (see sections 4.2 and 4.8).
Slovenian: Po potrebi je treba prekiniti zdravljenje oziroma znižati odmerek zdravila (glejte poglavji 4.2 in 4.8).
English: The use of concomitant medicinal products associated with bradycardia should be carefully evaluated.
Slovenian: Skrbno je treba ovrednotiti sočasno uporabo drugih zdravil, ki lahko povzročajo bradikardijo.
English: What Zykadia is and what it is used for What you need to know before you take Zykadia How to take Zykadia
Slovenian: Kaj je zdravilo Zykadia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zykadia Kako jemati zdravilo Zykadia Možni neželeni učinki
English: Do not stop taking this medicine before talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Zykadia, ne da bi se prej posvetovali z zdravnikom.
English: Efficacy data from Study A2303 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Slovenian: V preglednici 4 so prikazani podatki o učinkovitosti iz študije A2303, na slikah 3 in 4 pa sta Kaplan-Meierjevi krivulji PFS in OS.
English: Monitoring of the QT interval is indicated in the event of combinations of such medicinal products (see sections 4.2 and
Slovenian: V primeru uporabe v kombinaciji s takimi zdravili je indicirano spremljanje dolžine intervala QT (glejte poglavji 4.2 in 4.4).
English: Caution should be exercised with concomitant use of BCRP substrates (e.g. rosuvastatin, topotecan, sulfasalazine) and P-gp substrates (digoxin, dabigatran, colchicine, pravastatin) and ADRs carefully monitored.
Slovenian: Pri sočasni uporabi s substrati prenašalca BCRP (npr. z rosuvastatinom, topotekanom in sulfasalazinom) in substrati P-gp (z digoksinom, dabigatranom, kolhicinom ali pravastatinom) je potrebna previdnost in skrbno spremljanje pojavljanja neželenih učinkov.
English: Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
Slovenian: Bolnike je treba opazovati glede pojavljanja pljučnih simptomov, ki bi lahko kazali na IPB oziroma pnevmonitis.
English: Progression-free survival (based on BIRC) Number of events, n (%) Median, months d
Slovenian: preživetje brez napredovanja bolezni (PFS) (po presoji odbora BIRC) število dogodkov, n (%) mediana, meseci d
English: Your doctor should perform blood tests before you start treatment, every 2 weeks during the first three months of treatment and monthly therafter.
Slovenian: Krvne preiskave v času zdravljenja z zdravilom Zykadia Zdravnik vas mora pred začetkom zdravljenja napotiti na krvne preiskave in jih nato ponavljati v prvih treh mesecih zdravljenja vsaka 2 tedna, kasneje tekom zdravljenja pa vsak mesec.
English: All patients were treated with prior crizotinib.
Slovenian: Vsi bolniki so bili predhodno zdravljeni s krizotinibom.
English: In the majority of NSCLC cases, EML4 is the translocation partner for ALK; this generates an EML4-ALK fusion protein containing the protein kinase domain of ALK fused to the
Slovenian: V večini primerov nedrobnoceličnega pljučnega raka je translokacijski partner genu ALK gen EML4, kar omogoča nastanek fuzijskega proteina EML4-ALK.
English: Across the seven clinical studies, any grade ILD/pneumonitis has been reported in 2.1% of patients treated with ceritinib, and grade 3 or 4 events have been reported in 1.2% of patients.
Slovenian: V sedmih kliničnih študijah so o primerih intersticijske pljučne bolezni oziroma pnevmonitisa katerekoli stopnje poročali pri 2,1 % bolnikov, ki so prejemali ceritinib in o 3. ali 4. stopnji pri 1,2 % bolnikov.
English: ALT or AST elevation >3 times ULN with concurrent total bilirubin elevation >2 times ULN (in the absence of cholestasis or haemolysis)
Slovenian: zvišanje vrednosti ALT ali AST na >3-kratnik ZMN, če je vrednost celokupnega bilirubina >2-kratnik ZMN (ne gre pa za holestazo ali hemolizo)
English: Duration of follow-up Median (months) (min - max) Progression-free survival (based on BIRC) Number of events, n (%) Median, months (95% CI) HR (95% CI)
Slovenian: trajanje spremljanja mediana (meseci) (min - maks) preživetje brez napredovanja bolezni (PFS) (po presoji odbora BIRC) število dogodkov, n (%) mediana, meseci (95-odstotni IZ) HR (95-odstotni IZ)
English: The recommended dose of Zykadia is 450 mg taken orally once daily with food at the same time each day.
Slovenian: Priporočeni odmerek zdravila Zykadia je 450 mg peroralno enkrat na dan skupaj s hrano, in sicer vsak dan ob istem času.
English: Patients should be monitored for fasting plasma glucose prior to the start of Zykadia treatment and periodically thereafter as clinically indicated.
Slovenian: Bolnikom je treba izmeriti vrednost glukoze v plazmi na tešče pred začetkom zdravljenja z zdravilom Zykadia in nato občasno v skladu s kliničnimi indikacijami.
English: The in vitro apparent passive permeability of ceritinib was determined to be low.
Slovenian: Ugotovili so, da je navidezna pasivna permeabilnost ceritiniba in vitro majhna.
English: The efficacy of Zykadia 450 mg with food was evaluated in a multicentre, open-label dose optimisation study A2112 (ASCEND-8).
Slovenian: Študija za optimizacijo odmerka A2112 (ASCEND-8) Učinkovitost zdravila Zykadia v odmerku 450 mg skupaj s hrano so ovrednotili v multicentrični odprti študiji za optimizacijo odmerka z oznako A2112 (ASCEND-8).
English: Table 5 ASCEND-8 (Study A2112) - Efficacy results in patients with previously untreated ALK-positive locally advanced or metastatic NSCLC by BIRC
Slovenian: Preglednica 5 Študija ASCEND-8 (študija A2112) - rezultati za oceno učinkovitosti pri bolnikih s predhodno nezdravljenim ALK-pozitivnim lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom po presoji odbora BIRC
English: Final overall survival (OS) data are presented for Study A2201.
Slovenian: Podatki o končnem celokupnem preživetju (OS) so prikazani za študijo A2201, podatki o celokupnem preživetju za študijo X2101 pa v času analize še niso bili zreli.
English: There are no safety data in patients older than 85 years of age.
Slovenian: O varnosti uporabe pri bolnikih, ki so stari več kot 85 let, podatkov ni na voljo.
English: ALK translocation determines expression of the resulting fusion protein and consequent aberrant ALK signaling in NSCLC.
Slovenian: Translokacija ALK gena omogoči izražanje fuzijskega proteina in s tem nepravilno signaliziranje ALK v celicah nedrobnoceličnega pljučnega raka.
English: Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Slovenian: Zdravilo Zykadia je kot monoterapija indicirano za zdravljenje odraslih bolnikov z ALK-pozitivnim napredovalim nedrobnoceličnim pljučnim rakom (NDCPR), ki so se predhodno že zdravili s krizotinibom.
English: You and your doctor will decide together whether you should breast-feed or take Zykadia.
Slovenian: Skupaj z zdravnikom se odločite, ali boste dojili ali jemali zdravilo Zykadia, obojega sočasno ne smete.
English: The other ingredients are: Tablet core: cellulose, microcrystalline; hydroxypropylcellulose, low-substituted; povidone; croscarmellose sodium; magnesium stearate; silica, colloidal anhydrous.
Slovenian: Druge sestavine zdravila so: Jedro tablete: celuloza, mikrokristalna; hidroksipropilceluloza, malo substituirana; povidon; premrežen natrijev karmelozat; magnezijev stearat; silicijev dioksid, koloidni brezvodni.
English: In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC at the recommended dose of ceritinib 450 mg taken with food (N=89), adverse events of diarrhoea, nausea and vomiting were mainly grade 1 (49.4%).
Slovenian: V študiji za optimizacijo odmerka A2112 (ASCEND-8) pri predhodno zdravljenih in predhodno nezdravljenih bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom, so pri priporočenem odmerku ceritiniba 450 mg skupaj s hrano (N=89) neželeni dogodki diareja, navzea in bruhanje večinoma dosegali izraženost stopnje 1 (49,4 %).
English: Kaplan-Meier medians (95% CI) (Months) ceritinib 750 mg: NE (29.3, NE) Chemotherapy: 26.2 (22.8, NE) Logrank p-value = 0.056
Slovenian: Kaplan-Meierjeve mediane (95-odstotni IZ) (meseci) ceritinib 750 mg: NE (29,3, NE) kemoterapija: 26,2 (22,8, NE) vrednost p za logrank = 0,056
English: Ceritinib 450 mg with food (N=41)
Slovenian: parameter učinkovitosti ceritinib 450 mg skupaj s hrano (N=41)
English: In cases of symptomatic bradycardia that is not life-threatening, Zykadia should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, the use of concomitant medicinal products should be evaluated and the Zykadia dose adjusted if necessary.
Slovenian: V primeru simptomatske bradikardije, ki ne ogroža življenja, je treba zdravljenje z zdravilom Zykadia prekiniti do prenehanja simptomov bradikardije ali zvišanja srčne frekvence na 60 utripov na minuto ali več, preveriti sočasno uporabo drugih zdravil in ustrezno prilagoditi odmerjanje zdravila Zykadia, če je potrebno.
English: Zykadia should be withheld in patients who develop QTc >500 msec on at least two separate ECGs until recovery to baseline or a QTc ≤480 msec, then reinitiated with dose reduced by 150 mg (see sections 4.2, 4.8 and 5.2).
Slovenian: Pri bolnikih, pri katerih pride do podaljšanja intervala QTc na >500 ms na najmanj dveh ločenih EKG posnetkih, je treba zdravljenje z zdravilom Zykadia začasno prekiniti, dokler se interval QTc ne vrne na izhodiščno raven oziroma na vrednost ≤480 ms, nato pa je zdravljenje mogoče nadaljevati z odmerkom, ki je za 150 mg nižji od predhodnega (glejte poglavja 4.2, 4.8 in 5.2).
English: Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Slovenian: Črnilo za tisk: šelakova glazura 45 % (iz razbarvanega šelaka brez voska), železov oksid, črni (E172), propilenglikol in amonijev hidroksid 28 %.
English: Previously untreated ALK-positive advanced NSCLC - randomised phase 3 Study A2301 (ASCEND-4) The efficacy and safety of Zykadia for the treatment of advanced ALK-positive NSCLC patients who have not received previous systemic treatment anti-cancer therapy (including ALK inhibitor) with the exception of neo-adjuvant or adjuvant therapy, was demonstrated in a global multicentre, randomised, open-label phase 3 Study A2301.
Slovenian: Predhodno nezdravljeni bolniki z ALK-pozitivnim napredovalim nedrobnoceličnim pljučnim rakomrandomizirana študija faze 3 z oznako A2301 (študija ASCEND-4) Učinkovitost in varnost zdravila Zykadia pri zdravljenju bolnikov z napredovalim ALK-pozitivnim nedrobnoceličnim pljučnim rakom, ki predhodno še niso prejemali sistemskih protitumorskih zdravil (kar vključuje zaviralec ALK) z izjemo neoadjuvantnega ali adjuvantnega zdravljenja, sta bili dokazani v globalni, multicentrični, randomizirani, odprti študiji faze 3 z oznako A2301.
English: The median age was 51 years (range: 29-80 years); 87.1% of patients were younger than 65 years and 50.0% were female.
Slovenian: Mediana starost je bila 51 let (od 29 do 80 let); 87,1 % bolnikov je bilo starih manj kot 65 let in 50 % je bilo žensk.
English: Indigotine (E132) Titanium dioxide (E171)
Slovenian: Ovojnica kapsule želatina indigotin (E132) titanov dioksid (E171)
English: The PFS benefit of Zykadia was consistent across various subgroups including age, gender, race, smoking class, ECOG performance status, and presence of brain metastases or prior response to crizotinib.
Slovenian: Zdravilo Zykadia je omogočilo izboljšanje, ki je bilo podobno v različnih podskupinah, v katerih so se bolniki med drugim razlikovali po starosti, spolu, rasi, kadilskem statusu, statusu zmogljivosti po lestvici ECOG in prisotnosti možganskih metastaz ter predhodnem odzivu na krizotinib.
English: The geometric mean apparent clearance (CL/F) of ceritinib was lower at steady-state (33.2 litres/hour) after 750 mg daily oral dosing than after a single 750 mg oral dose (88.5 litres/hour), suggesting that ceritinib demonstrates non-linear pharmacokinetics over time.
Slovenian: Geometrična srednja vrednost navideznega očistka (CL/F) ceritiniba je bila v stanju dinamičnega ravnovesja pri vsakodnevnem odmerjanju 750 mg (33,2 litra/uro) nižja kot po enkratnem peroralnem odmerku 750 mg (88,5 litra/uro), kar pomeni, da je farmakokinetika ceritiniba v času nelinearna.
English: Skin and subcutaneous tissue disorders Rash j
Slovenian: Bolezni kože in podkožja izpuščaj j zelo pogosti
English: 90 hard capsules
Slovenian: 90 trdih kapsul
English: The incidence and severity of gastrointestinal adverse drug reactions were higher for patients treated with Zykadia 750 mg fasted (diarrhoea 76%, nausea 50%, vomiting 56%; 12% reported a grade 3/4 event) compared to 450 mg with food (diarrhoea 56%, nausea 45%, vomiting 35%; 1.1% reported a grade 3/4 event).
Slovenian: Pogostnost in resnost gastrointestinalnih neželenih učinkov sta bili večji pri bolnikih, ki so se zdravili z zdravilom Zykadia v odmerku 750 mg na tešče (diareja 76 %, navzea 50 %, bruhanje 56 %; 12 % poročil so bili dogodki stopnje 3/4) v primerjavi z bolniki, ki so se zdravili z odmerkom 450 mg s hrano (diareja 56 %, navzea 45 %, bruhanje 35 %; 1,1 % poročil so bili dogodki stopnje 3/4).
English: Do not chew or crush them.
Slovenian: Kapsul ne grizite in jih ne drobite.
English: Agents that may increase ceritinib plasma concentrations
Slovenian: Zdravila, ki lahko zvišajo koncentracijo ceritiniba v plazmi
English: If unavoidable, dose reduction for co-administered medicinal products that are CYP2C9 substrates with narrow therapeutic indices should be considered.
Slovenian: Če se sočasni uporabi ni mogoče izogniti, je treba razmisliti o znižanju odmerka sočasno uporabljanih zdravil, ki so substrati CYP2C9 z nizkim terapevtskim indeksom.
English: The median age was 54 years (range: 22 to 81 years); 78.5% of patients were younger than 65 years.
Slovenian: Mediana starost bolnikov je bila 54 let (od 22 do 81 let); 78,5 % bolnikov je bilo starih manj kot 65 let.
English: Cardiac disorders Pericarditis b
Slovenian: Srčne bolezni perikarditis b pogosti bradikardija c pogosti
English: There are no available data on patients over 85 years of age.
Slovenian: O uporabi pri bolnikih, ki so stari več kot 85 let, podatkov ni na voljo.
English: You should take special care when driving and using machines when taking Zykadia as you may experience visual disturbances or tiredness.
Slovenian: V času jemanja zdravila Zykadia morate biti posebno pozorni pri upravljanju vozil in strojev, saj lahko pride do motenj vida in utrujenosti.
English: The median PFS by BIRC using RECIST 1.1 was longer in the ceritinib arm compared to the chemotherapy arm in both subgroups of patients with brain metastases and without brain metastases.
Slovenian: Mediano preživetje brez napredovanja bolezni (PFS) po presoji odbora BIRC v skladu s kriteriji RECIST 1.1 je bilo v skupini s ceritinibom daljše kot v skupini s kemoterapijo, kar velja za obe podskupini bolnikov z možganskimi metastazami in brez njih.
English: Reproductive toxicology studies (i.e. embryo-foetal development studies) in pregnant rats and rabbits indicated no foetotoxicity or teratogenicity after dosing with ceritinib during organogenesis; however, maternal plasma exposure was less than that observed at the recommended human dose.
Slovenian: V študijah reproduktivne toksičnosti (torej v študijah razvoja zarodka in plodu), ki so jih izvajali na brejih podganah in kuncih, po odmerjanju ceritiniba v času organogeneze ni bilo opaziti znakov škodljivega delovanja na plod ali teratogenosti.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0/1/2 in 37.0%/56.4%/6.4% of patients, and 32.2% had brain metastasis at baseline.
Slovenian: Stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) lestvici z oceno 0 je imelo 37,0 % bolnikov, z oceno 1 56,4 % bolnikov in z oceno 2 6,4 % bolnikov.
English: Efficacy data from Study A2301 are summarised in Table 3, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and Figure 2, respectively.
Slovenian: V preglednici 3 so prikazani podatki o učinkovitosti iz študije A2301, na slikah 1 in 2 pa sta Kaplan-Meierjevi krivulji PFS in OS.
English: Other potential causes of ILD/pneumonitis should be excluded, and Zykadia permanently discontinued in patients diagnosed with any grade treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Slovenian: Izključiti je treba druge možne vzroke za razvoj IPB oziroma pnevmonitisa in pri bolnikih z diagnozo z zdravilom povzročene IPB oziroma pnevmonitisa katere koli stopnje dokončno ukiniti zdravilo Zykadia (glejte poglavji 4.2 in 4.8).