FrancophonIA/ELRC3.0 huggingface dataset:
English: STOP taking Zykadia and seek medical help immediately if you experience any of the following, which may be signs of an allergic reaction:
Croatian: PRESTANITE uzimati Zykadiu i odmah zatražite liječničku pomoć ako osjetite bilo što od niže navedenoga, što bi mogli biti znakovi alergijske reakcije:
English: Permanently discontinue in the event of recurrence
Croatian: Trajno prekinuti primjenu u slučaju ponovne pojave.
English: Date of first authorisation: 06 May 2015 Date of latest renewal: 22 March 2017
Croatian: Datum posljednje obnove odobrenja: 22. ožujka 2017.
English: No. of patients still at risk
Croatian: Br. bolesnika još pod rizikom
English: A risk for induction of other PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Croatian: Rizik od indukcije drugih PXR-om reguliranih enzima osim CYP3A4 ne može se u potpunosti isključiti.
English: What Zykadia is and what it is used for
Croatian: Što je Zykadia i za što se koristi
English: Most of these severe/life-threatening cases improved or resolved with interruption of treatment.
Croatian: Većina se tih teških/po život opasnih slučajeva poboljšala ili riješila uz privremeni prekid liječenja.
English: Metabolism and nutrition disorders Decreased appetite
Croatian: Poremećaji metabolizma i prehrane Smanjeni apetit
English: It may make the amount of Zykadia in your blood increase to a harmful level.
Croatian: To bi moglo povećati količinu Zykadie u Vašoj krvi do štetne razine.
English: Limited efficacy data are available in elderly patients.
Croatian: Dostupni su ograničeni podaci o djelotvornosti u starijih bolesnika.
English: Do not take Zykadia: if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Zykadiu: ako ste alergični na ceritinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Then take the next tablets at the usual time.
Croatian: Zatim uzmite sljedeće tablete u uobičajeno vrijeme.
English: if you are currently taking steroids.
Croatian: ako imate problema s gušteračom. ako trenutačno uzimate steroide.
English: If you cannot eat food while taking Zykadia, talk to your doctor.
Croatian: Ako ne možete jesti hranu dok uzimate Zykadiu, porazgovarajte sa svojim liječnikom.
English: Food/drink interactions
Croatian: Interakcije s hranom/pićem
English: You and your doctor will decide together whether you should breast-feed or take Zykadia.
Croatian: Vi i Vaš liječnik odlučit ćete zajedno trebate li dojiti ili uzimati Zykadiu.
English: It is important that Zykadia is taken with food to reach the appropriate exposure.
Croatian: Bitno je da se Zykadia uzme uz hranu radi postizanja prikladne izloženosti.
English: Difficulty in breathing or swallowing
Croatian: Poteškoće u disanju ili gutanju
English: HR=hazard ratio; CI=confidence interval; BIRC=Blinded Independent Review Committee; NE=not estimable a
Croatian: HR=omjer hazarda; CI=interval pouzdanosti; BIRC=odbor za slijepo neovisno ocjenjivanje; NP=ne može se procijeniti a
English: Final overall survival (OS) data are presented for Study A2201.
Croatian: Završni podaci o ukupnom preživljenju (OS) su prikazani za Ispitivanje A2201.
English: Severe itching of the skin, with a red rash or raised bumps
Croatian: Jaki svrbež kože, s crvenim osipom ili izdignutim kvržicama
English: Of these patients 81 received ceritinib.
Croatian: Od tih bolesnika, 81 je primao ceritinib.
English: a p-value b
Croatian: a p-vrijednost b
English: If you take more Zykadia than you should
Croatian: Ako uzmete više Zykadie nego što ste trebali
English: You should also tell your doctor if you are already taking Zykadia and you are prescribed a new medicine that you have not already taken at the same time as Zykadia.
Croatian: Također trebate obavijestiti svog liječnika ako već uzimate Zykadiu, a propisan Vam je novi lijek koji niste još uzimali istodobno sa Zykadiom.
English: Dose optimisation Study A2112 (ASCEND-8)
Croatian: Ispitivanje optimizacije doze A2112 (ASCEND-8)
English: In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each ADR: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Croatian: Uz to, odgovarajuća kategorija učestalosti prema sljedećem prikazu (CIOMS III) također je navedena za svaku nuspojavu: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The main efficacy data for both studies are summarised in Table 6.
Croatian: Glavni podaci o djelotvornosti za oba ispitivanja sažeti su u Tablici 6.
English: Bradycardia (bradycardia, sinus bradycardia)
Croatian: Bradikardija (bradikardija, sinusna bradikardija)
English: There is no reported experience with overdose in humans.
Croatian: Nema zabilježenih iskustava s predoziranjem u ljudi.
English: Swallow the tablets whole with water.
Croatian: Progutajte tablete cijele s vodom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription such as vitamins or herbal supplements, because they might interact with Zykadia.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koji se izdaju bez recepta kao što su vitamini ili biljni dodaci, zato što oni mogu stupati u interakcije sa Zykadiom.
English: ALK testing
Croatian: Testiranje na ALK
English: If you have any questions contact your doctor right away.
Croatian: Ako imate ikakvih pitanja, odmah se obratite svom liječniku.
English: The overall survival (OS) data was not mature with 107 deaths representing approximately 42.3% of the required events for the final OS analysis.
Croatian: Podaci o ukupnom preživljenju (OS) nisu bili zreli, jer je 107 smrti predstavljalo približno 42,3% potrebnih događaja za konačnu analizu OS-a.
English: P-gp inhibitors
Croatian: P-gp inhibitori
English: None of these events led to discontinuation of ceritinib treatment.
Croatian: Nijedan od tih događaja nije doveo do prekida liječenja ceritinibom.
English: Food can range from a light to a full meal (see section 5.2).
Croatian: Hrana može varirati od laganog do potpunog obroka (vidjeti dio 5.2).
English: The safety and efficacy of ceritinib in children and adolescents aged up to 18 years have not been established.
Croatian: Sigurnost i djelotvornost ceritiniba u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: Zykadia should be taken with food.
Croatian: Zykadia se mora uzimati uz hranu.
English: Non-adenocarcinoma histology
Croatian: Histologija ne-adenokarcinoma
English: A total of 11 metabolites were found circulating in plasma at low levels with mean contribution to the radioactivity AUC of ≤2.3% for each metabolite.
Croatian: Ukupno je pronađeno 11 metabolita koji su cirkulirali u plazmi u niskim razinama sa srednjim doprinosom AUC-u radioaktivnosti ≤2,3% za svaki metabolit.
English: The EQ-5D questionnaire showed a significant overall health status improvement for Zykadia in comparison to the chemotherapy.
Croatian: Upitnik EQ-5D pokazao je značajno poboljšanje cjelokupnog zdravstvenog stanja uz Zykadiu u usporedbi s kemoterapijom.
English: Zykadia blocks the action of this abnormal protein and thus slows down the growth and spread of NSCLC.
Croatian: Zykadia blokira djelovanje tog abnormalnog proteina i tako usporava rast i širenje NSCLC-a.
English: Persistent hyperglycaemia greater than 250 mg/dl despite optimal anti-hyperglycaemic therapy
Croatian: Perzistentna hiperglikemija veća od 250 mg/dl usprkos optimalnoj antidijabetičkoj terapiji
English: Your doctor may need to adjust your treatment or stop Zykadia temporarily or permanently.
Croatian: Liječnik će Vam možda morati prilagoditi liječenje ili privremeno ili trajno prekinuti primjenu Zykadie.
English: The safety profile in patients aged 65 years or older was similar to that in patients less than 65 years of age (see section 4.2).
Croatian: Sigurnosni profil u bolesnika u dobi od 65 godina ili starijih bio je sličan profilu u bolesnika mlađih od 65 godina (vidjeti dio 4.2).
English: Addition of a thiol group to O-dealkylated ceritinib was also observed.
Croatian: Dodavanje tiolne skupine O-dealkiliranom ceritinibu također je bilo uočeno.
English: Oral contraceptives If you take Zykadia whilst using oral contraceptives, the oral contraceptives may become ineffective.
Croatian: Ako uzimate Zykadiu dok uzimate oralne kontraceptive, oralni kontraceptivi mogli bi postati neučinkoviti.
English: These medicines should be used with care or may need to be avoided during your treatment with Zykadia.
Croatian: Te lijekove treba uzimati oprezno ili će ih možda trebati izbjegavati tijekom liječenja Zykadiom.
English: Severe or intolerable nausea, vomiting or diarrhoea despite optimal anti-emetic or anti-diarrhoeal therapy
Croatian: Teška ili nepodnošljiva mučnina, povraćanje ili proljev usprkos optimalnoj terapiji antiemeticima ili antidijaroicima
English: As these non-clinical effects were mild, variable and inconsistent, the relationship between ceritinib and thyroid gland changes in animals is unclear.
Croatian: Budući da su ti neklinički učinci bili blagi, promjenjivi i nedosljedni, odnos između ceritiniba i promjena štitne žlijezde u životinja nije jasan.
English: Zykadia with food and drink
Croatian: Zykadia s hranom i pićem
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Croatian: Testiranje za ALK-pozitivan NSCLC mora se provoditi u laboratorijima s dokazanim stručnim znanjem o specifičnoj tehnologiji koja se za to koristi.
English: Other factors apart from study treatment could have impacted on observed events of hepatic encephalopathy, however, the relation between study treatment and events cannot be fully ruled out.
Croatian: Osim ispitivanog liječenja, na uočene slučajeve hepatičke encefalopatije mogli su utjecati i drugi čimbenici, međutim, veza između ispitivanog liječenja i događaja ne može se u potpunosti isključiti.
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Croatian: Učinkovitost istodobne primjene oralnih kontraceptiva mogla bi biti smanjena.
English: A key secondary efficacy endpoint was ORR according to RECIST 1.1 as evaluated by BIRC.
Croatian: Ključna mjera djelotvornosti sekundarnog ishoda bio je ORR prema RECIST-u 1.1, prema procjeni BIRC-a.
English: Agents that are substrates of transporters
Croatian: Tvari koje su supstrati transportera
English: If adequate glucose control cannot be achieved with optimal medical management, permanently discontinue Zykadia.
Croatian: Ako se ne može postići odgovarajuća kontrola glukoze uz optimalno medicinsko zbrinjavanje, trajno prekinuti primjenu Zykadie.
English: Bradycardia a
Croatian: Bradikardija a
English: Secondary biotransformation pathways involving the primary biotransformation products included glucuronidation and dehydrogenation.
Croatian: Putevi sekundarne biotransformacije koji uključuju produkte primarne biotransformacije uključivali su glukuronidaciju i dehidrogenaciju.
English: Based on the stratified Cox proportional hazards analysis.
Croatian: Na temelju stratificirane Coxove analize proporcionalnih hazarda.
English: QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs)
Croatian: QT korigiran za srčanu frekvenciju (QTc) >500 msec na najmanje 2 zasebna elektrokardiograma (EKG-a)
English: A total of 55.8% of patients were female.
Croatian: Ukupno je 55,8% bolesnika bilo ženskog spola.
English: The ORR, DOR and PFS (by BIRC assessment) for patients with brain metastases at baseline were in line with those reported for the overall population of these studies.
Croatian: ORR, DOR i PFS (prema ocjeni BIRC-a) za bolesnike s metastazama na mozgu na početku bili su u skladu s onima zabilježenima za cjelokupnu populaciju ovih ispitivanja.
English: Blood tests during treatment with Zykadia
Croatian: Krvne pretrage tijekom liječenja Zykadiom
English: Patients were allowed to continue the assigned study treatment beyond initial progression in case of continued clinical benefit as per the investigator's opinion.
Croatian: Bolesnici su smjeli nastaviti dodijeljeno ispitivano liječenje nakon početne progresije u slučaju kontinuirane kliničke koristi prema mišljenju ispitivača.
English: The capsules should be swallowed whole with water and should not be chewed or crushed.
Croatian: Kapsule se trebaju progutati cijele s vodom i ne smiju se žvakati ili drobiti.
English: Study X2101: Responses assessed using RECIST 1.0 Study A2201: Responses assessed using RECIST 1.1 *Includes only patients with confirmed CR, PR
Croatian: Ispitivanje X2101: Odgovori ocijenjeni koristeći RECIST 1.0 Ispitivanje A2201: Odgovori ocijenjeni koristeći RECIST 1.1 *Uključuje samo bolesnike s potvrđenim CR-om, PR-om
English: The majority of cases were manageable with dose interruption and/or dose reduction.
Croatian: Većina slučajeva mogla se kontrolirati privremenim prekidom primjene i/ili smanjenjem doze.
English: System organ class Preferred term
Croatian: Klasifikacija organskih sustava Preporučeni izraz
English: In contrast with single-dose data, pre-dose concentration (Cmin) after repeated daily dosing appeared to increase in a greater than dose-proportional manner.
Croatian: Za razliku od podataka koji se odnose na jednokratnu dozu, izgleda da se koncentracija prije doze (Cmin) nakon ponavljanog svakodnevnog doziranja povećava više nego proporcionalno dozi.
English: Population pharmacokinetic analyses showed that age, gender and race had no clinically meaningful influence on ceritinib exposure.
Croatian: Populacijske farmakokinetičke analize pokazale su da dob, spol i rasa nemaju klinički značajan utjecaj na izloženost ceritinibu.
English: A total of 57.4% of patients were female.
Croatian: Ukupno je 57,4% bolesnika bilo ženskog spola.
English: General supportive measures should be initiated in all cases of overdose.
Croatian: U svim slučajevima predoziranja potrebno je započeti opće suportivne mjere.
English: Few events required discontinuation of treatment.
Croatian: Mali je broj događaja zahtijevao trajni prekid liječenja.
English: Bradycardia c
Croatian: Bradikardija c
English: If you have questions about how long to take Zykadia, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Zykadiu, obratite se svom liječniku ili ljekarniku.
English: If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours.
Croatian: Ako propusti dozu, bolesnik treba nadoknaditi tu dozu, osim ako sljedeću dozu mora uzeti unutar 12 sati.
English: What Zykadia is and what it is used for What you need to know before you take Zykadia How to take Zykadia
Croatian: Što je Zykadia i za što se koristi Što morate znati prije nego počnete uzimati Zykadiu Kako uzimati Zykadiu
English: In patients with ALK defects, an abnormal protein is produced that stimulates the growth of the cancer cells.
Croatian: U bolesnika s oštećenjima ALK-a proizvodi se abnormalni protein koji stimulira rast stanica raka.
English: Patients with severe renal impairment (CLcr <30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
Croatian: Bolesnici s teškim oštećenjem bubrega (CLcr <30 ml/min) nisu bili uključeni u klinička ispitivanja Zykadie (vidjeti dio 4.2).
English: Zykadia should not be used during pregnancy unless the clinical condition of the woman requires treatment with ceritinib.
Croatian: Zykadia se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje ceritinibom.
English: Do not change the dose without talking to your doctor.
Croatian: Ne mijenjajte dozu ako niste prije o tome razgovarali sa svojim liječnikom.
English: ALK-positive NSCLC status should be established prior to initiation of Zykadia therapy.
Croatian: Status ALK-pozitivnog NSCLC-a potrebno je utvrditi prije uvođenja terapije Zykadiom.
English: Other medicines and Zykadia
Croatian: Drugi lijekovi i Zykadia
English: The PFS benefit was further supported by local investigator assessment, and analysis of overall response rate (ORR) and disease control rate (DCR).
Croatian: Tu su korist za PFS dodatno poduprli ocjena lokalnog ispitivača te analiza stope ukupnog odgovora (engl. overall response rate, ORR) i stope kontrole bolesti (engl. disease control rate, DCR).
English: Probability (%) of event-free
Croatian: Vjerojatnost (%) izostanka događaja
English: Significantly decreased urine flow (potential sign of a kidney problem)
Croatian: Značajno smanjeno mokrenje (potencijalni znak problema s bubrezima)
English: Early identification and management of ADRs with standard supportive care measures should be considered.
Croatian: Valja razmotriti rano prepoznavanje i zbrinjavanje nuspojava uz standardne mjere suportivne skrbi.
English: For subsequent dose adjustment and management recommendations for ADRs, please follow table 1 (see section 4.2).
Croatian: Za naredno prilagođavanje doza i preporuke za zbrinjavanje nuspojava, molimo slijediti upute u Tablici 1 (vidjeti dio 4.2).
English: Hazard Ratio = 0.55
Croatian: Omjer hazarda = 0,55
English: Log rank p-value = <0.001
Croatian: Log rang p-vrijednost = <0,001
English: Dose adjustment due to adverse reactions
Croatian: Prilagođavanje doze zbog nuspojava
English: In addition, 81 patients (69.8%) in the chemotherapy arm received subsequent Zykadia as first antineoplastic therapy after study treatment discontinuation.
Croatian: Uz to, 81 bolesnik (69,8%) u kemoterapijskoj skupini primao je naknadno Zykadiu kao prvu antineoplastičnu terapiju nakon prekida ispitivanog liječenja.
English: For patients who develop a concurrent medical condition and are unable to take Zykadia with food, Zykadia can be taken on an empty stomach as the alternate continued treatment regimen, in which no food should be eaten for at least two hours before and one hour after the dose.
Croatian: Za bolesnike koji razviju istodobno medicinsko stanje te nisu u mogućnosti uzeti Zykadiu uz hranu, Zykadia se može uzimati na prazan želudac kao alternativni kontinuirani režim liječenja po kojem se nikakva hrana ne smije uzimati barem dva sata prije i jedan sat nakon uzimanja doze.
English: In patients treated with Zykadia 450 mg with food, 10% of patients had an adverse event that required at least one dose reduction and 42% of patients had an adverse event that required at least one dose interruption.
Croatian: U bolesnika liječenih Zykadiom od 450 mg uz hranu, 10% bolesnika imalo je štetni događaj koji je zahtijevao najmanje jedno smanjenje doze i 42% bolesnika imalo je štetni događaj koji je zahtijevao barem jedan prekid doziranja.
English: Your doctor should also perform blood tests to check the functioning of your pancreas and the level of sugar in your blood before you start treatment with Zykadia and regularly during treatment.
Croatian: Liječnik bi Vam također trebao obaviti krvne pretrage kako bi Vam provjerio funkcioniranje gušterače i razinu šećera u krvi prije nego započnete liječenje Zykadiom te redovito tijekom liječenja.
English: Lipase or amylase elevation grade ≥3
Croatian: Povišenje lipaze ili amilaze stupnja ≥3
English: Formal non-clinical studies on the potential effects of ceritinib on fertility have not been conducted.
Croatian: Formalna neklinička ispitivanja potencijalnih učinaka ceritiniba na plodnost nisu provedena.
English: Based on available data, ceritinib elimination via the kidney is negligible (1.3% of a single oral administered dose).
Croatian: Na temelju dostupnih podataka, eliminacija ceritiniba putem bubrega je zanemariva (1,3% jednokratne peroralno primijenjene doze).
English: The tablets should be swallowed whole with water and should not be chewed or crushed.
Croatian: Tablete se trebaju progutati cijele s vodom i ne smiju se žvakati ili drobiti.
English: No patients had diarrhoea, nausea, or vomiting that required dose reduction or discontinuation of study drug.
Croatian: Nijedan bolesnik nije imao proljev, mučninu ili povraćanje koji su zahtijevali smanjenje doze ili prekid primjene ispitivanog lijeka.
English: 75% or more of patients in the ceritinib and chemotherapy arms completed the LCSS questionnaires at most of the time points during the course of the study.
Croatian: 75% ili više bolesnika u skupinama liječenim ceritinibom ili kemoterapijom popunilo je LCSS upitnike u većini vremenskih točaka tijekom ispitivanja.
English: Oral absorption was estimated to be ≥25% based on metabolite percentages in the faeces.
Croatian: Peroralna apsorpcija bila je procijenjena na ≥25% na temelju postotaka metabolita u stolici.
English: Significant improvements were reported for the majority of lung cancer specific symptoms for Zykadia compared to chemotherapy (four out of six LCSS and 10 out of 12 QLQ-LC13 symptom scores).
Croatian: Značajna su poboljšanja bila zabilježena za većinu simptoma specifičnih za rak pluća uz Zykadiu u usporedbi s kemoterapijom (četiri od šest rezultata za simptome na LCSS-u i deset od dvanaest na QLQ-LC13).
English: Based on available data, ceritinib is eliminated primarily via the liver.
Croatian: Na temelju dostupnih podataka, ceritinib se primarno eliminira putem jetre.
English: The maximum allowable dose under fasted condition is 750 mg (see section 5.2).
Croatian: Najviša dopuštena doza natašte iznosi 750 mg (vidjeti dio 5.2).
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Zykadia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Croatian: Mora se donijeti odluka da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Zykadia uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu (vidjeti dio 5.3).
English: There are no data related to brain-to-blood exposure ratio in humans.
Croatian: Nema podataka o omjeru izloženosti mozga i krvi u ljudi.
English: The study met its primary objective demonstrating a statistically significant improvement in progression free survival (PFS) by BIRC (see Table 3 and Figure 1).
Croatian: Ispitivanje je ostvarilo svoj primarni cilj dokazavši statistički značajno poboljšanje u preživljenju bez progresije (PFS) prema ocjeni BIRC-a (vidjeti Tablicu 3 i Sliku 1).
English: Permanently discontinue Zykadia.
Croatian: Trajno prekinuti primjenu Zykadie.
English: Number of events, n (%) Median, months d
Croatian: Broj događaja, n (%) Medijan, mjeseci d
English: In Studies X2101 and A2201, brain metastases were seen in 60.1% and 71.4% of patients, respectively.
Croatian: Ispitivanjima X2101 i A2201, metastaze na mozgu bile su uočene u 60,1% odnosno 71,4% bolesnika.
English: The limited data on the safety and efficacy of ceritinib in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Croatian: Ograničeni podaci o sigurnosti i djelotvornosti ceritiniba u bolesnika u dobi od 65 godina i starijih ne ukazuju na potrebu za prilagođavanjem doze u starijih bolesnika (vidjeti dio 5.2).
English: Zykadia has minor influence on the ability to drive or use machines.
Croatian: Zykadia malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Overall Response Rate (ORR: CR+PR), n (%) (95% CI)
Croatian: Stopa ukupnog odgovora (ORR: CR+PR), n (%) (95% CI)
English: Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
Croatian: Liječenje Zykadiom mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Pharmacotherapeutic group: antineoplasic and immunomodulating agents, ATC code: L01XE28.
Croatian: Farmakoterapijska skupina: antineoplastici i imunomodulatori, ATK oznaka: L01XE28.