FrancophonIA/ELRC3.0 huggingface dataset:
English: What Odomzo is and what it is used for What you need to know before you take Odomzo How to take Odomzo
Croatian: Što je Odomzo i za što se koristi Što morate znati prije nego počnete uzimati Odomzo
English: Effect of ethnicity
Croatian: Učinak etničkog podrijetla
English: Warnings and precautions - Odomzo may cause muscle problems.
Croatian: Upozorenja i mjere opreza - Odomzo može uzrokovati mišićne tegobe.
English: Odomzo should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Croatian: Odomzo se smije propisivati samo od strane liječnika specijalista ili pod nadzorom liječnika specijalista s iskustvom u liječenju odobrene indikacije.
English: Odomzo must be taken at least two hours after a meal and at least one hour before the following meal to prevent increased risk of adverse events due to higher exposure of sonidegib when taken with a meal (see section 5.2).
Croatian: Odomzo se mora uzeti najmanje dva sata nakon obroka i najmanje jedan sat prije sljedećeg obroka kako bi se prevenirao povećani rizik od štetnih događaja uslijed povećane izloženosti sonidegibu kada se uzima uz obrok (vidjeti dio 5.2).
English: These medicines should be used with caution or may need to be avoided during your treatment with Odomzo.
Croatian: Ovi se lijekovi moraju upotrebljavati s oprezom ili će ih možda biti potrebno izbjegavati tijekom liječenja Odomzom.
English: Patients should be monitored closely for adverse events and given appropriate supportive measures in all cases of overdose.
Croatian: Bolesnike je potrebno pažljivo pratiti zbog štetnih događaja te im pružiti odgovarajuće potporne mjere u svim slučajevima predoziranja.
English: If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.
Croatian: Ako bolesnica zatrudni, ako joj izostane menstruacija ili ako iz bilo kojeg razloga posumnja da bi mogla biti trudna, mora odmah obavijestiti liječnika koji provodi liječenje.
English: Central
Croatian: Centralno
English: • high level of sugar in the blood (known as hyperglycaemia)
Croatian: • visoka razina šećera u krvi (poznato kao hiperglikemija)
English: • you must take precautions so that you do not become pregnant while taking Odomzo,
Croatian: • morate poduzeti mjere opreza kako ne biste zatrudnjeli dok uzimate Odomzo,
English: Do not take Odomzo if any of the above apply to you.
Croatian: Odomzo ako bilo što od navedenog vrijedi za Vas.
English: Therefore, therapeutic doses of Odomzo are not expected to cause clinically significant QTc prolongation.
Croatian: Stoga se ne očekuje da će terapijske doze Odomza uzrokovati klinički značajno produljenje QTc-a.
English: If dose reduction is required, then the dose should be reduced to 200 mg every other day.
Croatian: Ako je potrebno smanjenje doze, dozu tada treba smanjiti na 200 mg svaki drugi dan.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX48
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici, ATK oznaka: L01XX48
English: Of the 230 patients, 16 had a diagnosis of Gorlin Syndrome (15 laBCC and 1 mBCC).
Croatian: Od tih 230 bolesnika, 16 ih je imalo dijagnozu Gorlinovog sindroma (15 luKBS i 1 mKBS).
English: What Odomzo is and what it is used for
Croatian: Što je Odomzo i za što se koristi
English: You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you could be pregnant.
Croatian: Morate prestati uzimati Odomzo i odmah se obratiti svom liječniku ako zatrudnite ili sumnjate da ste trudni.
English: • She must tell her healthcare provider if any of the following occur during treatment and during the 20 months after her final dose: o she becomes pregnant or thinks for any reason that she may be pregnant, o she misses her expected menstrual period, o she stops using contraception unless she commits to not having sexual intercourse (abstinence), o she needs to change contraception.
Croatian: • mora reći svom zdravstvenom djelatniku ako se dogodi bilo što od navedenoga tijekom liječenja i tijekom 20 mjeseci nakon zadnje doze: o ako zatrudni ili iz bilo kojeg razloga misli da bi mogla biti trudna, o ako joj izostane očekivana menstruacija, o ako prestane koristiti kontracepciju, osim ako se obveže da neće imati spolne odnose
English: • Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Croatian: • Opis programa sprječavanja trudnoće i kategorizacije bolesnika na temelju spola i reproduktivnog potencijala
English: Re-introduce sonidegib at 200 mg every other day and follow the same monitoring recommendations.
Croatian: Ponovno uvesti sonidegib u dozi od 200 mg svaki drugi dan te slijediti iste preporuke za praćenje.
English: • low level of haemoglobin (needed to transport oxygen in the blood)
Croatian: • niska razina hemoglobina (koji je potreban za transport kisika u krvi)
English: What you need to know before you take Odomzo
Croatian: Što morate znati prije nego počnete uzimati Odomzo
English: Management of severe or intolerable adverse reactions may require temporary dose interruption (with or without a subsequent dose reduction) or discontinuation.
Croatian: Zbrinjavanje teških ili nepodnošljivih nuspojava moglo bi zahtijevati privremeni prekid doziranja (s naknadnim smanjenjem doze ili bez njega) ili trajni prekid terapije.
English: The key efficacy results per central review and local investigator assessment are presented in Table 4.
Croatian: Ključni rezultati djelotvornosti prema centralnom ocjenjivanju i procjeni lokalnog ispitivača prikazani su u Tablici 4.
English: Cr: creatinine; ULN: upper limit of normal
Croatian: Cr: kreatinin; GGN: gornja granica normale Ostale prilagodbe doze
English: The bioavailability of sonidegib is increased in the presence of food (see section 5.2).
Croatian: Bioraspoloživost sonidegiba povećava se u prisutnosti hrane (vidjeti dio 5.2).
English: Longer concomitant treatment with inducer is not recommended because sonidegib exposure will be decreased and this may compromise efficacy.
Croatian: Dulje istodobno liječenje induktorom se ne preporučuje zato što će se izloženost sonidegibu smanjiti, a to može narušiti djelotvornost.
English: • National or other applicable specific arrangements for a prescription for Odomzo to be dispensed
Croatian: • Nacionalne ili druge primjenjive specifične mehanizme za izdavanje Odomza na temelju recepta
English: The CTCAE is a standardised classification of side effects used in assessing medicinal products for cancer therapy.
Croatian: CTCAE je standardizirana klasifikacija nuspojava koja se koristi u ocjeni lijekova za terapiju raka.
English: 12 months a Full analysis set included all randomised patients (intent-to-treat population).
Croatian: 6 mjeseci 12 mjeseci aPotpuni set za analizu uključivao je sve randomizirane bolesnike (populacija planirana za liječenje).
English: • high level of creatinine (kidney function)
Croatian: • visoka razina kreatinina (bubrežna funkcija)
English: All patients starting therapy with Odomzo must be informed of the risk of muscle-related adverse events, including the possibility of rhabdomyolysis.
Croatian: Svi bolesnici koji započinju terapiju Odomzom moraju biti obaviješteni o riziku od štetnih događaja povezanih s mišićima, uključujući i mogućnost rabdomiolize.
English: Sonidegib may pass into the semen.
Croatian: Sonidegib može prijeći u sjeme.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Based on the mechanism of action, in animal studies, sonidegib has been shown to be teratogenic and foetotoxic.
Croatian: Na temelju mehanizma djelovanja, u ispitivanjima na životinjama pokazalo se da je sonidegib teratogen i fetotoksičan.
English: During Odomzo treatment, you may also have some abnormal blood test results.
Croatian: Tijekom liječenja Odomozom mogli biste imati i poremećene rezultate krvnih pretraga.
English: In order to help healthcare providers and patients avoid embryonic and foetal exposure to Odomzo, the Marketing Authorisation Holder will provide educational materials (Odomzo Pregnancy Prevention Programme) to reinforce the potential risks associated with use of the medicinal product.
Croatian: Kako bi se pružateljima zdravstvene skrbi i bolesnicima pomoglo da izbjegnu embrionalnu i fetalnu izloženost Odomzu, nositelj odobrenja osigurat će edukacijske materijale (Program za sprječavanje trudnoće uz Odomzo) kako bi dodatno informirao o potencijalnim rizicima povezanima s primjenom ovog lijeka.
English: FAS: Full analysis set
Croatian: Full analysis set, potpuni set za analizu
English: 10 x 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters.
Croatian: 10 x 1 tvrda kapsula u PCTFE/PVC/Al perforiranim blisterima djeljivima na jedinične doze.
English: Sonidegib is primarily metabolised by CYP3A4.
Croatian: Sonidegib se prvenstveno metabolizira putem CYP3A4.
English: The recommended dose is 200 mg sonidegib taken orally once daily at least two hours after a meal and at least one hour before the following meal, at the same time each day.
Croatian: Preporučena doza je 200 mg sonidegiba peroralno jedanput na dan najmanje dva sata nakon obroka i najmanje jedan sat prije sljedećeg obroka, u isto vrijeme svakoga dana.
English: • Methodology to collect information on the use of Odomzo and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Croatian: • Metodologiju prikupljanja informacija o primjeni Odomza i pridržavanju programa farmakovigilancije za trudnoću te njegovoj učinkovitosti
English: Unchanged sonidegib in faeces represented 88.7% of the administered dose and was not detectable in urine.
Croatian: Nepromijenjeni sonidegib u stolici predstavlja 88,7% primijenjene doze i ne može se detektirati u mokraći.
English: Laboratory test
Croatian: Laboratorijska pretraga
English: Do not use while pregnant or breast-feeding.
Croatian: Ne uzimati za vrijeme trudnoće ili dojenja.
English: • Check renal function (serum creatinine) regularly and ensure that patient is adequately hydrated.
Croatian: • Redovito provjeravati bubrežnu funkciju (kreatinin u serumu) i osigurati dostatnu hidraciju bolesnika.
English: Steady-state level of sonidegib in the skin was 6-fold higher than in plasma.
Croatian: Razina sonidegiba u stanju dinamičke ravnoteže u koži bila je 6 puta viša nego u plazmi.
English: Do not crush, open or chew the capsule.
Croatian: Ne drobiti, otvarati ili žvakati kapsulu.
English: • That the patient should tell the healthcare professional about any adverse event
Croatian: • Da bolesnici trebaju obavijestiti zdravstvenog djelatnika o svakom štetnom događaju
English: If you vomit after you swallow the capsule, do not take any more capsules until your next scheduled dose.
Croatian: Ako povraćate nakon što ste progutali kapsulu, ne uzimajte drugu kapsulu do sljedeće planirane doze.
English: Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) must be closely monitored due to an increased risk of muscle toxicity.
Croatian: Bolesnici s neuromuskularnim poremećajima (npr. upalne miopatije, mišićna distrofija, amiotrofična lateralna skleroza, spinalna mišićna atrofija) moraju se pažljivo pratiti zbog povećanog rizika od mišićne toksičnosti.
English: This switches on signals that make the cancer cells grow out of control.
Croatian: On pokreće signale zbog kojih stanice raka nekontrolirano rastu.
English: Effects of sonidegib on other medicinal products
Croatian: Učinci sonidegiba na druge lijekove
English: The capsules must not be opened due to risk of teratogenicity (see section 5.3).
Croatian: Kapsule se ne smiju otvarati zbog rizika od teratogenosti (vidjeti dio 5.3).
English: Based on the available data, sonidegib elimination via the kidney is negligible.
Croatian: Na temelju dostupnih podataka, eliminacija sonidegiba putem bubrega je zanemariva.
English: Semen donation
Croatian: Doniranje sjemena
English: For healthcare professionals
Croatian: Za zdravstvene djelatnike
English: Odomzo is provided in perforated unit-dose blisters containing 10 x 1 capsule.
Croatian: Odomzo se isporučuje u perforiranim blisterima djeljivim na jedinične doze koji sadrže 10 x 1 kapsulu.
English: Sonidegib was highly bound to human plasma proteins (human serum albumin and alpha-1 acid glycoprotein) in vitro (>97%), and binding was not concentration-dependent from 1 ng/ml to 2500 ng/ml.
Croatian: Sonidegib je u velikoj mjeri vezan za proteine ljudske plazme (ljudski serumski albumin i alfa-1 kiseli glikoprotein) in vitro (> 97%), a vezanje nije bilo ovisno o koncentraciji od 1 ng/ml do 2500 ng/ml.
English: <2D barcode carrying the unique identifier included>
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom
English: Best % change from baseline (target lesions)
Croatian: Najbolji % promjene od početne vrijednosti (ciljne lezije)
English: They must be instructed to report promptly any unexplained muscle pain, tenderness or weakness occurring during treatment with Odomzo or if symptoms persist after discontinuing treatment.
Croatian: Mora ih se uputiti da odmah prijave svaku neobjašnjenu mišićnu bol, osjetljivost ili slabost koja se pojavi tijekom liječenja Odomzom ili ako simptomi ustraju nakon prekida liječenja.
English: Carcinogenicity studies have not been performed with sonidegib, but sonidegib was not genotoxic in studies conducted in vitro and in vivo.
Croatian: Kancerogeneza i mutageneza Ispitivanja kancerogenosti nisu provođena sa sonidegibom, ali sonidegib nije bio genotoksičan u ispitivanjima provedenim in vitro i in vivo.
English: Some other medicines can also affect how Odomzo works, or make it more likely that you will have side effects.
Croatian: Neku drugi lijekovi također mogu utjecati na to kako Odomzo djeluje, ili povećati vjerojatnost nuspojava.
English: Progression-free survival probability (%), (95% CI)
Croatian: Vjerojatnost preživljenja bez progresije (%), (95% CI)
English: In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”.
Croatian: U bolesnika s karcinomom bazalnih stanica javljaju se promjene gena koji kontroliraju dio ovog procesa koji se naziva „hedgehog put“.
English: The evaluation of safety in the paediatric population is based on data from 16 adult and 60 paediatric patients from Study CLDE225X2104 and 16 adult and 2 paediatric patients from Study CLDE225C2301.
Croatian: Procjena sigurnosti u pedijatrijskoj populaciji temelji se na podacima od 16 odraslih i 60 pedijatrijskih bolesnika iz ispitivanja CLDE225X2104 te 16 odraslih i 2 pedijatrijska bolesnika iz ispitivanja CLDE225C2301.
English: • Do not eat for 2 hours before taking Odomzo and for 1 hour afterwards.
Croatian: • Nemojte jesti 2 sata prije uzimanja Odomza i 1 sat nakon uzimanja Odomza.
English: • Swallow the capsule whole.
Croatian: • Progutajte kapsulu cijelu.
English: There was no evidence of clearance change with repeated dosing based on the population pharmacokinetic analysis and estimated accumulation at steady state was 19-fold irrespective of dose.
Croatian: Nije bilo dokaza promjene klirensa uz ponovljeno doziranje na temelju populacijske farmakokinetičke analize, a procijenjeno nakupljanje u stanju dinamičke ravnoteže bilo je 19 puta veće bez obzira na dozu.
English: A woman of childbearing potential must understand that:
Croatian: Žena reproduktivne dobi mora razumjeti da:
English: Safety and efficacy data in patients aged 65 years and older do not suggest that a dosage adjustment is required in these patients (see section 5.2).
Croatian: Podaci o sigurnosti i djelotvornosti u bolesnika u dobi od 65 i više godina ukazuju na to da nije potrebna prilagodba doziranja u tih bolesnika (vidjeti dio 5.2).
English: No efficacy and safety data are available in patients with severe renal impairment.
Croatian: Nema dostupnih podataka o djelotvornosti i sigurnosti u bolesnika s teškim oštećenjem bubrega.
English: Unchanged sonidegib represented 36% of circulating radioactivity and the major circulating metabolite (45% of parent exposure) identified in plasma is the hydrolysis product of sonidegib and is pharmacologically inactive.
Croatian: Nepromijenjeni sonidegib predstavljao je 36% cirkulirajuće radioaktivnosti, a glavni cirkulirajući metabolit (45% izloženosti ishodišne tvari) identificiran u plazmi je produkt hidrolize sonidegiba i farmakološki je neaktivan.
English: • He must always use the recommended contraception (see the “Contraception” section below and section 4.6).
Croatian: • mora uvijek koristiti preporučenu kontracepciju (vidjeti dio „Kontracepcija“ u nastavku i dio 4.6).
English: Very common * Based on worst laboratory value post-treatment regardless of baseline, grading by CTCAE version 4.03
Croatian: vrlo često povišena amilaza vrlo često * Na temelju najgore laboratorijske vrijednosti nakon liječenja bez obzira na početnu vrijednost, stupnjevi prema CTCAE-u verzija 4.03
English: Patients should be closely monitored and dose adjustments should be considered if muscle symptoms develop.
Croatian: Bolesnike je potrebno pažljivo pratiti i razmotriti prilagodbu doze ako se razviju mišićni simptomi.
English: This dose of sonidegib is predicted to adjust the AUC to the range observed without inducers based on pharmacokinetic data when the concomitant treatment with the inducer is no longer than 14 days.
Croatian: Za ovu dozu sonidegiba predviđa se da će prilagoditi AUC rasponu opaženom bez induktora na temelju farmakokinetičkih podataka kada istodobno liječenje induktorom ne traje dulje od 14 dana.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Sonidegib did not inhibit apical efflux transporters, P-gp or MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Croatian: Sonidegib nije inhibirao apikalne efluksne prijenosnike, P-gp ili MRP2, prijenosnike unosa u jetru OATP1B1 ili OATP1B3, prijenosnike unosa organskih aniona u bubrege OAT1 i OAT3, ili prijenosnike unosa organskih kationa OCT1 ili OCT2 pri klinički relevantnim koncentracijama.
English: • Odomzo exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman.
Croatian: • Odomzo izlaže nerođeno dijete teratogenom riziku ako se muškarac upušta u nezaštićene spolne aktivnosti s trudnicom.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: − Measures to ensure that all appropriate actions have been performed prior to Odomzo being prescribed and dispensed
Croatian: − Mjere koje osiguravaju da su poduzete sve primjerene radnje prije propisivanja i izdavanja Odomza
English: • thirst, not passing much urine, weight loss, dry flushed skin, irritability (possible symptoms of low level of fluids in the body, known as dehydration).
Croatian: • žeđ, smanjeno mokrenje, smanjenje tjelesne težine, suha crvena koža, razdražljivost (mogući simptomi niske razine tekućina u tijelu, što se naziva dehidracijom).
English: In case of pregnancy occurring during treatment, Odomzo must be stopped immediately (see section 5.3).
Croatian: U slučaju da dođe do trudnoće tijekom liječenja, primjena Odomza mora se odmah prekinuti (vidjeti dio 5.3).
English: Studies in animals have shown teratogenicity and foetotoxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su teratogenost i fetotoksičnost (vidjeti dio 5.3).
English: Based on in vitro data, sonidegib is not a substrate of P-gp, BCRP or multi-resistance protein 2 (MRP2).
Croatian: Na temelju in vitro podatka, sonidegib nije supstrat P-gp-a, BCRP-a ili proteina višestruke rezistencije na lijekove 2 (MRP2).
English: Patients concomitantly using substrates of BCRP transporters should be carefully monitored for adverse drug reactions.
Croatian: Bolesnike koji istodobno uzimaju supstrate BCRP transportera treba pažljivo pratiti zbog nuspojava.
English: Odomzo contains lactose (milk sugar).
Croatian: Odomzo sadrži laktozu (mliječni šećer).
English: Following the administration of a single dose of Odomzo (100 mg to 3000 mg) without food in patients with cancer, the median time-to-peak concentration (Tmax) was 2 to 4 hours.
Croatian: Nakon primjene jednokratne doze Odomza (100 mg do 3000 mg) bez hrane u bolesnika s rakom, medijan vremena do vršne koncentracije (Tmax) bio je 2 do 4 sata.
English: The median duration of treatment was 11.0 months for patients treated with Odomzo at the recommended dose of 200 mg (range 1.3 to 41.3 months).
Croatian: Medijan trajanja liječenja bio je 11,0 mjeseci za bolesnike liječene Odomzom u preporučenoj dozi od 200 mg (raspon 1,3 do 41,3 mjeseci).
English: • If CK and serum creatinine levels return to baseline consider resuming treatment at 200 mg every other day and measure CK levels weekly for 2 months and monthly thereafter; otherwise discontinue treatment permanently.
Croatian: • Ako se razine CPK i kreatinina u serumu vrate na početnu razinu, razmotriti nastavak liječenja s 200 mg svaki drugi dan i mjeriti razine CPK svaki tjedan tijekom 2 mjeseca te svaki mjesec nakon toga; u suprotnom trajno prekinuti liječenje.
English: Foetotoxicity in rabbits was also seen at very low maternal exposure.
Croatian: Fetotoksičnost u kunića bila je također opažena pri vrlo niskim izloženostima za majku.
English: Further, sonidegib plasma concentrations above those achieved with the therapeutic doses were not associated with life-threatening arrhythmias or torsades de pointes.
Croatian: Nadalje, koncentracije sonidegiba u plazmi iznad onih postignutih terapijskim dozama nisu bile povezane s aritmijama opasnim po život ili torsades de pointes.
English: Data from studies in rats and dogs indicate that male and female fertility may be irreversibly compromised by treatment with Odomzo (see section 5.3).
Croatian: Podaci iz ispitivanja na štakorima i psima ukazuju da muška i ženska plodnost može biti nepovratno narušena uz liječenje Odomzom (vidjeti dio 5.3).
English: If you forget to take Odomzo If you forget to take a dose of Odomzo, take it as soon you realise.
Croatian: Ako zaboravite uzeti dozu Odomza, uzmite je čim se sjetite.
English: Embryofoetal death or severe birth defects
Croatian: Embriofetalna smrt ili teške urođene anomalije
English: • Do not use this medicine after the expiry date which is stated on the pack and the blister after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i blisteru iza
English: In clinical trials, treatment with Odomzo was continued until disease progression or until unacceptable toxicity.
Croatian: U kliničkim ispitivanjima liječenje Odomzom nastavljalo se do progresije bolesti ili do neprihvatljive toksičnosti.