FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetics of pixantrone proved to be linear in a broad range of doses, from 3 mg/m2 to 105 mg/m2.
Croatian: Farmakokinetika piksantrona pokazuje linearnost u širokom rasponu doza, od 3 mg/m2 do 105 mg/m2.
English: Figure 1 PIX301 Progression-free survival - end of study
Croatian: Slika 1 PIX301 - preživljenje bez progresije bolesti - na kraju ispitivanja
English: Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting
Croatian: Svaka lijekom izazvana nekardijalna toksičnost stupnja 3 ili 4, osim mučnine i povraćanja
English: It is not known whether Pixuvri has an effect on the ability to drive a car or use machines.
Croatian: Nije poznato utječe li Pixuvri na sposobnost upravljanja vozilima i rada sa strojevima.
English: The most common toxicity is bone marrow suppression, particularly of the neutrophil lineage.
Croatian: Najčešća toksična reakcija je supresija koštane srži, posebno njene neutrofilne loze.
English: Some caution is advised in obese patients as data on BSA- based dosing is very limited for this group.
Croatian: Savjetuje se oprezno doziranje u pretilih bolesnika, budući da su podaci o korištenju BSA u doziranju lijekova kod ove skupine ograničeni.
English: A comprehensive retrospective population PK/PD analysis of Phase 1 trials and combination regimens (Phase 1/2) demonstrated that progression-free survival and Grade 2-3 neutropenia were related to Pixuvri exposure.
Croatian: Sveobuhvatna retrospektivna analiza populacijske farmakokinetike i farmakodinamike (PK/PD) u ispitivanjima faze 1 i s kombiniranim režimima (faza 1/2) pokazala je da su preživljenje bez progresije tumora i neutropenija stupnja 2-3 bili povezani s izloženosti lijeku Pixuvri.
English: ADRs are listed in Table 3 below by MedDRA system organ class and by frequency: 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), not known (cannot be estimated from available data).
Croatian: (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In dogs, the heart was not affected by treatment, as no ECG changes were seen at different treatment times, nor heart changes were detected at gross- and histopathology.
Croatian: U pasa, srce nije bilo pogođeno liječenjem, jer nisu zabilježene promjene u EKG-u snimanom u različitim vremenskim intervalima tijekom liječenja, niti su primijećene makro- i histopatološke promjene na srcu.
English: Pixantrone did inhibit OCT1-mediated metformin transport in vitro, but is not expected to inhibit OTC1 in vivo at clinically relevant concentrations.
Croatian: In vitro piksantron je inhibirao transport metformina pomoću OCT1, ali se ne očekuje da će inhibirati OTC1 in vivo u klinički relevantnim koncentracijama.
English: The non-vesicant properties of Pixuvri minimise the risk of local reaction following extravasation.
Croatian: Pixuvri nema svojstva iritansa, rizik za pojavu lokalne reakcije nakon ekstravazacije je nizak.
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatinine increased
Croatian: Povišena alanin-aminotransferaza, povišena aspartataminotransferaza, povišena alkalna fosfataza u krvi, povišen kreatinin u krvi
English: Patient demographics and baseline disease characteristics were well balanced between the treatment groups, and no statistically significant differences were noted.
Croatian: Demografski podaci bolesnika i polazne karakteristike bolesti bile su podjednake između dviju ispitivanih skupina, bez statistički značajnih razlika.
English: Patients with poor performance status
Croatian: Bolesnici lošeg funkcionalnog stanja
English: Pixantrone had only a weak or no capability to inhibit P-gp, BCRP, and BSEP transport mechanism in vitro.
Croatian: Piksantron ima slabu ili nikakvu sposobnost inhibicije transportnih mehanizama P-gp, BCRP, i BSEP in vitro.
English: What Pixuvri looks like and contents of the pack Pixuvri is a powder for concentrate for solution for infusion.
Croatian: Kako Pixuvri izgleda i sadržaj pakiranja Pixuvri je prašak za koncentrat za otopinu za infuziju.
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton Lancashire BL5 3XX United Kingdom
Croatian: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton Lancashire BL5 3XX Ujedinjeno Kraljevstvo
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX United Kingdom
Croatian: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX Ujedinjeno Kraljevstvo
English: Three Pixuvri patients (4.4%) had tachycardia, arrhythmia, sinus tachycardia, supraventricular tachycardia or bradycardia.
Croatian: Tri bolesnika u skupini lijeka Pixuvri (4,4%) imala su tahikardiju, supraventrikularnu tahikardiju, aritmiju, sinusnu tahikardiju ili bradikardiju.
English: Patients with impaired hepatic function
Croatian: Bolesnici s oštećenom funkcijom jetre
English: A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity.
Croatian: Preporučuje se procjena osnovnog polaznog kardiološkog stanja pomoću MUGA-snimki ili UZV-a, posebno u bolesnika s faktorima povećanog rizika za kardijalnu toksičnost.
English: Genotoxicity studies confirmed the potential for clastogenic effects in mammalian cells in vitro and in vivo.
Croatian: Ispitivanja genotoksičnosti potvrdila su potencijal za klastogene učinke na stanicama sisavaca in vitro i in vivo.
English: Recombinant hematopoietic growth factors may be used according to institutional or European Society for Medical Oncology (ESMO) guidelines.
Croatian: Rekombinantni hematopoetski faktor rasta može se primijeniti prema važećim smjernicama ustanove u kojoj se terapija provodi ili ESMO-a (European Society for Medical Oncology).
English: Skin and subcutaneous tissue disorders*
Croatian: Poremećaji kože i potkožnog tkiva*
English: Pixuvri should not be administered to patients with an active, severe infection or in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection.
Croatian: Pixuvri se ne smije primijeniti u bolesnika s aktivnom, teškom infekcijom ili u pacijenata s recidivirajućim ili kroničnim infekcijama u anamnezi ili koji su u takvom zdravstvenom stanju koje može pogodovati nastanku ozbiljnih infekcija.
English: There is limited data in patients previously treated with rituximab (38 patients in the Pixuvri arm and 39 patients in the comparator arm).
Croatian: Podaci o bolesnicima ranije liječenim rituksimabom ograničeni su (38 bolesnika u skupini liječenoj lijekom Pixuvri i 39 u skupini s usporednim lijekom).
English: However, the benefit of Pixuvri has not been established when used as fifth line or greater in patients refractory to last therapy, and there is very limited data in this group of patients.
Croatian: Ipak, korist od liječenja lijekom Pixuvri nije utvrđena kada se koristio kao lijek pete ili kasnije linije liječenja u bolesnika refraktornih na posljednje liječenje, i u toj skupini bolesnika podaci su vrlo ograničeni.
English: Table 1 and Table 2 are recommended as guides to dosage adjustments for days 8 and 15 of the 28- day cycles.
Croatian: Tablica 1 i Tablica 2 preporučene su smjernice za prilagodbu doze 8. i 15. dana 28-dnevnog ciklusa liječenja.
English: Although a risk to inhibition of pixantrone towards CYP2C8 could not be ascertained, caution should be observed when co-administering substances that are primarily metabolised via CYP2C8, such as repaglinide, rosiglitazone, or paclitaxel e.g. by careful monitoring for side effects.
Croatian: Iako se rizik od inhibicije CYP2C8 piksantronom ne može sa sigurnošću utvrditi, potreban je oprez kod istovremene primjene s tvarima koje se prvenstveno metaboliziraju pomoću CYP2C8, kao što su repaglinid, roziglitazon ili paklitaksel, uz pažljivo praćenje pojave nuspojava.
English: The development of haematological malignancies such as secondary acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) is a recognised risk associated with anthracycline treatment and other topoisomerase II inhibitors.
Croatian: Razvoj hematoloških maligniteta, kao što su sekundarna akutna mijeloična leukemija (AML) ili mijelodisplastični sindrom (MDS), poznat je rizik povezan s liječenjem antraciklinima i drugim inhibitorima topoizomeraze II.
English: Pixantrone may induce hyperuricaemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of neoplastic cells (tumour lysis syndrome) and can lead to electrolyte imbalances, which can result in kidney damage.
Croatian: Piksantron može inducirati nastanak hiperuricemije kao posljedicu brzog katabolizma purina koji prati brzu lizu tumorskih stanica (sindrom lize tumora) izazvanu lijekovima i može dovesti do disbalansa elektrolita, koji pak može uzrokovati oštećenje bubrega.
English: The skin discolouration generally disappears over a few days to weeks as the drug is cleared.
Croatian: Promjena boje kože obično nestaje za nekoliko dana ili tjedana nakon što se lijek izlučio.
English: The lyophilised powder should completely dissolve in 60 seconds with agitation.
Croatian: Liofilizirani prašak trebao bi se potpuno otopiti za 60 sekundi uz protresanje.
English: As with other agents in the general class of deoxyribonucleic acid (DNA) damaging agents, Pixuvri may be associated with fertility impairment.
Croatian: Kao i drugi lijekovi iz skupine tvari koje oštećuju deoksiribonukleinsku kiselinu (DNK), Pixuvri može biti povezan s oštećenjem plodnosti.
English: The amount of Pixuvri in milligrams that is to be administered to a patient should be determined on the basis of the patient's body surface area (BSA).
Croatian: Količinu Pixuvri u miligramima koju treba primijeniti na bolesniku treba odrediti na temelju njegove tjelesne površine
English: Active or dormant cardiovascular disease, prior therapy with anthracyclines or anthracenediones, prior or concurrent radiotherapy to the mediastinal area, or concurrent use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Croatian: Aktivna ili pritajena kardiovaskularna bolest, ranija terapija antraciklinima ili antracendionima, ranija ili istovremena terapija zračenjem medijastinalnog područja ili istovremena primjena drugih kardiotoksičnih lijekova mogu povećati rizik za kardiotoksičnost.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: Patients in PIX 301 were required to have been sensitive to prior anthracycline therapy (confirmed or unconfirmed CR or PR).
Croatian: Za bolesnike uključene u ispitivanje PIX 301traženo je da budu osjetljivi na prethodnu terapiju antraciklinom (s potvrđenim ili nepotvrđenim potpunim [CR - engl. complete response] ili djelomičnim [PR - engl. partial response] odgovorom).
English: log rank p-value = 0.005 HR = 0.60 (95% CI 0.42, 0.86)
Croatian: log rang p-vrijednost= 0,005 HR = 0,60 (95% CI 0,42; 0,86)
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza “Rok valjanosti”.
English: Devices and surfaces accidentally contaminated with Pixuvri must be treated with a solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% of available chlorine] for 0.58 mg of Pixuvri).
Croatian: Uređaji i površine koje se nehotice kontaminiraju lijekom Pixuvri moraju se tretirati otopinom natrijevog hipoklorita (100 µl vode i 20 µl natrijeva hipoklorita [7 ± 2% oslobođenog klora] za 0,58 mg lijeka Pixuvri).
English: Cardiac failure events (MedDRA terms cardiac failure, cardiac failure acute and cardiac failure congestive) occurred in 6 patients (8.8%) treated with Pixuvri (2 patients with grade 1-2, 1 patient with grade 3, and 3 patients, 2 considered as unrelated, with grade 5).
Croatian: Zatajenje srca (prema MedDRA terminologiji zatajenje srca, akutno zatajenje srca i kongestivno zatajenje srca) pojavilo se u 6 bolesnika (8,8%) liječenih lijekom Pixuvri (2 bolesnika stupnja 1-2, 1 bolesnik stupnja 3 i 3 bolesnika stupnja 5, od čega se za 2 smatralo da nije povezano).
English: One case of photosensitivity reaction has been reported in the clinical trial program considered as non-serious and with outcome recovered.
Croatian: U programu kliničkih ispitivanja opisan je jedan slučaj fotosenzitivne reakcije, koji se smatrao ne-ozbiljnim te je ishod nuspojave bio oporavak.
English: For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to acceptable levels.
Croatian: Kod sljedećih ciklusa liječenja prethodna doza obično može biti ponovljena ako se broj leukocita i trombocita obnovio na zadovoljavajuću razinu.
English: Other toxicities such as nausea, vomiting, and diarrhoea were generally infrequent, mild, reversible, manageable, and expected in patients treated with cytotoxic agents.
Croatian: Drugi znakovi toksičnosti poput mučnine, povraćanja i proljeva bili su općenito neučestali, blagi i prolazni, podnošljivi i očekivani za bolesnike koji se liječe citotoksičnim lijekovima.
English: Cardiac function should be monitored before initiation and during the treatment with Pixuvri .
Croatian: Potrebno je pratiti srčanu funkciju prije početka i tijekom liječenja lijekom Pixuvri.
English: Equipment such as vials, needles and syringes used for Pixuvri administration should be handled as toxic waste.
Croatian: S opremom, kao što su bočice, igle i štrcaljke korištene za primjenu lijeka Pixuvri, treba postupati kao s toksičnim otpadom.
English: All initial treatment with Pixuvri should be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, serum levels of total creatinine, and cardiac function as measured by left ventricular ejection fraction (LVEF).
Croatian: Prije svake prve primjene lijeka Pixuvri potrebno je učiniti i pažljivo procijeniti novi nalaz kompletne krvne slike, serumske razine ukupnog bilirubina, serumske razine ukupnog kreatinina i provjeru srčane funkcije mjerenjem ejekcijske frakcije lijevog ventrikula (LVEF).
English: Hydration, urine alkalinisation, and prophylaxis with allopurinol or other agents to prevent hyperuricaemia may minimise potential complications of tumour lysis syndrome.
Croatian: Hidracija, alkalizacija urina i profilaktička primjena alopurinola ili drugih spojeva za sprječavanje hiperuricemije mogu smanjiti potencijalne komplikacije sindroma lize tumora.
English: Theophylline levels should be carefully monitored in the weeks immediately following initiation of Pixuvri concurrent therapy.
Croatian: Razinu teofilina treba pažljivo pratiti u tjednima neposredno nakon početka njegove istovremene primjene s lijekom Pixuvri.
English: Experience administering Pixuvri to patients with more significant cardiac compromise is limited and should only be undertaken in the context of a clinical trial.
Croatian: Iskustva s primjenom lijeka Pixuvri u bolesnika sa značajnije kompromitiranom srčanom funkcijom su ograničena te ga kod takvih bolesnika treba primjenjivati samo u kontekstu kliničkog ispitivanja.
English: The occurrence of secondary cancers, including AML and MDS, may occur during or after treatment with Pixuvri.
Croatian: Pojava sekundarnih maligniteta, uključujući AML i MDS, može se javiti za vrijeme ili poslije liječenja lijekom Pixuvri.
English: Following intravenous administration, plasma concentrations of pixantrone reached the maximal concentration at the end of infusion and then declined poly-exponentially.
Croatian: Apsorpcija Nakon intravenske primjene koncentracija piksantrona u plazmi doseže svoj maksimum na kraju infuzije i zatim postepeno opada polieksponencijalno.
English: Pixuvri is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Pixuvri tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The safety and efficacy of Pixuvri as single-agent therapy were evaluated in a multicentre, randomised, active controlled trial in patients with relapsed or refractory aggressive NHL after receiving at least two prior therapies.
Croatian: Sigurnost i djelotvornost lijeka Pixuvri kao monoterapijskog lijeka procjenjivana je u multicentričnom, randomiziranom, aktivno kontroliranom ispitivanju u bolesnika s relapsnim ili refraktornim agresivnim ne-Hodgkinovim limfomom (NHL), nakon što su već primili najmanje dvije prethodne terapije.
English: Table 1 Dose modifications for hematologic toxicity on days 8 and 15 of any cycle Grade Platelet count
Croatian: Prilagodba doze zbog hematološke toksičnosti 8. i 15. dana bilo kojeg ciklusa liječenja
English: Careful monitoring of blood counts is required, including leukocyte, red blood cells, platelet, and absolute neutrophil counts.
Croatian: Potrebno je pažljivo pratiti broj krvnih stanica, uključujući leukocite, eritrocite, trombocite i apsolutni broj neutrofila.
English: Pain/redness of the injection site may occur rarely during infusion of Pixuvri.
Croatian: Bol/crvenilo na mjestu injekcije događa se rijetko prilikom primjene lijeka Pixuvri.
English: Tell your doctor if you get any symptoms of an infection (for example, fever, chills, trouble breathing, cough, sores in your mouth, trouble swallowing, or severe diarrhoea) after Pixuvri treatment.
Croatian: Obavijestite svog liječnika ako nakon primjene lijeka Pixuvri dobijete bilo kakve simptome infekcije (npr. vrućicu, zimicu, smetnje disanja, kašalj, rane u ustima, smetnje gutanja ili teški proljev).
English: Although the incidence of severe marrow suppression with clinical consequences is relatively low, patients have been treated with Pixuvri were closely monitored by frequent blood counts, particularly for neutropenia.
Croatian: Iako je incidencija teške supresije koštane srži s kliničkim posljedicama relativno rijetka, bolesnici koji su liječeni lijekom Pixuvri pažljivo su praćeni čestim provjerama krvne slike, naročito na pojavu znakova neutropenije.
English: Very common Chromaturia
Croatian: Vrlo često Kromaturija
English: In the clinical trial program, there has been one report of overdose with Pixuvri with no reported concomitant adverse events.
Croatian: U programu kliničkih ispitivanja opisan je jedan slučaj predoziranja lijekom Pixuvri, bez zabilježenih štetnih događaja.
English: Use gloves, masks, and protective eyewear when handling and during decontamination procedures.
Croatian: Koristite rukavice, maske i zaštitne naočale prilikom rukovanja i za vrijeme postupaka dekontaminacije.
English: In a colony-forming units study in mice, the myelotoxicity of Pixuvri and mitoxantrone administered at their LD10 (pixantrone dimaleate 38 mg/kg and mitoxantrone 6.1 mg/kg) was similar.
Croatian: U ispitivanju stvaranja kolonija u miševa, mijelotoksičnost lijeka Pixuvri i mitoksantrona primijenjenih u njihovim LD10 dozama (piksantrondimaleat 38 mg/kg i mitoksantron 6,1 mg/kg) bila je slična.
English: Males were more sensitive to treatment, with respect to reduction in white blood cells and platelet count (reversible) and lymphoid depletion (spleen and thymus), as well as the marked toxicity to reproductive organs, as expected from a cytotoxic agent.
Croatian: Mužjaci su bili osjetljiviji na liječenje, posebno radi sniženja broja leukocita i trombocita (reverzibilno) i gubitka limfatičkog tkiva (slezena i timus), kao i naglašene toksičnosti za reproduktivne organe, kako se i očekivalo od citotoksičnih agenasa.
English: Pixuvri kills cancer cells by binding to DNA, resulting in cell death.
Croatian: Pixuvri uništava stanice tumora tako da se veže na DNK, čime izaziva smrt stanice.
English: With the recommended dose and schedule, neutropenia is usually transient, reaching its nadir on days 15-22 following administration on days 1, 8, and 15 with recovery usually occurring by day 28.
Croatian: Uz preporučene doze i raspored primjene, neutropenija je obično prolazna, dostižući najniže vrijednosti između 15. i 22. dana od primjene 1., 8. i 15. dana ciklusa, i obično se oporavlja do
English: log rank p-value = 0.251 HR = 0.79 (95% CI 0.53, 1.18)
Croatian: log rang p-vrijednost = 0,251 HR = 0,79 (95% CI 0,53; 1,18)
English: Breast-feeding should be discontinued during treatment with Pixuvri.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Pixuvri.
English: Since most medicinal product-induced photosensitivity reactions are caused by wavelengths within the UV-A range, sunscreen that strongly absorbs UV-A is recommended.
Croatian: Budući da većina fotosenzitivnih reakcija uzrokovanih lijekovima nastaje djelovanjem svjetlosnih zraka valnih duljina koje pripadaju rasponu UV-A, preporučuju se kreme za sunčanje s visokim UV-A zaštitnim faktorom.
English: Based on in vitro studies, pixantrone was found to be a substrate for the membrane transport proteins P-gp/BRCP and OCT1 and agents which inhibit these transporters have the potential to decrease hepatic uptake and excretion efficiency of pixantrone.
Croatian: Na temelju in vitro ispitivanja utvrđeno je da je piksantron supstrat proteina P-gp/BCRP i OCT1 koji sudjeluju u membranskom transportu, a tvari koje inhibiraju ove transportne proteine imaju sposobnost smanjiti preuzimanje (engl. uptake) piksantrona u jetru i učinkovitost njegovog izlučivanja.
English: Although the occurrence of cardiac toxicity manifested by CHF appears to be lower than that would be expected with related medicinal products such as anthracyclines, monitoring of LVEF either by MUGA scans or ECHO is recommended to assess subclinical cardiotoxicity.
Croatian: Iako se čini da je pojava kardijalne toksičnosti, koja se manifestira kroničnim zatajenjem srca, manja nego bi se to moglo očekivati sa srodnim lijekovima kao što su to antraciklini, preporučuje se praćenje LVEF pomoću MUGA-snimki ili UZV-a radi ocjene subkliničkih znakova kardiotoksičnosti.
English: Use gloves, masks, and protective eyewear when handling Pixuvri and during decontamination procedures.
Croatian: Koristite rukavice, maske i zaštitne naočale kada rukujete lijekom Pixuvri i za vrijeme postupka dekontaminacije.
English: No drug interactions have been reported in human subjects and no drug-drug interaction studies in humans have been performed.
Croatian: Kod ljudi nisu zabilježene interakcije s drugim lijekovima i nisu provedena ispitivanja interakcija.
English: This study randomised 140 patients (1:1) to treatment with either Pixuvri or to an investigator chosen single-agent chemotherapy on the comparator arm.
Croatian: ovom randomiziranom ispitivanju 140 bolesnika (1:1) liječeno je ili lijekom Pixuvri ili jednim po izboru voditelja ispitivanja izabranim kemoterapeutikom u kontrolnoj skupini, u obliku monoterapije.
English: Delay treatment until recovery to grade 1.
Croatian: Odgoditi terapiju do oporavka na stupanj 1. Smanjiti dozu za 20%.
English: Uncommon Spontaneous penile erection
Croatian: Manje često Spontana erekcija
English: Table 2 Treatment modifications for non-hematologic toxicities
Croatian: Prilagodbe doze zbog nehematološke toksičnosti
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pixuvri in all subsets of the paediatric population in treatment of non-Hodgkin lymphoma.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Pixuvri u svim podskupinama pedijatrijske populacije u liječenju ne-Hodgkinovog limfoma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Skin discolouration and chromaturia are known related effects of Pixuvri administration due to the colour of the compound (blue).
Croatian: Promjena boje kože i kromaturija poznati su učinci povezani s primjenom lijeka Pixuvri koji nastaju zbog boje same tvari (plava).