FrancophonIA/ELRC3.0 huggingface dataset:
English: An infusion time of > 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Slovenian: Razmisliti je treba o času infundiranja, krajšem od 2 ur, da bi zmanjšali simptome tesnobe in razdražljivosti ter preprečili pretirano visoke maksimalne koncentracije klofarabina (glejte poglavje 5.2).
English: The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles (see section 5.1).
Slovenian: Pri večini bolnikov, ki se odzovejo na zdravljenje s klofarabinom, do odziva pride po 1 ali 2 ciklih zdravljenja (glejte poglavje 5.1).
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Slovenian: Bolnike je treba spremljati za znake in simptome okužbe in jo takoj zdraviti.
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 oseb): - vnetje jeter (hepatitis).
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Slovenian: ** V tabeli zgoraj so vključeni vsi neželeni učinki, ki so se pojavili najmanj dvakrat (tj., 2 ali več neželenih učinkov (1,7 %))
English: In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Slovenian: Poleg tega je treba zdravljenje s klofarabinom prekiniti, če se pri bolniku med 5-dnevnim odmerjanjem razvije hipotenzija zaradi katerega koli vzroka.
English: Ask your doctor to explain what can be done to protect you or allow you to have a family.
Slovenian: Zdravnika vprašajte, kako se lahko zaščitite ali kaj lahko storite, če bi želeli imeti otroke.
English: The minimal effects seen at lower doses suggest that there is a threshold for toxicities on the heart and nonlinear plasma pharmacokinetics in the rat may play a role in the observed effects.
Slovenian: Minimalni učinki, ki so jih opazili pri manjših odmerkih, kažejo, da obstaja prag toksičnosti za srce in da ima lahko nelinearna farmakokinetika v plazmi pri podganah pomembno vlogo pri teh učinkih.
English: In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment.
Slovenian: Pri večini bolnikov (8/10) so perikardni izliv in perikarditis ocenili kot asimptomatična in kot klinično nepomembna ali malo pomembna po ehokardiografski oceni.
English: It is unknown whether clofarabine or its metabolites are excreted in human breast milk.
Slovenian: Ni znano, ali se klofarabin ali njegovi presnovki izločajo v materino mleko.
English: The recommended dosage should be administered by intravenous infusion although it has been administered via a central venous catheter in ongoing clinical trials.
Slovenian: Priporočeni odmerek je treba dajati v obliki intravenske infuzije, čeprav ga v potekajočih kliničnih preskušanjih dajejo prek centralnega venskega katetra.
English: Because of the way this medicine works, it will affect your blood and other organs.
Slovenian: Zdravilo bo zaradi načina delovanja vplivalo na kri in druge organe.
English: For instructions on dilution of the medicinal product before administration (see section 6.6).
Slovenian: Za navodila glede redčenja zdravila pred dajanjem (glejte poglavje 6.6).
English: Response durations are confounded in patients who received a HSCT.
Slovenian: Trajanje odziva pri bolnikih, ki so prejeli HSCT, je mešano.
English: Nearly all patients (98%) experienced at least one adverse event considered by the study investigator to be related to clofarabine.
Slovenian: Pri skoraj vseh bolnikih (98 %) se je pojavil najmanj en neželeni dogodek, za katerega je raziskovalec v klinični študiji menil, da je povezan s klofarabinom.
English: However, Cmax is inversely proportional to patient weight and, therefore, small children may have a higher Cmax at the end of infusion than a typical 40 kg child given the same dose of clofarabine per m2.
Slovenian: Vendar je vrednost Cmax obratno sorazmerna s telesno maso bolnika, zato je pri majhnih otrocih vrednost Cmax na koncu infundiranja lahko večja kot pri tipičnem 40 kilogramskem otroku, ki prejme enak odmerek klofarabina na m2.
English: Ivozall is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Slovenian: Zdravilo Ivozall se uporablja za zdravljenje otrok, najstnikov in mladih odraslih do starosti 21 let z akutno limfoblastno levkemijo (ALL), pri katerih predhodna zdravljenja niso delovala ali so prenehala delovati.
English: Other exfoliative conditions have also been reported.
Slovenian: Poročali so tudi o drugih eksfoliativnih stanjih na koži.
English: • Disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.
Slovenian: • motnje integritete mitohondrijske membrane s sproščanjem citokroma C in drugih proapoptotičnih faktorjev, kar povzroči programirano celično smrt, tudi pri limfocitih, ki se ne delijo.
English: Before enrolling in the trial, 58 of the 61 patients (95%) had received 2 to 4 different induction regimens and 18/61 (30%) of these patients had undergone at least 1 prior haematological stem cell transplant (HSCT).
Slovenian: Pred sodelovanjem v preskušanju je 58 od 61 bolnikov (95 %) prejelo 2 do 4 različna indukcijska zdravljenja, 18/61 (30 %) teh bolnikov pa je imelo vsaj 1 predhodno presaditev krvotvornih matičnih celic (HSCT).
English: Patients with moderate renal impairment (creatinine clearance 30 - < 60 ml/min) require a 50% dose reduction (see section 5.2).
Slovenian: Bolniki z zmerno okvaro ledvic (kreatininski očistek 30 - <60 ml/min) potrebujejo 50 % zmanjšanje odmerka (glejte poglavje 5.2).
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l, free from visible particles.
Slovenian: Prozorna, skoraj brezbarvna raztopina s pH 4,5 do 7,5 in osmolarnostjo 270 do 310 mOsm/l, brez vidnih delcev.
English: The diluted concentrate should be a clear, colourless solution.
Slovenian: Razredčeni koncentrat mora biti bistra, brezbarvna raztopina.
English: Use in patients with severe renal insufficiency or severe hepatic impairment.
Slovenian: Uporaba pri bolnikih s hudo okvarjenim ledvičnim delovanjem ali hudo okvaro jeter.
English: Young men and women must use effective contraception during and after treatment.
Slovenian: Mladi moški in ženske morajo med zdravljenjem in po njem uporabljati učinkovito kontracepcijsko zaščito.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 20 mg/20 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 20 mg/20 ml
English: Your treatment with Ivozall has been prescribed by a qualified doctor experienced in treating leukaemia.
Slovenian: Zdravljenje z zdravilom Ivozall vam je predpisal zdravnik, ki ima izkušnje z zdravljenjem levkemije.
English: Discard unused contents appropriately.
Slovenian: Neuporabljeno vsebino ustrezno zavrzite.
English: Patients should be monitored for signs and symptoms of enterocolitis.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov enterokolitisa.
English: Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Slovenian: Študije genotoksičnosti so pokazale, da klofarabin pri preizkusu reverzne mutacije pri bakterijah ni bil mutagen, vendar je sprožil klastogene učinke pri preizkusu neaktivirane kromosomske aberacije na celicah ovarijev kitajskega hrčka (CHO - Chinese Hamster Ovary) in pri testu mikronukleusa na podganah in vivo.
English: Administration of clofarabine resulted in a dramatic and rapid reduction in peripheral leukaemia cells in 31 of the 33 patients (94%) who had a measurable absolute blast count at baseline.
Slovenian: Uporaba klofarabina je dramatično in hitro zmanjšala število perifernih levkemičnih celic pri 31 od 33 bolnikov (94 %), ki so na začetku zdravljenja imeli merljivo absolutno število blastov.
English: Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Slovenian: Klinična učinkovitost in varnost Klinična učinkovitost: Da bi omogočili sistematično oceno odzivov pri bolnikih, so v neodvisni panelni raziskavi odzivov (Independent Response Review Panel - IRRP) določili naslednje stopnje odziva, glede na opredelitve Skupine za otroško onkologijo (Children's Oncology Group):
English: • - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Slovenian: • (število bolnikov s PR + število bolnikov s PRt) ÷ število primernih bolnikov, ki so prejemali klofarabin
English: • No evidence of circulating blasts or extramedullary disease
Slovenian: • ni znakov blastov v krvnem obtoku ali ekstramedularne bolezni
English: Females of childbearing potential and sexually active males must use effective methods of contraception during treatment.
Slovenian: Ženske v rodni dobi in spolno aktivni moški morajo uporabljati učinkovite metode kontracepcije med zdravljenjem.
English: In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Slovenian: Poleg tega ni verjetno, da bi klofarabin zaviral katero koli od petih glavnih izoform CYP pri človeku (1A2, 2C9, 2C19, 2D6 in 3A4) ali da bi sprožil delovanje dveh od teh izoform (1A2 in 3A4) pri doseženih koncentracijah v plazmi po intravenski infuziji
English: • Ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools.
Slovenian: • inhibicija ribonukleotid reduktaze z zmanjšanjem zalog celičnih deoksinukleotid trifosfatov
English: No apparent difference in pharmacokinetics was observed between patients with ALL or AML, or between males and females.
Slovenian: Vidne razlike v farmakokinetiki med bolniki z ALL in AML ter med moškimi in ženskami niso opazili.
English: Ivozall is for intravenous use.
Slovenian: Zdravilo Ivozall je namenjeno za intravensko uporabo.
English: Clofarabine should not be used during pregnancy unless clearly necessary.
Slovenian: Klofarabina med nosečnostjo ne smete uporabljati, razen če je njegova uporaba neizogibno potrebna.
English: In addition, at initiation of treatment, most patients in the clinical studies had haematological impairment as a manifestation of leukaemia.
Slovenian: Poleg tega je imela večina bolnikov ob začetku zdravljenja v kliničnih študijah poslabšano hematološko stanje kot posledico levkemije.
English: 1.45 to 2.40
Slovenian: 1,45 do 2,40
English: These likely represent the superimposition of degenerative and regenerative changes as a result of treatment cycles, and were not associated with changes in serum chemistry.
Slovenian: Ti učinki so verjetno posledica degenerativnih in regenerativnih sprememb, ki so rezultat ciklov zdravljenja in niso povezani s kemičnimi spremembami v serumu.
English: Clofarabine must first diffuse or be transported into target cells where it is sequentially phosphorylated to the mono- and bi-phosphate by intracellular kinases, and then finally to the active conjugate, clofarabine 5'-triphosphate.
Slovenian: Klofarabin mora najprej difundirati ali se prenesti v ciljne celice, kjer ga znotrajcelične kinaze zaporedno fosforilirajo v mono- in difosfate, in na koncu v aktivni konjugat, klofarabin 5'-trifosfat.
English: However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Ivozall (see section 4.3).
Slovenian: Vendar je zaradi možnosti resnih neželenih učinkov pri dojenčkih treba dojenje prekiniti pred zdravljenjem z zdravilom Ivozall, med njim ali po njem (glejte poglavje 4.3).
English: Women who are able to get pregnant: you must use effective contraception during treatment with clofarabine.
Slovenian: Ženske, ki lahko zanosijo: med zdravljenjem s klofarabinom morate uporabljati učinkovito kontracepcijsko zaščito.
English: There is currently limited experience of patients receiving more than 3 treatment cycles (see section 4.4).
Slovenian: Izkušnje z bolniki, ki prejemajo več kot 3 cikle zdravljenja, so trenutno omejene (glejte poglavje 4.4).
English: Other medicines and Ivozall
Slovenian: Druga zdravila in zdravilo Ivozall
English: In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevated ALT, 36/100 elevated AST and 15/114 elevated bilirubin levels.
Slovenian: Poleg tega je 50/113 bolnikov, ki so prejemali klofarabin, imelo vsaj huje (vsaj 3. stopnje po CTC NCI v ZDA) povišane vrednosti ALT, 36/100 povišane vrednosti AST, 15/114 pa povišane vrednosti bilirubina.
English: If you think that you have missed a dose, tell your doctor straight away.
Slovenian: Če mislite, da vam niso dali odmerka, takoj povejte zdravniku.
English: Grade 3 or 4 elevated creatinine occurred in 8% of patients.
Slovenian: Pri 8 % bolnikov je prišlo do povišanja vrednosti kreatinina 3. ali 4. stopnje.
English: Common: Anorexia, decreased appetite, dehydration Frequency not known: Hyponatremia
Slovenian: Pogosti: anoreksija, zmanjšan apetit, dehidracija Pogostnost neznana: hiponatriemija
English: Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Slovenian: Čeprav stopnja presaditve ni bila končna točka študije, je po zdravljenju s klofarabinom 10/61 bolnikov (16 %) prejelo HSCT (3 po PR, 2 po PRt, 3 po DR, zdravljenje 1 bolnika je bilo ocenjeno kot neuspelo po IRRP, zdravljenje enega po so pri IRRP označili kot zdravljenje, ki ga ni mogoče oceniti).
English: Clofarabine is one of a family of medicines called anticancer medicines.
Slovenian: Klofarabin je eno izmed zdravil iz skupine zdravil proti raku.
English: The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade ≥ 3.
Slovenian: Najpogostejše hematološke laboratorijske nenormalnosti, ki so jih opazili pri bolnikih, ki so se zdravili s klofarabinom, so bile anemija (83,3 %; 95/114), levkopenija (87,7 %; 100/114), limfopenija (82,3 %; 93/113), nevtropenija (63,7 %; 72/113) in trombocitopenija (80,7 %; 92/114).
English: However, these data indicate that clofarabine may accumulate in such patients (see figure below).
Slovenian: Vendar ti podatki kažejo, da se lahko klofarabin pri teh bolnikih kopiči (glejte prikaz spodaj).
English: Two paediatric reports (1.7%) of veno-occlusive disease (VOD) were considered related to study drug.
Slovenian: Dve poročili venookluzivne bolezni (VOD) pri pediatričnih bolnikih (1,7 %) naj bi bili povezani z zdravilom v študiji.
English: Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every 2 to 6 weeks depending on toxicity and response.
Slovenian: Odmerjanje se je začelo pri 11,25, odmerek pa so nato povečevali na 15, 30, 40, 52 in 70 mg/m2/dan z intravensko infuzijo 5 dni zaporedoma, vsakih 2 do 6 tednov, glede na toksične učinke in odziv.
English: Each vial contains 70.77mg sodium (main component of cooking/table salt).
Slovenian: Ena viala vsebuje 70,77 mg natrija (glavna sestavina kuhinjske soli).
English: Patients receiving clofarabine may experience vomiting and diarrhoea; they should, therefore, be advised regarding appropriate measures to avoid dehydration.
Slovenian: Pri bolnikih, ki prejemajo klofarabin, se lahko pojavita bruhanje in diareja, zato jim je treba svetovati o ustreznih ukrepih proti dehidraciji.
English: Patients who underwent transplant while in continued remission*
Slovenian: PRt bolniki s presaditvijo med trajajočo remisijo*
English: Patients with advanced stages of ALL or AML may have confounding medical conditions that make causality of adverse events difficult to assess due to the variety of symptoms related to the underlying disease, its progression and the co-administration of numerous medicinal products.
Slovenian: Bolniki z napredovalimi stopnjami ALL ali AML imajo lahko bolezni, ki lahko otežujejo oceno vzrokov neželenih učinkov, zaradi različnih simptomov, povezanih z obstoječo boleznijo, njenim napredovanjem in sočasno uporabo številnih zdravil.
English: Forty-eight percent of patients had one or more ongoing infections prior to receiving treatment with clofarabine.
Slovenian: Oseminštiridest odstotkov bolnikov je pred zdravljenjem s klofarabinom imelo eno ali več aktivnih okužb.
English: Tell your doctor if you are using or have recently used: - medicines for heart disease (e.g. amiodarone, valsartan); - any medicine that changes your blood pressure (e.g. captopril, propranolol); - medicines that affect your liver (e.g. paracetamol, diclofenac) or kidneys (e.g. ibuprofen,
Slovenian: Obvestite zdravnika, če jemljete ali ste pred kratkim jemali: - zdravila za srčne bolezni (npr. amiodaron, valsartan); - kakršna koli zdravila, ki vplivajo na krvni tlak (npr. kaptopril, propanolol); - zdravila, ki vplivajo na jetra (npr. paracetamol, diklofenak) ali ledvice (npr. ibuprofen, amfotericin B);
English: Clofarabine is eliminated by a combination of renal and non-renal excretion.
Slovenian: Klofarabin se izloča s kombinacijo ledvičnega in neledvičnega izločanja.
English: Multivariate analysis showed that the pharmacokinetics of clofarabine are weight dependent and although white blood cell (WBC) count was identified as having an impact on clofarabine pharmacokinetics, this did not appear sufficient to individualise a patient's dosage regimen based on their WBC count.
Slovenian: Multivariantna analiza je pokazala, da je farmakokinetika klofarabina odvisna od telesne mase, in čeprav so ugotovili, da število belih krvnih celic vpliva na farmakokinetiko klofarabina, ta učinek ni bil zadosten, da bi odmerjanje za posameznega bolnika določili na podlagi števila belih krvnih celic.
English: If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
Slovenian: Če se pri bolniku pojavi klinično pomembna okužba, se lahko zdravljenje s klofarabinom prekine, dokler okužba ni klinično nadzorovana.
English: Your doctor will work out the dose that is right for you depending on your height, weight and how well you are.
Slovenian: Zdravnik bo določil ustrezni odmerek za vas glede na vašo višino, telesno maso in zdravstveno stanje.
English: (9.1 to 42)
Slovenian: (9,1 do 42)
English: Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were the primary target organs of toxicity.
Slovenian: 5.3 Predklinični podatki o varnosti Toksikološke študije klofarabina na miših, podganah in psih so pokazale, da so bila hitro proliferajoča tkiva primarni ciljni organi za toksične učinke.
English: 2.41 to 2.50
Slovenian: 2,41 do 2,50
English: Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment (creatinine clearance 30 - < 60 ml/min) receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
Slovenian: Populacijski farmakokinetični podatki, pridobljeni pri odraslih in pediatričnih bolnikih, kažejo, da bolniki s stabilno zmerno okvaro ledvic (kreatininski očistek 30 - <60 ml/min), ki prejemajo za 50 % manjši odmerek, dosežejo podobno izpostavljenost klofarabinu kot bolniki z normalnim ledvičnim delovanjem, ki prejemajo standardni odmerek.
English: (4.6 to 38.3)
Slovenian: (4,6 do 38,3)
English: Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Slovenian: Benigne in maligne novotvorbe (vključno s cistami in polipi) in bolezni imunskega sistema Uporaba klofarabina povzroči hitro zmanjšanje perifernih levkemičnih celic.
English: They were reported at exposure levels (Cmax) approximately 7 to 13 fold (after 3 or more dosing cycles) or 16 to 35 fold (after one or more dosing cycles) higher than clinical exposures.
Slovenian: O toksičnih učinkih so poročali pri izpostavljenosti (Cmax), ki je bila približno 7- do 13-krat (po 3 ali več ciklih odmerjanja) ali 16- do 35-krat (po enem ali več ciklih odmerjanja) večja od klinične.
English: Studies in animals have shown reproductive toxicity including teratogenicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno s teratogenostjo (glejte poglavje 5.3).
English: Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 109/l) and return to baseline organ function.
Slovenian: Cikle zdravljenja je treba ponoviti vsakih 2 do 6 tednov (od začetnega dne prejšnjega cikla) po vzpostavitvi normalne hematopoeze (tj. ANC (Absolute Neutrophile Count - absolutno število nevtrofilcev) ≥ 0,75 × 109/l) in izhodiščnega delovanja organov.
English: Chemical and physical in-use stability has been demonstrated for seven days at room temperature and under refrigeration (2°C - 8°C) at a concentration range of 0.15 mg/ml to 0.83 mg/ml after dilution with sodium chloride 9 mg/ml (0.9%).
Slovenian: Kemična in fizikalna stabilnost zdravila med uporabo je bila dokazana za sedem dni pri sobni temperaturi in na hladnem (2 °C-8 °C) pri razponu koncentracij od 0,15 mg/ml do 0,83 mg/ml po redčenju z 0,9 % raztopino natrijevega klorida (9 mg/ml).
English: In vitro studies have demonstrated that clofarabine inhibits cell growth in and is cytotoxic to a variety of rapidly proliferating haematological and solid tumour cell lines.
Slovenian: Študije in vitro so pokazale, da klofarabin zavira celično rast in da je citotoksičen za različne hitro proliferajoče celične linije hematoloških in solidnih tumorjev.
English: • An M1 bone marrow (≤ 5% blasts)
Slovenian: • kostni mozeg M1 (≤ 5 % blastov)
English: Ivozall is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Slovenian: Zdravilo Ivozall je močan antineoplastik z morebitno pomembnimi hematološkimi in nehematološkimi neželenimi učinki (glejte poglavje 4.8).
English: Systemic clearance
Slovenian: Sistemski očistek
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, fainting spells, or decreased urine output.
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če imajo simptome omotice, omedlevice ali zmanjšanega uriniranja.