FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as 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),
Slovenian: Frekvence so definirane kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: The safety analysis included patients from one phase 3 study (MURANO), two phase 2 studies (M13-982 and M14-032), and one phase 1 study (M12-175).
Slovenian: Analiza varnosti je vključevala bolnike iz ene študije 3. faze (MURANO), iz dveh študij 2. faze (M13-982 in M14-032) in ene študije 1. faze (M12-175).
English: Venclyxto tablets are provided in blisters which are packed in cartons as follows:
Slovenian: Venclyxto tablete so na voljo v pretisnih omotih, ki so pakirani v škatle, kot sledi:
English: Based on population pharmacokinetic analyses, age, sex, and weight do not have an effect on venetoclax clearance.
Slovenian: Na podlagi analiz populacijske farmakokinetike starost, spol in telesna masa ne vplivajo na očistek venetoklaksa.
English: The risk of TLS was reduced after revision of the dosing regimen and modification to prophylaxis and monitoring measures.
Slovenian: Tveganje za TLS se je zmanjšalo po reviziji režima odmerjanja in prilagoditvi profilakse ter ukrepov za spremljanje bolnika.
English: This is because Venclyxto may affect the way some other medicines work.
Slovenian: To pa zato, ker zdravilo Venclyxto lahko vpliva na način delovanja drugih zdravil.
English: Venclyxto may be given to you in combination with rituximab or alone.
Slovenian: Zdravilo Venclyxto vam lahko dajo v kombinaciji z rituksimabom ali samo.
English: IRC assessment (N=107)a
Slovenian: Ocena neodvisnega odbora za pregled (IRC) (N = 107)a
English: Patients should be adequately hydrated during the dose-titration phase to reduce the risk of TLS.
Slovenian: Bolniki morajo biti med fazo titracije odmerka ustrezno hidrirani, da se zmanjša tveganje za TLS.
English: When resuming treatment after interruption due to TLS, the instructions for prevention of TLS should be followed (see “Prevention of tumour lysis syndrome” above).
Slovenian: Ob vnovični uvedbi zdravljenja po prekinitvi zaradi TLS, je treba upoštevati navodila za preprečevanje TLS (glejte »Preprečevanje sindroma tumorske lize« zgoraj).
English: The cut-off for a negative status was one CLL cell per 104 leukocytes.
Slovenian: Mejna vrednost za negativno stanje je bila ena KLL celica na 104 levkocitov.
English: Patients received venetoclax via a recommended dose-titration schedule.
Slovenian: Bolniki so prejemali venetoklaks po priporočeni shemi titracije odmerka.
English: Median DOR was not reached with median follow up of approximately 23.8 months.
Slovenian: Mediana trajanja odziva (duration of response - DOR) ni bila dosežena s spremljanjem mediane približno 23,8 mesecev.
English: • medicines to lower cholesterol levels in the blood known as statins
Slovenian: • zdravila za zniževanje vrednosti holesterola v krvi, poznana kot statini
English: Carcinogenicity studies have not been conducted with venetoclax.
Slovenian: Študij kancerogenosti z venetoklaksom niso izvedli.
English: • a medicine used to prevent organ rejection known as sirolimus
Slovenian: • zdravilo, ki se uporablja za preprečevanje zavračanja organov, poznano kot sirolimus
English: An additional 51 patients were enrolled in a safety expansion cohort.
Slovenian: Dodatnih 51 bolnikov je bilo vključenih v razširjeni kohorti študije o varnosti.
English: Drinking plenty of water, at least 1.5 to 2 litres per day, helps to remove cancer cell breakdown products from your body through urine, and may decrease your risk of getting TLS (see section 3).
Slovenian: Pitje večjih količin vode, najmanj 1,5 do 2 litrov vode na dan, pomaga pri odstranjevanju razpadnih produktov rakavih celic iz telesa z urinom in lahko zmanjša tveganje, da se pri vas razvije TLS (glejte poglavje 3).
English: • you have liver problems as this may increase your risk for side effects.
Slovenian: • imate težave z jetri, ker je tveganje za neželene učinke pri vas lahko povečano.
English: After 77/389 patients were enrolled in the study, the protocol was amended to incorporate the current TLS prophylaxis and monitoring measures described in Posology (see section 4.2).
Slovenian: Po vključitvi 77/389 bolnikov v študijo, je bil protokol spremenjen tako, da so se vključili sedanja profilaksa TLS in ukrepi spremljanja, ki so opisani v poglavju Odmerjanje (glejte poglavje 4.2).
English: Both effects were reversible after cessation of dosing with venetoclax, with recovery of lymphocytes occurring 18 weeks post treatment.
Slovenian: Oba učinka sta bila po prenehanju uporabe venetoklaksa reverzibilna in okrevanje števila limfocitov se je pojavilo 18 tednov po zdravljenju.
English: Intravenous fluids should be administered as indicated based on overall risk of TLS or for those who cannot maintain an adequate level of oral hydration.
Slovenian: Dajanje tekočine intravensko je potrebno, če je indicirano na podlagi celokupnega tveganja za TLS, ali pri tistih, pri katerih ni mogoče vzdrževati primerne stopnje hidracije peroralno.
English: Safety in patients with severe renal impairment (CrCl <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.
Slovenian: Varnost pri bolnikih s hudo okvaro ledvic (CrCL < 30 ml/min) ali pri tistih na dializi ni bila dokazana in priporočeni odmerek za te bolnike ni bil določen.
English: • clarithromycin for bacterial infections
Slovenian: • klaritromicin za zdravljenje bakterijskih okužb,
English: • upper respiratory tract infection - signs include runny nose, sore throat or cough
Slovenian: • okužbe zgornjih dihal - znaki vključujejo izcedek iz nosu, vneto žrelo ali kašelj • driska
English: There is no specific antidote for venetoclax.
Slovenian: Za venetoklaks ni specifičnega antidota.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Če želite poslušati ali želite kopijo navodila za uporabo v Braillovi pisavi, natisnjeno z večjo pisavo ali v zvočni obliki, se obrnite na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: The same monitoring schedule should be followed at the start of the 50 mg dose and then for patients who continue to be at risk, at subsequent dose increases.
Slovenian: Enaka shema kontrole krvi je potrebna ob začetku 50 mg odmerka in nato pri bolnikih, ki so še naprej izpostavljeni tveganju ob vsakem naslednjem povečanju odmerka.
English: No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.1).
Slovenian: Posebna prilagoditev odmerka pri starejših bolnikih (stari ≥ 65 let) ni potrebna (glejte poglavje 5.1).
English: Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work:
Slovenian: Obvestite zdravnika, če jemljete katero od naslednjih zdravil, ker lahko zdravilo Venclyxto vpliva na njihovo delovanje:
English: The risk of TLS is a continuum based on multiple factors, including comorbidities.
Slovenian: Tveganje za TLS je stalno prisotno in temelji na več dejavnikih, vključno s pridruženimi boleznimi.
English: More intensive measures (intravenous hydration, frequent monitoring, hospitalisation) should be employed as overall risk increases.
Slovenian: Ob povečanju celokupnega tveganja je treba uporabiti bolj intenzivne ukrepe (intravensko hidracijo, pogosto spremljanje, hospitalizacijo).
English: Venclyxto is used to treat patients with chronic lymphocytic leukaemia (CLL) when the disease has come back or has not responded to other treatment.
Slovenian: Zdravilo Venclyxto se uporablja za zdravljenje bolnikov s kronično limfocitno levkemijo (KLL), ko se je bolezen vrnila ali se ni odzvala na drugo zdravljenje.
English: • feeling confused
Slovenian: • občutek zmedenosti
English: The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome.
Slovenian: 5-tedenska shema titracije odmerka je načrtovana za postopno zmanjšanje tumorske obremenitve (delna odstranitev) in zmanjšanje tveganja za sindrom tumorske lize.
English: Based on findings in animals, Venclyxto may cause male infertility (low or no sperm count).
Slovenian: Na podlagi ugotovitev pri živalih lahko zdravilo Venclyxto povzroči neplodnost pri moških (majhno število ali brez spermijev).
English: Once the toxicity has resolved to grade 1 or baseline level (recovery), therapy with venetoclax may be restarted at the same dose.
Slovenian: Čim se toksičnost povrne na 1. stopnjo ali na izhodiščno vrednost (ozdravitev), se lahko znova začne zdravljenje z venetoklaksom v enakem odmerku.
English: Based on venetoclax large volume of distribution and extensive protein binding, dialysis is unlikely to result in significant removal of venetoclax.
Slovenian: Glede na velik volumen distribucije venetoklaksa in obsežno vezavo na beljakovine, je malo verjetno, da bi z dializo dosegli pomembno odstranitev venetoklaksa.
English: • a medicine used to treat heart problems known as digoxin
Slovenian: • zdravilo za zdravljenje težav s srcem poznano kot digoksin
English: If you are not sure about this, talk to your doctor, pharmacist or nurse before taking Venclyxto.
Slovenian: Če o tem niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro preden vzamete zdravilo Venclyxto.
English: Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Slovenian: Uporaba venetoklaksa ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo visoko učinkovite kontracepcije.
English: Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics.
Slovenian: Prekomerna izraženost BCL-2 je bila dokazana v celicah KLL, kjer posreduje preživetje tumorskih celic in je povezana z odpornostjo proti kemoterapevtikom.
English: Pre-dose: For all patients, blood chemistries should be assessed prior to the initial dose to evaluate kidney function and correct pre-existing abnormalities.
Slovenian: Pred odmerkom: Pri vseh bolnikih je treba pred začetnim odmerkom oceniti rezultate krvnih preiskav, da se ovrednoti delovanje ledvic in popravi obstoječe nepravilnosti.
English: - Venclyxto should not be used during pregnancy.
Slovenian: - Zdravila Venclyxto se med nosečnostjo ne sme uporabljati.
English: The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L in patients.
Slovenian: Populacijska ocena navideznega volumna porazdelitve (Vdss/F) venetoklaksa je pri bolnikih segala od 256 do 321 l.
English: • feeling or being sick (nausea or vomiting)
Slovenian: • občutek slabosti ali slabost (siljenje na bruhanje ali bruhanje)
English: You may feel tired after taking Venclyxto, which may affect your ability to drive or use tools or machines.
Slovenian: Po jemanju zdravila Venclyxto se boste morda počutili utrujeno, kar lahko vpliva na vašo sposobnost upravljanja vozil ali uporabo orodja ali strojev.
English: 17p deletion and/or TP53 mutation status ORR, % (95% CI)
Slovenian: Status 17p delecija in/ali TP53 mutacija ORR, % (95% IZ)
English: The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
Slovenian: Pogostnosti neželenih učinkov, ki so jih poročali pri zdravilu Venclyxto, so povzete v preglednici 3.
English: 67.6% had ALC ≥25 x 109/l.
Slovenian: ALC ≥25 x 109/l.
English: Of the 194 patients with previously treated CLL who received venetoclax in combination with rituximab, 50% were 65 years or older.
Slovenian: Med 194 bolniki s predhodno zdravljeno KLL, ki so prejemali venetoklaks v kombinaciji z rituksimabom, je bilo 50 % starih 65 let ali več.
English: • you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase
Slovenian: • imate kakršne koli težave z ledvicami, ker je tveganje za neželeni učinek, imenovan sindrom tumorske lize, pri vas lahko povečano,
English: eOverall survival data are not yet mature.
Slovenian: e Podatki o celokupnem preživetju še niso na voljo.
English: Film-coated tablet Multipack: 112 (4 x 28) film-coated tablets
Slovenian: filmsko obložena tableta Večkratno pakiranje: 112 (4 x 28) filmsko obloženih tablet
English: CLL is a type of cancer affecting white blood cells called lymphocytes and the lymph nodes.
Slovenian: KLL je vrsta raka, ki prizadene bele krvne celice, imenovane limfociti, in bezgavke.
English: Your dose may need to be adjusted for side effects.
Slovenian: Vaš odmerek bo zaradi neželenih učinkov morda potrebno prilagoditi.
English: bIncludes 51 additional patients from the safety expansion cohort.
Slovenian: bVključuje 51 dodatnih bolnikov iz razširjene kohorte študije o varnosti.
English: Venclyxto has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Venclyxto nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In 168 patients with CLL starting with a daily dose of 20 mg and increasing over 5 weeks to a daily dose of 400 mg in studies M13-982 and M14-032, the rate of TLS was 2%.
Slovenian: Pri 168 bolnikih s KLL, ki so zdravljenje začeli z dnevnim odmerkom 20 mg ter ga nato v 5 tednih povečali do 400 mg v študijah M13-982 in M14-032, je bil delež TLS 2 %.
English: Alternative treatments with less CYP3A induction should be considered.
Slovenian: Treba je razmisliti o alternativnih zdravljenjih z manjšo indukcijo CYP3A.
English: Of these, 91 patients had received prior ibrutinib therapy (Arm A) and 36 had received prior idelalisib therapy (Arm B).
Slovenian: Od teh jih je 91 predhodno prejemalo ibrutinib (skupina A) in 36 idelalisib (skupina B).
English: Hospitalisation
Slovenian: Hospitalizacija
English: The median duration of grade 3 or 4 neutropenia was 8 days (range: 1-712 days).
Slovenian: Mediana trajanja nevtropenije 3. ali 4. stopnje je bila 8 dni (razpon: 1-712 dni).
English: Tell your doctor immediately if you have signs of an infection while taking this medicine.
Slovenian: Takoj povejte zdravniku, če med jemanjem tega zdravila opazite znake okužbe.
English: The effect of multiple doses of venetoclax up to 1200 mg once daily on the QTc interval was evaluated in an open-label, single-arm study in 176 patients.
Slovenian: Vpliv večkratnih odmerkov do 1200 mg venetoklaksa enkrat na dan na interval QTc so ocenili v odprti študiji z eno skupino 176 bolnikov.
English: Fatigue has been reported in some patients taking venetoclax and should be considered when assessing a patient's ability to drive or operate machines.
Slovenian: Pri nekaterih bolnikih, ki so jemali venetoklaks, so poročali o utrujenosti, kar je treba upoštevati, ko se ocenjuje bolnikovo sposobnost vožnje in upravljanja strojev.
English: The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
Slovenian: Upoštevajte navodila za »Preprečevanje sindroma tumorske lize« (glejte poglavje 4.2).
English: The overall safety profile of Venclyxto is based on data from 546 patients with CLL treated in clinical trials with venetoclax in combination with rituximab or as monotherapy.
Slovenian: Celoten varnostni profil zdravila Venclyxto temelji na podatkih 546 bolnikov s KLL, ki so v kliničnih študijah bili zdravljeni z venetoklaksom v kombinaciji z rituksimabom ali z monoterapijo.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
English: Take the next dose at the usual time the next day.
Slovenian: Naslednji odmerek vzemite naslednji dan ob običajnem času.
English: No human data on the effect of venetoclax on fertility are available.
Slovenian: Podatki o vplivu venetoklaksa na plodnost pri ljudeh niso na voljo.
English: Venetoclax also caused single cell necrosis in various tissues, including the gallbladder and exocrine pancreas, with no evidence of disruption of tissue integrity or organ dysfunction; these findings were minimal to mild in magnitude.
Slovenian: Venetoklaks je povzročil tudi nekrozo posamičnih celic v različnih tkivih, med drugim v žolčniku in eksokrinem pankreasu, a brez prizadetosti integritete tkiv in brez motenega delovanja organov; te spremembe so bile minimalne do blage.
English: Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of venetoclax and at each dose increase.
Slovenian: Spremembe v elektrolitih, ki so skladne s TLS in zahtevajo takojšnje ukrepanje, se lahko pojavijo že v 6 do 8 urah po prvem odmerku venetoklaksa in ob vsakem povečanju odmerka.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do.
English: Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje z venetoklaksom mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: The pharmacokinetics of venetoclax do not change over time.
Slovenian: Farmakokinetika venetoklaksa se sčasoma ne spreminja.
English: 24-month PFS estimate (95% CI) CI = confidence interval; NR = not reached aStratified P-value.
Slovenian: 12-mesečna ocena PFS (95% IZ) 24- mesečna ocena PFS (95% IZ) IZ = interval zaupanja; NR = ni doseženo arazčlenjena P-vrednost.
English: If you vomit after taking Venclyxto, do not take an extra dose that day.
Slovenian: Če ste po jemanju zdravila Venclyxto bruhali, tisti dan ne vzemite nobenega dodatnega odmerka.
English: During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2).
Slovenian: Med fazo titracije odmerka je treba zdravljenje prekiniti in bolnike skrbno spremljati glede znakov in simptomov TLS (zvišana telesna temperatura, mrzlica, navzea, bruhanje, zmedenost, kratka sapa, napadi krčev, neenakomeren srčni utrip, temen ali moten urin, nenavadna utrujenost, bolečina v mišicah ali sklepih, bolečina v trebuhu in napihnjenost) poleg drugih toksičnosti (glejte poglavje 4.2).
English: Supportive measures including antimicrobials for any signs of infection should be considered.
Slovenian: V primeru kakršnih koli znakov okužbe je treba razmisliti o podpornih ukrepih, vključno z antibiotiki.
English: Women of childbearing potential must use a highly effective method of contraception while taking venetoclax (see section 4.6).
Slovenian: Ženske v rodni dobi morajo med jemanjem venetoklaksa uporabljati visoko učinkovito metodo kontracepcije (glejte poglavje 4.6).
English: Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase.
Slovenian: Bolnikom je treba naročiti, naj na dan popijejo veliko vode; začnejo naj 2 dni pred in nadaljujejo vso fazo titracije odmerka.
English: Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients.
Slovenian: O nevtropeniji 3. stopnje so poročali pri 32 % bolnikov in o nevtropeniji 4. stopnje pri 26 % bolnikov.
English: What you need to know before you take Venclyxto Do not take Venclyxto if:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Venclyxto Ne jemljite zdravila Venclyxto, če:
English: Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Slovenian: Neželeni učinki so spodaj navedeni po organskih sistemih MedDRA in pogostnosti.
English: Minimal residual disease (MRD) was evaluated using flow cytometry in 93 of 158 patients who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) with limited remaining disease with venetoclax treatment.
Slovenian: Stanje minimalne rezidualne bolezni (MRD - Minimal Residual Disease) so ocenili s pretočno citometrijo pri 93 od 158 bolnikov, ki so z venetoklaksom dosegli popolno remisijo (CR), popolno remisijo z nepopolnim okrevanjem kostnega mozga (CRi) ali delno remisijo (PR) z omejeno preostalo boleznijo.
English: All six patients completed the dose titration and reached the recommended daily dose of 400 mg of venetoclax.
Slovenian: Vseh šest bolnikov je zaključilo titracijo odmerka in doseglo priporočeni dnevni odmerek 400 mg venetoklaksa.
English: It is very important that you drink plenty of water when taking Venclyxto during the first 5 weeks of treatment.
Slovenian: Zelo pomembno je, da v prvih 5 tednih jemanja zdravila Venclyxto pijete veliko vode.
English: It is unknown whether venetoclax or its metabolites are excreted in human milk.
Slovenian: Ni znano ali se venetoklaks ali njegovi presnovki izločajo v materino mleko.
English: Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Slovenian: Filmsko obložene tablete zdravila Venclyxto so pakirane v pretisnem omotu iz PVC/PE/PCTFE in aluminijaste folije, ki vsebuje 1, 2 ali 4 filmsko obložene tablete.
English: Patients in the Venclyxto + rituximab arm completed the Venclyxto 5-week dose-titration schedule and then received 400 mg once daily for 24 months from Cycle 1 Day 1 of rituximab in the absence of disease progression or unacceptable toxicity.
Slovenian: Bolniki v skupini Venclyxto + rituksimab so zaključili 5-tedensko shemo titracije odmerka zdravila Venclyxto in so nato prejemali 400 mg enkrat na dan 24 mesecev od 1. dne 1. cikla rituksimaba v odsotnosti napredovanja bolezni ali nesprejemljive toksičnosti.
English: MURANO was a randomised, controlled trial in which 194 patients with previously treated CLL received venetoclax in combination with rituximab.
Slovenian: MURANO je bilo randomizirano, kontrolirano preskušanje, v katerem je 194 bolnikov s predhodno zdravljeno KLL, prejelo venetoklaks v kombinaciji z rituksimabom.
English: Take your dose at the same time each day with a meal and water.
Slovenian: Vzemite vaš odmerek vsak dan ob istem času z vodo ob obroku.
English: Because venetoclax was not dosed to steady state, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving warfarin.
Slovenian: Ker venetoklaks ni bil odmerjan do stalnega odmerka, se pri bolnikih, ki prejemajo varfarin, priporoča skrbno spremljanje mednarodnega normaliziranega razmerja (INR).
English: Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Slovenian: Zmanjšano delovanje ledvic (očistek kreatinina [CrCL] <80 ml/min) dodatno poveča tveganje.
English: Your doctor will advise what your dose should be.
Slovenian: Zdravnik vam bo svetoval,
English: No TLS with clinical consequences such as acute renal failure, cardiac arrhythmias or sudden death and/or seizures was observed in these patients.
Slovenian: Pri teh bolnikih niso opazili nobenega primera TLS s kliničnimi posledicami kot so akutna odpoved ledvic, srčne aritmije ali nenadna smrt in/ali napadi krčev.