FrancophonIA/ELRC3.0 huggingface dataset:
English: If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Croatian: U slučaju sinkope, brzih ili nepravilnih srčanih otkucaj,a bolesnika se mora hospitalizirati i neprekidno nadzirati, te odrediti razinu elektrolita u serumu, a liječenje TRISENOXOM privremeno prekinuti sve dok se QTc interval ne vrati na vrijednost ispod 460 ms, abnormalne razine elektrolita ne korigiraju, a sinkopa i nepravilni srčani otkucaji ne prestanu.
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Croatian: TRISENOX se mora primjenjivati intravenski pri dozi od 0,15 mg/kg/dan, 5 dana u tjednu.
English: There are no data on the effect of arsenic trioxide on the QTc interval during the infusion.
Croatian: Nema podataka o učinku arsenovog trioksida na interval
English: Aspartate amino transferase increased
Croatian: Vrlo često porast aspartat aminotransferaze
English: Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10 %), which is consistent with the early mortality reported in the literature.
Croatian: U pivotalnim je ispitivanjima bolesti u fazi relapsa vrlo često bio prijavljivan (> 10%) mortalitet zbog krvarenja povezanog s diseminiranom intravaskularnom koagulacijom (DIK), što je u skladu s preuranjenim mortalitetom opisanim u literaturi.
English: In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Croatian: Među bolesnicima s novodijagnosticiranim APL-om, njih 15,6% pokazalo je produljenje QTc intervala uz arsenov trioksid u kombinaciji s ATRA-om (vidjeti dio 4.8).
English: It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.
Croatian: 1-2 sata, ali infuzija može trajati dulje ako se pojave nuspojave poput navale crvenila i omaglice.
English: Women of childbearing potential and men must use effective contraception during treatment with TRISENOX.
Croatian: Žene reproduktivne dobi i muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja
English: Thereafter, in the absence of worsening of the previous toxicity, TRISENOX might be resumed at full dosage.
Croatian: Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, liječenje TRISENOXOM može se nastaviti u punoj dozi.
English: Unused portions of each ampoule must be discarded properly.
Croatian: Neiskorišteni dio svake ampule mora se odložiti na ispravan način.
English: Dilution: Carefully insert the needle of a syringe into the ampoule and draw up all of the content.
Croatian: Razrjeđivanje: Pažljivo umetnite iglu štrcaljke u ampulu te povucite nagore sav sadržaj.
English: Treatment with TRISENOX must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Croatian: TRISENOXOM mora se prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti hepatotoksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak.
English: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all-trans-retinoic acid (ATRA)
Croatian: • novodijagnosticiranom akutnom promijelocitnom leukemijom (APL) niskog do srednjeg rizika (broj bijelih krvnih stanica ≤ 10 x 10 3/µl) u kombinaciji sa sve-trans-retinoatnom kiselinom (engl. all-trans-retinoic acid, ATRA)
English: For storage conditions after dilution of the medicinal products, see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: In general, treatment-emergent adverse events tended to decrease over time, in relapsed/refractory APL patients perhaps accounted for by amelioration of the underlying disease process.
Croatian: Općenito, štetni događaji koji su nastali tijekom liječenja težili su smanjivanju tijekom vremena, u bolesnika s ALP-om koji je bio u fazi relapsa/refraktoran na liječenje, moguće zbog poboljšanja procesa osnovne bolesti.
English: Twenty relapsed/refractory APL patients (50 %) experienced leucocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leucopheresis was not required.
Croatian: Dvadeset bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje (50%), imalo je leukocitozu; međutim, kod svih tih bolesnika broj leukocita bio je u padu ili se normalizirao do vremena remisije koštane srži pa citotoksična terapija ili leukofereza nije bila potrebna.
English: In newly diagnosed APL patients treated with arsenic trioxide and all-trans-retinoic acid (ATRA), APL differentiation syndrome was observed in 19 % including 5 severe cases.
Croatian: U bolesnika s novodijagnosticiranim APL-om liječenih arsenovim trioksidom i sve-trans-retinoatnom kiselinom (ATRA), sindrom diferencijacije APL-a primijećen je u njih 19% uključujući 5 teških slučajeva.
English: Treatment with TRISENOX must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to TRISENOX treatment.
Croatian: Liječenje TRISENOXOM mora se privremeno prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti toksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak te procijeni da su toksični učinci možda povezani s liječenjem
English: Skin and subcutaneous tissue disorders Pruritus
Croatian: Poremećaji kože i potkožnog tkiva pruritus
English: - Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in TRISENOX, may cause other cancers.
Croatian: - Liječnik će možda nadzirati Vaše zdravlje tijekom i nakon liječenja, jer arsenov trioksid,
English: The single institution study included 2 paediatric patients (< 18 years old), both of whom achieved CR.
Croatian: Provedeno monocentrično ispitivanje uključivalo je 2 pedijatrijska bolesnika (mlađa od 18 godina), od kojih su oba postigla potpunu remisiju.
English: Deaths
Croatian: Smrti
English: 35 days
Croatian: 35 dana
English: TRISENOX 1 mg/ml concentrate for solution for infusion EU/1/02/204/001
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju EU/1/02/204/001
English: Teva Pharmaceuticals Europe B.V. Swensweg 5,
Croatian: Teva Pharmaceuticals Europe B.V.
English: Any unused product, any items that come into contact with the product and waste material must be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek, bilo koji predmet koji dolazi u dodir s lijekom i otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Do not use this medicine after the expiry date which is stated on the ampoule label and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici ampule i kutiji.
English: TRISENOX 2 mg/ml concentrate for solution for infusion EU/1/02/204/002
Croatian: TRISENOX 2 mg/ml koncentrat za otopinu za infuziju EU/1/02/204/002
English: However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Croatian: Međutim, arsenov trioksid i drugi anorganski arsenovi spojevi imaju dokazano kancerogeno djelovanje na ljude.
English: TRISENOX must then be diluted immediately with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection.
Croatian: TRISENOX se mora odmah razrijediti pomoću 100 do 250 ml glukoze 50 mg/ml (5%) otopine za injekciju ili otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju.
English: Patients who experience such reactions that are considered TRISENOX related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption.
Croatian: moraju nastaviti liječenje samo nakon rješavanja toksičnih događaja ili nakon oporavka na početno stanje abnormalnosti koje je uzrokovalo prekid liječenja.
English: In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Croatian: U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika razvila se leukocitoza tijekom indukcijske terapije u 35 od 74 (47%)
English: No formal carcinogenicity studies of arsenic trioxide have been performed.
Croatian: Nisu provedena službena ispitivanja kancerogenosti s arsenovim trioksidom.
English: Metabolism and nutrition disorders Hyperglycaemia
Croatian: Poremećaji metabolizma i prehrane hiperglikemija
English: The total clearance of AsIII over the single-dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 l/h and the renal clearance is 9 l/h.
Croatian: Ukupni klirens AsIII u rasponu pojedinačnih doza od 7-32 mg (primijenjenih kao 0,15 mg/kg) iznosi 49 l/h, a bubrežni klirens je 9 l/h.
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia.
Croatian: Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekova koji produljuju QT interval (poput antiaritmika klase Ia i III (primjerice, kinidina, amiodarona, sotalola, dofetilida), antipsihotika (primjerice, tioridazina), antidepresiva (primjerice, amitriptilina), nekih makrolida (primjerice, eritromicina), nekih antihistaminika (primjerice, terfenadina i astemizola), nekih kinolonskih antibiotika (primjerice, sparfloksacina) i drugih pojedinačnih lijekova za koje je poznato da produljuju QT interval (primjerice, cisaprid)), anamnezom torsade de pointes, već postojećim produljenjem QT intervala, kongestivnim zatajenjem srca, primjenom diuretika koji troše kalij, amfotericina B ili s drugim stanjima koja rezultiraju hipokalemijom ili hipomagnezijemijom.
English: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Croatian: Djelatni sastojak TRISENOXA, arsenov trioksid, kancerogen je za ljude.
English: The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated.
Croatian: Multicentrično ispitivanje uključivalo je 5 pedijatrijskih bolesnika (mlađih od 18 godina), od kojih su 3 postigla potpunu remisiju.
English: TRISENOX is supplied in glass ampoules as a concentrated, clear, colourless, aqueous solution.
Croatian: TRISENOX je dostupan u staklenim bočicama u obliku koncentrirane, bistre, bezbojne, vodene otopine.
English: Respiratory, thoracic and mediastinal disorders Differentiation syndrome
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja sindrom diferencijacije
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Croatian: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: However, toxic effects resolved with temporary discontinuation of either TRISENOX, ATRA or both (see section 4.4).
Croatian: Međutim, toksični su se učinci povukli pri privremenom prekidu liječenja bilo TRISENOXOM, lijekom ATRA ili obama lijekovima (vidjeti dio 4.4).
English: 2031 GA Haarlem, The Netherlands
Croatian: 2031 GA Haarlem, Nizozemska
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37 % of relapsed/refractory APL patients in clinical trials.
Croatian: Sažetak sigurnosnog profila Povezane nuspojave CTC stupnja 3 ili 4 pojavile su se u 37% ispitanika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje u kliničkim ispitivanjima.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth,
Croatian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co.
English: Patients who are receiving, or who have received, medicinal products known to cause hypokalaemia or hypomagnesaemia, such as diuretics or amphotericin B,
Croatian: Bolesnici koji primaju, ili koji su primali, lijekove za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju, poput diuretika ili amfotericina B, mogu biti pod većim rizikom od torsade de pointes.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji.
English: 18-Month survival
Croatian: 59 dana preživljenje od 18 mjeseci
English: Time to CR (median)
Croatian: Vrijeme do potpune remisije (medijan)
English: Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 ml/min) or moderate renal impairment (creatinine clearance of 30-49 ml/min).
Croatian: Oštećenje bubrega Plazmatski klirens AsIII nije bio izmijenjen u bolesnika s blagim oštećenjem bubrega (klirens kreatinina od 50 do 80 ml/min) ili umjerenim oštećenjem bubrega (klirens kreatinina od 30 do
English: Leucocytosis occurred in 50 % of patients with relapsed/refractory APL, as determined by haematology assessments.
Croatian: Leukocitoza se pojavila u 50% bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje, kako je to utvrđeno hematološkim pretragama.
English: TRISENOX contains sodium
Croatian: TRISENOX sadrži natrij
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (< 50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Croatian: QT intervala, anamnezom ili prisutnošću značajnih ventrikularnih ili atrijskih tahiaritmija, klinički značajnom bradikardijom u mirovanju (< 50 otkucaja srca u minuti), QTc > 450 ms na probirnom EKG-u, blokom desne grane i prednjim lijevim hemiblokom, bifascikularnim blokom) ili neuropatijom.
English: In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with TRISENOX in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Croatian: U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika pojavili su se gastrointestinalna toksičnost, neutropenija 3.- 4. stupnja i trombocitopenija 3. ili 4. stupnja, međutim ti su učinci bili 2,2 puta manje česti u bolesnika liječenih TRISENOXOM u kombinaciji s ATRA-om u usporedbi s bolesnicima liječenima kombinacijom ATRA + kemoterapija (vidjeti tablicu 2).
English: Patients in the ATRA + chemotherapy treatment group also received maintenance treatment for up to 2 years, consisting of oral 6-mercaptopurine at 50 mg/m2 daily, intramuscular methotrexate at 15 mg/m2 weekly, and ATRA at 45 mg/m2 daily for 15 days every
Croatian: Bolesnici u skupini liječenoj kombinacijom ATRA+kemoterapija također su primali liječenje održavanja tijekom 2 godine koje se sastojalo od peroralno primijenjenog 6-merkaptopurina u dozi od 50 mg/m2 dnevno, metotreksata u dozi od 15 mg/m2 tjedno primijenjenog intramuskularno i ATRA-e u dozi od 45 mg/m2 dnevno tijekom
English: TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the ampoule or vial.
Croatian: TRISENOX se mora razrijediti pomoću 100 do 250 ml otopine glukoze za injekciju 50 mg/ml (5%) ili otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju odmah nakon izvlačenja lijeka iz ampule ili bočice.
English: Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Croatian: Bolesnici u multicentričnom ispitivanju doživjeli su relaps nakon 1 do 4 terapije prije liječenja, a 5 bolesnika doživjelo je relaps nakon transplantacije matičnim stanicama.
English: Hyperleucocytosis
Croatian: Hiperleukocitoza
English: Thereafter, in absence of worsening of the previous toxicity, TRISENOX should be resumed at full dosage.
Croatian: Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, potrebno je nastaviti liječenje TRISENOXOM u punoj dozi.
English: TRISENOX has been investigated in 77 newly diagnosed patients with low to intermediate risk APL, in a controlled, randomized, non-inferiority Phase 3 clinical study comparing the efficacy and safety of TRISENOX combined with all-trans-retinoic acid (ATRA) with those of ATRA + chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Croatian: Bolesnici s novodijagnosticiranim APL-om koji nije visokog rizika TRISENOX je ispitan u 77 novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika u kontroliranom, randomiziranom, kliničkom ispitivanju neinferiornosti faze 3 koje je uspoređivalo djelotvornost i sigurnost liječenja TRISENOXOM u kombinaciji sa sve-trans-retinoatnom kiselinom (ATRA) u odnosu na kombinirano liječenje ATRA+kemoterapija (npr. idarubicin i mitoksantron) (Ispitivanje APL0406).
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when TRISENOX is co-administered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Croatian: Lijekovi za koje je poznato da imaju hepatotoksične učinke Tijekom liječenja arsenovim trioksidom mogu se pojaviti hepatotoksični učinci; potreban je oprez kada se TRISENOX istodobno primjenjuje s drugim lijekovima za koje je poznato da imaju hepatotoksične učinke (vidjeti dijelove 4.4 i 4.8).
English: TRISENOX has been investigated in 52 APL patients, previously treated with an anthracycline and a retinoid regimen, in two open-label, single-arm, non-comparative studies.
Croatian: TRISENOX je ispitivan u 52 bolesnika s APL-om, koji su prethodno bili liječeni antraciklinom i retinoidima u dva otvorena, neusporedna ispitivanja s pojedinačnim skupinama.
English: Infections and infestations Herpes zoster
Croatian: Infekcije i infestacije
English: Dose delay and modification
Croatian: Odgoda i prilagodba doze
English: Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule.
Croatian: Protresite ampulu ili kucnite po njoj prstima kako bi se tekućina koncentrirala u tijelu ampule.
English: TRISENOX is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Croatian: TRISENOX se primjenjuje intravenski pri dozi od 0,15 mg/kg/dan po 25 doza koje se daju 5 dana u tjednu, nakon čega slijedi 2 dana pauze, a cijeli se ciklus ponavlja tijekom 5 tjedana.
English: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both.
Croatian: Međutim, toksični učinci povukli su se pri privremenom prekidu liječenja arsenovim trioksidom, lijekom ATRA ili obama lijekovima.
English: • some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole)
Croatian: • neke vrste lijekova za liječenje bakterijskih infekcija (primjerice, eritromicin i sparfloksacin) • neke lijekove za liječenje alergija poput peludne groznice, zvani antihistaminici (primjerice terfenadin i astemizol)
English: It must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Croatian: Ne smije se miješati ili davati istodobno s drugim lijekovima kroz istu intravensku liniju.
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Croatian: TRISENOX se mora primjenjivati intravenski pri dozi od 0,15 mg/kg/dan, svaki dan, sve dok se ne postigne potpuna remisija.
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Croatian: Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekovakoji produljuju QT interval , anamnezom torsade de pointes, postojećim prethodnim produljenjem QT intervala, kongestivnim zatajenjem srca, primjenom diuretika koji troše kalij ili druga stanja koja rezultiraju hipokalemijom ili hipomagnezijemijom.
English: Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Croatian: Bolesnici u monocentričnom ispitivanju doživjeli su relaps nakon 1 do 6 terapija prije liječenja, a 2 su bolesnika doživjela relaps nakon transplantacije matičnim stanicama.
English: Cardiac disorders Tachycardia
Croatian: Srčani poremećaji tahikardija
English: In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
Croatian: U jednog novodijagnosticiranog bolesnika indukcijsko je liječenje bilo prekinuto zbog jako produljenog Qtc intervala i poremećaja elektrolita 3. dana indukcijskog liječenja.
English: All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Sve parenteralne otopine treba prije primjene vizualno pregledati na strane čestice i promjenu boje.
English: There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Croatian: Nije se činilo da postoji veza između početnih vrijednosti leukocita i razvoja leukocitoza niti se pojavila korelacija između početnih i vršnih vrijednosti leukocita.
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with TRISENOX in combination with ATRA.
Croatian: Među novodijagnosticiranim bolesnicima s APL-om niskog do srednjeg rizika, njih 63,2% razvilo je hepatotoksične učinke 3. ili 4. stupnja tijekom indukcijskog ili konsolidacijskog liječenja TRISENOXOM u kombinaciji s ATRA-om.
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with TRISENOX, caution is advised in the use of TRISENOX in patients with hepatic impairment (see section 4.4 and 4.8).
Croatian: S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja TRISENOXOM, potreban je oprez kod primjene TRISENOXA u bolesnika s oštećenjem jetre (vidjeti dio 4.4 i 4.8).