FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data on the effect of arsenic trioxide on the QTc interval during the infusion.
Slovenian: Podatkov o učinku arzenovega trioksida na interval Q-Tc med infundiranjem ni.
English: Not evaluable RT-PCR for PML/ RAR
Slovenian: RT-PCR za PML/ RARα negativna pozitivna ni mogoče vrednotiti
English: Opening the ampoule: Hold the ampoule of TRISENOX with the coloured point upwards and in front of you.
Slovenian: Odpiranje ampule: Ampulo z zdravilom TRISENOX držite pred seboj z obarvano točko navzgor.
English: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Slovenian: Učinkovina zdravila TRISENOX, arzenov trioksid, je humani kancerogen.
English: If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100 % of the original dose.
Slovenian: Če v 7 dneh po ponovnem začetku zdravljenja s polovičnim odmerkom ne pride do toksičnosti, lahko dnevni odmerek zvišate spet na 100 % začetnega odmerka.
English: For storage conditions after dilution of the medicinal products, see section 6.3.
Slovenian: Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
English: In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Slovenian: V kliničnih preskušanjih pri relapsu ali refraktarni fazi je pri 40 % bolnikov, ki so jih zdravili z zdravilom TRISENOX, prišlo do vsaj enega podaljšanja popravljenega intervala Q-T (QTc), ki je trajal več kot 500 ms. Podaljšanje intervala Q-Tc se je pojavilo v 1 do 5 tednih po infundiranju zdravila TRISENOX in se je do konca 8. tedna po infundiranju zdravila TRISENOX
English: Single Center Multicenter Study
Slovenian: Multicentrična študija
English: TRISENOX must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Slovenian: Zdravilo TRISENOX vam morajo dati pod nadzorom zdravnika, izkušenega v zdravljenju akutnih levkemij.
English: The median age in the multicentre study was 40 years (age range 5 to 73).
Slovenian: Mediana starosti v multicentrični študiji je bila 40 let (obseg od 5 do 73).
English: Arsenic compounds induce chromosomal aberrations and morphological transformations of mammalian cells in vitro and in vivo.
Slovenian: Arzenove spojine povzročajo kromosomske aberacije in morfološke transformacije celic sesalcev in vitro in in vivo.
English: Because TRISENOX can harm nursing infants, do not breast-feed while on TRISENOX.
Slovenian: Ker lahko zdravilo TRISENOX škoduje dojenim otrokom, med zdravljenjem z zdravilom TRISENOX ne dojite.
English: TRISENOX has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo TRISENOX nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: There is no experience on the effect of TRISENOX on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Slovenian: Izkušenj z učinki zdravila TRISENOX na obliko APL s kromosomskima translokacijama t(11;17) in t(5;17) ni.
English: You must not receive TRISENOX
Slovenian: Ne smete dobiti zdravila TRISENOX
English: Do not use this medicine after the expiry date which is stated on the ampoule label and the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ampuli in škatli.
English: 54 days
Slovenian: 54 dni
English: In such cases, treatment must resume at 50 % of the preceding daily dose.
Slovenian: V takih primerih zdravljenje lahko nadaljujete s 50 % prejšnjega dnevnega odmerka.
English: Hydroxyurea should be continued at a given dose to keep the white blood cell count ≤ 10 x 103/μl and subsequently tapered.
Slovenian: Z odmerjanjem danega odmerka hidroksisečnine je treba nadaljevati, da se ohranja število belih krvničk ≤ 10 x 103/μl in se nato odmerek postopoma zmanjšuje.
English: 2-Year disease-free survival (DFS)
Slovenian: 2-letno preživetje brez bolezni (DFS)
English: The patient's electrolyte and glycaemia levels, as well as haematologic, hepatic, renal and coagulation parameter tests must be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.
Slovenian: Nadzor ravni elektrolitov in sladkorja v krvi ter preiskave hematoloških, jetrnih, ledvičnih in koagulacijskih parametrov morate opravljati vsaj dvakrat tedensko, pri klinično nestabilnih bolnikih med indukcijskim zdravljenjem tudi pogosteje in med konsolidacijskim zdravljenjem vsaj enkrat tedensko.
English: - The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: • Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Slovenian: • akutno promielocitno levkemijo (APL) v relapsu ali refraktarni fazi (bolniki bi se morali predhodno zdraviti z retinoidno terapijo in kemoterapijo), za katero je značilna prisotnost translokacije t(15;17) in/ali prisotnost gena za receptor za promielocitno levkemijo/retinojsko kislino alfa (PML/RAR-alfa).
English: Cytogenetics after TRISENOX therapy Table 5
Slovenian: Citogenetika po zdravljenju z zdravilom TRISENOX Tabela 5
English: In newly diagnosed patients with low to intermediate risk APL, differentiation syndrome was observed in 19 % including 5 severe cases.
Slovenian: Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem so zaznali sindrom diferenciacije pri 19 %, vključno s 5 resnimi primeri.
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.
Slovenian: Pri na novo diagnosticiranih bolnikih z APL, zdravljenih z arzenovim trioksidom in vse-trans-retinojsko kislino (ATRA), so sindrom diferenciacije APL opazili pri 19 %, vključno s 5 resnimi primeri.
English: Women of childbearing potential and men must use effective contraception during treatment with TRISENOX.
Slovenian: Ženske v rodni dobi in moški morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom TRISENOX.
English: TRISENOX must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5 % blasts present in cellular bone marrow with no evidence of leukaemic cells).
Slovenian: Zdravilo TRISENOX je treba uporabiti intravensko v stalnem odmerku 0,15 mg/kg/dan, dokler ni dosežena popolna remisija (prisotnih manj kot 5 % blastov v celičnem kostnem mozgu in brez sledi levkemičnih celic).
English: The following undesirable effects have been reported in the APL0406 study in newly diagnosed patients and in clinical trials and/or post-marketing experience in relapsed/refractory APL patients.
Slovenian: V študiji APL0406 pri na novo diagnosticiranih bolnikih in v kliničnih preskušanjih in/ali v obdobju trženja zdravila pri bolnikih z APL v relapsu ali refraktarni fazi so poročali o naslednjih neželenih učinkih.
English: Baseline white blood cell (WBC) counts did not correlate with development of leucocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Slovenian: Osnovno število belih krvnih celic (WBA) ni bilo povezano z razvojem levkocitoze, ki so jo raziskovali, in število WBA med konsolidacijskim zdravljenjem ni bilo tako visoko kot med indukcijo.
English: Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you TRISENOX once every day as an infusion.
Slovenian: Bolniki z na novo diagnosticirano akutno promielocitno levkemijo Zdravnik vam bo vsak dan dajal zdravilo TRISENOX v obliki infuzije.
English: Patients with acute promyelocytic leukaemia, whose disease has not responded to other therapies Your doctor will give you TRISENOX once every day as an infusion.
Slovenian: Bolniki z akutno promielocitno levkemijo, ki se ne odziva na druga zdravljenja Zdravnik vam bo vsak dan dajal zdravilo TRISENOX v obliki infuzije.
English: Biotransformation The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Slovenian: Presnova arzenovega trioksida poteka z oksidacijo arzenove kisline (AsIII), aktivne komponente arzenovega trioksida, v arzenovo kislino (AsV), ter z oksidativno metilacijo v monometilarzonično kislino (MMAV) in dimetilarzinično kislino (DMAV) z metiltransferazami, pretežno v jetrih.
English: For QTc greater than 500 msec, corrective measures must be completed and the QTc reassessed with serial ECGs and, if available, a specialist advice could be sought prior to considering using TRISENOX.
Slovenian: Pri vrednostih intervala Q-Tc nad 500 ms morate opraviti korekcijske ukrepe in z zaporednimi EKG-ji ponovno preveriti Q-Tc ter, če je mogoče, pridobite nasvet specialista, preden se odločite za ponovno uporabo zdravila TRISENOX.
English: Other antileukaemic medicinal products The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
Slovenian: Vpliv zdravila TRISENOX na učinkovitost drugih zdravil za levkemijo ni znan.
English: The median age in the single centre study was 33 years (age range 9 to 75).
Slovenian: Mediana starosti v enocentrični študiji je bila 33 let (obseg od 9 do 75).
English: Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukaemia/retinoic acid receptor-alpha (PML/RAR alpha).
Slovenian: Arzenov trioksid povzroča tudi poškodbe in razgradnjo fuzijske beljakovine receptorja za promielocitno levkemijo/retinojsko kislino alfa (PML/RAR-alfa).
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.
Slovenian: Pri dvajsetih bolnikih z APL v relapsu ali refraktarni fazi (50 %) se je pojavila levkocitoza; vendar je pri vseh teh bolnikih število WBC padalo ali se je normaliziralo do remisije kostnega mozga in citotoksična kemoterapija ali levkofereza nista bili potrebni.
English: Medicinal products known to cause QT/QTc interval prolongation, hypokalaemia or hypomagnesaemia
Slovenian: Zdravila, za katera je znano, da povzročajo podaljšanje intervala Q-T/Q-Tc, hipokaliemijo ali hipomagneziemijo
English: Unused portions of each vial must be discarded properly.
Slovenian: Neuporabljeno zdravilo iz vsake viale morate ustrezno zavreči.
English: Deaths
Slovenian: Smrti
English: The plasma concentration of AsIII declines from peak plasma concentration in a biphasic manner with a mean terminal elimination half-life of 10 to 14 hours.
Slovenian: Koncentracija AsIII v plazmi upada od najvišje koncentracije v plazmi na bifazni način s srednjo vrednostjo razpolovnega časa 10
English: APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur.
Slovenian: Akutna promielocitna levkemija je posebna vrsta mieloidne levkemije, pri kateri se pojavljajo nenormalne bele krvne celice in neobičajne krvavitve in modrice.
English: Dilution: Carefully insert the needle of a syringe into the ampoule and draw up all of the content.
Slovenian: Redčenje: V ampulo previdno vstavite iglo injekcijske brizge in izvlecite celotno vsebino.
English: Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro.
Slovenian: Arzenov trioksid povzroča morfološke spremembe in fragmentacijo deoksiribonukleinske kisline (DNA), ki so značilne za apoptozo celic človeške promielocitne levkemije NB4 in vitro.
English: In the presence of coagulopathy, the oral administration of the chelating agent Dimercaptosuccinic Acid Succimer (DCI) 10 mg/kg or 350 mg/m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Slovenian: Pri koagulopatiji priporočamo peroralno uporabo sredstva za kelacijo sukcimera dimerkaptosukcinske kisline (DCI - »dimercaptosuccinic acid succimer«) v odmerkih po 10 mg/kg ali 350 mg/m2 vsakih 8 ur prvih 5 dni in nato naslednja dva tedna vsakih 12 ur.
English: In newly diagnosed and relapsed/refractory APL patients who develop sustained leucocytosis after initiation of therapy, hydroxyurea should be administered.
Slovenian: Pri na novo diagnosticiranih bolnikih in bolnikih z APL v relapsu ali refraktarni fazi, pri katerih pride do trajne levkocitoze po začetku zdravljenja, je treba odmerjati hidroksisečnino.
English: One patient treated under a compassionate use program died from cerebral infarct due to leucocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Slovenian: Eden izmed bolnikov, ki so ga zdravili v okviru programa sočutne uporabe (Compassionate Use Program), je umrl zaradi možganske kapi, ki je bila posledica levkocitoze po zdravljenju s kemoterapevtiki za zniževanje števila belih krvnih celic.
English: Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Slovenian: Pri bolnikih v multicentrični študiji je prišlo do relapsa po 1-4 predhodnih krogih zdravljenja in pri 5 bolnikih je prišlo do relapsa po transplantaciji zarodnih celic.
English: Each pack contains 10 vials.
Slovenian: Eno pakiranje vsebuje 10 vial.
English: The majority of patients do not require permanent termination of TRISENOX therapy during treatment of the APL differentiation syndrome.
Slovenian: Pri večini bolnikov med zdravljenjem sindroma diferenciacije APL ni potrebna trajna prekinitev zdravljenja z zdravilom TRISENOX.
English: No data are available on patient with variant translocations like t(11;17) (PLZF/RARα).
Slovenian: O bolnikih s translokacijami različic, kot je t(11;17) (PLZF/RARα), ni na voljo podatkov.
English: All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Vse parenteralne raztopine morate pred uporabo vizualno pregledati in preveriti, ali so prisotni delci in ali je raztopina razbarvana.
English: Consolidation therapy began 6 weeks (range, 3-8) after induction in the single institution study and 4 weeks (range, 3-6) in the multicentre study.
Slovenian: V študiji z enim zavodom se je konsolidacijsko zdravljenje začelo 6 tednov (v obsegu 3-8 tednov), v multicentrični študiji pa se je začelo 4 tedne (v obsegu 3-6 tednov) po indukciji.
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.
Slovenian: Pri enem na novo diagnosticiranem bolniku je bilo indukcijsko zdravljenje ustavljeno zaradi resnega podaljšanja intervala Q-Tc in nepravilnosti elektrolitov 3. dan indukcijskega zdravljenja.
English: TRISENOX is expected to have no or negligible influence on your ability to drive and use machines.
Slovenian: Zdravilo TRISENOX naj ne bi imelo nobenega vpliva ali zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The single institution study included 2 paediatric patients (< 18 years old), both of whom achieved CR.
Slovenian: Enocentrična študija je vključevala 2 pediatrična bolnika (stara < 18 let).
English: Since no data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
Slovenian: Ker ni na voljo podatkov za nobeno skupino bolnikov z ledvično okvaro, se pri uporabi zdravila TRISENOX priporoča previdnost pri bolnikih z ledvično okvaro.
English: TRISENOX 2 mg/ml concentrate for solution for infusion EU/1/02/204/002
Slovenian: TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje EU/1/02/204/002
English: One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Slovenian: Ena bolnica, ki je prejemala več zdravil skupaj, vključno z amfotericinom B, je imela asimptomatično aritmijo torsade de pointes med indukcijskim zdravljenjem relapsa APL z arzenovim trioksidom.
English: Method and route of administration
Slovenian: Postopek in pot uporabe
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
Slovenian: Bolniki v skupini ATRA + kemoterapija so prejemali tudi vzdrževalno zdravljenje do 2 leti, ki je vsebovalo peroralno jemanje 6-merkaptopurina v odmerku 50 mg/m2 dnevno, intramuskularni metotreksat v odmerku 15 mg/m2 tedensko in ATRA v odmerku 45 mg/m2 dnevno 15 dni vsake 3 mesece.
English: TRISENOX is supplied in glass ampoules as a concentrated, clear, colourless, aqueous solution.
Slovenian: TRISENOX je na voljo v steklenih ampulah kot koncentrirana, čista, brezbarvna, vodna raztopina.
English: TRISENOX 1 mg/ml concentrate for solution for infusion EU/1/02/204/001
Slovenian: TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje EU/1/02/204/001
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.
Slovenian: Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je prišlo do gastrointestinalne toksičnosti, nevtropenije stopnje 3-4 in trombocitopenije stopnje 3-4, a so bile 2,2-krat manj pogoste pri bolnikih, zdravljenih z zdravilom TRISENOX v kombinaciji z ATRA, kot pri bolnikih, zdravljenih z ATRA in kemoterapijo.
English: Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called “differentiation syndrome”, which might be fatal: - difficulty in breathing - coughing - chest pain - fever
Slovenian: Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če opazite naslednje neželene učinke, saj so lahko ti znaki resnega bolezenskega stanja, ki se imenuje 'sindrom diferenciacije'
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.
Slovenian: TRISENOX morate nato takoj razredčiti s 100 do 250 ml glukoze 50 mg/ml (5 %) raztopina za injiciranje ali natrijevega klorida 9 mg/ml (0,9 %) raztopina za injiciranje.
English: It must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Slovenian: Ne smete ga mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili.
English: Teva Pharmaceuticals Europe B.V. Swensweg 5,
Slovenian: Teva Pharmaceuticals Europe B.V.
English: In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Slovenian: Pri na novo diagnosticiranih bolnikih z APL je pri 15,6 % prišlo do podaljšanja intervala Q-Tc z arzenovim trioksidom v kombinaciji z ATRA (glejte poglavje 4.8).
English: Unused portions of each ampoule must be discarded properly.
Slovenian: Neuporabljeno zdravilo iz vsake ampule morate ustrezno zavreči.
English: The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Slovenian: Stopnja učinkovitosti arzenovega trioksida pri drugih podvrstah akutne mielogenske levkemije niso preučevali.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV are 32 hours and
Slovenian: Srednja ocenjena vrednost razpolovnega časa presnovka MMAV je 32
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37 % of relapsed/refractory APL patients in clinical trials.
Slovenian: V kliničnih preskušanjih je do povezanih neželenih učinkov CTC stopnje 3 in 4 prišlo pri 37 % bolnikov z APL v relapsu ali refraktarni fazi.
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.
Slovenian: Na splošno so se neželeni učinki pri bolnikih z APL v relapsu ali refraktarni fazi, nastali zaradi zdravljenja, sčasoma zmanjšali, najverjetneje zaradi izboljšanja osnovnega bolezenskega stanja.
English: Infections and infestations Herpes zoster
Slovenian: Infekcijske in parazitske bolezni herpes zoster sepsa pljučnica
English: Not known (frequency cannot be estimated from the available data):
Slovenian: - pordelost kože, oteklina obraza, zamegljen vid Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: Arsenic is excreted in human milk.
Slovenian: Arzen se izloča v materino mleko.
English: Patients in the ATRA + TRISENOX treatment group received oral ATRA at 45 mg/m2 daily and IV
Slovenian: Bolniki v skupini ATRA + TRISENOX so prejemali peroralno dnevni odmerek ATRA 45 mg/m2 in i.v.
English: In the case of the reappearance of symptoms TRISENOX should be reduced to the previous dosage.
Slovenian: Če znova pride do simptomov, zmanjšajte odmerek zdravila TRISENOX na prejšnji odmerek.
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.
Slovenian: Pri bolnikih, pri katerih se pojavijo taki učinki, za katere menite, da so povezani z zdravilom TRISENOX, lahko nadaljujete zdravljenje šele po odpravi toksičnosti ali po vrnitvi anomalije, zaradi katere ste prekinili zdravljenje, na izhodiščno vrednost.
English: After dilution, if not used immediately, storage times and conditions before use are the responsibility of your doctor, pharmacist or nurse and would normally not be longer than 24 hours at 2 to 8 ºC, unless dilution has taken place in a sterile environment.
Slovenian: Če zdravilo ni porabljeno takoj po redčenju, je vaš zdravnik, farmacevt ali medicinska sestra odgovoren za čas in pogoje shranjevanja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi med 2 in 8 °C, razen če se je redčenje opravilo v sterilnih pogojih.
English: - fatigue (weariness), pain, fever, headache
Slovenian: - siljenje na bruhanje, bruhanje, driska
English: Clinically unstable APL patients are especially at risk and will require more frequent monitoring of electrolyte and glycaemia levels as well as more frequent haematologic, hepatic, renal and coagulation parameter tests.
Slovenian: Potreben je pogostejši nadzor ravni elektrolitov in sladkorja v krvi ter pogostejši testi hematoloških, jetrnih, ledvičnih in koagulacijskih parametrov.
English: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both.
Slovenian: Vendar pa so s prekinitvijo uporabe arzenovega trioksida, ATRA ali obeh toksični učinki začasno izginili.
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Slovenian: Zdravilo TRISENOX je treba uporabiti intravensko v odmerku 0,15 mg/kg/dan vsak dan, dokler ni dosežena popolna remisija.