natgillin/translations-raw huggingface dataset:
The results are summarised in the table 4 below. 
Rezultati so povzeti v preglednici 4 spodaj.
Conventional Cytogenetics [t(15;17)] 
Navadna citogenetika [t(15;17)]
The daily dose can be escalated back to 100% of the original dose if no prolongation occurs. 
Dnevni odmerek lahko zvečate na 100 % prvotnega odmerka, če ne pride do podaljšanja.
1/1,000 to < 1/100), not known (cannot be estimated from available data). 
≥ 1/100 do < 1/10), (občasni ≥1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Negative Positive Not evaluable 
negativna pozitivna ni mogoče vrednotiti
- if you are taking or have recently taken any medicine which may affect your liver. 
- če jemljete ali ste pred kratkim jemali katero koli zdravilo, ki lahko vpliva na jetra.
Kaplan-Meier estimates of 18-month survival for each study are shown below. 
Ocena 18-mesečnega preživetja po metodi Kaplan-Meier za obe študiji je prikazana spodaj.
You must be sure to tell your doctor about all medicines you are taking. 
Zdravnika morate obvezno obvestiti o vseh zdravilih, ki jih uporabljate.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leukocytosis, and no standard approach has proven effective. 
Zdravila za zmanjševanje števila belih krvnih celic pogosto poslabšajo toksične učinke, povezane z levkocitozo, in nobena izmed standardnih metod se ni pokazala kot učinkovita.
If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 
- če ste alergični na arzenov trioksid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Each pack contains 1, 5 or 10 vials. 
Eno pakiranje vsebuje 1, 5 ali 10 vial.
Concentrate for solution for infusion 1 vial of 10 ml (10 mg/10 ml) 5 vials of 10 ml (10 mg/10 ml) 10 vials of 10 ml (10 mg/10 ml) 
koncentrat za raztopino za infundiranje 1 viala z 10 ml (10 mg/10 ml) 5 vial z 10 ml (10 mg/10 ml) 10 vial z 10 ml (10 mg/10 ml)
The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established. 
Varnost in učinkovitost arzenovega trioksida pri otrocih, mlajših od 17 let, nista bili dokazani.
In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11. 
In vitro encimske študije človeških jetrnih mikrosomov so razkrile, da arzenov trioksid ne vpliva zaviralno na substrate večjih encimov citokroma P450 kot so 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
is large (>400 L) indicating significant distribution into the tissues with negligible protein binding. 
Volumen porazdelitve (Vd) za AsIII je velik (> 400 l), kar kaže na značilno porazdelitev v tkivu z zanemarljivo vezavo na beljakovine.
It is for single use only, and any unused portions of each vial must be discarded properly. 
Namenjeno je samo za enkratno uporabo in vso neuporabljeno zdravilo iz vsake viale morate ustrezno zavreči.
Peripheral neuropathy, characterised by paresthesia/dysesthesia, is a common and well known effect of environmental arsenic. 
Periferna nevropatija, za katero je značilna parestezija/disestezija, je pogost in dobro znan učinek arzena v okolju.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27 
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX27.
Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction: 
Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če opazite enega ali več od naslednjih neželenih učinkov, saj so lahko znak alergične reakcije:
Approximately 15% of the administered arsenic trioxide dose is excreted in the urine as unchanged AsIII. 
Približno 15 % apliciranega odmerka arzenovega trioksida se izloči v seču kot nespremenjen AsIII.
Arsenic trioxide Accord is normally given by a doctor or a nurse. 
Zdravilo Arzenov trioksid Accord vam bo običajno dal zdravnik ali medicinska sestra.
After first opening: Once opened the product should be used immediately. 
Po prvem odprtju: po odprtju je treba zdravilo porabiti takoj.
RT-PCR for PML/ RARα 
RT-PCR za PML/
Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted. 
Sistemska izpostavljenost MMAV in DMAV je bila večja pri bolnikih z okvarjenim delovanjem ledvic; klinične posledice tega niso znane, vendar zvečane toksičnosti niso opazili.
PVC-free plastic bags should be used. 
Uporabljajte plastične vrečke brez PVC.
Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide. 
Za učinkovine, ki so substrati encimov P450, se ne pričakuje, da bodo medsebojno delovale z arzenovim trioksidom.
If you experience discomfort or if you feel unwell after a Arsenic trioxide Accord injection, you should wait until the symptoms go away before driving or using machines. 
Če čutite neugodje ali če se ne počutite dobro po injekciji zdravila Arzenov trioksid Accord, morate pred vožnjo ali upravljanjem strojev počakati, da simptomi izginejo.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po redčenju ali prvem odprtju zdravila glejte poglavje 6.3.
- difficulty in breathing 
- težko dihanje
In these studies, leukocytosis was not treated with chemotherapeutic medicinal products. 
Levkocitoze v teh študijah niso zdravili s kemoterapevtiki.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: 
Arzenov trioksid je indiciran za indukcijo remisije in konsolidacijo pri odraslih bolnikih z:
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: 
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'
Arsenic trioxide Accord is not recommended in children and adolescents below 18 years of age. 
Zdravilo Arzenov trioksid Accord ni primerno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Each carton contains 1, 5 or 10 vials. 
Ena škatla vsebuje 1, 5 ali 10 vial.
Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2). 
Od 7 bolnikov, mlajših od 18 let (razpon od 5 do 16 let), ki so prejemali arzenov trioksid v priporočenem odmerku 0,15 mg/kg/dan, so pri 5 dosegli popoln odziv (glejte poglavje 4.2).
Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo, vse predmete, ki pridejo v stik z zdravilom, in odpadni material zavrzite v skladu z lokalnimi predpisi.
Arsenic trioxide Accord is supplied in glass vials as a concentrated, sterile, clear, colourless, aqueous solution . 
Zdravilo Arzenov trioksid Accord je na voljo v steklenih vialah kot koncentrirana, sterilna, čista, brezbarvna, vodna raztopina.
Arsenic trioxide was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days. 
Arzenov trioksid so dajali intravensko v trajanju 1-2 uri, dokler kostni mozeg ni bil brez levkemičnih celic, vendar največ 60 dni.
After first opening Once opened the product should be used immediately. 
Po prvem odprtju Po odprtju je treba zdravilo porabiti takoj.
- Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in Arsenic trioxide Accord, may cause other cancers. 
- Zdravnik bo tako med zdravljenjem kot po njem morda nadzoroval vaše zdravje, saj lahko arzenov trioksid, učinkovina v zdravilu Arzenov trioksid Accord, povzroči druge oblike raka.
It is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies. 
Uporablja se pri odraslih bolnikih z na novo diagnosticirano akutno promielocitno levkemijo (APL) z nizkim do srednjim tveganjem in pri odraslih bolnikih, pri katerih druge oblike zdravljenja niso pomagale.
If you are pregnant or you become pregnant during the treatment with Arsenic trioxide Accord, you must ask your doctor for advice. 
Če ste noseči ali med zdravljenjem z zdravilom Arzenov trioksid Accord zanosite, se morate posvetovati z zdravnikom.
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/min) was 40% lower when compared with patients with normal renal function (see section 4.4). 
Očistek AsIII v plazmi bolnikov s hudo okvaro delovanja ledvic (očistek kreatinina pod 30 ml/min) je bil 40 % nižji v primerjavi z bolniki z normalnim delovanjem ledvic (glejte poglavje 4.4).
Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed. 
Arzenov trioksid morate uporabljati pod nadzorom zdravnikov, izkušenih v zdravljenju akutnih levkemij in treba je upoštevati posebne nadzorne postopke, opisane v poglavju 4.4.
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3. 
koncentrat za raztopino za infundiranje sterilna, bistra, brezbarvna vodna raztopina brez vidnih delcev z razponom pH 7,7-8,3
Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given. 
Nato lahko uporabite penicilamin v odmerkih po ≤ 1 gram na dan.
Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha. 
Arzenov trioksid povzroča tudi poškodbe in razgradnjo fuzijske beljakovine receptorja za PML/RAR-alfa.
In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with arsenic trioxide. 
V nadaljevalnem zdravljenju po konsolidaciji so 7 bolnikom iz enocentrične študije in 18 bolnikom iz multicentrične študije odredili nadaljnje zdravljenje z arzenovim trioksidom.
No formal assessments of pharmacokinetic interactions between arsenic trioxide and other therapeutic medicinal products have been conducted. 
Uradne ocene farmakokinetičnih interakcij med arzenovim trioksidom in drugimi zdravili niso izvedli.
If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week. 
Če se podaljšanje intervala Q-Tc ne ponovi v 7 dneh po vnovičnem začetku zdravljenja z zmanjšanim odmerkom, lahko nadaljujete zdravljenje z arzenovim trioksidom z odmerkom 0,11 mg/kg telesne mase na dan še en teden.
While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions: 
Med zdravljenjem z zdravilom Arzenov trioksid Accord boste morda imeli nekatere od naštetih učinkov:
Arsenic trioxide has no or negligible influence on the ability to drive and use machines. 
Arzenov trioksid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
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). 
Očistek AsIII v plazmi ni bil spremenjen pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50-80 ml/min) ali zmerno okvaro delovanja ledvic (očistek kreatinina 30-49 ml/min).
Type I transparent colorless glass vial sealed with a silicon-oil free, elastomer type, grey rubber stopper made of bromobutyl and aluminium seal with a plastic flip off cap containing 10 ml of concentrate. 
Prosojna brezbarvna steklena viala tipa I s sivim elastomernim gumijastim zamaškom brez silikonskega olja, ki je narejen iz bromobutila, in aluminijasto zaporko s plastičnim snemljivim pokrovčkom, ki vsebuje 10 ml koncentrata.
The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown. 
Vpliv arzenovega trioksida na učinkovitost drugih zdravil za levkemijo ni znan.
If this happens, treatment with Arsenic trioxide Accord must be stopped immediately and your doctor will treat the arsenic overdose. 
Če se to zgodi, morate nemudoma prekiniti zdravljenje z zdravilom Arzenov trioksid Accord in zdravnik vas bo zdravil zaradi prevelikega odmerka arzena.
Arsenic trioxide Accord with food and drink 
Zdravilo Arzenov trioksid Accord skupaj s hrano in pijačo
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes. 
Pri bolnikih, ki prejemajo ali so prejemali zdravila, za katera je znano, da povzročajo hipokaliemijo ali hipomagneziemijo, kot so diuretiki ali amfotericin B, je večje tveganje nastanka aritmije Torsade de pointes.
The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord. 
Učinek teh zdravil na vaš srčni ritem se lahko z uporabo zdravila Arzenov trioksid Accord še okrepi.
See section 2, “Arsenic trioxide Accord contains sodium”. 
Glejte poglavje 2, ‘Zdravilo Arzenov trioksid Accord vsebuje natrij'.
What Arsenic trioxide Accord is and what it is used for 
Kaj je zdravilo Arzenov trioksid Accord in za kaj ga uporabljamo
As soon as signs and symptoms have subsided, treatment with arsenic trioxide can be resumed at 50 % of the previous dose during the first 7 days. 
Takoj ko izginejo znaki in simptomi, lahko nadaljujete zdravljenje z arzenovim trioksidom s 50 % prejšnjega odmerka v prvih 7 dneh.
However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4). 
Toda toksični učinki so izginili s prekinitvijo uporabe arzenovega trioksida, ATRA ali obeh (glejte poglavje 4.4).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni 'brez natrija'.
How to use Arsenic trioxide Accord Duration and frequency of treatment 
Kako uporabljati zdravilo Arzenov trioksid Accord Trajanje in pogostnost zdravljenja
The mechanism of action of arsenic trioxide is not completely understood. 
Načina delovanja arzenovega trioksida ne razumemo povsem.
What you need to know before you use Arsenic trioxide Accord 
Kaj morate vedeti, preden boste uporabili zdravilo Arzenov trioksid Accord
Induction treatment schedule 
Program indukcijskega zdravljenja
In case of reappearance of hepatotoxicity, arsenic trioxide must be permanently discontinued. 
Če znova pride do hepatotoksičnosti, je treba trajno prenehati zdravljenje z arzenovim trioksidom.
If you have any further question on the use of this medicine, ask your doctor or pharmacist. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
What Arsenic trioxide Accord is and what it is used for What you need to know before you use Arsenic trioxide Accord How to use Arsenic trioxide Accord Possible side effects 
Kaj je zdravilo Arzenov trioksid Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Arzenov trioksid Accord Kako uporabljati zdravilo Arzenov trioksid Accord
In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide 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 arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion. 
V kliničnih preskušanjih pri relapsu ali refraktarni fazi je pri 40 % bolnikov, ki so jih zdravili z arzenovim trioksidom, 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 arzenovega trioksida in se je do konca 8. tedna po infundiranju arzenovega trioksida vrnilo na osnovno vrednost.
Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RARα conversion to normal are shown in table 5 below. 
Citogenetska potrditev pretvorbe v normalen genotip in odkrivanje pretvorbe PML/RAR v običajno obliko z metodo polimerazne verižne reakcije z reverzno transkriptazo (RT-PCR - »reverse transcriptase - polymerase chain reaction«) je prikazana v preglednici 5 spodaj.
Dilution: Carefully insert the needle of a syringe into the vial through the rubber stopper and draw up all of the content. 
Redčenje: V vialo skozi gumijast zamašek previdno vstavite iglo injekcijske brizge in izvlecite celotno vsebino.
Patients with risk factors of QTc prolongation or risk factors of Torsade de pointes should be monitored with continuous cardiac monitoring (ECG). 
Bolnikom, ki imajo visoke dejavnike tveganja za podaljšanje intervala Q-Tc ali za aritmijo Torsade de pointes, morate nenehno nadzorovati srčno funkcijo (EKG).
- The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections. 
- Druge sestavine zdravila so natrijev hidroksid, koncentrirana klorovodikova kislina (za uravnavanje pH) in voda za injekcije.
Additional information about QT prolonging medicinal agents is provided in Section 4.4. 
Dodatne informacije o učinkovinah, ki podaljšujejo interval Q-T, so v poglavju 4.4.
The use of arsenic trioxide in patients on dialysis has not been studied. 
Uporabe arzenovega trioksida pri bolnikih na dializi niso preučili.
Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord. 
Zdravnik bo določil, kako dolgo morate prejemati zdravilo Arzenov trioksid Accord.
Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride. 
Zdravilo Arzenov trioksid Accord se mora razredčiti z raztopino, ki vsebuje glukozo, ali raztopino, ki vsebuje natrijev klorid.
Women of childbearing potential and men must use effective contraception during treatment with arsenic trioxide. 
Ženske v rodni dobi in moški morajo uporabljati učinkovito kontracepcijo med zdravljenjem z arzenovim trioksidom.
In such cases, treatment must resume at 50% of the preceding daily dose. 
V takih primerih zdravljenje lahko nadaljujete s 50 % prejšnjega dnevnega odmerka.
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. 
Če v 7 dneh po ponovnem začetku zdravljenja s polovičnim odmerkom ne pride do toksičnosti, lahko dnevni odmerek zvišate spet na 100 % začetnega odmerka.
There is no experience on the effect of arsenic trioxide on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations. 
Izkušenj z učinki arzenovega trioksida na obliko APL s kromosomskima translokacijama t(11;17) in t(5;17) ni.
Other antileukaemic medicinal products 
Druga zdravila za levkemijo
As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with arsenic trioxide should be resumed at 50 % of the previous dose during the first 7 days. 
Takoj ko se vrednosti bilirubina in/ali serumske aspartat-aminotransferaze (SGOT) in/ali alkalne fosfataze znižajo pod vrednost 4-kratnika zgornje meje normale, je treba zdravljenje z arzenovim trioksidom nadaljevati s 50 % prejšnjega odmerka v prvih 7 dneh.
Arsenic trioxide 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). 
Arzenov trioksid je treba uporabiti intravensko v odmerku 0,15 mg/kg/dan vsak dan, dokler ni dosežena popolna remisija (prisotnih manj kot 5 % blastov v celičnem kostnem mozgu in brez sledi levkemičnih celic).
Because Arsenic trioxide Accord can harm nursing infants, do not breast-feed while on Arsenic trioxide Accord. 
Ker lahko zdravilo Arzenov trioksid Accord škoduje dojenim otrokom, med zdravljenjem z zdravilom Arzenov trioksid Accord ne dojite.
Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia 
Zdravila, za katera je znano, da povzročajo podaljšanje intervala Q-T/Q-Tc, hipokaliemijo ali hipomagneziemijo
If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, arsenic trioxide must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 gm per day may be considered. 
Če se pojavijo simptomi, značilni za resno akutno zastrupitev z arzenom (npr. krči, mišična slabotnost in zmedenost), morate zdravljenje z arzenovim trioksidom nemudoma prekiniti in pretehtati kelacijsko zdravljenje z dnevnim odmerkom penicilamina (≤ 1 gram na dan).
- Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with Arsenic trioxide Accord. 
- Testiranje krvi (kalij, kalcij , magnezij in delovanje jeter) je treba med zdravljenjem z zdravilom
ATRA + Arsenic trioxide (n = 77) 
arzenov trioksid (n = 77)
Hydrochloric acid, concentrated (for pH adjustment) Water for injections 
natrijev hidroksid klorovodikova kislina, koncentrirana (za uravnavanje pH) voda za injekcije
If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, arsenic trioxide 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. 
Če se pojavi sinkopa, pospešen ali nepravilen srčni utrip, morate bolnika sprejeti v bolnišnico in ga nenehno nadzorovati, pregledati morate ravni elektrolitov v serumu, začasno morate prekiniti zdravljenje z arzenovim trioksidom, dokler se trajanje intervala Q-Tc ne vrne pod 460 ms, se anomalije ravni elektrolitov ne popravijo in sinkopa in nepravilen srčni utrip ne prenehata.
• 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) 
• na novo diagnosticirano akutno promielocitno levkemijo (APL) z nizkim do srednjim tveganjem (število belih krvničk ≤ 10 x 103/µl) v kombinaciji z vse-trans-retinojsko kislino (ATRA),
• 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. 
• 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).
Patients with acute promyelocytic leukaemia, whose disease has not responded to other therapies Your doctor will give you Arsenic trioxide Accord once every day as an infusion. 
Bolniki z akutno promielocitno levkemijo, ki se ne odziva na druga zdravljenja Zdravnik vam bo vsak dan dajal zdravilo Arzenov trioksid Accord v obliki infuzije.