FrancophonIA/ELRC3.0 huggingface dataset:
English: Edurant does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Edurant ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: Edurant was also effective in adolescents, with around 72% of patients responding to treatment after 48 weeks.
Slovenian: Zdravilo Edurant je bilo učinkovito tudi pri mladostnikih, saj se je po 48 tednih na zdravljenje odzvalo okoli 72 % bolnikov.
English: Treatment with Edurant should be started by a doctor experienced in treating HIV infection.
Slovenian: Zdravljenje z zdravilom Edurant mora uvesti zdravnik z izkušnjami z zdravljenjem okužbe z virusom HIV.
English: What is the risk associated with Edurant?
Slovenian: Kakšna tveganja so povezana z zdravilom Edurant?
English: It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Slovenian: Uporablja se samo pri bolnikih, ki zaradi okužbe z virusom HIV predhodno še niso bili zdravljeni in pri katerih ravni virusa HIV v krvi (virusno breme) niso višje od 100 000 HIV-1 RNK kopij/ml.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Slovenian: Kljub temu je ugotovil, da obstaja manjše tveganje za razvoj odpornosti virusa HIV-1 za rilpivirin in da se zdi, da je to tveganje manjše pri bolnikih z manjšim virusnim bremenom.
English: The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes).
Slovenian: Najpogostejši neželeni učinki zdravila Edurant (opaženi pri več kot 1 bolniku od 10) so glavobol, nespečnost, omotica, navzeja (slabost) ter povišane ravni skupnega holesterola, holesterola LDL (lipoproteina majhne gostote), pankreazne amilaze (encima, ki se tvori v trebušni slinavki in razgradi škrob na sladkorje) in transaminaz (jetrnih encimov).
English: If Edurant is given together with rifabutin, the doctor should increase the dose of Edurant to two tablets once a day during rifabutin treatment.
Slovenian: Če se zdravilo Edurant daje skupaj z rifabutinom, mora zdravnik med jemanjem rifabutina povečati odmerek zdravila Edurant na dve tableti enkrat na dan.
English: Edurant must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Edurant:
Slovenian: Zdravilo Edurant se ne sme uporabljati skupaj z naslednjimi zdravili, ki lahko povzročijo znižane ravni rilpivirina v krvi in posledično zmanjšajo njegovo učinkovitost:
English: Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Slovenian: Zato je zaključil, da so koristi zdravila Edurant večje od z njim povezanih tveganj pri bolnikih z majhnim virusnim bremenom HIV-1, in priporočil, da se zanj izda dovoljenje za promet pri tej skupini bolnikov.
English: Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.
Slovenian: V obeh študijah skupaj se je po enem letu na zdravljenje odzvalo 84 % bolnikov, ki so jemali zdravilo Edurant, in 82 % bolnikov, ki so jemali efavirenz.
English: • rifampicin, rifapentine (antibiotics);
Slovenian: • rifampicin in rifapentin (antibiotični zdravili);
English: The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Slovenian: Zdravilna učinkovina zdravila Edurant, rilpivirin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
English: Edurant is an antiviral medicine.
Slovenian: Zdravilo Edurant je protivirusno zdravilo.
English: Why has Edurant been approved?
Slovenian: Zakaj je bilo zdravilo Edurant odobreno?
English: For the full list of all side effects reported with Edurant, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Edurant, glejte navodilo za uporabo.
English: Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Slovenian: Zdravilo Edurant so proučevali v dveh glavnih študijah pri 1 368 predhodno nezdravljenih bolnikih, ki so bili okuženi z virusom HIV-1.
English: The Committee noted that Edurant causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Slovenian: Ugotovil je, da zdravilo Edurant povzroča manj neželenih učinkov v zgodnjih fazah zdravljenja in je priročnejše, saj se jemlje v obliki ene tablete na dan.
English: Edurant is a medicine that contains the active substance rilpivirine.
Slovenian: Edurant je zdravilo, ki vsebuje zdravilno učinkovino rilpivirin.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
Slovenian: • karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov);
English: Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Edurant se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Slovenian: Zdravilo Edurant so proučevali še v eni študiji pri 36 predhodno nezdravljenih mladostnikih (starih med 12 in 18 let), ki so bili okuženi z virusom HIV-1.
English: Edurant must be taken with a meal.
Slovenian: Zdravilo Edurant je treba vzeti med jedjo.
English: In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.
Slovenian: V drugi študiji so zdravilo Edurant primerjali z efavirenzom, pri čemer sta bili obe zdravili uporabljeni v kombinaciji s fiksno shemo jemanja protivirusnih zdravil, ki je vključevala tenofovirdizoproksilat in emtricitabin ali dva druga nukleozidna ali nukleotidna zaviralca reverzne transkriptaze.
English: In the first study, Edurant was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine.
Slovenian: V prvi študiji so zdravilo Edurant primerjali z drugim zdravilom NNRTI, imenovanim efavirenz, pri čemer sta bili obe zdravili uporabljeni v kombinaciji s fiksno shemo jemanja protivirusnih zdravil, ki je vključevala tenofovirdizoproksilat in emtricitabin.
English: By blocking this enzyme, Edurant, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Edurant, ki se jemlje v kombinaciji z drugimi protivirusnimi zdravili, z zaviranjem tega encima zmanjša količino virusov HIV v krvi in jo ohranja na nizki ravni.
English: Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
Slovenian: To zdravilo je bilo uporabljeno v kombinaciji s fiksno shemo jemanja protivirusnih zdravil in ga niso primerjali z nobenim drugim zdravilom.
English: How has Edurant been studied?
Slovenian: Kako je bilo zdravilo Edurant raziskano?
English: In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood.
Slovenian: Pri odraslih je bilo zdravilo Edurant v kombinaciji z drugimi protivirusnimi zdravili pri zniževanju ravni virusa HIV-1 v krvi enako učinkovito kot primerjalno zdravilo.
English: The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Slovenian: CHMP je zaključil, da je zdravilo Edurant v kombinaciji z drugimi protiretrovirusnimi zdravili enako učinkovito kot glavna zdravila NNRTI, ki se trenutno uporabljajo kot zdravljenje prve izbire pri odraslih bolnikih, okuženih z virusom HIV-1.
English: How is Edurant used?
Slovenian: Kako se zdravilo Edurant uporablja?
English: What is Edurant used for?
Slovenian: Za kaj se zdravilo Edurant uporablja?
English: • St John's wort (a herbal antidepressant medicine).
Slovenian: • šentjanževka (antidepresiv rastlinskega izvora).
English: What is Edurant?
Slovenian: Kaj je zdravilo Edurant?
English: How does Edurant work?
Slovenian: Kako zdravilo Edurant deluje?
English: AsV is present in plasma only at relatively low levels.
Slovenian: AsV je prisoten v plazmi samo v relativno nizki ravni.
English: This syndrome can be fatal.
Slovenian: Ta sindrom je lahko smrten.
English: The same dose is recommended for adults and elderly.
Slovenian: Isti odmerek se priporoča za odrasle in starejše bolnike.
English: Observation is the recommended approach with intervention only in selected cases.
Slovenian: Priporočen pristop je opazovanje, poseg pa le v izbranih primerih.
English: Monitoring and management for these patients should be as described above.
Slovenian: Nadzor in zdravljenje pri teh pacientih morata biti takšna, kot je opisano zgoraj.
English: NEW CONCENTRATION
Slovenian: NOVA KONCENTRACIJA
English: At Risk
Slovenian: S tveganjem
English: From a microbiological point of view, the product must be used immediately.
Slovenian: Z mikrobiološkega vidika morate zdravilo porabiti takoj.
English: Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
Slovenian: Datum prve odobritve: 05. 03. 2002 Datum zadnjega podaljšanja: 05. 03. 2007
English: The results are summarised in the table 4 below.
Slovenian: Rezultati so povzeti v tabeli 4 spodaj.
English: Caution is needed in these patients.
Slovenian: Pri teh bolnikih je potrebna posebna previdnost.
English: The response rate was similar for both genders.
Slovenian: Stopnja odzivnosti je bila podobna pri obeh spolih.
English: This accumulation was slightly more than expected based on single-dose results.
Slovenian: Ta akumulacija je bila nekoliko višje od pričakovanega na podlagi rezultatov enkratnega odmerka.
English: Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki pri otrocih, starih od 5 do 16 let, so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: 18-Month survival
Slovenian: 18-mesečno preživetje
English: In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zaradi odsotnosti študij inkompatibilnosti tega zdravila ne smete mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: If you are not sure, show the bottle or pack to your doctor.
Slovenian: Če niste prepričani, zdravniku pokažite stekleničko ali embalažo.
English: Development of second primary malignancies
Slovenian: Razvoj drugega primarnega malignoma
English: Monitor patients for the development of second primary malignancies.
Slovenian: Spremljajte bolnike glede razvoja drugega primarnega malignoma.
English: 2-Year overall survival (OS)
Slovenian: 2-letno celokupno preživetje (OS)
English: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
Slovenian: Konsolidacijsko zdravljenje se mora začeti 3-4 tedne po koncu indukcijskega zdravljenja.
English: Confidence interval (CI)
Slovenian: Interval zaupanja (IZ)
English: Months
Slovenian: Mesecev
English: 2-Year cumulative incidence of relapse (CIR)
Slovenian: 2-letna kumulativna pojavnost relapsa (CIR)
English: Vd is also weight dependent, increasing with increasing body weight.
Slovenian: Vd je odvisen tudi od telesne mase in z naraščanjem telesne mase narašča.
English: • cisapride (a medicine used to relieve certain stomach problems).
Slovenian: cisaprid (zdravilo, ki se uporablja za lajšanje nekaterih želodčnih težav).
English: Post-marketing experience suggests that a similar syndrome may occur in patients with other types of malignancy.
Slovenian: Izkušnje po začetku trženja navajajo, da do podobnega sindroma lahko pride pri pacientih z drugimi vrstami malignosti.
English: 95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX
Slovenian: 95-% IZ za razliko, 2-22 odstotnih točk p < 0,001 za neinferiornost p = 0,02 za superiornost ATRA+TRISENOX
English: Do not save any unused portions for later administration.
Slovenian: Ne shranjujte neporabljenega zdravila za poznejšo uporabo.
English: The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Slovenian: Dnevni odmerek lahko zvečate na 100 % prvotnega odmerka, če ne pride do podaljšanja.
English: Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Slovenian: Osebje mora biti poučeno o rokovanju z arzenovim trioksidom in njegovim redčenjem, ter pri tem nositi ustrezna zaščitna oblačila.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden boste dobili to zdravilo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: No data are available for children under 5 years.
Slovenian: Podatki o uporabi pri otrocih, mlajših od 5 let, niso na voljo.
English: The diluted solution must be clear and colourless.
Slovenian: Razredčena raztopina mora biti bistra in brezbarvna.
English: Some cases recovered with vitamin B1 supplementation.
Slovenian: Pri nekaterih primerih je ob dodajanju vitamina B1prišlo do okrevanja.
English: A central venous catheter is not required.
Slovenian: Centralni venski kateter ni potreben.
English: Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Slovenian: Bolniki morajo biti ob začetku zdravljenja zaradi bolezenskih simptomov in zagotovitve ustreznega nadzora sprejeti v bolnišnico.
English: CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)
Slovenian: POZOR, NOVA KONCENTRACIJA (2 mg/ml)
English: Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding.
Slovenian: Volumen porazdelitve (Vd) za AsIII je velik (> 400 l), kar kaže na značilno porazdelitev v tkivu z zanemarljivo vezavo na beljakovine.
English: If clinically justified/required, concomitant diuretic therapy is also recommended.
Slovenian: Če je klinično upravičeno/potrebno, je priporočeno tudi sočasno diuretično zdravljenje.
English: These include:
Slovenian: Ta zdravila vključujejo:
English: Procedure for proper disposal
Slovenian: Postopek za ustrezno odlaganje
English: Responses were seen across all age groups tested, ranging from 6 to 75 years.
Slovenian: Odzive so opazili pri vseh starostnih skupinah, od 6 do 75 let.
English: However all cases were successfully managed with hydroxyurea therapy.
Slovenian: Toda vsi primeri so bili uspešno nadzorovani z zdravljenjem s hidroksisečnino.
English: ECG and electrolyte monitoring recommendations
Slovenian: Priporočila za nadzor EKG in elektrolitov
English: Haematologic complete remission (HCR)
Slovenian: Popolna hematološka remisija (HCR)
English: ATRA + Chemotherapy (n = 79)
Slovenian: ATRA + kemoterapija (n = 79)
English: - you have any liver problems.
Slovenian: imate okvarjeno delovanje ledvic, imate kakršne koli težave z jetri.
English: Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leucocytosis, and no standard approach has proven effective.
Slovenian: Zdravila za zmanjševanje števila belih krvnih celic pogosto poslabšajo toksične učinke, povezane z levkocitozo, in nobena izmed standardnih metod se ni pokazala kot učinkovita.
English: TRISENOX is normally given by a doctor or a nurse.
Slovenian: Zdravilo TRISENOX vam bo običajno dal zdravnik ali medicinska sestra.
English: Hepatotoxicity (grade 3 or greater)
Slovenian: Hepatotoksičnost (stopnje 3 ali več)
English: The extent of accumulation of these metabolites is dependent on the dosing regimen.
Slovenian: Obseg nalaganja teh presnovkov je odvisen od režima odmerjanja.
English: Grades ≥ 3
Slovenian: Stopnje ≥ 3
English: If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na arzenov trioksid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: P-value
Slovenian: P-vrednost
English: This medicine must not be used if you notice foreign particulate matter or if the solution is discoloured.
Slovenian: Ne uporabljate tega zdravila, če opazite tuje delce ali če je raztopina obarvana.
English: One was a single investigator clinical study (n=12) and the other was a multicentre, 9-institution study (n=40).
Slovenian: Ena je bila klinična študija z enim raziskovalcem (n = 12), druga pa multicentrična študija, ki je potekala v 9 zavodih (n = 40).
English: Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Slovenian: Bolniki so na splošno prenašali konsolidacijsko in vzdrževalno zdravljenje z manj toksičnih učinkov kot pri indukcijskem zdravljenju.
English: 500 mg four times a day
Slovenian: 500 mg štirikrat na dan
English: Haematological and gastrointestinal toxicity
Slovenian: Hematološka in gastrointestinalna toksičnost
English: The decline from peak plasma concentration of AsIII occurs in a biphasic manner and is characterized by an initial rapid distribution phase followed by a slower terminal elimination phase.
Slovenian: Upad največjih koncentracij AsIII v plazmi se pojavi na bifazni način, zanj pa je značilna začetna hitra porazdelitvena faza, ki jih sledi počasnejša končna faza izločanja.
English: 1000 mg four times a day
Slovenian: 1.000 mg štirikrat na dan
English: Pharmacokinetic data from patients with hepatocellular carcinoma having mild to moderate hepatic impairment indicate that AsIII or AsV do not accumulate following twice-weekly infusions.
Slovenian: Farmakokinetični podatki bolnikov s hepatoceličnim karcinomom z blago do zmerno okvaro delovanja jeter kažejo, da se AsIII ali AsV ne nalagata po infundiranju dvakrat na teden.
English: You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Slovenian: ga morate obvestiti o vseh novih ali izjemnih simptomih ali okoliščinah.
English: Peripheral neuropathy, characterised by paraesthesia/dysaesthisia, is a common and well known effect of environmental arsenic.
Slovenian: Periferna nevropatija, za katero je značilna parestezija/disestezija, je pogost in dobro znan učinek arzena v okolju.
English: The key efficacy results are summarised in table 3 below:
Slovenian: Ključni rezultati učinkovitosti so povzeti v preglednici 3 spodaj Preglednica 3
English: Approximate accumulation ranged from 1.4- to 8-fold following multiple as compared to single dose administration.
Slovenian: Približen razpon nalaganja je bil od 1,4- do 8-krat po dajanju večkratnega odmerka v primerjavi z enkratnim odmerkom.
English: The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Slovenian: Pentavalentni presnovki, MMAV in DMAV, se v plazmi pokažejo počasi (približno 10-24 ur po prvem dajanju arzenovega trioksida), vendar se zaradi daljšega razpolovnega časa bolj nalagajo po več odmerkih kot AsIII.
English: Approximately 15 % of the administered TRISENOX dose is excreted in the urine as unchanged AsIII.
Slovenian: Približno 15 % apliciranega odmerka zdravila TRISENOX se izloči v seču kot nespremenjen AsIII.
English: Table 4
Slovenian: Tabela 4
English: If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
Slovenian: Če čutite neugodje ali če se ne počutite dobro po injekciji zdravila TRISENOX morate pred vožnjo ali upravljanjem strojev počakati, da simptomi izginejo.
English: Kaplan-Meier estimates of 18-month survival for each study are shown below.
Slovenian: Ocena 18-mesečnega preživetja po metodi KaplanMeier za obe študiji je prikazana spodaj.
English: WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation.
Slovenian: Število WBC med konsolidacijo ni bilo tako visoko, kot med indukcijskim zdravljenjem in je bilo < 10 x 103/μl, razen pri enem bolniku, pri katerem je bilo med konsolidacijskim zdravljenjem število WBC 22 x 103/μl .
English: Patients at risk of B1 deficiency should be closely monitored for signs and symptoms of encephalopathy after arsenic trioxide initiation.
Slovenian: Bolnike, pri katerih obstaja tveganje za pomanjkanje vitamina B1, je treba natančno opazovati glede znakov in simptomov encefalopatije po začetku dajanja arzenovega trioksida.
English: APL = acute promyelocytic leukaemia; ATRA = all-trans-retinoic acid
Slovenian: APL = akutna promielocitna levkemija; ATRA = vse-trans-retinojska kislina
English: Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Slovenian: Popolna remisija (CR - »complete remission«) je bila opredeljena kot odsotnost vidnih levkemičnih celic v kostnem mozgu ter periferna obnovitev krvnih ploščic in belih krvnih celic.
English: Substances that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Slovenian: Za učinkovine, ki so substrati encimov P450, se ne pričakuje, da bodo medsebojno delovale z zdravilom TRISENOX.
English: Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Slovenian: Elektrokardiogram morate opraviti dvakrat tedensko, pri klinično nestabilnih bolnikih med indukcijskim in konsolidacijskim zdravljenjem pa tudi pogosteje.
English: No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Slovenian: Jasne težnje po zvečanju sistemske izpostavljenosti AsIII, AsV, MMAV ali DMAV ni bilo opaziti z zmanjšanjem ravni delovanja jeter pri oceni AUC z normaliziranim odmerkom (na mg odmerka).
English: For ECG, electrolytes abnormalities and hepatotoxicity see section 4.4.
Slovenian: Za anomalije EKG in elektrolitov ter hepatotoksičnost glejte poglavje 4.4.
English: QT interval prolongation
Slovenian: Podaljšanje intervala Q-T
English: ATRA + TRISENOX (n = 77)
Slovenian: TRISENOX (n = 77)