natgillin/translations-raw huggingface dataset:
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.
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with arsenic trioxide must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Ob prvih znakih, ki bi kazali na ta sindrom (nepojasnjena zvišana telesna temperatura, dispneja in/ali pridobivanje telesne mase, nenormalni avskultatorni izvidi ali radiografske anomalije prsnega koša), morate zdravljenje z arzenovim trioksidom začasno prekiniti in takoj začeti dajati visoke odmerke steroidov (deksametazon 10 mg intravensko dvakrat na dan) in z njimi nadaljevati vsaj 3 dni ali dlje, dokler bolezenski znaki ne izginejo, ne glede na število levkocitov.
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 arsenic trioxide.
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 arzenovega trioksida.
Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Bolniki z na novo diagnosticirano akutno promielocitno levkemijo Zdravnik vam bo vsak dan dajal zdravilo Arzenov trioksid Accord v obliki infuzije.
Baseline white blood cell (WBC) counts did not correlate with development of leukocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
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.
In newly diagnosed APL patients treated with arsenic trioxide and ATRA, APL differentiation syndrome was observed in 19 % including 5 severe cases.
Pri na novo diagnosticiranih bolnikih z APL, zdravljenih z arzenovim trioksidom in ATRA, so sindrom diferenciacije APL opazili pri 19 %, vključno s 5 resnimi primeri.
Arsenic trioxide Accord may cause harm to the foetus when used by pregnant women.
Zdravilo Arzenov trioksid Accord lahko škoduje plodu, če ga jemljejo nosečnice.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2- 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja 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 nadzorovanih in preverjeno aseptičnih pogojih.
Twenty relapsed/refractory APL patients (50 %) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
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.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi 2 °C - 8 °C, razen če se je redčenje opravilo v nadzorovanih in preverjeno aseptičnih pogojih.
Contents of the pack and other information What Arsenic trioxide Accord contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Arzenov trioksid Accord
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur pri temperaturi 25 °C in 48 ur pri temperaturah 2 °C - 8 °C.
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.
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.
Arsenic trioxide dose, mg/kg/day (median, range) Complete remission
odmerek arzenovega trioksida, mg/kg/dan (mediana, obseg) popolna remisija čas do remisije kostnega mozga (mediana)
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 3 months.
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.
Cytotoxic: handle with caution.
Citotoksično: ravnajte previdno
Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Zdravilo Arzenov trioksid Accord vam morajo dati pod nadzorom zdravnika, izkušenega v zdravljenju akutnih levkemij.
Must be diluted before use.
Pred uporabo je treba zdravilo razredčiti.
One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
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.
The arsenic in Arsenic trioxide Accord passes into breast milk.
Arzen v zdravilu Arzenov trioksid Accord prehaja v materino mleko.
In newly diagnosed and relapsed/refractory APL patients who develop sustained leukocytosis after initiation of therapy, hydroxyurea should be administered.
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.
If your disease responds to Arsenic trioxide Accord, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
Če se bolezen odzove na zdravilo Arzenov trioksid Accord, boste opravili drugi cikel zdravljenja, v katerem boste prejeli 25 odmerkov, ki jih boste dobivali 5 dni v tednu (ki jim sledi 2dnevna prekinitev) v obdobju 5 tednov.
Because of the potential for serious adverse reactions in breastfeeding infants from arsenic trioxide, breast-feeding must be discontinued prior to and throughout administration.
Zaradi morebitnih resnih neželenih učinkov arzenovega trioksida pri dojenčkih morate z dojenjem prenehati pred uporabo in med njo.
If your disease responds to Arsenic trioxide Accord, you will be given 4 additional treatment cycles of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption.
Če se bolezen odzove na zdravilo Arzenov trioksid Accord, boste opravili 4 dodatne cikle zdravljenja z 20 odmerki, ki jih boste dobivali 5 dni v tednu (ki jim sledi 2-dnevna prekinitev) v obdobju 4 tednov, temu pa bo sledila 4-tedenska prekinitev.
After dilution in intravenous solutions, Arsenic trioxide Accord is chemically and physically stable for 24 hours at 25°C and 48 hours at refrigerated (2-8°C) temperatures.
Po redčenju v intravenskih raztopinah je zdravilo Arzenov trioksid Accord kemijsko in fizikalno stabilno 24 ur pri temperaturi 25 °C in 48 ur pri nižjih temperaturah (2-8 °C).
Arsenic trioxide Accord contains arsenic trioxide which is an anticancer medicine.
Zdravilo Arzenov trioksid Accord vsebuje arzenov trioksid, ki je zdravilo za zdravljenje raka.
No data are available on patient with variant translocations like t(11;17) (PLZF/RAR alpha).
O bolnikih s translokacijami različic, kot je t(11;17) (PLZF/RAR alfa), ni na voljo podatkov.
Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical trials.
V kliničnih preskušanjih je do povezanih neželenih učinkov CTC stopnje 3 in 4 prišlo pri 37 % bolnikov z APL v relapsu ali refraktarni fazi.
Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
Trem bolnikom iz enocentrične študije in 15 bolnikom iz multicentrične študije so po koncu zdravljenja z arzenovim trioksidom transplantirali zarodne celice.
For patients with severe, acute arsenic overdose, dialysis should be considered.
Pri pacientih s hudim akutnim prevelikim odmerkom arzena utegne biti potrebna dializa.
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 arsenic trioxide in combination with ATRA compared to patients treated with ATRA + chemotherapy.
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 arzenovim trioksidom v kombinaciji z ATRA, kot pri bolnikih, zdravljenih z ATRA in kemoterapijo.
The majority of patients do not require permanent termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome.
Pri večini bolnikov med zdravljenjem sindroma diferenciacije APL ni potrebna trajna prekinitev zdravljenja z arzenovim trioksidom.
Arsenic trioxide Accord is expected to have no or negligible influence on your ability to drive and use machines.
Zdravilo Arzenov trioksid Accord naj ne bi imelo nobenega vpliva ali pa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Arsenic trioxide Accord 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.
Zdravilo Arzenov trioksid Accord 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.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Patients who experience such reactions that are considered arsenic trioxide related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption.
Pri bolnikih, pri katerih se pojavijo taki učinki, za katere menite, da so povezani z arzenovim trioksidom, lahko nadaljujete zdravljenje šele po odpravi toksičnosti ali po vrnitvi anomalije, zaradi katere ste prekinili zdravljenje, na izhodiščno vrednost.
Arsenic trioxide Accord must be administered intravenously over 1-2 hours.
Zdravilo Arzenov trioksid Accord morate dajati intravensko 1-2 uri.
You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Kadar koli obiščete zdravnika, ga morate obvestiti o vseh novih ali izjemnih simptomih ali okoliščinah.
Arsenic trioxide 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.
Arzenov trioksid so raziskovali pri 52 bolnikih z APL, predhodno zdravljenih z antraciklinom in retinoidno terapijo, v dveh odprtih, enokračnih neprimerjalnih študijah.
Arsenic trioxide must be administered intravenously over 1-2 hours.
Arzenov trioksid morate dajati intravensko 1-2 uri.
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 hypokalemia or hypomagnesaemia.
Nevarnost aritmije torsade de pointes je povezana s stopnjo podaljšanja intervala Q-T, sočasno uporabo zdravil za podaljšanje intervala Q-T (kot so antiaritmiki razredov Ia in III (npr. kinidin, amiodaron, sotalol, dofetilid), antipsihotikov (npr. tioridazin), antidepresivov (npr. amitriptlin), nekaterih makrolidov (npr. eritromicin), nekaterih antihistaminov (npr. terfinadin in astemizol), nekaterih kinolonskih antibiotikov (npr. sparfloksacin) in drugih zdravil, za katera je znano, da podaljšajo interval Q-T (npr. cisaprid)), pojavljanjem aritmije torsade de pointes v preteklosti, že obstoječim podaljšanjem intervala Q-T, kongestivno srčno odpovedjo, uporabo diuretikov, ki ne varčujejo s kalijem, amfotericinom B ali drugimi stanji, ki lahko povzročijo hipokaliemijo ali hipomagneziemijo.